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 .
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 7 and 13 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation wherein the at least one species of Formula (I) is held within the polymer structure, and the claim also recites within the three-dimensional structure of the polymer which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation X is a halogen that is independently chosen from: fluorine, chlorine, bromine, and iodine, and the claim also recites wherein X is iodine which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(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.
Claim(s) 1-6, 13-16, 18, 21-25 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Buffa et al (US 2020/0179445 A1 hereafter Buffa).
Buffa discloses an antibacterial wound dressing comprising a substrate comprising at least a species is of Formula (I) [I-I-X]-, wherein X is a halogen and the species is complexed with a non-polymeric counterion [abstract, 0036-0038, claims]. The species is complexed with the non-polymeric counterion and the wound dressing substrate [Example 146]. When the substrates are anionic, their complexes would be completed with ionic interactions [003-005, 0028, claim 15]. The substrate can be chemically modified with a counterion such as sodium [Example 29]. The species can comprise cationic components compounds [0036, 0043]. The non-polymeric counterion is an alkali metal cation such as sodium, X can comprise triiodide, where the total amount of the species is present about 4% [Example 13]. The dressing is formed in a method comprising: providing a wound dressing substrate, dissolving molecular iodine and one halide species is to provide a species and treating the wound dressing substrate with the solution to form the dressing [0043-49, Example 25-26]. Dissolving the iodine in a solution comprising water and a water-miscible polar organic solvent in a ratio of 1/1 to 1/9 [0031, Example 5,6]. The polar solvent is ethanol [Examples]. The substrate can be knitted fibers that are combined together and soaked in the Formula (I) solution, with the solution soaking into the internal structure of the fibers [Example 31-33]. These disclosures render the claims anticipated.
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.
Claim(s) 1, 10, 17, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined Buffa et al (US 2020/0179445 A1 hereafter Buffa) in view of Zhang et al (US 2019/0290676 A1 hereafter Zhang).
As discussed above, Buffa discloses an antibacterial wound dressing comprising an iodide-based formulation on a substrate. The reference, whiles disclosing a polysaccharide substrate, specifically carboxymethylcellulose, the reference is silent to the specific degree of substation of the polysaccharide. The use of carboxymethylcellulose substrates is well known in the art as seen in the rt Zhang.
Zhang discloses an antibacterial wound dressing comprising a substrate is carboxymethylcellulose [abstract]. The carboxymethyl cellulose substrate has a degree of substitution from 0.1-0.6 [abstract, 0014-0015]. Compositions comprising a halogen and non-porous counterion such as sodium chloride can be included in the formulation [0119]. The pH of the system applied to the substrate is from 4-6 [0031]. The active agent is present on the substrate about 9% [claims]. It would have been obvious to include the carboxymethylcellulose substrate onto the wound dressing of Buffa as they solve the same problem.
Regarding the surface density of the applied formulation, it is the position of the Examiner that such limitations and do not distinguish over the prior art. The formulation of Buffa is applied in a sufficient concentration meeting the limitation s of claim 14 and that the releasable iodine content meets the concentration of claim 16. These limitations meet the general conditions of the claims and it would have been obvious to optimize these concentrations and ranges through routine experimentation. 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. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind, it would have been obvious to combine the prior art with an expected result of a stable antibacterial wound dressing. It would have been obvious to combine the carboxymethylcellulose of Zhang as a substrate to the formulation of Buffa as they solve the same problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable wound dressing that can release iodine as an antibacterial substance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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