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 .
Applicant's election with traverse of Group I (Claims 1-32) in the reply filed on February 18, 2026 is acknowledged. The traversal is on the ground(s) that it would not be unduly burdensome to perform a search on all of the claims together in present application. This is not found persuasive because those four groups of inventions have acquired a separate status in the art in view of their different classification and due to their recognized divergent subject matter, and those four groups of inventions require a different field of search (for example, searching different classes/subclasses or electronic resources (including Google search, AI Similarity Search and chemical structure search in STN database) and employing different search strategies or search queries). Thus, it would be a serious search and examination burden if restriction were not required (besides, the Examiner already showed in the previous restriction requirement dated January 28, 2026 that Groups I-IV lack unit of invention because the shared technical feature of the thermoreversible polymer of claim 1 is not a special technical feature as it does not make a contribution over the prior art in view of Maitra et al (WO’558).
The requirement is still deemed proper and is therefore made FINAL.
Claims 33-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 18, 2026. Applicant must use appropriate status identifiers for the withdrawn claims.
Claim Interpretation
The phrase “lower alkyl” appearing on the 3rd line of claim 1 is interpreted by the Examiner (based on [0020] of present specification) to mean an alkyl group having 1-6 carbon atoms.
Claim Objections
Claim 23 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 objected to because of the following informalities: on the 2nd line from the bottom, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: (i) on the 4th line from the bottom, applicant need to change “and” to --- or ---. (ii) on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: on the 6th line from the bottom, applicant need to change “and” to --- or ---. (ii) on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: on line 3, applicant need to change “and” (located between “an aldehyde” and “protected”) to --- or ---. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: on the last line, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claims 24-25 are objected to because of the following informalities: (i) in claim 24, applicant need to change “are independently selected a modifying agent selected from” to --- are modifying agents independently selected from ---, and need to change “and” on the last line to --- or ---. (ii) In claim 25, applicant need to change “are independently selected a modifying agent selected from” to --- are modifying agents independently selected from ---. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: on line 2, applicant need to place a comma between “hepatic growth factor” and “insulin”. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: on line 2, applicant need to change “and” to --- or ---. Appropriate correction is required.
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.
Claims 1-32 are 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.
In claim 1, applicant recites “[a] thermoreversible polymer comprising a N-isopropylacrylamide (NIPAM) co-monomer; a lower alkyl amine co-monomer; and a poly(ethylene glycol) (PEG) co-monomer, wherein . . .”. It is unclear to the Examiner what applicant exactly mean by a polymer “comprising” co-monomer(s).
For the purpose of examining the claim on the merit, the Examiner assumed that instant claim 1 as claiming a polymer comprising a repeating unit formed of a NIPAM co-monomer; a repeating unit formed of a lower alkyl amine co-monomer; and a repeating unit formed of a PEG co-monomer: also, “a lower alkyl amine co-monomer” was interpreted by the Examiner to mean a lower alkyl amine group-containing co-monomer, and “a poly(ethylene glycol) (PEG) co-monomer” was interpreted to mean a poly(ethylene glycol) (PEG) group-containing co-monomer. If the Examiner’s interpretation is wrong, are applicant is claiming (in claim 1) a polymer (a reaction product) produced by reacting those monomers listed in claim 1 instead? However, if that is the case, it seems that there should be additional monomers required for the reaction to produce instant polymer (based on the reaction scheme shown in Fig.1, for example. Appropriate correction and/or clarification by applicant is required.
Secondly, it is also unclear and confusing to the Examiner what applicant mean by a lower alkyl “amine” co-monomer. It is the Examiner’s understanding that “the lower alkyl amine co-monomer” of claim 1 corresponds to the monomer unit (b) of claims 4, 12 and 14. However, monomer unit (b) of claims 4, 12 and 14 is not an amine co-monomer unit, but an amide co-monomer unit. Did applicant mean to claim a lower alkyl amide co-monomer in claim 1 (for the purpose of examining the claim on the merit, the Examiner assumed that applicant meant to claim a lower alkyl amide co-monomer)? Appropriate correction and/or clarification is required.
Lastly, it is also unclear whether the polymer of claim 1 has a repeating unit formed of PEG co-monomer and/or a repeating unit formed of the lower alkyl amine co-monomer on the backbone or on a side chain of the polymer. For the purpose of examining the claim on the merit, the Examiner assumed the latter (based on the reading of present specification and in view of the chemical formulas shown in claims 4, 12 and 14). Appropriate correction and/or clarification is required.
Instant 112(b) rejection on claims 1-32 can be overcome if applicant limit instant thermoreversible polymer of claim 1 to a polymer represented by a specific formula (such as formula (I) shown in claim 4, formula (II) shown in claim 12 or formula (III) shown in claim 14) thereby removing any confusion, vagueness and indefiniteness.
Claims 4-10, 12, 14-22 and 24-28 are 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.
In claim 4, applicant recite “[t]he thermoreversible polymer of claim 1, comprising the formula (I):”. It is unclear and confusing to the Examiner that by using the open-ended transitional phrase “comprising”, whether applicant is implying that the polymer of claim 1 can include other components than the polymer of formula (I). If so, how is that possible? Instant rejection can be overcome by changing “comprising” to --- represented by --- in claim 4 (for the purpose of examining the claim on the merit, the Examiner assumed that applicant meant to say “[t]he thermoreversible polymer of claim 1, represented by the formula (I):”).
By the same logic, instant claim 12 is also rejected. Applicant can overcome instant rejection by changing “comprising” to --- represented by --- in claim 12. Applicant also need to define what the variables “a”, “b”, “c” and “PEGn” are (as they did in claim 4) in claim 12.
By the same logic, instant claim 14 is also rejected. Applicant can overcome instant rejection by changing “comprising” to --- represented by --- in claim 14. Applicant also need to define what the variable
Claim 13 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.
Claim 13 recites the limitation "the PEG or PEGn" in line 2. There is insufficient antecedent basis for this limitation (the PEGn) in the claim.
Claims 24-28 are 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.
In each of claims 24, 25 and 26, applicant recite “wherein one or more of G1, G2 and Z2 are independently selected . . . from . . .” There is insufficient antecedent basis for the limitation Z2 in the claims because the chemical formula (I) of claim 4 (from which claims 24, 25 and 26 depend) does not include the variable Z2.
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.
Claims 4 and 14 are 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.
It is the Examiner’s understanding that the lower alkyl amine co-monomer (unit) of instant claim 1 is represented by the monomer unit b in the formula (I) of claim 4 and by the monomer unit b in the formula (III) of claim 14. Yet, in claims 4 and 14 (both of which depending from claim 1), applicant define R1 in the monomer unit b as an alkyl or a substituted alkyl, without limiting the number of carbon atoms in the alkyl group ([0020] of present specification define “lower alkyl” to mean an alkyl group having 1-6 carbon atoms). Thus, each of claims 4 and 14 fails to further limit the subject matter of claim 1.
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.
Instant rejection can be overcome by changing “R1 is an alkyl or a substituted alkyl;” to --- R1 is a C1-C6 alkyl or a substituted C1-C6 alkyl --- in both claims 4 and 14.
Claims 4, 12 and 14 are 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.
The monomer unit b shown in each of claims 4, 12 and 14 is an acrylamide monomer unit. However, claim 1 requires a lower alkyl amine co-monomer (unit). Thus, claims 4, 12 and 14 fail to further limit the subject matter of claim 1.
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 21 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.
In claim 14, the variable Z2 is required to be a modifying agent. Yet, claim 21, which depends from claim 14, states that Z2 is a chemoselective functional group chosen from those listed in claim 21. Those chemical groups listed in claim 21 are not modifying agents. Thus, claim 21 fails to further limit the subject matter of instant claim 14.
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
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.
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) 1-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rodrigues et al (US 2018/0251730 A1) in view of Yao et al (CN 101580585 A and its English translation) and Schonhammer (EP 2 323 623 B1).
Rodrigues teaches (claim 3 and [0102]) a thermoreversible polymer comprising (i) a N-isopropylacrylamide co-monomer, (ii) an alkyl [meth]acryl[ate/amide] co-monomer (which refers to a co-monomer that is an alkyl acrylate, an alkyl methacrylate, an alkyl acrylamide or an alkyl methacrylamide) and (iii) a PEG acrylamide co-monomer. Based on such teaching, one skilled in the art would immediately envisage a thermoreversible polymer comprising (i) a N-isopropylacrylamide co-monomer, (ii) an alkyl acrylamide co-monomer and (iii) a PEG acrylamide co-monomer.
The N-isopropylacrylamide co-monomer in Rodrigues’s thermoreversible polymer teaches instant a N-isopropylacrylamide (NIPAM) co-monomer of claim 1 as well as instant monomer unit “a” of claims 4 and 12.
With respect to instant lower alkyl amine co-monomer, Rodrigues teaches ([0078]) that the “alkyl” group (as in its alkyl acrylamide co-monomer) refers to a monovalent saturated aliphatic hydrocarbyl group having 1-6 carbon atoms (instant lower alkyl group – see [0020] of present specification) , which specific examples include methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, t-butyl, n-pentyl and neopentyl. Based on such teaching, it would have been obvious to one skilled in the art to have Rodrigues’s alkyl acrylamide co-monomer to be n-butyl acrylamide co-monomer (instant lower alkyl amine co-monomer of claim 1 as well as instant monomer unit “b” of claims 4 and 12) with a reasonable expectation of success.
With respect to instant poly(ethylene glycol) (PEG) co-monomer, wherein the terminal PEG monomer is substituted with alkyl, substituted alkyl, heteroalkyl, substituted heteroalkyl, cycloalkyl, substituted cycloalkyl, heterocycloalkyl, substituted heterocycloalkyl, aryl, substituted aryl, arylalkyl, substituted arylalkyl, heteroaryl, substituted heteroaryl, heteroarylalkyl, and substituted heteroarylalkyl, Rodrigues teaches ([0103]) that its PEG acrylamide co-monomer refers to an N-alkyl acrylamide further substituted on the alkyl sidechain with a polyethylene glycol (PEG) or modified polyethylene glycol where the PEG polymeric group includes water-soluble repeat units of –(CH2-CH2-O)- or –(O-CH2-CH2)-, and the reference further teaches that the number of such water-soluble repeat units can be from 2 to 50. According to such teaching, the resulting PEG acrylamide co-monomer unit in Rodrigues’s thermoreversible polymer would have a chemical structure of -(CH2-CH2)c-C(=O)-NH-R-(PEG)n, with c being a molar fraction of the co-monomer, R being the alkyl group (of the N-alkyl acrylamide) on which the (PEG)n polymeric group is attached and n being the number (from 2 to 50) of the water-soluble repeat units of –(CH2-CH2-O)- or –(O-CH2-CH2)-. Since, as discussed above, Rodrigues teaches ([0078]) that “alkyl” refers to monovalent saturated aliphatic hydrocarbyl group of 1-6 carbon atoms, which specific examples include methyl, ethyl, n-propyl, isopropyl, n-butyl, isobutyl, sec-butyl, t-butyl, n-pentyl and neopentyl, it would have been obvious to one skilled in the art to have the alkyl group R (as in the chemical structure of -(CH2-CH2)c-C(=O)-NH-R-(PEG)n) to be an ethyl group with a reasonable expectation of success, and the resulting chemical structure would be -(CH2-CH2)c-C(=O)-NH-CH2CH2-PEGn, with n being 2-50. In such structure, the terminal PEG monomer in the PEGn is not further substituted as instantly required in claim 1 (i.e., the hydroxyl group in the terminal PEG monomer is not end-capped). However, as evidenced by Yao et al ([0018]) and Schonhammer ([0007]), it is well known in the art to end-cap polyethylene glycol by using inert groups, such as methoxy group, to seal the polyethylene glycol and obtain improved stability. It would have been obvious to one skilled in the art to end-cap the terminal PEG monomer of (PEG)n by using inert groups, such as methoxy group, so as to seal the (PEG)n and obtain improved stability (by preventing unwanted reactions resulting from the chemically active hydroxyl group of the terminal PEG monomer). After the end-capping with a methoxy group, Rodrigues’s PEG acrylamide co-monomer unit as discussed above would have the final chemical structure of -(CH2-CH2)c-C(=O)-NH-CH2CH2-(PEG)n-OCH3 (i.e., hydroxyl group of the terminal PEG monomer in (PEG)n is substituted with methoxy group, the methoxy group teaching instant heteroalkyl group of claim 1, instant alkoxy groups of claims 2-3, instant R2 (heteroalkyl) group of claim 4 and instant R2 (alkoxy) groups of claims 8-10), and such structure (after the end-capping with a methoxy group) is the same as instant monomer unit “c” of claim 12 and also teaches instant monomer unit “c” of claim 4. Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant poly(ethylene glycol) (PEG) co-monomer, wherein the terminal PEG monomer is substituted with heteroalkyl (alkoxy) group.
Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant claims 1-10 and 12 (with respect to instant claims 4 and 12, Rodrigues teaches (see [0114], claims 4 and 12) that its thermoresponsive polymer comprises instant G1 and G2 moieties selected from a polymer segment, a terminal group, a linker or a linked modifying agent).
With respect to instant claims 11 and 23, as discussed above, Rodrigues in view of Yao and Schonhammer teaches instant monomer units a, b and c of claims 4 and 12. Rodrigues further teaches (see claim 8) that a>0.8; 0.1>b>0; and 0.2>c>0. Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant claims 11 and 23.
With respect to instant claim 13, Rodrigues teaches (claim 21) that the PEG or PEGn has a Mw of from 2kDa to 100 kDa. Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant claim 13.
With respect to instant claims 14-22, as already explained above, Rodrigues in view of Yao and Schonhammer teaches instant monomer units a, b and c and instant G1 and G2 moieties (with instant R1 being n-butyl, instant R2 being methoxy and instant n being 2-50). As to instant monomer unit d of instant formula (III), Rodrigues teaches ([0104]) that its thermoreversible polymer discussed above may further comprises a modifying acrylamide co-monomer comprising a linked functional group and/or a linked modifying agent, i.e., a substituted N-alkyl acrylamide co-monomer, which is substituted with an optional linker (instant “L” moiety in the monomer unit d) terminated with a functional group and/or a linked modifying agent (instant modifying agent, Z2). Rodrigues further teaches ([0125] and [0115]) that the functional group (included in its modifying acrylamide co-monomer) can be thiol, alkyne, cyclooctyne, azide or maleimide (instant chemoselective functional group of claim 21) and teaches that the modifying agent (included in its modifying acrylamide co-monomer) can be heparin, hyaluronic acid, specific binding member, peptide, nucleic acid, gelatin, fibronectin, collagen, laminin, bFGF, EGF, insulin, progesterone, glucose, thymosin beta-4, SHH, Noggin, Activin, TGFb3, FGF8, BDNF, GDNF, NT3, PDGF-AA or IGF-1 (instant modifying agent of claim 22). Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant claims 14-22.
With respect to instant claims 24-28, as discussed above, Rodrigues’s thermoresponsive polymer comprises instant G1 and G2 moieties selected from a polymer segment, a terminal group, a linker or a linked modifying agent (see [0114], claims 4 and 12). It would be obvious to one skilled in the art to have Rodrigues’s thermoresponsive polymer to comprise instant G1 and G2 moieties that are linked modifying agents. Among examples for the modifying agent, Rodrigues teaches ([0115]) heparin, hyaluronic acid, specific binding member, peptide, nucleic acid, gelatin, fibronectin, collagen and laminin (all of which teach instant modifying agents of claims 24 and 25) . Furthermore, as also discussed above, Rodrigues teaches ([0140]) that its modifying acrylamide co-monomer comprise a linked modifying agent, and among examples for the linked modifying agent, Rodrigues teaches growth factors, such as EGF (epidermal growth factor), TGF (transforming growth factor), FGF (fibroblast growth factor, for example, FGF-8), PDGF (platelet-derived growth factor), IGF(insulin-like growth factor) and a bone morphogenetic protein (all of which teach instant polypeptides of claims 27 and 28). Thus, Rodrigues in view of Yao and Schonhammer renders obvious instant claims 24-28.
With respect to instant claims 29-32, Rodrigues teaches ([0063] and [0092]) that in some cases, its thermoresponsive polymer is liquid at 4oC (which is 30oC or less as recited in claim 31) and is a solid, semi-solid or gel at 37oC (which is 20oC or more as recited in claim 29). Thus, Rodrigue in view of Yao and Schonhammer renders obvious instant claims 29-32.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
March 20, 2026