Ex Parte LANGGUTH et alDownload PDFPatent Trials and Appeals BoardMay 30, 201914607861 - (D) (P.T.A.B. May. 30, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/607,861 01/28/2015 Thomas LANGGUTH 23599 7590 06/03/2019 MILLEN, WHITE, ZELANO & BRANIGAN, P.C. 2200 CLARENDON BL VD. SUITE 1400 ARLINGTON, VA 22201 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. BAYSCH-0238-DOl 6742 EXAMINER ORWIG, KEVIN S ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 06/03/2019 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): docketing@mwzb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte THOMAS LANGGUTH and STEFANBRACHT 1 Appeal2017-008707 Application 14/607 ,861 2 Technology Center 1600 Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and JOHN E. SCHNEIDER, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to a solid transdermal therapeutic system (TTS) with a UV absorber. The Examiner rejected the claims under 35 U.S.C. § 103 as obvious and under obviousness-type double-patenting as unpatentable. Pursuant to 35 U.S.C. § 134(a) Appellants appeal the Examiner's determination that the claims are unpatentable. We have jurisdiction for the appeal under 35 U.S.C. § 6(b ). The Examiner's decision is affirmed. 1 The Appeal Brief ("Appeal Br." entered Dec. 7, 2016) lists Bayer Intellectual Property GmbH as the Real-Party-in-Interest. Appeal Br. 1. 2 "The '861 Application." Appeal2017-008707 Application 14/607,861 STATEMENT OF THE CASE The claims stand finally rejected by the Examiner as follows: 1. Claims 25--46, 62, and 63 under 35 U.S.C. § I03(a) as obvious in view of Schumacher et al. (WO 2004/073696 Al, published Sept. 2, 2004) (all references to the English equivalent (US 2006/0251707 Al, published Nov. 9, 2006) ("Schumacher"), Decker, C., et al. (Prog. Org. Coatings, 1996, 29: 81-87) ("Decker"), (Ye, Yijun, et al. (Ciba Specialty Chemicals, 1997, Tarrytown NY, 21 pgs.) ("Ye"), and either of Podhaisky et al. (US 2005/0129756 Al, published June 16, 2005, priority to Dec. 30, 2003) ("Podhaisky") or Seyler et al. (US 2004/0009200 Al, published Jan. 15, 2004) ("Seyler"). Ans. 2. 2. Claims 25-63 under 35 U.S.C. § I03(a) as obvious in view of Schumacher, Decker, Ye, and either of Podhaisky or Seyler, and further in view of Gale et al. (US 5,376,377, issued Dec. 27, 1994) ("Gale"). Ans. 9. 3. Claims 25---63 under the judicially created doctrine of obviousness- type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 8,486,443, in view of Decker, Ye, and optionally Gale, Podhaisky, or Seyler. Ans. 12. 4. Claims 25-63 under the judicially created doctrine of obviousness- type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8,671,945, in view of Decker, Ye, and optionally Gale, Podhaisky, or Seyler. Ans. 13. 5. Claims 25-63 under the judicially created doctrine of obviousness- type double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 8,962,013 ("the '013 patent"). Ans. 13. 2 Appeal2017-008707 Application 14/607,861 Independent claim 25, which is illustrative of the rejected claims, is reproduced below: 25. A solid transdermal therapeutic system (TTS) with a UV absorber, said solid transdermal therapeutic system comprising a sequence of at least five layers; wherein said at least five layers comprise a backing layer ( 1 ), an adhesive layer ( 4 ), a separating layer ( 5), at least one active ingredient-containing matrix (2), and a detachable protective film (3); wherein the adhesive layer ( 4) is between the backing layer ( 1) and the separating layer ( 5), the separating layer ( 5) is between the adhesive layer ( 4) and the at least one active ingredient-containing matrix (2), and the at least one active ingredient-containing matrix (2) is between the separating layer (5) and the detachable protective film (3); wherein said UV absorber consists of 2,4-bis-([4-(2'- ethylhexyloxy)-2- hydroxy Jphenyl)-6-( 4-methoxyphenyl)-(1,3,5)-triazine as the sole UV absorber in the system, said UV absorber is present in a concentration of from 0.5 to 4.0% (m/m) in dissolved form in the adhesive layer and said UV absorber is also optionally present in the backing layer (1); and wherein the solid transdermal therapeutic system is transparent. REJECTION 1 The Examiner found that Schumacher describes a transdermal therapeutic system ("TTS ") having "the exact arrangement" of layers ( 1 }-( 5) as recited in the rejected claims. Final Act. 4. The Examiner found that Schumacher describes the presence of a UV absorber, including a triazine as claimed, but not the specifically recited triazine UV absorber. Id. However, the Examiner found that "the selection of a different UV absorbent is not considered inventive as it is completely within the purview 3 Appeal2017-008707 Application 14/607,861 of the skilled artisan to make such a choice." Id. To meet this deficiency, the Examiner cited Decker, Ye, Podhaisky, and Seyler. The Examiner found that Decker reports "clear polyvinyl chloride plates were effectively protected against photodegradation by hydroxyphenyltriazine." Final Act. 4. The Examiner further cited the teaching in Decker "[ a ]mong the different types of UV As examined, triazine derivatives proved to be the most stable and provide the best long-term protection of PVC-made materials." Decker 97 ("Conclusions"). The Examiner also cited Ye for teaching that triazines stabilize thermoplastic films. Final Act. 5---6. In other words, triazines were well-known UV absorbents at the time of the invention, The Examiner acknowledged that neither of Schumacher, Decker, or Ye disclose the specifically claimed UV absorber which is also known under its tradename as Tinosorb S. Final Act. 7. For brevity, we use the term "Tinosorb S" in this decision for the UV absorber recited in the rejected claims. The Examiner found that Podhaisky discloses transdermal preparations for the administration of light sensitive active ingredients, such as gestodene (a progestogen) and ethinyl estradiol (an estrogen), which comprises Tinuvin 326 (disclosed also by Schumacher) or Tinosorb Sas preferred UV-absorbing substances. Id. The Examiner found that Seyler describes Tinosorb S as a preferred UV absorber in topical preparations comprising active agents to protect skin against UV radiation. Id. The Examiner found that Podhaisky and Seyler disclose UV absorbers which overlap with those of Schumacher, providing evidence that such UV absorbers are functionally equivalent. Final Act. 7, 8. The Examiner 4 Appeal2017-008707 Application 14/607,861 determined it would have been obvious to substitute one functionally equivalent UV absorber for another to have arrived at the claimed subject matter. Id. Discussion Appellants contend that Schumacher's list of UV absorbers does not include Tinosorb S "either specifically or generically encompassed," and provides no suggestion at all of a transdermal therapeutic system (TTS) using Tinosorb S as a UV absorber. Appeal Br. 6. With respect to Podhaisky which discloses Tinosorb S, Appellants argue that the UV absorber is "merely" incorporated into a solution or gel with no layer structure as recited in the claims, and specifically distinguish its compositions from a transdermal patch as claimed. Id. at 6. For this reason, Appellants contend that the ordinary skilled worker would not have considered "Podhaisky's teaching regarding the use of Tinosorb®S in its semisolid, gel or liquid solutions relevant to replacement of the UV absorbers used in the solid TTS of Schumacher or the claimed invention." Id. at 8-9. Appellants make a similar argument with regard to Seyler. Id. Appellants also cite Leo Pharmaceutical Products, Ltd. v. Rea 726 F.3d 1346, 1356 (Fed. Cir. 2013) which stated that "KSR did not create a presumption that all experimentation in fields where there is already a background of useful knowledge is 'obvious to try,' without considering the nature of the science or technology." (Internal citations removed). Appellants argue that the selection of Tinosorb S to use in a solid TSS would not have been suggested "where there was already 'a background of useful knowledge' of what is 'obvious to try' from Schumacher's own broad teachings of useful UV absorbers for a solid TTS - which teachings do not, 5 Appeal2017-008707 Application 14/607,861 even in their broadest sense, include Tinosorb®S." Appeal Br. 10. These arguments do not persuade us that the Examiner erred in rejecting the claims as obvious. We begin by addressing Leo. In Leo, 726 F.3d 1346, 1356, the background of knowledge was disparaged by the court for having been published decades before the patent and because it had been used by the inventors of the patent to solve a problem that was not even known: And, until the advancement made by the inventors of the '013 patent, no one had proposed a new formulation that would be storage stable. The problem was not known, the possible approaches to solving the problem were not known or finite, and the solution was not predictable. Therefore, the claimed invention would not have been obvious to try to one of ordinary skill in the art. Indeed ordinary artisans would not have thought to try at all because they would not have recognized the problem. Leo, 1356-57. In this case, there is no evidence that Tinosorb Sis being used to solve a problem that was not known. Rather, the evidence before us establishes that Tinosorb Sis being used for its known property and function as a UV absorber. Podhaisky ,r 32. For this reason, we do not consider Leo pertinent to the set of facts in this appeal. As held in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007): [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 . . . . [A] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions. 6 Appeal2017-008707 Application 14/607,861 Appellants do not dispute Schumacher describes a TTS system ( also referred to herein as a "patch") with the same layer structure as claimed. Schumacher also describes a hormone, including a progestogen, such as gestodene, in the adhesive layer of its TTS patch along with a UV absorber to protect the progestogen. Schumacher ,r,r 17, 24. Podhaisky specifically teaches hormone-containing preparations, such as ethinyl estradiol and gestodene (spelled "gestoden"). Podhaisky ,r,r 46, 49. Podhaisky teaches that these compounds degrade under UV light. Id. To address this problem, Podhaisky teaches adding a UV absorber, and specifically discloses Tinosorb S in its examples as UV absorber for estradiol and gestoden. Id. Based on this teaching, one of ordinary skill in the art would have recognized that Tinosorb S is effective for protecting the UV degradation of the same type of compounds disclosed by Schumacher, such as gestodene, providing a strong reason to have used Tinosorb S in the TTS system described by Schumacher. Schumacher is not restricted to the list of UV absorbers disclosed in it, as suggested by Appellants. Appeal Br. 6, 7, 9. In the first paragraph, Schumacher describes its invention in general terms as "a novel UV-stable transdermal therapeutic system (TTS) which consists of a backing layer, of at least one active ingredient-containing matrix and optionally of a detachable sheet, and comprises a UV absorber, with at least one UV absorber-containing adhesive layer." Schumacher ,r 1. Schumacher describes the shortcomings of the prior art (i1i1 2-8) and states that its solution "is achieved" by a transdermal therapeutic system (TTS) consisting of a backing layer, of at least one active ingredient-containing matrix and optionally of a detachable sheet, and comprising a 7 Appeal2017-008707 Application 14/607,861 UV absorber, with at least one UV absorber-containing adhesive layer being provided between the backing layer and the active ingredient-containing matrix which is furthest away from the surface of the skin, and at least one separating layer which is impermeable to active ingredient and impermeable to the UV absorber being present between the adhesive layer containing the UV absorber and the active ingredient- containing matrix which is furthest away from the surface of the skin. Schumacher ,r 10. Appellants have not pointed us to a statement in Schumacher that a specific UV absorber is necessary for its TTS system to work or that it requires a specific compatibility between the UV absorber and TTS. Schumacher lists specific UV absorbers, but in doing so, states that the "adhesive layer in the transdermal therapeutic system of the invention may moreover have a UV absorber content composed of a mixture of two or more substances which absorb in the UV region, it being possible to select the UV absorber(s) from the group" and lists a group of compounds. Schumacher ,r 15. The list disclosed in Schumacher is therefore expressly disclosed as a "possible" list of UV absorbers and is not limiting. In view of this evidence, we do not understand Schumacher to provide any reason not to use other UV absorbers, including the UV absorber Tinosorb S which is described by Podhaisky (i1i1 10, 34, 43, 46, 50) to protect the same hormones as in Schumacher (i-f 1 7). Appellants argue that the skilled worker would not have relied on the disclosure in Podhaisky because it is directed to "a gel or other type of liquid or semi-solid solution" and "specifically distinguishes such solutions from transdermal patches - i.e., from a solid TTS." Appeal Br. 12 (emphasis omitted). Appellants argue that "[t]he reference itself says they are distinct 8 Appeal2017-008707 Application 14/607,861 type of uses .... One of ordinary skill in the art would consider from this teaching in Podhaisky that the consideration of what ingredients to use would be different and would require different functional considerations." Id. We tum to Podhaisky's teachings regarding the differences between its gel formulations and TTS. Podhaisky teaches: In recent years semisolid transdermal pharmaceutical preparations and, above all, gels have become established in this field. In contrast to the transdermal patch this non- occlusive form has the advantage that skin compatibility is improved. Other advantages are individual disability and that the user is not viewed as sick or is not stigmatized as a person needing treatment. Podhaisky ,r 9. This disclosure, pointed to by Appellants (Appeal Br. 8), does not provide evidence that a UV absorber used in a gel would not be understood by one of ordinary skill in the art as suitable for TTS. Podhaisky states that a UV absorber is preferred "which penetrates or permeates the skin as little as possible" (Podhaisky ,r,r 22, 25). However, Appellants have not provided evidence that UV absorbers with this property would not useful in Schumacher's TTS patch nor that such teaching would discourage one of ordinary skill in the art from using these absorber in a TTS. Appellants also challenge the Examiner's findings regarding the functional equivalence of UV absorbers. Appellants argue: Podhaisky and Seyler do not teach that its UV absorbers are all functionally equivalent to each other for any use. As detailed above, Podhaisky and Seyler only provide such teachings in the context of solid or semi-solid, homogeneous, solutions, such as gels or lotions. The references do not provide any teachings about functional equivalence of UV absorbers when they are 9 Appeal2017-008707 Application 14/607,861 used as a distinct layer in a solid state transdennal system for protecting drug active ingredients. Appeal Br. 12. Appellants have not explained why the UV absorber would not act equivalently when present in a gel as in Podhaisky and Seyler, or in TTS as in Schumacher. Ye explains that the UV absorbers absorb the UV component of sunlight. Ye (in section titled "UV Stabilization"). Appellants have not explained why one of ordinary skill in the art would not have expected Tinosorb S to exhibit this functional activity in absorbing UV radiation from the sun when used in the TTS of Schumacher and why the different environments (Appeal Br. 9) would affect the compound's UV absorbing properties. The Examiner reasonably found that Tinosorb S would be active in the TTS because: (1) UV absorbers are active in the adhesive layer of TTS (Schumacher ,r 1 O); and (2) Podhaisky describes the ability of Tinosorb S to protect compounds from UV degradation (Podhaisky ,r,r 46, 50) and this ability is a property of the compound, itself. Appellants also argue that cited publications do not provide an expectation that "Tinosorb®S, particularly, would be useful to protect active drug ingredients such as hormones - and do so in advantageous ways in comparison to other UV absorbers." Appeal Br. 7, 9. This argument does not demonstrate persuasive error in the Examiner's rejection. First, as explained above, Podhaisky specifically teaches that the Tinosorb®S is useful to protect hormones. Second, the prior art does not have to teach that a compound is advantageous for it to have been obvious to use. Indeed, simply because a product is described as "inferior" in some respects does not by itself constitute a teaching away from using the 10 Appeal2017-008707 Application 14/607,861 teaching of the "inferior" product in an obviousness analysis. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). We have considered Appellants' arguments regarding Decker and Ye (Appeal Br. 6-8), but find them unpersuasive as Podhaisky and Seyler provide adequate reason to have used Tinosorb S in the TTS of Schumacher. Claims 42 and 43 Claims 42 and 43 further require that the active ingredient is a progestogen and an estrogen. Appellants contend that "[ n Jone of the cited references provide any teachings regarding inclusion of an estrogen as an active ingredient in a layered TTS system." Appeal Br. 19. This argument is not persuasive. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Schumacher discloses that the "active pharmaceutical ingredient acting in the transdermal therapeutic system of the invention may be at least one hormone and be progestogen( s ), preferably gestodene or levonorgestrel." Schumacher ,r 17. Thus, Schumacher recognized that its transdermal system was useful to deliver hormones. Podhaisky further teaches transdermal delivery of an estrogen ("ethinyl estradiol") and a progestogen ("gestoden"). Podhaisky ,r,r 46, 50. One of ordinary skill in the art would have found it obvious to use Podhaisky' s estrogen in Schumacher's TTS because estrogen is suitable for transdermal delivery as disclosed by Podhaisky and Schumacher's TTS is described as useful for the 11 Appeal2017-008707 Application 14/607,861 transdermal delivery of hormones, providing a reason to have used TTS to deliver estrogen. Appellants also argue that one of ordinary skill "in the hormone delivery arts knows that hormones, such as progestogens and estrogens, are very sensitive with regard to change of their chemical structure either by chemical influence or irradiation and that a TTS for fertility control has to keep the hormones stable over a period of several days, preferably at least 7 days." Appeal Br. 21. Appellants address the teachings in Decker, Ye, Seyler, and Gale, but not Podhaisky which expressly teaches Tinosorb S as a UV protective agent for progestogens and estrogens. Thus, Podhaisky expressly teaches how to protect these agents from UV radiation. Unexpected results Appellants provide a declaration by Dr. Stefan Bracht ("Bracht Deel."), a co-inventor of the '861 Application, which they contend establishes the unexpected advantages of the claimed UV absorber, Tinosorb S, in the claimed TTS. Appeal Br. 12-13. In particular, the declaration is said to establish that the recited concentration of from 0.5 to 4.0% (m/m) of Tinosorb S in dissolved form in the adhesive layer of TTS achieves an unexpected result when compared to the closest prior art. "One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of 'unexpected results,' i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected." In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). "To be particularly probative, evidence of unexpected results must establish that 12 Appeal2017-008707 Application 14/607,861 there is a difference between the results obtained and those of the closest prior art, and that the difference would not have been expected by one of ordinary skill in the art at the time of the invention." Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Unexpected results must be "commensurate in scope with the degree of protection sought by the claimed subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). The Bracht declaration compares the degradation of gestodene in a TTS comprising (1) Tinuvin 326, the UV absorber used in the examples of Schumacher, to (2) Tinosorb S, the UV absorber which is claimed and disclosed in Podhaisky and Seyler. Bracht Deel. 2. It was not disputed by the Examiner that Tinuvin 326 is the closest prior art and that Dr. Bracht has made a proper comparison against Tinosorb S. Dr. Bracht used a TTS containing Tinuvin 326 as the UV absorber in amounts of 2% and 3%, and a TTS containing from 2% to 4% of Tinosorb Sas the UV absorber. The first figure in the Bracht declaration, and table summarizing the data, shows the UV-degradation of gestodene in a TTS in accordance with claim 25. Bracht Deel. 6. Two different concentrations of Tinuvin 326 (2% and 3%) were compared to three different concentrations of Tinosorb S (2%, 2.5%, and 3%). The data shows that about the same level of protection for 2% of Tinuvin 326 at 14 hours (92.5%) was achieved for 2% of Tinosorb S at 34 hours (95.9%). 2% Tinosorb S therefore performed better than 2% Tinuvin 326 because its effect lasted longer. 2% Tinosorb S also performed comparably to 3% Tinuvin (although no direct comparison was done because Tinosorb S was tested at only one time and data for Tinuvin 326 was not collected at this same time). Thus, at an amount of 2% of UV 13 Appeal2017-008707 Application 14/607,861 absorber, less Tinosorb S was needed to achieve the same level of protection as Tinuvin 326. This result is the basis for unexpected results at the 2% value of the claimed range of"0.5 to 4%". At the 3% concentration of UV absorber, however, only one time point for Tinosorb S was measured- 96.5% protection at 34 hours-while 3% Tinuvin 326 showed about the same level protection at all times measured, namely 99% protection at 14 hours, 97 .5% at 28 hours, and 93.6% at 42 hours. Bracht Deel. 6. Therefore, at 3% concentration, both Tinuvin 326 and Tinosorb S performed comparably. There is no advantage of Tinosorb S over Tinuvin 326 at 3% of UV absorber because the same amount of each UV absorber achieves about the same level of protection. Appellants explained: The need to use of higher amount of the UV absorbers, however, has a negative influence on the skin compatibility of the TTS. Therefore, an objective of the claimed invention was to provide a TTS with more effective UV protection of the active ingredient(s) in a solid TTS while using the lowest possible amount of UV absorber. Appellants discovered - surprisingly -- that the particular UV absorber Tinosorb ®s was significantly and unexpectedly advantageous over UV absorbers used in previous TTS 's. Appeal Br. 5. Appellants' statement is true for 2% Tinosorb Sas explained above, but not for 3% Tinosorb S because, at that concentration, the same amount of both Tinosorb Sand Tinuvin 326 achieved about the same level of protection. The second figure in the Bracht declaration shows the same result as in the first figure, but also contains data for 4% Tinosorb S. Bracht Deel. 7. There is no comparison to Tinuvin 326 at 4% so it cannot be ascertained 14 Appeal2017-008707 Application 14/607,861 whether less Tinosorb S is needed to achieve the same level of protection of Tinuvin 326 at 4%. However, as recognized by Appellants, it appears that the protection level for Tinosorb S maxes out at 2%, while Tinuvin 326 maxes out at 3%. Appeal Br. 18 ("ceiling of protection"). Thus, the evidence supports "unexpected results" for a concentration of 2% Tinosorb S, but not 3% or 4%. In sum, we agree that Dr. Bracht has provided evidence of an unexpected result for at least a concentration of 2% of Tinosorb S. However, for the reasons explained above, the data does not support the argument that amounts of 3 % and 4 % achieve the same unexpected result in comparison to Tinuvin 326. The results are not commensurate with the full scope of claim 25. Harris, 409 F.3d at 1344. In addition to this, only one active ingredient was tested. Appellants have not demonstrated that the same level of protection would be shown for other active ingredients that fall within the scope of the claims. This analysis is consistent with the prosecution of the '013 patent, which is an ancestor and divisional of the '861 Application involved in this appeal. The same Bracht declaration was filed in U.S. Pat. Appl. No. 11/416,148 which matured into the '013 patent. The claims were rejected by the Examiner based on Schumacher, Decker, Ye, and either Podhaisky or Seyler. Appellants appealed the rejection to the Patent Trial and Appeal Board. Appeal Brief filed in U.S. Pat. Appl. No. 11/416,148 ("the '013 Appeal Br."). Claim 1 of the rejected claims in the appeal was directed to a TTS with Tinosorb Sin a concentration of from 1.0 to 4.0%. '013 Appeal Br. 19. In response to the Brief, the Examiner proposed an amendment to the claims, which was agreed upon by Appellants, narrowing the range 15 Appeal2017-008707 Application 14/607,861 "from 1.0 to 4%" to "from 0.5 to 2%" and limiting the active ingredient in the TSS to comprising "at least one hormone." Notice of Allowance in the '013 patent (Examiner's Initiated Interview Summary and Examiner's Amendment). The Examiner explained in the Interview Summary that the amendments proposed the amendment "to craft claims that were reasonably commensurate in scope with the limited showing of unexpected results." Id. The claims in this appeal are not so limited. SUMMARY For the foregoing reasons and those of the Examiner, the obviousness rejection of claims 25, 42, and 43 are affirmed. Claims 26-41, 44--46, 62, and 63 were not argued separately and fall with claims 25, 42, and 43. 37 C.F.R. § 41.37( c)(l )(iv). REJECTIONS 2--4 Except for claims 42 and 43 (Appeal Br. 21 ), Appellants rely on the same arguments for rejections 2 through 4 as for claim 25. Appeal Br. 20- 23. We thus affirm rejections 2, 3, and 4 listed above for the same reasons and those of the Examiner. Appellants' arguments for claims 42 and 43 were addressed above. REJECTION 5 Appellants traverse the obviousness-type double patenting rejection based on the '013 patent, but do not provide substantive arguments as to why the rejection is improper. Accordingly, the rejection is summarily affirmed for the reason provided by the Examiner. 16 Appeal2017-008707 Application 14/607,861 TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 17 Copy with citationCopy as parenthetical citation