DETAILED ACTION
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.
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) 12, 13, 15-23 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2013/0176529, “Li”) in view of Rathore et al. (US 2014/0296440, “Rathore”).
Regarding claim 12, Li teaches an ophthamalic device ([0001], [0006] – [0009]) comprising the reaction product of a crosslinked substrate network ([0130], [0139], [0140] - [0143]) that may be reacted via an initiator (e.g., [0130]) and a grafting composition containing one or more ethylenically unsaturated compounds ([0130], material to be grafted to substrate, [0160] – [0165]). While Li teaches the inclusion of a general initiator (e.g., [0261]), Li fails to teach that the initiator that is capable of forming two or more free radical groups. However, such initiators are well known in the prior art. For example, in the same field of endeavor of the manufacture of contact lenses (e.g., [0003]), Rathore teaches bis(2,4,6-trimethylbenzoyl)-phenyl phosphine oxide as a preferred photoinitiator and is suitable for use with silicone containing monomers, hydrophilic monomers, and the like for use in contact lenses ([0061], [0062]). It therefore would have been obvious to the ordinarily skilled artisan to have substituted the specific photoinitiator of Rathore for that of Li for its good initiation properties, commercial availability, and industry preference for its use ([0061], [0062]). Further, the simple substitution of a known compound or element that would have provided predictable results (in this case photoinitiation of polymerization) would have been obvious to the ordinarily skilled artisan at the time of filing (please see MPEP 2143). The Examiner notes that bisacylphosphine oxides (BAPO) such as bis(2,4,6-trimethylbenzoyl)-phenyl phosphine oxide are described in the present specification as effective initiators having the claimed properties (see present specification at pp. 14-15, describing the above BAPO as having the claimed absorption properties). Modified Li additionally teaches the substrate material may include a crosslinker (Li, [0140]), one or more ethylenically unsaturated compounds (Li, e.g., [0140] – [0144], various acrylic components), and an initiator capable of forming two free radical groups wherein at least one is further activatable by subsequent activation (Rathore, wherein the initiator may be a various bisacylphosphine oxides, Rathore, [0061]).
Regarding claim 13, Li additionally teaches that the grafting composition further includes a crosslinker ([0163], [0164]).
Regarding claims 15 and 16, modified Li (Rathore) additionally teaches the initiator may be a bisacylphosphine oxide (Rathore, [0061]).
Regarding claim 17, Li additionally teaches that the one or more ethylenically unsaturated compounds in the grafting composition may include, for example, a methacrylate ([0200], [0219]).
Regarding claim 18, Li additionally reaches that the crosslinked substrate network may be made from one or more silicone-containing components ([0140] – [0144], various silicone-containing monomers) and the grafting composition may contain hydrophilic reactive components ([0165], [0248]).
Regarding claim 19, Li additionally reaches that the crosslinked substrate network may be made from one or more hydrophilic reactive components ([0140], [0143], [0149], various hydrophilic materials) and the grafting composition may contain silicone-containing components ([0164]).
Regarding claim 20, Li additionally reaches that the crosslinked substrate network may be made from one or more hydrophilic reactive components ([0140], [0143], [0149], various hydrophilic materials) and the grafting composition may contain hydrophilic reactive components ([0165], [0248]).
Regarding claim 21, Li additionally reaches that the crosslinked substrate network may be made from one or more silicone-containing components ([0140] – [0144], various silicone-containing monomers) and the grafting composition may contain silicone-containing components ([0164]).
Regarding claim 22, modified Li (Rathore) additionally teaches the inclusion of additives, such as release agents or dyes and their inclusion would have been obvious in order to provide additional functionality, such as for example pharmaceutical deliver, to the ophthamalic devices of Li (Rathore, [0016]).
Regarding claim 23, Li additionally teaches that the concentration of the grafting composition is greater at the substrate network’s surface than at its core ([0131]).
Regarding claim 36, Li additionally teaches that the ophthamalic device may be, for example, a contact lens ([0036], [0097]).
Response to Arguments
Applicant’s arguments filed 7/23/26 are considered moot in light of the new grounds of rejection, which were necessitated by Applicant’s amendments. Arguments that are relevant to the current rejections are addressed below.
Applicant argues that Li fails to teach the inclusion of a sequentially activatable initiator that is covalently bonded to the polymer structure of the first reaction product. As described above, modified Li teaches a substrate network is the reaction product of a “polymerization initiator that is capable, upon a first activation, of forming two or more free radical groups, at least one of which is further activatable by subsequent activation, one or more ethylenically unsaturated compounds and a crosslinker” (emphasis added). Applicant admits that the bisacylphosphine oxide initiator described by Rathore (e.g., Irgacure 819) is capable of undergoing sequential activation to form two free radical groups (Applicant’s Remarks, 7/23/26, pp. 6-7), but argues that “the point is not the inherent capability of the compound but the manner in which it is to be used.” The Examiner respectfully disagrees and notes that he claim language simply requires the initiator have the capability of subsequent activation following an initial activation. Applicant argues that the initiator of Li may be extracted from the polymeric structure and therefore cannot be considered to be covalently bonded to the structures. But as Applicant notes, this refers to excess initiator (Li [0279]), that is, unreacted initiator. Reacted initiator would be expected to form covalent bonds with the polymeric structure in much the same way that is described in the present invention (see present specification at pp. 14-15, describing the above BAPO as being a preferred initiator having the properties desired in the present invention). Indeed, Li further notes that “unreacted initiator residue in non-extracted lenses can be used to facilitate surface modification via UV reaction.” (Li, [0279]). That is, unreacted excess initiator, such as would be created by the BAPO compounds of Rathore, may be used to carry out further grafting and thus the inclusion of an additional initiator may be unnecessary. Finally, the Examiner notes that it is not entirely clear from the language of the claim what is meant by the phrase “covalently bound” in claim 12. The broadest reasonable interpretation of such language could seemingly mean either unreacted initiator (i.e., covalently integral or bound to itself, prior to activation) or could mean covalently bound to the polymeric structure.
Applicant argues that the claim language requires sequential activation. Applicant appears to argue that the initiator included in the reaction product of the first reaction composition effects a subsequent reaction with the grafting composition. But the language of the claim does not strictly require this. While such a subsequent reaction would be capable of performing with the use of a BAPO initiator as described above, the broadest reasonable interpretation of the claim does not require a subsequent reaction be performed with the polymerization initiator of the crosslinked substrate network reaction product. The Examiner therefore maintains that the BAPO initiator of modified Li as described above would form covalent bonds with the polymeric structure, would be capable of subsequent reaction, and would further be formed from an ethylenically unsaturated compound and a crosslinker as described above. Modified Li further teaches subsequent grafting to this structure and a grafting composition containing one or more ethylenically unsaturated compounds ([0130], material to be grafted to substrate, [0160] – [0165]; and further see Li [0279] appearing to disclose subsequent grafting via unreacted or excess initiator from initial reaction product).
For these reasons, claims 12, 13, 15-23, and 36 are rejected as described above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 ANTHONY J FROST whose telephone number is (571)270-5618. The examiner can normally be reached on Monday to Friday, 8:00am to 4:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin, can be reached on 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTHONY J FROST/Primary Examiner, Art Unit 1782
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