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 examiner has considered the reply filed by applicants on October 27, 2025. Applicant’s arguments were not found to be persuasive; as such the following rejections have been maintained.
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.
Claim(s) 27-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muller-Lierheim et al. (WO 2018/069763).
The claims are drawn to an ophthalmic drug-delivery system comprising high molecular weight hyaluronic acid (HMWHA) fluid and a bioactive agent, wherein the hyaluronic acid has an intrinsic viscosity of at least 2.5 m3/kg, and wherein the fluid is capable of transporting the bioactive agent into the eye. The claims are also drawn to a method for delivering a bioactive agent into the eye, by topically co-administering HMWHA fluid and a bioactive agent to the ocular surface of a human or animal subject.
Muller-Lierheim et al. teach a method for reducing or delaying the onset of irritation, discomfort, inflammation, and/or immune response at the ocular surface by topically administering a fluid comprising HMWHA to the ocular surface of the eye of a human or non-human animal subject, wherein the HMWHA has an intrinsic viscosity of greater than 2.5 m3/kg and a concentration of less than 0.2% w/v (abstract).
The reference further teaches that the condition affecting the eye may be caused by a wound, including from ocular surgery, including glaucoma surgery; from an allergy of the eye, e.g. non-infectious, or infectious keratoconjunctivitis; or autoimmune disease (pages 6-7).
The reference does not specifically require a bioactive agent, as required in the instant claims; however, it does teach that the HMWHA-containing fluid may optionally, further include one or more bioactive agents, including, inter alia, a drug molecule or biologic, such as steroids, antibiotics, beta blockers, prostaglandin analogs, etc. (page 7-8).
The instant claims are rendered obvious by Muller-Lierheim et al., since the reference specifically teaches a method for reducing or delaying the onset of irritation, discomfort, inflammation, and/or immune response at the ocular surface by topically administering a fluid comprising HMWHA to the ocular surface of the eye of a human or non-human animal subject, wherein the HMWHA has an intrinsic viscosity of greater than 2.5 m3/kg; and, the reference teaches that a bioactive agent may be included in the HMWHA-containing fluid.
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 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 44, 45, and 51-53 of copending Application No. 18/002,682 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to an ophthalmic composition comprising hyaluronic acid and at least one active ingredient comprising a prostaglandin analog (bioactive agent), wherein the hyaluronic acid acts as a transporter of the prostaglandin analog into the eye. The reference application also teaches the hyaluronic acid having an intrinsic viscosity that encompasses the viscosity recited in the instant claims, and having a molecular weight of at least 3 million Daltons, making HMWHA.
The claims of the reference application encompass the scope of the instant claims, thereby rendering the instant claims obvious over the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 19, 20, 22, and 26 of copending Application No. 17/309,463 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method for relieving idiopathic ocular pain by topically administering a fluid containing hyaluronic acid having an intrinsic viscosity of greater than 2.5 m3/kg and a concentration of less than 0.2% w/v to the eye of a human or non-human animal subject. According to claims of the reference application, the fluid may further comprise a bioactive agent, and comprises hyaluronic acid having a molecular weight of at least 3 million Daltons, making HMWHA.
The claims of the reference application encompass the scope of the instant claims, thereby rendering the instant claims obvious over the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 79-89 of copending Application No. 17/048,436 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to a method for restoring or replenishing hyaluronic acid within the epithelium by topically administering HMWHA having an intrinsic viscosity of greater than 2.9 m3/ kg to the epithelial surface of the subject. The composition may further comprise a bioactive agent.
The claims of the reference application encompass the scope of the instant claims, thereby rendering the instant claims obvious over the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive. Applicants argue that the reference is silent in regard to the capability of the HMWHA fluid being able to transport a bioactive agent to the eye, and that “speculative and tentative disclosure of what might or may lead to” a specific result does not sufficiently direct or instruct one of skill in this art.
The ability of the HMWHA fluid to transport a bioactive agent to the eye is an inherent characteristic of the HMWHA fluid itself, and the fluid possesses such an ability whether or not expressly mentioned by the reference. The reference actually teaches the advantage of HMWHA fluid when including a bioactive agent, as the latter can alleviate and/or protect the eye from irritative and/or damaging effects of the bioactive agent (p 8, lines 12-16). Therefore, the examiner contends that the rejection under 35 U.S.C. 103 is proper.
Applicants have not provided any material arguments to the provisional non-statutory double patenting rejections of record, and no amendments have been made to the claim in the present invention; as such, these rejections are also maintained.
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 SIKARL A WITHERSPOON whose telephone number is (571)272-0649. The examiner can normally be reached M-F 9am-9pm IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIKARL A WITHERSPOON/Primary Examiner, Art Unit 1692