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 .
Claims 1-22, 41 and 42 are presented for examination.
Claims 23-40 are withdrawn from examination.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (US 20150342984 submitted by the applicant) in view of Wong et al. (Bactericidal and Virucidal ultrathin films assembled layer by layer polycationic N-alkylated polyethyleneimines and polyanions (submitted by the applicant) and further in view of Onis et al. (WO 2014174237 submitted by the applicant)
Regarding claim 2, Cheng teaches antimicrobial cationic polyamines, and more specifically, the cationic modified polyethylene imines for antimicrobial applications. See para [0002]. The use of alkyl urea polyalkylene imine is taught in Paras [0062],[0065] and claims 5-6. Cheng teaches a base polyamine selected from the group consisting of polyethylene imines, partially N-acylated polyethylene imines, and combinations thereof, and ii) a solvent. See Para [0023] and [0127]. The use of an organic solvent, such as, menthol is taught in Para [0089]. Cheng teaches the low average mass, high antimicrobial activity, and low hemolytic tendencies of the cationic polyamines makes these materials attractive as broad spectrum antimicrobial agents for a wide range of medical and household uses, including wound treatments, treatment of infections, antibiotic drugs, treatment of tuberculosis, and disinfectants for household and hospital surfaces and medical instruments. See Para [0144]. Cheng teaches that the film forming compositions can be applied to a surface of an object using any suitable coating technique (e.g., dip coating, spray coating, spin coating, roll coating, brush coating, and "ink jet" coating). See Para [0129]. Cheng teaches that cationic polyamines are soluble in water and are not crosslinked, making them attractive as injectable and aerosol delivered agents. See Para [0287]. Cheng makes clear that the claimed alkyl urea polyalkylene imine polymer has been used as an antimicrobial coating agent, which can be used as a drug or applied to a surface of an object using any suitable coating technique (e.g., dip coating, spray coating, spin coating, roll coating, brush coating, and "ink jet" coating. Cheng does not teach the addition of an anionic polymer. However, Wong teaches contact-killing ionically cross-linked polymeric thin films using Layer-by-Layer technology. A polycation, N,N-dodecylmethyl-polyethylene imine, with microbicidal activity was layered with a polyanion, such as poly(acrylic acid), to create films highly effective against both airborne and waterborne Escherichia coli and Staphylococcus aureus (Gram negative and positive bacteria, respectively), as well as influenza A/WSN (H1N1) virus. See the Abstract and conclusion. It would have been obvious to a person skilled in the art to add an anionic polymer to the composition of Cheng, motivated by the teachings of Wong, which teaches the addition of polyanions and polycations in a film form as a coating was lethal to both airborne and waterborne Gram negative bacteria and gram positive bacteria. To combine ingredients being used for the same purpose would have been obvious to a person skilled in the art. Applicant's attention is drawn to In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), wherein the court states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose [T]he idea of combining them flows logically from their having been individually taught in the prior art". Therefore, it would have been obvious to combine the cationic antimicrobial coating taught by Cheng and anionic antimicrobial coating taught by Wong, since each individually is used for the same purpose as antimicrobial coating agent. Cheng teaches the cationic polyamines comprise one or more polymer chains (branches) comprising ethylenimine units. A linear cationic polyamine comprises i) one branch comprising a plurality of ethylenimine units and ii) two polymer chain end groups (also referred to as peripheral end groups). See Para [0059] as claimed in claim 2.
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 1-22, 41 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64-73 of copending Application No. 18/579,412 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The claims of the instant application are drawn to an anti-microbial coating comprising an alkyl urea polyalkylene imine polymer and an anionic polymer, the alkyl urea polyalkylene imine polymer being a polyalkylene imine polymer having at least one alkyl group attached to the polyalkylene imine polymer backbone by way of at least one urea linkage that includes a nitrogen heteroatom on the polyalkylene imine polymer backbone; which anti-microbial coating does not comprise heparin or a polymer comprising heparin. The claims of the copending application are drawn to a liquid coating composition comprising an alkyl urea polyalkylene imine polymer and an anionic polymer; wherein the liquid coating composition is suitable for forming an anti-microbial coating. The alkyl urea polyalkylene imine of the instant application having at least one alkyl group attached to the polyalkylene imine polymer backbone by way of at least one urea linkage that includes a nitrogen heteroatom on the polyalkylene imine polymer backbone is within the scope of the alkyl urea polyalkylene imine of the copending application. The dependent claims of the instant application and the copending application are drawn to a cationic compound, a biguanide and a cross-linking agent
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments regarding obviousness rejection have been noted. Applicant in his remarks argues that “Neither Cheng nor Wong disclose the following:
A polyalkylene imine polymer having at least one alkyl group attached to the polyalkylene imine polymer backbone by way of at least one urea linkage that includes a nitrogen heteroatom on the polyalkylene imine polymer backbone; and
anionic antimicrobial properties or coatings”. It is the examiner’s position that option (a) and (b) of claim 2 is not drawn to a polyalkylene imine polymer having at least one alkyl group attached to the polyalkylene imine polymer backbone by way of at least one urea linkage that includes a nitrogen heteroatom on the polyalkylene imine polymer backbone.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
