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 .
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
Claims 1-20 are pending in this application. This application claims priority to provisional application 63/440,790, filed on 06/24/2023.
Election/Restrictions
During a telephone conversation with Michael E. Carmen on restriction on 10/28/2025 a provisional election was made to prosecute invention I, claims 1-19. Affirmation of this election must be made by applicant in replying to this office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected inventions and species.
Claims 1-19 will presently be examined to the extent they read on the elected subject matter of record.
Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to an ophthalmic device which is a polymerization product of a monomeric mixture comprising: (a) about 15-75% by total monomer weight of one or more cycloaliphatic (meth)acrylic monomers; (b) >25% by total monomer weight of one or more hydrophilic monomers; and (c) one or more crosslinking agents; wherein the ophthalmic device has a refractive index of about 1.48-1.52 and an Abbe number ≥50, classified in A61L 27/50.
II. Claims 20, drawn to a method for making an ophthalmic device, comprising: (a) providing a monomeric mixture comprising: (i) about 15-75% by total monomer weight of one or more cycloaliphatic (meth)acrylic monomers; (ii) >25% by total monomer weight of one or more hydrophilic monomers; and (iii) one or more crosslinking agents; and (b) subjecting the monomeric mixture to polymerization conditions to provide an ophthalmic device having a refractive index of about 1.48-1.52 and an Abbe number ≥50, classified in A61L 27/16.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process as claimed can be used to make another and materially different product: US 2007/0004868 A1 discloses polymerization products formed from a monomeric mixture comprising (a) one or more first monomers of the general formula I: A-L-R1-(X-CF=CF2)n; (b) one or more second crosslinking monomers comprising at least three trifluorovinyl groups and (c) one or more prepolymers comprising one or more trifluorovinyl groups (abstract).
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
In the instance application, the inventions require different search queries as well are likely to raise different non-prior are issues under 35 USC 112(a).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention.
If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Multiple Inventors
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 and 16-19 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 less than <4% (the instant claim 17) (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 weight percentage of component b) in the instant claims 1, 10, and 13 (5-25% vs the claimed >25%, >25 and ≤ about 40% while 25% is approximate according to the instant specification paragraph 13, thus, > approximate 25%, > approximate 25% and ≤ about 40% → ≥ 25, 25-48% 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 overlaps with the range disclosed in the prior art, such as in the instant rejection.
The claimed ranges of component b) are ≥ 25 and 25-48% 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.
Or alternatively, the claimed weight percentages of component b) are >25%, >25 and ≤ 48% without the “approximate”, this deficiency is cured by the rationale that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties.
The claimed ranges of component b) are >25%, >25 and ≤ 48% by weight and the range of component b) taught in the prior art is 5-25% by weight and therefor, very close to the claimed range that one skilled in the art would have expected them to have the same properties while formed polymerized material does have the same properties as the claimed polymerized material. 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 1-19 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.
Correspondence
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
Prosecution Insights