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 .
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.
Claims 1, 2, 4-7 are pending.
Response to Amendment
Applicant’s amendment of 08/09/26 has been entered. Applicant's amendment has necessitated new grounds of rejection and the remarks are not persuasive.
It is noted that the insertion of Balafilcon into claim 1 lacks proper claim markup. It appears that this is the only missing markup in the claim amendment (see interview summary) and this office action relies on that being the only non-marked up change to the claims.
Claim Rejections - 35 USC § 112(b)/second paragraph
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.
Claim(s) 1-2, 4-7 is/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 pre-AIA the applicant regards as the invention.
The recitation of Balafilcon in the claims is vague because it is tradenamed product recited for a particular material.
If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parteSimpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. MPEP 2173.05(u).
The rest of the rejected claims not specifically addressed above are rejected because they depend from one of the claims specifically addressed above and therefore include the same indefiniteness issue(s) via their dependency.
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 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.
If 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.
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 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 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
When something is indicated as being “obvious” this should be taken as shorthand for “prima facie obvious to one having ordinary skill in the art to which the claimed invention pertains before the effective filing date of the invention”.
When a range is indicated as overlapping a claimed range, unless otherwise noted, this should be taken as short hand to indicate that the claimed range is obvious in view of the overlapping range in the prior art as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 1-2, 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tapper (U.S. 7,939,579) in view of Dukes (U.S. 2005/0254002) in view of Oxygen permeability of hydrogel contact lenses with organosilicon moieties (2002) in view of Linhardt (U.S. 2010/0069522) in view of Nandu (U.S. 5,260,000).
Regarding claims 1-2 and 4-7, Tapper discloses a contact lens (inherently having anterior and posterior surfaces with a medium therebetween) formed from a hydrogel of high oxygen permeability (col. 4, lines 15-20) that may be formed to a constant thickness of 0.10-0.30 mm (overlapping claims 5-7, col. 12, lines 5-20). Tapper does not disclose the claimed medium or the diameter of the lens. However, Dukes discloses that a suitable diameter for a contact lens may be e.g., 12mm to provide aesthetic benefits related to the user’s iris, and discloses that Balafilcon is a preferred contact lens material (see abstract, [0032] and claim 4). Furthermore, the Oxygen… NPL document indicates that Balafilcon has an oxygen permeability of about 107 Barrer (see abstract).
Based on the above, it would have been obvious to have used the diameter from Dukes for the contact lens in Tapper because Dukes shows that such a diameter is suitable for covering the user’s iris and thereby allows for aesthetic benefits. Because Tapper discloses that the lenses are constant thickness, the thicknesses from Tapper (0.10-0.30 mm) would be applicable over the entire lens diameter (e.g., 12mm diameter provides an area of over 50 mm2), as in claim 4.
Additionally, it would have been obvious to have used Balafilcon as the hydrogel lens material in Tapper because Dukes teaches that it is preferrable for that use, and the NPL document teaches that it has relatively high oxygen permeability (as sought by Tapper). Linhardt and Nandu further render obvious that Balafilcon is a crosslinked PDMS polymer as claimed (see [0085] of Linhardt, indicating that the teachings of Nandu correspond to Balafilcon, and, from Nandu, col. 1, lines 5-15, disclosing that the hydrogel is crosslinked, and col. 4, lines 30-45, disclosing PDMS crosslinker). Thus, based on the teachings of Linhardt, it would have been obvious to have looked to the teachings of Nandu for the structure of Balafilcon and Nandu makes the crosslinked PDMS structure of Balafilcon obvious to use in Tapper because Dukes and the NPL document show that Balafilcon is preferred and has high oxygen permeability (and also because Nandu teaches that the material provides good contact lens machinability, col. 7, lines 25-30).
Because the prior art renders obvious Balafilcon at an overlapping thickness relative to the present disclosure, this medium material and thickness will inherently produce the same properties as claimed.
Response to Arguments
Applicant’s remarks are moot in light of the new grounds of rejection which were necessitated by Applicant's amendment. Remarks which are still deemed relevant are addressed below and are not persuasive.
The previous specification objection, 112 rejections, and double patenting rejection are withdrawn due to Applicant’s amendment.
Applicant argues that the claims are patentable over the cited references because they do not disclose the claimed property ranges. This is irrelevant because the claimed properties are inherent when the same material is used in the same thickness, as explained in the rejection above.
Applicant then argues that the cosmetic aspects of Dukes would alter the barrier properties of the lens. There is no support for this assertion and mere attorney arguments are not sufficient for this kind of technical argument. Furthermore, Dukes was cited for the dimensions of the lens and the Balafilcon material and the cosmetic features disclosed by Dukes and cited yb Applicant are then later applied to this blank lens (e.g., via printing, [0028]) such that the blank lens would have the material and dimensions discussed in the rejection (and thus meet the claimed barrier limitations) prior to being printed with the cosmetic aspects.
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 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 date of this final action.
References cited in any corresponding foreign applications have been considered but would be cumulative to the above. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B NELSON whose direct telephone number is (571)272-9886 and whose direct fax number is (571)273-9886 and whose email address is Michael.Nelson@USPTO.GOV. The examiner can normally be reached on Mon-Sat, 7am - 7pm.
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, Callie Shosho can be reached on 571-272-1123. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300 (faxes sent to this number will take longer to reach the examiner than faxes sent to the direct fax number above).
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/MICHAEL B NELSON/
Primary Examiner, Art Unit 1787
Prosecution Insights