CTFR 18/249,663 CTFR 79041 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement 06-52 AIA The information disclosure statement (IDS) submitted on 5/4/26 was filed after the mailing date of the Non-Final Office Action on 10/1/25 . The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1, 2 and 5-7 is/are rejected under 35 U.S.C. 102 a1,2 as being anticipated by Rao et al (WO 2019/104381 A1 hereafter Rao) . Rao et al discloses a composition of matter comprising a chemotherapeutic agent and a monoamine oxidase A inhibitor [abstract, 0035, 0099]. The monoamine oxidase A inhibitor comprises phenelzine [0035, 0199]. The composition comprises a pharmaceutical acceptable carrier, and a lipid [0092, 0458]. The monoamine oxidase A inhibitor is applied to treat and modulate CD8 T cells [0009, 0012-0013]. The CD8T cells phenotype comprises tumor immunoreactivity and decreased expression of PD-1 [0013, 0436-0465]. The chemotherapy agent present is carboplatin or paclitaxel [0099]. The chemotherapy agent may include an antibody such as nivolumab, pembrolizumab [0009, 0099]. A method of for modulating the phenotype of CD8 T cells comprises administration to the environment that the cells exist [0037, Figure 3]. The CD8 T cells is dispersed in an individual with cancer such as colorectal, lung or prostate cancer [0012, 0097, 0479]. The monoamine oxidase A inhibitor can be disposed with a nanoparticle [0458]. These disclosures render the claims anticipated . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1, 2, 5-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Rao et al (WO 2019/104381 hereafter Rao) in view of Jacobsen et al (WO 2019/254925 A1 hereafter Jacobsen) . As discussed above, Rao discloses a composition of matter comprising a monoamine oxidase A inhibitor and a chemotherapeutic agent, and a method of treating CD8 T cell disorders including cancers by administering the combination to patient in need thereof. The formulation can take the form of liposomes of any kind, however the reference is silent to the specific structure of the liposomes. The use of a crosslinked multilamellar or bilayered liposome for the delivery of monoamine oxidase A inhibitor are known in the art as seen in the Jacobsen patent. Jacobsen discloses a composition of matter comprising a monoamine oxidase A inhibitor and various other active agents (abstract, Examples, pg. 25, lin. Lin. 10-25). The monoamine oxidase A inhibitors include phenelzine and moclobemide (pg. 25, lin. 15-20). The dosage form can be a crosslinked bilayered/multilamellar liposome where the layers are covalently bound via the crosslinking (pg 34, lin. 10-25). It would have been obvious to apply the liposome formulation of Jacobsen as they both solve the same problem of treating disorders by administering monoamine oxidase A inhibitors. With these aspects in mind, it would have been obvious to combine the disclosures of the prior art to produce a stable liposome formulation for the delivery of cancer treating compositions. It would have been obvious to follow the suggestion of Rao to produce stable liposome for the delivery of monoamine oxidase A inhibitors and chemotherapy agents, using the liposomes of Jacobsen as ty solve the same problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable liposome nanoparticle useful in treating a variety of cancers . Double Patenting 08-33 AIA 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. 08-35 Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 18/249,907 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition of matter comprising a chemotherapeutic agent and a monoamine oxidase A inhibitor. The monoamine oxidase A inhibitor is used to treat CD8T cell disorders including various cancers. The claims further disclose a method for treating said conditions by the delivery of these compositions of matter to environments where the disorders are present. The claims differ in that the 907 recite a specific lipid formulation while the instant claims broadly disclose a composition of matter. The claims eventually recite crosslinked lipids, such that the scopes of the claims overlap and would act as art over each other. For these reason, the claims are obvious variants of each other and cannot be allowed together . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Arguments 07-37 AIA Applicant's arguments filed 3/2/26 have been fully considered but they are not persuasive. Applicant argues that the Rao does not anticipate the instant claims and the combination of Rao and Jacobenson does not render the claims obvious . It remains the position of the Examiner that Rao continues to anticipate the instant claims. As discussed above, Rao discloses a composition comprising a chemotherapeutic agent [abstract, 0035]. Rao continues to meet the limitations of claims 1, by disclosing a carrier and a lipid [0094, 0458]. A monoamine oxidase inhibitor disposed as a nanoparticles [0458]. The monoamine oxidase A inhibitor is present in the in the composition sufficiently to modulate CD8 T cells upon administration [Figure 3, 0436-0465]. The monoamine oxidase A inhibitor is phenelzine meeting the limitations of claim 2. Tumor immunoreactivity is enhanced by the composition meeting the limitations of claims 5. The formulation comprises an antibody, paclitaxel carboplatin, and a PD-1 antigen [0099, 0127, 0153] meeting the limitation of claim 6. The formulation comprises pembrolizumab [0009, 0099] meeting the limitations of claims 7. These disclosures render the claims anticipated as they meet the limitation of claims. Regarding the obviousness rejection, it remains the position of the Examiner, even after claim amendment, the combination continues to render the claims obvious. As discussed above Rao discloses a composition comprising an antibody, monoamine oxidase A inhibitor, chemotherapy agent in the form of a nanoparticle, liposome or emulsion [0548]. The formulation can take the form of liposomes of any kind, however the reference is silent to the specific structure of the liposomes. The use of a crosslinked multilamellar or bilayered liposome for the delivery of monoamine oxidase A inhibitor are known in the art as seen in the Jacobsen patent. The dosage form can be a crosslinked bilayered/multilamellar liposome where the layers are covalently bound via the crosslinking (pg 34, lin. 10-25). It would have been obvious to apply the liposome formulation of Jacobsen as they both solve the same problem of treating disorders by administering monoamine oxidase A inhibitors. With these aspects in mind, it would have been obvious to combine the disclosures of the prior art to produce a stable liposome formulation for the delivery of cancer treating compositions. It would have been obvious to follow the suggestion of Rao to produce stable liposome for the delivery of monoamine oxidase A inhibitors and chemotherapy agents, using the liposomes of Jacobsen as ty solve the same problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable liposome nanoparticle useful in treating a variety of cancers. For these reasons, the claims remain obviated. Regarding the Non-Obvious Double Patenting Rejections, it remains the position of the Examiner that the rejection will remain of record until allowable subject matter can be determined in either the instant application or the copending application. Conclusion 07-40 AIA 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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 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, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618 Application/Control Number: 18/249,663 Page 2 Art Unit: 1618 Application/Control Number: 18/249,663 Page 3 Art Unit: 1618 Application/Control Number: 18/249,663 Page 4 Art Unit: 1618 Application/Control Number: 18/249,663 Page 5 Art Unit: 1618 Application/Control Number: 18/249,663 Page 6 Art Unit: 1618 Application/Control Number: 18/249,663 Page 7 Art Unit: 1618
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