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 .
CONTINUING DATA
This application is a 371 of PCT/KR2023/002353 02/17/2023
FOREIGN APPLICATIONS
KOREA, REPUBLIC OF 10-2022-0023811 02/23/2022
Claims 1-12 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 3-12 recite “high-molecular-weight hyaluronic acid.” The term “high” in claims 1 and 3-12 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification provides an exemplary molecular weight range 5.0 x 105 to 2.0 x 106 (page 11), but it is not a definition of “high.” Limitations from the specification are not read into the claims. Claim 2 depends from claim 1 and recites the molecular weight range 5.0 x 105 to 2.0 x 106. Because claim 2 depends from claim 1, the range recited in claim 2 is presumably narrower than the range encompassed by claim 1. It is unclear which molecular weight range is required to meet the limitation “high.”
Claims 1-12 recite a viscosity or an intrinsic viscosity, but do not recite the conditions under which the viscosity or intrinsic viscosity is measured. Viscosity or intrinsic viscosity depends on the conditions under which it is measured, so the meaning of viscosity or intrinsic viscosity in the claims is unclear.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aragona (TVST 2019, Vol. 8, No. 6).
Aragona teaches hyaluronic acid-based lubricant eye drops. See title. The eye drops are used to alleviate dry eye disease. Page 1, Introduction. Table 2 describes HA-based commercially available artificial tear solutions. Hylo-Comod contains 0.10% HA, has a molecular weight of 2026 kDa, and a standard viscosity of 13.2 cP. Hylo-Parin contains 0.10% HA, has a molecular weight of 1428 kDa, and a viscosity of 9.1 cP. Vismed Multi contains 0.18% HA, has a molecular weight of 918 kDa, and has a viscosity of 11.5 cP. All the products contained sodium, which is a tonicity regulator. An eye drop composition necessarily comprises a container for dispensing drops.
Claims 1-12 are product-by process claims. Page 8 of the current specification states that “high molecular weight hyaluronic acid structure” refers to a structure having a single polymer chain structure formed by applying shear stress to high-molecular-weight hyaluronic acid having a pair of polymer chain structures. In this instance, Aragona’s viscosity is determined under shear (Table 2). Furthermore, Aragona’s products contain HA which meets the structural limitations of the claims, so the product is the same regardless of how it was prepared. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added but is instead produced in-situ does not change the end product.). See MPEP 2113.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aragona (TVST 2019, Vol. 8, No. 6) as evidenced by Pashier (Opthalmol Ther (2024) 13:2799-2812).
Aragona teaches Vismed Mulit eye drops as set forth above but is silent about the intrinsic viscosity of the composition.
Pashier teaches that Vismed Multi eye drops have an intrinsic viscosity of 2.2 m3/kg. Table 2.
MPEP 2131.01 states that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date.
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aragona (TVST 2019, Vol. 8, No. 6) as evidenced by COMOD (The COMOD system – the safe solution for your eyes, internet article downloaded September 24, 2026, https://hylodryeye.net/comod-system/1000/).
Aragona teaches as set forth above but does not teach the volume of the drops dispensed by the eye drop formulation.
COMOD teaches that the COMOD system provides 300 drops in 10 ml. Page 3. This corresponds to 0.03 ml per drop.
MPEP 2131.01 states that the critical date of extrinsic evidence showing a universal fact need not antedate the filing date.
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.
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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aragona (TVST 2019, Vol. 8, No. 6) in view of Van Santvliet (Surv Ophthalmol 49:197–213, 2004.).
Aragona teaches as set forth above but is silent about the droplet size.
Van Santvliet teaches that eye drop volumes range from .025-.069 ml, and 0.05-.015 ml should be preferred. See page 197.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare eye drop formulations having a droplet size of 0.05-0.015 ml because Van Santvliet teaches that 0.05-0.015 ml is ideal from bioavailability and toxicological points of view.
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 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/838,139 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims HA which has a single polymer chain, has a molecular weight of 5.0 x 104 to 5.0 x 106 g/mol (claim 4) and a viscosity of 10 to 700 cP (claim 10), and an intrinsic viscosity of 0.1-2.0 m3/kg (claim 14). The ratio of a/b is 0.10 to 0.99 (claim 11). The concentration may be 0.1-2.0% (claim 10).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05. In the current instance, the claimed molecular weight range lies inside the reference molecular weight range. In the current instance, the claimed viscosity range overlaps with the reference viscosity range. In the current instance, the claimed intrinsic viscosity range overlaps with the reference intrinsic viscosity range. In the present instance, the claimed a/b ratio lies inside the reference a/b ratio. In the present instance, the claimed concentration range lies inside the reference concentration range.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
