14622662 - (D) (P.T.A.B. Apr. 10, 2020)

CPAP COMFORT COVER, LLC

Patent Trials and Appeals BoardApr 10, 2020

14622662 - (D) (P.T.A.B. Apr. 10, 2020)

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. 14/622,662 02/13/2015 John Norman Paulk PA9.001.US 1493 23893 7590 04/10/2020 Timothy E Siegel Patent Law, PLLC Mari Yamamoto 777 108th Avenue, Suite 2240 Bellevue, WA 98004-5178 EXAMINER STUART, COLIN W ART UNIT PAPER NUMBER 3785 NOTIFICATION DATE DELIVERY MODE 04/10/2020 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Michele@intproplaw.com tim@intproplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN NORMAN PAULK Appeal 2018-007485 Application 14/622,662 Technology Center 3700 ____________ Before JEREMY M. PLENZLER, FREDERICK C. LANEY, and ARTHUR M. PESLAK, Administrative Patent Judges. LANEY, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision (entered Nov. 22, 2017, “Final Act.”) to reject claims 1–7 and 13–20 (all the claims on appeal). Claims 8–12 have been cancelled. Appellant’s counsel appeared for an oral hearing on March 12, 2020. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “CPAP COMFORT COVER, LLC.” Appeal Br. 1. Appeal 2018-007485 Application 14/622,662 2 CLAIMED SUBJECT MATTER The disclosed subject matter relates to “creating a CPAP mask assembly that facilitates comfort during CPAP treatment, makes use of a CPAP mask, including a rigid portion adapted to connect to an air-delivery hose and to provide structure and a pliable, soft, face-contacting portion, supported by the rigid portion.” Spec. 2. Claims 1, 13, and 19 are independent. Claim 1 is illustrative of the claims on appeal and is reproduced below with emphasis to highlight the elements central to this appeal (hereinafter, collectively referred to as the “outer elastic limitations”). 1. A method of creating a CPAP mask assembly that facilitates comfort during CPAP treatment while said CPAP mask assembly is being worn on a patient's face, comprising: a) providing a CPAP mask, including: i) a rigid portion adapted to connect to an air- delivery hose and to provide structure; and ii) a pliable, soft, face-contacting portion, supported by said rigid portion; b) providing a mask cover, having: i) an annular piece of bio-compatible, absorbent material, having an outer edge and an inner edge that defines a plain opening, in said mask cover; and ii) an elastic loop attached about said outer edge, thereby causing said outer edge to retract inwardly; c) stretching said elastic loop and placing said mask cover over said CPAP mask so that said material covers said face- contacting portion, such that said material will be interposed between said face-contacting portion and said patient’s face, during CPAP treatment, and said plain opening is positioned in said interior space defined by said face-contacting portion; and d) releasing said elastic loop, permitting it to retract inwardly so that part of said rigid portion is interposed between said elastic loop and said inner edge, thereby retaining said mask cover about said rigid portion of said CPAP mask, without deforming said pliable, soft face-contacting portion. Appeal 2018-007485 Application 14/622,662 3 EVIDENCE Name Reference Date Clowers US 6,698,427 B1 Mar. 2, 2004 Allan US 2011/0146685 A1 June 23, 2011 Groll US 2011/0253144 A1 Oct. 20, 2011 Davidson US 2012/0204881 A1 Aug. 16, 2012 Kramer US 2014/0251334 A1 Sept. 11, 2014 Pad A Cheek www.web.archive.org//www.padacheek. com May 31, 2010 REJECTIONS Claims 1–7 and 13–18 is rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention. Claims 1, 5–7, 13, and 17–20 are rejected under 35 U.S.C. § 103(a) as obvious over Pad A Cheek, Davidson, and Clowers. Claims 2 and 14 are rejected under 35 U.S.C. § 103(a) as obvious over Pad A Cheek, Davidson, Clowers, and Allan. Claims 3 and 15 are rejected under 35 U.S.C. § 103(a) as obvious over Pad A Cheek, Davidson, Clowers, and Groll. Claims 4 and 16 are rejected under 35 U.S.C. § 103(a) as obvious over Pad A Cheek, Davidson, Clowers, and Kramer. Appeal 2018-007485 Application 14/622,662 4 ANALYSIS The indefiniteness rejection The Examiner rejects claims 1–7 and 13–18 as indefinite because independent claims 1 and 13 recite “said interior space” without providing a sufficient antecedent basis. Final Act. 3. Appellant does not present any arguments contesting this rejection. See Appeal Br. 5–11. Thus, Appellant has waived any argument of error, and we summarily sustain the indefiniteness rejection claims 1–7 and 13–18. See In re Berger, 279 F.3d 975, 984–85 (Fed. Cir. 2002) (holding that the Board did not err in sustaining a rejection under 35 U.S.C. § 112, when the applicant failed to contest the rejection on appeal). The obviousness rejections Appellant only seeks to have us review the Examiner’s obviousness determination of the independent claims, which it contends traverses the rejections of all of the claims. Appeal Br. 5, 11. Appellant argues these claims collectively. See id. at 5–11. We select independent claim 1 for review, with the remaining claims (i.e., claims 2–7 and 13–18) standing or falling together with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv). Appellant has waived, however, all other arguments of error that it could have raised regarding the other rejections. See In re Berger, 279 F.3d at 984–85. The Examiner finds that, at the time of the invention, the combination of Davidson, Pad A Cheek, and Clowers discloses the recited elements of claim 1 and that a skilled artisan would have known to combine them in the manner claimed. Final Act. 4–6. Appellant does not dispute that the prior art discloses the recited elements, but instead contends that the Examiner has not established properly that, to a skilled artisan at the time of the invention, Appeal 2018-007485 Application 14/622,662 5 it would have been obvious to modify the Pad A Cheek/Davidson combination of elements to incorporate an annular shape and elastic loop that Clowers discloses. See Appeal Br. 5–10. In particular, Appellant contends that the Examiner failed to establish that a skilled artisan would have considered replacing the annular shape and elastic loop of Clowers to be a simple substitution with predicable results. Id. at 5–7. Moreover, Appellant contends evidence of overcoming a long felt need and commercial success shows further the nonobviousness of the claimed invention. Id. at 7–9. Recognizing that Pad A Cheek does not disclose a mask cover “being annual[ar] shaped having an outer edge with an elastic loop attached about the outer edge to cause the outer edge to retract inwardly,” the Examiner finds Clowers teaches that it was known to use such a configuration with a mask cover. Final Act. 5 (citing Clowers, 2:47–49, Figs. 1, 2); see also Clowers, 2:49–52, 3:1–11. The Examiner determines, It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the Pad A Cheek system’s mask cover to be annular shaped and including the outer edge having an elastic loop thereat, as taught by Clowers, as this would have been simple substitution of one well-known element for another to produce predictable results (replacing of the Velcro strap elements of Pad A Cheek with an outer edge having an elastic loop which provides for predictable securement of the mask cover to the mask body). Id. The Examiner explains further that The shape of the inner edge (i.e. opening which confronts the user during use) of The Pad A Cheek Mask Liner is already shaped/configured such that it does not need an attachment element such as an elastic loop or Velcro straps located thereon. The Pad A Cheek Mask Liner only requires a securement mechanism, such as Velcro straps, provided to the exterior Appeal 2018-007485 Application 14/622,662 6 surface of the mask frame and one would have recognized that Velcro straps and an outer elastic loop as taught by Clowers are functional equivalents and would expect the modified Pad A Cheek Mask Liner device to perform equally, and predictably, as well with an outer elastic loop for a securement mechanism. Id. at 15. Still further, the Examiner explains, [o]ne of ordinary skill in the art would recognize that replacing the Velcro strap connection mechanism of Pad A Cheek with the elastic loop of Clowers, and thus including modification of the Pad A Cheek liner shape to be substantially annular, would still provide for all the stated benefits and fundamental aspects of Pad A Cheek, namely the increase in comfort/reduction in soreness caused by the silicone seal, prevention of leaks, absorption of moisture/oils which provide skin breathability, and washable/reusable feature as the mask liner would still provide the smooth micro fabric material between the patient's face and the mask seal. Ans. 15. First, Appellant contends that modifying the mask cover of Pad A Cheek with the annular shape and elastic loop of Clowers is not a simple substitution. Appeal Br. 6–7. Appellant supports this argument by asserting “the straps define the shape of the Pad A Cheek Liner, and that this shape–– in combination with their choice of materials––is precisely the innovation that Pad A Cheek touts to customers.” Id. at 6. Appellant also asserts, “in addition to requiring a change in the shape of the Pad a Cheek Mask Liner–– a change in the principle of operation––the proposed combination would also fundamentally change the securement method of Clowers, which utilizes two elastic loops working in cooperation.” Id. “Because Clowers carefully explains the need for having two elastic loops,” Appellant states, “the securement achievable with a one loop system would not be a predictable result.” Id. at 7. Appeal 2018-007485 Application 14/622,662 7 Second, Appellant contends that the Examiner has not properly valued the evidence presented of long felt but unresolved needs and commercial success. Appeal Br. 7–9. Appellant’s evidence of a long felt but unresolved need consists of a declaration by Dr. Steven J. Scheer. Id. at 7–8 (citing App’x A, ¶ 8). Dr. Scheer attests “to the long felt need in the industry for an apparatus and method of addressing the problems of CPAP therapy (including contact dermatitis and whistling leaks) that is easy to use for the broad spectrum of CPAP patients.” Id. Dr. Scheer, according to Appellant, provides evidence that the Velcro straps of a Pad A Cheek liner creates difficulties with attaching the liner to a mask when a “patient may be very sleepy” or “working in the dark to avoid awakening an already-sleeping partner” because the straps require “manual dexterity and attentiveness.” Id. at 8. Appellant argues that the long felt need “is further supported by the commercial success of the initial Applicant, John Norman Paulk.” Id. Appellant points to the representation by declarant Paulk that his product has reached sales of $20,000 a month in two years and he has spent only about $500 on advertisement during that time. Id. (citing App’x B, 2). Appellant argues that the above declarations establish the claimed invention is nonobvious and that the Examiner failed to give them appropriate weight. Id. at 8–9. Appellant notably does not dispute the Examiner’s finding that the combined teachings of Davidson, Pad A Cheek, and Clowers disclose the recited elements of claim 1. We find the evidence cited by the Examiner supports these findings. Appellant only disputes whether the Examiner has shown properly that a skilled artisan would have modified the Pad A Cheek Appeal 2018-007485 Application 14/622,662 8 CPAP mask cover with the outer elastic annular ring that Clowers discloses for attaching a mask cover to the outer surface of a medical mask. “[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). We “must ask whether the improvement is more than the predictable use of prior art elements according to their established function.” Id. The Examiner finds that the improvement is “the substitution of one known securement mechanism for another known securement mechanism, i.e. using elastic loop instead of Velcro straps,” that yield the predicable result of “secur[ing], yet removable attachment of the mask liner to the mask.” Final Act. 18. The evidence firmly supports this finding. Appellant takes issue with the fact that Clowers discloses an elastic annular ring at both the inner and outer diameters of the mask cover (Appeal Br. 7; Reply Br. 3, 4), but “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . .” In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). “A reference must be considered for everything that it teaches, not simply the described invention or a preferred embodiment.” In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012). While Clowers discloses two elastic rings, a skilled artisan would recognize that these rings function independently to secure different portions of the cover to different portions of the mask. Clowers, 3:1–28, Fig. 1. Appellant offers no evidence or technical reason why these elastic rings are both necessary to perform their respective functions. A skilled artisan would recognize that the inner Appeal 2018-007485 Application 14/622,662 9 elastic ring operates separately from the outer elastic ring to secure the inner portion of the cover to the inner portion of the mask, which allows aperture 50 to conform to the opening in the mask that receives a patient. Id. We do not find an error with the Examiner’s finding that the outer elastic ring of Clowers’ mask cover functions as a connection mechanism for securing the outer portion of the cover to the outer portion of the mask. We agree with the Examiner that the Pad A Cheek liner only requires a single connection mechanism located on the front/outer side of the CPAP mask and one of ordinary skill in the art would have recognized that the well-known Velcro strap type connection mechanism could be replaced with other well-known types of connection mechanisms such as . . . an elastic loop such as the elastic loop on the front/outer side of the mask of Clowers. Ans. 19 (citing Clowers Fig. 1). Appellant contends that substituting the Velcro connection mechanism used by Pad A Cheek with the elastic ring connection mechanism used by Clowers would change Pad A Cheek’s principle of operation. Appellant argues that Pad A Cheek’s Velcro straps, and the shape associated with the straps, are “perhaps the most fundamental aspect of this simple apparatus.” Appeal Br. 6. Appellant, however, has identified a component of operation rather than the principle of operation. We find In re Mouttet, 686 F.3d 1322, 1331–32 (Fed. Cir. 2012), to be instructive on this point because the modification involved changing the circuitry from one based on electrical conductivity to one based on optical paths. There was no dispute this would significantly change the operation of the apparatus, but the Federal Circuit held that it did not change the principle of operation. In re Mouttet, 686 F.3d at 1332. Instead, the principle of operation was defined Appeal 2018-007485 Application 14/622,662 10 more broadly to describe the purpose and objectives for the operation of the apparatus and, while the modification would change how the apparatus operated, it did not change the purpose and objectives of the operations. Id. The same is true here. We agree with the Examiner that the principle of operation in this case is to provide a material between a patient’s face and the seal of a CPAP mask, which will provide for a smooth comfortable surface for the face to contact, prevents contact sores, reusable, and prevents leaks. Ans. 13–14; see also, Appeal Br. 17–8 (App’x A, ¶¶ 3–6). The Velcro straps and associated shape of the Pad A Cheek apparatus are merely the apparatus components used to secure the material to a mask. Changing this component with the elastic ring securing mechanism that Clowers teaches would not change the principle of operation because it would likewise function to provide a material between a patient’s face and the seal of a CPAP mask. Regarding the evidence of secondary considerations, it does not outweigh the evidence showing the claimed subject matter is simply an arrangement of old elements with each performing as expected and yielding nothing more than expected in combination. See Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008) (“[A]s we have often held, evidence of secondary considerations does not always overcome a strong prima facie showing of obviousness.”). While declarants Dr. Scheer and Paulk provide some evidence that the invention improves the Pad A Cheek mask cover, it does little to show the improvement is not a predictable use of prior art elements according to their established function. We note initially that Dr. Scheer confirms that the Pad A Cheek mask cover is an acceptable solution to the long felt need for a mask liner that Appeal 2018-007485 Application 14/622,662 11 would stay in position through a sleeping period, prevent air leaks, prevent contact dermatitis, and enhance a user’s comfort. Appeal Br. 18 (App’x, ¶ 7). Dr. Scheer contends the Pad A Cheek may cause some challenges in certain situations (e.g., its dark and/or the user is half-asleep), however, because some manual dexterity and attentiveness is required to attach the cover to the mask. Id. We agree with the Examiner that this is not a strong showing of a long felt, but unresolved, need. Ans. 22. Even accepting the manual dexterity and attentiveness required by Velco attachment mechanism has drawbacks, there is nothing to establish that there were widespread efforts by skilled artisans to solve those drawbacks and failed to find a solution to the problem. In re Allen, 324 F.2d 993, 997 (C.C.P.A. 1963) (“While appellant’s arguments imply that there may have been an unsolved problem in the art, an allegation to this effect is not evidence of unobviousness unless it is shown, as was not done here, that the widespread efforts of skilled workers having knowledge of the prior art had failed to find a solution to the problem.”); see Texas Instruments v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1178 (Fed. Cir. 1993) (“[L]ong-felt need is analyzed as of the date of an articulated identified problem and evidence of efforts to solve that problem.”) (emphasis added). Additionally, Clowers teaches that the elastic ring it discloses enables the cover to be added to and removed from a mask by “highly untrained personnel, such as family members,” which suggest to a skilled artisan that the elastic rings allow the cover to be attached without much dexterity or attentiveness. Clowers, 3:44–47. Similarly, we agree with the Examiner that the evidence of commercial success is weak. Ans. 22–23. Merely specifying sales figures Appeal 2018-007485 Application 14/622,662 12 alone is not sufficient to establish commercial success. Other evidence such as market share, growth in market share, replacement of earlier products sold by others, etc. need to be present. See In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (without evidence that the sales are a substantial quantity in the relevant market, “bare sales numbers” are a “weak showing” of commercial success, if any). Appellant merely provides a sales number without any context to support a finding of success or to support a finding that the invention is the cause of the sales. For example, we do not know even know the price being charged for each CPAP Comfort Cover and whether that price is significantly lower than what was being charged for a comparable product. Thus, even accepting the invention has had some success, that success does not translate to strong evidence of nonobviousness because there is no evidence showing the magnitude of the success or linking the driver of that success to the improvement that the invention provides. After weighing all of the evidence and arguments, we find the Examiner has made a stronger case of obviousness that outweighs Appellant’s weak evidence of secondary considerations to the contrary. Therefore, we sustain the Examiner’s obviousness rejections of claims 1–7 and 13–18. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7, 13– 18 112(b) Indefiniteness 1–7, 13– 18 1, 5–7, 13, 17–20 103(a) Pad A Cheek, Davidson, Clowers 1, 5–7, 13, 17–20 Appeal 2018-007485 Application 14/622,662 13 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2, 14 103(a) Pad A Cheek, Davidson, Clowers, Allen 2, 14 3, 15 103(a) Pad A Cheek, Davidson, Clowers, Groll 3, 15 4, 16 103(a) Pad A Cheek, Davidson, Clowers, Kramer 4, 16 Overall Outcome2 1–7, 13– 18 No period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED 2 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim on any of the grounds specified constitutes a general affirmance of the decision of the examiner on that claim.”