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
Election/Restrictions and Status of the Claims
Applicant’s addition of new claim 69 in the response filed on February 12th 2026 is acknowledged. Claims 1-7, 10-16, 20-38, 56, and 63-69 are pending. Claims 4-7, 13-16, 23, 33-38, and 63-68 are withdrawn as being directed towards nonelected species. Claims 1-3, 10-12, 20-22, 24-32, 56, and 69 are examined on their merits.
Response to Arguments
Applicant’s arguments in the response filed on February 12th 2026 are acknowledged. Applicant argues that the instant compounds require a breaking of symmetry in the breaking of a single linker position and one of ordinary skill in the art would not reasonably expect that breaking said symmetry would result in a preservation of glutamine transport inhibition activity. Applicant’s argument is found not persuasive.
As a preliminary matter, Applicant does not argue the commonality of homologation in drug design, but only that one of ordinary skill in the art would not reasonably break the symmetry of the compounds demonstrated in the art. While Examiner acknowledges that such symmetry in linker-chain lengths exists in the compounds of Broer and U.S. Patent No. 10,793,514 (‘514 Patent), in neither case is such symmetry discussed or even suggested as a determining factor in glutamine transport uptake activity. Furthermore, compounds are presented in the ‘514 Patent wherein both m=n=1 and m=n=0. One of ordinary skill in the art would thereby at least acknowledge the variance in chain length as a possibility.
As evidence, applicant cites Schulte’s 2016 paper and states that said paper demonstrates unpredictability in the art, even between “close” analogs. However, the cited Schulte paper does not provide any discussion of symmetry as a determining factor in glutamine transport uptake activity. As described by Applicant, the paper does provide a comparison in activity between analogs wherein m=n=1 or m=n=0. In each case, however, while the glutamine transport uptake activity varies between analogs, the activity is still present. That is, one of ordinary skill in the art would recognize that some activity will be preserved when varying the linker-chain length. Furthermore, as such variance in activity is observed, one of ordinary skill in the art would recognize linker-chain length as a factor in the biological activity of the compounds and would be motivated to find the optimal m and n chain lengths that maximize inhibition of glutamine transport uptake activity. Thus, the variance in chain length of the compounds via a homologation strategy is prima facie obvious and the 103 rejections and nonstatutory double patenting rejections are maintained.
35 U.S.C. § 103 Rejections Maintained
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.
The rejection of claims 1-3, 10-12, 20-22, 24-32, and 56 under 35 U.S.C. 103 as being unpatentable over Broer (Broer et al., Front. Pharmacol., 18 July 2018 Sec. Pharmacology of Anti-Cancer Drugs Volume 9 – 2018) in view of Ing (Ing, H.R. (1964). The Pharmacology of Homologous Series. Progress in Drug Research vol 7. 1964, pg. 306) is maintained.
The claims are directed towards a compound of Formula I:
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wherein m and n are not equivalent.
Broer teaches the compounds,
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(Broer, pg. 3).
Broer’s compounds differ from applicant’s compound genus only in that both m and n equal 1. One of ordinary skill in the art would have had a reasonable expectation of success in modifying Broer’s compounds to come upon applicant’s compound genus, because this difference amounts to homologation of a carbon chain. Such a drug modification technique is long-known to be commonplace in the field of drug design. See Ing:
It is the common practice of organic chemists who are concerned with the discovery of new drugs to take some compound which is known, or has been unexpectantly found, to possess some interesting or clinically desirable pharmacological properties, as a model, and to study the effect of making relatively small changes in its structure. The simplest chemical change that can be made is to alter the size of an alkyl group or of a polymethylene chain; in other words to investigate the pharmacology of a homologous series. An investigation of this type not only has practical advantages, such as ease of preparation of homologues, the small changes in physical and chemical properties involved, etc. but also it has frequently led to the discovery of highly active drugs. Moreover there is the theoretical likelihood that a detailed study of homologous compounds may reveal mechanisms of drug action which could not be revealed by a study of drugs differing more fundamentally in structure.
[Ing, pg. 306]
As one of ordinary skill in the art would have reasonably either lengthened or shortened one of the m/n chains of Broer’s compounds to come upon applicant’s compound genus, claims 1-3, 10-12, 20-22, and 24-30 are prima facie obvious.
Claim 32 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutical carrier. Broer teaches the inhibition of glutamine transport and the resulting decrease in cancer cell proliferation with Broer’s compounds (Broer, pg. 6). Scaling the administration of the compound to humans would necessarily be done in a pharmaceutical composition, and claim 32 is therefore prima facie obvious.
Claim 56 is directed towards a therapeutic or prophylactic agent for cancer, which comprises the compound of claim 1 or a pharmaceutically acceptable salt thereof. As the intended use of a compound is not patentably distinct from the compound itself, claim 56 is prima facie obvious.
The rejection of claim 31 under 35 U.S.C. 103 as being unpatentable over Broer (Broer et al., Front. Pharmacol., 18 July 2018 Sec. Pharmacology of Anti-Cancer Drugs Volume 9 – 2018) in view of Ing (Ing, H.R. (1964). The Pharmacology of Homologous Series. Progress in Drug Research vol 7. 1964, pg. 306) and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012) is maintained.
Claim 31 is directed to a series of particular compounds falling into applicant’s genus of claim 1. One such compound is compound 21:
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Compound 21 differs from Broer’s compound V-9302 in just the homologation of the m chain (see the above 103 rejection of claim 1) and the replacement of a methyl group with a chlorine group. The replacement of a methyl group with a halogen is considered one of the most common classical bioisosteric replacements in the art of drug design (Brown, pg. 17). One of ordinary skill in the art would therefore have a reasonable expectation of success in developing applicant’s compound 21, and claim 31 is prima facie obvious.
35 U.S.C. § 103 Rejections Necessitated by Amendment
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Broer (Broer et al., Front. Pharmacol., 18 July 2018 Sec. Pharmacology of Anti-Cancer Drugs Volume 9 – 2018) in view of Ing (Ing, H.R. (1964). The Pharmacology of Homologous Series. Progress in Drug Research vol 7. 1964, pg. 306) and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012).
Claim 31 is directed to the compound of claim 1 wherein Ar1 and Ar2 are different. One such compound is compound 21:
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Compound 21 differs from Broer’s compound V-9302 in just the homologation of the m chain (see the above 103 rejection of claim 1) and the replacement of a methyl group with a chlorine group. The replacement of a methyl group with a halogen is considered one of the most common classical bioisosteric replacements in the art of drug design (Brown, pg. 17). One of ordinary skill in the art would therefore have a reasonable expectation of success in developing applicant’s compound 21, and claim 69 is prima facie obvious.
Nonstatutory Double Patenting Rejections Maintained
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.
The rejection of claims 1-3, 10-12, 20-22, 24-32, and 56 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,793,514 in view of Ing (Ing, H.R. (1964). The Pharmacology of Homologous Series. Progress in Drug Research vol 7. 1964, pg. 306) and in further view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012) is maintained.
The reference patent teaches compounds identical to those in Broer (see above):
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(reference patent, claim 2),
as well as pharmaceutical compositions of the compound (reference patent, claim 17), and the treatment of cancer with the compound (reference patent, claims 18-20).
For the teachings of Ing and Brown as they relate to the obviousness of claims 1-3, 10-12, 20-22, 24-32, and 56 over the two above compounds, see the above 103 rejections over Broer, Ing, and Brown.
Conclusion
THIS ACTION IS MADE FINAL. 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629