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 .
Claim Status
Claims 1-9, 11-15, and 20 are pending.
Claim 2 is currently amended.
Claims 10 and 16-19 is cancelled.
The elected species of L-glutamate N-carboxyanhydride dated 11/10/2021 is still valid. According to the previous office action dated 10/30/2024, claim 2 is interpreted as a linear homopolymer of L-glutamate in consistent with the species election. Any peptide sequences NOT homopolymer of L-glutamate will be withdrawn in compliance with RCE filing. Thus, claims 4, 6, and 8 are withdrawn as being directed to a non-elected species.
Claims 1 and 11-15 are withdrawn as being directed to a non-elected compound invention, the election having been made on 11/10/2021.
Claims 2-3, 5, 7, 9, and 20 have been examined.
Priority
This application is a 371 of PCT/KR2018/008328 filed on 07/24/2018, which claim foreign priority of REPUBLIC OF KOREA10-2017-0093530 filed on 07/24/2017.
Withdrawn Objection
The objection to claims 5 and 20 is withdrawn because the amendment to claim 5 and cancellation of claim 20 overcomes the objection.
Modified 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.
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 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.
Claims 2-3, 5, 7, 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Guo et al. (J. Am. Chem. Soc. 2012, 134, 9163−9171, previously cited 1/10/2022) in view of Fevre et al. (Polym. Chem. 2013; (4):1995-2003, previously cited 1/10/2022), Cheng et al. (Top Curr Chem. 2012:310:1-26, previously cited 1/14/2026) and evidenced by (i) Zhang et al. (COMMUNICATIONS CHEMISTRY. 2018; 1:40), (ii) De Greef et al. (Chem. Rev. 2009; 109: 5687–5754), and (iii) Deming et al. (Chem. Rev. 2016, 116, 786−808, previously cited 1/14/2026).
Claim 2 is drawn to a method for producing a linear polypeptide comprising:
preparing a mixture of an α-amino acid N-carboxyanhydride and an organic solvent in an oxygen-removed and dried reaction vessel;
adding an a hexylamine compound to the reaction vessel;
adding an anhydrous catalyst represented by a following Chemical Formula 2-1, 2-2, 2-3, or 2-4 to the reaction vessel;
reacting the α-amino acid N-carboxyanhydride with the anhydrous catalyst in an anhydrous reaction to produce a linear polypeptide;
wherein the hexylamine compound acts as an initiator for producing the linear polypeptide,
wherein a content of the hexylamine compound is 0.2 to 10 moles based on 1 mole of the anhydrous catalyst, and a content of the α-amino acid N-carboxyanhydride is 2 to 10,000 moles based on 1 mole of the anhydrous catalyst, and
wherein the linear polypeptide produced using the method has a polydispersity index (PDI) of 1.5 or lower.
Guo et al. teach a method for producing a compound of polymerizing α-amino acid N-carboxyanhydride using N-heterocyclic carbene of NHC 1 or a functional equivalent analogue as a catalyst for ring open polymerization of amino acids (reading on α-amino acid N-carboxyanhydride) in an anhydrous reaction as shown follows (p9164, scheme 1) to produce
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linear polymer by end-capping with electrophiles (e.g., acetyl chloride) (p9170, col 2, line 1-3). Guo et al. further show the method has a polydispersity index (PDI) of 1.5 or lower (pS4, Table S1; pS5, Table S2).
Guo et al. teach the polymerization reaction is performed under a nitrogen atmosphere before isolation of the polymer (p9165, col 1, last para; S2, Experimental details, para 1), but do not teach the use of N-heterocyclic carbene with a pharmaceutical sat of HCO3-.
Similarly, Fevre et al. teach NHCs are relative instable when exposed to air makes them difficult to handle. As a consequence, NHCs must often be stored and manipulated under dry and inert conditions. Fevre et al. teach a general strategy to circumvent this limitation is to convert the NHC into a masked form, the in situ generation of the free NHC being generally achieved by
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thermal activation (p1995, col 2, para 2). Fevre et al. teach [NHC(H)][HCO3-] pre-catalysts (p1998, Fig 1) are air-stable and easily accessible via a one-step undemanding process (p2002, col 1, Conclusion). Fevre et al. further teach all experiments were performed under an inert atmosphere using standard Schlenk techniques. Dry, oxygen-free solvents and reagents were employed (p1996, col 1, Materials). Because Fevre et al. teach beneficial use of a stable and easily accessible [NHC(H)][HCO3-] pre-catalyst to substitute Guo’s air-sensitive NHC catalysts for ring-opening polymerisations, one of ordinary skill in the art would have found it obvious to prepare the reactants of mixed α-amino acid N-carboxyanhydride and an organic solvent in an oxygen-removed and dried reaction vessel for conducting the polymerization reaction according to Guo’s scheme 1 shown above.
Guo et al. in view of Fevre et al. did not specify adding a hexylamine compound to initiate the reaction of Ring-Opening Polymerization of α-Amino Acid N-Carboxyanhydrides.
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Cheng et al. teach Synthesis of Polypeptides by Ring-Opening Polymerization of α-Amino Acid N-Carboxyanhydrides (Title). Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide shown as follows (p5, scheme 2). Because (i) Guo et al. in view of Fevre et al. and (ii) Cheng et al. teach synthesis of polypeptides by ring-opening polymerization of α-amino acid N-carboxyanhydrides, it would be obvious to combine Guo et al. in view of Fevre et al. and Cheng et al. for the same purpose of synthesizing polypeptides by ring-opening polymerization of α-amino acid N-carboxyanhydrides. See MPEP 2144.06(I). Zhang et al. is cited as evidence to show a linear polypeptide is produced by the bifunctional organocatalysis strategy for [NHC(H)(HCO3)] in the present of a primary amine compound (p3, Fig 2), further demonstrating a linear peptide produced in the presence of Chen’s primary amine initiator of n-hexylamine initiator.
De Greef et al. is cited to show common knowledge of adding a small amount of initiator lowering the value of polydispersity index (p5694, Col 2, para 1) by preventing monomers from reacting with each other (p5716, col 2, para 1) known in the art. Consistently, Deming is further cited to show polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2) known in the art.
With respect to the limitation (i), Guo et al. teach the polymerization in a polar solvent of DMSO or DMF without water for synthesis a polymer of low molecular weight (p9170, col 2, line 8). Guo et al. show polymerization of an α-amino acid N-carboxyanhydride in an organic solvent with an N-Heterocyclic carbene (NHC) as a catalyst (p9164, scheme 1). Guo et al. teach the polymerization reaction is performed under a nitrogen atmosphere before isolation of the polymer (p9165, col 1, last para; S2, Experimental details, para 1). Similarly, Fevre et al. teach all experiments were performed under an inert atmosphere using standard Schlenk techniques. Dry, oxygen-free solvents and reagents were employed (p1996, col 1, Materials).
With respect to the limitation (ii), Cheng et al. teach adding n-hexylamine initiator to polymerization solvents for polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) shown in scheme 2 (p5). De Greef et al. teach the addition of a small amount of initiator lowering the value of polydispersity index to a value of 1.5 (p5694, Col 2, para 1) by preventing monomers from reacting with each other (p5716, col 2, para 1). Consistently, Deming et al. teach polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2).
With respect to the limitation (iii), Guo et al. show addition of N-heterocyclic carbene of NHC 1 or a functional equivalent analogue as a catalyst for ring open polymerization of amino
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acids to produce a linear peptide (p9164, scheme 1). Fevre et al. teach beneficial use of air-stable and easily accessible [NHC(H)][HCO3-] pre-catalysts (p1998, Fig 1) converted to active catalyst by the thermal activation (p1995, col 2, para 2; p2002, col 1, Conclusion).
With respect to the limitation (iv), Guo et al. in view of Fevre et al. teach addition of [NHC(H)][HCO3-] pre-catalysts for ring open polymerization of amino acids to produce a linear peptide (p9164, scheme 1) in organic solvent ,such as DMF, under a nitrogen atmosphere and anhydrous condition (See Guo et al. p9164, scheme 1; p9170, col 2, line 8).
With respect to the limitation (v), Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2).
With respect to the limitation (vi), the molar ratio of Chen’s hexylamine initiator to the anhydrous catalyst of N-heterocyclic carbene and a content of the α-amino acid N-carboxyanhydride to the anhydrous catalyst are result-effective variable that can be optimized by routine experimentation under the prior art conditions. See MPEP 2144.05 (II).
With respect to the limitation (vii), Guo et al. further show the method has a polydispersity index (PDI) of 1.5 or lower (pS4, Table S1; pS5, Table S2). De Greef et al. teach the addition of a small amount of initiator lowering the value of polydispersity index to a value of 1.5 (p5694, Col 2, para 1) by preventing monomers from reacting with each other (p5716, col 2, para 1). Consistently, Deming et al. teach polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2).
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to modify Guo’s method for producing a compound of polymerizing α-amino acid N-carboxyanhydride with Fevre’s pre-catalysts for ring open polymerization of amino acids to produce a linear peptide because (a) Guo et al. teach polymerizing α-amino acid N-carboxyanhydride using N-heterocyclic carbene and (b) Fevre et al. teach beneficial use of a stable and easily accessible [NHC(H)][HCO3-] pre-catalyst to substitute Guo’s air-sensitive NHC catalysts for ring-opening polymerisations (p2002, col 1, Conclusion). The modification would have reasonable expectation of success because Fevre’s [NHC(H)][HCO3-] pre-catalyst can become the active catalyst by thermal activation (p1995, col 2, para 2).
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One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine (i) Guo et al. in view of Fevre et al. with (ii) Cheng et al. because (a) Guo et al. in view of Fevre et al. teach ring-opening polymerization of α-amino acid N-carboxyanhydrides and (b) Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) shown by Scheme 2 (p5). The combination would have reasonable expectation of success because all references teach ring-opening polymerization of α-amino acid N-carboxyanhydrides. De Greef et al. is cited to show common knowledge of adding a small amount of initiator lowering the value of polydispersity index (p5694, Col 2, para 1) by preventing monomers from reacting with each other (p5716, col 2, para 1) known in the art. Consistently, Deming is further cited to show polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2) known in the art. Zhang et al. is further cited as evidence to show a linear polypeptide is produced by the organocatalysis strategy for [NHC(H)(HCO3)] in the present of a primary amine compound (p3, Fig 2), further demonstrating a linear peptide produced in the presence of Chen’s primary amine initiator of n-hexylamine initiator.
With respect to claim 3, Fevre et al. show the air-stable and easily accessible [NHC(H)][HCO3-] pre-catalyst of compound 4a shown as follows, reading on the limitation and elected species of claim 3 (p1998, Fig 1).
With respect to claim 5, Guo et al. teach the synthesized product is poly(N-butyl glycine) (p9164, col 2, Results and Discussion, line 3), reading on L-glycine N-carboxyanhydride for polymerization of a liner peptide. Cheng et al. teach adding n-hexylamine initiator to polymerization solvents for polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) shown in scheme 2 (p5), reading on the elected species of L- glutamate N-carboxyanhydride.
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With respect to claim 7, Guo et al. teach the polymerization reaction is in an inert N2 atmosphere (pS12, Table S6).
With respect to claim 9, Guo et al. teach the reaction time of polymerization is within 100 minutes shown as follows (p9165, Fig 1).
Applicant’s Arguments
The amended claims are different from the cited prior art of record for the following reasons.
Argument to Guo et al. (Remarks, p15, last 3 para to p16, para 1)
Guo’s method of primarily to produce cyclic peptide
did not teach the use of hexylamine initiator to produce linear polypeptides
Guo et al. did not teach [NHC(H)][HCO3-] salt form of the catalyst
Guo's NHC process was presented as an alternative to conventional amine-initiated
polymerization; thus, there is no reason to modify a working NHC system by adding an amine initiator.
Argument to Ferve et al. (Remarks, p16, para 2-5)
Fevre's work is directed to lactide polymerization, not a-amino acid NCA polymerization.
Fevre does not disclose or suggest the use of an amine initiator (hexylamine or otherwise) in combination with the [NHC(H)][HCO3] catalyst.
Fevre does not disclose the production of linear polypeptides or the selective control of product topology (linear vs. cyclic) through the addition of an initiator.
Argument to Cheng et al. (Remarks, p16, last 4 para to p17, para 1-2)
There is no disclosure or suggestion of combining hexylamine with an NHC or [NHC(H)][HCO3] catalyst by Cheng et al.
Cheng does not disclose or suggest the three-component system (NCA + [NHC(H)][HCO3] catalyst + hexylamine initiator) or the specific molar ratios among these three components as claimed.
The arguments (A)-(C) are summarized in a Table by applicant as shown follows.
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These are fundamentally different and alternative reaction mechanisms. As established in Ex parte Fryer (Appeal No. 2010-010327, BPAI 2012) and Ex parte Manning (Appeal No. 2012-010718, PTAB 2014), obviousness rejections premised on modifications that are not needed should be reversed (Remarks, p17, last 2 para to p18, para 1).
The Examiner combines three references (Guo+ Fevre + Cheng) in a mosaic fashion, taking the NCA polymerization from Guo, the [NHC(H)][HCO3] catalyst from Fevre, and the hexylamine initiator from Cheng. However, no cited reference discloses or suggests what happens when a [NHC(H)][HCO3] catalyst and a hexylamine initiator are used together in the same NCA polymerization reaction. Thus, one of ordinary skill would have no basis to predict that this combination would (a) successfully produce linear polypeptides, (b) achieve a PDI of 1.5 or lower, or (c) maintain the catalytic efficiency (Remarks, p18, 2nd last para).
The Examiner cites De Greef and Deming as evidence that adding an initiator to lower PDI is "common knowledge." However, these references address conventional polymerization systems, not the unique dual-component system of the present invention. The fact that initiators can lower PDI in some systems does not mean that a [NHC(H)] [HCQ3] catalyst combined with hexylamine would predictably produce linear polypeptides with PDI ≤ 1.5. In Guo' s NHC system (without amine initiator), the NHC itself controls the polymerization; adding hexylamine introduces a competing initiation pathway whose outcome on PDI is unpredictable from the cited references alone (Remarks, last para to p19, para 1).
Response to Arguments
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive because (i) applicant argues the cited references individually whereas the rejection is based on a combined of the cited references and (ii) applicant improperly limited the teachings of cited references. See response to individual arguments in the following.
Applicant’s argument (A) is not persuasive for the reasons as follows.
A(1) Guo et al. explicitly teach synthesis of a linear peptide in the presence of AcCl (Abstract; p9164, Scheme 1), not limited to cyclic peptide as argued by applicant.
A(2) Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2) with expected success.
A(3) Fevre et al. teach NHCs are relative instable when exposed to air makes them difficult to handle. Fevre et al. teach [NHC(H)][HCO3-] pre-catalysts (p1998, Fig 1) are air-stable and easily accessible via a one-step undemanding process (p2002, col 1, Conclusion). The expected beneficial result of using [NHC(H)][HCO3-] pre-catalysts for ring open polymerization of amino acids is obvious. See MPEP 716.02(c)(II).
A(4) See response to argument A(3) for reason to modify Guo’s N-heterocyclic carbene above, not repeated here. Also, Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2) for producing a linear peptide with expected success. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145(IV).
Applicant’s argument (B) is not persuasive for the reasons as follows.
B(1) Applicant improperly limit the teachings of Fevre et al. Fevre et al. teach NHCs has been exploited for several chain polymerization reactions, including the ring-opening polymerization (ROP) of N-carboxyanhydrides (p10135, col 1, Introduction, para 1) consistent with Guo et al. and Cheng et al. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See MPEP 2123.
B(2)-B(3) Applicant improperly argues a single reference of Fevre et al. whereas the rejection is based on a combination of cited references. Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2) with expected success. Fevre et al. teach NHCs are relative instable when exposed to air makes them difficult to handle. Fevre et al. teach [NHC(H)][HCO3-] pre-catalysts (p1998, Fig 1) are air-stable and easily accessible via a one-step undemanding process (p2002, col 1, Conclusion). The expected beneficial result of using [NHC(H)][HCO3-] pre-catalysts for ring open polymerization of amino acids is obvious. See MPEP 716.02(c)(II).
Applicant’s argument (C) is not persuasive for the reasons as follows.
C(1)-C(2) Applicant improperly argues a single reference of Fevre et al. whereas the rejection is based on a combination of cited references. See Chen’s teaching in the rejection and response to arguments above, not repeated here. Applicant’s summary Table improperly limits teachings of cited references (e.g., Guo et al. explicitly teach synthesis of a linear polypeptide not limited a cyclic peptide. See, p9164, scheme 1) and argues a limitation not taught by the cited references but ignore what was taught by the cited references. See response to arguments above. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145(IV).
Applicant’s argument (D) is not persuasive because the examiner explicitly point the reason and/or benefit of combining/modifying the cited prior art references above, not repeated here. In particular, the cited prior art references teach the benefit to combine and/or modify one or more cited references. The expected beneficial result of using [NHC(H)][HCO3-] pre-catalysts for ring open polymerization of amino acids with primary amine initiator of n-hexylamine initiator taught by a combination of cited references is obvious. See MPEP 716.02(c)(II).
Applicant’s argument (E) is not persuasive for the reasons as follows.
In response to argument E(a), E(b), and E(c), (1) Guo et al. teach a method for producing a compound of polymerizing α-amino acid N-carboxyanhydride using N-heterocyclic carbene of NHC 1, (2) Fevre et al. teach NHCs are relative instable when exposed to air makes them difficult to handle. Fevre et al. teach a general strategy to circumvent this limitation is to convert the NHC into a masked form, the in situ generation of the free NHC being generally achieved by
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thermal activation (p1995, col 2, para 2). Fevre et al. teach [NHC(H)][HCO3-] pre-catalysts (p1998, Fig 1) are air-stable and easily accessible via a one-step undemanding process (p2002, col 1, Conclusion), and (3) Cheng et al. teach Synthesis of Polypeptides by Ring-Opening Polymerization of α-Amino Acid N-Carboxyanhydrides (Title). Cheng et al. teach
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beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2). Guo et al. further show the method has a polydispersity index (PDI) of 1.5 or lower (pS4, Table S1; pS5, Table S2). All the claimed limitations have been taught by the combined references with reasonable expectation of success. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See MPEP 2121(I). Furthermore, arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). See MPEP 2145(I).
Applicant’s argument (F) is not persuasive because (a) Cheng et al. teach beneficially adding n-hexylamine initiator to polymerization solvents for ring-open polymerization of γ-benzyl-L-glutamate NCA (p3, 2nd last para) to produce a linear polypeptide (p5, scheme 2) whereas applicant argues the individual reference of Guo' s NHC system without amine initiator and (b) De Greef et al. is cited to show the function of an initiator in favor of chemical and/or physical reaction of polymerization/polycondensation (p5716, col 2, para 1) also applied to polymerization of amino acid anhydrides into synthetic polypeptides (p5616, col 2, last para). Consistently, Deming is further cited to show polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2) known to the level of ordinary skill in the art. The two references demonstrate applicant’s limitation a linear polypeptide produced has a polydispersity index (PDI) of 1.5 or lower within the knowledge level of an ordinary skill in the art and the result of polymerization of amino acid anhydrides into synthetic polypeptides is expected. "[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom."In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01.
Furthermore, in response to the argument of data in Table 3, Examples 21-26, the data is not commensurate in scope with the rejected claims because Examples 21-26 are based on glutamate carboxyanhydride monomer. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. "Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b). Deming is further cited to show polymerization of side chain modified L-glutamate NCA in the presence of an initiator to generate a homopolymer with polydispersity index of 1.05 (p792, col 2, para 2) known in the art.
Conclusion
No claim is 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 JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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/J.L/Examiner, Art Unit 1658
21-June-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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