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 .
Application Status
The amended claims filed March 11, 2026 are acknowledged. Claim 3 is canceled. Claims 1-2, 7-8, 13, and 16 are amended.
Claims 1-2 and 4-20 are pending and under examination herein.
WITHDRAWN OBJECTIONS AND REJECTIONS
All prior grounds of rejection to claim 3 are rendered moot by the cancelation of the claim.
The objections to claims 2 and 13 are withdrawn in view of Applicant's claim amendments to update the spelling of “metralindole.”
The rejection of claim 7 under 35 U.S.C. § 112(b) are withdrawn in view of Applicant's claim amendments.
The rejection of claims 1-2, 4-13, and 15-19 under 35 U.S.C. § 102 as being anticipated by Rao ’19 (WO 2019/104381 A1; cited in IDS) is withdrawn in view of Applicant's amendments to claim 1.
The rejection of claims 1-2, 6, 8-11, 13, 15-16, and 18-19 under 35 U.S.C. § 102 as being anticipated by Rao ’21 (US 2021/0121496 A1) is withdrawn in view of Applicant's amendments to claim 1.
MAINTAINED OBJECTIONS AND NEW REJECTIONS NECESSITATED BY AMENDMENT
Specification (Maintained)
The abstract of the disclosure is objected to because the abstract refers to purported merits and speculative applications, similar in format to an academic journal article abstract, instead of clearly outlining a description of the present invention (e.g., compositions or methods of use thereof). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because “metraindol”, as used throughout the disclosure to refer to a species of monoamine oxidase A (MAO-A) inhibitor, appears to be either a misspelling of or otherwise not widely used spelling of “metralindole” (Inkazan), a reversible inhibitor of MAO-A that was investigated in Russia as a potential antidepressant.
Appropriate correction is requested.
The disclosure is further objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See, e.g., pages 53 and 60. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Applicant is reminded of the “duplicate” specification issue noted in the Application Status above.
Response to Arguments
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Applicant submits that marked up and clean versions of an amended specification have been included with the response.
However, these papers do not appear to have been filed with the Response on March 11, 2026. Accordingly, the objection is maintained.
Claim Rejections - 35 USC § 112(b) (Maintained)
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 8-15 and 20 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.
Claim 8 recites the limitation "the environment in which the CD8 T cell is disposed" in lines 2-3. There is insufficient antecedent basis for these limitations in the claim. The claim does not earlier refer to “an environment” or “a CD8 T cell” to which these limitations refer.
Claims 9-15 and 20, which depend from claim 8 and do not remedy these deficiencies, are similarly rejected.
Response to Arguments
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Applicant submits that claim 8 has been amended to overcome the rejection.
However, the amendments made to claim 8 do not further provide antecedent basis for “the environment” or “the CD8 T cell” as recited in line 3 of the claim. Accordingly, the rejections are maintained.
Claim Rejections - 35 USC § 112(d))
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is a new rejection necessitated by claim amendment.
Claim 14 recites that the MAO-A inhibitor used in the claimed method “is disposed within a nanoparticle”. However, the claim earlier depends from the method of claim 8, which also recites that the composition administered in the method comprises an MAO-A inhibitor “disposed within a nanoparticle.” Given that the “optional” limitation is not required to meet the limitations of the claim, claim 14 is not considered to be further limiting and is thus rejected.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
(1)
Claims 1-2 and 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rao ’19 (WO 2019/104381 A1; cited in IDS) in view of Shih (US 2018/0185303 A1; cited in IDS) and Wang (WO 2014/197500 A1; cited in IDS). This is an updated rejection necessitated by Applicant's claim amendments.
Rao ’19 discloses pharmaceutical compositions comprising a LSD inhibitor (which may be a MAO inhibitor, e.g., phenelzine, clorgyline) and a programmed cell death protein 1 (PD-1) binding antagonist (e.g., an antibody such as nivolumab or pembrolizumab), and methods of use thereof to enhance T cell (CD4+ or CD8+ T cell) function or treat T-cell dysfunctional disorders such as breast cancer, colorectal cancer, or lung cancer (e.g., Abstract; ¶ 0009-0014, 0454-0492; claims 1-4, 24-26, 35-91), relevant to claims 1-2, 6-11, 13, 15-16, and 18-19. In some embodiments, the method of treatment further comprises administering an ancillary or additional chemotherapeutic agent, which Rao ’19 defines to include paclitaxel and carboplatin (e.g., ¶ 0009-0012, 0099, 0478-0480; claims 1-4, 28-33, 35-91), further relevant to claims 6 and 15.
Relevant to claims 4-5, 12, and 17, Rao ’19 discloses that combination treatment with an anti-PD-1 antibody and phenelzine sulfate (“Group F”) in a 4T1 mouse model (breast cancer) strongly inhibited CD206 expression (Example 2, ¶ 0544-0545; Figure 4).
However, Rao ’19 does not expressly teach an embodiment in which the MAO-A inhibitor (e.g., phenelzine or clorgyline) is disposed within a nanoparticle, e.g., a nanoparticle comprising a crosslinked multilamellar liposome having an exterior surface and an interior surface, or that the pharmaceutical composition comprises a lipid.
Shih discloses methods of treating cancer by administering an effective amount of an MAO-A inhibitor, e.g., phenelzine or clorgyline, with or without encapsulation within a nanoparticle (e.g., Abstract; claims 26-27; ¶ 0008-0031, 0086-0096, 0104-0123). Shih discloses that the invention is based in part on the unexpected discovery that nanoparticles that are preferentially taken up by cancer cells (e.g., those having near-infrared dyes) may be used as a delivery vehicle to deliver a pharmaceutically active agent to cancer cells (e.g., ¶ 0012). The near-infrared dye can be conjugated to clorgyline at the amine nitrogen via a linker without inhibiting its potency (e.g., ¶ 0086-0096). See also Figure 2.
Wang teaches that nanoparticle-based drug delivery systems have been used to modulate the toxicity profile of anticancer drugs and improve drug circulation time (e.g., ¶ 0005). Wang discloses a liposome compositions that are useful for treating a subject in need of cancer treatment, said composition including a nanoparticle drug delivery system having a targeting peptide linked to a cross-linked multilamellar liposome having an exterior surface and an interior surface, as well as methods of treatment that comprise administering at least one anticancer compound disposed within the liposome (e.g., Abstract; claims 1-47). The cross-linked multilamellar liposomes (CMLs) have an exterior surface and an interior surface, said interior surface defining a central liposomal cavity, and the multilamellar liposome includes at least a first lipid bilayer and a second lipid bilayer (e.g., ¶ 0008-0011), reading on a lipid as required by claims 1, 8, and 16. Wang teaches that the CML compositions of the invention are a nanoparticle delivery system having superior ability to co-deliver multiple drugs with vastly different hydrophobicities to the same site of action while possessing superior stability as compared to previously described liposome formulations known in the art (e.g., ¶ 0151-0154). Wang notes that chemotherapeutic compounds such as paclitaxel is among the hydrophobic chemotherapeutic compounds that can be encapsulated within the CML (e.g., ¶ 0151-0154).
In view of the above, it would have been obvious to one of ordinary skill in the art, before the filing date of the instantly claimed invention, to modify the combination method of treatment disclosed by Rao ’19 such that at least the MAO-A inhibitor (e.g., clorgyline or phenelzine) is encapsulated in a nanoparticle, e.g., a CML liposome-based nanoparticle delivery system, based on the further teachings of Shih and Wang. The skilled artisan would have been motivated to do so because Wang teaches that the CML nanoparticle drug delivery system has superior stability and superior ability to co-deliver multiple drugs with vastly different hydrophobicities to the same site of action (e.g., a cancer tumor) in comparison to previously described liposome formulations. There would have been a reasonable expectation of success because Shih discloses that MAO-A inhibitors can be encapsulated within a nanoparticle and effectively treat cancer, and one of ordinary skill in the art would have recognized the suitability of the CML nanoparticle delivery system disclosed by Wang for achieving this same functional purpose.
(2)
Claims 1-2, 6, 8-11, 13-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rao ’21 (US 2021/0121496 A1; cited in PTO-892 mailed November 17, 2025) in view of Shih (US 2018/0185303 A1; supra) and Wang (WO 2014/197500 A1; supra). This is an updated rejection necessitated by Applicant's claim amendments.
Rao ‘21 discloses compositions and methods that use lysine demethylase (LSD) inhibitors for inhibiting the growth of cancer stem cells (CSCs) or tumor initiating cells and for enhancing the biological effects of chemotherapeutic drugs (e.g., Abstract). Regarding claims 8-11, 13, 15-16 and 18-19, Rao ‘21 discloses a method for treating a cancer (e.g., metastatic breast cancer, prostate cancer, lung cancer) in a human subject that comprises concurrently administering an LSD inhibitor (a MAO-A inhibitor, e.g., clorgyline, phenelzine) and a cancer therapy or agent that inhibits proliferation, survival, or viability of non-CSCs (a chemotherapy agent, e.g., paclitaxel (e.g., claims 99-113; ¶ 0016-0023, 0344-0353). The cancer therapy may also be an antibody-based immunotherapy (e.g., claims 99, 108-109; ¶ 0354-0355), relevant to claims 6 and 15.
Rao ‘21 further discloses pharmaceutical compositions for treating a cancer, comprising an LSD inhibitor (e.g., phenelzine, toloxatone) and an agent that inhibits the proliferation, survival, or viability of non-CSC tumor cells (¶ 0026-0027, 0047-0048, 0143-0353), anticipating claims 1-2 and 6.
However, Rao ’21 does not expressly teach an embodiment in which the MAO-A inhibitor (e.g., phenelzine or clorgyline) is disposed within a nanoparticle, e.g., a nanoparticle comprising a crosslinked multilamellar liposome having an exterior surface and an interior surface.
The teachings of Shih and Wang are recited in the 35 U.S.C. § 103 rejection above.
In view of the above, it would have been obvious to one of ordinary skill in the art, before the filing date of the instantly claimed invention, to modify the combination method of treatment disclosed by Rao ’21 such that at least the MAO-A inhibitor is encapsulated in a nanoparticle, e.g., a CML liposome-based nanoparticle delivery system, based on the further teachings of Shih and Wang. The skilled artisan would have been motivated to do so because Wang teaches that the CML nanoparticle drug delivery system has superior stability and superior ability to co-deliver multiple drugs with vastly different hydrophobicities to the same site of action (e.g., a cancer tumor) in comparison to previously described liposome formulations. There would have been a reasonable expectation of success because Shih discloses that MAO-A inhibitors can be encapsulated within a nanoparticle and effectively treat cancer, and one of ordinary skill in the art would have recognized the suitability of the CML nanoparticle delivery system disclosed by Wang for achieving this same purpose.
Response to Arguments (Combined)
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Applicant has presented combined arguments against the 35 U.S.C. § 103 rejections of record. Applicant traverses the rejections under 35 U.S.C. § 103, stating that the Office “has failed to identify a reason that would have prompted a person of ordinary skill in the art in the relevant field to combine the various elements in Rao, Shih and Wang in a manner that results in the invention recited in claims 1, 8, and 16”. Remarks at page 8. Applicant further submits that the “supposed ‘motivation to combine’ is nothing more than the Examiner’s identification of a functional property that is shared by certain lipid compositions” and that the Examiner’s rationale cannot meet the requirements of KSR and In re Kahn because the Examiner’s rationale is “merely a generic or boilerplate rationale” that is “globally applicable to ALL inventions formed from lipid combinations of known/old elements”. Remarks at pages 8-9.
Applicant further asserts that “the various elements of Applicant's claimed invention together provide advantages over Rao and Shih and Wang. In addition, Applicant's claimed invention solves problems not recognized by Rao and Shih and Wang”. Remarks at page 10.
With respect to Applicant's arguments regarding motivation to combine the teachings of the cited references, it is held that the motivation for one of ordinary skill in the art to choose the specific nanoparticle delivery system set forth by Wang, which has clear advantages over previously described systems, is provided in part by Shih, who establishes at least a proof-of-concept that MAO inhibitors including clorgyline are suitable for encapsulation within a nanoparticle. Furthermore, one of ordinary skill in the art would recognize from the teachings of Shih that this MAO-I nanoparticle delivery system could be used to treat cancer, which is relevant to the technical field of the instantly claimed invention (“methods and materials for treating cancers”, as set forth in the specification at page 1). Thus, it is held that one of ordinary skill in the art, understanding the teachings of Shih and Wang, would understand that the “globally applicable” CML compositions described by Wang would also be expected to have clear utility for encapsulating at least an MAO-I in the context of, e.g., cancer therapy.
In addition, it is further noted that Rao ’19 teaches that the active ingredients of compositions and formulations of the invention “may be entrapped in microcapsules”, including colloidal drug delivery systems (e.g., liposomes or “nano-particles”) (¶ 0454-0460, in particular ¶ 0457-0458).
With respect to Applicant's arguments regarding “advantages over Rao and Shih and Wang” and solving problems “not recognized by Rao and Shih and Wang”, it is held that Applicant does not expand on the specific advantages of the instantly claimed invention or the problems to be solved which are not addressed by the combination of Rao, Shih, and Wang. Without specific examples of how the instantly claimed invention has specific advantages which differ from the cited prior art, this line of reasoning is not found persuasive.
For these reasons, the rejection is maintained.
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.
(1)
Claims 1-2, 6-11, 13-16, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/249,663 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims anticipate or otherwise render obvious the instantly claimed invention. This is a maintained rejection that has been updated to reflect Applicant's claim amendments.
Regarding claims 1-2 and 6-7, co-pending claims 1-2 and 6-7 recite a composition of matter comprising a chemotherapeutic agent (antibody, carboplatin, paclitaxel, or at least one immune checkpoint inhibitor), a monoamine oxidase A inhibitor (e.g., phenelzine, moclobemide, and others), and a pharmaceutically acceptable carrier, wherein the composition comprises a lipid and the MAO-A inhibitor is disposed within a nanoparticle.
Regarding claims 8-11, 13-15, and 20, co-pending claims 8-11 and 13-15 recite a similar method comprising introducing an MAO-A inhibitor in the environment in which the CD8 T cell is disposed in an amount sufficient to modulate the phenotype of the tumor-infiltrating CD8 T cell, wherein the MAO-A inhibitor is disposed within a crosslinked multilamellar liposome having an exterior surface and an interior surface.
Regarding claims 16 and 18-19, co-pending claim 16 recites a similar method of treating a cancer in an individual that comprises administering to the individual an MAO-A inhibitor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(2)
Claims 1, 4-5, 8, 12, and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/249,663 as applied to claims 1-3, 6-11, 13-16, and 18-19 above, further in view of Rao ’19 (WO 2019/104381 A1; supra).
The teachings of the co-pending reference application are recited in the non-statutory double patenting rejection above.
However, the co-pending claims do not expressly disclose that the MAO-A inhibitor is administered in an amount sufficient to modulate the phenotype of tumor-associated macrophages by, e.g., by decreasing expression of CD206. However, this deficiency is remedied by Rao ’19.
It would have been obvious to one of ordinary skill in the art, before the filing date of the instantly claimed invention, to administer an MAO-A inhibitor (in combination with a chemotherapeutic agent) in an amount sufficient to reduce CD206 expression in tumor-associated macrophages based on the further teachings of Rao ‘19. The skilled artisan would have been motivated to do so because Rao ’19 teaches that said combination treatment enhances T-cell function and is advantageous for treating a cancer, e.g., breast cancer, in a subject in need thereof. There would have been a reasonable expectation of success because one of ordinary skill in the art would have recognized the suitability of administering an MAO-A inhibitor for achieving multiple functional effects (e.g., decreasing CD206 expression, enhancing T-cell function, etc.) in light of the teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments (Combined)
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Applicant has presented combined arguments against the provisional non-statutory double patenting rejections of record. Applicant notes that if a provisional non-statutory double patenting rejection is the only rejection of record in the earlier filed of the two co-pending applications, the provisional rejection should be withdrawn and the earlier-filed application issued without a terminal disclaimer.
In response, it is held that the provisional non-statutory double patenting rejections are not the only rejections of record for the instant application and will thus not be withdrawn. Furthermore, the instant application appears to be the later-filed application.
Accordingly, the provisional rejection is maintained.
Conclusion
No claims are allowed.
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 Elizabeth A Shupe whose telephone number is (703) 756-1420. The examiner can normally be reached Monday to Friday, 9:30am - 6:00pm EST.
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/ELIZABETH A SHUPE/Examiner, Art Unit 1643
/Brad Duffy/Primary Examiner, Art Unit 1643
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