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 .
Election/Restrictions
Claims 1-9 and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 18, 2025.
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.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent application 2023/0076717 to which a notice of allowance was issued on January 13, 2026. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent does not include the limitation that the polymer alters the hydration, rheology or both is achieved through mucoadhesion, mucolability, mucointegration, or combinations thereof. However, the specification of the patent does include the missing information in the application paragraph 0009.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10-12 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Davidson et al (US 2023/0076717).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
With regards to claim 10, Davidson teaches a water-soluble polymer and methods of making said polymer (abstract) hat has a backbone formed from a methacrylamide monomer (0039) and a mucin-binding unit (0041) and being a branched or hyperbranched polymer (0036) having a molecular weight of 10 kDa to 10,000 kDa (0031). Davidson teaches the amount of the muncin-binding unit to be from 1 unit to 50% based on the molecular weight (0044). Davidson teaches the polymer to alter the hydration, rheology, or both through mucoadhesion, mucolability, mucointegration, or combinations thereof (0009).
With regards to claim 11, Davidson teaches the polymerization to include radical polymerization, conventional radical polymerization, RAFT, MADIX, ATRP, or SFRP (0054).
With regards to claim 12, Davidson is silent on the use of multifunctional monomers, however, the broadest reasonable interpretation of the claim reads that less than 1% includes 0. Therefore, the limitations of this claim have been met.
With regards to claim 14, Davidson teaches the mucin binding unit to include a compound including a boronic acid group, a carboxylate group, a carboxylica acid group, a hydrogen bonding group, a hydrophobic group, and a group capable of forming disulfide linkages (0041).
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.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al (US 2023/0076717).
The disclosure of Davidson is adequately set forth in paragraph 6 above and is herein incorporated by reference.
With regards to claim 13, Davidson does not teach the degree of branching of the polymer.
However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 124 (CCPA 1955). In this case, one skilled in the art prior to the effective filing date of the present invention would know that altering the degree of branching alters the flexibility, strength, and versatility of the polymer. Therefore, through routine experimentation, the degree of branching would be optimized in order to achieve the desired properties listed above.
Claims 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderbilt et al (US 7,832,856) in view of Favero et al (US 2021/0171684).
With regards to claim 10, Vanderbilt teaches a first polymer having a backbone formed from N,N-dimethylacrylamide (column 2 line 64 to column 3 line 14) and a group having affinity to mucin being a boronic acid group compound (column 7, lines 45-57) wherein the amount of the boronic acid group is from 1 to 30 mole percent (column 8 lines 46-67).
Vanderbilt is silent on the molecular weight of the polymer.
Favero teaches a water-soluble polymer obtained by the polymerization of acrylamide (as applicants cite in the specification as reading on the claimed backbone) and acrylic acid (as applicants cite in the specification and dependent claims a reading on a mucin-binding unit) (abstract) wherein the amount of the acrylic acid is 25 mol% (0048). Favero teaches the molecular weight of the polymer to 10 to 15 millions g/mol (0051). One skilled in the art prior to the effective filing date of the present invention would know to alter the molecular weight of a polymer in order to achieve the desfired mechanical properties such as tensile strength, processability, thermal properties, and chemical resistance.
With regards to claim 11, Vanderbilt teaches the polymers to be formed by radical polymerization (column 2, lines 39-63).
With regards to claim 12, Vanderbilt is silent on the use of multifunctional monomers, however, the broadest reasonable interpretation of the claim reads that less than 1% includes 0. Therefore, the limitations of this claim have been met.
With regards to claim 14, Vanderbilt teaches the compound with affinity to mucin to be a boronic acid group compound (column 7, lines 45-57).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WHITELEY whose telephone number is (571)272-5203. The examiner can normally be reached 8 - 5:00.
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/JESSICA WHITELEY/Primary Examiner, Art Unit 1763