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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-20 is/are finally rejected under 35 U.S.C. 103 as being unpatentable over Awasthi (11,660,370).
Initially, and as set forth in the last Office action:
“the examiner notes that the instant application specification describes that silicone hydrogel contact lenses are prior art. For example only, see specification [002] through [005] and [040] through [041]. Also acknowledged to be prior art by the applicant is the addition of hydroxyalkyl celluloses such as HEC etc. to contact lens packaging solutions in order to increase the viscosity of the packaging solutions. For example only, see specification [024] and [025], including the way they are drafted as it relates to hydroxyalkyl celluloses. Finally, also acknowledged by the applicant to be within the prior art, is the autoclaving of packages containing contact lenses in solution. For example only, see [025], including the manner in which autoclaving is mentioned therein. Therefore, the packaging of silicone hydrogel contact lenses in solutions containing hydroxyalkyl cellulose and the autoclaving of the packaging appears to be acknowledged by the applicant not to be the invention of the applicant, given the manner in which the subject application specification is drafted.
On the other hand, in view of the noted specification, applicant’s contribution to the art appears to be that the applicant discovered that “surprisingly” the viscosity of the packaging solution dropped significantly after autoclave (see specification [025]), and the applicant has hypothesized that this is due to a portion of the hydroxyalkyl cellulose from the packaging solution being embedded in the silicone hydrogel material of the contact lens during autoclaving (for example, see specification [027] –[030]). Moreover, this improves the surface wettability of the lens. Id. This embedded or absorbed hydroxyalkyl cellulose can be extracted from the contact lens in an amount that corresponds to the amount of hydroxyalkyl cellulose that was absorbed by the silicone hydrogel during autoclaving. Thus, the disclosed and claimed extractable amount of hydroxyalkyl cellulose corresponds to the amount of hydroxyalkyl cellulose that is embedded in the silicone hydrogel material of the contact lens due to autoclaving (for example only, see specification [057] and [059])”.
Now, regarding claim 1:
Awasthi discloses most of the features of the claim as follows: Awasthi discloses an autoclaved (including autoclaving to the same temperatures disclosed but not claimed in the subject application) packaged contact lens as recited in the claim preamble. See at least column 6 including lines 54-67. The autoclaved packaged contact lens of Awasthi comprises a packaging solution comprising a hydroxyalkyl cellulose as recited in the claim. See Awasthi column 6 lines 8-24 and 29-32. The autoclaved packaged contact leans of Awasthi also comprises a contact lens immersed in the packaging solution, the contact lens comprising a silicone hydrogel. See at least claim 15. (Additionally, the examiner notes that each one of these disclosures in Awasthi that meet the requirements of claim 1 is consistent with what applicant has disclosed is the prior art as indicated in italics above. For example, Awasthi discloses that the known hydroxyalkyl cellulose additive to contact lens packaging solutions is added as a viscosity builder, disclosure that is consistent with applicant’s own disclosure of the prior art in specification [024] and [025] of the subject application disclosure. For example, as disclosed by applicant in specification [024], “Hydroxyalkyl celluloses such as HEC and HPMC increase the viscosity of contact lens packaging solutions”. This is clearly not described in the specification as the invention of the applicant, but rather is described as something that is conventional.)
Therefore, what Awasthi does not disclose relative to claim 1 is the new requirement therein that the silicone hydrogel is formed from silicone hydrogel material having a U.S. Adopted Name (USAN) of stenfilcon A or somofilcon A. However, as disclosed in the subject application specification in [041] well known silicone hydrogel contact lenses include stenfilcon A and somofilcon A lenses in addition to the others disclosed in the same paragraph. In view of this disclosure of the prior art and Awasthi’s disclosure that a silicone hydrogel contact lens can be packaged in the Awasthi package, it would have been obvious to provide for the silicone hydrogel in Awasthi to be formed from stenfilcon A or somofilcon A, for the purpose of providing a user of the Awasthi invention with known contact lenses or contact lenses that were medically, economically or otherwise, appropriate for such a user.
Finally, the examiner notes that the modification to Awasthi is based on admission of the prior art in the application specification, per specification [041], as indicated in the rejection above. Therefore, although the prior art rejection does not include an anticipatory rejection over applicant’s own disclosure of the prior art, at least all of claim 1 as amended appears to be admitted prior art (refer to the specification disclosure in italics above as well as specification [041] providing the feature missing from Awasthi.
Regarding claim 2:
Refer again to Awasthi column 6 lines 29-32.
Regarding claim 3:
Refer to Awasthi column 3 line 45, for example only.
Regarding claim 4:
The feature is inherent in Awasthi. That is to say the autoclaved Awasthi contact lens package has a sessile drop contact angle that is inherently equal to or lower than that of some lens lacking hydroxyalkyl cellulose.
Regarding claim 5:
The examiner notes that as indicated in the last Office action, given the autoclaving in Awasthi the silicone hydrogel of the contact lens comprises an extractable amount of the hydroxyalkyl cellulose embedded in the silicone hydrogel (the hydroxyalkyl cellulose absorbed or embedded into the silicone hydrogel of the contact lens due to the autoclaving, as also discovered by applicant), although perhaps this embedded or absorbed hydroxyalkyl cellulose may not specifically be mentioned in Awasthi. However, the amount of the hydroxyalkyl cellulose claimed is not specified in Awasthi. On the other hand, given that the processes in Awasthi and in the subject application appear to be very similar if not identical (conventional silicone hydrogel contact lenses are packaged in the same solution and autoclaved to the same temperatures) the embedded hydroxyalkyl cellulose should fall within the claimed range. See also applicant’s hypotheses in specification [027].
Regarding claim 20:
See at least column 2 lines 34-48. Thus, the claimed package can be the sealed container or blister pack disclosed in Awasthi. The claimed base member can be the blister containing the container concave well and the claimed cover can be the metal or plastic sheet sealing the concave well, as is also conventional in the relevant art.
Regarding features of some dependent claims not specifically discussed above, Awasthi may not specifically disclose some of these features. However, the subject application specification is drafted in such a way that the features all appear to be well within the prior art or within the skill level of the artisan to provide. Or the features appear to be inherent in the practice of the Awasthi invention. Thus:
With regard to contact lens solution features, the artisan has the skill to provide known additives to the packaging solution or vary their concentration as claimed, including to vary the types and amounts of hydroxyalkyl cellulose (thus to vary the viscosity of the solution) to within the claimed ranges. Therefore, it would have been obvious to provide Awasthi with the claimed features in order to provide appropriate amounts of viscosity or other features to the solution for the benefit of particular packaged lenses.
Similar for the claimed contact lens features per se. It is within the prior art or the level of skill of the artisan to vary the contact lenses of Awasthi as claimed, including to vary exactly how they are constructed. Therefore, it would have been obvious to provide the contact lenses of Awasthi with the claimed contact lens features for the purpose of providing more durable and/or more economical contact lenses.
Applicant's arguments filed 4/9/26 have been fully considered but they are not persuasive.
Applicant appears to argue generally that the examiner is incorrect in finding that certain features have been admitted by applicant to be prior art. In support of these arguments applicant, further argues that the apparent admissions were not made in the Background section of the specification and/or that the applicant did not state in the specification that the features are “known”. These arguments are unconvincing because clearly the applicant in any patent application can admit prior art in different ways. A statement that something is “known” is not required. Moreover, and just as clearly, the admission need not be in the Background section of the patent application. Refer to the various admissions of prior art in the subject application including those in specification [041] that are not part of the Background section of the application specification.
Regarding the obviousness rejection of independent claim 1 the applicant appears to have anticipated that such a rejection might be made, based on the thrust of the applicant’s arguments. In any event the logic of applicant’s specific arguments is not understood. For example, applicant argues that there is a decrease in contact angles of somofilcon A and stenfilcon A contact lenses in HEC packaging solution as compared to the control packaging solution, whereas contact angles of contact lenses made with comfilcon A and omafilcon A increased when autoclaved in HEC packaging solution. This may be so, but applicant does not explain what this has to do with the obviousness of packaging somofilcon A and/or stenfilcon A lenses in HEC packaging solution, given that these types of lenses are conventional silicone hydrogel lenses. Nor does applicant explain how or why the decrease in contact angles negates applicant’s apparent admission in the application that it is prior art to package somofilcon A and/or stenfilcon A lenses in HEC solution and autoclave the package. Nor does the argument explain what the comparison with comfilcon A and omafilcon A would have to do with a potential rejection over Awasthi or with the knowledge to package any known silicone hydrogel lenses (whether somofilcon A, stenfilcon A, comfilcon A and/or omafilcon A and/or others) in known packaging solution and perform known autoclaving, as apparently admitted by applicant in the application record and as found to have been obvious over Awasthi at least in the case of somofilcon A and stenfilcon A .
THIS ACTION IS MADE FINAL. 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 JACOB K ACKUN whose telephone number is (571)272-4418. The examiner can normally be reached Monday-Thursday 11am-7pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at (571) 270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACOB K ACKUN/Primary Examiner, Art Unit 3736
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