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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 03/02/2026 is acknowledged. Claim 17 has been canceled and claim 20 has been withdrawn. Claims 1-16, 18, and 19 are under examination in the instant office action.
It is noted that the status of withdrawn claim 20 is incorrectly stated as “(currently amended)”. It should be corrected as “(Withdrawn, currently amended)”.
Election/Restrictions
Applicants’ confirmation of election with traverse of invention I, claims 1-19, filed on 03/02/2026 is acknowledged.
The traversal is on the ground(s) that there is no evidence of search burden. This is not found persuasive because all these inventions are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required and the inventions require different search queries as well are likely to raise different non-prior are issues under 35 USC 112(a).
The requirement is still deemed proper and is therefore made FINAL.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. The rejections are modified based on the amendments.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-14, 16, 18, and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Schlueter (US 2019/0339419 A1).
Schlueter teaches an ophthalmic device material made by polymerizing a mixture of monomers comprises (abstract and claim 19):
a) 70-90% by weight of 2-cyclohexylethyl acrylate (the claimed a) in the instant claims 1-5, 7, and 13) and 2-(cyclohexyloxy)ethyl acrylate (the claimed a) in the instant claims 1-6 and 13) (paragraph 22 and 24);
b) 5-25% by weight of 2-hydroxyethyl methacrylate (the claimed b) in the instant claims 1, 8-10, and 13) (paragraph 25);
c) 1-3% by weight of a cross-linking agent such as 1,4-butanediol diacrylate and 0.5-10% by weight of cross-linking agents include ethylene glycol dimethacrylate (the claimed c) in the instant claims 1 and 10-13) (paragraph 26 and 27);
a reactive (polymerizable) UV absorber and optionally contains a reactive blue-light absorber (the instant claim 14) (paragraph 29);
polymerization initiators include thermal initiators, i.e., the claimed thermally cured polymerization product (the instant claim 18) (paragraph 33);
wherein the ophthalmic device material is suited for use as intraocular lens (the instant claim 19) (paragraph 1);
wherein the ophthalmic device material has a refractive index of 1.48-1.50 and an Abbe number >52 (the instant claim 1) (paragraph 35), Tg < about 15 °C (the instant claim 16) (paragraph 36), an equilibrium water content (EWC) of <4% (paragraph 38).
The claimed about 15-75% and about 30-75% weight percentage of component a) → 12-90% and 24-90% with ±20% deviation according to the instant specification paragraph 14, thus the 70-90% weight percentage of component a) taught by Schlueter is within the claimed about 15-75% (12-90%) and about 30-75% (24-90%).
Schlueter does not specify the same claimed EWC (<4% vs the claimed 4.4-9% in the instant claim 1 → 3.52-10.8% based on ±20% deviation according to the instant specification paragraph 13 and 14).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of EWC is 4.4-9% (3.52-10.8%) and the range of EWC taught in the prior art is <4% and therefor, overlaps with the claimed range.
Schlueter does not specify the same claimed weight percentage of component b) in the instant claims 1, 10, and 13 (5-25% vs the claimed >28.49%, >28.49 and ≤ about 40% → >22.79% and ≤ 48% based on ±20% deviation according to the instant specification paragraph 13 and 14).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed ranges of component b) are >28.49%, >28.49 and ≤ about 40% (>22.79% and ≤ 48%) by weight and the range of component b) taught in the prior art is 5-25% by weight and therefor, overlaps with the claimed range. Please refer to MPEP 2144.05.II.A:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
(“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”).
Schlueter does not specify the same claimed weight percentage of component c) in the instant claim 12 (0.5-10% vs the claimed about 3-5% → 2.4-6% with ±20% deviation).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of component c) is about 3-5% (2.4-6%) by weight and the range of component c) taught in the prior art is 0.5-10% by weight and therefor, includes the claimed range.
Claims 1-16, 18, and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Schlueter (US 2019/0339419 A1) in view of Molock et al. (US 6,218,463 B1).
The teachings of Schlueter are discussed above and applied in the same manner.
Schlueter does not teach the monomer further including C3-12 alkyl methacrylate in the instant claim 15.
This deficiency is cured by Molock et al. who teach ocular devices formed from compositions comprising at least one ocular device-forming monomer includes hydroxy alkyl esters of acrylic or methacrylic such as hydroxyethyl methacrylate (the claimed component b)), alkyl acrylates and methacrylates including butyl acrylate, cycloalkyl acrylates and methacrylates (the claimed component a), and a crosslinker (abstract and column 3, line 11-25 and line 55). A person of ordinary skill in the art before the effective filing date of the claimed invention would readily envisage the alkyl acrylates and methacrylates including butyl methacrylate based on the teachings of alkyl acrylates and methacrylates including butyl acrylate (the claimed further monomer in the instant claim 15).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Schlueter and Molock et al. to add butyl methacrylate in the monomer mixture taught by Schlueter. Ocular devices formed from monomer including hydroxyethyl methacrylate, cycloalkyl acrylates and methacrylates, and a crosslinker and an additional butyl methacrylate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for adding butyl methacrylate flows from butyl methacrylate having been used in the prior art and as useful for the same purpose in a monomer mixture for forming ocular devices.
Response to Applicants’ arguments:
Argument based on the amendments are addressed in the modified rejections above (newly underlined).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
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