DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of the amendments submitted on 12/05/2025, the 112(b) rejection of claims 21, 25-26, 29, 41, and 50 is withdrawn.
The 112(d) rejection of claim 33, is also withdrawn.
However the rejection 112(d) rejection of claims 54 and 55 is maintained, the rejection is stated in the 112(d) rejection below.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
The Applicant argues that the references do not disclose or suggest a composition comprising both a polymer of Formula (I) and a protein. A skilled artisan, seeking to make or use the composition of the instant claims, would take no motivation from any of Pardakhty in view of Weber, Hu, and Weber II, as the polymers described in each are simply too different that the polymer disclosed in the instantly claimed composition.
The Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Rejections - 35 USC § 112
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 54 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.
The amine-containing initiator must have the alkyl group corresponding to R in claim 51. This claim recites a much broader range of C12-C20 initiators.
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 55 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.
The amine-containing initiator of Formula Va must have the alkyl group corresponding to R in claim 51. This claim recites a much broader range of the initiators of formula Va where x is 11-19.
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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21, 25, 29, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Pardakhty, A., et al., (In vitro study of polyoxyethylene alkyl ether niosomes for delivery of insulin, International Journal of Pharmaceutics 328 (2007) 130–141) in view of Weber, B., et al., (Solution Properties of Polysarcosine: From Absolute and Relative Molar Mass Determinations to Complement Activation Macromolecules 2018, 51, 2653−2661), Hu, Y., et al., (Polysarcosine as an Alternative to PEG for Therapeutic Protein Conjugation ) Bioconjugate Chem. 2018, 29, 2232−2238 ), and Weber, B., et al., (Polysarcosine-Based Lipids: From Lipopolypeptoid Micelles to Stealth-Like Lipids in Langmuir Blodgett Monolayers, Polymers 2016, 8(12)) .
Regarding claims 21, and 25, Pardakhty teaches a method of delivering a protein (insulin) using a PEG modified with an alkyl chain end group as a liposome. (Abstract, Page 131).
Polysarcosine is well known in the art as a potential alternative to PEG because it is comprised of an amino acid that is formed naturally in the body and does not comprise the same potentially harmful immunogenic effects as PEG (Weber, Solution Properties of Polysarcosine: From Absolute and Relative Molar Mass Determinations to Complement Activation Macromolecules 2018, 51, 2653−2661, Page 2653 and Hu Page 2232) and Weber, B., et al., (Polysarcosine-Based Lipids: From Lipopolypeptoid Micelles to Stealth-Like Lipids in Langmuir Blodgett Monolayers, Polymers 2016, 8, 427).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to form the composition of PEG and a protein with polysarcosine and a protein instead because of the advantage of the low immunogenicity of polysarcosine in comparison to PEG.
Weber (Polysarcosine-Based Lipids: From Lipopolypeptoid Micelles to Stealth-Like Lipids in Langmuir Blodgett Monolayers), henceforth referred to as Weber, teaches a polysarcosine based liposome that has the structure of
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132
213
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(Abstract, Scheme 1). R2 is a C2 aliphatic groups substituted with a carboxylic acid group off the 2nd carbon. This reads on the claimed R2. Weber teaches that the value of x can be 12, 30, 45, 11, and 34 (Table 2). These values fall within the claimed range of 5-50. The value of 12-16 overlaps with the claimed range of 11-19. This reads on the limitation of claim 25.
It would have been obvious to one of ordinary skill in the art at the time of filing to use the polysarcosine liposome of Weber instead of the pegylated liposome of Pardakhty because it has the advantage of being comprised of polysarcosine which is biodegradable and nonimmunogenic, unlike PEG.
Regarding claims 29 and 41, Pardakhty teaches the liposome is hydrated with PBS (Page 131). Pardakhty also teaches the liposome is washed with PBS prior to being loaded with insulin (Page 132). Therefore the liposome insulin complex comprises PBS. PBS is a pH adjuster. This reads on the claimed “pH adjuster.”
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 25, 26, 29, 41-43, and 50-51, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11718754 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Bradford teaches claims 1, 2 and 3. This reads on the limitations of claim 25, 26, 51, and 52. Bradford also teaches claims 14 and 15. This reads on the limitations of claims 29, 41 and 50. Bradford also teaches claim 16. This reads on the claim 42. Bradford also teaches claims 17-24. These read on the claim 43.
Allowable Subject Matter
Claims 30-32 are allowed.
Claims 54-56 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 LILY K SLOAN whose telephone number is (703)756-5875. The examiner can normally be reached Monday-Friday 9:00-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones can be reached at (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LILY K SLOAN/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762