Ex Parte 8070957 et alDownload PDFPatent Trial and Appeal BoardDec 21, 201595001986 (P.T.A.B. Dec. 21, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/001,986 05/10/2012 8070957 12100.1005 REX 8699 25099 7590 12/22/2015 DAVID M. QUINLAN, P.C. P.O. Box 8088 22 Monterey Drive PRINCETON, NJ 08543 EXAMINER XU, LING X ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 12/22/2015 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ BIOTAGE AB Requester v. Patent of SCIENTIFIC PLASTIC PRODUCTS, INC. Patent Owner and Appellant ____________ Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and RAE LYNN P. GUEST, Administrative Patent Judges. ROBERTSON, Administrative Patent Judge. DECISION ON APPEAL Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 2 Patent Owner Scientific Plastic Products, Inc. (“Patent Ownerâ€) appeals under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA) the Examiner’s final decision to reject claims 1–4.1 Third-Party Requester Biotage AB (hereinafter “Requesterâ€) urges that the Examiner’s decision must be affirmed.2 We have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA). We affirm the Examiner’s decision to reject claims 1–4. However, because our reasoning differs from that of the Examiner’s, we designate our affirmance of the rejection of claims 3 and 4 as a new ground of rejection under 37 C.F.R. § 41.77(b). STATEMENT OF THE CASE United States Patent 8,070,957 B2 (hereinafter the “’957 Patentâ€), which is the subject of the current inter partes reexamination, issued to Samuel A. Ellis and Jeffrey L. Harlan on December 6, 2011 from Application 12/152,166. The ’957 Patent claims to be a continuation of United States Patent 7,410,571 B2 (hereinafter the “’571 Patentâ€), which issued August 12, 2008 from Application 11/476,292. Application 11/476,292 claims to be a divisional of United States Patent 7,138,061, (hereinafter the “’061 Patentâ€), which issued on November 21, 2006 from Application 10/842,288, filed May 10, 2004. 1 See Patent Owner’s Appeal Brief 1 (filed February 4, 2014) (hereinafter “App. Br.â€); Examiner’s Answer (mailed March 21, 2014) (hereinafter “Ans.â€); Right of Appeal Notice (mailed September 13, 2013) (hereinafter “RAN.â€). 2 See Requester’s Respondent Brief (filed March 4, 2014) (hereinafter “Resp’t Br.â€). Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 3 The ’571 Patent was the subject of reexamination control 95/000,496 (Appeal No. 2012-012468). The ’061 Patent was the subject of reexamination control 95/000,497 (Appeal No. 2012-007322). United States Patent 7,381,327 (hereinafter the “’327 Patentâ€) is also related and was the subject of reexamination control 95/000,495 (Appeal No. 2012-007321). Decisions were rendered by the Board in each of the appeals on November 30, 2012 affirming the Examiners’ rejection of the claims. The Court of Appeals for the Federal Circuit affirmed the Board’s decisions. Scientific Plastic Products, Inc. v. Biotage AB, 766 F.3d 1355 (Fed. Cir. 2014), cert denied. We are also informed that the ’327 Patent, the ’061 Patent, and the ’571 Patent are the subject of litigation styled Scientific Plastics Products, Inc. v. Biotage AB et al., Case No. 3:09-cv-00677 (S.D. Cal.), which has been stayed. (App. Br. 1.) United States Patent 8,066,875 B2 (hereinafter “the ’875 Patentâ€) is also related and is currently the subject of reexamination control 95/001,985 (Appeal No. 2015-004633), a decision on which will be mailed concurrently herewith. We are also informed that the ’875 Patent and the ’957 Patent are the subject of litigation styled Scientific Plastics Products, Inc. v. Biotage AB et al., Case No. 11-cv-2778 (S.D. Cal.), which has been stayed. (PO App. Br. 1.) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 4 We heard oral arguments from Patent Owner and Requester on April 15, 2015, a transcript of which was entered into the record on May 15, 2015.3 The ’957 Patent relates to low pressure liquid chromatography. (Col. 1, ll. 15–17.) Claims 1 and 3, which are illustrative of the appealed subject matter, read as follows: 1. A method for low pressure liquid chromatographic analysis of a material using a liquid chromatographic cartridge kit assembled by a user of the kit, said kit including a hollow cylindrical polymer container and a polymer cap with a fluid inlet for attachment to one end of said container by the user to form a chromatographic cartridge, wherein said container includes a fluid outlet at another end thereof and has a chromatographic packing material placed therein before said kit is obtained by the user, said packing material having a surface spaced from said one end of said container to form a predetermined volume between said surface and said cap sufficient to hold a sample for chromatographic analysis when said cap is attached to said container, and said container further includes a threaded portion on an external surface thereof proximate to said one end and said cap comprises a depending skirt having a threaded portion on an internal surface thereof for engaging said threaded portion on said container, the method comprising: placing the sample in said volume; thereafter screwing said cap onto said container into a final position by engaging said respective threaded portions to provide a seal between said container and said cap capable of withstanding pressures up to about 100 psi, said seal being formed between (a) an inner surface of said container proximate to said upstream end thereof, said container including an 3 Pursuant to 37 C.F.R. § 41.73(e)(1), the arguments considered in rendering this decision are those which were relied upon in the briefs. Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 5 inclined lip portion surrounding said inner surface of said upstream end, and (b) a cap flange disposed for accepting said container between said skirt and said flange with said inclined container lip portion contacting said cap flange to urge said flange inwardly toward said longitudinal axis as said cap is screwed onto said container and into said final position; attaching a low pressure liquid chromatographic apparatus to said inlet for introducing chromatographic process fluid into said inlet under a pressure up to about 100 psi; and introducing said chromatographic process fluid from said outlet to said low pressure liquid chromatographic apparatus for analysis. 3. A method for low pressure liquid chromatographic analysis as in claim 1, wherein said cap includes a single said cap flange that depends from the interior of said cap and contacts said container when said cap is in said final position, said flange extending beyond the most upstream end of said threaded portion on said skirt, and wherein said inclined lip portion presents a flat surface extending to the upstream end of said container. (App. Br. 30, Claims App’x.) Patent Owner contests the Examiner’s final decision to reject the claims as follows: I. Claims 1-4 under 35 U.S.C. § 103(a) as obvious over Yamada et al. (U.S. Patent No. 5,693,223, issued December 2, 1997) (“Yamadaâ€), King (WO 02/42171 A1, published May 30, 2002) and Hargro et al. (U.S. Patent No. 6,139,733, issued October 31, 2000) (“Hargroâ€); Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 6 II. Claims 1-4 under 35 U.S.C. § 103(a) as obvious over Yamada, King, and Argonaut (International Sorbent Technology, Catalogue of Sample Preparation Products and Services (2001)); III. Claims 3 and 4 under 35 U.S.C. § 103(a) as obvious over Yamada, King, Hargro or Argonaut, Aichinger (U.S. Patent No. 4,033,472, issued July 5, 1977) or Victor et al. (U.S. Patent No. 4,057,160, issued November 8, 1977) (“Victorâ€); IV. Claims 3 and 4 under 35 U.S.C. § 103(a) as obvious over Yamada, King, Hargro or Argonaut, and any of Husar et al. (U.S. Patent No. 5,916,525, issued June 29, 1999) (“Husarâ€), Omi et al. (JP H10-35699, published February 10, 1998, English Translation of record) (“Omiâ€), or Odajima et al. (JP 2001-114310A, published April 24, 2001, English Translation of record) (“Odajimaâ€); V. Claim 4 under 35 U.S.C. § 103(a) as obvious over Yamada, King, Hargro or Argonaut, and Hawkins (U.S. Patent No. 4,844,273, issued July 4, 1989); and VI. Claim 4 under 35 U.S.C. § 103(a) as obvious over Yamada, King, Hargro or Argonaut, any of Aichinger, Victor, Husar, Omi, or Odajima, and further in view of Hawkins. Patent Owner additionally relies on the following as evidence: Declaration of Barry C. Holwerda executed October 16, 2012 (App. Br., Ex. MM, Ex. A.) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 7 Declaration of Suhas Kulkarni executed October 16, 2012 (App. Br., Ex. MM, Ex. B) Declaration of Samuel A. Ellis executed October 16, 2012 (App. Br., Ex. MM, Ex. C) Second Declaration of Barry C. Holwerda executed June 28, 2013 (App. Br., Ex. OO, Ex. G) Second Declaration of Suhas Kulkarni executed June 28, 2013 (App. Br., Ex. OO, Ex. H) Second Declaration of Samuel A. Ellis executed June 28, 2013 (App. Br., Ex. OO, Ex. I) Declaration of Daniel C. Hill executed June 26, 2013 (App. Br., Ex. OO, Ex. J) Requester additionally relies on the following as evidence: Declaration of Bob Towill executed May 2, 2012 (See App. Br., Ex. LL) First Declaration of Juha Esala executed April 3, 2012 (See App. Br., Ex. LL) Second Declaration of Juha Esala executed November 13, 2012 (See App. Br., Ex. NN) Third Declaration of Juha Esala executed July 30, 2013 (See App. Br., Ex. PP) First Declaration of William H. Pearson executed March 29, 2012 (See App. Br., Ex. LL) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 8 Second Declaration of William H. Pearson executed November 15, 2012 (See App. Br., Ex. NN) Third Declaration of William H. Pearson executed July 31, 2013 (See App. Br., Ex. PP) ISSUES Patent Owner has limited the issues on appeal to the rejections of independent claim 1 and dependent claim 3 (App. Br. 4), which are included in Rejections I-IV. Rejections IV-VI are directed only to claims 3 and 4. Accordingly, we confine our discussion to claims 1 and 3, with claims 2 and 4 standing or falling with claims 1 and 3, respectively. (See App. Br. 4, n. 1.) Patent Owner contends that the Examiner is relying solely on the prior art apparatus in rejecting the claims and thus erred by not giving weight to the method limitations in the appealed claims. (App. Br. 4-5.) Patent Owner argues that the relevant inquiry is whether it would have been obvious to have modified Yamada’s apparatus and method to perform the method recited in the claims. (Id. at 7.) Specifically, Patent Owner argues that Yamada is directed solely to the analysis of physiologically active materials, and as a result, one of ordinary skill in the art would not incorporate a method step of placing a sample in a volume above the chromatographic packing material before screwing on the head portion. (Id. at 6, 8-9.) Patent Owner argues further that contrary to the Examiner’s finding, Yamada does not disclosed pre-packed chromatographic columns. (Id. at 7-8.) Patent Owner contends that any empty volume in Yamada would have been insufficient to receive a sample. (Id. at 8.) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 9 Regarding claim 3, Patent Owner argues that the prior art does not disclose the structure of the seal recited in the claim. (App. Br. 20.) In particular, Patent Owner contends that the Examiner erred in construing claim 3 to allow for more than one cap flange depending from the interior of the cap. (Id. at 20-21.) Patent Owner argues that King, Omi, and Odajima disclose multiple cap flanges, and thus do not disclose a single cap flange as recited in claim 3. (Id. at 22-23.) Patent Owner argues that Aichinger does not disclose that the portion of the container relied on by the Examiner to disclose an inclined lip portion having a flat surface does not contact the cap flange as required in claim 3. (Id. at 23–24.) Patent Owner contends that Victor does not disclose a threaded cap, such that even if combined with Yamada, the combination would not meet the recited method step of screwing the cap onto the container recited in claim 1, from which claim 3 depends. (Id. at 24.) Patent Owner also argues that Husar discloses a chamfer that contacts a sealing lip and not an inclined surface that extends to the upstream end of the container as required by claims 1 and 3. (Id. at 25-26.) Patent Owner argues that there is objective evidence of nonobviousness including industry praise and commercial success, which is unopposed by evidence, and must be given proper weight. (App.Br. 26–28.) Patent Owner contends also that King and other references to bottle caps are not analogous art and that the Examiner did not identify sufficient reason to modify Yamada’s seal structure with the seal structure disclosed in King. (App. Br. 9–20.) We previously addressed similar arguments by Patent Owner regarding non-analogous art and modification of Yamada Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 10 based on King in the previous decisions on appeals (see, e.g., Decision on Appeal mailed November 20, 2012, in Appeal No. 2012-007322, Reexam Control No. 95/000,497, pages 11–16), which as indicated above, was affirmed by the Federal Circuit. Scientific Plastic Products, 766 F.3d at 1359–1361. For the same reasons to those discussed in detail in our previous decisions, we are not persuaded by Patent Owner’s arguments. We need not repeat that our analysis here. Accordingly, the dispositive issues for this appeal are: 1. Did the Examiner err in concluding that the method recited in claim 1 would have been obvious to one of ordinary skill in the art in view of the evidence of record? 2. Did the Examiner err in concluding that the cap flange structure recited in claim 3 would have been obvious in view of the prior art of record? FINDINGS OF FACT (“FFâ€) 1. Yamada discloses a plastic column and column device for low pressure-high speed liquid chromatography “to be used for separating and purifying materials, particularly physiologically active materials . . . .†(Col. 1, ll. 10-15, col. 2, ll. 15-20.) 2. Yamada discloses that a “variety of materials may be separated and purified by using the column for the low pressure-high speed liquid chromatography according to the present invention.†(Col. 7, ll. 36-38.) 3. Yamada discloses: The maximum flow rate of the gear pump assembled into the chromatography system used was 50 Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 11 ml/min., and the separating and purifying operation was effected at the treating flow rate of 80 column volume/hr. In that case, a column having a column volume up to 37.5 ml can be fitted to the system. An amount of the granular filler can be selectively determined, based on the adsorbing volume of the granular filler and the amount (treating amount) of the intended material contained in the liquid to be treated. (Col. 13, ll. 16-24.) 4. Figure 2 of King is reproduced below: Figure 2 depicts a cross section view of the lip region of a container with the closure at the sealing position including inwardly tapered surface 7 of the container neck adjacent to the Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 12 lip and cylindrical sealing plug 8 including continuous sealing ribs 9. (Page 7, ll. 30-32, page 8, ll. 21-30.) 5. King discloses a threaded cap having a cylindrical sealing plug 8 that projects downwardly from the base of the closure cap and is tapered. (Page 8, ll. 21-25, Figs. 2, 3.) 6. Figure 9 of Husar is reproduced below: Figure 9 depicts a diagrammatic partial cross-section of a closure 11, having a sealing lip 20 (the unlabeled flange of the cap/closure 11) and a lip sealing surface 21, and vessel 1 having a wall with a vessel sealing surface 23, wherein lip sealing surface 21 contacts vessel sealing surface 23. (Col. 4, ll. 44-62; col. 5, ll. 46-62; col. 6, ll. 6-36.) 7. Regarding the length of the sealing lip, Husar discloses only that the “length of the sealing lip is selected so that its lip sealing surface is urged against the vessel sealing surface due to an overpressure within the vessel as caused by the vapor Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 13 pressure of the fluid probe within the vessel.†(Col. 3, ll. 27-33.) 8. The ’957 Patent discloses that the threads of the container mate with the internal threads of the skirt in a variety of configurations. (Col. 4, ll. 23–30.) 9. The ’957 Patent discloses that “the threads represent one specific form of inclined mating surfaces, and other means for fastening the cap to the container include the broader use of inclined mating surfaces.†(Col. 8, ll. 39-43.) PRINCIPLES OF LAW As stated by the Supreme Court in KSR, “any need or problem known in the field of endeavor at the time of [the] invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.†KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). KSR instructs that “familiar items may have obvious uses beyond their primary purposes.†Id. at 420–421. It is not necessary that the prior art suggest the combination for the same reason as contemplated by Appellants. In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006). ANALYSIS All of the rejections on appeal rely on the base combination of Yamada and King. The Examiner found that Yamada discloses a similar method as recited in claims 1 and 2, but Yamada does not disclose applying Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 14 the sample to the column before sealing the column with the cap as required by the claims. (RAN 7, 9.) Claim 1 Yamada-Physiologically Active Materials Much of Patent Owner’s contentions on appeal rely on the premise that Yamada’s disclosure is limited to physiologically active materials, such that the one of ordinary skill in the art would not have modified the structure of Yamada’s column to allow for a space of a sufficient volume to hold a sample for chromatographic analysis. According to Patent Owner, the presence of such a space would compromise a physiologically active sample due to “unpredictable mixing.†(App. Br. 6, 8-9.) We are not persuaded by Patent Owner’s contentions. Initially, we observe that Yamada disclosed that the materials for separation are “particularly†physiologically active materials, but more generally describes separating a “variety of materialsâ€. (FF 1, 2.) Thus, on its face, Yamada contemplates that the column apparatus would be used to separate other materials. In addition, even accepting Patent Owner’s position that Yamada is directed exclusively to physiologically active materials, Patent Owner has not provided sufficient evidence that all physiologically materials either would need to remain hydrated or would be compromised by a mixing space. (App. Br. 8-9; First Holwerda Decl. ¶¶ 19, 20 and 22; Second Holwerda Decl. ¶ 27.) In this regard, Dr. Pearson, who holds a Ph.D. in organic chemistry and has extensive experience with molecules of biological interest and in the field of liquid chromatography, declared that “physiologically active materials†is a very broad term, which may Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 15 encompass small-molecule drugs, “which are often rather normal organic compounds.†(First Pearson Decl. ¶¶ 1-3; Second Pearson Decl. ¶ 10.) While Patent Owner’s declarant Dr. Holwerda implies that Dr. Pearson’s characterization of small-molecule drugs as physiologically active materials is inappropriate, Dr. Holwerda fails to explain why Dr. Pearson’s understanding of the term is too broad and fails to offer a definition of “physiologically active material†that would exclude the organic compounds identified by Dr. Pearson. (First Holwerda Decl. ¶ 19; Second Holwerda Decl. ¶ 22.) Accordingly Patent Owner’s position that one of ordinary skill in the art would have understood Yamada’s disclosure to be limited to the particular types of physiologically active material is not supported by a preponderance of the evidence. Space for introducing a sample Regarding the structure of the cartridge as claimed, the Examiner found that, inter alia, Yamada discloses a predetermined volume between the surface of the packing material and the head portion. (RAN 7.) The Examiner explained that in Figures 1, 2, and 4 of Yamada, the granular filler or packing material does not fully occupy the column chamber such that there is sufficient volume between the head portion and the granular fillers to hold a sample. (Id. at 28.) The Examiner stated further that Yamada discloses that the amount of granular filler can be determined based on the adsorbing volume of the granular filler and the amount of material in the liquid sample to be treated. (FF 3; RAN 28.) To support this statement, the Examiner pointed to an example in Yamada, where there was a 2 milliliter volume space between the head portion and the surface of the granular filler, Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 16 which the Examiner found was sufficient to hold a sample for chromatographic analysis. (RAN 28-29.) Requester agrees with the Examiner, arguing that Yamada’s described empty space is evidence that it would have been obvious to one of ordinary skill in the art to selectively dictate the amount of free space left in the column for adding a sample. (Resp’t Br. 7, citing Second Pearson Decl. ¶ 9 and Yamada, col. 13, ll. 15-34.) Requester contends also that it was common in the LPLC (low pressure liquid chromatography) field for columns to be supplied pre-packed by the manufacturer as evidenced by Argonaut and declaration evidence of record. (Id., citing Argonaut ¶ 87; Second Holwerda Decl. ¶¶ 20, 31; Pearson Decl. ¶ 6-7.) Initially, we disagree with the Examiner and Requester that Figures 1 and 2 of Yamada show a space within a column sufficient to add a sample. Figure 2 of Yamada is reproduced below. Figure 2 depicts a sectional view of an embodiment according to the patent in an assembled state. (Col. 4, ll. 31-37.) Yamada discloses that a head portion 2 is inserted into cylindrical column body 1 to define a column chamber 7. (Col. 8, ll. 1–9.) Yamada discloses that a pair of filters 8, 8’ are Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 17 fitted at opposite ends of the column chamber 7, and granular filler 9 is charged between the pairs of filters. (Col. 8, ll. 9–12.) Yamada is silent as to how much filler is “charged†into the column chamber 7 as depicted in Figure 2. As a result, we do not interpret Figure 2 as showing actual amounts of filler in the column chamber, but rather Figure 2 provides an illustration that filler is present in it. In addition, when the column is in the assembled state as depicted in Figure 2, no space is shown between the end of the head portion 2 and filter 8, nor does the disclosure describe the presence of any space. Thus, even if there is space remaining in the filler area, it would not be accessible to be filled with sample in the assembled state. The Examiner relies also on Yamada’s disclosure of an example having a 2 milliliter empty space for support. (RAN 28-29 (citing Yamada, col. 13, ll. 15-34).) However, as pointed out by Patent Owner, the particular example relied on in Yamada was conducted using a column device in accordance with Figure 3, which is generally the same as the embodiments depicted in Figures 1 and 2. (Reb. Br. 5; Yamada, col. 9, ll. 21-32.) As explained by Patent Owner: while there may be a space under the filter 8, there is none into which a sample can be placed prior to affixing the head portion, as required by claim 1. Yamada explicitly states that Test No.1 was performed using the column device shown in Figure 3, which Yamada says is the same as the Figures 1 and 2 embodiment except for stepped portions on the column body and head portion that mesh to prevent leakage. Yamada, col. 9, lines 22-32. As Dr. Holwerda pointed out, the Figure 3 embodiment also has no space for a sample. Second Holwerda Declaration, at para. 25, citing Yamada, col. 2, lines 55-58. Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 18 (Reb. Br. 5.) Accordingly, we cannot agree with the Examiner that Yamada describes sufficient space in the columns disclosed in Figures 1 and 2 to allow for the addition of a sample, as recited in claim 1. Figure 4 of Yamada is reproduced below. Figure 4 of Yamada depicts a sectional view of an alternative embodiment in an assembled state. (Col. 4, ll. 41-44.) Yamada discloses an “axially inwardly conical shape 22,†which results in a space in order to “facilitate removal of bubbles.†(Col. 9, ll. 42-46.) Requester contends that the space depicted in Figure 4 would be suitable for preloading small samples in need of separation. (Resp’t Br. 6-7; Second Pearson Decl. ¶ 9.) Patent Owner argues that the space depicted in Figure 4 is not sufficient to hold a sample. (App. Br. 8, citing First Holwerda Decl. ¶ 19.) Further, Patent Owner’s expert, Dr. Holwerda clarified that the space in Figure 4 may have been theoretically capable of receiving small samples, but Yamada would not have suggested using the space in Figure 4 for holding a sample, because Yamada expressly stated the Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 19 purpose of the space was to facilitate removal of bubbles. (Second Holwerda Decl. ¶ 26.) We do not find Patent Owner’s argument to be persuasive. As the Supreme Court has stated, “familiar items may have obvious uses beyond their primary purposes.†KSR, at 420–421. Thus, the fact that Yamada refers to the purpose of the space as related to bubble removal is not fatal to an obviousness determination. Accordingly, we agree with the Examiner and Requester that Figure 4 of Yamada depicts a space sufficient to hold a sample for chromatographic analysis as recited in claim 1. However, the issue is still whether it would have been obvious to have placed a sample into this volume, which is discussed below. Method Steps The claim also requires a step of placing a sample in the volume prior to sealing the column with the cap. The Examiner found that Hargro discloses a liquid chromatographic method including pre-absorbing a sample onto a packing material in a column prior to sealing the column and then carrying out the chromatographic separation. (RAN 9, citing Hargro col. 1, ll. 29-40 “The pre-absorbed media is then placed at the head of a pre-packed glass, metal or plastic chromatography column . . . .â€) The Examiner concluded that it would have been obvious to use Hargro’s method of introducing the sample into the column before sealing the column as an alternative method of introducing sample in the column, because both Yamada and Hargro disclose LPLC methods and disclose Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 20 equivalent processes of introducing samples into columns for separation. (RAN 9-10.) The Examiner similarly found that Argonaut discloses a chromatographic column with additional volume for sample loading as well as the pre-absorption of liquid samples. (RAN 11, citing Argonaut, p. 87 “The ISOLUTE Flash-XL (4x 22 cm) incorporates additional volume above the top frit for dry loading of samples.â€) The Examiner concluded that it would have been obvious to have used Argonaut’s method of introducing a sample for similar reasons as with respect to Yamada and Hargro. (Id. at 12-13.) As discussed above, a preponderance of the evidence supports the Examiner’s position that Yamada’s teachings are not limited to physiological materials that require hydration or that would be compromised by a mixing space. Therefore, we agree also with the Examiner’s position that it would have been obvious to have applied the method of pre-absorbing samples disclosed in Hargro or Argonaut using the column apparatus disclosed in Yamada as a predictable substitution of equivalent sample loading process steps in low pressure liquid chromatographic analysis. Pre-packing Patent Owner contends that there is no disclosure in Yamada indicating that the columns disclosed therein are pre-packed. (App. Br. 7, citing RAN 26-27.) Thus, according to Patent Owner, Yamada does not disclose the limitation in claim 1 of a chromatographic cartridge that “has a chromatographic packing material placed therein before said kit is obtained by the user.†We agree with Patent Owner that Yamada alone does not Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 21 sufficiently describe this limitation. The passage in Yamada relied on by the Examiner as teaching a pre-packed column, is a description in Yamada of Figure 11 with reference to a low pressure-high speed liquid chromatography system manufactured by Millipore, Inc. under the name Consep LC100. (RAN 26-27, citing Yamada, col. 10, ll. 19–26.) However, Yamada does not describe explicitly that such a system includes a pre- packed column, and the Examiner points to no additional evidence for support of this position. In addition, we agree with Patent Owner that Dr. Pearson’s view that the limitation in claim 1 would read on a column that is received by one lab technician and packed prior to being used by another worker is unreasonable. (App. Br. 7; Third Pearson Decl. ¶ 7.) Claim 1 clearly recites that the packing material is placed in the chromatographic cartridge before the kit is obtained by the user and the ’957 patent clearly distinguishes a user from the manufacturer. (’957 Patent, col. 7, ll. 30-35.) The notion that the user would be only the person actually running the column and would not include a person in the same lab preparing for the experiment is simply without merit. However, the Examiner also relies on Argonaut for teaching pre- packing LPLC columns before sale to the user. (RAN 27, citing Argonaut pages 83-84.) Patent Owner does not persuasively challenge the Examiner’s finding in this regard. Accordingly, a preponderance of the evidence supports the Examiner’s position that pre-packing the columns of Yamada would have been obvious to one of ordinary skill in the art in view of the prior art of record. Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 22 Claim 3 Regarding claim 3, the Examiner found that Yamada discloses a single flange structure that depends from the cap as well as an O-ring in an annular groove at the head portion to ensure liquid tightness. (RAN 10.) The Examiner found also that King discloses a single flange extending below the most upstream end of the threads of the cap skirt and an incline lip portion structure such that the sealing surface between the cap and the container is a flat surface extending to the upstream end of the container. (Id.) The Examiner concluded that it would have been obvious to have incorporated the sealing configuration of King with the threaded cap and column configuration of Yamada to achieve a resealing/sealing function between the LPLC cap and column. (Id.) The Examiner also found that Aichinger, Victor, Husar, Omi, or Odajima disclose the seal structure recited in claim 3, and that it would have been obvious to have incorporated the seal structure disclosed in any of the cited prior art into the LPLC device of Yamada. (Id. at 16-17, 19-20.) Patent Owner contends that the Examiner incorrectly interpreted the recited “said cap includes a single said cap flange†to allow for the presence of other cap flanges. (App. Br. 20-22.) Thus, Patent Owner contends that King, Omi, and Odajima are distinguished from the seal structure of claim 3 because they have multiple cap flanges. (Id. at 22-23.) Patent Owner acknowledges that Aichinger, Victor, and Husar disclose a single cap flange, but argues that each of these references is distinguished for other reasons. (Id. at 22, 23-26.) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 23 ANALYSIS After reviewing the evidence of record, we conclude that the seal structure recited in claim 3 would have been obvious to one of ordinary skill in the art in view of King and Husar, and that it would have been obvious to have incorporated such a seal structure based on the combined teachings of Yamada in view of Hargro or Argonaut. We acknowledge that with respect to Husar, the argument centers around Figures 11-13. (App. Br. 25-26; Resp’t Br. 18; RAN 19-20, 45-46.) Figure 11 of Husar is reproduced below. Figure 11 depicts a longitudinal cross section of an alternative vessel 33 and closure 26 assembly, having sealing lip 30. (Col. 4, ll. 66-67; col. 6, ll. 47-51.) We agree with Patent Owner that Figures 11-13 fail to disclose all the requirements of the recited seal structure, because claim 3, as a result of depending from claim 1, also requires that the seal is formed between a single cap flange and a container lip portion “proximate to said upstream portion thereof.†Husar expressly discloses that, as shown in Figure 11, contact is made between the cap flange and the container at chamfer 38, and Figure 11 Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 24 shows a gap between the cap flange 30 and the container lip portion 34 proximate to the upstream end of container lip portion 34. (Husar, Fig. 11, Col. 6, ll. 36-65.) Similarly, Husar discloses a gap 40 (not labeled in Fig. 11) between the sealing lip 30 and the vessel wall 36 that extends to the vessel mouth as depicted in Figures 12 and 13. (Id. at Figures 12, 13, Col. 7, ll. 10-13.) Accordingly, Figures 11-13 fail to disclose that the seal is formed between a single cap flange and a container lip portion “proximate to said upstream portion thereof.†However, Husar discloses another embodiment of a sealing configuration as depicted in Figures 7-9. (See FF 6.) In this embodiment, the sealing surface 23 of vessel 1 is an inclined flat surface, and as shown in Figure 9, forms a seal with the sealing surface 21 of single sealing lip 20 proximate to the upstream end of the inner surface of the container. (FF 6.) In Husar, the single sealing lip 20 does not extend downstream beyond the most upstream end of the threaded portion of the cap skirt as required by claim 1. Regarding the length of the sealing lip, Husar discloses only that the length is selected so that the lip sealing surface is urged against the vessel sealing surface. (FF 7.) In view of the evidence of record, it would have been obvious to have provided a cap with a single flange extending downstream beyond the most upstream end of the threaded portion of the cap skirt, either by extending the length of the cap flange or by configuring the threads of the skirt to extend further toward the upstream end of the cap skirt in combining the teachings of Husar and King with Yamada and Hargro or Argonaut. That is, both King and Husar provide evidence that sealing arrangements having cap Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 25 flanges extending beyond the threaded portions of cap skirts were known in the art. (See FF 4, 5; Husar Figs. 11–13, Resp’t. Br. 17, 18.) In addition, the ’957 Patent discloses that the configurations of threads on the cap skirt and container may be varied, and also that other mechanisms besides threads may be used to lock the container and cap together. (FF 8, 9.) Thus, the ’957 Patent does not assign any particular criticality to the relationship between the extent of the threads on the cap skirt and the length of the cap flange. Accordingly, it would have been obvious to have incorporated the sealing arrangement of Figures 7-9 of Husar into the combination of Yamada in view of Hargro or Argonaut to provide a seal between a container lip portion with an inclined flat inner surface decreasing in thickness and extending to the upstream end of the lip portion and a single cap flange depending from the interior of a cap. The reason would have been that Husar discloses that such arrangements provide for effective sealing between containers and caps with threaded portions. It would also have been obvious to configure the sealing arrangement such that the single cap flange extends downstream beyond the most upstream end of the threaded portion. The reason would have been that Husar and King provide evidence that such arrangements are known design alternatives for caps and containers with fluid tight seals. KSR, 550 U.S. at 417 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.â€). Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 26 In view of the rejection set forth above, we are not persuaded by Patent Owner’s arguments that the claims would not have been obvious because King and other references of record disclose multiple cap flanges. (App. Br. 22-23.) The Examiner interpreted the word “includes†of the phrase “said cap includes a single said cap flange†as synonymous with the open language “comprising,†which does not exclude unrecited elements, including additional flanges. RAN 40. Even if we were to agree with Patent Owner that the Examiner’s interpretation renders the recitation of a specific number of cap flanges to be meaningless (see App. Br. 20-21), Husar demonstrates that caps having an effective sealing surface formed from a single flange “proximate to said upstream portion thereof†was well known in the art. Patent Owner’s arguments focus on the individual teachings of these references, rather than the prior art as a whole. “[T]he test for combining references is not what the individual references themselves suggest but rather what the combination of disclosures taken as a whole would suggest to one of ordinary skill in the art.†In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Secondary Considerations Patent Owner contends that the record includes evidence of industry praise of the claimed methods and commercial success of the cartridges used in the claimed methods, which is unopposed by any contrary evidence. (App. Br. 26-28.) The Examiner determined that the evidence of peer recognition and commercial success presented in the First Ellis Declaration does not show Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 27 that all of the features of the claims are present in the commercial products, including the sealing configuration and that LPLC analysis was performed according to the claimed methods. (RAN 47-48.) The Examiner also found that the e-mails referred to in the Second Ellis Declaration were insufficient to show that the SINGLE StEP® columns possess all the claimed features. (Id. at 48-49.) The Examiner further found that there is no evidence that the Thompson columns referred to in the Hill Declaration contain the sealing configuration recited in the claims. (Id. at 50.) Regarding the sales figures presented in the Second Ellis Declaration, the Examiner found that there is no evidence of a nexus between the sales figures and the claimed invention, or of any market share. (Id. at 50-51.) As a result, the Examiner determined that Patent Owner had not established a nexus between the merits of the claimed invention and the evidence of secondary considerations, and as such, the evidence provided by Patent Owner was insufficient to overcome the obviousness rejections presented. (Id. at 51-52.) Requester agrees with the Examiner that Patent Owner’s evidence is unsubstantiated and does not overcome the strong evidence weighing in favor of obviousness. (Resp’t Br. 19-22.) DISCUSSION The ultimate determination of whether a claimed invention would have been obvious or non-obvious is a legal conclusion, which is made based on considering and weighing all of the facts in evidence. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 28 A “nexus†must be established between the merits of the claimed invention and the evidence of secondary considerations in order for the evidence to be given substantial weight. See In re GPAC, Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). We have reviewed the evidence of record and we are not persuaded that the evidence of nonobviousness outweighs the evidence of obviousness present in the record. That is, the solicited e-mail feedback attached to the First Ellis Declaration, while being complimentary of the SINGLE StEP® columns, discusses sample loading accuracy and tighter packed silica as well as convenience. (First Ellis Decl. ¶ 4.) The First Ellis Declaration relates these features to the ability to remove and reseal the cap. Id. However, resealable caps were known in the art as discussed above. In addition, we have also reviewed the Hill article attached to the First Ellis Declaration and discussed in the Second Ellis Declaration, which also refers to the SINGLE StEP® column. (Second Ellis Decl. ¶ 8; First Ellis Decl., Ex. 3.) According to the Hill Declaration (the author of the Hill article), cartridges with removable caps and headspace for accepting a sample provided equivalent performance to permanently sealed cartridges. (Hill Decl. ¶¶ 2, 5.) While the Second Ellis Declaration stated that the SINGLE StEP® columns possess the seal structure recited in claim 1 (Second Ellis Decl. ¶ 6), the two e-mails discussed in the First and Second Ellis Declarations contain no further explanation that the particular seal arrangement recited in the claims contributed to the testimonials related to the SINGLE StEP® columns expressed in the e-mails. Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 29 Regarding commercial success, the Second Ellis Declaration provides sales figures for the SINGLE StEP® cartridge between 2005 and 2013. (Second Ellis Decl. ¶ 9.) While the sales in the reported period range from $93,000 to $881,000 dollars per year, we agree with the Examiner that the magnitude of sales by itself is insufficient to assess the overall success in the market of the SINGLE StEP® cartridge. Id. That is, no comparison is made with the number of units of other LPLC cartridges sold in the market over the same period. Thus, this evidence alone does not establish market share or whether the cartridges were indeed successful as compared to other competing cartridges sold at the same time. Thus, the evidence of industry praise and commercial success, while providing some evidence that customers using the SINGLE StEP® cartridge were happy with its results and that Patent Owner was able to sell a significant number of the cartridges, does not sufficiently outweigh the evidence of obviousness on the record discussed above. CONCLUSION To be clear, we affirm the Examiner’s rejection of claims 1 and 2 as detailed in Rejection I and II. We reverse the Examiner’s rejection of claims 3 and 4 as applied in Rejections I and II. We affirm the Examiner’s rejections of claims 3 and 4 as set forth in Rejections IV and VI based on the rejection of claim 3 over Yamada, King, Hargro or Argonaut, and Husar as discussed above. Because our reasoning differs from that of the Examiner’s we designate the affirmance of Rejections IV and VI as a new ground of rejection. In view of the discussion above, we find it unnecessary to discuss Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 30 the remaining references applied against claims 3 and 4 in Rejections IV and VI, and we do not reach Rejections III and V. DECISION The Examiner’s decision to reject claims 1–4 is affirmed. Pursuant to 37 C.F.R. § 41.77(a), the above-noted affirmance includes a new ground of rejection. Section 41.77(b) provides that “[a] new ground of rejection . . . shall not be considered final for judicial review.†That section also provides that Patent Owner, WITHIN ONE MONTH FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal proceeding as to the rejected claims: (1) Reopen prosecution. The owner may file a response requesting reopening of prosecution before the examiner. Such a response must be either an amendment of the claims so rejected or new evidence relating to the claims so rejected, or both. (2) Request rehearing. The owner may request that the proceeding be reheard under § 41.79 by the Board upon the same record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the appeal may file a request for rehearing of the decision within one month of the date of: . . . [t]he original decision of the Board under § 41.77(a).†A request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 31 Comments in opposition to the request and additional requests for rehearing must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) of this section, for requesting further rehearing under paragraph (c) of this section, and for submitting comments under paragraph (b) of this section may not be extended. An appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an inter partes reexamination proceeding “commenced†on or after November 2, 2002 may not be taken “until all parties’ rights to request rehearing have been exhausted, at which time the decision of the Board is final and appealable by any party to the appeal to the Board.†37 C.F.R. § 41.81. See also MPEP § 2682 (8th ed., Rev. 8, July 2010). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). Requests for extensions of time in this inter partes reexamination proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79. In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. AFFIRMED; 37 C.F.R. § 41.77(b) Appeal 2015-000196 Reexamination Control 95/001,986 Patent 8,070,957 B2 32 bar PATENT OWNER: DAVID M QUINLAN, PC 32 NASSAU STREET SUITE 300 PRINCETON, NJ 08542 THIRD-PARTY REQUESTER: FOLEY AND LARDNER, LLP 3000 K STREET NW SUITE 600 WASHINGTON, DC 20007 Copy with citationCopy as parenthetical citation