-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 .
Applicant’s response dated January 13, 2026 is acknowledged.
Priority
This application is a continuation of 15/319,014 filed on 12/15/2016, which is a 371 of PCT/IL2015/050605 filed on 06/15/2015, which claims benefit in provisional application 62/012,379 filed on 06/15/2014.
Claim Status
Claims 1-29 are pending. Claims 1-8 and 20-29 are withdrawn. Claims 9-19 are examined.
Election/Restriction
Applicant’s election of Group II (Claims 9-19), drawn to a kit, in the reply filed on January 13, 2026, is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1-8 and 20-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of November 13, 2026 was timely filed.
Claims 9-19 are examined on the merits.
Information Disclosure Statement
In IDS dated 02/05/2024, foreign patent document citated under number 49 and non-patent literature document cited under number 57 were not considered because applicant did not provide a copy of these documents to the Office.
In IDS dated 02/05/2024, non-patent literature citation number 121 was amended to include “English language Abstract” because the abstract is the only part of the document that was considered because it is in English.
In IDS dated 02/05/2024, non-patent literature citation under number 138 author name “Ogsten” was amended because the name is misspelled. The name on the reference is “Ogston”.
Double Patenting Rejections
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 9, 10, 11, 16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,883,533 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1 and 3 are drawn to a kit comprising at least one water-soluble polymer, liposome, and an aqueous carrier, wherein the concentration of phospholipids of said liposomes in the solution is in the range of from 0.5 mM to 500 mM and a method of treating ocular discomfort by applying said contact lens and said composition to subject, respectively, which anticipate instant claim 9.
Instant claim 10 is anticipated by patented claims 4 and 10 because patented claims require the contact lens to comprises a hydrogel surface.
Instant claim 16 is anticipated by patented claims 1 and 3 because patented claims require an aqueous carrier, which is an ophthalmically acceptable carrier.
Instant claim 19 is anticipated by patented claim 2 because the patented claim requires the contact lens to be immersed in the solution.
Claim 11 is anticipated by patented claim 7, which requires the composition to further comprise an ionic polymer.
Claims 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,883,533 B2, as applied to claims 9, 10, 11, 16, and 19, above, and further in view of Zhou (CN 101332308 A Published December 31, 2008 – English language machine translation appended thereto).
Patented claims are relied upon as summarized above, however the claims do not teach an anionic polymer or hyaluronic acid.
The teachings Zhou are related to a contact lens solution comprising sodium hyaluronate as a moisturizing component (Abstract). It was found that hyaluronic acid can form a hydrated layer on the contact lens surface, which can provide a unique and effective lubricity to contact lens, and can safely be sterilized and will not lose their lubricating effect together with the lens. Contact lenses solution contains moisturizing ingredient and water containing sodium
hyaluronate; the moistening component with 0.1 to 0.3 wt % in each liter of solution present in
the packaging solution, and enhances the comfort of contact lenses when placed in the eye of the wearer (second page of the translation).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the solution in patented claims by adding sodium hyaluronate as the water-soluble polymer, with a reasonable expectation of success because patented claims require a water-soluble polymer in the solution and it was known from Zhou that sodium hyaluronate is a suitable polymer for use in contact lens solutions. The selection of a known material based on its suitability for its intended purpose supports obviousness. One of skill would have been motivated to do so because Zhou teaches that sodium hyaluronate has moisturizing and lubricating effect on contact lenses enhancing the comfort when placed on the eye of wearer. Sodium hyaluronate meets the limitations of claims 11-13 because sodium hyaluronate is water-soluble ionic polymer.
Claims 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,883,533 B2, as applied to claims 9, 10, 11, 16, and 19, above, and further in view of Zhou and Guo (Patent 4,818,537 Date of Patent April 4, 1989).
Patented claims do not teach limitations of claims 12-15.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the solution in patented claims by adding sodium hyaluronate as the water-soluble polymer, with a reasonable expectation of success because patented claims require a water-soluble polymer in the solution and it was known from Zhou that sodium hyaluronate is a suitable polymer for use in contact lens solutions. The selection of a known material based on its suitability for its intended purpose supports obviousness. One of skill would have been motivated to do so because Zhou teaches that sodium hyaluronate has moisturizing and lubricating effect on contact lenses enhancing the comfort when placed on the eye of wearer. Sodium hyaluronate meets the limitations of claims 11-13 because sodium hyaluronate is water-soluble ionic polymer.
Regarding instant claim 15, patented claims do not teach the chemical compositions of liposomes. It would have been obvious to have formed the liposomes from 70-85 mole percent of phosphatidylcholine and 15-30 mole percent of benzyldimethylstearylammonium chloride, with a reasonable expectation of success because it was known from Gou that liposomes having a lipid composition of 70-85 mole percent of phosphatidylcholine and 15-30 mole percent of benzyldimethylstearylammonium chloride are useful for treating dry eye (Abstract). The claimed range is obvious because it encompasses 70-85 mole percent.
Regarding claim 14, patented solution modified in view of Zhou and Guo comprises sodium hyaluronate, which is an anionic water-soluble polymer, and liposomes formed from phosphatidycholine and benzyldimethylstearylammonium chloride. It would have been reasonable to expect the surface of the liposomes to have a positive charge because Guo teaches that the liposomes have a charged surface component where benzyl/aliphatic chain amine is anchored in the liposome bilayer by virtue of its aliphatic chain and benzyl groups and is positively charged at a pH between about 6.2 and 6.8 (column 4 lines 52-68). The charged, amine-containing liposomes show little or no eye irritation (column 5 lines 52-30). This embodiment meets the limitations of claim 14 because the positively charged surface of the liposomes has an opposite sign of a net charge of sodium hyaluronate, which is anionic.
Claims 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,883,533 B2, as applied to claims 9, 10, 11, 16, and 19, above, and further in view Jessen (Patent Number 4,925,017 Date of Patent May 15, 1990).
Patented claims do not teach how the contents of the kit are arranged.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have packaged the solution and the contact lenses in the patented kit separately, with a reasonable expectation of success because it was known from Jessen that contact lenses and a solution for contact lenses may be packaged separately in a kit. FIG. 1 of Jessen illustrates a lens storage kit 10 comprising: a storage case 12 having a base 14 with a bottle storage area 16 upon which at least one removably mounted bottle 18 containing contact lens cleaning and lens storage area 16 upon which a pair of open topped storage cups 20 are attached and structured to accommodate and separately hold a pair of contact lenses. A pair of removable caps 22 are attached with flexible members 24 to the base 14. The caps 22 are sized and structured to secure and fluid seal the opening of each respective storage cup 20 to hold within said cup a contact lens and various types of lens cleaning and storage contact lens solutions. The bottle 18 is held within the storage area 16 by a ridge 26 attached to the base 14 forming an open topped compartment into which the bottle 18 is placed. The caps 22 have flaps 28 which extend beyond the cups 20 when sealed, to secure the bottle 18 within the storage area (column 7 lines 8-28). Jessen does not limit where the lenses are stored prior to use, therefore it would have been obvious to have stored the lenses in the storage cups 20 or another suitable container for storing lenses. Either of these embodiments meets the claimed limitation that requires the lenses to be stored separately from the solution. The bottle 18 reads on a container configured for dispensing a solution required by claim 18. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Claims 9, 10, and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,274,786 B2 in view of Jessen (Patent Number 4,925,017 Date of Patent May 15, 1990).
Patented claims are drawn to a method of reducing a friction coefficient of a surface of a contact lens, the method comprising rinsing and/or immersing the contact lens in a solution comprising at least one water-soluble polymer, liposomes, and an aqueous carrier, wherein said at least one water-soluble polymer comprises a non-ionic polymer, and an average molecular weight of said at least one water-soluble polymer is in a range of from 3 kDa to 10 MDa, and wherein a concentration of phospholipids of said liposomes in the solution is in a range of from 0.5 mM to 500 mM.
Patented method does not teach a kit comprising the contact lenses and the solution.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the contact lenses and the solution in a kit wherein each is packaged separately, with a reasonable expectation of success because it was known from Jessen that contact lenses and a solution for contact lenses may be organized in a kit wherein each is packaged separately. FIG. 1 of Jessen illustrates a lens storage kit 10 comprising: a storage case 12 having a base 14 with a bottle storage area 16 upon which at least one removably mounted bottle 18 containing contact lens cleaning and lens storage area 16 upon which a pair of open topped storage cups 20 are attached and structured to accommodate and separately hold a pair of contact lenses. A pair of removable caps 22 are attached with flexible members 24 to the base 14. The caps 22 are sized and structured to secure and fluid seal the opening of each respective storage cup 20 to hold within said cup a contact lens and various types of lens cleaning and storage contact lens solutions. The bottle 18 is held within the storage area 16 by a ridge 26 attached to the base 14 forming an open topped compartment into which the bottle 18 is placed. The caps 22 have flaps 28 which extend beyond the cups 20 when sealed, to secure the bottle 18 within the storage area (column 7 lines 8-28). Jessen does not limit where the lenses are stored prior to use, therefore it would have been obvious to have stored the lenses in the storage cups 20 or another suitable container for storing lenses. Either of these embodiments meets the claimed limitation that requires the lenses to be stored separately from the solution. Combining prior art elements according to known methods to obtain predictable results supports obviousness.
Instant claim 9 is obvious because patented solution comprise at least one water-soluble polymer, liposomes, and an aqueous carrier, wherein a concentration of phospholipids of said liposomes in the solution is in a range of from 0.5 mM to 500 mM.
Instant claim 10 is obvious over patented claim 2 because patented claim requires the contact lens to comprise a hydrogel surface.
Instant claim 15 is obvious over patented claim 7 because the patented claim requires a molar percentage of phosphatidylcholine in said liposomes of at least 50%.
Instant claim 16 is obvious over patented claim 11 because the patented claim requires the carrier to be an ophthalmically acceptable carrier.
Instant claim 17 is obvious because patented claims modified in view of Jessen require a kit where the solution is packaged separately from the contact lenses.
Instant claim 18 is obvious because the bottle 18 reads on a container configured for dispensing a solution.
Instant claim 19 is obvious because it would have been obvious to immerse the contact lenses into the solution in order to treat the lenses because Jessen teaches to utilize the storage kit, the caps 22 are opened, releasing the bottle 18, the bottle 18 is then removed and opened to treat the user's contact lenses and fill the storage cups 20, and the contact lenses are then placed within each respective cup 20, and sealed therein with the caps 22 (column 7 lines 28-33).
Claims 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,274,786 B2, as applied to claims 9, 10, and 15-19, above, and further in view of Zhou and Guo (Patent 4,818,537 Date of Patent April 4, 1989).
Patented claims do not teach limitations of claims 11-14.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the solution in patented claims by adding sodium hyaluronate as the water-soluble polymer, with a reasonable expectation of success because patented claims require a water-soluble polymer in the solution and it was known from Zhou that sodium hyaluronate is a suitable polymer for use in contact lens solutions. The selection of a known material based on its suitability for its intended purpose supports obviousness. One of skill would have been motivated to do so because Zhou teaches that sodium hyaluronate has moisturizing and lubricating effect on contact lenses enhancing the comfort when placed on the eye of wearer. Sodium hyaluronate meets the limitations of claims 11-13 because sodium hyaluronate is water-soluble ionic polymer.
Regarding instant claim 14, patented claims do not teach the surface charge of the liposomes. It would have been obvious to have formed the liposomes from 70-85 mole percent of phosphatidylcholine and 15-30 mole percent of benzyldimethylstearylammonium chloride, with a reasonable expectation of success because it was known from Gou that liposomes having a lipid composition of 70-85 mole percent of phosphatidylcholine and 15-30 mole percent of benzyldimethylstearylammonium chloride are useful for treating dry eye (Abstract). Patented solution modified in view of Zhou and Guo comprises sodium hyaluronate, which is an anionic water-soluble polymer, and liposomes formed from phosphatidycholine and benzyldimethylstearylammonium chloride. It would have been reasonable to expect the surface of the liposomes to have a positive charge because Guo teaches that the liposomes have a charged surface component where benzyl/aliphatic chain amine is anchored in the liposome bilayer by virtue of its aliphatic chain and benzyl groups and is positively charged at a pH between about 6.2 and 6.8 (column 4 lines 52-68). The charged, amine-containing liposomes show little or no eye irritation (column 5 lines 52-30). This embodiment meets the limitations of claim 14 because the positively charged surface of the liposomes has an opposite sign of a net charge of sodium hyaluronate, which is anionic.
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617