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
This Office Action is in response to Applicants’ Amendment and Remarks filed on 6/23/2026 in which claims 1, 4 and 5 are amended and claim 22 is newly added.
Claims 1-22 are pending in the instant application and are examined on the merits herein.
Priority
The application is a continuation-in-part of application 18/654457, now US 12,440,510, filed on 5/3/2024, which is a continuation-in-part of application 18/555982, now US 12,310,981, filed on 10/18/2023, which is the National Stage entry of PCT/US2022/027177 filed on 5/1/2022, which claims priority to provisional application 63/186747 filed on 5/10/2021. With respect to claims 1-4 and 8-17, the only priority document that contains support for the claim 1 limitation of chondroitin sulfate being 0.1-2.5% wt/wt is 18/654457. Therefore, the effective filing date of claims 1-4 and 8-17 is 5/3/2024. With respect to claims 5-7 and 18-21, none of the priority documents contain support for the claim 5 limitation of the viscosity being 1-25 cps . Therefore, the effective filing date of claims 5-7 and 18-21 is 9/15/2025.
Withdrawn Rejections
Applicant’s amendment, filed on 6/23/2026, with respect to the rejection of claim 4 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant amended the claims to replace a trademarked name with a common chemical name. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 6/23/2026, with respect to the rejection of: Claims 1, 3, 5 and 6 under 35 U.S.C. 103 as being unpatentable over Funayama et al. (US 2017/0368093A1); and
Claim 2 under 35 U.S.C. 103 as being unpatentable over Funayama et al. (US 2017/0368093A1), in view of Lindstrom et al. (US 9,233,123; 2016), has been fully considered and is persuasive. Funayama does not teach a non-crosslinked chondroitin sulfate and Lindstrom does not remedy the deficiency of Funayama. The rejections are hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) or modified rejections necessitated by Applicants' amendment, filed on 6/23/2026, wherein instant independent claim 1 are amended to alter the breadth and scope of the claim, and claim 22 is newly added, wherein the remaining pending claims depend from said independent claims. Therefore, new grounds of rejection have been made or rejections from the previous Office Action have been modified.
Modified Rejections
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Melles et al. (US 2020/0093941A1, reference of record).
Melles discloses a staining composition for administration to the eye comprising hyaluronic acid and another viscosity increasing compound, namely chondroitin sulfate at 0.05-0.5 wt% and a dye, where the composition has a preferred viscosity in the range 2-20 mPa•s (1 mPa•s = 1 centipoise). (¶0039-0040) Melles further discloses that the staining composition may be delivered as an eye drop. (¶0009)
Melles does not exemplify of claim a composition comprising chondroitin sulfate. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select chondroitin sulfate from among the list of functionally equivalent viscosity modifying agents, taught by Melles, thereby arriving at the instant invention.
With respect to claims 1 and 5 and the limitation that the composition comprises “an eye dropper bottle or an eye dropper dose vial”, this limitation is an obvious modification of Melles. Because Melles teaches that the composition may be in the form of an eye drop, one of ordinary skill recognizes that to deliver an eye drop requires a device capable of doing so, of which an eye dropper bottle is the most common and has been available since antiquity.
With respect to claims 1 and 5 and the limitation that the composition is “for treating optical pain or discomfort”, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
With respect to claim 1 and the limitation that the viscosity is “about the same as water”, the specification states at ¶0029 that, “formulation containing chondroitin sulfate has a viscosity about the same as water (e.g. 1-25 cps preferably 1-5 cps)”. Thus, the viscosity values of the prior art are considered to meet the limitation “about the same as water” based on the specification guidance.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Melles, has been fully considered but is not persuasive.
Applicant argues that Melles is not directed to using the disclosed composition for treating ocular pain or discomfort and that the preamble of claim 1 stating “for treating optical pain or discomfort” breathes life, meaning and vitality to the claims which distinguishes it from the eye staining composition of Melles.
Applicants’ argument is not persuasive because the Office maintains that the preamble of claim 1 merely recites an intended use, which would necessarily be met by the prior art composition. Not only does the prior art composition satisfy all structural imitations of the claim, the composition is suitable for direct delivery to the eye of a subject. It has been decided that, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) In addition, to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431. (MPEP § 2111.02)
The rejection is still deemed proper and is maintained.
Claims 1, 3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ando et al. (US 2025/0228887A1, filed 2021, reference of record).
Ando discloses an eye drop composition, in an eye drop bottle/container, comprising chondroitin sulfate at 0.5 wt%, potassium chloride at 0.45%, sodium phosphate dibasic at 0.15% and sodium dihydrogen phosphate at 0.1%, where the composition has a most preferred viscosity in the range 1.5-10 mPa•s (1 mPa•s = 1 centipoise). (¶0137, 0433, 0470, 0479; Table 27, Example 15) Ando further discloses that the eye drop composition may contain other additives/excipients, including dextran, glycerin and pluronic F-127. (¶0290, 0424)
Ando does not cite that the exemplified composition has a viscosity in the range instantly claimed. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the viscosity of any of the compositions of Ando to be in the range 1.5-10 mPa•s, because Ando suggests that this is the most preferred viscosity range, thereby arriving at the instant invention.
With respect to claims 1 and 5 and the limitation that the composition is “for treating optical pain or discomfort”, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
With respect to claim 1 and the limitation that the viscosity is “about the same as water”, the specification states at ¶0029 that, “formulation containing chondroitin sulfate has a viscosity about the same as water (e.g. 1-25 cps preferably 1-5 cps)”. Thus, the viscosity values of the prior art are considered to meet the limitation “about the same as water” based on the specification guidance.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicants’ response with respect to the rejection over Ando, has been fully considered but is not persuasive.
Applicant argues that Ando is not directed to using the disclosed composition for treating ocular pain or discomfort and that the preamble of claim 1 stating “for treating optical pain or discomfort” breathes life, meaning and vitality to the claims which distinguishes it from the composition for reducing eye dryness of Ando.
Applicants’ argument is not persuasive because the Office maintains that the preamble of claim 1 merely recites an intended use, which would necessarily be met by the prior art composition. Not only does the prior art composition satisfy all structural imitations of the claim, the composition is suitable for direct delivery to the eye of a subject suffering from discomfort due to dry eye. It has been decided that, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) In addition, to satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431. (MPEP § 2111.02)
The rejection is still deemed proper and is maintained.
Claims 2, 4 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Ando et al. (US 2025/0228887A1, filed 2021, reference of record), in view of Lindstrom et al. (US 9,233,123; 2016, IDS).
The disclosure of Ando is referenced as discussed above. Ando does not teach that the eye drop composition specifically comprises dextran-70.
Lindstrom discloses a composition, prepared as eye drops, for ophthalmic use comprising chondroitin sulfate at 0.1-5.0%, glycerol at 0.1-5.0% and dextran at 0.1-10%, where dextran may be dextran-70. (Example 2; Col. 4, Ln 16-33; Col. 3, Ln. 49)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Ando could be select dextran-70 as a species of the dextran taught by Ando, there by arriving at the instant invention. Ando suggests that the composition may contain ophthalmically acceptable additives, including dextran. Lindstrom teaches that dextran-70 is known in the field of eye drops to be an effective additive. Thus, one would expect selecting dextran-70 as a dextran species in the composition of Ando would be reasonable based on the teaching of Lindstrom.
With respect to the claimed amount of components, the prior art range overlaps the instant range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
With respect to claim 22, the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). However, for the purposes of searching for and applying prior art under 35 U.S.C. § 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. (see also MPEP § 2111.03) In the instant case, there is no clear indication either in the specification or in the claims, which additional components are excluded, in order to aid in determining the scope of the phrase "consisting essentially of". Therefore, the teachings of the cited prior art are within the scope of the instant claims.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant argues that the combined prior art does not render the independent claims prima facie obvious for the reasons outlined above, thus the rejection of dependent claims that reply on the teachings of said combined prior art, should be withdrawn. Applicants' arguments are not persuasive because the rejection of the independent claims is maintained as prima facie obvious over said combined prior art, as per the response to arguments above.
The rejection is still deemed proper and is maintained.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 8-21 of the instant application are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over US 12,440,510. Although the conflicting claims are not identical, they are not patentably distinct from each other because: 1) With respect to claims 8-17, the only difference between the instant claims and those of ‘510 are that the instant claims require the presence of an eye dropper container in the composition. However, because the claims of ‘510 are directed to administering eye drops, the inclusion of an eye dropper container to house the eye drop composition is an obvious variant of ‘510. One of ordinary skill recognizes that to deliver an eye drop requires a device capable of doing so, of which an eye dropper bottle is the most common and has been available since antiquity; 2) With respect to claims 18-21, in addition to the points in 1) above, the instant claims and those of ‘510 differ in that the instant claims recite a numerical viscosity range whereas the claims of ‘510 recite “viscosity about the same as water”. The specification states at ¶0029 that, “formulation containing chondroitin sulfate has a viscosity about the same as water (e.g. 1-25 cps preferably 1-5 cps)”. Thus, one of ordinary skill in the art reading the instant claims in light of the specification, would conclude that a viscosity range of 1-25 cps is equivalent to “viscosity about the same as water”. Therefore, the instant claims are an obvious variant of the claims of ‘510 that also recite “viscosity about the same as water”.
Response to Arguments
Applicants’ response with respect to the double patenting rejections over US 12,440,510, has been fully considered.
Applicant responds to the provisional double patenting rejections requesting that the rejections be held in abeyance should patentability hinge on the double patenting rejections alone. Applicants’ request is improper because filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary to overcome a provisional obvious type double patenting rejection. Obvious type double patenting rejections may not be held in abeyance because they are not related to objections or requirements “as to form”. (MPEP § 804) The rejection is still deemed proper and maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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