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 1-20 are presented for examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered.
Response to arguments
Applicant’s arguments and declaration have been noted. Applicant in his remarks argues that Wang teaches lack of the stability and the addition of a stabilizer or a buffering agent is necessary to achieve stability. It is the examiner’s position that the claims of the instant application use “comprising”, which permits the addition of other ingredients. Furthermore, applicant also uses a buffering agent in the dependent claims. Applicant in his remarks further argues that “As for the antimicrobial agents (responsible for the composition's effectiveness), paragraph [0036] is the first and only paragraph in the description of the invention of Wang et al. that mentions PHMB, within a list of other biguanides. In fact, this document does not provide a single embodiment suggesting a preference for PHMB, let alone an experimental example of a composition comprising PHMB”. It is the examiner’s position that obviousness does not require that the prior art teaches the compound to be preferable or used in the examples. Furthermore, applicant’s attention is drawn to Para [0008], [0013], [0015], [0016], [0017], [0018] and [0019] of wang, which mentions polyhexamethylene biguanide, specifically used for treating keratitis. Additionally, applicant’s attention is drawn to the abstract, Para [0009], [0010], [0024], [0031], [0041], [0043], claims 1, 2 and 14, which teaches biguanide, which encompasses polyhexamethylene biguanide. Therefore, there are ample references made by Wang relating to the claimed compound. Applicant in his remarks alleges criticality to the molecular weight of the claimed invention. Applicant goes on by saying that “In fact, the disclosed range (up to 100k) is extremely broad when compared with the claimed range of 2,300 to 6,000. As mentioned above, examples 3 and 4 of the specification show that within the claimed range, the composition is stable, but when the molecular weight of the PHMB polymer is lower, the composition is no longer stable”. It is the examiner’s position that newly relied upon reference, Kirschner et al., in claims 1-12 teaches the use of polyhexamethylene biguanide at the concentrations overlapping with the claimed concentrations and molecular weight overlapping with the claimed molecular weights for the treatment of infections of an eye. The presented data and declaration in view of the relied upon prior art, which teaches the use of polyhexamethylene biguanide for the treatment of ophthalmic infections overlapping with claimed concentrations and molecular weights are considered to be moot. The advantage presented in the declaration is the inherent property the prior art composition, specifically Kirschner et al.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US
20070140897) in view of Yu et al. (US 20050196370) and further in view of Borazjani et al. (EP 1852133
Submitted by the applicant) and Kirschner et al. (EP0788797).
Wang et al. teach an ophthalmic acceptable composition for use in the ocular region of a
patient, the ophthalmic acceptable composition comprising water, a biguanide containing antimicrobial
agent and a pH adjusting agent to adjust the pH to a minimum of 4 and a maximum of 6. The invention
further comprises administering the ophthalmic acceptable composition to the eye of a patient in need
of treatment. See the abstract. Wang et al. teach that biguanide antimicrobial agents have been used
to preserve ophthalmic solutions and demonstrate relatively low toxicity in ocular tissues. Biguanide
antimicrobial agents include polyhexamethylene biguanide, chlorhexidine and Alexidine. See Para
[0008]. Wang et al. teach that to effectively preserve an ophthalmic composition, sufficient
preservative is necessary to prevent growth of S. aureus, P. aeruginosa and E. coli bacteria and C.
albicans and A. Niger fungi over the shelf life of the product. Typically, a clinically effective formulation
will contain the lowest amount of a preservative required to accomplish the desired effect. Between 0.5
ppm and 3.0 ppm of a biguanide has been used to preserve most ophthalmic solutions. See Para [0009].
The use of polyhexamethylene biguanide and/or chlorhexidine for treatment of Acanthamoeba keratitis
and Fungal keratitis is taught in Para [0013]. Wang et al. teach that the amount of antimicrobial agent in
the ophthalmic composition is a maximum of about 1 ppm and a minimum of about 0.1 wt. %. typically, the amount of antimicrobial agent in the multipurpose solution is a minimum of about 4.5
ppm, about 5 ppm, about 10 ppm, about 15 ppm or about 20 ppm. Typically, the amount of
antimicrobial agent in the ophthalmic solution is a maximum of about 1000 ppm, about 500 ppm, about
300 ppm, about 100 ppm, about 75 ppm or about 50 ppm. See Para [0037]. Wang et al. teach that one or more penetration enhancers will generally be utilized in a minimum amount of about 0.01 weight percent and/or a maximum of about 10 wt. %. See Para [0039]. Wang et al. teach examples of stabilizers that are effective in an aqueous solution include but are not limited to ophthalmic acceptable antioxidants (ascorbate, methionine, citric acid, BHT), complexing agents (cyclodextrin and derivatives, hyaluronic acid, citric acid), non-ionic surfactants (poloxamers such as Tetronics. RTM. 908, tyloxapol) and chelating agents and salts thereof (hydroxyl alkyl phosphonate, sodium edentate). See Para [0041]. The concentrations of stabilizers is taught to be about 0.001 wt. %, about 0.005 wt. %, about 0.01 wt. % and/or a maximum amount of about 0.5 wt. %, about 0.3 wt. %, about 0.1 wt. %, about 0.08 wt. %, about 0.05 wt. %, about 0.03 wt. %, about 0.01 wt. %. See Para [0043]. Wang et al. teach the viscosity enhancing agents include natural polysaccharides and gums, such as alginate, carrageenan, guar, karaya, locust bean, tragacanth agarose and xanthan; modified naturally occurring polymers such as carboxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, hydroxypropylmethyl guar and carboxymethyl guar, synthetic polymers, such as carboxy vinyl polymers, polyvinyl alcohol and polyvinyl pyrrolidone. See Para [0050]. Wang et al. teach Suitable buffers include, but not limited to, acetate buffer, citrate buffer, formate buffer, histidine, succinate buffer, phosphate buffer, maleate buffer, propionate buffer, malate buffer, pyridine buffer, piperazine buffer, cacodylate buffer, MES buffer, bis-tris buffer, carbonate buffer, imidazole buffer, ADA buffer, ACES buffer, PIPES buffer, MOPSO buffer, HEPES buffer, MOPS buffer, BES buffer, triethanolamine buffer, triethanolamine buffer and borate buffer. Generally, buffers will be used in amounts ranging from about 0.05 to about 2.5 weight percent, and preferably, from about 0.1 to about 1.5 weight percent. See Para [0054], claim 22 and claim 45. The 0.9 percent solution of sodium chloride as a tonicity agents is taught in Para [0056]. Wang et al. teach that Preferably, the tonicity agent is employed in an amount to provide a final osmotic value that is a minimum of 200 mOsm/kg, 220 mOsm/kg and/or a maximum of about 450 mOsm/kg, 350 mOsm/kg or about 320 mOsm/kg. See
Para [0056]. The use of an eye drop is taught in Para [0061]. The treatment of Aspergillus keratitis is
taught in Para [0016]. The treatment of Fusarium keratomycosis is taught in Para [0017].
Wang differs from the claimed invention in specifically teaching the addition of benzalkonium
chloride and the molecular weight of polyhexamethylene biguanide. Yu et al. teach that the addition of
chlorhexidine and benzalkonium chloride to polyhexamethylene biguanide in ophthalmic formulations
as old and well known. See claim 9. Borazjani et al. teach an ophthalmic composition that exhibits
enhanced biocidal efficacy against acanthamoeba relative to a reference ophthalmic solution that does
not contain the polycationic compound. See the abstract. The use of polyhexamethylene biguanide is
taught in claim 7. The molecular weight of PHMB is taught to be up to 100,000, which overlaps or
encompassed the claimed molecular weight. Furthermore, Kirschner teaches the use of polyhexamethylene biguanide at the concentration of 0.001 to 0.04% and the molecular weight of 1000-4000 in an ophthalmic formulation. It would have been obvious to a person to use the claimed molecular weight of polyhexaymethylene biguanide in the composition of Wang, motivated by the teachings of Kirschner, which teaches the use of polyhexamethylne biguanide at the concentrations and molecular weight overlapping with the claimed concentrations and molecular weights in ophthalmic formulation as old and well known.
Mixing and filtering the claimed ingredients taught by the prior art does not create a patentably distinct
process of making an ophthalmic solution in the absence of evidence to the contrary. The
determination of polydispersity index is considered to be within the skill of the
artisan in the absence of evidence to the contrary.
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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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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