DETAILED ACTION
Applicant’s reply, filed 24 October 2025 in response to the requirement for restriction mailed 22 October 2025, has been fully considered. As per Applicant’s filed claim amendments claims 21-35 are pending, wherein: claims 21-33 are as presented previously and claims 34-35 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 21-33, in the reply filed on 24 October 2025 is acknowledged.
Claims 34 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 October 2025.
Claim Objections
Claim 21 is objected to because of the following informalities: the claim is missing a recitation of –glyoxalated polyacrylamide (GPAM)-- to properly establish/define the GPAM abbreviation used throughout the instant claim and those that depend therefrom. Appropriate correction is required.
Claims 25-29 are objected to because of the following informalities: “The aqueous” should instead be –An aqueous--. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: “said process” should instead be –the process—(note the 112(b) rejection set forth below). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 33 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 33, the claim does not define the term “RSV” such that the claim meaning is not readily ascertained. In addition, as the claimed process of independent claim 21 recites multiple steps the reaction window of ‘said process’ as claimed is not clear with respect to when the assessment is to be made.
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.
Claims 21-33 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al. (US PGPub 2008/0308242) in view of Shida et al. (JP 2930979 B2; using Clarivate Analytics machine translation for English language citations).
Regarding claims 21-23, Lu teaches high solids glyoxalated polyacrylamide polymers, aqueous compositions thereof, and methods of making (abstract; [0013]; [0022]). Lu teaches the glyoxalated polyacrylamide polymer comprises about 25 to about 90 wt% cationic monomer, about 75 to about 10 wt% acrylamide monomer, and sufficient glyoxalation of the acrylamide groups by glyoxal to be thermosetting ([0019]-[0021]; [0035]-[0041])(instant cationic glyoxalated polyacrylamide).
Lu teaches the base polymer is obtained by free radical polymerization of the acrylamide monomers and cationic monomers in an aqueous system ([0043]) (instant polymerizing step) and further teaches the so-prepared base polymer is then reacted with glyoxal (instant reacting step), at a pH of 7 to 10 and at a weight ratio of glyoxal:base polymer of about 0.01 to about 0.60:1, until a desired viscosity is obtained whereupon the reaction is quenched ([0044]). Lu teaches that either of the glyoxal solution or the base polymer solution can be added to the reaction mixture slowly over time or both may be added slowly over time, where options for addition/reaction are recognizable to one of ordinary skill in the art ([0044]).
Lu does not specifically teach a step of removing residual glyoxal via membrane filtration (instant claim 21), having a molecular weight cutoff of about 1,000 Daltons (instant claim 22) via a diafiltration process (instant claim 23). However, Shida teaches a known issue with solution polymerization methods is the presence of impurities, in the form of unreacted monomers and low molecular weight impurities, which may be not only difficult to remove but are harmful to the human body (pg1-2). Shida teaches diafiltration methods using a ceramic membrane having a pore size of 40 Å to 1000 Å are advantageous as they allow for the facile removal of unreacted monomers, polymerization initiators, impurities, low molecular weight by-products and solvents, up to several hundred ppm without the danger or complexity of other known methods (pg3). Shida further teaches such filtration is suitable for use in purification of (meth)acrylamides (pg2) and post-addition reactions (pg2). Shida and Lu are analogous art and are combinable because they are concerned with the same filed of endeavor, namely solution polymerization methods of (meth)acrylamide polymers. At the time of filing a person having ordinary skill in the art would have found it obvious to include the purification method of Shida in the method of Lu to obtain a purified glyoxalated polyacrylamide solution (where glyoxal is known to be a low molecular weight compound) and would have been motivated to do so as Shida teaches such purification is versatile, facile and advantageous, as doing so removes unreacted monomers and any low molecular weight by-products and impurities which may be harmful to the human body from the solution, while maintaining a constant polymer concentration (pg2-3).
Regarding claim 24, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu further teaches the pH of the reaction can be controlled via a buffer and quenching occurs via acid addition, reducing the pH to a final range of 2 to 5 ([0044]).
Regarding claims 25-27, Lu in view of Shida renders obvious the method as set forth in claim 21 above. As noted above Shida teaches removal of up to several hundred ppm, a range that is readable over, and renders obvious, instant less than about 1.2 wt% (claim 25), less than about 1.0 wt% (claim 26), and less than about 0.1 wt% (claim 27) of residual glyoxal.
Regarding claim 28, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu further teaches the aqueous polymer composition has a solids concentration of about 1 to about 30 wt% ([0047]).
Regarding claims 29 and 32, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu further teaches the aqueous polymer composition is storage stable, wherein very little if any gelling occurs after 28 days storage at 37ºC ([0046]) (instant physically uniform).
Lu does not specifically state the uniformity after ‘more than a month’ of storage at about 40 ºC (claim 29) and does not specifically test viscosity of a 10% solids composition at pH of 3.5 after aging about 30 days at about 40 ºC (claim 32). However, Lu teaches storage stability after a substantially similar time of 28 days at a substantially similar temperature of 37 ºC. Lu renders obvious the claimed method, as noted above, wherein the as-produced glyoxalated cationic polyacrylamide has substantial storage stability and Lu in view of Shida renders obvious purification thereof and removal of unreacted/by-product/impurity components. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 15 USPQ2d 1655, (Fed. Cir. 1990); see also In re Best, 562 F.2d 1252, 195 USPQ 430, (CCPA 1977). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”; MPEP 2112.01)).
Regarding claim 30, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu teaches reacting the glyoxal with the base polymer at a pH of from 7 to 10, teaches a reaction temperature range of 15 to 50 ºC, and teaches the slow addition of one solution to the other over time ([0044]). As such, Lu teaches and envisions a slow addition over time of the polymer solution to the glyoxal solution.
While Lu does not specifically teach greater than 50 mol% of the reaction occurring before 100% polymer addition, the rates of addition and reaction are result effective variables that could be optimized. The experimental modification of this prior art in order to ascertain optimum operating conditions fails to render applicant’s claims patentable in the absence of unexpected results (see: In re Aller, 105 USPQ 233; and MPEP 2144.05). At the time of the invention a person having ordinary skill in the art would have found it obvious to optimize the rate of addition and would have been motivated to do so in order to obtain a desired/sufficient level of cross-linking, solution viscosity, solid content and/or stability ([0038]). A prima facie case of obviousness may be rebutted, however, where the results of the optimizing variable, which is known to be result-effective, are unexpectedly good (see In re Boesch and Slaney, 205 USPQ 215).
Regarding claim 31, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu further teaches that the primary reaction site of the base polymer for the glyoxal are the acrylamide monomer units which must be present in a sufficient amount to obtain a final functionalized product that is thermosetting. Lu teaches an excess of 60 wt% acrylamide monomer ([0041]) in the base polymer. Lu further teaches reacting sufficient amounts of glyoxal to obtain crosslinking and the desired thermosetting property ([0038]) in a ratio of 0.01 to 0.6:1 glyoxal to base polymer (instant at least about 20 mol% conversion absent evidence to the contrary).
Lu does not specifically teach that less viscosity increase occurs when the polymer solution is added to the glyoxal solution than if the glyoxal solution were to be added to the polymer solution. However, Lu does teach that the polymer solution can be added to the glyoxal solution, as claimed, to obtain a desired product having a desired viscosity ([0044]). Lu is assumed to meet the recited hypothetical situation regarding a non-claimed order of addition, absent evidence (MPEP 2112.01).
Regarding claim 33, Lu in view of Shida renders obvious the method as set forth in claim 21 above. Lu is silent as to a reaction window as claimed. However, Lu teaches the claimed components, present in the claimed amounts and added at the claimed rates, and renders obvious the claimed process in view of Shida having the claimed reaction conditions, concentrations, etc. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 15 USPQ2d 1655, (Fed. Cir. 1990); see also In re Best, 562 F.2d 1252, 195 USPQ 430, (CCPA 1977). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”; MPEP 2112.01)).
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 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 5-6 of U.S. Patent No. 12,065,527 in view of Shida et al. (JP 2930979 B2; using Clarivate Analytics machine translation for English language citations).
The claims of the granted patent and the instant application are directed to substantially similar methods of preparing an aqueous glyoxalated polyacrylamide composition comprising substantially similar reactants, amounts, conditions and steps including aqueous free radical polymerization. The claims of the instant patent differ from those of the instant application in that the granted patent is silent as to a step of removing residual glyoxal via membrane filtration and diafiltration and resulting in the claimed residual amount of glyoxal. However, Shida teaches a known issue with solution polymerization methods is the presence of impurities, in the form of unreacted monomers and low molecular weight impurities, which may be not only difficult to remove but are harmful to the human body (pg1-2). Shida teaches diafiltration methods using a ceramic membrane having a pore size of 40 Å to 1000 Å are advantageous as they allow for the facile removal of unreacted monomers, polymerization initiators, impurities, low molecular weight by-products and solvents, up to several hundred ppm without the danger or complexity of other known methods (pg3). Shida further teaches such filtration is suitable for use in purification of (meth)acrylamides (pg2) and post-addition reactions (pg2). Shida and the granted patent are analogous art and are combinable because they are concerned with the same filed of endeavor, namely solution polymerization methods of (meth)acrylamide polymers. At the time of filing a person having ordinary skill in the art would have found it obvious to include the purification method of Shida in the method of the granted patent to obtain a purified glyoxalated polyacrylamide solution (where glyoxal is known to be a low molecular weight compound) and would have been motivated to do so as Shida teaches such purification is versatile, facile and advantageous, as doing so removes unreacted monomers and any low molecular weight by-products and impurities which may be harmful to the human body from the solution, while maintaining a constant polymer concentration (pg2-3).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANE L STANLEY whose telephone number is (571)270-3870. The examiner can normally be reached M-F 7:30 AM to 3:30 PM.
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/JANE L STANLEY/ Primary Examiner, Art Unit 1767