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 1-4 and 6-10.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Applicants' arguments, filed 03/02/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 2, 9 and 10 are objected to because of the following informalities: “biguanidine” should be recites as --- biguanide ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
Claims 9 and 10 recite wherein the ratio between antimicrobial biguanide polymer derivatives (ABP) and hyaluronic acid or chondroitin (GAG) is >40 and >20, respectively. The claims fail to comply with the written description requirement since this limitation is not supported in the specification. At best the specification discloses on page 3, line 3, a ratio between GAG equivalents and ABP equivalents >10 and not the inverse.
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 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 2010/0234319, Sep. 16, 2010) (IDS reference).
Yu discloses ophthalmic solutions which contain complexes of at least one cationic component and an anionic polymer as antimicrobial agents (¶ [0001]). The complexes 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 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 complexes may be used in compositions for treating conditions of the eye (¶ [0043]).
The prior art discloses ophthalmic solutions which contain complexes of at least one cationic component and an anionic polymer as antimicrobial agents (¶ [0001]), wherein the anionic polymer is hyaluronic acid (i.e., glycosaminoglycan) (¶ [0013]) and the cationic component is a polymeric quaternary ammonium compound (¶ [0039]), such as polyaminopropyl biguanide (¶ [0035]). Together these would provide a composition as claimed instantly.
The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
In regards to instant claim 9 reciting wherein the ratio between antimicrobial biguanide polymer derivative and hyaluronic acid is > 40, Yu discloses about 0.00001% to about 5% polyaminopropyl biguanide and about 0.000001% to about 5% hyaluronic acid (i.e., glycosaminoglycan). 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.
2. Claim 10 is 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).
The teachings of Yu are discussed above. Yu does not teach wherein the complexes 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 complexes comprise an anionic polymer. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated chondroitin sulfate into the complexes 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 claim 10 reciting wherein the ratio between antimicrobial biguanide polymer derivative and chondroitin sulfate is > 20, Yu discloses about 0.00001% to about 5% polyaminopropyl biguanide and about 0.000001% to about 5% hyaluronic acid (i.e., glycosaminoglycan). 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.
Response to Arguments
Applicant argues that the second cationic component described by Yu is excluded in virtue of the presence of the transitional phrase “consisting of.”
Yu discloses wherein the complex comprises at least one cationic component. At least one cationic component means that only one cationic component may be present. Therefore, the complex of Yu does not need to comprise a second cationic component. As such, Yu does not teach away from the claimed invention.
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.
The Examiner does not find Applicant’s argument to be persuasive. The claims are not commensurate in scope. Applicant has only shown wherein a ratio of 39.82 hyaluronic acid/PHMB, a ratio of 39.82 chondroitin/PHMB, and a ratio of 19.91 chondroitin/PHMB has 0 mg of precipitate. The ratio in claims 9 and 10 do not encompass these ratios since the ratio in claims 9 and 10 is between PHMB and GAG and not between GAG and PHMB. Additionally, even if claims 9 and 10 were to recite a ratio between GAG and PHMB, claims 9 and 10 recite a ratio of >40 or >20. Applicant has not shown wherein the entire claimed range is effective for not having any precipitate. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d). Therefore, since applicant did not compare a sufficient number of tests both inside and outside the claimed range, Applicant’s argument is unpersuasive. Additionally, even if the ratios in claims 9 and 10 were to be unexpected, the claimed invention would not be patentable since the independent claim does not recite the ratios. As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-4 and 6-10 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614