Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
This action is in response to claim amendments filed 11/17/25. Claims 1, 3, 6, 7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 are pending and under examination.
Withdrawn Rejections
The claim objection is withdrawn in light of the amendments.
The rejection under §112(d) is withdrawn in light of the amendments.
The rejection under §103 over Daley is withdrawn. Applicant has amended the claims to place the limitations of claim 28 into claim 1; the limitations of previous claim 28 were not obvious over Daley alone.
The §103 rejection including Riddell is withdrawn; the amendments have removed any limitation to BMS-986115, which renders the Riddell document presently unnecessary.
The double patenting rejection over 18/162821 is withdrawn; the co-pending application was abandoned.
The double patenting rejection over 11504354 is withdrawn. As stated in the non-final mailed 5/19/25, previous claim 2 was not subject to a rejection over this document. As the limitations of previous claim 2 are now in claim 1, the rejection is withdrawn.
Maintained Rejections and New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 50 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new rejection necessitated by amendment.
Claim 50 depends from claim 2; however, claim 2 has been canceled. Thus, claim 50 is per se indefinite as there is no way of determining the metes and bounds of “the method of claim 2” as recited in claim 50.
For the purpose of prosecution, claim 50 will be treated as depending from claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 17-18, 24-25, 30, 34, 37-38, 41, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daley (WO2018201051; previously cited) in view of Kummar (previously cited). This rejection has been modified solely to address the amendments.
Regarding claim 1, Daley discloses a method of treating a disease associated with expression of B-cell maturation antigen (BCMA; claim 2; p.2 L10-11), specifically cancer like multiple myeloma (MM) (p.1 L33-35; p.2 L11-12), by administering a composition comprising a BCMA-targeting antibody drug conjugate and a gamma-secretase inhibitor (GSI), noting that the combined therapy enhances potency and activity of the therapy (see claims 1-4; Fig. 10A-C; Example 1 on page 192). It is noted that CAR-T therapy is listed with other BCMA-targeted therapies; nevertheless, these are disclosed in a small list (four items) all related to antibody-based BCMA targeting therapies with a known efficacy. Therefore, it would have been obvious to a person of ordinary skill in the art to combine one of these known BCMA-therapies, specifically CAR-T, with a gamma secretase inhibitor to treat cancer based on the known efficacy of these treatments individually as well as the known benefit to combining these therapies. Daley discloses nirogacestat as an exemplary GSI and demonstrates the efficacy of this compound (figure 9; p.25 L12-17; p.49 L14). Nirogacestat has the formula of instant compound 1; see claim set filed 7/15/22 where claim 50 (nirogacestat) depended from claim 2 (Compound I) and therefore must meet those limitations.
Further, Daley discloses adjusting the dosage regimens based on the desired outcome; see p. 151 “Dosage regimens are adjusted to provide the desired response (e.g., a therapeutic response).”; p. 152 “Dosages and therapeutic regimens of the BCMA-targeting agent (e.g., an anti-BCMA antibody molecule or a recombinant non-antibody protein that binds to BCMA) can be determined by a skilled artisan.”; p. 163 “When administered in combination, the BCMA-targeting agent, GSI, and/or the additional agent, or all, can be administered in an amount or dose that is higher, lower or the same than the amount or dosage of each agent used individually, e.g., as a monotherapy.” However, Daley is silent regarding nirogacestat dosage.
Kummar teaches administering tumor patients with 150 mg PF-03084014 (nirogacestat in hydrobromide salt form; instant specification p.13) twice daily in 3-week cycles (see abstract).
Nevertheless, one of ordinary skill in the art at the time of filing would have found it obvious to use known therapeutic doses of the GSI nirogacestat. Kummar teaches 150 mg one or twice per day, which is such a dose and falls within the instantly claimed range. Further, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP §2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05(II). As stated in the MPEP, “it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions” (MPEP §2144.05(II)(A)).
Regarding claim 17, Daley teaches administering one of the treatments before the other (p.163 L 11; L29-31), rendering such a choice obvious.
Regarding claim 18, Daley would have made obvious treatment of multiple myeloma as described with respect to claim 1. This is also described in Daley at, e.g., p.174 L36 and Example 1 (p.192).
Regarding claims 24-25, Daley teaches administration of the above combination of therapeutics (“of the present invention”) further in combination (“before, simultaneously, or following”) with fludarabine or cyclophosphamide “(p.184 L8-20).
Regarding claim 30, the once or twice a day for a three-week cycle of Kummar is, e.g., once or twice daily for at least one week.
Regarding claim 34, the instant application has no definition of “about”. As the dose of Kummar (150mg) is also therapeutic, it is reasonably considered “about” 100mg. Further, routine optimization, differences in concentration, and changes of proportion analysis above applies here.
Regarding claim 37, Daley discloses administration of both compounds simultaneously (see above) and administration orally (p.151 L21-22). Thus, administering the GSI orally would have been a known, obvious route of administration. Additionally, Kummar teaches nirogacestat is therapeutic when administered orally (abstract).
Regarding claim 38, Daley discloses the therapeutic composition as a suspension (p.150 L9) and as tablets (p.151 L25). See above for obviousness of combining the compositions.
Regarding claim 41, this claim describes a property that flows from the combination itself and therefore inherently flows from the active steps of the method, which would have been obvious as above. Applicant's attention is directed to MPEP § 2112 (II), which states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. The court has noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003). See MPEP § 2111.04). However, it is also noted that this increased efficacy is explicitly disclosed by Daley as noted above.
Regarding claim 50, the compound being nirogacestat would have been obvious as described above. Further, Daley discloses pharmaceutical salts including hydrobromide (p.39 L25).
Therefore, claims 1, 17-18, 24-25, 30, 34, 37-38, 41, and 50 would have been obvious.
Claim(s) 1, 3, 6-7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daley (WO2018201051) in view of Kummar as applied to claims 1, 17-18, 24-25, 30, 34, 37-38, 41, and 50 above, and further in view of Kuo (US20160297884; previously cited). This rejection has been modified solely to address the amendments.
The teachings of Daley and Kummar are discussed above and are incorporated herein. As noted, Daley discloses the benefits of BCMA CAR-Ts in treating cancer. Daley does not disclose the specifics of the CAR-T therapy.
Kuo is also concerned with using BCMA CARs to treat cancer (abstract). Kuo discloses certain specifics of CAR-T therapeutics for treating cancer.
Regarding claim 3, it would have been obvious to one of ordinary skill in the art at the time of filing to use CAR-Ts known to be effective in targeting BCMA and treating cancer because Daley teaches the benefits of this therapy. Kuo teaches one such BCMA CAR-T comprises scFvs (e.g., paragraphs 53, 94, 95, and 242), where the antibody comprises in the VH/VL the sequences wherein, e.g., VH1 is Seq 150, VH2 is 153, VH3 is 155, VL1 is 209, VL2 is 221, and VL3 is 222 (paragraph 12); the SEQ ID Nos in Kuo are identical to those same SEQ ID NOs in the instant application. Thus, it would have been obvious to use a BCMA CAR-T with the sequences of Kuo in the method of Daley/Kummar because both Daley and Kuo disclose the efficacy of BCMA CAR-T in treating cancer and Kuo provides the sequences of the antibody for the useful therapeutic.
Regarding claims 6-7, the reasons for combination are the same as for claim 3. Kuo teaches an effective antibody comprises VH SEQ ID NO: 33 and VL SEQ ID NO: 34 (paragraph 104), which are identical to instant SEQ ID NOs: 33 and 34.
Regarding claim 9, the reasons for combination are the same as for claim 3. Kuo teaches an effective antibody comprises SEQ ID NO: 344, which is identical to instant SEQ ID NO: 344 (table 5; P5A-V2).
Regarding claim 10, Kuo teaches SEQ ID NO: 344 as above, which is a CAR. Further, Kuo teaches the CAR may comprise a CD20 epitope (paragraph 23). Thus, it would have been obvious to include this epitope because Kuo explicitly suggests this.
Regarding claim 13, using the CAR of Kuo in the method of Daley/Kummar would have been obvious as above. Further, as noted, Kuo discloses the particular structure of certain CARs and it would have been obvious to use those elements which are explicitly suggested in the art, such as by Kuo. Further, the SEQ ID NOs of Kuo are identical to the instant SEQ ID NOs. Thus, the instant claim would have been obvious because Kuo teaches including:
CD8 alpha signal peptide having the SEQ ID NO 318 (table 3)
A VH having SEQ ID NO: 112 (table 1)
A GS linker of SEQ ID NO: 333 (paragraph 95)
A VL having SEQ ID NO: 38 (table 1)
A CD20 epitope having SEQ ID NO: 398 (paragraph 180)
A CD8 alpha hinge of SEQ ID NO: 320 (table 3)
A CD8 transmembrane domain having SEQ ID NO: 322 (table 3)
A 4-1BB intracellular signaling domain having SEQ ID NO: 323 (table 3), and
A CD3 intracellular domain having SEQ ID NO: 324 (table 3).
It is appreciated that obviousness cannot be found by the mere disclosure of disparate elements. However, a person of ordinary skill in the art would have recognized that a CAR-T may have many components, including based on the disclosure of Kuo. Kuo describes these elements in turn, suggesting their inclusion as well as providing the above sequences as exemplary sequences for those components. This is sufficient motivation for one of ordinary skill in the art to have selected these known elements to use for their known purpose to create a CAR-T with a predictable expectation of success.
Regarding claim 20, Kuo teaches a dose of 3 million cells in a single dose, i.e., 3x10^6 cells/dose (paragraph 230) as well as 4x10^6 CAR-expressing T cells (paragraph 237). Kuo also recognizes the amount as a result-effective variable, noting that a dose may be 10^5-10^6 cells per kg of body weight (paragraph 188) thereby recognizing a range that overlaps with the instant range (1x10^6-1x10^7) which varies based on weight. For example, a 0.5kg male rat would receive 2x10^6-2x10^7 cells/dose; given that the same therapeutic effect is achieved and there is no definition of “about” in the instant application, any of these doses, e.g., 4x10^6, is reasonably considered “about” 7x10^6. Additionally, the amount may also be separated into many doses (paragraph 188), offering another avenue to optimize the amount of cells per dose. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP §2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05(II). As stated in the MPEP, “it is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions” (MPEP §2144.05(II)(A)).
Therefore, claims 1, 3, 6-7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 would have been obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Note that Applicant’s portfolio of applications directed to GSI, CAR-T, and using one or both of these to treat cancer, is extensive. While the Examiner has done their best to identify these applications and patents as well as articulate the reasoning for finding the claims obvious, Applicant is in the best position to identify co-pending applications and patents that use GSIs to treat cancer, BCMA CAR-T cells to treat cancer, or combination therapy of these two therapeutics to treat cancer.
Claims 1, 3, 6-7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 32-43, and 45-48 of copending Application No. 17/602434 in view of Daley, Kummar, and Kuo.
Reference claim 30 is a method of treating BCMA-expressing cancer (a method of treating cancer) comprising administering belantamab mafodotin (a BCMA antibody) and nirogacestat. Thus, the difference between instant claim 1 and reference claim 30 is in the choice of BCMA binding therapeutic. However, as discussed above in detail and incorporated herein, Daley teaches an alternative BCMA therapeutics—CAR-T cells—which are effective for treating cancer in combination with GSIs including nirogacestat and Kuo teaches specific forms of those CAR-T cells that are effective for treating cancer. It would have been obvious to combine these references to substitute the instantly claimed BCMA binding therapeutic into the method of the reference claims because the instant BCMA binding therapeutic was a known cancer therapeutic also known to be combined with GSI to obtain superior results. Instant claims 1 and 50 are drawn to nirogacestat, which is the claimed GSI of the reference claims (claim 1).
The reference claims are also directed to the dosing (claim 32-33), dosing regimen (claim 34-35), treating multiple myeloma (claim 36), and receiving previous chemotherapy (claim 38-39). The remaining details of the instant claims would have been considered an obvious variation of the reference claims based on the teachings of Daley, Kummar, and Kuo as discussed above in the 103 rejection and incorporated herein.
This is a provisional nonstatutory double patenting rejection as the co-pending application has not issued as a patent at the time of writing.
Claims 1, 3, 6-7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 16, 22-29, 31, 33-42 of copending Application No. 17/906089 in view of Daley, Kummar, and Kuo.
Reference claim 1 is a method of treating cancer comprising administering a BCMA chimeric T-cell (reference claim 34/35) and nirogacestat. The reference claims are also directed to treating multiple myeloma (claim 5), the dosing (claim 16, 22-25), receiving previous chemotherapy (claim 29), and dosing regimen (claim 33, 41). The remaining details of the instant claims would have been considered an obvious variation of the reference claims based on the teachings of Daley, Kummar, and Kuo as discussed above in the 103 rejection and incorporated herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 6-7, 9-10, 13, 17-18, 20, 24-25, 30, 34, 37-38, 41, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16-33 of copending Application No. 18/440869 in view of Daley, Kummar, and Kuo.
Reference claim 1 claims a method of treating ovarian cancer (a species of the instantly claimed “cancer”) by administering nirogacestat (reference claim 1). The reference application does not claim the inclusion of a CAR-T. However, as discussed above in detail and incorporated herein, Daley teaches CAR-T cells are also effective for treating cancer, particularly in combination with GSIs including nirogacestat and Kuo teaches specific forms of those CAR-T cells that are effective for treating cancer. It would have been obvious to combine these references to include the instantly claimed BCMA binding therapeutic into the method of the reference claims because the instant BCMA binding therapeutic was a known cancer therapeutic also known to be combined with GSI to obtain superior results. The remaining details of the instant claims would have been considered an obvious variation of the reference claims based on the teachings of Daley, Kummar, and Kuo as discussed above in the 103 rejection and incorporated herein.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 11/17/25 have been fully considered but they are not persuasive.
Regarding the §103 rejection over Daley/Kummar, Applicant argues there is no reasonable expectation that that amounts of the GSI used in Kummar to treat desmoid tumors would also treat BMCA-associated cancer in Daley. Applicant argues this is because Kummar teaches Notch is the substrate being acted upon in Kummar while Daley teaches that BMCA is the substrate.
This argument has been fully considered but is not persuasive. First, Applicant has advanced no reasoning nor objective evidence to suggest that nirogacestat was expected to act on the different substrates with surprisingly varied or unpredictable results. Other than Applicant’s bare assertion that one would not expect the GSI to function on another known substrate, there is no support nor evidence of this statement. Applicant is reminded that “arguments of counsel cannot take the place of factually supported objective evidence" (MPEP§2415)
Second, while there may have been some expectation that the efficiency would vary—though this has not been established—this still meets the bar for reasonable expectation. Nirogacestat was known to act on both of these substrates as agreed upon by Applicant, who cites this knowledge from the prior art documents. Further, Daley explicitly states that the GSI is more effective at inhibiting cleavage of BCMA, e.g., p.3 L3-5. There is no reason to expect that an amount of a GSI which is effective to treat cancer via inhibition of Notch cleavage (Kummar) would fail to inhibit cleavage of BCMA at those same doses, particularly when the art recognized the inhibitor was more effective in the latter case. The fact that Kummar teaches an effective dose of a known drug to treat cancer provides sufficient expectation that the same dose would also be effective when inhibiting another known substrate, where the drug is more effective at inhibiting the second (BCMA) substrate.
Applicant further argues that one would not be motivated to apply the dosage used to treat desmoid tumor to treat BCMA cancers. As above, Applicant offers no scientific reasoning nor any objective evidence to support this assertion and “arguments of counsel cannot take the place of factually supported objective evidence" (MPEP§2415). In contrast, there is a clear expectation to apply the GSI as set forth in the rejection and in this response. Briefly, both cancers respond to GSIs, nirogacestat inhibits the cleavage of both Notch (desmoid tumors) and BCMA (BCMA tumors), and so one informed of the therapeutic potential of GSIs by Daley would look to known, effective GSIs such as those in Kummar. The argument that the two are non-analogous art simply because the documents exemplify different cancers is insufficient to outweigh the extensive evidence and reasoning provided.
Finally, these arguments do not address the second rationale set forth in the rejection: routine optimization. Where the differences are solely in the “therapeutic amount”, this is generally not sufficient to support a patent. In this case, there is not even such a difference: the claims are directed to a known amount of a known drug which is known to treat cancer. Applicant claims a range of “about” 20 mg to “about” 440 mg (20 mg once up to 220 mg twice) per day with no guidance on what constitutes “about”. The art clearly recognizes the amount as a result-effective variable and there is no objective evidence provided to support any allegation of non-enablement or unpredictability.
Applicant makes no unique arguments regarding the inclusion of Kuo. As the rejection was modified as necessitated by amendment, the argument that Daley/Kuo do not teach the limitations of previous claim 28 is not persuasive as the inclusion of Kummar arrives at these limitations.
Regarding the double patenting rejections, Applicant requests the rejections be held in abeyance. This is not a proper reply. Nonstatutory double patenting rejections, including provisional rejections, are not held in abeyance (MPEP §804(I)(B)(1)).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/Primary Examiner, Art Unit 1675