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
Claims 1-12 are presented for examination.
Applicant’s Amendment filed July 8, 2025 has been received and entered into the present application.
Claims 1-12 remain pending. Claims 5 and 9 are amended.
Applicant’s arguments, filed July 8, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Status of Objections/Rejections in the April 9, 2025 Non-Final Action
In reply to the objection to claim 5 as set forth at p.6 of the previous Office Action dated April 9, 2025, Applicant now amends claim 5 to remove the phrase “in need thereof of”. Accordingly, the objection is now hereby withdrawn.
In reply to the objection to claim 9 as set forth at p.6 of the previous Office Action dated April 9, 2025, Applicant now amends claim 9 to remove the phrase “in need thereof of”. Accordingly, the objection is now hereby withdrawn.
In reply to the rejection of claims 5-8 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.6-8 of the previous Office Action dated April 9, 2025, Applicant now (i) removes the term “distant” from the limitation “distant metastasis” in the preamble objective of the claim, (ii) further clarifies that the “patient” of the method is one “having cancer” and that the administration step is performed in this same “patient”, and (iii) amends the phrase “selected from the group comprising” to now recite “selected from the group consisting of”, which obviates the issues of indefiniteness. Accordingly, the rejection is now hereby withdrawn.
In reply to the rejection of claims 9-12 under 35 U.S.C. §112(b) (pre-AIA second paragraph), as set forth at p.8-10 of the previous Office Action dated April 9, 2025, Applicant now (i) further clarifies that the “patient” of the method is one “having cancer” and that the administration step is performed in this same “patient”, and (ii) amends the phrase “selected from the group comprising” to now recite “selected from the group consisting of”, which obviates the issues of indefiniteness. Accordingly, the rejection is now hereby withdrawn.
Terminal Disclaimers
Applicant’s submission of an acceptable electronic Terminal Disclaimer in the papers filed July 8, 2025 necessitates the withdrawal of the following nonstatutory double patenting rejections:
(i) the provisional nonstatutory double patenting rejection of claims 1-12 over claim 10 of U.S. Patent Application No. 17/921,060, as set forth at p.14-16 of the previous Office Action dated April 9, 2025;
(ii) the nonstatutory double patenting rejection of claims 1-2, 5-6 and 9-10 over claims 2-3 of U.S. Patent No. 10,512,618 B2, as set forth at p.16-18 of the previous Office Action dated April 9, 2025;
(iii) the nonstatutory double patenting rejection of claims 1, 4-5, 8-9 and 12 over claims 3 and 6-7 of U.S. Patent No. 11,311,501 B2, as set forth at p.18-20 of the previous Office Action dated April 9, 2025;
(iv) the nonstatutory double patenting rejection of claims 1, 3, 5, 7, 9 and 11 over claims 4-5 of U.S. Patent No. 11,364,210 B2, as set forth at p.20-22 of the previous Office Action dated April 9, 2025;
(v) the nonstatutory double patenting rejection of claims 1, 4-5, 8-9 and 12 over claim 2 of U.S. Patent No. 11,547,679 B2, as set forth at p.22-24 of the previous Office Action dated April 9, 2025;
(vi) the nonstatutory double patenting rejection of claims 1-4 over claim 8 of U.S. Patent No. 11,672,810 B2, as set forth at p.24-25 of the previous Office Action dated April 9, 2025; and
(vii) the nonstatutory double patenting rejection of claims 1-12 over claim 1 of U.S. Patent No. 12,006,553 B2, as set forth at p.25-28 of the previous Office Action dated April 9, 2025.
Upon further reconsideration of the claimed subject matter, however, new grounds for rejection are necessitated and set forth infra.
Priority
To reiterate, acknowledgement is made of the present application as a continuation-in-part (CIP) of U.S. Patent Application No. 16/670,443, filed October 31, 2019, which is a continuation of U.S. Patent Application No. 16/204,173, filed November 29, 2018, which is a continuation of PCT Application No. PCT/US2018/022403, filed March 14, 2018, which claims benefit under 35 U.S.C. §119(a-d) to U.S. Provisional Patent Application No. 62/471,688, filed March 15, 2017.
In the Remarks filed July 8, 2025, Applicant traverses the determination of effective filing date afforded to the instant claims, stating that “the Office Action is applying the wrong standard for enablement” (Remarks, p.6). Applicant argues that “Figs. 4A-4D [of the ‘688 application] illustrate chemical structures of ten mitoriboscin compounds, and that [this] specification is replete with data and examples showing the anti-cancer efficacy of the disclosed compounds” (Remarks, p.7-8). Applicant states that “paragraph [0043]” of the ‘688 application states “that the disclosed compounds show efficacy against metastasis” and the skilled artisan “would have understood from the disclosure that the disclosed compounds had efficacy against cell migration – otherwise known in the art as metastasis” (Remarks, p.8). Applicant opines that “the evidence shows that the person having ordinary skill in the art would have been able to practice claims 5-12 without undue experimentation” because “the publication to Ozsvari et al. shows that test compound 23/G4 is, in fact, compound B from Fig.4A” (Remarks, p.8). Applicant contends that “[e]nablement does not require the hypothetical person having ordinary skill in the art to know that the results would be the same, only that she be able to practice the claims without undue burden” (Remarks, p.8).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s remarks regarding the adequacy of enabling guidance under the requirements of 35 U.S.C. §112(a) (pre-AIA first paragraph) as it pertains to the disclosure of the ‘688 provisional application are unavailing. Here, the absence of a specific correlation between the proffered test data and a particular chemical structure from which it yields fails to properly inform the ordinarily skilled artisan of whether such proffered data is at all germane to those compounds instantly claimed. Instead of providing this necessary clarification, Applicant places the burden on the ordinarily skilled artisan to make and test the compounds disclosed in the ‘688 application to determine if they provide the asserted properties with no reasonable expectation of success that it is those compounds instantly claimed that exhibit the therapeutic activities asserted in the working examples. Applicant is reminded that the standard for enablement is how to make and use – not how to make and test with no reasonable expectation of success. It is incumbent upon Applicant to provide sufficient guidance to enable his invention – not to place such undue burden onto the ordinarily skilled artisan – particularly when Applicant claims new chemical compounds for which no prior knowledge about the compounds’ activity was previously known (or, thus, could be relied upon as additional guidance) in the art at the time of the ‘688 disclosure. MPEP §2164.05(a).
To the extent that Applicant urges Ozsvari’s publication clearly establishes the identity and chemical structures of the acronyms used in Applicant’s working examples of the ‘688 application, this position is unavailing because Ozsvari et al. was published online July 7, 2017 – after the March 15, 2017 publication date of the ‘688 application – and, therefore, fails to establish what was known in the art at the time of such ‘688 disclosure (and, thus, fails to establish that the skilled artisan would have needed nothing more than Ozsvari’s disclosure to affirmatively identify the chemical structures of the compounds referenced in the ‘688 application).
Finally, insofar as Applicant argues that the Office Action utilizes an “erroneous conclusion with respect to additional applications in the present application’s chain of parents” (Remarks, p.9), the remarks have been fully and carefully considered, and are found persuasive regarding the claims for benefit to the prior-filed ‘403, ‘173, and ‘443 applications.
Accordingly, the effective filing date of claims 1-4 is March 15, 2017 (the filing date of the ‘688 provisional application) and claims 5-12 is March 14, 2018 (the filing date of the ‘403 PCT application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
Claim Rejections - 35 USC § 103 (New Grounds of Rejection)
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.
(1) Claims 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ozsvari et al. (“Mitoriboscins: Mitochondrial-Based Therapeutics Targeting Cancer Stem Cells (CSCs), Bacteria and Pathogenic Yeast”, Oncotarget, 2017, 8(40):67457-67472, Published Online July 7, 2017, cited by Applicant on the 05/19/22 IDS) in view of Holliday et al. (“Choosing the Right Cell Line for Breast Cancer Research”, Breast Cancer Research, 2011; 13:215, cited by Applicant on the 05/19/22 IDS).
Ozsvari et al. teaches an experimental study of compounds 23/G4, 24/D4 and 24/F9 in an aggressive MDA-MB-231 breast cancer cell model to assess cell migration as a marker of distant metastasis (col.2, para.3, p.67461). Ozsvari et al. teaches that 23/G4, 24/D4 and 24/F9 all inhibited cell migration in this cellular model by > 70% at a concentration of 2.5 mM (col.2, para.3, p.67461). Ozsvari et al. teaches that 23/G4 is the compound
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, 24/D4 is the compound
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, and 24/F9 is the compound
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(Fig.4, p.67460).
Ozsvari et al. differs from the instant claims only insofar as it does not explicitly teach administration of the disclosed compounds to a patient having cancer to prevent and/or reduce the likelihood of metastasis (claim 5) or tumor recurrence (claim 9).
Holliday et al. teaches that MDA-MB-231 breast cancer cells are a widespread and commonly used experimental model of human breast cancer worldwide (col.1, para.2, p.1-col.2, para.1, p.1; Table 1, p.2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in administering the compound 23/G4, 24/D9 or 24/F9 of Ozsvari et al. to a breast cancer patient because Holliday et al. teaches that MDA-MB-231 breast cancer cells – the same breast cancer cells used in Ozsvari et al. – were a commonly used experimental model for human breast cancer. The skilled artisan would have been motivated to administer Ozsvari’s compounds 23/G4, 24/D4, or 24/F9 to a human breast cancer subject in view of the demonstrated efficacy of this compound to inhibit tumor cell migration, an effect known to be associated with tumor metastasis and recurrence in a well-known MDA-MB-231 in vitro experimental model of human breast cancer, as evidenced by Holliday. It would, therefore, have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer Holliday’s compound 23/G4, 24/D4 or 24/F9 to a breast cancer patient in view of the efficacy demonstrated in a well-established cellular model of human breast cancer to inhibit tumor cell migration.
The effect of such compounds to inhibit tumor cell migration by > 70% as described by Ozsvari meets Applicant’s therapeutic objectives to “prevent and/or reduce the likelihood of distant metastasis” in the patient having cancer (claim 5) or “prevent and/or reduce the likelihood of tumor recurrence” in the patient having cancer (claim 9), as the inhibition of tumor cell migration naturally inhibits the development of other metastases or tumor recurrence at the primary (or other more distant) sites in the breast cancer patient.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Rejection of claims 5-12 is proper.
Claims 1-4 are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren can be reached at (571)-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
November 2, 2025