DETAILED ACTION
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 .
Status of the Claims
Claims 8-27 are pending.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Instant application is a continuation of U.S. Application No. 17/008,617, filed 08/31/2020. U.S. Application No. 17/008,617 is a continuation-in-part of U.S. Application No. 16/149,892, filed 10/02/2018. U.S. Application No. 16/149,892 claims benefit of the U.S. Provisional Application No. 62/567,089, filed 10/02/2017. Therefore, the effective filing date is 10/02/2017.
Information Disclosure Statement
The information disclosure statement filed 04/07/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16, 17, 26, and 27 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
These claims recite a pharmaceutical composition “for inhibiting” and “for treating”. This rejection would be overcome if the intended use is removed from the claims, or alternatively, if the claims instead recited a method of inhibiting or a method of treating.
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.
Claims 16, 17, 26, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the administration of the pharmaceutical composition.
These claims recite a pharmaceutical composition “for inhibiting” and “for treating” with no associated method steps involved. This rejection would be overcome by removing the intended use phrases, or alternatively, if the claims instead recited a method of inhibiting or a method of treating.
Claims 16 and 26 are 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.
The inventor or joint inventor should note that claims 16 and 26 are reach-through claims. The claim attempts to obtain protection for subject matter that is prophetic and/or has yet to be invented. Similarly, the metes and bounds of the “HAT malfunction related pathology” are not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on pages 3, describes HAT malfunction related pathology as “Alzheimer, diabetes, hyperlipidemia, as well as in asthma, and COPD”. The specification also teaches that HAT malfunction related pathology includes cancer.
However, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments, including, but not limited to, the above listed diseases. Consequently, the “HAT malfunction related pathology” has been rendered indefinite by the use of the reach-through protocol.
This rejection would be overcome by removing “in a HAT malfunction related pathology” from claims 16 and 26.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 8, 13, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carvallo (Bisamidoximes: Synthesis and Reactions as Tetradentate Ligands, Thesis for Texas Woman’s University College of Arts and Sciences, 1995, pages 1-53).
Carvallo teaches, on page 15, the compound 13g shown below, which is instant compound JJMB9. Compound 13g was a crystalline solid, and by the broadest reasonable interpretation, constitutes a pharmaceutical composition that reads on instant claims 8, 13, and 18.
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Claims 8, 11-13, 18, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (Bisamidoximes: Synthesis and Complexation with Iron (III), Aust. J. Chem., 2007, Vol. 60, pages 685-690).
Johnson et al. teaches compounds 3d, 3e, 3f, and 3g, shown below, which are instant compounds JJMB7, JJMB5, JJMB6, and JJMB9, respectively.
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Compounds 3d, 3e, 3f, and 3g existed in crystalline form, and were recrystallized in a solution of ethanol/water (page 689), which by the broadest reasonable interpretation, constitutes a pharmaceutical composition that reads on instant claims 8, 11-13, 18, and 23.
Claims 8, 11-13, 16-18, 23, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dhanireddy et al. (Induction of Apoptosis by Novel Amidoximes Involves Decreased Histone Acetylation and p300 Inhibition, Texas Genetics Society, 37th Annual Meeting, M.D. Anderson Cancer Center, Houston, Poster and Abstract, April 2010), cited by Applicant in the IDS.
Dhanireddy et al. teaches, in Figure 1, that JJMB5, JJMB7, and JJMB9 induced apoptosis in colon, breast, and lung cancer cell lines, and that JJMB6 induced apoptosis in colon cancer cells, as in instant claims 8, 11-13, 17, 18, 23, and 27. It is taught, in the abstract that these compounds inhibit HAT and can therefore be used to treat specific cancers, as in instant claims 16 and 26.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 9, 10, 14, 19-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Dhanireddy et al. (cited above) as applied to claims 8, 11-13, 16-18, 23, 26, and 27 above.
Dhanireddy et al. teaches compositions and methods of treating colon, breast, and lung cancer comprising administering anticancer compounds JJMB5, JJMB6, JJMB7, or JJMB9. See above rejection.
Dhanireddy et al. fails to teach a combination of JJMB5, JJMB6, JJMB7, and/or JJMB9.
These compounds are very structurally similar and are taught to be used for the same purpose with the same mechanism of action, which is HAT inhibition that induces apoptosis in specific cancer cell lines. MPEP 2144.06 I states: "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, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would be prima facie obvious to combine any of JJMB6, JJMB6, JJMB7, and/or JJMB9, in order to use them for the same purpose, as in instant claims 9, 10, 14, 19-22, and 24. One of ordinary skill in the art would have a reasonable expectation of success in combining any of these anticancer compounds with each other since they are structurally similar, have the same mechanism of action, and are taught in the prior art to be used for the same purpose.
Claims 15 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dhanireddy et al. (cited above), as applied to claims 8-14, 16-24, 26, and 27 above, further in view of Dasari et al. (Cisplatin in cancer therapy: molecular mechanisms of action, Eur. J. Pharmacol., 2014, Vol. 740, pages 364-378).
Dhanireddy et al. teaches compositions and methods of treating colon, breast, and lung cancer comprising administering anticancer compounds JJMB5, JJMB6, JJMB7, or JJMB9. See above rejection.
Dhanireddy et al. fails to teach a combination of JJMB5, JJMB6, JJMB7, or JJMB9 with cisplatin.
However, Dasari et al. teaches in the abstract, that cisplatin is a well-known chemotherapeutic drug used to treat lung cancer. In section 3.4, it is taught that “cisplatin is an important chemotherapeutic agent used widely for the treatment of a variety of malignancies, including breast, … and lung …lymphomas”. In section 4.5, it is taught that cisplatin is used in combination with vitamin D to treat colon cancer. Cisplatin is taught to damage DNA and induce apoptosis of cancer cells (section 5.3).
MPEP 2144.06 I states: "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, 205 USPQ 1069, 1072 (CCPA 1980).
Therefore, it would be prima facie obvious to combine any of JJMB6, JJMB6, JJMB7, and/or JJMB9 with cisplatin, since all are taught to be used in the treatment of colon, breast, and lung cancer. One would have a reasonable expectation in combining equivalents that are taught in the prior art to be used for the same purpose, since these compounds are taught to induce apoptosis of cancer cells independently. Thus, one would expect that combining them would have the same result of inducing apoptosis and treating breast, colon, or lung cancer.
Nonstatutory 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.
Claims 8-15, 17, 18-25, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-13 of U.S. Patent No. 10,758,501. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘501 teaches, in claim 1, a method of using a pharmaceutical composition comprising one or more of JJMB5, JJMB6, JJMB7, and JJMB9, as in instant claims 8, 12, and 18. Claims 2 of patent ‘501 reads on instant claims 9 and 19. Claims 3-5 and 11-13 of patent ‘501 reads on instant claims 10, 11, 13, and 20-23. Patent ‘501 teaches, in claims 9 and 10, a method of treating colon cancer, breast cancer, or lung cancer comprising administering a pharmaceutical composition comprising on or more of JJMB5, JJMB6, JJMB7, and JJMB9 in combination with an anticancer agent, wherein the anticancer agent is cisplatin, as in instant claims 14, 15, 17, 24, 25, and 27.
Claims 8-13, 16, 18-20, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,648,217. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘217 teaches, in claim 1, a method of inhibiting HATs comprising administering one or more of JJMB5, JJMB6, and JJMB9, as in instant claims 8, 10-13, 16, 18, 20, and 26. Claim 2 of patent ‘217 reads on instant claims 9 and 19.
Conclusion
Claims 8-27 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624