DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of invention group I, claims 22-32, in the reply filed on 09/15/2026 is acknowledged.
Claims 33-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/15/2026.
Applicants further elect a specific biocompatible polymer comprising t-butyl acrylate, hydroxypropyl acrylate and N-(3-aminopropyl) methacryamide, claims 22-31 read on the elected species and are under examination, claim 32 does not read on the elected species and is withdrawn from consideration.
Claims 22-41 are pending, claims 22-31 are under examination.
Priority
Acknowledge is made that this application is a continuation of U.S. patent application serial number 17/744192, filed on 06/04/2024; which is a continuation of U.S. patent application serial number 16/806, 936 filed March 2, 2020, which is a continuation of U.S. patent application serial number 16/232,929 filed December 26, 2018, which is a continuation of U.S. patent application serial number 15/924,028 filed March 16, 2018, which is a continuation of U.S. patent application serial number 15/142,395 filed April 29, 2016, which is a divisional of U.S. patent application serial number 13/917,323 filed June 13, 2013, which claims the benefit of U.S. provisional patent application number 61/659,916, filed June 14, 2012.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/23/2024 is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 22-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hobbs et al. (US20100282409) in view of Johansen et al. (EP1128730B1) and Kulkarni et al. (US20060134054)
Determination of the scope and content of the prior art
(MPEP 2141.01)
Hobbs et al. teaches Antimicrobial compositions are provided that include a hydroalcoholic solvent system comprising a lower C2-C5 alcohol and water; a cationic antimicrobial agent such as chlorhexidine gluconate; a hydrophobic polymer soluble in the lower alcohol (abstract). Examples of monomers which may be used to make the hydrophobic polymer include but are not limited to: vinyl pyridine, methyl acrylate, ethyl acrylate, butyl acrylate, ethylhexyl acrylate, isooctyl acrylate, isoamyl acrylate, isobornyl acrylate, isotetradecyl acrylate, lauryl acrylate, stearyl acrylate, behenyl acrylate, ethyl hexyl diglycol acrylate, 2-hydroxy-3-phenoxypropyl acrylate, hydroxybutyl acrylate, hydroxyethyl acrylate, hydroxypropyl acrylate, butoxyethyl acrylate, ethoxy diethyleneglycol acrylate, hexyl polyethyleneglycol acrylate, methoxy triethyleneglycol acrylate, phenoxyethyl acrylate, phenoxy polyethyleneglycol acrylate, tetrahydrofurfuryl acrylate, glycidyl methacrylate, trimethylpropane benzoate acrylate, methyl methacrylate, ethyl methacrylate, butyl methacrylate, octadecyl acrylate, hydroxypropyl methacrylate, hydroxyethyl methacrylate, vinyl acetate, N-vinylpyrrolidone, N-vinyllactams, styrene, styrene macromer, vinyl butyral, acrylamide, dimethylaminoethyl methacrylate, dimethylamino ethylacrylate, diethylamino ethylstyrene, diethylaminoethyl methacrylate, butylaminoethyl methacrylate, aminoethyl methacrylate hydrochloride, diisopropylaminoethyl methacrylate, morpholinoethyl acrylate, morpholinoethyl methacrylate, dimethylaminoneopentyl acrylate, diallylamine, aminoethyl methacrylamide, aminopropyl methacrylamide, dimethylaminopropyl acrylamide, dimethylaminopropyl methacrylamide, dimethylaminoethyl acrylate, dimethylaminoethyl methacrylamide, and their quaternary salts such as dimethylaminoethyl acrylate methylchloride, diallyldimethylammonium chloride, aminopropyl methacrylamide hydrochloride, aminoethyl methacrylamide hydrochloride. The hydrophobic polymer derived from the polymerization of at least one of these monomers may be a homopolymer, copolymer, terpolymer, or a blend of polymers ([0057]). Hydrophobic polymers useful in the antimicrobial compositions described herein are soluble in the hydroalcoholic solvent system, and particularly the lower alcohol. In general, the hydrophobic polymers used herein are insoluble or only sparingly soluble in water. When used alone, the hydrophobic polymers can be capable of forming water-resistant films. Such polymers are desirable in the antimicrobial compositions described herein because they would produce surgical hand preparations and antimicrobial hand lotions, for example, that cannot be easily washed off with water after being applied and dried ([0059]). The hydrophobic polymer is at 0.1% to 10% of the composition ([0062]). The composition includes aqueous solution ([0045,0117])
Johansen et al. teaches an enzymatic composition capable of killing or inhibiting microbial cells or micro-organisms, e.g. in laundry, on hard surfaces, in water systems, on skin, on teeth or on mucous membranes, comprising a phenoloxidizing enzyme system and an enhancing agent of formula (I). The present invention also relates to the use of said enzymatic composition for preserving food products, cosmetics, paints, coatings, etc. (abstract). In one aspect of the invention pH is in the range of pH 3 to 10.5, and in another aspect of the invention pH is in the range of pH 5 to 9 ([0069]).
Kulkarni et al. teaches a novel pH sensitive polymer which exhibits pH dependent swelling/dissolution behavior. The said polymer comprises a hydrophobic monomer polymerized along with a basic monomer or a hydrophobic monomer polymerized along with a basic monomer and a hydrophilic monomer (abstract). In one embodiment the hydrophobic monomer (A) comprises a acrylic and methacrylic acid ester selected from
the group consisting of cyclohexyl acrylate, dodecyl acrylate, 2 ethyl hexyl acrylate, octyl acrylate, tertiary butyl acrylate, phenyl acrylate, butyl acrylate, methyl methacrylate, benzyl methacrylate, cyclohexyl methacrylate, phenyl methacrylate, tertiary butyl methacrylate, butyl methacrylate, 2 ethyl hexyl methacrylate, propyl methacrylate preferably butyl acrylate, methyl methacrylate and butyl methacrylate. In another embodiment of the invention, the basic monomer (B) is selected from the group consisting of a amino alkyl acrylic acid and a methacrylic acid esters. In yet another embodiment of the invention, the basic monomer (B) is selected from the group consisting of dimethyl amino ethyl methacrylate, dimethyl amino ethyl
acrylate, diethyl amino ethyl methacrylate, diethyl amino ethyl acrylate, piperidine ethyl methacrylate, 2 tert-butyl amino ethyl methacrylate, preferably dimethyl amino ethyl
methacrylate and diethyl amino ethyl acrylate. In yet another embodiment of the invention the hydrophilic monomer (C) is a acrylic or methacrylic acid ester is selected from the group consisting of hydroxy ethyl methacrylate, hydroxy propyl methacrylate, hydroxyethyl ethyl methacrylate, hydroxy ethyl acrylate, hydroxy propyl acrylate, hydroxyethyl ethyl acrylate preferably hydroxy ethyl methacrylate and hydroxyethyl ethyl methacrylate (page 4, [0045-0051]). The pH sensitive polymers were synthesized by
bulk polymerisation. The monomers methyl methacrylate 35% w/w, vinyl pyridine 30% w/w and hydroxyethyl methacrylate 35% w/w were mixed together and an azo initiator,
azo bis isobutyronitrile 1 % w/w of total monomer, was added (page 6, [0077]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Hobbs et al. is that Hobbs et al. do not expressly teach polymer comprising t-butyl acrylate, hydroxypropyl acrylate and N-(3-aminopropyl) methacryamide and pH below 6. This deficiency in Hobbs et al. is cured by the teachings of Johansen et al. and Kulkarni et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to modify the invention of Hobbs et al., as suggested by Johansen et al. and Kulkarni et al., and produce the instant invention.
Hobbs et al. teaches Antimicrobial cosmetic compositions comprising a polymer comprising butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide and an aqueous solution.
One of ordinary skill in the art would have been motivated to replace t-butyl acrylate for butyl acrylate as monomer in polymer comprising butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide because t-butyl acrylate is position isomer of butyl acrylate. MPEP 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Furthermore, t-butyl acrylate is alternative monomer to butyl acrylate as suggested by Kulkarni et al. Therefore, it is obvious for one of ordinary skill in the art to replace t-butyl acrylate for butyl acrylate as monomer in polymer comprising butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide and produce polymer comprising t-butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide.
One of ordinary skill in the art would have been motivated to adjust pH of the antimicrobial cosmetic composition to about 5 because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Johansen et al. teaching antimicrobial cosmetic composition with pH 5-9, it is obvious to have antimicrobial cosmetic composition of Hobbs et al. at pH 5.
Regarding claims 22, 24-26, 30-31, prior art teaches an antimicrobial composition comprising 0.1% to 10% of polymer comprising t-butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide; an aqueous solution at pH 5 (non-physiological pH). N-(3-aminopropyl) methacryamide is a known and common Aminopropyl methacrylamide, thus, is obvious. Since prior art teaches the same polymer comprising t-butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide, the same polymer is biocompatible.
Regarding claim 24, a polymer comprising t-butyl acrylate, hydroxypropyl acrylate and aminopropyl methacrylamide as hydrophobic and insoluble in about neutral pH (physiological pH) aqueous solution; at acidic pH, for example, pH 5, the amino group of aminopropyl methacrylamide is protonated, then the polymer is soluble.
Regarding claims 27-29, it is a common method for polymerization with a initiator. Under guidance from Kulkarni et al. teaching polymerization of acrylate monomers with azo bis isobutyronitrile at 1 % by weight, it is obvious to prepare polymer with azo bis isobutyronitrile at 1 % by weight and produce instant claimed invention with reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 22-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9351993. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising t-butyl acrylate, aminopropyl methacrylamide and hydroxypropyl methacrylate (homolog of hydroxypropyl acrylate), thus, teaches applicant’s claimed invention.
Claims 22-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9937201. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising t-butyl acrylate, aminopropyl methacrylamide and hydroxypropyl methacrylate (homolog of hydroxypropyl acrylate), thus, teaches applicant’s claimed invention.
Claims 22-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11998563. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent teaches a composition comprising t-butyl acrylate, aminopropyl methacrylamide and hydroxypropyl methacrylate (homolog of hydroxypropyl acrylate), thus, teaches applicant’s claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
