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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 3, 2026 has been entered.
Status of the Claims
Claims 1-17 were originally filed January 27, 2022.
A duplicate claim set was also filed on January 27, 2022.
The amendment received August 26, 2025 amended claims 1, 4-6, 11, 12, and 17; canceled claims 2, 3, and 13; and added new claim 18. Please note: the status identifier for present claim 11 should be “(Withdrawn, Currently Amended)” and the status identifier for present claim 17 should be “(Currently Amended)”.
The amendment received April 3, 2026 amended claims 1, 4, 5, 12, 14, and 16-18. Please note: claim 18 was amended from a product claim to a method claim (i.e. nonelected and withdrawn Group II – see the restriction mailed September 23, 2024).
Claims 1, 4-7, 10-12, and 14-18 are currently pending.
Claims 1, 4, 5, 12, and 14-17 are currently under consideration.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-5 and 12-17) in the reply filed on December 23, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 6-11 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim.
Applicants elected, without traverse, the peptoid monomer of claim 2, the alginate polymer of claim 5, the formulation of claim 4, and the additional component of claim 14 as the species in the reply filed on December 23, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: applicants neglected to elect a species of peptide (species B). It is assumed that applicants would have elected a-CGRP since this is the only peptide in the claims.
Please note: due to the amendment received August 26, 2025 changing claims 12-18 from improper use claims to product claims, the claims are no longer withdrawn.
Please note: due to the amendment received April 3, 2026 changing claim 18 from a product claim to a method claim, claim 18 is now withdrawn.
Priority
The present application is a 371 (National Stage) of PCT/US2020/044417 filed July 31, 2020 which claims the benefit of 62/880,749 filed July 31, 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 1, 2026 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Objections
The objection to the disclosure regarding an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of the amendment received April 3, 2026.
The objection to claim 1 regarding “molecul” should read “molecule” is withdrawn in view of the amendment received April 3, 2026.
The objection to claim 1 regarding “of a-CGRP” should read “of an a-CGRP” is withdrawn in view of the amendment received April 3, 2026.
The objection to claim 1 regarding “an end terminus of a peptide” in lines 5 should read “the N-terminus end of an a-CGRP peptide” is withdrawn in view of the amendment received April 3, 2026.
The objection to claim 12 regarding “of a-CGRP” should read “of an a-CGRP” is withdrawn in view of the amendment received April 3, 2026.
The objection to claim 14 regarding “a-CCRP” should read “a-CGRP” is withdrawn in view of the amendment received April 3, 2026.
Maintained and/or Modified* Objections Necessitated by Amendment
*wherein the modification is due to amendment
Claim Objections
Claim 1 is objected to because of the following informalities: “at least two N-methoxyethylglycine s” should read “at least two N-methoxyethylglycines”. Appropriate correction is required.
Arguments and Response
Applicants contend that the amendments negate the objection.
Applicants arguments are not persuasive because the amendment received April 3, 2026 reads “at least two N-methoxyethylglycine s” and not “at least two N-methoxyethylglycines”.
Claim 12 is objected to because of the following informalities: “at least two N-methoxyethylglycine s” should read “at least two N-methoxyethylglycines”. Appropriate correction is required.
Arguments and Response
Applicants contend that the amendment negate the objection.
Applicants arguments are not persuasive because the amendment received April 3, 2026 reads “at least two N-methoxyethylglycine s” and not “at least two N-methoxyethylglycines”.
Claim 15 is objected to because of the following informalities: a single conjunction should be present in the Markush group and “and” should be utilized with “selected from the group consisting of” (see lines 5 and 6). Appropriate correction is required.
Arguments and Response
Applicants contend that the amendments negate the rejection.
Applicants arguments are not persuasive because the amendment received April 3, 2026 reads “and or”.
New Objections
Claim 1 is objected to because of the following informalities: “an alginate polymer matrix an alginate polymer” should read “an alginate polymer matrix” or “an alginate polymer”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: “peptoid- peptide” should read “peptoid-peptide”. Appropriate correction is required.
Claims 12 and 14-17 are objected to because of the following informalities: “novel” should be removed from the preamble. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: “an N-terminus” should read “the N-terminus”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the claim is missing a period. Appropriate correction is required.
Withdrawn Rejections
The objection to claim 5 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 is withdrawn in view of the amendment received April 3, 2026.
The rejection of claims 12 and 14-18 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 is withdrawn in view of the amendment received April 3, 2026.
The rejection of claim 18 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 is withdrawn due to the conversion of the product claim into a withdrawn method claim in the amendment received April 3, 2026 (i.e. the claim is currently withdrawn).
The rejection of claim 17 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 is withdrawn in view of the amendment received April 3, 2026.
The rejection of claim 18 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 is withdrawn in view of the amendment received April 3, 2026.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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, 4, and 5 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. One of skill in the art would not be able to determine the final structure of the “biologically active molecule”. For example, it is unclear what “via Fmoc chemistry” does to the structure of the “biologically active molecule”. The method of making the final product typically does not alter the final structure per se. In addition, the support, protecting groups, and additional reagents utilized in Fmoc chemistry are either not covalently attached and/or are detached to achieve the final product which is then purified (i.e. reagents are washed away). The method of making will not be provided patentable weight when the structure of the final product is clearly within the body of the claim.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claims 1, 4, and 5 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the method of making “via Fmoc chemistry” is still present in the claims. Applicants should claim the structure of the biologically active molecule clearly (i.e. how does “via Fmoc chemistry” structurally alter the biologically active molecule).
Claim 5 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. One of skill in the art would not be able to determine the final structure of the “biologically active molecule”. For example, it is unclear how the intended use of “configured for application via an electrospray method” alters the final structure of the alginate polymer.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 5 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the method of utilizing or method of making “configured for application via an electrospray method” is still present in the claims. Applicants should claim the structure of the biologically active molecule clearly (i.e. how does “configured for application via an electrospray method” structurally alter the biologically active molecule).
Claim 14 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. One of skill in the art would not be able to determine the final structure of the “peptoid-peptide hybrid”. For example, it is unclear how the dependent claim can be “further comprising” and simply reciting the function of the structure recited in independent claim 12 “increased stability in human plasma as compared to a-CGRP peptide” when the specification only teaches N-methoxyethylglycine (of independent claim 12) as increasing stability.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 14 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the claim simply refers to the function of the structure recited in independent claim 12 (i.e. cannot be further comprising because the function is an inherent property of the structure of independent claim 12).
Claim 15 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 15 recites the limitation "the cardiovascular disease" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 15 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since claim 15 was not amended in the amendment received April 3, 2026.
Claim 15 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.
Regarding claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 15 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since claim 15 was not amended in the amendment received April 3, 2026.
Claim 17 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. One of skill in the art would not be able to determine the final structure of the “peptoid-peptide hybrid”. For example, it is unclear how the intended use of “configured for application via an electrospray method” alters the final structure of the alginate polymer.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 17 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the claim still includes the intended use or method of making.
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.
Claim 14 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. Claim 14 depends on independent claim 12. Independent claim 12 requires at least two N-methoxyethylglycine coupled to the N-terminus of a-CGRP. Dependent claim 14 reads “further comprising increased stability in human plasma as compared to a-CGRP”. However, only N-methoxyethylglycine is disclosed in the specification as having increased stability. Thus, it appears that dependent claim 14 is broadening the scope of independent claim 12. 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(d) as failing to further limit for claim 14 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the claim still includes the inherent function.
Claim 15 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. Claim 15 is dependent on independent claim 12. The intended use language of claim 12 was deleted. The limitations of claim 15 refer to the intended use. The intended use is not provided patentable weight as the intended use does not “breath life” into the claim. Therefore, dependent claim 15 fails to alter the structure of the “peptoid-peptide hybrid”. 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(d) as failing to further limit for claim 15 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment addresses the concern directly.
Applicants’ arguments are not convincing since the claim still includes the Markush group for the cardiovascular diseases which are not part of the peptoid-peptide hybrid.
New Rejections Necessitated by Amendment
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, 4, and 5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, the body of the structure required by the claim does not match the structure in the wherein clause. Therefore, it is unclear if the more narrow structure is required or if the broader structure of the wherein clause is required.
Claims 1, 4, and 5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear what the difference is between the alginate polymer matrix and the alginate polymer is.
Claim 4 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 4 recites the limitation "the peptoid- peptide hybrid" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the “alginate polymer” is the alginate polymer matrix or the alginate polymer and what the difference is between each.
Claim 4 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how claim 4 alters the structure of claim 1. Claim 1 already requires an alginate polymer microcapsule for subcutaneous administration.
Claim 5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear if the “alginate polymer” is the alginate polymer matrix or the alginate polymer and what the difference is between each.
Claim 5 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how claim 5 alters the structure of claim 1. Claim 1 already requires an alginate polymer microcapsule.
Claim 16 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the method of electrospraying alters the microcapsule.
Claim 17 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. One of skill in the art would not be able to determine the scope of the present claims. For example, it is unclear how the method of electrospraying alters the microcapsule.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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, 5, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gegg et al. WO 2007/048026 published April 26, 2007 and Park et al., 2011, NMEGylation: A novel modification to enhance the bioavailability of therapeutic peptides, Biopolymers, 96(5): 688-693.
For present claims 1, 4, 5, 12, and 14-17, Gegg et al. teach PEG-a-CGRP conjugates and alginate which may be formulated for subcutaneous administration and wherein PEG and alginate are utilized to increase pharmacological half-life wherein glycine linkers are utilized and the formulation can be in microparticles, microspheres, or microcapsules (please refer to the entire specification particularly the abstract; pages 5, 6, 8-11, 14-18, 30, 34, 64, 71, 75-78, 81-89, 91, 92, 95, 96, 98, 99).
However, Gegg et al. do not teach N-methyloxyethyl glycine (NMEG).
For present claims 1, 4, 5, 12, and 14-17, Park et al. teach NMEGylation as an alternative to PEGylation wherein NMEGylation is an N-terminal addition of one or more NMEG to a peptide to increase stability and solubility and utilization of glycine linkers (please refer to the entire reference particularly the abstract; page 2; Synthesis, purification and characterization of NMEGylated C20 therapeutics; Figure 1).
The claims would have been obvious because the substitution of one known element (i.e PEG) for another (i.e. NMEG) would have yielded predictable results (i.e. increased half-life, stability, etc.) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. NMEGylation; utilization of glycine for a linker) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Gegg et al. and Park et al. for claims 1, 4, 5, 12, and 14-17 were considered but are not persuasive for the following reasons.
Applicants contend that the substitution is unpredictable and hindsight was utilized.
Applicants’ arguments are not convincing since the teachings of Gegg et al. and Park et al. render the product of the instant claims prima facie obvious.
Applicants provided no evidence for unpredictability.
The claims would have been obvious because the substitution of one known element (i.e PEG) for another (i.e. NMEG) would have yielded predictable results (i.e. increased half-life, stability, etc.) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. NMEGylation; utilization of glycine for a linker) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
In addition, Park et al. teach that NMEGylation can be utilized for various peptides and proteins and provide increased stability as an alternative to PEGylation. Park et al. teach simple screening methods to determine the number of NMEG monomers to utilize to increase stability while retaining activity.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claims 1, 4, 5, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Franco-Cereceda et al., 1987, Cardiovascular Effects of Calcitonin Gene-Related Peptides I and II in Man, Circulation Research, 60: 393-397; Park et al., 2011, NMEGylation: A novel modification to enhance the bioavailability of therapeutic peptides, Biopolymers, 96(5): 688-693; and Sun et al., 2013, Alginate-Based Biomaterials for Regenerative Medicine Applications, Materials, 6: 1285-1309.
For present claims 1, 4, 5, 12, and 14-17, Franco-Cereceda et al. teach CGRP I (i.e. a-CGRP) for IV infusions (i.e. formulation similar to subcutaneous) (please refer to the entire reference particularly the abstract; In Vivo Studies; Discussion).
However, Franco-Cereceda et al. do not teach NMEG.
For present claims 1, 4, 5, 12, and 14-17, Park et al. teach NMEG as an N-terminal addition of one or more NMEG to a peptide to increase stability and solubility and utilization of glycine linkers (please refer to the entire reference particularly the abstract; page 2; Synthesis, purification and characterization of NMEGylated C20 therapeutics; Figure 1).
However, Franco-Cereceda et al. do not teach alginate.
For present claims 1, 4, 5, 12, and 14-17, Sun et al. teach alginate for peptide delivery to increase half-life, stability, etc. and in forms of microspheres and microcapsules (please refer to the entire reference particularly the abstract; Introduction; sections 2.1, 2.2, 2.2.1, 2.2.2, 3.4, 4; Figures 1, 7).
The claims would have been obvious because a particular known technique (i.e. NMEGylation; utilization of alginate in forms of microspheres or microcapsules; utilization of glycine linkers) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Franco-Cereceda et al.; Park et al.; and Sun et al. for claims 1, 4, 5, 12, and 14-17 were considered but are not persuasive for the following reasons.
Applicants argue the references individually. Applicants contend that NMEGylation is unpredictable.
Applicants’ arguments are not convincing since the teachings of Franco-Cereceda et al.; Park et al.; and Sun et al. render the products of the instant claims prima facie obvious.
It is respectfully noted that a glycine or NMEG at residue 24 does not read on a glycine and NMEG at the N-terminus of a-CGRP as presently claimed.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants did not provide evidence of unpredictability.
The claims would have been obvious because a particular known technique (i.e. NMEGylation; utilization of alginate in forms of microspheres or microcapsules; utilization of glycine linkers) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Double Patenting
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.
Claims 1, 4, 5, 12, and 14-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, and 8-18 of copending Application No. 17/630,628 in view of Park et al., 2011, NMEGylation: A novel modification to enhance the bioavailability of therapeutic peptides, Biopolymers, 96(5): 688-693.
Copending Application No. 17/630,628 claims a-CGRP encapsulated in alginate microparticles and utilized for subcutaneous administration as a microcapsule.
Park et al. teach NMEG as a N-terminal addition of one or more NMEG to a peptide to increase stability and solubility and utilization of glycine linkers (please refer to the entire reference particularly the abstract; page 2; Synthesis, purification and characterization of NMEGylated C20 therapeutics; Figure 1).
The claims would have been obvious because a particular known technique (i.e. NMEGylation) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 17/630,628 in view of Park et al. for claims 1, 4, 5, 12, and 14-17 were considered but are not persuasive for the following reasons.
Applicants contend that the claims of copending Application No. 17/630,628 are different from the present claims.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 17/630,628 in view of Park et al. renders obvious the products of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
The claims would have been obvious because a particular known technique (i.e. NMEGylation) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wawrzynska et al., 2018, Alginate Matrices for Protein Delivery – a Short Review, Physiol Res, 67(2): S319-S334.
Moore et al., 2013, Characterization of Polymeric Microcapsules Containing a Low Molecular Weight Peptide for Controlled Release, Microsc Microanal, 19: 213-226.
Annamalai et al., 2018, Encapsulated Cell Technology-Based Delivery of a Complement Inhibitor Reduces Choroidal Neovascularization in a Mouse Model, Trans Vis Sci Tech, 7(2): 3 (13 pages).
Huang et al., 2015, Calcitonin Gene-Related Peptide-Induced Calcium Alginate Gel Combined with Adipose-Derived Stem Cells Differentiating to Osteoblasts, Cell Biochem Biophys, 73: 609-617.
Mahmoudi et al., 2020, Low Fouling, Peptoid-Coated Polysulfone Hollow Fiber Membranes – the Effect of Grafting Density and Number of Side Chains, Applied Biochemistry and Biotechnology, 191: 824-837.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
Prosecution Insights