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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6 and 20, the amended claims now require that the claimed ophthalmic device “has an equilibrium water content of at least about 60 wt. %.” However, the claim does not specify what qualifies as the claimed “equilibrium.” Claims are given their broadest reasonable interpretation in light of the specification as it would be interpreted by one of ordinary skill in the art (see MPEP 2111).
In this case, the instant Specification teaches that the water % (presumably equivalent to “equilibrium water content” because the description of water % refers to equilibration within its procedure) refers to a content which is calculated from wet and dry weights, wherein the wet weight is the mass of a hydrated lens which has been blotted dry using filter paper and wherein the dry weight is the mass of a lens which has been dried for 10 minutes in a microwave oven inside a jar containing desiccant and subsequently allowed to sit for 30 minutes to equilibrate to room temperature (c.f. instant Specification at [00143]). However, said procedure fails to provide critical parameters for this process, including the wattage, size, and power conditions of the microwave, and the temperature and relative humidity conditions of the room in which the lens is equilibrated. Furthermore, it is unclear if the microwave oven is turned on and operated during the procedure, as no indication of such is made. The lens is indicated as being placed inside the microwave oven inside a jar containing desiccant, and therefore it is unclear if the microwave itself is critical (i.e., the microwave is turned on and microwave radiation is being used to remove water from the contact lens product), or if the desiccant within the jar is responsible for water removal (in which case, the microwave is merely incidental and essentially any similarly sized container would suffice).
One having ordinary skill in the art would therefore be unable to ascertain the limitations of the claimed “equilibrium water content.”
Regarding claims 7-19 and 21-25, the claims are rendered indefinite because they depend, either directly or indirectly, on one of claims 6 and 20, which are indefinite as described above.
Response to Arguments
As-amended, the claims are rendered indefinite by the incorporation of the “equilibrium water content” phrasing, as described above. An examiner should not simply speculate about the meaning of the claim language and then enter an obviousness rejection in view of that speculative interpretation (see MPEP 2143.04.I.). Therefore, the previous grounds of rejection are withdrawn because the application of the prior art therein would require considerable speculation as to the meaning of the claims.
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 JOSHUA CALEB BLEDSOE whose telephone number is (703)756-5376. The examiner can normally be reached Monday-Friday 8:00 a.m. - 5:00 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones can be reached at 571-270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762
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