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 1-7 are pending.
Specification Objections
The specification is objected to because it appears to include errors. See, for example, [0044] of the present PGPub which provides various calculations based on Barrers, thickness and B/t that appear incorrect (e.g., 11,110 B/0.008 cm indicated as 13887.5 B/cm when actually 11110/0.008 would be 1,388,750--similar issues are present for the calculation based on 40,000 Barrers).
Claim Objections
Claim 1 includes a period in the middle of the claim which must be removed.
Claim Rejections - 35 USC § 112(a)/first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for certain embodiments, does not reasonably provide enablement for the full claimed scope. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to arrive at the invention in a manner commensurate in scope with the claims.
Upon review of the disclosure in its entirety, one having ordinary skill in the art would not be enabled to make the full scope of the invention as claimed without undue experimentation.
Claim 1 recites a medium containing cross-linked polydimethylsiloxane that has a thickness, oxygen permeability, and water permeability that must fall within both the water transmissibility and oxygen transmissibility ranges as claimed. The present specification, at best, appears to disclose Balafilcon as a cross-linked PDMS (see art-based rejection below) that is capable of achieving the claimed water transmissibility and oxygen transmissibility ranges for the thicknesses usable as a contact lens (see the water permeability reported in Table 1 of the specification and the oxygen permeability cited in the NPL document below). However, this material is far more specific than the cross-linked polydimethylsiloxane recited in the claims. The claims allow for the medium to have any amount of the cross-linked polydimethylsiloxane, and the cross-linked polydimethylsiloxane itself encompasses countless possible variants (i.e., allowing for any possible co-monomer, any possible crosslinking bonds, with any respective amounts thereof relative to the polydimethylsiloxane, and allowing for any MW). Having to experiment with all the possible permutations of the above variants of “medium containing cross-linked polydimethylsiloxane” as claimed to determine which material provides the oxygen permeability and water permeability that would fall within both the water transmissibility and oxygen transmissibility ranges as claimed (for thicknesses suitable for a contact lens) constitutes an undue/unreasonable amount of experimentation. That is, the claimed scope of material is far too broad compared to the enabled scope of the specification (i.e., Balafilcon).
Case law holds that applicant’s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all embodiments within the scope of the claim can be made and/or used as claimed and whether the claim meets the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988).
Upon applying the Wands factors to claim 1, undue experimentation would be required:
(A) The breadth of the claims; (as explained above, the claims are broad in terms of the medium relative to the much narrower guidance provided in the specification)
(B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (the water transmissibility and oxygen transmissibility ranges as claimed would not be readily arrived at by one having ordinary skill in the art without significant guidance)
(E) The level of predictability in the art; (to achieve the full scope of the claimed invention with the limited guidance provided in the specification would require testing various mediums without any apparent predictability)
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (the direction in the specification, at best, is sufficient for certain Balafilcon, without any corresponding direction provided for achieving the claimed properties with the broader medium as claimed)
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. (based on the broader claimed scope compared to the limited guidance in the specification and the apparent lack of predictability, the quantity of experimentation would be unreasonable).
The rest of the rejected claims not specifically addressed above are rejected because they depend from one of the claims specifically addressed above and fail to resolve the above enablement problem.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Upon review of the disclosure in its entirety, one having ordinary skill in the art would not be enabled to make the claimed invention without undue experimentation.
Claim 3 suffers from all the above issues discussed with respect to the properties of claim 1 (i.e., scope of enablement problems), but additionally requires that the medium has an oxygen permeability of greater than 200 Barrers. Because Balafilcon does not have this property, there is no enabling disclosure at all for claim 3. The only disclosure of a medium that can achieve such a property is one that is entirely composed of “one variant of polydimethylsiloxane.” No further information/example is provided regarding the “variant” of polydimethylsiloxane that is being referred to (i.e., the type/amount of co-monomers, the type/amount of crosslinking bonds, or the MW). The property of claim 3 is also combined with the properties of claim 1 via dependency, which provides further constraints on the variant of polydimethylsiloxane that would have to be enabled by the present disclosure.
If (arguendo) Balafilcon is found to not be a crosslinked polydimethylsiloxane that can achieve the properties of claim 1, then the properties of claim 1 would likewise not be enabled (i.e., not just not enabled in scope).1 That is, without Balafilcon, the only disclosure of a medium that can achieve such properties of claim 1 would be one that is entirely composed of “one variant of polydimethylsiloxane” with no further information/example being provided regarding the “variant” of polydimethylsiloxane that is being referred to (i.e., the type/amount of co-monomers, the type/amount of crosslinking bonds, or the MW). If this was the case (without Balafilcon), the same Wands factors below with respect to claim 3 would apply to claim 1 (for the properties of claim 1) and all the claims depending therefrom.
Upon applying the Wands factors to claim 3, undue experimentation would be required:
(A) The breadth of the claims; (as explained above, the claims are broad in terms of the type and amount of crosslinked polydimethylsiloxane,)
(B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (the property of claim 3, especially in combination with the properties of claim 1, would not be readily arrived at by one having ordinary skill in the art without significant guidance)
(E) The level of predictability in the art; (to achieve the claimed invention with the limited guidance provided in the specification would require testing various mediums without any apparent predictability)
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (at best, there is only generic direction in the specification, e.g., “one variant of polydimethylsiloxane”, without any specific working examples or guidance as to how to reduce the generic disclosure to a specific working example that possesses the claimed property)
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. (based on the lack of specific guidance in the specification and the apparent lack of predictability, the quantity of experimentation would be unreasonable).
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:
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.
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).
The oxygen permeability of Balafilcon as reported by the NPL document produces an oxygen transmissibility as in claim 1 (applying the same calculation as in [0043] of the present PGPub, a Dk of 107 from the NPL document at a thickness of 0.3 mm from Tapper would become a Dk/t of 35.6 in the units recited in claim 1, which is above 24.1). Furthermore, Balafilcon is reported in Table 1 of the present specification as having a water permeability in Barrers of 18964 (as in claim 2) which, for a thickness of 0.3 mm, would have a Barrers/cm value of about 6300 (i.e., using the same math as in [0044] of the present PGPub, see specification objection above), which is below 13887.5.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-7 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-10 of U.S. Patent No. 12,105,360 (the patent). Although the claims at issue are not identical, they are not patentably distinct from each other. The contact lens of the patented claims inherently has anterior and posterior surfaces as claimed.
Conclusion
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
1 That is, without Balafilcon as an enabling disclosure, claims 1-7 would be rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement based on the claim(s) containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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