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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-18 with species election of miR-429, small molecule, EGFR inhibitor, osimertinib in the reply filed on June 15, 2026 is acknowledged.
Status of Claims
Claims 1-20 are currently pending in the instant application. Claims 8-9 and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Accordingly, claims 1-7 and 10-18 are under examination on the merits in the instant application.
Claim Rejections - 35 USC § 102
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.
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 1-7, 10-11, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bader et al. (US 2009/0163435 A1, applicant’s citation).
Bader discloses a pharmaceutical composition comprising one or more of cancer therapy agents including “one or more nucleic acids corresponding to a miRNA and a therapeutic drug” that is a combination of cancer therapeutic drugs including “EGFR inhibitors” such as “gefitinib” and “cisplatin”, wherein the miRNA includes “miR-200”, in particular “miR-200c”, wherein the pharmaceutical composition further comprises a delivery vehicle such as liposomes. See paragraphs 0022, 0110, 0133, and 0283.
Since Bader’s composition fully satisfies all structural limitations set forth in claim 1, it necessarily follows that Bader’s composition would inherently possess the functional property to target a tissue associated with cancer and reduces EMT, thereby sensitizing cancer cells to gefitinib, absent objective evidence to the contrary.
“[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mkt. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). That is, “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, claims 1-7, 10-11, and 14-18 are described by Bader et al.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-6, 10, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Adam et al. (US 2013/0018088 A1, applicant’s citation).
Adam discloses making a “composition for enhancing the sensitivity of cancer cells to anti-EGFR treatment, said composition comprising: an isolated miR-200 miRNA”, which includes “miR-429”, wherein the anti-EGFR treatment includes a “small molecule EGFR tyrosine kinase inhibitor”, wherein the composition “may be used in vivo, such as in a live animal or a human being, to treat cancer.” See paragraphs 0007, 0051, 0054, and 0075; claims 28 and 33.
Although Adam does not expressly disclose that the composition comprising miR-429 also comprises a small molecule EGFR TKI, it would have been obvious to one of ordinary skill in the art to readily envision a combination composition comprising both miR-429 and a small molecule EGFR TKI with a reasonable expectation of success because the purpose/function of Adam’s miR-429-containing composition is “for enhancing the sensitivity of cancer cells to anti-EGFR treatment”, which therefore suggests the presence of both miR-429 and an anti-EGFR treatment such as a small molecule EGFR TKI for enabling the purpose/function of Adam’s composition. Further, since the goal of combining miR-429 with EGFR TKI is for in vivo therapeutic use “to treat cancer” in a human being as taught by Adam, it would have been obvious to one of ordinary skill in the art to further include a pharmaceutically acceptable carrier when making the combination composition rendered obvious in the instant rejection.
Since the composition rendered obvious in the instant rejection fully satisfies all structural limitations set forth in claim 1, it necessarily follows that the composition rendered obvious would inherently possess the functional property to target a tissue associated with cancer and reduces EMT, thereby sensitizing cancer cells to EGFR TKI, absent objective evidence to the contrary.
Accordingly, claims 1-6, 10, and 14-16 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 1-7, 10, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. (Biomedicine & Pharmacotherapy, 2017, 85:113-119, applicant’s citation).
Zhou reports that “miR-200c enhanced of drug-resistant NSCLC cells to gefitinib” in xenograft mouse model injected with both miR-200c and gefitinib and that “miR-200c induced gefitinib related cell apoptosis significantly”. See page 118.
Although Zhou does not expressly disclose a single combination composition comprising both miR-200c and gefitinib, it would have been obvious to one of ordinary skill in the art to readily envision such combination composition with a reasonable expectation of success because the presence of both miR-200c and gefitinib achieved therapeutically meaningful results including enhanced sensitivity to gefitinib-induced cancer cell apoptosis. Further, since the goal of combining miR-200c with gefitinib is for in vivo therapeutic use as demonstrated by Zhou, it would have been obvious to one of ordinary skill in the art to further include a pharmaceutically acceptable carrier when making the combination composition rendered obvious in the instant rejection.
Since the composition rendered obvious in the instant rejection fully satisfies all structural limitations set forth in claim 1, it necessarily follows that the composition rendered obvious would inherently possess the functional property to target a tissue associated with cancer and reduces EMT, thereby sensitizing cancer cells to gefitinib, absent objective evidence to the contrary.
Accordingly, claims 1-7, 10, and 14-16 taken as a whole would have been prima facie obvious before the effective filing date.
Claims 1-7 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Adam et al. (US 2013/0018088 A1, applicant’s citation) in view of Nash (WO 2020/201097 A1) and Lyon et al. (US 2011/0091562 A1).
Adam discloses making a “composition for enhancing the sensitivity of cancer cells to anti-EGFR treatment, said composition comprising: an isolated miR-200 miRNA”, which includes “miR-429”, wherein the anti-EGFR treatment includes a “small molecule EGFR tyrosine kinase inhibitor”, wherein the composition “may be used in vivo, such as in a live animal or a human being, to treat cancer” including “lung cancer”. See paragraphs 0007, 0011, 0051, 0054, 0066, and 0075; claims 28 and 33.
Adam does not teach that the composition further comprises cisplatin and a nanogel. Adam does not teach that the small molecule EGFR TKI is osimertinib.
Nash teaches that a combination of cisplatin and an EGFR TKI, which is osimertinib is useful for advanced or metastatic lung cancer treatment with “improved prognosis” including “improved overall survival”. See pages 4-5, 7-8, 10-11, and 14-15.
Lyon teaches that a nanogel comprising “poly(N-isopropylmethacrylamide)” and “N,N’-methylenebis(acrylamide)” is “configured to substantially contain an active agent”, wherein the active agent includes one or more therapeutic or pharmaceutical components including but not limited to “anti-cancer agents” and “RNA”, wherein the nanogel can be further configured to provides targeted delivery to cancer cells, thereby “increasing the efficacy of chemotherapy while simultaneously reducing the associated negative side effects.” See paragraphs 0038-0039, 0044-0047, 0110, and 0112.
It would have been obvious to one of ordinary skill in the art before the effective filing date to make an anti-cancer combination composition comprising miR-429, osimertinib, and cisplatin encapsulated in Lyon’s nanogel. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to make an anti-cancer composition that is more therapeutically effective than that of Adam or Nash because one of ordinary skill in the art would have reasonably deemed that osimertinib qualifies as the “small molecule EGFR tyrosine kinase inhibitor” whose anti-cancer efficacy was taught to be enhanced in combination with miR-429 as taught by Adam, wherein the anti-cancer efficacy of osimertinib was also known to be further improved when combined with cisplatin as evidenced by the teachings of Nash. As such, each of miR-429, osimertinib, and cisplatin was not only recognized as an anti-cancer agent but also suggested to provide enhanced, greater anti-cancer effects when combined. Further, one of ordinary skill in the art would have been motivated to select and use Lyon’s nanogel as the carrier of the combination composition rendered obvious in the instant rejection because Lyon’s nanogel was taught to be useful as a carrier of multiple therapeutic agents including anti-cancer agents and RNA and was also known to provide targeted delivery to cancer cells, thereby increasing cancer therapy efficacy and reducing side effects.
Since the composition rendered obvious in the instant rejection fully satisfies all structural limitations set forth in claim 1, it necessarily follows that the composition rendered obvious would inherently possess the functional property to target a tissue associated with cancer and reduces EMT, thereby sensitizing cancer cells to gefitinib, absent objective evidence to the contrary.
Accordingly, claims 1-7 and 10-18 taken as a whole would have been prima facie obvious before the effective filing date.
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 1-7 and 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 8,895,509 B2 in view of Adam et al. (US 2013/0018088 A1, applicant’s citation) and Nash (WO 2020/201097 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the ‘509 patent claims that require a cytotoxic therapy that is administered “concurrently with” a miR-429 in a nanogel delivery system, wherein the cytotoxic therapy claimed in the ‘509 patent claims is defined to read on cisplatin in light of the ‘509 patent specification. It would have been obvious to one of ordinary skill in the art to make a combination product simultaneously containing miR-429 and a cytotoxic chemotherapeutic agent (cisplatin) so as to “concurrently” administer the two agents when practicing the method of ‘509 patent claims. It would also have been obvious to further include osimertinib in the combination product so as to concurrently administer miR-429, cisplatin, and osimertinib, thereby enhancing the therapeutic effects of the method of the ‘509 patent claims in view of the improved/enhanced anti-cancer effects suggested by the combination of miR-429, cisplatin, and osimertinib as evidenced by the combined teachings of Adam and Nash as explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-7 and 10-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of copending Application No. 19/507,686 in view of Adam et al. (US 2013/0018088 A1, applicant’s citation) and Nash (WO 2020/201097 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are encompassed by and/or rendered obvious by the ‘686 claims drawn to and require a nanogel composition comprising different anti-cancer agents comprising a “miRNA”, “an inhibitor of EGFR”, and “chemotherapeutics” (or “a chemotherapeutic agent”). It would have been obvious to readily envision that the anti-cancer miRNA, the inhibitor of EGFR, and the chemotherapeutic agent claimed in the ‘686 claims to read on miR-429, osimertinib, and cisplatin, respectively, in light of the art-recognized knowledge as evidenced by Adam and Nash as explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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