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 1-4 are pending in the application. Claims 5-10 have been canceled. Preliminary amendment filed 19 April 2024.
Priority
This application is a 371 of PCT/JP2021/040030 filed 10/29/2021.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Saeko et al (WO 2019216381 A1; machine English translation, pages 1-10).
Saeko teaches an ophthalmic composition comprising chondroitin sulfate or a salt thereof. The molecular weight of the chondroitin sulfate or a salt thereof is in the range 10,000 to 100,000 (page 2, see first five paras under sub-title: Ophthalmic composition; composition as in claims 1-2).
Therefore, Saeko et al anticipates claims 1-2.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Saeko et al (WO 2019216381 A1; machine English translation, pages 1-10) in view of Yusufu et al (Int Ophthamol, 2018, 38, 1261-1273).
The teachings of Saeko et al are set forth above. In addition, Saeko teaches that its ophthalmic composition can contain hydroxypropylmethylcellulose as a component (page 13, line 2; anti-inflammatory agent as in claim 3, and limitation of claim 4).
According to Yusufu, hydroxypropyl methylcellulose (HPMC) reduced dry eye syndrome in subjects (page 1270, right col., last para through page 1272). Therefore, for this added benefit of reduced dry eye syndrome one of ordinary skill in the art will include HPMC as a component in the composition of Saeko.
The composition can also contain vitamins A and E (page 7, see first two paras under sub-title: B-5 component; limitation of claim 3). The composition can also contain allantoin as the anti-inflammatory agent, and can also include pyridoxine and panthenol (page 12, third and seventh full para; as in claim 4). Therefore, these can also be included as components in the composition of Saeko.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, chondroitin sulfate having the claimed molecular weight range is known in the art for use in ophthalmic compositions. The other components like hydroxypropyl methylcellulose (HPMC), vitamins A and E, allantoin pyridoxine and panthenol are also suggested as components.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. One of ordinary skill in the art would be motivated to arrive at the claimed composition since Saeko teaches that its composition, when instilled, the ease of blinking and moisturizing were felt stronger. The composition can be instilled when wearing and not wearing contact lenses. Therefore, one of ordinary skill in the art will look for alternative compositions for the purpose taught by Saeko.
Conclusion
1. Pending claims 1-4 are rejected.
2. Claims 5-10 have been canceled.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
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