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 .
DETAILED ACTION
The instant application having Application No. 18615784 filed on 03/25/2024 is presented for examination by the examiner.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Priority
As required by e M.P.E.P. 201.14(c), acknowledgement is made of applicant’s claim for priority based continuation of application #16403837 that is a Continuation of PCT/US2017/060950, filed 11/09/2017 that claims priority from Provisional application 62505017, filed 05/11/2017 and claims priority from Provisional Application 62421121, filed 11/11/2016.
Drawings
The applicant’s drawings submitted are acceptable for examination purposes.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11982880. Although the claims at issue are not identical, they are not patentably distinct from each other as outlined in the claims correspondence table below:
Instant application #18615784
U.S. Pat. # 11982880
Notes
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1
(*)
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9
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(*) The soluble insert material is the material that get dissolved as dissolved material, as photo decomposable material (see claim 19).
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1, 4-15, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Waite et al. (hereafter Waite, of record, see IDS dated 06/04/2024) US 20160004098 A1 in view of Petrash et al. (hereafter Petrash, of record, see IDS dated 06/04/2024) US 20140235553 A1.
In regard to independent claim 1, Waite teaches (see Figs. 1-7) a soft contact lens for correcting vision of an eye (soft contact lens e.g.100 with fluidic module 150, for improved optical correction, see Abstract, paragraphs [09-16, 36-41, 54-56, 82-99,121-125]), comprising:
a hydrogel contact lens body comprising water and cross-linked polymer (as soft contact lens hydrogel, including fluidic module 150 with central; 160 and peripheral 180 chambers, having faces of flexible distensible membrane(s) and channels, including cross linked polymers see e.g. abstract, paragraphs [10-12, 57, 96-97, 155-157]), wherein said contact lens body (100) defines an internal cavity (150, as 160, 180 and channels) formed by material, the internal cavity comprising a fluid (i.e. as fluidic module 150 with central chamber and peripheral chambers 180 with membrane material 162-166, and biocompatible fluid 190 in 100, 110, paragraphs [10-14, 89-102, 140], e.g. Figs. 1-4). But Waite does not explicitly disclose that cavity formed by dissolution of a soluble material that dissolved material is capable of diffusing through said cross-linked polymer of said hydrogel contact lens body.
However, Petrash teaches methods for introduction of macromolecules and nanoparticles into living cells (see e.g. Fig. 1-11, Title, Abstract, paragraphs [29, 53-63]) and further teaches that cavity formed by dissolution of a soluble material and said dissolved material is capable of diffusing through said cross-linked polymer of said hydrogel contact lens body (i.e. as solid carrier for eye treatment application in form of hydrophilic soft contact lenses(s) device with insert that is biodegradable and soluble, and such soluble ocular inserts can be composed of any degradable substance that can be tolerated by the eye such as poly(vinyl alcohol) (PVA), polymers and copolymers of polyacrylamide, ethylacrylate and vinylpyrrolidone, as well as cross-linked polypeptides or polysaccharides, that is diffusible through diffusible wall of polymer material(s) of soft contact lens, and that is compatible with the compound of the invention that is to be administered for eye treatment (see paragraphs [53-63]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the soluble material including, but not limited to PVA as cavity insert shaped material according to teachings of Petrash to the internal cavity (insert) shaped material of soft contact lens device of Waite in order to provide the hydrophilic soft contact lenses(s) device with biodegradable or soluble insert composed of degradable substance that can be tolerated by the eye and that is compatible with the eye treatment compound that is to be administered for eye treatment (see Petrash, paragraphs [53-63]).
Regarding claim 4, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said hydrogel contact lens body (i.e. body of soft contact lens 100, paragraphs [10-12, 57,155-157], as modified with Petrash paragraphs [53-63]) comprises internal surfaces defining the cavity (i.e. as surfaces of membranes of fluidic module 150 , paragraphs [54-56, 82-103]), said internal surfaces comprising internal surface structures defined with erosion of a material from within the cavity (i.e. as per combination with Petrash as insert is biodegradable of degradable substance, paragraphs [53-63]).
Regarding claim 5, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said hydrogel contact lens body (i.e. body of soft contact lens 100, paragraphs [10-12, 57,155-157], as modified with Petrash paragraphs [53-63]) comprises a first portion on a first side of the cavity and a second portion of the second side of the cavity with the cavity extending therebetween (i.e. as e.g. central or peripheral chambers between first/second portions of the 100, 110 with membranes, as depicted in e.g. Figs.1-4, paragraphs [10-14, 89-102, 140]), the first portion bonded to the second portion away from the cavity to contain fluid within the cavity and optionally wherein an interface of the first material bonded to the second material is detectable by dark field microscopy (i.e. as parts of bonded membranes 162-166, fluid e.g. 190 contained in chamber(s), paragraphs [98-103, 89-91]; note recitations connected with the term ”optionally” are treated as optional, as they are not positively recited).
Regarding claim 6, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said cross-linked polymer directly contacts liquid of the cavity (i.e. as optically transmissive materials and hydrogels directly contact liquid in 160, 180, paragraphs [10-12, 16, 26, 41-42, 95-103], e.g. Figs. 1-4).
Regarding claim 7, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said polymer comprises sufficient stiffness to retain a shape of an insert dissolved from within the lens body to form the cavity (i.e. as optically transmissive materials and hydrogels have sufficient stiffness for the cavity and dissolved insert allowing functionality of the soft contact lens 100, 110 with 190, in 160, 180, paragraphs [12, 41-42, 95-103], and due to combination including biodegradable, soluble insert, see Petrash, paragraphs [53-63]).
Regarding claim 8, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said dissolved material comprises a material of an insert dissolved to form the internal cavity (i.e. as dissolved insert material, for functionality of the soft contact lens 100, 110 with 190, in 160, 180, paragraphs [12, 41-42, 95-103], and due to combination including biodegradable material, soluble insert, see Petrash, paragraphs [53-63]).
Regarding claim 9, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said dissolved material comprises a material of an insert photo-decomposed to form the internal cavity (i.e. as per combination with Petrash where insert is biodegradable and soluble, and such soluble ocular inserts can be composed of any degradable substance that can be tolerated by the eye such as poly(vinyl alcohol) (PVA), polymers and copolymers of polyacrylamide, ethylacrylate and vinylpyrrolidone, as well as cross-linked polypeptides or polysaccharides, and is compatible with the compound of the invention that is to be administered for eye treatment (see paragraphs [53-63])..
Regarding claim 10, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said internal cavity comprises a shape profile corresponding to the dissolved insert (as fluidic module 150 chamber with central 160 chamber and peripheral chambers 180 with membrane material 162-166, and biocompatible fluid 190 in 100, 110, paragraphs [10-14, 89-102, 140], e.g. Figs. 1-4, formed due to combination including biodegradable material, soluble insert, see Petrash, paragraphs [53-63]).
Regarding claim 11, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that cavity comprises an optical portion configured to correct vision of the eye and a lower portion fluidically coupled to the optical portion (i.e. as the fluidic module 150 includes central chamber, reservoir for correcting eye vision 160 that is fluidically via channel(s) 172 connected to lower chamber(s) 180, paragraphs [82-84, 88-103]), and wherein the optical portion is configured to provide near vision correction when an eyelid engages the lower portion (i.e. as eyelid engages the eyelid chamber(s) 180 to provide near vision correction, abstract, paragraphs [11-14, 54-56, 112-114, 141]).
Regarding claim 12, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said polymer comprises a sufficient amount of cross-linking to retain fluid in the optical portion when the lower portion engages the eyelid to correct near vision of the eye (i.e. as optically transmissive materials and hydrogels have sufficient stiffness and cross-linking to retain fluid in 160, 180 when 180 is engaged with eyelid for the cavity for functionality of providing near vision correction, abstract, paragraphs [11-14, 41-42, 54-56, 95-103, 112-114, 141, 155]).
Regarding claim 13, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said contact lens body (100, 110) comprises one or more hinges coupled to said optical portion and said lower portion (i.e. as flanges coupled to 160 and 180, see paragraphs [10, 12, 32-34128-132, 136-139], e.g. Figs. 4A-C).
Regarding claim 14, the Waite-Petrash combination teaches the invention as set forth above, and Waite as modified teaches (see Figs. 1-7) that said cavity comprises one or more internal structures shaped with an erodible material (i.e. as due to combination with Petrash, interna structures of 150 including parts shaped with insert that is biodegradable or soluble, see paragraphs [10-14, 89-102, 140], e.g. Figs. 1-4, Petrash paragraphs [53-63]).
Regarding claim 15, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said polymer comprises hydrogel (i.e. as hydrogel material, paragraphs [12, 57, 155]).
Regarding claim 17, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said cavity comprises dissolved particles of differing sizes, with higher molecular weight particles being unable to diffuse through channels of the lens body and lower molecular weight particles diffuse out of the internal cavity (i.e. as per combination with Petrash where insert is biodegradable and soluble, and such soluble ocular inserts can be composed of any degradable substance that can be tolerated by the eye such as poly(vinyl alcohol) (PVA), polymers and copolymers of polyacrylamide, ethylacrylate and vinylpyrrolidone, as well as cross-linked polypeptides or polysaccharides, and is compatible with the compound of the invention that is to be administered for eye treatment, see paragraphs [53-63]. Although the Waite-Petrash combination does not specifically mention that higher molecular weight particles being unable to diffuse through channels of the lens body and lower molecular weight particles diffuse out of the internal cavity, this feature is seen to be an obvious or inherent teaching of that device since different size and molecular weight particles are present in dissolvable material as disclosed, and it is apparent that larger particles with higher (but unspecified) molecular wight would not diffuse through container/cavity wall, and moreover such features would be present for the device to function as intended (see paragraphs [10-14, 89-102, 140], e.g. Figs. 1-4; Petrash paragraphs [17,30,53-63]).
Regarding claim 19, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said soluble insert comprises a photo decomposable material. (i.e. as per combination with Petrash where insert is biodegradable and soluble, and such soluble ocular inserts can be composed of any degradable substance that can be tolerated by the eye such as poly(vinyl alcohol) (PVA), polymers and copolymers of polyacrylamide, ethylacrylate and vinylpyrrolidone, as well as cross-linked polypeptides or polysaccharides, and is compatible with the compound of the invention that is to be administered for eye treatment (see paragraphs [53-63]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Waite et al. (hereafter Waite, of record, see IDS dated 06/04/2024) US 20160004098 A1 in view of Petrash et al. (hereafter Petrash, of record, see IDS dated 06/04/2024) US 20140235553 A1, and further in view of Nicolson US 20090039535 A1.
Regarding claim 2, the Waite-Petrash combination teaches the invention as set forth above, and Waite teaches (see Figs. 1-7) that said cavity is shaped to correct vision when in equilibrium with tear fluid of the eye (i.e. as cavity 160 with fluid 190 is configured to correct eye vision while on tear fluid of the eye, and engaged with eye, or eyelid for such functionality of providing vision correction, abstract, paragraphs [11-14, 41-42, 54-56, 82-9595-103, 112-114, 141]). But the Waite is silent that said cross-linked polymer (optically transmissive materials and hydrogels, paragraphs [155]) allows water to diffuse in and out of the contact lens body to the cavity from an external surface of the body.
However, Nicolson teaches in the same field of invention of an extended wear ophthalmic lens (see Title, Abstract, paragraphs [03, 12-21, 63-67, 75-77]) and further teaches that cross-linked polymer allows water to diffuse in and out of the contact lens body to the cavity from an external surface of the body (i.e. as cross-linked ionoperm polymer allows water permeation between the front and base curves of the lens, abstract, paragraphs [49, 52, 68, 75, 82-86], as such polymeric materials provide balance of ion and oxygen permeability to maintain good corneal health, adequate movement of the lens on the eye and wearer comfort during extended wear periods (paragraphs [18-21, 75]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt and modify the polymer lens body material of Waite to include cross-linked ionoperm polymer that allows water permeation through the lens surfaces according to teachings of Nicolson, in order to provide balance of ion and oxygen permeability to maintain good corneal health, adequate movement of the lens on the eye and wearer comfort during extended wear periods (paragraphs [18-21, 75]).
Potentially Allowable Subject Matter
Claims 3, 16 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if double patenting rejections are overcome and if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten to overcome the double patenting rejection(s) noted above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bar-Or US 20120172294 A1 also discloses eye treatment and features of soft contact lenses with soluble, degradable insert (see paragraphs [91-100]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIN PICHLER whose telephone number is (571)272-4015. The examiner can normally be reached Monday-Friday 8:30am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas K Pham can be reached on (571)272-3689. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIN PICHLER/Primary Examiner, Art Unit 2872