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 .
Priority
This application has PRO of 63338128 filed 05/04/2022.
Accordingly, claims 1-25 of this instant application are afforded the effective filing date of 05/04/2022.
Information Disclosure Statement
The first information disclosure statement (IDS) submitted on 07/17/2023 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-23, in the reply filed on 04/29/2026 is acknowledged. The traversal is on the ground(s) that claims 24 and 25 as written require the composition of claim 1.
This is not found persuasive because as discussed in the Restriction filed 03/04/2026, while the method of Invention II uses the composition of claim 1, the method of Invention II and the product of Invention I remained independent or distinct because the product of Invention I have alternative uses such as the product of Invention I can also be used in in vitro drug assays. Furthermore, as discussed in the Restriction, in addition to Inventions I and II being independent or distinct (as discussed supra), there is would also be a serious search and/or examination burden if restriction were not required because for at least the following reason:
(C) A different field of search: Where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries, a different field of search is shown, even though the two are classified together. The indicated different field of search must in fact be pertinent to the type of subject matter covered by the claims. Patents need not be cited to show different fields of search.
Accordingly, for at least the reasons discussed above and in the Restriction 03/04/2026, the Restriction for examination purposes as indicated is deemed proper.
Applicant further elected the species of poly(2-butyrate trimethylene carbonate-2-hydroxytrimethylene carbonate-trimethylene carbonate) P(BtT-HT-T) as the specie of polymer. Applicant asserted that claims 1-11 and 13-23 encompassed the elected species.
However, upon further consideration, the Examiner hereby withdraws the election of species requirement and extend the search to all species of polymer.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24 and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/29/2026
Status of the Claims
Claims 1-25 are pending in this instant application, of which claims 24 and 25 are withdrawn at this time being drawn to a nonelected group/invention.
Claims 1-23 are examined herein on the merits for patentability.
Claim Objections
Claim 2 is objected to because of the following informalities: the recitation of “one or more of hydrolysis, oxidation, and enzymatic action” is an improper Markush language. See below for proper Markush languages. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the recitation of “one or more of ester, anhydride, carbonate, amide, thioester, urethane, acetal, disulfide, and orthoester” is an improper Markush language. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the recitation of “one or more of acetate, propionate, and butyrate” is an improper Markush language. See below for proper Markush languages Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the recitation of “the polymer is selected from a vinyl polymer, a polyester, and an aliphatic polycarbonate” is an improper Markush language. See below for proper Markush languages. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the recitation of “the polymer is selected from poly(vinyl alcohol), poly(5-hydroxy caprolactone), poly(5-hydroxy caprolactone-co-lactide) and combinations with glycolide and/or trimethylene carbonate, poly(5,6-hydroxy tetramethylene carbonate), poly(5,5- dihydroxy trimethylene carbonate), and poly(1,2-glycerol carbonate)” is an improper Markush language. See below for proper Markush languages. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: the recitation of “at least one of a therapeutic compound, a pharmaceutical agent, a biopharmaceutical agent, a bioactive agent, a medicament, an antineoplastic agent, a hormone, a peptide, a protein, a nucleic acid, a vector, a virus, an antigen, and an antibody” is an improper Markush language. See below for proper Markush languages. Appropriate correction is required.
When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.
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 9 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.
The recitation of “and combinations with …” followed by “and/or” and “and” in the Markush group recited in claim 9 renders the claim indefinite because the metes and bounds of which polymer(s) recited in the Markush group is used in combination and which ones are not used in combination. The Markush group recited in claim 9 is an improper Markush language and thus, it is not clear the alternative species encompassed by the claimed Markush group. Clarification by amendment in claim 9 is required.
As a result, claim 9 does not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 102
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 –
(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.
Claim(s) 1-7, 9-11, 13, 16-17 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wan et al (WO 2020/232399 A1).
Regarding claims 1-4, 6-7, 9, and 13, Wan teaches a composition comprising a polymer conjugate of polyvinyl alcohol as a polymeric backbone covalently linked to histone deacetylase (HDAC) inhibitor such as butyrate, wherein the covalently linked is via an ester bond that is degradable by hydrolysis (Abstract; [0005]-[0016], [0047]-[0078], [0100]-[0147]; claims 1-4).
Regarding claim 5, Wan teaches the polymer conjugate 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of the monomers within the polymer have conjugated HDAC inhibitor (butyrate) ([0072]).
Regarding claim 10, Wan teaches the polymer conjugate is degradable ([0020], [0038], [0078], [0171]).
Regarding claim 11, Wan teaches the release of the butyrate from the polymer conjugate is gradually and slowly based on the molar ratio of the butyrate in the polymer conjugate ([0020], [0038], [0073], [0078], [0171]).
Regarding claim 16, Wan teaches the composition contains an implantable device that is also degradable for use in delivery the polymer conjugate to a subject by injection ([0132]).
Regarding claim 17, Wan teaches the polymer conjugate release the HDAC inhibitor (butyrate) through slow hydrolysis ([0020], [0038], [0073], [0078], [0171]).
Regarding claims 21 and 22, Wan teaches the composition contains and implantable device that is also degradable for use in delivery the polymer conjugate to a subject by injection, wherein the composition further contains a bioactive agent such as retinoid (Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4).
Regarding claim 23, Wan teaches an implantable device containing a composition comprising a polymer conjugate of polyvinyl alcohol as a polymeric backbone covalently linked to histone deacetylase (HDAC) inhibitor such as butyrate, wherein the covalently linked is via an ester bond that is degradable by hydrolysis (Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4).
As a result, the aforementioned teachings from Wan are anticipatory to claims 1-7, 9-11, 13, 16-17 and 21-23 of the instant invention.
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.
Claim(s) 1-7, 9-11, 13, 16-18 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al (WO 2020/232399 A1), and further in view of Zhang et al (Macromolecules, 2013, 46: 9554-9562).
The compositions of claims 1-7, 9-11, 13, 16-17 and 21-23 are discussed above, said discussion being incorporate herein in its entirety.
Regarding claim 18, Wan teaches the polymer conjugate (polyvinyl alcohol covalently linked to butyrate) release butyrate through slow hydrolysis (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4). Zhang teaches the controlled degradation of polyester containing butyrate via intramolecular cyclization in which hydrolysis of the polyester cleaves the polymer backbone to produce oligomers of butyrate (Zhang: Abstract; Introduction; pages 9555-9562).
It would have been obvious to one of ordinary skill in the art that the hydrolysis of the polyvinyl alcohol covalently linked to butyrate (a polyester) of Wan would implicitly include an intramolecular cyclization reaction that cleaves the polyvinyl alcohol backbone to produce oligomers of butyrate because per Zhang supra, the controlled degradation of polyester containing butyrate via intramolecular cyclization in which hydrolysis of the polyester cleaves the polymer backbone to produce oligomers of butyrate.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-7, 9-11, 13, 16-17 and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al (WO 2020/232399 A1), and further in view of Schulthess et al (Immunity, 2019, 50: 432-445).
The compositions of claims 1-7, 9-11, 13, 16-17 and 21-23 are discussed above, said discussion being incorporate herein in its entirety.
Regarding claims 19 and 20, Wan teaches the polymer conjugate (polyvinyl alcohol covalently linked to butyrate) release butyrate (a HDAC inhibitor) through slow hydrolysis (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4). Wan teaches the polymer conjugate is formulated in a formulation for delivery via injection to a subject ([0128]-[0132]). Schulthess teaches that butyrate is a HDAC inhibitor that plays an immune regulatory role in vivo in which butyrate induces macrophage polarization towards an M2 phenotype in tissue (Schulthess: Summary; Introduction; pages 432 and 440-442)
It would have been obvious to one of ordinary skill in the art that the butyrate that is released from the polymer conjugate of Wan when administered to a subject via injection would implicitly induce an immunomodulatory response via macrophage polarization towards an M2 phenotype because as discussed above, Wan established that the butyrate is released from the polymer conjugate is an HDAC inhibitor, thereby the butyrate would induce an immunomodulatory response via macrophage polarization towards an M2 phenotype per Schulthess supra.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-17 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohajeri et al (US 2019/0134202 A1) in view Wan et al (WO 2020/232399 A1) and Eisenfrats et al (US 2019/0038454 A1).
Regarding claim 1, Mohajeri teaches a composition comprising a copolymer of trimethylene carbonate and 5-hydroxytrimethylene carbonate (Abstract; [0005]-[0140]; claims 1-13).
However, Mohajeri does not teach the pendant group comprising short chain fatty acid groups that is beared on the polymer of claim 1.
Regarding the pendant group comprising short chain fatty acid groups of claim 1, Wan teaches a polymer conjugate comprising a polymer (polyvinyl alcohol) containing a plurality of hydroxyl groups, wherein a HDAC inhibitor such as butyrate is covalently attached to the polymer via the plurality of hydroxyl groups (Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4).
It would have been obvious to one of ordinary skill in the art to modify the copolymer of Mohajeri such that a short chain fatty acid group such as butyrate is covalently linked to or conjugated to the hydroxyl group on the hydroxytrimethylene carbonate of the copolymer of Mohajeri, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Eisenfrats establishes both poly(trimethylene carbonate) and polyvinyl alcohol are suitable polymers for modifying with butyrate by functionalizing of the butyrate to the polymer (Eisenfrats: Abstract; [0013] and [0066]-[0067]; claims 1-5). One of ordinary skill in the art would have reasonable expectation of success of modifying the copolymer of Mohajeri such that a short chain fatty acid group such as butyrate is covalently linked to or conjugated to the hydroxyl group on the hydroxytrimethylene carbonate of the copolymer of Mohajeri because Wan indicated that a polymer containing plurality of hydroxyl groups can be modified with a HDAC inhibitor such as butyrate so to provide a polymer conjugate that is useful for treating cancer (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4), and the copolymer of trimethylene carbonate and 5-hydroxytrimethylene carbonate of Mohajeri is within the scope of said polymer containing plurality of hydroxyl groups describe by Wan, as well as, Mohajeri is also drawn to using the copolymer for the treatment of cancer (Mohajeri: [0047]). Thus, an ordinary artisan seeking to provide a polymer with improved efficacy in treating cancer, would have looked to modify the copolymer of Mohajeri such that a short chain fatty acid group such as butyrate is covalently linked to or conjugated to the hydroxyl group on the hydroxytrimethylene carbonate of the copolymer of Mohajeri per guidance from Wan and Eisenfrats, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 2-4, Wan provides the guidance for covalently linking the butyrate to hydroxyl group on the polymer of Mohajeri via an ester bond (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4).
Regarding claim 5, Wan provides the guidance for the polymer of Mohajeri to contain 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of butyrate conjugated within the polymer (Wan: [0072]).
Regarding claim 6, as discussed above, Wan in view of Eisenfrats provided the guidance for conjugating or functionalizing butyrate to the hydroxyl group on the polymer of Mohajeri.
Regarding claims 7-9, as discussed above, Mohajeri teaches the polymer includes trimethylene carbonate and 5-hydroxytrimethylene carbonate.
Regarding claim 10, Mohajeri teaches the polymer is biodegradable ([0011]; claims 8 and 9).
Regarding claim 11, Mohajeri teaches the degradation rate of the polymer can be controlled by the molar ratio of the repeating units of trimethylene carbonate and 5-hydroxytrimethylene carbonate in the polymer ([0005]-[0015], [0045], [0056]; claims 1-9).
Regarding claim 12, as discussed above, Mohajeri teaches copolymer of trimethylene carbonate and 5-hydroxytrimethylene carbonate,
Regarding claim 13, as discussed above, Wan in view of Eisenfrats provided the guidance for conjugating or functionalizing butyrate to the hydroxyl group on the polymer of Mohajeri.
Regarding claim 14, as discussed above, Mohajeri teaches copolymer of trimethylene carbonate and 5-hydroxytrimethylene carbonate. As discussed above, Wan in view of Eisenfrats provided the guidance for conjugating or functionalizing butyrate to the hydroxyl group on the polymer of Mohajeri, thereby providing a resultant composition that contains butyrate trimethylene carbonate, hydroxy trimethylene carbonate, and trimethyl carbonate.
Regarding claim 15, Mohajeri teaches the ratio of trimethylene carbonate to 5-hydroxytrimethylene carbonate can be optimize from 15:1 to 1:10 so as to provide a desired degradation rate (Mohajeri: [0005]-[0015], [0045], [0056]; claims 1-9). Wan provides the guidance for the polymer of Mohajeri to contain 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 100% of butyrate conjugated within the polymer (Wan: [0072]). Thus, provided the combined guidance from Mohajeri and Wan, it would have been obvious to one of ordinary skill in the art to optimize the ratio of butyrate trimethylene carbonate, hydroxy trimethylene carbonate, and trimethyl carbonate in the composition to a ratio within the range of about 12-15-60 to about 10-30-60 as claimed because “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 16, Mohajeri teaches the composition contains an implantable device that is biodegradable for use in delivery the polymer to a subject by injection (Abstract; [0041], [0098], [0108] and [0116]-[0117]; claims 1-13).
Regarding claim 17, Wan teaches and provides guidance for the polymer conjugate release the HDAC inhibitor (butyrate) through slow hydrolysis ([0020], [0038], [0073], [0078], [0171]).
Regarding claims 21 and 22, Mohajeri teaches the composition contains an implantable device for use in delivery the polymer to a subject by injection, wherein the composition further contains a drug selected from a therapeutic compound, pharmaceutical, biopharmaceutical, bioactive agent, medicament, antineoplastic, hormone, peptide, protein, nucleic acid, vector, virus, antigen, antibody, or combination thereof (Abstract; [0041], [0098], [0108] and [0116]-[0117]; claims 1-13).
Regarding claim 23, Mohajeri in view of Wan and Eisenfrats teaches a implantable device comprising a polymer containing trimethylene carbonate and 5-hydroxytrimethylene carbonate, wherein butyrate is covalently linked via an ester bond to the hydroxyl group in the polymer (Mohajeri: Abstract; [0005]-[0140]; claims 1-13; Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4; Eisenfrats: Abstract; [0013] and [0066]-[0067]; claims 1-5).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohajeri et al (US 2019/0134202 A1) in view Wan et al (WO 2020/232399 A1) and Eisenfrats et al (US 2019/0038454 A1), as applied to claim 1 above, and further in view of Zhang et al (Macromolecules, 2013, 46: 9554-9562).
The composition of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 18, Wan teaches the polymer conjugate release butyrate through slow hydrolysis (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4). Zhang teaches the controlled degradation of polyester containing butyrate via intramolecular cyclization in which hydrolysis of the polyester cleaves the polymer backbone to produce oligomers of butyrate (Zhang: Abstract; Introduction; pages 9555-9562).
It would have been obvious to one of ordinary skill in the art that the hydrolysis of the polymer covalently linked to butyrate (a polyester) of Mohajeri in view of Wan and Eisenfrats would implicitly include an intramolecular cyclization reaction that cleaves the polymer backbone to produce oligomers of butyrate because per Zhang supra, the controlled degradation of polyester containing butyrate via intramolecular cyclization in which hydrolysis of the polyester cleaves the polymer backbone to produce oligomers of butyrate.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mohajeri et al (US 2019/0134202 A1) in view Wan et al (WO 2020/232399 A1) and Eisenfrats et al (US 2019/0038454 A1), as applied to claims 1 and 16 above, and further in view of Schulthess et al (Immunity, 2019, 50: 432-445).
The composition of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 19 and 20, Wan teaches the polymer conjugate release butyrate through slow hydrolysis (Wan: Abstract; [0005]-[0016], [0020], [0038], [0047]-[0078], [0100]-[0147], [0171]; claims 1-4). Mohajeri and Wan teach the polymer conjugate is formulated in a formulation for delivery via injection to a subject (Mohajeri: Abstract; [0041], [0098], [0108] and [0116]-[0117]; claims 1-13; Wan: [0128]-[0132]). Schulthess teaches that butyrate is a HDAC inhibitor that plays an immune regulatory role in vivo in which butyrate induces macrophage polarization towards an M2 phenotype in tissue (Schulthess: Summary; Introduction; pages 432 and 440-442)
It would have been obvious to one of ordinary skill in the art that the butyrate that is released from the polymer conjugate of Mohajeri in view of Wan and Eisenfrats when administered to a subject via injection would implicitly induce an immunomodulatory response via macrophage polarization towards an M2 phenotype because as discussed above, Wan established that the butyrate is released from the polymer conjugate is an HDAC inhibitor, thereby the butyrate would induce an immunomodulatory response via macrophage polarization towards an M2 phenotype per Schulthess supra.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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