Ex Parte RUBIN

Patent Trial and Appeal BoardJan 8, 2019

14051043 (P.T.A.B. Jan. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/051,043 10/10/2013 Arkady RUBIN 122066 7590 01/10/2019 M&B IP Analysts, LLC 500 Headquarters Plaza Morristown, NJ 07960-7070 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. ARST P0103 3355 EXAMINER BARSKY, JARED ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 01/10/2019 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): pair@mb-ip.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ARKADY RUBIN 1 Appeal2017-011596 Application 14/051,043 Technology Center 1600 Before FRANCISCO C. PRATS, JAMES A WORTH, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal2 under 35 U.S.C. Â§ 134 of the Examiner's rejection of claims to a method for relieving menstrual pain and reducing menstrual blood loss which have been rejected for non-statutory obviousness-type double patenting and as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellant identifies the Real Party in Interest as ARSTAT, Inc. Br. 3. 2 We have considered and herein refer to the Specification of Oct. 10, 2013 ("Spec."); Non-Final Office Action of June 9, 2016 ("Non-Final Act."); Appeal Brief of Mar. 8, 2017 ("Br."); and Examiner's Answer of June 29, 2017 ("Ans"). Appeal2017-011596 Application 14/051,043 STATEMENT OF THE CASE "Menstrual disorders affect the lives of millions of women. Painful menstrual periods associated with heavy menstrual bleeding often require medical attention and initiation of appropriate therapy." Spec. 1. Non- steroidal anti-inflammatory drugs (NSAIDs) are currently considered the most appropriate initial therapy for menstrual pain. Spec. 2. NSAIDs have also been shown to reduce menstrual blood loss. Spec. 3. The Specification describes a method for treating "menstrual pain and reducing excessive menstrual blood loss ... without the undesirable side effects of currently recommended doses for oral medications." Spec. 5. Claims 1-9, 11-19, and 21-24 are on appeal. Claim 1 is representative and reads as follows: 1. A method for relieving menstrual pain and reducing menstrual blood loss in a female comprising: administering to the female an oral combination drug formulation comprising a first therapeutically effective dose of a non-steroidal anti-inflammatory drug (NSAID) and a second complementary low dose of tranexamic acid, wherein the NSAID is formulated to relieve the menstrual pain and to reduce a volume of menstrual blood loss of the female, wherein the dose of tranexamic acid ranges from 50 mg to 250 mg per the oral combination drug formulation. The claims stand rejected3 as follows: 3 Claims 1-9, 11-19 and 21-24 were rejected for non-statutory obviousness- type double patenting over USSN 14/041,501. Ans. 9. USSN 14/041,501 has been abandoned rendering the rejection moot. Notice of Abandonment filed May 12, 2017. 2 Appeal2017-011596 Application 14/051,043 Claims 1-9, 11-19, and 21-24 have been rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Moore4 in view ofLethaby. 5 Claims 1-9, 11-19, and 21-24 have been rejected for non-statutory obviousness-type double patenting over claims 1-7 and 10-16 of co-pending application USSN 13/973 ,394. 6 Claims 1-9, 11-19, and 21-24 have been rejected for non-statutory obviousness-type double patenting over claims 1-10 of co-pending application USSN 13/973,337. 7 DOUBLE PATENTING Appellant has not offered any substantive argument with respect to the rejections for obviousness-type double patenting. Appellant's only argument is that the rejection is premature as no patentable subject matter has been identified in any of the cited applications. Br. 30-31. We therefore summarily affirm the rejections for obviousness-type double patenting. 37 C.F.R. Â§ 4I.37(c)(l)(iv); MPEP Â§ 1205.02. 4 Moore et al., US 2005/0244495 Al, published Nov. 3, 2005 ("Moore"). 5 Lethaby et al., Nonsteroidal anti-inflammatory drugs for heavy menstrual bleeding (Review), Cochrane Database of Systematic Reviews 2007, Issue 4 ("Lethaby"). 6 USSN 13/973,394 was the subject of Appeal No. 2017-008646. We issued our decision in that appeal on Oct. 16, 2018 affirming the rejection of all pending claims. 7 USSN 13/973,337 was the subject of Appeal No. 2017-010273. We issued our decision in that appeal on Dec. 10, 2018 affirming the rejection of all pending claims. 3 Appeal2017-011596 Application 14/051,043 OBVIOUSNESS Issue 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 Moore combined with Lethaby. The Examiner finds that Moore teaches compositions comprising tranexamic acid for treating bleeding during menstruation. Ans. 3. The Examiner finds that Moore discloses dosages of 375 mg and 650 mg of a modified release formulation which is the equivalent of immediate release formulations of 300 mg to 468. 7 mg. Id. at 4. The Examiner also finds that Moore discloses daily dose concentration of at least 750 mg. Id. The Examiner finds that Moore does not teach the co-administration of an NSAID. Id. The Examiner finds that Lethaby teaches methods for controlling menstrual bleeding using NSAIDs. Id. The Examiner also finds that Lethaby teaches that NSAIDs may help with dysmenorrhea (menstrual pain). Id. at 4--5. The Examiner concludes It would have been prima facie obvious to combine the teachings of Moore and Lethaby to arrive at the instantly claimed method. One would have been motivated to do so because both compounds (i.e., tranexamic acid and mefenamic acid, e.g.) were taught to be administered to the same subject population through various routes of administration to treat heavy menstrual bleeding, e.g. According to M.P.E.P. Â§ 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea 4 Appeal2017-011596 Application 14/051,043 of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,850,205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) Ans. 5 ( emphasis omitted). The Examiner finds that neither Moore nor Lethaby teach the claimed dosages. Ans. 7. The Examiner finds it would be prima facie obvious to optimize the dosages of two drugs both known for use through administration to the same subject population to treat the same disorders. One would be motivated to do so with a reasonable expectation of success because the prior art teaches using 375 mg tranexamic acid and the instant claims have been amended to recite 325 mg, which may fluctuate from 80-125% of the plasma concentration of an a subject administered an immediate release formulation. As such, the same effect could be provided to a subject when a higher dosage is gradually released and when a lower dosage is immediately released into a subject's bloodstream. Overall, the prior art combination is obvious as discussed above for two reasons: (1) optimization would be achievable through routine experimentation, absent evidence to the contrary; and (2) based on the higher dosage of a sustained release formulation taught by the prior art, as compared to a lower dosage of an immediate release formulation as claimed, it is not clear that the concentration of API entering a subject's bloodstream at a given time is non-identical. Additionally, based on the teachings of prior art claims 42 and 43 of Moore an identical amount is administered daily to the same subject population. As such, the only difference is the number of administrations daily. The examiner believes that a prima facie case of obviousness has been established, as discussed above, on the basis that the instant claims modify the dosage of two agents that are combined to treat a same subject population that each agent is taught to treat when administered independently. Applicant can offer secondary considerations, such as unexpected results, to 5 Appeal2017-011596 Application 14/051,043 overcome a prima facie showing of obviousness. However, there does not appear to be unexpected results of record. Ans. 7-8 ( emphasis omitted). Appellant contends that the claims are directed to a method for treating heavy menstrual bleeding and menstrual pain and the references are only directed to treating heavy menstrual bleeding. Br. 12-13. Appellant argues that the references do not teach or suggest the specific doses recited in the claims. Br. 13-17. Appellant contends that one skilled in the art would not have been motivated to combine the references to produce the claimed method nor would one skilled in the art have had a reasonable expectation of success. Br. 18-21. Findings of Fact We adopt the Examiner's findings as our own, including with regard to the scope and content of, and motivation to modify or combine, the prior art. Ans. 3-8. The following findings are included for emphasis and reference purposes. FF 1. Moore discloses "modified release oral tranexamic acid formulations and methods of treatment therewith." Moore Abstract. FF2. Moore teaches that the disclosed formulations minimize or eliminate "the undesirable gastrointestinal side effects in patients on oral tranexamic acid therapy, e.g. women treated for menorrhea (heavy menstrual bleeding)." Moore ,r 5. FF3. Moore goes on to teach that the disclosed formulations reduce the concentration of tranexamic acid dissolved in the stomach contents such as e.g., preventing a large bolus of tranexamic acid being introduced in the stomach. The beneficial 6 Appeal2017-011596 Application 14/051,043 effect of this reduced tranexamic acid concentration is to lower the amount of tranexamic acid in the gastric contents so that there are fewer adverse effects with tranexamic acid therapy. This reduction in adverse effects preferably results in improved patient compliance with therapy, because preferably patients will not intentionally miss taking a dose to avoid these adverse side effects. Physicians will also preferably be more likely to initiate and maintain tranexamic acid treatment for their patients because of the reduced patient complaints. Id. ( emphasis added). FF4. Moore teaches It is a further object of certain embodiments of the present invention to provide a modified release oral dosage form comprising tranexamic acid and a modified release material which minimizes or eliminates the undesirable gastrointestinal side effects in patients on oral tranexamic acid therapy while maintaining or improving the therapeutic effect of tranexamic acid. Moore ,r 8. FF5. Moore teaches dosage forms of from 375 mg to 1 gram. Moore claim 15. FF6. Moore teaches that the doses of tranexamic acid can be taken two or three times a day. Moore ,r 18. FF7. Lethaby teaches that NSAIDs help reduce heavy menstrual bleeding. Lethaby 2. FF8. Lethaby teaches "NSAIDs also can have a beneficial effect on dysmenorrhea, a symptom often related to heavy menstrual bleeding." Lethaby 3. 7 Appeal2017-011596 Application 14/051,043 FF9. In the background section the present Specification teaches "Non-steroidal anti-inflammatory drugs (NSAIDs) are currently considered the most appropriate initial therapy for dysmenorrhea." Spec. 2. 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 of unpatentability. If that burden is met, the burden of 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). "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'! 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." Id. at 417. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850 (CCP A 1980). To show criticality of a claimed range, "'it is not inventive to discover the optimum or workable ranges by routine experimentation.' In re Aller, 8 Appeal2017-011596 Application 14/051,043 220 F.2d 454, 456 (CCPA 1955). Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620 (CCPA 1977)." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Analysis We find the Examiner has established that the matter of the claims would have been obvious to one of ordinary skill in the art at the time the invention was made over Moore combined with Lethaby. Appellant has not produced evidence showing, or persuasively argued, that the Examiner's determinations on obviousness are incorrect. Only those arguments made by Appellant in the Brief have been considered in this Decision. Arguments not presented in the Brief are waived. See 37 C.F.R. Â§ 4I.37(c)(l)(iv) (2015). We have identified claim 1 as representative. Claims 8, 9, 11, 12, 19, and 21-24 have been argued separately. The remaining claims fall with claim 1. We address Appellant's arguments below. Appellant begins by pointing out that the claims are directed to treating both heavy menstrual bleeding and menstrual pain. Br. 12-13. Appellant contends that even if Moore and Lethaby were properly combinable, the combined teachings would not lead one of skill in the art to a method which treats both disorders. Id. Appellant argues that Moore does not contain any teaching regarding treating menstrual pain and Lethaby teaches that NSAIDs perform the same as placebos with respect to relieving menstrual pain. Br. 13. We have considered Appellant's arguments and find them unpersuasive. While Lethaby reports that some studies have shown that 9 Appeal2017-011596 Application 14/051,043 NSAIDs perform the same as placebos, in the summary Lethaby teaches that NSAIDs can have a beneficial effect on menstrual pain. FF8. Moreover, the present Specification teaches that NSAIDs are considered the appropriate treatment for menstrual pain. FF9. Lethaby also teaches that heavy menstrual bleeding is often accompanied by menstrual pain. FF8. One skilled in the art would understand from the teachings of Lethaby and common practice in the field that NSAIDS can be used to treat both heavy menstrual bleeding and menstrual pain. Appellant next argues that neither of the references teaches or suggests the specific doses recited in the claims. Br. 13. Appellant contends that Moore discusses specific dosage forms (e.g. amount in each pill) and not specific doses ( amount taken at any given time) as required by the claims. Br. 13-14. Appellant contends that the Examiner improperly equates the dosage form of Moore with the doses recited in the claims. Br. 14. Appellant also contends that the Examiner's calculation that a 375 mg dosage form of Moore yields the equivalent of an immediate dosage form of a 300 mg dose is mistaken. Br. 15. Appellant also argues that Moore teaches daily amounts of tranexamic acid well above the ranges taught in the Specification and recited in the claims. Br. 16-17. Appellant refers to the Declaration 8 of the inventor Mr. Rubin to support its contention that Moore does not teach the doses recited in the claims. Br. 20-21. While we agree with Appellant that Moore teaches higher doses than those recited in the claims, we are not persuaded that the Examiner erred in 8 Declaration under 37 C.F.R. Â§ 1.132, filed Mar. 10, 2016 ("Deel."). 10 Appeal2017-011596 Application 14/051,043 finding the subject matter of the claims obvious. Moore teaches that administration of a large dose of tranexamic acid results in significant side effects, particularly gastrointestinal distress. FF2--4. While Moore addresses the problem by using a modified release composition, we find that that one skilled in the art would be motivated to use the lowest dose of tranexamic acid possible to avoid side effects. Any diminished effect that reducing the amount of tranexamic acid would be offset by the co- administration of an NSAID which is known to reduce menstrual bleeding and reduce menstrual pain. FF7-9. It would have been a matter of routine optimization to find the lowest level tranexamic acid that could be used in combination with an NSAID to achieve the desired results. The Declaration of Mr. Rubin does not persuade us that the Examiner's conclusion of obviousness was in error. The Declaration refers to the results of two studies that purport to show that dosages of less than 500 mg of tranexamic acid were never considered or approved for use in humans. Deel. ,r 19. Copies of the articles referenced by Mr. Rubin are not part of the record. We cannot judge the veracity of Mr. Rubin's statements. Moreover, as discussed above, Moore specifically teaches the desirability of using lower doses of tranexamic acid. FF2--4. Mr. Rubin does not address this teaching of Moore in his declaration. Appellant argues that one skilled in the art would not have been motivated to optimize the dosage form of Moore let alone use an amount of less than 375 mg. Br. 21. We do not agree. As discussed above, Moore teaches the desirability of using a low amount of tranexamic acid to avoid gastrointestinal distress. FF2--4. 11 Appeal2017-011596 Application 14/051,043 Appellant contends that the Examiner's suggested motivation to combine the references is improper in that the references relate to reducing menstrual bleeding and do not teach or suggest relieving menstrual pain as called for in the claims. Br. 18-19. Appellant also argues that Lethaby teaches away from using NSAIDs to treat menstrual pain. Br. 19. Appellant argues that one skilled in the art would not have had a reasonable expectation that combining an NSAID with tranexamic acid would be beneficial in treating both heavy menstrual bleeding and menstrual pain. Id. Appellant's arguments are unpersuasive. As the Examiner points out, the references teach that tranexamic acid and NSAIDs reduce menstrual blood flow. Ans. 17; Moore ,r 4; FF7. Lethaby also teaches that NSAIDs can help menstrual pain. FF8. One skilled in the art seeking to treat both heavy menstrual blood loss and menstrual pain would have been motivated to combine the teachings of the references to develop the claimed treatment method. Moreover, the motivation to combine the references need not be the same as Appellant. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." KSR, 550 U.S. at 419. We are also unpersuaded by Appellant's argument that Lethaby teaches away from using an NS AID to treat menstrual pain. Br. 19. Lethaby clearly teaches that NSAIDs can be beneficial in treating menstrual pain. FF8. Thus, Lethaby "does not criticize, discredit, or otherwise 12 Appeal2017-011596 Application 14/051,043 discourage the" use ofNSAIDs to treat menstrual pain. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Claim 8 While Appellant has argued claim 8 separately, Appellant's only argument is to refer to the arguments made with respect to claim 1. Br. 22. As discussed above, we found the arguments presented with respect to claim 1 unpersuasive. Claims 9 and 11 Appellant has presented the same separate arguments for these claims. In addition to the arguments presented with respect to claim 1, Appellant contends that the references do not teach or suggest treating menstrual bleeding and menstrual pain together. Br. 24. For this reason, one skilled in the art would not have optimized the amount of the components to produce the claimed invention. Id. Appellant also argues that the dosage ofNSAID and tranexamic acid are not result effective variables. Id. Appellant argues that since the dosage of the two drugs are not result effective variables, there would have been no motivation to optimize the dosages. Id. We have considered Appellant's arguments and find them unpersuasive. As discussed above, Lethaby teaches that NSAIDs can be used to treat both heavy menstrual bleeding and menstrual bleeding. FF7 & 8. With respect to the dosage of the drugs, we agree with the Examiner that they are result effective variables. As the Examiner points out the dosage administered can certainly be optimized to achieve the desired bleeding reduction. This is especially true when an NSAID is used concomitantly with tranexamic acid. It would 13 Appeal2017-011596 Application 14/051,043 not be unexpected that when using multiple agents taught and known to reduce heavy menstrual bleeding that less amount of each dosage form would be necessary. Thus, a person of ordinary skill could certainly optimize the concentrations of 2 result-effective variables absent evidence to the contrary. See M.P.E.P. Â§ 2144.05. Ans. 21 ( emphasis omitted). We agree with the Examiner that the subject matter of claims 9 and 11 would have been obvious over Moore combined with Lethaby. Claim 12 While Appellant has argued claim 12 separately, the arguments either rely on the arguments presented from claims 9 and 11, Br. 24--25, or reiterate arguments presented with respect to claim 1. Compare Br. 20-22 with Br. 26-29. For the reasons stated above, we do not find these arguments persuasive. We therefore affirm the rejection of claim 12. Claims 19 and 21-24 While Appellant has argued these claims separately, the argument simply refers to the arguments presented with respect to claims 1 and 9. Br. 29-30. As discussed above, we find those arguments unpersuasive. We therefore affirm the rejection of claims 19 and 21-24. The Remaining Claims Appellant suggests that since the Examiner only provided reasons to reject claims 1, 8, 11, and 12, and thus, considers the others claims non- obvious. Br. 20. We are not persuaded. As the Examiner points out, while the rejection only specifically addressed claims 1, 8, 11, and 12 in the Non- Final Action, the limitations of all the claims were addressed. Ans. 24. 14 Appeal2017-011596 Application 14/051,043 Moreover, the Action specifically stated that all the pending claims were rejected under 35 U.S.C. Â§ 103(a). Non-Final Act. 8. SUMMARY We affirm the rejections for obviousness-type double patenting. We affirm the rejection 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 15