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 . Claims included in the prosecution are claims 1, 4 and 6-8.
Applicants' arguments, filed 07/01/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 1 and 6 are objected to because of the following informalities: “and is 19.91” in the last line should be recited as --- is 19.91 --- to be grammatically correct. Appropriate correction is required.
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, 4 and 6-8 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, claims 1 and 6 recites the broad recitation “wherein the glycosaminoglycans are selected from chondroitin, chondroitin sulphate, hyaluronic acid, hyaluronic acid complexes, and crosslinking products there”, and the claim also recites “wherein the ratio between hyaluronic acid: antimicrobial biguanide polymer derivatives is 39:82 and the ratio between chondroitin sulfate: antimicrobial biguanide antimicrobial polymer derivatives is 19.91”, 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. It is unclear whether the glycosaminoglycans are limited to hyaluronic acid and chondroitin sulfate.
Claims 1 and 6 are additionally indefinite since the claims do not recite wherein the glycosaminoglycans may include mixtures in the Markush group. Therefore, if the claims require hyaluronic acid or chondroitin sulfate as the glycosaminoglycans, it is unclear whether the claim requires either one or both hyaluronic acid and chondroitin sulfate.
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.
1. Claims 1, 4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 2010/0234319, Sep. 16, 2010) (IDS reference) in view of Ellis et al. (US 6, 277, 365, Aug. 21, 2001) (hereinafter Ellis).
Yu discloses ophthalmic solutions which comprises a complex formed of and/or comprising at least one cationic component and at least one anionic polymer as antimicrobial agents (¶ [0001]). The complex can be dissolved in aqueous ophthalmic solution or in an aqueous medium or both (¶ [0014]). The anionic polymer may be hyaluronic acid (i.e., glycosaminoglycan) (¶ [0013]). The hyaluronic acid is present from about 0.000001% to about 5% (¶ [0014]). The hyaluronic acid has a molecular weight between 10,000 and 5,000,000 (¶ [0015]). The cationic compound can be a polymeric quaternary ammonium compound (¶ [0039]). Polymeric quaternary ammonium compounds include compounds, monomers and polymers containing at least two quaternary ammonium groups. Examples of polyquaternary ammonium compounds include hexamethylene biguanide (¶ [0034]). Hexamethylene biguanide polymers are referred to as polyaminopropyl biguanide (¶ [0035]). The polymeric quaternary ammonium compound is present in a liquid aqueous medium at concentrations of about 0.00001% to about 5% (¶ [0034]). The total antimicrobial component (e.g., the combined quaternary ammonium compound and anionic polymer) is present in a liquid aqueous medium at concentrations of about 0.00001%, about 0.0001%, or about 0.0015%, to about 0.0025%, about 0.01%, about 0.1%, about 1%, or about 3% (w/w) (¶ [0039]). The compositions may further comprise effective amounts of other components, such as detergents or surfactants, viscosity-inducing or thickening components (i.e., rheological additives), chelants or sequesterants, and tonicity agents (i.e., excipients) (¶ [0047]). The antimicrobial components in the complex may be used in compositions for treating conditions of the eye (¶ [0043]).
Yu differs from the instant claims insofar as not teaching wherein the complex comprise chondroitin sulfate.
However, Ellis discloses a composition for treating the surface of the eye comprising a therapeutic agent (abstract). The therapeutic agent may be an anionic therapeutic agent including glycosaminoglycans such as hyaluronic acid and chondroitin sulfate (col. 3, lines 53-56).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Yu discloses wherein the complex comprises at least anionic polymer. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated chondroitin sulfate into the complex of Yu as an anionic polymer since it is a known and effective anionic polymer for ophthalmic compositions as taught by Ellis.
In regards to instant claims 1 and 6 reciting wherein the ratio between hyaluronic acid and antimicrobial biguanide polymer derivatives is 39.82, Yu discloses about 0.00001% to about 5% polyaminopropyl biguanide and about 0.000001% to about 5% hyaluronic acid. Thus, one of ordinary skill in the art would have arrived at a ratio from these ranges overlapping with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
In regards to instant claims 1 and 6 reciting wherein the ratio between chondroitin sulfate and antimicrobial biguanide polymer derivatives is 39.82, Yu discloses about 0.00001% to about 5% polyaminopropyl biguanide and wherein the total antimicrobial component (e.g., the combined quaternary ammonium compound and anionic polymer) is present in a liquid aqueous medium at concentrations of about 0.00001%, about 0.0001%, or about 0.0015%, to about 0.0025%, about 0.01%, about 0.1%, about 1%, or about 3% (w/w) (¶ [0039]). Thus, one of ordinary skill in the art would have arrived at an amount of chondroitin sulfate (i.e., anionic polymer) from these ranges and once arriving at such amount, one would have arrived at a ratio overlapping the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Arguments
Applicant argues that the presently claimed invention provides for surprising and unexpected results because at specific ratio as shown on Tables 1.2 and 1.3, a soluble complex is obtained. In fact, above this ratio as claimed in claim 1, no precipitate is formed.
The Examiner submits that Applicant’s showing appears to be probative of unexpected results; however, instant claim 1 is not commensurate in scope. Applicant uses a specific molecular weight of PHMB, hyaluronic acid, and chondroitin. Instant claim 1 does not recite a molecular weight for PHMB, hyaluronic acid, and chondroitin sulfate. One of ordinary skill in the art would not reasonably expect any molecular weight to be representative of the showing since molecular weight affects solubility, which affects whether there are precipitates. Additionally, instant claim 1 is not limited to PHMB. Instant claim 1 recites wherein the antimicrobial biguanide polymer derivative may be polyaminopropyl biguanide. One of ordinary skill in the art would not reasonably expect the same results with polyaminopropyl biguanide since polyaminopropyl biguanide and polyhexamethylene biguanide are different compounds with different solubilities.
Conclusion
Claims 1, 4 and 6-8 are rejected.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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