Ex Parte Maitland et al

Patent Trial and Appeal BoardOct 15, 2018

14307691 (P.T.A.B. Oct. 15, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/307,691 06/18/2014 Duncan J. Maitland 24981 7590 10/17/2018 Lawrence Livermore National Security, LLC LA WREN CE LIVERMORE NATIONAL LABORATORY PO BOX 808, L-703 LIVERMORE, CA 94551-0808 UNITED ST A TES OF AMERICA 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. IL-12509B 2547 EXAMINER VU, JAKE MINH ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 10/17/2018 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): llnl-docket@llnl.gov PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DUNCAN J. MAITLAND and THOMAS S. WILSON 1 Appeal2017-008487 Application 14/307,691 Technology Center 1600 Before TONI R. SCHEINER, ULRIKE W. JENKS, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to vascular implants which have been rejected as anticipated, as obvious, and for failing to comply with the written description requirement. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. STATEMENT OF THE CASE The Specification describes implants comprising shape memory open cell biocompatible polymer foams. Spec. ,r 1. The implants are used to treat 1 Appellants identify the Real Parties in Interest as Lawrence Livermore National Security and The Texas A&M University System. Appeal Br. 3. Appeal2017-008487 Application 14/307 ,691 aneurisms as well as similar vascular and septal abnormalities. Spec. ,r,r 9- 11. Claims 1--4, 8, and 20-24 are on appeal. Claim 1 is illustrative and reads as follows: 1. An apparatus comprising: a vascular implant comprising a polyurethane shape memory polymer foam scaffold having partially open cells; wherein each of the partially open cells is hollow and includes a partially reticulated membrane and struts coupled to each other by the partially reticulated membrane; wherein in each of the partially open cells the partially reticulated membrane: (a) separates the partially open cell from an adjacent partially open cell, (b) is partially reticulated, but not fully reticulated, by physical reticulation; ( c) has at least 50%, but less than 100%, of its membrane removed in response to the physical reticulation; wherein the polyurethane is amorphous and crosslinked. App. Br. 19 (Claims Appendix). The claims stand rejected as follows: Claims 20-24 have been rejected under 35 U.S.C. Â§ 112, first paragraph, for failure to comply with the written description requirement. Claims 1 and 20 have been rejected under35 U.S.C. Â§ 102(b) as anticipated by Volz2 as evidenced by Stevens. 3 2 Volz, US 3,171,820, issued Mar. 2, 1965 ("Volz"). In the Final Action, the Examiner refers to the reference as Voz. Final Act. 3. The correct spelling for the inventor is Volz. 3 Malcom P. Stevens, Chemistry of Industrial Polymers, Britannica Online Encyclopedia, https://www.britannica.com/print/469716, (2016) ("Stevens"). 2 Appeal2017-008487 Application 14/307 ,691 Claims 1--4, 84, and 20-24 have been rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Volz in view ofWilson. 5 WRITTEN DESCRIPTION Issue The issue with this rejection is whether the Examiner properly determined that the term "a molecular structure that is amorphous" as it appears in claims 20, 21, and 24 constitutes new matter. The Examiner contends that the term "a molecular structure that is amorphous" is not clearly disclosed in the present Specification. Final Act. 3. Appellants acknowledge that the term "molecular structure" is not used in the Specification, but argue that Stevens provides evidence that one skilled in the art would understand that the term amorphous, when used in conjunction with a polymer, refers to the molecular structure of the polymer. Appeal Br. 17-18. Principles of Law The Examiner bears the initial burden ... of presenting a prima facie case of unpatentability.' In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992). Insofar as the written description requirement is concerned, that burden is discharged by 'presenting evidence or reasons why persons skilled in the 4 The Final Action and the Answer refer to claim 9 and not claim 8. Final Act. 5. Claim 9 was cancelled by amendment on Aug. 12, 2016. Appellants list claim 8 as pending in the application. Appeal Br. 5. 5 Wilson et al., US 2007/0135907 Al, published June 14, 2007 ("Wilson"). 3 Appeal2017-008487 Application 14/307 ,691 art would not recognize in the disclosure a description of the invention defined by the claims.' . . . If ... the specification contains a description of the claimed invention, albeit not in ipsis verbis (in the identical words), then the examiner ... , in order to meet the burden of proof, must provide reasons why one of ordinary skill in the art would not consider the description sufficient. In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) Analysis We have considered the parties' arguments and find that Appellants have the better position. While we agree that the Specification does not explicitly define the term "amorphous," the evidence of record shows that one skilled in the art of polymer chemistry would understand the term amorphous refers to the molecular structure of the polymer as having random orientation of monomers making up the polymer. Stevens teaches Polymers exhibit two types of morphology in the solid state: amorphous and semicrystalline. In an amorphous polymer the molecules are oriented randomly and are intertwined, much like cooked spaghetti, and the polymer has a glasslike, transparent appearance. In semicrystalline polymers, the molecules pack together in ordered regions called crystallites. Stevens 2 ( emphasis added). The definition of amorphous used in Stevens clearly refers to a specific molecular structure of the polymer. The Examiner contends that under the broadest reasonable interpretation, the term amorphous can refer to the polymer being in disorder, such as shown in Figure 2 of Volz. Ans. 17. The Examiner also contends that the narrower construction advanced by Appellants is improper in that Appellants did not provide such a definition in the Specification. Id. 4 Appeal2017-008487 Application 14/307 ,691 We have considered the Examiner's arguments and find them unpersuasive. Volz describes Figure 2, reproduced below, as showing "an enlarged view of the surface of the block of cellular polyurethane shown in FIGURE 1." Volz, col. 9, 11. 30-31. Figure 2 of Volz shows the surface of a block of cellular polyurethane. Volz describes this structure in Figure 2: the strands 3 form junctions between the faces or walls of the cells of the foam with the thin membrane-like polymer 4 forming faces or walls themselves. A portion of the areas 5 between strands contain no membrane-like materials and thus provide an open face to the cell. Such areas result from rupture during cell formation. Volz co 1. 9, 11. 51-59. Nothing in Figure 2 or the accompanying discussion of the figure in Volz refers to the polymer as being disorganized or being amorphous. We 5 Appeal2017-008487 Application 14/307 ,691 therefore find the Examiner's proposed definition of amorphous to be unsupported by the evidence of record. Conclusion of Law We conclude that the Examiner's reasoning does not support a rejection under 35 U.S.C. Â§ 112, first paragraph. ANTICIPATION Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner's conclusion that claims 1 and 2 are anticipated by Volz. The Examiner finds that Volz discloses a method for making reticulated polyurethane foams comprising open-cell foams wherein the membranes are substantially removed. Final Act. 4. The Examiner finds that Volz teaches that the flexibility of the product can be adjusted by controlling the branching of the polymer resulting in a more amorphous molecular structure. Id. Appellants argue that the polymer systems of Volz are not shape memory polymers. Appeal Br. 11. Appellants contend that the polymers in Volz are not amorphous and that flexible polymers are not necessarily amorphous. Appeal Br. 13-14. Principles of Law [T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case ofunpatentability. If that burden is met, the burden of 6 Appeal2017-008487 Application 14/307 ,691 coming forward with evidence or argument shifts to the applicant. After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Analysis After considering the parties' arguments and the evidence of record, we conclude that a preponderance of the evidence does not support the Examiner's conclusion with respect to anticipation. We agree with Appellants that the Examiner has not established that the polymers in Volz are amorphous. The Examiner points to the teaching in Volz as establishing that flexibility can be regulated by controlling the branching in the polymer resulting in an amorphous polymer. Final Act. 4; Ans. 12. The Examiner relies on the teaching of Stevens to show that semicrystalline polymers tend to be very tough in order to support the contention that a more flexible polymer would be amorphous. Id. We are unpersuaded. Stevens teaches that some semicrystalline polymers tend to be tough, while others are not. For example, Steven teaches that network polymers, which have very few branches, are elastic or flexible. Stevens 2. Volz, however, is silent on the degree of branching that can be introduced and the degree of flexibility the can be introduced. As shown in Stevens, highly branched polymers such as low density polyethylene is flexible, whereas lightly branched high density polyethylene is tough and stiff. Id. 7 Appeal2017-008487 Application 14/307 ,691 The Examiner relies on Figure 2 of Volz as showing that the polymers used in Volz are amorphous. Ans. 12. The Examiner contends that Figure 2, shown above, shows a disorganized polymer that is not crystalline. Id. We are not persuaded. As discussed above, Figure 2 of Volz does not relate to the polymer structure or morphology but instead relates to the structure of the cells within the block of foam. Volz col. 9, 11. 51-59. Nothing in the cited portion of Volz teaches that the polymer is amorphous. Conclusion of Law We conclude that a preponderance of the evidence does not support the Examiner's conclusion that claims 1 and 20 are anticipated by Volz. OBVIOUSNESS The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner's conclusion that the subject matter of the claims would have been obvious over Volz combined with Wilson. The Examiner finds that Volz describes a method for making reticulated foams as discussed above. Final Act. 5---6. The Examiner finds that Volz does not teach that the polyurethane foam is made from N, N, N', N' -Tetrakis (2-hydroxypropyl), ethylenediamine ("HPED"), 1,6 diisocyanatohexane ("HDI") and 2,2 ',2" -Nitrilotriethanol ("TEA"). Id. at 6. The Examiner finds that Wilson teaches the preparation of polyurethane foams from HPED, HDI and TEA. Id. The Examiner goes on to find that the polyurethane foam in Wilson is made with the same components as the foam in the present invention. Id. The Examiner finds that, absent evidence 8 Appeal2017-008487 Application 14/307 ,691 to the contrary, the polyurethane of Wilson would be amorphous. Id. The Examiner concludes It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the polyurethane foam in WILSON into the polyurethane foam in VOZ [sic]. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success, because they are functional equivalents of polyurethane foams. The reference does not specifically teach the exact ranges of pore size and density as claimed by Applicant. The pore size and density of a foam composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal pore size and density in order to best achieve the desired results, such as flexibility, porosity, tear strength for the utility purpose. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of pore size and density would have been obvious at the time of Applicant's invention. Id. at 6-7. Appellants contend that Wilson is not cited for the limitation of a shape memory polymer and that Volz is deficient in such teaching. Appeal Br. 11-12. Appellants also contend that the Examiner only relies on Volz for the limitation that the polyurethane be amorphous. Id. at 12. Appellants also contend that, with respect to claims 3, 21, and 23, one skilled in the art would not have a reasonable expectation of success in combining the teachings of Wilson with that of Volz. Id. at 15. 9 Appeal2017-008487 Application 14/307 ,691 Finally, with respect to claims 2, 22, and 24, Appellants contend that Volz does not teach or suggest the pore sizes recited in the claims. Id. at 16. Principles of Law 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 claimed product. Whether the rejection is based on 'inherency' under 35 U.S.C. Â§ 102, on 'prima facie obviousness' under 35 U.S.C. Â§ 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the answer depends on "whether the improvement is more than the predictable use of prior art elements according to their established functions." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). "A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Analysis We adopt the Examiner's findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and 10 Appeal2017-008487 Application 14/307 ,691 Answer regarding this rejection. Final Act. 5-7, Ans. 5-7. We find the Examiner has established that the subject matter of the claims would have been obvious to one of ordinary skill in the art at the time the invention was made over Volz combined with Wilson. Appellants have not produced evidence showing, or persuasively argued, that the Examiner's determinations on obviousness are incorrect. Only those arguments made by Appellants in the Briefs have been considered in this Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015). We address Appellants' arguments below. Appellants argue that the Examiner has not cited Wilson to satisfy the claim limitation that the polymer be a shape memory polymer and that the polymer in Volz is not a shape memory polymer. Appeal Br. 11-12. We are not persuaded. In the Answer, the Examiner specifically points to the teaching in Wilson that the polymers are shape memory polymers. Ans. 8, citing Wilson ,r 65. Appellants next contend that the Examiner does not cite to Wilson for the limitation that the polymers are amorphous. Appeal Br. 12. Appellants argue that Volz does not disclose an amorphous polymer and that then combination does not teach this limitation. Id. Again we are not persuaded. While we agree that the Examiner has not established that the polymer in Volz is amorphous, the record is clear that the Examiner found the polymers in Wilson to be amorphous. The Examiner specifically found that since the components of the polymers in Wilson are essentially the same as those used to make the claimed composition, the polyurethane of Wilson would inherently have an amorphous structure, absent evidence to the 11 Appeal2017-008487 Application 14/307 ,691 contrary. Final At. 6. Appellants have offered no evidence to show that the polyurethane disclosed in Wilson is not amorphous. See, Appeal Br. 12. Appellants argue that, with respect to claims 3, 21, and 23, one skilled in the art would not have a reasonable expectation of success in combining the teachings of Wilson and Volz to produce the claimed invention. Appeal Br. 15. Appellants contend that methods for reticulation in Volz would not work with the polymers in Wilson. Id. Appellants contend that hydrolysis based reticulation will not work because the polymers of Wilson do not contain ester linkages that are required for hydrolysis. Id. Appellants contend that gas reticulation will not work as the density of the polymers in Wilson is too low. Id. at 16. We have considered Appellants' arguments and find them unpersuasive. As the Examiner points out, the polyurethane in Wilson and that in Volz are functional equivalents. One skilled in the art would have a reasonable expectation that one could be a substitute for the other. This is especially true since both Volz and Wilson teach that the polyurethanes can be used to prepare foams. Volz col. 2, 11. 18-21; Wilson ,r 65. Finally, Appellants argue that, with respect to claims 2, 22, and 24, Wilson does not teach the pore sizes recited in the claims. We are not persuaded. Claims 2, 22, and 24 all recite a pore size ranging from 50 nm to 5 mm. Appeal Br. 19-20 (Claims App'x.). Wilson teaches that the foams used have a pore size of ten microns to 500 microns with from 10 to 50 microns preferred which falls within the claimed range. Wilson ,r 68. Where the ranges overlap, a prima facie case of obviousness exists. In re Peterson, 315 F.3d at 1329. 12 Appeal2017-008487 Application 14/307 ,691 Conclusion of Law We conclude that a preponderance of the evidence supports the Examiner's conclusion that the subject matter of claims 1, 2, 3, and 21-24 would have been obvious over Volz combined with Wilson. Claims 4, 8, and 20 have not been argued separately and therefore fall with claim 1. 37 C.F.R. Â§ 4I.37(c)(l)(iv). SUMMARY We reverse the rejection of claims 20-24 under 35 U.S.C. Â§ 112, first paragraph. We reverse the rejection of claims 1 and 20 under 35 U.S.C. Â§ 102(b). We affirm the rejection of claims 1--4, 8, and 20-24 under 35 U.S.C. Â§ 103(a). TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 13