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 .
DETAILED ACTION
Claims 1-31 are currently pending and original claims filed 01/13/2025 are acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The two (2) information disclosure statements (IDS) submitted on 04/10/2025 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies thereof are enclosed herewith.
Claim Objections
Claims 2-4 and 8 are objected to minor informalities.
Each of dependent claims 2-4 and recites “at least one adhesive” in line 1, but which would be better to write as “the at least one adhesive layer”.
Dependent claim 8 recites “at least one bioactive compound” in line 2, but which would be better to write as “the at least one bioactive compound”.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
Claims 1-31 are 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.
Each of claims 5-7 and 13-17 recites “the adhesive” (claim 17 in line 3), “the phase-separated hydrophilic material” (claims 5, 7 and 16), and “the bioactive compound” (claims 6, 8, and 13-17), but which lacks of antecedent basis because base claim 1 recites “at least one adhesive”, “at least one phase-separated hydrophilic material”, and “at least one bioactive compound”, and thus, ambiguity arises to determine whether a dependent claim limitation refers to one or more than one element that is previously presented, either in the same claim or a preceding claim. See also MPEP 2173.05 (e). Applicant may amend them to recite “the at least one adhesive”, “the at least one phase-separated hydrophilic material” and “the at least one bioactive compound”, respectively.
Claim 7 recites “the concentration” in line 1 which lacks sufficient antecedent basis.
The remaining claims are also rejected due to the vagueness of base claim 1.
Appropriate correction is requested.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 7, 25, 27-29 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiyama et al. (JP2002/272831A, IDS10/06/2022).
Applicant claims the below claim 1 filed 01/13/2025:
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Prior Art
Kamiyama teaches wound coating tacky adhesive sheet (title); the adhesive sheet is pressure-sensitive adhesive layer comprising an acrylic copolymer comprising hydroxy group which reads on the elected species alcohol functionalized acrylic adhesive, a zinc oxide which reads on the claimed phase-separated hydrophilic material and a disinfectant such as chlorhexidine gluconate which reads on the claimed bioactive agent biguanide salt, benzalkonium chloride, etc. which reads on the claimed bioactive agent comprising elected species antimicrobial agent (claims 1 and 6 of prior art); the adhesive layer is formed on at least one surface of a support such as non-woven flexible polyester sheet which reads on the claimed substrate having waterproof; and the adhesive layer is applied to the skin for wound covering and the adhesive sheet is sandwiched between a polyethylene terephthalate release film (the Examples and claims 1-7 of prior art) (instant claims 1, 2, 8-11, 25 and 27-31).
In light of the foregoing, instant claims 1, 2, 8-11, 25 and 27-31 are anticipated by Kamiyama.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
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.
Claims 1-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wibaux (US2015/0367021A, IDS of 10/06/2022).
Applicant claims the below claim 1 filed 01/13/2025:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical wound healing research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Wibaux teaches adhesive compositions exhibiting antimicrobial properties, good stability, long shelf lives and enhanced release of antimicrobial agents (abstract) and the composition contains 1) pressure-sensitive adhesive components such as for example acrylic-based adhesives, silicone-based adhesives, rubber-based adhesives, polyurethane-based adhesives, and other types of adhesives and/or agents ([0031]), in particular, at least one acrylic-based adhesive which may be any pressure sensitive adhesive ([0227]) and is capable of adhering to mammalian skin without undue irritation or toxicity to mammals ([0035]) and the adhesives typically include one or more acrylate copolymers having hydroxy alkyl esters of acrylic acid ([0036]) which may read on the claimed alcohol functionalized acrylic acid or hybrid in an amount of 25-98.99 or 55-79.9% ([0022] and [0034]) which overlaps the ranges of about 60 to about 95% of instant claim 4 or about 80 to about 90% of instant claims 7 and 17; 2) antimicrobial agents in an amount of 0.01 to 15% or 0.1 to 5% ([0034]) such as chlorhexidine or its salt such as chlorhexidine gluconate (=chlorhexidine digluconate, CHG) ([0052] and claim 39 of prior art) in an amount of 0.01 to 15% ([0022]) which reads on the claimed bioactive compound bis-biguanide salt and the prior art amount overlaps the ranges of about 1 to about 10% of instant claim 6 or about 4 to about 8% of instant claim 17; 3) hydrocolloids such as carboxymethyl cellulose, starches, microcrystalline cellulose in an amount of about 30 to about 60% ([0057]-[0059]), and disintegrant such as alkali metal carbonates, cellulose including carboxymethylcellulose, crosslinked polyvinylpyrrolidone (=crospovidone), clay, etc. ([0057] and [0073]) which also reads on the claimed phase-separated hydrophilic material and the prior art amount overlaps the ranges of about 2 to about 40% of instant claim 5 or about 7 to about 15% of instant claim 7; the medical adhesive article may also one or more layers such as a release liner ([0087])(instant claims 1-11, 17 and 31); the compositions rapidly release the antimicrobial agents upon exposure to water or moisture ([0032]), and the antimicrobial adhesive composition inhibits or decrease microbial growth (e.g., Staphylococcus aureus, Aspergillus brasiliense, Pseudomonas aeruginosa, Escherichia coli, Candida albican) by more than 2 log after 24 hours contact or more than 3.5 log after 6 hours contact ([0049], [0053] and [0095]) (instant claims 14-16 and 18-22, in part); the antimicrobial adhesive composition has a grade 0 to cytotoxicity ([0101]) which overlaps the instant range of less than or equal to 2(instant claim 23); the adhesive composition is applied or laminated to the surface of substrate ([0087] and [0168]), and the substrate includes non-woven polyester ([0141]) and polyethylene substrate ([0127]) which reads on the substrate layer having waterproof and the adhesive layer directly contacts at least a portion of the substrate layer, and then the adhesive composition is applied to the skin ([0087] and claim 168 of prior art) (instant claims 25-28 and 30); the adhesive composition is provided in the form of medical article including wound dressing, surgical dressing, surgical tape, incise films, medical tapes, etc. (claim 264 of prior art) (instant claim 29); the adhesive achieves relatively high release rate and/or extents of release of antimicrobial agents incorporated in the adhesive, and high release rates and/or extents of release of antimicrobial agents in relatively short time periods can be a prerequisite for medical incise films or peripheral IV dressings ([0009]); and the adhesive composition inhibits microbial growth by more than 2 log throughout a 7 day contact time period ([0007] and [0013]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Wibaux is that Wibaux does not expressly teach properties of the release rates of instant claims 12-16; and antimicrobial activity of instant claims 18-22; and primary irritation index value of instant claim 24.
However, Wibaux teaches the same ingredients of acrylic-based adhesive, bioactive agent such as chlorhexidine gluconate, and hydrophilic agent such as cellulose (e.g., microcrystalline cellulose) and overlapping amounts thereof, and also the adhesive compositoin has relatively high release rates and/or extents of release of antimicrobial agents incorporated in the adhesive ([0009]) and high log reduction of greater than 2 ([0013]), and thus, the composition of Wibaux would have implicit properties as claimed. In this regard, please see MPEP 2112.01 II.COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” That is, the Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. Ans. 7. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of the claimed product.
Although Wibaux teaches overlapping ranges of adhesive, phase-separated hydrophilic material and bioactive compound as noted above, it does not expressly teach the exact ranges as claimed. However, MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Therefore, in the absence of criticality, the prior art overlapping ranges would be optimized to achieve the claimed ranges.
Although Wibaux teaches the said species of phase-separated hydrophilic material of claim 16 and of substrate layer of claim 26, species as claimed other than the said species by Wibaux would have equivalent function and they would be an obvious variation and a matter of choice or design, in the absence of evidence to the contrary.
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.
From the combined 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 combined 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 1-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of patent no. 12,245,919B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets require at least one adhesive being an alcohol-functionalized acrylic adhesive, at least one phase-separated hydrophilic material selected from silicon dioxide, titanium dioxide, and combinations thereof, at least one bioactive compound including chlorhexidine salt with overlapping amounts thereof, release rate of bioactive compound, same antimicrobial activities, substrate layer and its materials, and release liner (instant claims 1-31 and 1-25 of patent claims).
Therefore, instant claims are obvious over patent ‘919 subject matter.
Conclusion
All claims examined are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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