13170716 (P.T.A.B. Mar. 8, 2019)

Ex Parte Mercier

Patent Trial and Appeal BoardMar 8, 2019

13170716 (P.T.A.B. Mar. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/170,716 06/28/2011 23628 7590 03/12/2019 WOLF GREENFIELD & SACKS, P.C. 600 ATLANTIC A VENUE BOSTON, MA 02210-2206 FIRST NAMED INVENTOR Fabrice Mercier 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. L0707.70002US01 4329 EXAMINER HUANG, GIGI GEORGIANA ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 03/12/2019 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): Patents_eOfficeAction@WolfGreenfield.com WGS_eOfficeAction@WolfGreenfield.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte F AB RICE MERCIER 1 Appeal2017-010417 Application 13/170,716 Technology Center 1600 Before DONALD E. ADAMS, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellant identifies Laboratoires Thea, of Clennont-Ferrand, France, as the real party-in-interest. App. Br. 4. Appeal2017-010417 Application 13/170,716 SUMMARY Appellant files this appeal under 35 U.S.C. Â§ I34(a) from the Examiner's Final Rejection of claims 16-18, 21, 23-25, and 27-35. Specifically, claims 16, 17, 21, 23-25, 27-31, and 33-35 stand rejected as unpatentable under 35 U.S.C. Â§ I03(a) over the combination of Hellberg et al., (US 2002/0103255 Al, August 1, 2002) ("Hellberg"), Kis (US 6,455,547 Bl, September 24, 2002) ("Kis"), R.M.E. Richards, Ophthalmic Products, in PHARMACEUTICAL PRACTICE (A.J. Winfield, ed., 3rd ed. 2004) ("Winfield")2, and S. Kalachandra et al., Lubrication and Swface Chemical Properties of Ophthalmic Solutions, 17(11) 708-13 (1985) ("Kalachandra"). Claim 18 stands rejected as unpatentable under 35 U.S.C. Â§ I03(a) as being obvious over the combination of Hellberg, Kis, Winfield, Kalachandra, and Mitra et al., (US 2009/0092665 Al, April 9, 2009) ("Mitra"). Claim 32 is rejected as unpatentable under 35 U.S.C. Â§ I03(a) as being obvious over the combination of Hellberg, Kis, Winfield, Kalachandra, and Richardson et al., (US 2003/0018079 Al, January 23, 2003) ("Richardson"). Claims 16-18, 21, 24, 25, 27-31, and 33-35 also stand rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting over claim 5 of Mercier (US 8,637,054 B2, January 28, 2014) (the "'054 Patent"). 2 Although Richards is the author of this reference, we herein refer to it as "Winfield," so as to be consistent with the usage in the briefs. 2 Appeal2017-010417 Application 13/170,716 Claim 23 also stands rejected as unpatentable under the nonstatutory doctrine of obviousness-type double patenting over claim 5 of the '054 Patent in view of Hellberg. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant's invention is directed to an ophthalmic solution including at least one prostaglandin, a solubilizing agent, a gelling agent of the carbomer type, a carbomer polymerization-inhibiting agent, and a co- gelling/co-solubilizing agent. Abstract. REPRESENTATIVE CLAIM Claim 16 is representative of the claims on appeal and recites: 16. A bottle containing an ophthalmic solution, the solution compnsmg: 0.002 to 0.15% w/v of a prostaglandin selected from the group consisting of: latanoprost, travoprost, 1 7-phenyl trinor prostaglandin F 2aamide, bimatoprost, tafluprost prostaglandin F2a ethanolamide, bimatoprost (free acid)-d4, bimatoprost-d4, latanoprost ethyl amide, unoprostone, and unoprostone isopropyl ester; 0.1 to 20% w/v of a solubilizing agent selected from the group consisting of macrogol glycerol hydroxystearate, macrogol 15 hydroxystearate, polysorbate 20, polysorbate 60, and polysorbate 80; 0.01 to 1 % w/v of a carbomer polymerization-inhibiting agent selected from the group consisting of sodium EDT A, sodium acetate, and sodium chloride; 3 Appeal2017-010417 Application 13/170,716 0.05 to 0.2% w/v of a carbomer gelling agent; and 0.5 to 2.5% w/v of a co-gelling/co-solubilizing agent selected from the group consisting of polyethylene glycol (PEG), polyvinyl alcohol (PV A), and polyvinylpyrrolidone (PVP); wherein the ophthalmic solution comprises no anti- microbial preservatives of the quaternary ammonium type, wherein the ophthalmic solution has a Brookfield viscosity at 25 Â°C that is between 8 and 20 mPa-s, and wherein the bottle is a single-use bottle containing the ophthalmic solution. App. Br. 42=43. ISSUE AND ANALYSIS We adopt the Examiner's findings, reasoning, and conclusion that the claims are prima facie obvious over the combined cited prior art. We address the arguments raised by Appellant below. A. Rejection of claims 16-18, 21, 23-25, and 27-31, and 33-35 under 35 U.S.C. Â§ 103(a) Issue 1 Appellant argues that the Examiner erred because the references do not provide a sufficient reason for a skilled artisan to contemplate formulating a prostaglandin-based composition without a quaternary ammonium anti-microbial preservative, or provide any guidance that would lead an artisan to pick and choose certain elements from within each of the 4 Appeal2017-010417 Application 13/170,716 references to arrive at the combination of elements recited in the claims. App. Br. 17. Analysis The Examiner finds that Hellberg teaches ophthalmic compositions solutions comprising actives including: (1) prostaglandin analogs like latanoprost and travoprost from about 0.001-1.0% [67]; (2) preservatives including edetate disodium from about O.001-1. 0% ( carbomer polymerization inhibitor, salt of EDTA, [70]); (3) cosolvents/surfactants (solubilizers) such as polysorbate 20, polysorbate 60, polysorbate 80, and CremophoreÂ®EL, among other known agents are typically from about 0.01- 2% [72]; ( 4) viscosity agents such as hydroxypropylmethylcellulose and other known agents in the art such as the exemplified Carbopol 974P from about 0.01-2% [72]; (5) and other known components in ophthalmically- acceptable vehicles [ 66] such as the exemplified tonicity agents like mannitol at 2.4% and 4.6%. Final Act. 4 (citing Hellberg ,r,r 64, 66, 67, 70, 72, 66, Ex. 2, 3). The Examiner finds that Hellberg teaches that the preferred dosing is via topical solutions with drops and that ophthalmic products are typically packaged in multidose form. Id. ( citing Hellberg ,r,r 66-68). The Examiner finds that, although Hellberg does not expressly teach the exact claimed values for the components in the dependent claims, the claimed values are either embraced by the taught ranges or significantly overlap the ranges taught by Hellberg. Id. The Examiner finds that Hellberg does not expressly teach a mixture of solubilizers/cosolvents such as polysorbate 80 or macrogol glycerol 5 Appeal2017-010417 Application 13/170,716 hydroxystearate (also known as CremophorÂ®RH40), with polyethylene glycol (PEG), but does teach the inclusion of solubilizers/cosolvents such as polysorbates, Pluronics, CremophoreÂ®EL, and cyclodextrin, and other known components and combinations of substances for the ophthalmic acceptable vehicle (carrier). Final Act. 5 (citing Hellberg ,r,r 66-72) The Examiner also finds that, although Hellberg does not expressly teach single dose bottles, or the viscosity of the composition, Hellberg teaches packaging for ophthalmic products, like multidose forms, and the inclusion of viscosity agents from about 0.01-2%. Id. The Examiner finds that Kis teaches ophthalmically functionally equivalent solubilizers, including polyethylene glycols, cyclodextrins, polysorbate 20, polysorbate 80, CremophorÂ®EL, CremophorÂ®RH40, or mixtures thereof; and that known forms of PEG/carbowax include carbowax/PEG 4000. Final Act. 6. The Examiner finds that Kis teaches that the amount of solubilizer added is typically sufficient to solubilize the active ingredient, and can be from 0.1 to 5000 times the concentration of the active ingredient. Id. ( citing Kis col. 4, 11. 13--43). The Examiner finds that Kis also teaches that ophthalmically equivalent tonicity agents include sorbitol and mannitol. Id. (citing Kis col. 3, 11. 53-55). The Examiner finds Winfield teaches that eye drop solutions can be placed in containers such as single-dose containers and in plastic/ glass bottles (as common multidose containers for eye drops). Final Act. 6. The Examiner relies upon Kalachandra as teaching that commercial ophthalmic solutions have a viscosity ranging from 2 to 25 cps. Id. The Examiner concludes that it would have been prima facie obvious to a person of ordinary skill in the art to incorporate CremophorÂ®RH40, 6 Appeal2017-010417 Application 13/170,716 PEG, and sorbitol into the solution of Hellberg and package it in a single dose container with optimized viscosity within the conventional viscosity for commercial ophthalmic solutions, as suggested by Kis and Winfield and Kalachandra, to produce the instant invention. Final Act. 6. The Examiner also concludes that a skilled artisan would have been motivated to combine the references because combining of functionally equivalent solubilizers is known and would have yielded a reasonable expectation of success. Id. at 6-7. Furthermore, concludes the Examiner, it would have been similarly obvious to optimize the amount of the solubilizers within the taught ranges and ratios to attain the desired solubilization of the active, absent evidence of criticality of the claimed solubilizers and values. Id. at 7. Appellant argues that the primary focus of Hellberg is on the choice and use of a nonsteroidal cyclooxygenase inhibitor for the treatment of a particular glaucoma, GLC 1 A glaucoma, and not on the choice of a prostaglandin. App. Br. 17. According to Appellant, Hellberg particularly highlights the discovery that certain non-steroidal cyclooxygenase inhibitors act to prevent the expression of GLC 1 A, and the subsequent development of ocular hypertension, and that use of these non-steroidal cyclooxygenase inhibitors may combat certain negative side-effects associated with prostaglandin therapy. Id. (citing Hellberg ,r,r 18, 22-54). Appellant points to Figures 1 and 2 of Hellberg, which, Appellant contends, constitutes the extent of the experimental results in Hellberg, and which, Appellant argues are deficient in that they do not describe the components of the 0.3% nepafenac (a cyclooxegenase inhibitor) formulation referred to in the Figures. App. Br. 18. Appellant further argues that, although Examples 1-8 of Hellberg describe various formulations 7 Appeal2017-010417 Application 13/170,716 containing a non-steroidal cyclooxygenase inhibitor ( e.g., nepafenac or a generic place-holder, i.e., a "PG synthesis inhibitor") and a prostaglandin (e.g., travoprost, latanoprost, or bimatoprost), it would have been clear to a person of ordinary skill in the art - especially from the language of paragraph [0075] introducing these formulations, as well as the lack of any physical characterization of the formulations beyond teaching a particular concentration range, and the fact that none of the formulations contain 0.3% nepafenac, that the formulations of Examples 1-8 of Hellberg are merely prophetic in nature. Id. Consequently, Appellant argues, a skilled artisan would have viewed Examples 1-8 of Hellberg as describing typical formulations containing a non-steroidal cyclooxygenase inhibitor and a prostaglandin which may be used, and nothing more. Id. Appellant therefore argues that solving problems associated with formulating prostaglandins, and particularly recognizing and solving problems associated with the use of anti-microbial preservatives, is not a focus of Hellberg. App. Br. 18. According to Appellant, Hellberg promotes the use of anti-microbial preservatives, because Hellberg teaches that: "[ o Jphthalmic products are typically packaged in multidose form. Preservatives are thus required to prevent microbial contamination during use." Id. (quoting Hellberg ,r 70). Appellant points out that Hellberg expressly teaches the use of: "benzalkonium chloride, thimerosal, chlorobutanol, methyl paraben, propyl paraben, phenylethyl alcohol, sodium EDT A, sorbic acid, Onamer M, or other agents known to those skilled in the art." Id. Appellant also notes that Examples 1-8 of Hellberg also teach the use of benzalkonium chloride ("BAK"), in combination with sodium EDT A, as the preferred anti-microbial preservative. Id. at 18-19. This is not 8 Appeal2017-010417 Application 13/170,716 surprising, Appellant argues, because BAK is typically included in marketed prostaglandin ophthalmic solutions, as there are many known benefits to its use as anti-microbial preservative and as a solubilizer and stabilizing agent of the prostaglandin. Id. at 19 (citing, e.g., Spec. 2, Richardson ,r 14). Appellant therefore asserts that a person of ordinary skill in the art would have known of these benefits of BAK and, understanding the teachings of Hellberg, would find no motivation to develop BAK-free formulations of prostaglandins. Id. With respect to the teachings of Kis, Winfield, Mitra, Kalachandra, and Richardson, Appellant argues that none of these references would Have directed a person of ordinary skill to diverge from the teachings of Hellberg to include BAK, an anti-microbial preservative of the quaternary ammonium type, in the formulation. App. Br. 19. The Examiner responds that Hellberg expressly teaches that the formulations may contain preservatives, including EDT A at about 0.001- 1.0%. Ans. 14. The Examiner therefore concludes that it would have been prima facie obvious to a person of ordinary skill in the art to utilize EDT A alone, as taught by the prior art or in combination with other taught preservatives (i.e., thimerosal, chlorobutanol, methyl paraben, propyl paraben, sorbic acid) with a reasonable expectation of success. Id. We are not persuaded by Appellant's arguments. Hellberg is directed to: "methods and compositions for the treatment of glaucoma and ocular hypertension, comprising the administration of a prostaglandin FP receptor agonist and a prostaglandin synthesis inhibitor." Helberg Abstr. Specifically, Hellberg teaches: 9 Appeal2017-010417 Application 13/170,716 The following are preferred prostaglandin analogs of formula (III): latanoprost, travoprost, bimatoprost, and UF0-21 [ unoprostone ], as well as, cloprostenol, fluprostenol, 13, 14 dihydro-cloprostenol and 13, 14-dihydrofiuprostenol and their isopropyl esters and salts. Also preferred is isopropyl [2R (1E,3R), 3S(4Z), 4R]-7-[tetrahydro-2-[ 4-(3-chlorophenoxy)-3- hydroxy-l-butenyl]-4-hydroxy-3-furanyl]-4-heptenoate. The most preferred prostaglandin analogs of the present invention are latanoprost, travoprost, and bimatoprost. Hellberg ,r 64 ( emphasis added). The italicized compounds are also recited in Appellant's claims. Moreover, Examples 1-8 of Hellberg each include one of the prostaglandins recited in the claims at concentrations within, or closely adjacent to, the claimed range of0.002 to 0.15% w/v; viz., latanoprost at 0.005% (Hellberg Examples 2 and 4); travoprost at 0.004%, 0.0015%, 0.004%, 0.004% (Examples 1, 3, 6, and 8, respectively); and bimatoprost at 0.03% (Examples 5 and 7). We acknowledge Appellant's point that Hellberg also teaches the inclusion of: "nonsteroidal cyclooxygenase inhibitors [including nepafenac] in combination with prostaglandin FP receptor agonists" in its compositions for the treatment of glaucoma and ocular hypertension. See Hellberg ,r 2, Examples 1-8. However, the use of such cyclooxygenase inhibitors is not precluded by the language of the claims, which are directed to: "A bottle containing an ophthalmic solution, the solution comprising .. .. " (Emphasis added). "[U]se of. .. the transition 'comprising' [in the language of a claim] creates a presumption ... that the claim does not exclude additional, unrecited elements." Crystal Semiconductor Corp. v. Tri Tech Microelectronics Int 'l, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001). Consequently, the claim does 10 Appeal2017-010417 Application 13/170,716 not preclude from its scope the use of cyclooxygenase inhibitors such as napefenac, as taught by Hellberg. With respect to the use of BAK as an antimicrobial preservative, Hellberg teaches that: "Ophthalmic products are typically packaged in multidose form. Preservatives are thus required to prevent microbial contamination during use." Hellberg ,r 70. In this statement, the teaching of Hellberg conditions the requirement for the use of antimicrobial preservatives on multi-dose packaging, because opening of the package for the initial use in a multi-dose package exposes the product to bacterial contamination. However, Winfield teaches that single-use packaging was well-known in the art at the time of Appellant's filing; such single-use packaging would obviate the need for inclusion of a preservative. Furthermore, Hellberg teaches the use of preservatives other than BAK that are well-known in the art: Suitable preservatives include: benzalkonium chloride [i.e., BAK], thimerosal, chlorobutanol, methyl paraben, propyl paraben, phenylethyl alcohol, edetate disodium, sorbic acid, Onamer M, or other agents known to those skilled in the art. Such preservatives are typically employed at a level between about 0.001 % and about 1.0% by weight. Hellberg ,r 70. Claim 16 recites, in relevant part: "wherein the ophthalmic solution comprises no anti-microbial preservatives of the quaternary ammonium type." The claim language thus expressly excludes the use of quaternary ammonium-type antimicrobial preservatives (i.e., BAK), but the "comprising" language of the claim does not exclude the use of other antimicrobial preservative agents that are not of the quaternary ammonium type. See Crystal Semiconductor, 246 F.3d at 1348. None of the 11 Appeal2017-010417 Application 13/170,716 antimicrobial agents recited in paragraph [0070] of Hellberg, other than BAK, are of the quaternary ammonium type, and are therefore not excluded by the language of the claims. We acknowledge Appellant's point that the compositions of Examples 1-8 of Hellberg all employ BAK, but this does not alter the fact that Hellberg also teaches the use of other, non-quaternary ammonium type, antimicrobial preservatives. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that, in an obviousness analysis, "all disclosures of the prior art, including unpreferred embodiments, must be considered" (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)). Issue 2 Appellant argues that, even if the claims are prima facie obvious over the combined cited prior art, the superior properties of the claimed formulations are sufficient to overcome the Examiner's conclusion of obviousness. App. Br. 24. Analysis Appellant points to Example 1 of the Specification, as presented in Tables 1 and 4 of the Declaration of Fabrice Mercier, June 24, 2015 (the "Mercier Declaration"). App. Br. 25. Appellant contends that, in developing this formulation, what was of importance was the obtaining a composition with a low viscosity but having a shear stress as high as possible in order to lengthen the formulation's contact time with the eye. Id. Appellant also points to the Mercier Declaration as attesting that a higher shear stress, e.g., above 20 D/cm2 at a shear rate of 180 1/s, ensures a better 12 Appeal2017-010417 Application 13/170,716 stability of the formulation in the eye after administration and improves resistance to undesirable lachrymal films. Id. (see, e.g., Mercier Deel. ,r 7). Appellant also asserts that the Specification discloses additional advantageous properties of the claimed composition. App. Br. 26. According to Appellant, the BAK-containing latanoprost formulation XalatanÂ® demonstrates an undesired peak in intraocular pressure ("IOP") within 1 hour of administration, however, the BAK-free latanoprost formulation of Example 1 demonstrates a constant and progressive reduction ofIOP without XalatanÂ®'s early hypertensive phase. Id. (citing, e.g., Spec. 11, Fig. 1 ). Furthermore, Appellant argues, the latanoprost formulation of Example 1 is as effective as XalatanÂ® in reducing IOP. Id. (citing Spec. 15). Appellant also asserts that the Example 1 formulation demonstrates less frequent ocular side effects, such as burning or stinging, compared to the BAK-containing latanoprost formulation XalatanÂ®, and also demonstrates less frequent conjunctiva! hyperaemia. Id. (citing Spec. 17-18, Figs. 2A- 2C). Appellant reports that a global assessment of the patients treated with the formulation indicated that the latanoprost formulation of Example 1 was generally viewed as better than XalatanÂ® since it had the same efficacy as XalatanÂ® but had better local tolerability, presumably due, in part, to the absence of BAK in the formulation. Id. (citing Spec. 18). Appellant contends that the cumulative superior properties of the claimed five-component ("ABCDE") formulation, in which the formulation satisfied each of the desired parameters - appearance, solubility, viscosity, and rheological profile - sought by Appellant, in addition to its beneficial therapeutic IOP profile, is unexpected. App. Br. 26. 13 Appeal2017-010417 Application 13/170,716 Appellant also claims that the desired appearance, viscosity, and solubility, which are all specific parameters found to be desirable in the development of prostaglandin formulations which do not include anti- microbial preservatives of the quaternary ammonium type, requires all five Components: A, B, C, D, and E. Id. at 26-27. Appellant points to Table 4 of the Declaration, comparing the ABCDE formulation with formulations comprising AB, AC, AD, AE, ABC, ACD, ABD, and ACE, and ABCE, lack the sum desirable properties of the ABCDE formulation. App. Br. 27-30. Appellant also contends that the ABCD'E ( containing PVP as D' in lieu of PEG 4000), and ABCD"E ( containing PV A as D" in lieu of PEG 4000), as claimed, demonstrate equally desirable properties. Id. at 31. Appellant further argues that the ABE formulation demonstrates an early increase in IOP similar to that observed for XalatanÂ®. App. Br. 33 (citing Figure 1 of Response to Non-Final Action, January 4, 2016). Appellant suggests that inclusion of the "non-gelling delivery system" (Components C, D, and E) is thought to attenuate the strength of the solubilizing agent (Component B) and allows a more gradual delivery of the prostaglandin lanatoprost, which exerts its effect on IOP in a time frame similar to that of XalatanÂ® and T2340, but without the undesired early increase in IO P. Id. Finally, Appellant argues that the claims are also commensurate in scope with the results described. App. Br. 34. Specifically, Appellant argues, claim 16 and its dependencies recite a formulation comprising a set of specific components, each of which fall within a narrow range of concentrations and which, taken as a whole, closely encompass the five- component formulations studied. Id. 14 Appeal2017-010417 Application 13/170,716 We are not persuaded by Appellant's arguments. "[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art." In re Baxter Travenol Labs., 952 F.2d 388,392 (Fed. Cir. 1991); see also Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (holding that a showing of "new and unexpected results" must be "relative to the prior art"). Appellant argues that Example 1 of the Specification, a species of the claimed compositions, shows that, whereas the BAK-containing latanoprost formulation XalatanÂ®, a single species of the prior art3, demonstrates an undesired peak in intraocular pressure (IOP) within 1 hour of administration, the BAK-free latanoprost formulation of Example 1 demonstrates a constant and progressive reduction of IOP without XalatanÂ®'s early hypertensive phase, and is as effective as XalatanÂ® in reducing IOP. See App. Br. 26 ( citing Spec. 11, Fig. 1 ). Appellant also argues that the Specification demonstrates that patients find the latanoprost formulation of Example 1 was generally viewed as better than XalatanÂ® since it had the same efficacy as XalatanÂ® but had better local tolerability, presumably due, in part, to the absence of BAK in the formulation. Id. (citing Spec. 18). However, as we have concluded, Appellant's claimed compositions are obvious over the prior art cited by the Examiner, which teaches both 3 Notably, Appellant provides no evidence concerning the composition of XalatanÂ®, other than that both Example 1 of the Specification and XalatanÂ® contain latanoprost at a concentration of 0.005% and that XalatanÂ® contains BAK. As such, it is not possible to ascertain that Xalatan corresponds with the composition of the combined prior art cited by the Examiner. 15 Appeal2017-010417 Application 13/170,716 compositions using antimicrobial preservatives other than quaternary ammonium type (including BAK), as well as suggesting, in the case of single-use dosage preparations, the use of no antimicrobial preservatives. See Hellberg ,r 70; Winfield 269. Appellant makes no showing of evidence of record that these other teachings of the prior art would not have the same properties of the claimed compositions. Consequently, Appellant's argument that the claimed compositions have unexpected properties over the prior art do not succeed. Furthermore, our reviewing court has held that: Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, 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, or "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 (C.C.P.A. 1977). Appellant has pointed to no evidence of record to demonstrate that the compositions taught by the combination of Hellberg and Kis would not possess the properties that they claim are unexpected, surprising, or "superior" in their claimed compositions. As such, Appellant's argument that the claimed composition has unexpected properties is not persuasive. Consequently, we affirm the Examiner's rejection of the claims. 16 Appeal2017-010417 Application 13/170,716 B. Claim 35 under 35 U.S.C. Â§ 103(a) Appellant argues claim 35 separately. 4 App. Br. 39. Appellant presents essentially the same arguments presented above with respect to the Examiner's rejection of claims 16-18, 21, 23-25, and 27-35. Id. at 39-40. We have explained why we are not persuaded by Appellant's arguments with respect to the latter claims and, for the same reasons, we are not persuaded by those arguments with respect to claim 35 alone. We consequently affirm the Examiner's rejection. C. Rejection of claims 16-18, 21, 24, 25, 27-31, and 33-35 under the nonstatutory doctrine of obviousness-type double patenting Appellant acknowledges these rejections, but "defer[ s] commenting on these rejections until the claims in the present Application are considered allowable." App. Br. 40-41. Because we affirm the rejection of these claims under Section 103(a), and because Appellant makes no argument with respect to these obviousness-type double patenting rejections, we summarily affirm the Examiner's rejections of the claims on this ground. 4 We consider the possibility that Appellant, despite repeated references to claim 35, perhaps intended to address the Examiner's rejection of claim 32, which was rejected as unpatentable as being obvious over the combination of Hellberg, Kis, Winfield, Kalachandra, and Richardson. See Final Act. 12; App. Br. 39. Nevertheless, because Appellant here relies upon the same arguments presented with respect to the other claims, we affirm the Examiner's rejection of both claims 32 and 35. 17 Appeal2017-010417 Application 13/170,716 DECISION The Examiner's rejection of claims 16-18, 21, 23-25, and 27-35 under 35 U.S.C. Â§ 103(a) is affirmed. The Examiner's rejection of claims 16-18, 21, 23-25, 27-31, and 33- 35 under the nonstatutory doctrine of obviousness-type double patenting is affirmed. 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)(l )(iv). AFFIRMED 18