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 .
Response to Amendments
Applicant’s amendments to the claims of June 11, 2026, in response to the Office Action of December 11, 2025, are acknowledged.
Response to Arguments
With regard to the Scope of Enablement Rejection, Applicant argues that they do not need to reduce the invention to practice and argues that they amended the claims.
The amendments to the claims appear to require a subject to have a condition rather than merely preventing the condition.
Applicant argues that the cited prior art does not teach metabolites derived from apoptotic cells.
The examiner notes that Salzman teaches treating arthritis, RA, and OA by administering IMP; Perlmutter teaches treating arthritis by administering an aliphatic polyamine, including spermidine among a limited list; and Gurny teaches treating rheumatoid arthritis by administering guanosine 5’-monophosphate or a salt or tautomer thereof. Thus, the combination of Salzman, Perlmutter, and Gurny teaches administration of the claimed agents for treating arthritis. It 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. This is the case here. While the prior art does not teach deriving the claimed agents from an apoptotic cell, the prior art renders obvious administration of each of the claimed agents for treating the claimed subject population. Unexpected results have not been alleged and shown. Absent evidence to the contrary or a showing that the source of these compounds as derived from an apoptotic cell would yield a different result, a prima facie showing remains set forth in view of the prior art.
The examiner also note the following on the state of the art.
Saas et al., “Harnessing Apoptotic Cell Clearance to Treat Autoimmune Arthritis,” Frontiers in Immunology October 9, 2017. Apoptotic cells as the early stage are taught to possess immunomodulatory properties. There was a therapeutic effect that was noted with respect to treating RA. See Abstract. Saas notes that early stage apoptotic cells have been injected in arthritis models before. The therapeutic effect was only tested in one model previously, however. Overall, Saas concludes that apoptotic cell infusion is an additional therapeutic tool for treating RA. While the metabolites were not recognized, a method of using apoptotic cells for treating the claimed subject population was also recognized in the art.
Status of the Claims
Claim 5 is withdrawn for being directed to a non-elected species combination. Applicant elected a specific combination of spermidine, IMP, and GMP. Applicant amended claim 5 to require a combination of five compounds.
Claims 1-27 are pending. Claims 5 and 16-27 are withdrawn. Claims 1-4 and 6-15 are examined.
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 1-4 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Salzman et al., (US2003/0040502), in view of Perlmutter et al., (US02013/0338098), in view of Gurny et al., (US2013/0017197).
Salzman teaches compositions for treating inflammatory conditions of the joints, including arthritis, such as rheumatoid and osteoarthritis. See par. 238. A preferred compound includes IMP. See par. 234. Example 6 tests IMP against inflammatory bowel disease. See par. 288. Paragraph 230 explains that the compounds including inosine 5’-monophosphate can be used to treat many inflammatory disorders and diseases. See par.’s 230, 234, and 238. Also see prior art claims 1-3, 6, and 9, e.g. A carrier is contemplated for use with the composition. See par. 33 and 34, e.g. Formula I is shown in paragraph 62, with a PO32- in the position of R1. Finally, Salzman cites another reference in teaching that IMP is shown to have an additive effect in resolving inflammatory response when combined with aspirin. See par. 14. Compositions can be administered through many routes of administration including oral, IM, IV, topically, and others. See par. 260. The compounds can be administered with additional agents useful as a combination, including an immunosuppressant, NSAID, and other additional APIs. See par. 246. The inosine compounds can be administered at a dose of about 0.01 g to 20 g. See par. 248.
Perlmutter teaches compositions for treating arthritis and rheumatism. See par. 24. Table 2 is directed to evaluating arthritis pain in a subject. The method comprises administering an aliphatic polyamine, including spermidine among a limited list. See prior art claims 42 and 45. Moreover, spermidine can treat arthritis and rheumatism. See prior art claim 54. A diluent or carrier is contemplated. See par. 29 and 32, e.g. Perlmutter also teaches topical administration. See prior art claim 42.
Finally, Gurny teaches a method for treating and ameliorating conditions including rheumatoid arthritis by administering a compound of formula (I), such as guanosine 5’-monophosphate or a salt or tautomer thereof. See prior art claims 32, 42 and 44. Arthritis is preferred among a limited list of conditions. See par.’s 30, 34, and 35. Incorporation of a liquid carrier is contemplated. See Abstract. Routes of administration include topical, parenteral, IV, IP, IM, and others. See par. 98.
With regard to claims 7 and 9, when an effective amount of the claimed agents is used to mitigate arthritis as taught by the cited prior art, absent evidence to the contrary, such active step of administration would modulate gene expression. One reason for this is that the claimed agents are known result effective variables taught to treat a subject with arthritis, e.g. See M.P.E.P. § 2144.05. Similarly, when the elected combination is administered to a subject, absent evidence to the contrary, it would induce an anti-inflammatory or other response that is secondary to the active step of administration.
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed methods in view of the cited prior art. One would be motivated to do so because spermidine, GMP, and IMP are each taught for independent use in treating conditions such as arthritis and rheumatoid arthritis. "It 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). In this case, because spermidine, GMP, and IMP are each known to treat arthritis, e.g., it would be obvious to administer them to a subject with arthritis and such administration could be in a single or multiple dosage forms administered simultaneously, sequentially, or even in a single form. One would do so because they are obvious to administer and there is no reason that they could not be administered at an optimized time through routine experimentation. As such, there is a reasonable and predictable expectation of success in arriving at the claimed methods in view of Salzman, Perlmutter and Gurny.
As such, no claim is allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights