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 .
DETAILED ACTION
1. Applicant's amendment, filed 05/25/26 is acknowledged.
2. Claims 1,2, 7, 8-10,12,13,15,17,19,20,23,25,28,31,37,40, 43,47-49,56,58,61, are pending.
Claims 1,2,7, 8-10,12,13,15,17,19,20,23,25,28,31,37,40, 43,47-49,56,58,61 read on a method of treating GREM1-expressing cancer in a subject comprising administering an effective amount of GREM1 antagonist are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 05/25/26
3. 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.
4. Claims 1,2, 7, 8-10,12,13,15,17,19,20,23,25,28,31, 43,47-49,56,58,61 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20230192831 or US Parent Application 20210253688 in view of newly cited US Patent Application 20210062269.
Applicant’s arguments filed on 05/25/26 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claim now recited that the subject is receiving or has received an androgen deprivation therapy or is resistant to said therapy. None of the prior art reference teaches said feature.
Newly cited US Patent Application 269 teaches that various AR expressing cancer, including lung cancer, prostate cancer , skin cancer, etc can be treated with androgen-deprivation therapy ( see entire document paragraphs 0480 and 0481 in particular)
US Patent Application’831 teaches a method of treating GREM-1 expressing cancer on the patient comprising administering to the patient an effective amount of anti-GREM1 antibody. US Patent Application’831 teaches thar said cancer can be sarcoma or lung cancer of prostate. US Patent Application’831 teaches that administering of anti-GREM1 antibody can be combine with second therapeutic agent ( see entire document, paragraphs 0010, 0012, 0026, 0040, 0043 0052 in particular).
US Patent Application’688 teaches a method of treating GREM-1 expressing cancer on the patient comprising administering to the patient an effective amount of anti-GREM1 antibody. US Patent Application’688 teaches thar said cancer can be sarcoma or lung cancer of prostate. US Patent Application’688 teaches that administering of anti-GREM1 antibody can be combine with second therapeutic agent ( see entire document, paragraphs 0002, 0019, 0035, 0067, 0085, 0095, 0154 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use androgen-deprivation therapy taught by US Patent’269 in a method of treating GREM-1 expressing cancer taught by US Patent Application’831 or US Patent Application’688 with a reasonable expectation of success because the prior art suggests that androgen-deprivation therapy is successfully use for treating of AR expressing cancer.
“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 of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
It is noted that though US Patent Application’831 or US Patent Application’688 does not explicitly teaches that anti-GREM1 antibody are capable of binding a second antigen, said functional properties would be an obvious properties of the recited anti-GREM1 antibody, because the recited and instantly claimed anti- GREM1 antibody are the same in the absence of evidence of structural difference. Thus the reference antibody would inherently/obviously performed the intended use. If the prior art structure is capable of performing the intended use, then it meets the claim. When a claim recites using an old composition or structure (e.g. anti-GREM1 antibody)) and the use is directed to a result or property of that composition or structure then the claim is anticipated/obviouse. See MPEP 2112.02. Also, see Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 58 USPQ2d 1508 (CA FC 2001); Ex parte Novitski 26 USPQ 1389 (BPAI 1993); Mehl/Biophile International Corp. V. Milgraum, 52 USPQ2d 1303 (Fed. Cir. 1999); Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999).
Claims 49, 56,58, 59 are included because it would be conventional and within the skill of the art to : (i) identify and administered an optimal type of the second therapeutic agent or cancer drug Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
"The test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965).
5. 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.
6. The claims 1,2, 7, 8-10,12,13,15,17,19,20,23,25,28,31, 43,47-49,56,58,61 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application No. 18/261834 in view of newly cited US Patent Application20210062269.
Claims of copending Application No. 18/261834 recited a method of treating a GREM1-expressing cancer comprising administering anti-GREM1 antibody.
Newly cited US Patent Application 269 teaches that various AR expressing cancer, including lung cancer, prostate cancer , skin cancer, etc can be treated with androgen-deprivation therapy ( see entire document paragraphs 0480 and 0481 in particular)
It would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use androgen-deprivation therapy taught by US Patent’269 in a method recited in claims of copending Application No. 18/261834 with a reasonable expectation of success because the prior art suggests that androgen-deprivation therapy is successfully use for treating of AR expressing cancer.
“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 of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
7. Claims 37 and 40 stand objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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