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 17-18, 22-23, and 32-44 are pending in this application. Claims 1-16, 19-21, and 24-31 have been cancelled by applicant.
Claim Interpretation
Applicant is advised that the limitation “the method comprising inhibiting La-related protein 1 (LARP1)” is not further limiting. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
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 38 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.
Regarding claim 38, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 17-18, 22-23, 32-35, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Chem Biol Drug Des 2012; 79: 897–906) (“Wu”); in view of Shah et al. (Frontiers in Oncology, 2020, 10, Article 405, 8 pages – Pub. Date: March 31st, 2020) (“Shah”).
Regarding claims 17-18 and 32, Wu discloses their compound 7d below (which anticipates one of the instantly claimed compounds), as a dipeptidyl peptidase IV inhibitor (DPP4) (Table 2, page 904).
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While Wu does not teach their compound specifically for the treatment of cancers, the teachings of Shah are relied upon for these disclosures.
Shah teaches DPP4 exhibits a crucial role in tumor biology and regulation of the immune system, and discloses that DPP4 inhibition seemed to improve survival in prostate cancer patients (PRC) (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Wu’s compound for the treatment of prostate cancer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Wu discloses their compound 7d as a DPP4 inhibitor with an IC50 of about 36 µM; further because Shah teaches that DPP4 inhibition improved survival in prostate cancer patients.
Regarding claims 22-23 and 34-35, Shah discloses administration of a DPP4 inhibitor in combination with metformin, which is an mTOR inhibitor (abstract) – reading on a chemotherapy (claim 37).1
Regarding claim 33, Shah discloses inhibition improved survival in prostate cancer patients (abstract).
Claims 36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Chem Biol Drug Des 2012; 79: 897–906) (“Wu”); in view of Shah et al. (Frontiers in Oncology, 2020, 10, Article 405, 8 pages – Pub. Date: March 31st, 2020) (“Shah”); as applied to claims 17-18, 22-23, 32-35, and 37; further in view of Imrali et al. (Am. J. Cancer Res., 2016; 6(8): 1772-1784) (“Imrali”).
The teachings of Wu and Shah are disclosed above and incorporated herein.
While Wu in view of Shah does not teach other mTOR inhibitors or chemotherapeutics for the treatment of cancer; the teachings of Imrali are relied upon for these disclosures.
Imrali teaches rapamycin and cisplatin treatment of PRC and showed that the combination had a more than additive effect in both androgen dependent and independent prostate cancer cells (abstract).
Therefore, regarding claims 36 and 38, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Wu’s in view of Shah’s prostate cancer treatment, further comprising rapamycin and cisplatin. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Wu and Shah disclose their treatment for prostate cancer; further because Imrali teaches that administration of rapamycin with cisplatin showed more than an additive effect in inhibition of both androgen dependent and independent prostate cancer cells.
Applicant is advised that the courts have found that “[i]t 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).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Claims 17 and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Chem Biol Drug Des 2012; 79: 897–906) (“Wu”); in view of Valencia et al. (Front. Pharmacol., 2020, 11, Article 1161, 14 pages – Pub. Date: August 7th, 2020) (“Valencia”).
Regarding claim 17, Wu discloses their compound 7d below (which anticipates one of the instantly claimed compounds), as a dipeptidyl peptidase IV inhibitor (DPP4) (Table 2, page 904).
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While Wu does not teach their compound specifically for the treatment of viral infections, RNA viral infections, or MERS coronavirus infections (claims 39-42); the teachings of Valencia are relied upon for these disclosures.
Valencia teaches DPP4 has been established as a receptor for MERS-CoV (abstract), disclosing that MERS-CoV virus binds to human DPP4 to infect host cells (page 4, col. 1, para. 4, lines 1-3).
Therefore, regarding claims 17 and 39-42, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Wu’s DPP4 inhibitor for the treatment of MERS coronavirus infections, in view of Valencia. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Wu discloses their DPP4 inhibitor compound; further because Valencia teaches that MERS-CoV virus binds to human DPP4 to infect host cells, thus suggesting that DPP4 inhibition would prevent virus entry into host cells, thus treating/preventing an infection.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Chem Biol Drug Des 2012; 79: 897–906) (“Wu”); in view of Valencia et al. (Front. Pharmacol., 2020, 11, Article 1161, 14 pages – Pub. Date: August 7th, 2020) (“Valencia”); as applied to claims 17 and 39-42; further in view of Lehrer et al. (World Academy of Sciences Journal, 2020, 2, 5 pages – Pub. Date: March 29th, 2020) (“Lehrer”).
The teachings of Wu and Valencia are disclosed above and incorporated herein.
While Wu and Valencia do not teach administration of an mTOR inhibitor for the treatment of MERS-CoV; the teachings of Lehrer are relied upon for these disclosures.
Lehrer teaches that PI3K/AKT/mTOR signaling responses play important roles in MERS‑CoV infection and may represent a novel drug target for therapeutic intervention strategies (page 1, lines bridging col. 1-2). Lehrer teaches inhalable biguanides as an mTOR inhibitor for treatment.
Therefore, regarding claims 43-44, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Wu’s in view of Valencia’s MERS-CoV treatment further comprising an mTOR inhibitor in view of Lehrer. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Wu and Valencia disclose their DPP4 inhibitor as a potential treatment to inhibit MERS-CoV cell penetration; further in view of Lehrer’s teaching that inhalable mTOR inhibitor (biguanides) may be a therapeutic strategy for MERS-CoV.
Applicant is reminded that the courts have found that “[i]t 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. It is therefore obvious to provide a mixture of the two agents.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Specification
Applicant’s arguments, see page 8, filed 01/07/2025, with respect to objections to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Claim Rejections - 35 USC § 112(a)
Applicant’s arguments, see page 9-11, filed 01/07/2025, with respect to 35 USC § 112(a) rejections have been fully considered and are persuasive. The 35 USC § 112(a) rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 11-13, filed 01/07/2025, with respect to 35 USC § 112(b) rejections have been fully considered and are persuasive. The 35 USC § 112(b) rejection of the claims has been withdrawn. However, in view of new claims added, a new ground of 35 USC § 112(b) rejection has been raised.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 13-15, filed 01/07/2025, with respect to 35 USC § 103 rejections have been fully considered and are persuasive. The 35 USC § 103 rejections of the claims have been withdrawn. However, in view of claim amendments, new grounds of 35 USC § 103 rejections have been raised herein.
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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
1 Sahra et al. (Metformin, independent of AMPK, induces mTOR inhibition and cell cycle arrest through REDD1. Cancer Res 2011; canres.1769.2010. <URL:https://doi.org/10.1158/0008-5472.CAN-10-1769>)