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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 10, 2024 and July 16, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1 – 5 are examined here-in.
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.
(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.
Claims 1 – 5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by Matsumura (US 2014/0308368 A1).
Matsumura teaches an aqueous ophthalmic composition containing zinc chloride and a vinyl-based polymeric compound (abstract).
Matsumura teaches the vinyl-based polymeric compound is preferably polyvinyl pyrrolidone with a characteristic viscosity value in a range of 15 to 100 (paragraphs 0046 – 0049). Matsumura teaches the amount of vinyl-based polymer compound is from 0.001 to 10 w/v% (paragraph 0058).
Matsumura teaches the aqueous ophthalmic composition is useful as an eye drop for dry eyes (paragraph 0018).
Matsumura’s teaching for an aqueous ophthalmic composition containing zinc chloride and a vinyl-based polymeric compound (abstract) anticipates instant claim 1.
Matsumura’s teaching that the vinyl-based polymeric compound is preferably polyvinyl pyrrolidone (paragraphs 0046 – 0049) anticipates instant claim 2.
Matsumura teaches the amount of vinyl-based polymer compound is from 0.001 to 10 w/v% (paragraph 0058) with Examples 4 and 15 including polyvinyl pyrrolidone in the amount of 0.2 w/v % each (Tables 2 and 8), anticipating instant claim 3. According to MPEP 2131.03(i), a specific example in the prior art which is within a claimed range, anticipates the range.
Matsumura’s teaching polyvinyl pyrrolidone should have a characteristic viscosity value in a range of 15 to 100 (paragraphs 0046 – 0049) anticipates instant claim 4. Matsumura’s teaching of characteristic viscosity value range of 15 to 100 falls within the claimed range of 10 to 150, and is thus anticipatory according to MPEP 2131.03(ii).
Matsumura’s teaching the aqueous ophthalmic composition is useful as an eye drop for dry eyes (paragraph 0018) anticipates instant claim 5.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 3 and 5 are also rejected under 35 U.S.C. 103 below.
Claims 1 – 3 and 5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by Takeji (US 2014/0294991 A1).
Takeji teaches a composition for the treatment of dry eye (paragraph 0009).
Takeji teaches the composition includes zinc chloride (paragraphs 0019 – 0020, 0024, 0042, 0048 – 0051).
Takeji teaches the composition also includes polyvinyl pyrrolidone (paragraphs 0042, 0048 – 0051). In formulation examples 2 – 5, polyvinylpyrrolidone is in the amount of 30 g per 1,000 mL solution (paragraphs 0048 – 0051), which is 3 w/v%.
Takeji’s teaching for an ophthalmic composition which includes zinc chloride and polyvinyl pyrrolidone (paragraphs 0009, 0019 – 0020, 0024, 0042, 0048 – 0051) anticipates instant claims 1 and 2.
Takeji’s examples 2 – 5 showing polyvinylpyrrolidone is in the amount of 30 g per 1,000 mL solution (paragraphs 0048 – 0051), which is 3 w/v%, anticipates instant claim 3. According to MPEP 2131.03(i), a specific example in the prior art which is within a claimed range, anticipates the range.
Takeji’s teaching that the composition is for the treatment of dry eye (paragraph 0009) anticipates instant claim 5.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 3 and 5 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 1 – 5 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumura (as cited above).
Matsumura’s teachings are discussed above.
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Matsumura does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by the claim without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Matsumura thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Claims 1 – 5 are rendered prima facie obvious over the teachings of Matsumura, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., zinc chloride, polyvinyl pyrrolidine) were known in the prior art (e.g., ophthalmic compositions) 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 (e.g., an ophthalmic composition for dry eye) to one of ordinary skill in the art (MPEP 2143(i)(a)).
Matsumura’s teaching for an aqueous ophthalmic composition containing zinc chloride and a vinyl-based polymeric compound (abstract) reads on instant claim 1.
Matsumura’s teaching that the vinyl-based polymeric compound is preferably polyvinyl pyrrolidone (paragraphs 0046 – 0049) reads on instant claim 2.
Matsumura teaches the amount of vinyl-based polymer compound is from 0.001 to 10 w/v% (paragraph 0058) which overlaps with the instantly claimed range of 0.001 to 5 w/v% as recited in claim 3. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Matsumura’s teaching polyvinyl pyrrolidone should have a characteristic viscosity value in a range of 15 to 100 (paragraphs 0046 – 0049) overlaps the instantly claimed range of 10 to 150 as recited in claim 4.
Matsumura’s teaching the aqueous ophthalmic composition is useful as an eye drop for dry eyes (paragraph 0018) reading on instant claim 5.
Claims 1 – 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Takeji (as cited above).
Takeji’s teachings are discussed above.
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Takeji does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by the claim without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Takeji thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Claims 1 – 3 and 5 are rendered prima facie obvious over the teachings of Takeji, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., zinc chloride, polyvinyl pyrrolidine) were known in the prior art (e.g., ophthalmic compositions) 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 (e.g., an ophthalmic composition for dry eye) to one of ordinary skill in the art (MPEP 2143(i)(a)).
Takeji’s teaching for an ophthalmic composition which includes zinc chloride and polyvinyl pyrrolidone (paragraphs 0009, 0019 – 0020, 0024, 0042, 0048 – 0051) reads on instant claims 1 and 2.
Takeji’s examples 2 – 5 showing polyvinylpyrrolidone is in the amount of 30 g per 1,000 mL solution (paragraphs 0048 – 0051), which is 3 w/v%, reading on instant claim 3.
Takeji’s teaching that the composition is for the treatment of dry eye (paragraph 0009) reads on instant claim 5.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Takeji (as cited above) in view of Takahashi (US 2021/0000844 A1).
Takeji’s teachings are discussed above.
Takeji does not teach polyvinyl pyrrolidone has a viscosity characteristic of 10 to 150.
Takahashi teaches the missing element of Takeji.
Takahashi teaches an ophthalmic composition with polyvinyl pyrrolidone (abstract, paragraphs 0004, 0010 – 0017). Takahashi teaches polyvinyl pyrrolidone should have a characteristic viscosity value K of 17 to 90 (paragraph 0015, claim 31).
In Table 8, Takahashi shows that the instillation of a composition with polyvinyl pyrrolidone K90 results in greater tear volume than instillation of a composition with polyvinyl pyrrolidone K30 (paragraphs 0139 – 0144, Table 8). These results suggest that the characteristic viscosity value of polyvinyl pyrrolidone in the composition influences tear volume.
With Takeji and Takahashi’s teachings, claim 4 is prima facie obvious according to MPEP 2143(i)(g) because Takahashi’s teachings would motivate a person of ordinary skill in the art to modify the prior art teachings of Takeji to arrive at the claimed invention. A person of ordinary skill in the art would be motivated to use polyvinyl pyrrolidone with a characteristic viscosity value K between 17 and 90 in the composition of Takeji because Takahashi shows that the K value of polyvinyl pyrrolidone influences the tear volume (paragraphs 0139 – 0144, Table 8).
Takahashi’s teaching of polyvinyl pyrrolidone should have a characteristic viscosity value K of 17 to 90 (paragraph 0015, claim 31) overlaps on the instantly claimed range of 10 to 150 as recited in claim 4. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612