Ex Parte HarmanliDownload PDFPatent Trials and Appeals BoardJun 28, 201913633247 - (D) (P.T.A.B. Jun. 28, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/633,247 10/02/2012 113961 7590 07/01/2019 Bulkley, Richardson and Gelinas, LLP 1500 Main Street, Suite 2700 Springfield, MA 01115-5507 FIRST NAMED INVENTOR Oz Harmanli 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 09023P-DIV-002 2245 EXAMINER NGUYEN,CAMTUTRAN ART UNIT PAPER NUMBER 3786 MAIL DATE DELIVERY MODE 07/01/2019 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 Ex parte OZ HARMANLI Appeal 2018-008715 Application 13/633,247 Technology Center 3700 Before CHARLES N. GREENHUT, BRETT C. MARTIN, and WILLIAM A. CAPP, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant seeks our review under 35 U.S.C. § 134(a) of the final rejection of claims 1-11, 13, 14, and 16. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. Appeal 2018-008715 Application 13/633,247 THE INVENTION Appellant's invention is a vaginal pessary. Spec. ,i 2. Claim 1, reproduced below, with paragraph indentation added, is illustrative of the subject matter on appeal. 1. A vaginal pessary, which comprises: a cylindrical body which terminates in blunt, rounded or shaped distal and proximal ends, which is yieldably extensible into an uncoiled elongate configuration for placement in an insertion/withdrawal device and self-retracting into a helically or spirally coiled configuration having a non-cylindrical overall shape upon leaving the insertion/withdrawal device; and means for withdrawal of the pessary from a vaginal cavity attached to the proximal end of the cylindrical body, wherein the vaginal pessary is adapted for use within the vaginal cavity and manages pelvic organ prolapse. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Warmoth Mohajer Biswas Yeung Ulmsten Zunker'025 Zunker '485 Kusleika Sokal Ellingwood us 328,553 us 4,821,741 us 5,036,867 WO 01/26588 A2 US 6,645,137 B2 US 6,770,025 B2 US 6,808,485 B2 US 7,166,120 B2 US 2008/0051740 Al US 8,556,930 B2 2 Oct. 20, 1885 Apr. 18, 1989 Aug. 6, 1991 June 7, 2000 Nov. 11, 2003 Aug. 3, 2004 Oct. 26, 2004 Jan.23,2007 Feb.28,2008 Oct. 15, 2013 Appeal 2018-008715 Application 13/633,247 The following rejections are before us for review: 1 1. Claims 1, 2, 6, and 7 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, and Mohajar. 2. Claim 3 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, and Ulmsten. 3. Claim 4 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, Biswas, and Zunker '025. 4. Claim 5 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, and Yeung. 5. Claim 8 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, and Sokal. 6. Claims 9 and 16 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, and Kusleika. 7. Claims 10, 11, 13, and 14 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Warmoth, Zunker '485, Ellingwood, Mohajar, and Biswas. Claim 1 OPINION Unpatentability of Claims 1, 2, 6, and 7 over Warmoth, Zunker '485, Ellingwood, and Mohajar The Examiner finds that the combination of Warmoth, Zunker '485, Ellingwood, and Mohajar disclose all of the elements of claim 1 and 1 A rejection under 35 U.S.C. § 112, second paragraph, has been withdrawn by the Examiner. Ans. 3 7. 3 Appeal 2018-008715 Application 13/633,247 concludes that it would have been obvious to achieve the claimed invention by combining the teachings of the four references. Non-Final Action 5-7. In particular, the Examiner finds that Warmoth' s pessary is yieldably extensible into an uncoiled elongate configuration as claimed. Id. at 5. Appellant argues that Warmoth' s pessary is not yieldably extensible as claimed. Appeal Br. 10. Appellant asserts that Warmoth would reach its elastic limit before becoming uncoiled in which case it would undergo plastic deformation and never return to its original shape. Id. In response, the Examiner states that the claim does not recite any degree or amount of uncoiling. Ans. 38. With that in mind, the Examiner finds that Warmoth is yieldably extensible into an uncoiled elongate configuration. Id. Appellant's claims have not recite to what degree of elongation or uncoiled configuration being exerted on the claimed cylindrical body. Warmoth's spring-metal wire is yieldable extensible to an uncoiled elongate configuration and self- retracts to a point prior to the elastic limit or yield point. Id. The Examiner's response requires us to construe the terms "uncoiled" and "elongate," which terms are used in conjunction with each other. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under the broadest reasonable interpretation standard, claim terms are given their ordinary and customary meaning as would be understood by one of ordinary skill in the art in the context of the entire disclosure. In re Trans logic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). However, even under the broadest reasonable interpretation, the Board's construction "cannot be divorced from the specification and the record evidence." In re NTP, 4 Appeal 2018-008715 Application 13/633,247 Inc., 654 F.3d 1279, 1288 (Fed. Cir.2011). A construction that is "unreasonably broad" and which does not "reasonably reflect the plain language and disclosure" will not pass muster. Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015).2 In construing claims, we cannot look at the ordinary meaning of a term in a vacuum. E.I. Du Pont De Nemours & Co. v. Unifrax I LLC, 921 F.3d 1060, 1068 (Fed. Cir. 2019). It is the use of words in the context of the written description and as customarily used by those of skill in the relevant art that accurately reflects both the 'ordinary' and 'customary' meaning of the terms in the claims." Ferguson Beauregard/Logic Controls, Div. of Dover Res., Inc. v. Mega Sys., LLC, 350 F.3d 1327, 1338 (Fed. Cir. 2003). Thus, construing the terms of a claim without considering the context in which those terms appear is not reasonable. Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1062 (Fed. Cir. 2016). In the instant case, the context of the claim, as read in light of the Specification, informs us that the pessary is "uncoiled" into an "elongate" configuration and that it uncoils to fit into an insertion/withdrawal device. Claims App. claim 1 Spec. 47, Fig. 15. In this regard, the pessary is forcibly elongated to a preferred diameter of not more than about 2.5 cm. Claims App., claim 1, Spec. 47, Fig. 15. Following deployment, it exhibits a diameter on the order ofup to about 9.0 cm. Spec. 36. Moreover, the insertion/withdrawal device is not just for insertion. The context of claim 1, supported by the Specification, indicates that the pessary is both inserted and removed using the insertion/withdrawal device. Id. Claims App., claim 1, 2 Overruled on other grounds by Aqua Products, Inc. v. Mata!, 872 F.3d 1290 (Fed. Cir. 2017). 5 Appeal 2018-008715 Application 13/633,247 Spec. ,i,i 58-59. Not only that, but the device, once deployed, must be capable of returning to an elongated uncoiled state for removal. Claims App. claim 1. Thus, while the claim does not expressly recite a precise amount of uncoiling and elongation, there is sufficient context from which a person of ordinary skill in the art may discern that the claimed device is designed and intended to transition in diameter from a stowed condition of about 2.5 cm to a deployed condition that may be as large as about 9.0 cm and then, be capable of returning to its pre-deployment size and condition for removal. Spec. ,i,i 36-37, See, e.g., MPEP § 2 l 73.05(b )(I)( explaining that it is appropriate to consult the Specification to ascertain a standard for measuring the degree implied by a claim term) Furthermore, with respect to removal, a person of ordinary skill in the art would understand that the force required to return the device to its pre- deployment size and condition must be such that removal can be readily performed by the patient wearing the device. The present invention ... provides a compactable vaginal pessary that easily expands once inside a patient's vagina, that can be removed, cleaned and reinserted daily, or as needed, by the patient. Spec. ,i 10; see also ,i,i 11, 14, 18, 29. Warmoth discloses a deployed condition diameter of about 2.5 inches (or about 6.25 cm). Warmoth is silent on the issue of whether, and to what extent, its spring-wire coil may be elongated in length and compressed in width to permit being placed within an insertion/withdrawal device. Warmoth is equally silent as to the amount of force required to return its device to an uncoiled state for removal through and with an insertion/withdrawal device. In that regard, we note that neither the 6 Appeal 2018-008715 Application 13/633,247 Examiner nor Appellant provide evidence or persuasive technical reasoning regarding the extent to which Warmoth is capable of being stretched in length and narrowed in width. We decline to speculate as to any precise limit that may be required by uncoiling and deployment of Appellant's invention. Under the circumstances, the uncertainty in regard to the evidence, or lack thereof, will need to resolved against the party who bears the burden of proof on this issue. The PTO bears the initial burden of showing a prima facie case of obviousness. In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014). When a prima facie case of obviousness is made, the burden then shifts to the applicant to come forward with evidence and/or argument supporting patentability. Id. However, where the Examiner fails to set forth a prima facie case of obviousness, the burden to rebut the Examiner's findings and conclusion never shifts to Appellant. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We are mindful that, in a proper case, the Examiner may shift the burden to Appellant by demonstrating a "sound basis" for believing that the product of the prior art and Appellant's invention are the same. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (explaining that when the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not); see also In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (explaining that where the claimed and prior art products are identical or substantially identical, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his 7 Appeal 2018-008715 Application 13/633,247 claimed product). However, we decline to invoke Spada or Best under the facts and circumstances of this case. Warmoth discloses a pessary from the late 19th Century. Warmoth (issued 1885). It is comprised of spring-metal wire. Warmoth 1, 1. 42. The wire is coiled a number to times from its lower end. Id. at 1, 11. 57-59. The coils are about two and one-half inches ( 6.25 cm) in diameter. Id. at 1, 11. 59-65. To insert the device, it is disposed sideways to the orifice of the vagina, compressed, and inserted in its compressed condition. Id. at 1, 11. 68-71. After being inserted, it is turned or arranged to a desired orientation and then the compression is relieved. Id. at 1, 11. 70-87. There is no evidence in the record to support a finding that Warmoth is capable of being uncoiled and elongated in the manner claimed by Appellant, whether for insertion or removal. In particular, there is no evidence that Warmoth, modified as proposed, could be removed in accordance with claim 1. Moreover, the Examiner fails to demonstrate a sound basis for believing that Warmoth is capable of satisfying the yieldably extensible limitation of claim 1 for either insertion or removal. Inasmuch as the Examiner failed to make out a prima facie case of unpatentability, we need not further address Appellant's arguments and evidence. We do not sustain the rejection of claim 1. Claims 2, 6, and 7 Claims 2, 6, and 7 are all independent claims. Claims App. As with claim 1, they all contain a limitation directed to a pessary that is yieldably extensible into an uncoiled elongate configuration for placement in an insertion/withdrawal device. Id. The Examiner's rejection of these claims suffers from the same infirmities that we have discussed above with respect 8 Appeal 2018-008715 Application 13/633,247 to claim 1. Consequently, we do not sustain the rejection of claims 2, 6, and 7. Unpatentability of Claims 3-5, 8-11, 13, 14, and 16 over Combinations based on Warmoth, Zunker '485, Ellingwood, and Mohajar These claims are rejected over Warmoth, Zunker '485, Ellingwood, and Mohajar in combination with various other references. Claims 3-5, 8, 9, 11, 13, and 14 are independent claims. Claims App. Claim 10 depends from claim 9. Id. With respect to each independent claim, there is a limitation directed to the pessary being "yieldably extensible into an uncoiled elongate configuration for placement in an insertion/withdrawal device" in a manner substantially similar, if not identical, to the limitation discussed above in connection with the rejection of claim 1. Claims App. As with claim 1, the Examiner, once again, makes unsupported assertions of fact that Warmoth's device is yieldably extensible as claimed. Non-Final Action 13-30. We have reviewed the additional cited art and the Examiner's findings and we determine that these additional references do not cure the deficiencies we have noted above with respect to the rejection of claim 1. Thus, for the same reasons, we do not sustain the rejection of claims 3-5, 8-11, 13, 14, and 16. DECISION The decision of the Examiner to reject claims 1-11, 13, 14, and 16. REVERSED 9 Copy with citationCopy as parenthetical citation