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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 18, 2026, that includes a response to the Final Office Action mailed February 19, 2026, has been entered. Claim 1 has been amended; claims 3, 4, 6-9, 11-13, 15, 16, 20-25, 27-62, 64, and 69 have been canceled; and claims 76-81 have been newly added. Claims 2 and 26 have been withdrawn. Newly added claim 81 is hereby also withdrawn as being directed to a non-elected species of constituent which is excluded from the composition (the elected species is decorin). Claims 1, 2, 5, 10, 14, 17-19, 26, 63, 65-68, and 70-81 are now pending in the application.
Election/Restrictions – Original Presentation
Applicant is further required under 35 U.S.C. 121 to elect the following species to which the claims shall be restricted if no generic claim is finally held to be allowable:
1. A single disclosed species of requisite further constituent (e.g. pharmaceutically active agent, or a buffer comprising phosphate).
There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Since Applicant has received an action on the merits for the species of pharmaceutically active agent, this species has been constructively elected by original presentation for prosecution on the merits.
Accordingly, newly added claim 77 is hereby withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, Applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should Applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1, 5, 10, 14, 17-19, 63, 65-68, 70-76, and 78-80 are under examination.
Withdrawal of Prior Claim Objections
Claim 1 has been satisfactorily amended. Therefore, the objection to claim 1 presented in the Final Office Action mailed February 19, 2026 is hereby withdrawn.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 78 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 78 stipulates in a wherein clause that “the shear thinning hydrogel composition has an elastic modulus (G’) of 5 Pa to 200 Pa at zero shear between 20C and 30C”. Applicant points to paragraphs [0292] and [0304] in the original specification for support. Adequate support for this limitation is not found.
This constitutes new matter.
NEW GROUND OF REJECTION
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.
The factual inquiries 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.
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.
Claims 1, 5, 10, 14, 17-19, 63, 65-68, 70-76, and 78-80 are rejected under 35 U.S.C. 103 as being unpatentable over Grover et al. (U.S. Patent Application Pub. No. 2016/0045553), in view of Wu (U.S. Patent Application Pub. No. 2014/0112964), Abelson et al. (Review of Ophthalmology. 2017: pages 56-59), and Bialek et al. (U.S. Patent No. 6,136,363).
Applicant Claims
Applicant’s elected subject matter is directed to a shear-thinning hydrogel composition, in the form of microgel particles dispersed in an aqueous medium, comprising i) 0.5-1.35 wt%, or 0.9 wt%, gellan; and ii) 5-20 mM, or 10 mM, of NaCl; wherein the composition further comprises an active agent; wherein the elastic modulus (G’) is 5-200 Pa, or 5-40 Pa; wherein the pH is 3-8, or 7-7.5; wherein the viscosity is 5-200 Pa-s when exposed to zero shear, wherein the microgel particles have a “stranded” microstructure (i.e. the length is greater than the width); and wherein the hydrogel does not contain decorin.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Grover et al. disclose a shear-thinning hydrogel composition, in the form of microgel particles dispersed in an aqueous medium, the microgel particles comprising e.g. gellan gum and having e.g. a needle or threadlike microstructure (i.e. the length is greater than the width); and the aqueous medium is e.g. Dulbecco’s Modified Eagles Medium (DMEM) buffered by e.g. HEPES (i.e. the pH is thus commonly understood to be about 7-7.4); and wherein the hydrogel can further comprise an active agent, need not comprise decorin, and can be applied to tissues for the treatment of damage or disease (abstract; paragraphs 0005, 0006, 0009, 0010, 0018, 0019, 0021, 0023, 0039, 0043, 0044).
Wu discloses a hydrogel composition, in the form of microgel particles dispersed in an aqueous medium, comprising e.g. about 0.1-1 wt% gellan, and up to about 3 wt% NaCl, e.g. 0.1-3 wt% NaCl (i.e. up to about 500 mM NaCl, 0.1 wt% NaCl is about 17 mM NaCl, 0.05 wt% NaCl is about 9 mM NaCl); wherein the composition can further comprise an active agent; wherein the viscosity is 100-500,000 cps (i.e. 0.1-500 Pa-s); wherein the hydrogel does not necessarily contain decorin; and wherein the hydrogel can be topically applied to skin, hair, or other epithelial tissues (abstract; paragraphs 0005, 0012-0017, 0031, 0033).
Abelson et al. disclose that compositions for topical application to the corneal epithelium, which can be in the form of e.g. hydrogels and colloids, have a pH of 4.75-7.40 to minimize irritation of the ocular surface and other adverse effects.
Bialek et al. disclose a hydrogel composition, in the form of microgel particles dispersed in an aqueous medium; wherein the microgel particles can comprise gellan with Na+ ions, which combination of gellan with Na+ ions forms soft gels (i.e. soft gel particles); wherein the hydrogel has a viscosity of 1000-30,000 cps (i.e. 1-30 Pa-s); and wherein softgel particles (e.g. gellan with Na+ ions) have an elastic modulus G’ of 1-1,000 Pa with the assumption that the elastic modulus of quiescent hydrogels is the same, i.e. 1-1000 Pa, and that the elastic modulus of hydrogels made with shearing are at the lower end of this elastic modulus range since sheared gels are less rigid (abstract; Col. 1, lines 60-65; Col. 2, lines 58-60; Col. 3, lines 22-26; Col. 4, lines 4-18).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Grover et al. do not explicitly disclose that the gellan microgel particles comprise 0.5-1.35 wt% gellan; and 5-20 mM NaCl; that the the viscosity is 5-200 Pa-s; and that the elastic modulus (G’) is 5-200 Pa, or 5-40 Pa. These deficiencies are cured by the teachings of Wu, Abelson et al., and Bialek et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Grover et al., Wu, Abelson et al., and Bialek et al., outlined supra, to devise Applicant’s claimed hydrogel.
Grover et al. disclose a shear-thinning hydrogel composition, in the form of microgel particles dispersed in an aqueous medium, the microgel particles comprising e.g. gellan gum and having e.g. a needle or threadlike microstructure (i.e. the length is greater than the width); and the aqueous medium is e.g. Dulbecco’s Modified Eagles Medium (DMEM) buffered by e.g. HEPES, i.e. the pH is thus commonly understood to be about 7-7.4; and wherein the hydrogel can further comprise an active agent, need not comprise decorin, and can be applied to tissues for the treatment of damage or disease. Since Wu discloses that a hydrogel composition, in the form of microgel particles dispersed in an aqueous medium and containing an active agent, suitable for topical application to skin, hair, or other epithelial tissues for treatment of damage or disease, can have microgel particles comprising e.g. about 0.1-1 wt% gellan, and up to about 3 wt% NaCl, e.g. 0.1-3 wt% NaCl; and a viscosity of 100-500,000 cps (i.e. 0.1-500 Pa-s); since Abelson et al. disclose that compositions for topical application to the corneal epithelium, which can be in the form of e.g. hydrogels and colloids, have a pH of 4.75-7.40 to minimize irritation of the ocular surface and other adverse effects; and since Bialek et al. disclose that a hydrogel composition with a viscosity of 1000-30,000 cps (i.e. 1-30 Pa-s), in the form of microgel particles dispersed in an aqueous medium, wherein the microgel particles comprise gellan with Na+ ions, form soft gels (i.e. soft gel particles), and wherein softgel particles (e.g. gellan with Na+ ions) have an elastic modulus G’ of 1-1,000 Pa with the assumption that the elastic modulus of quiescent hydrogels is the same, i.e. 1-1000 Pa, and that the elastic modulus of hydrogels made with shearing are at the lower end of this elastic modulus range since sheared gels are less rigid; one of ordinary skill in the art would thus be motivated to employ gellan microgel particles comprising specifically about 0.1-1 wt% gellan, and up to about 3 wt% NaCl, e.g. 0.1-3 wt% NaCl in the Grover hydrogel, such that the viscosity is e.g. 1-30 Pa-s and the elastic modulus G’ is 1-1,000 Pa, with the reasonable expectation that the resulting hydrogel, with a physiological pH (i.e. about 7-7.4) can be successfully applied to cornea or other epithelial surfaces for treatment of damage or disease.
Since the composition one of ordinary skill in the art would thus arrive at is this not patentably distinct from the claimed composition, with the same concentrations of the gellan gum and NaCl, and viscosity and G’ values that overlap the claimed values, the properties of the composition must be effectively the same as well, including the mechanistic effects if applied to a human dermal fibroblast cell or to a cornea.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed March 18, 2026 have been fully considered but they are mostly moot in view of the new grounds of rejection. However, the following arguments pertaining to Wu are addressed:
i) Applicant contends that “Wu is entirely silent as to the elastic modulus of the disclosed compositions”, and that “Wu teaches away from the claimed composition” because Wu teaches that inclusion of “one or more surfactants” in the hydrogel composition results in “improved stability as compared to other comparable compositions” and that “surfactant is not recited in amended claim 1”.
The Examiner, however, would like to point out the following:
1. Wu is not being relied on for disclosing the elastic modulus. Wu is merely a secondary reference being relied on for disclosing that gellan microgel particles can be made specifically from 0.1-1 wt% gellan, and up to about 3 wt% NaCl, e.g. 0.1-3 wt% NaCl. No doubt it would reasonably be expected that a hydrogel with such gellan microgel particles can be successfully applied to tissues for treatment of disease. Bialek teaches that microgel particles comprising gellan and Na+ ions form soft gels (i.e. soft gel particles) with an elastic modulus G’ of 1-1,000 Pa, with the assumption that the elastic modulus of quiescent hydrogels is the same, i.e. 1-1000 Pa, and that the elastic modulus of hydrogels made with shearing are at the lower end of this elastic modulus range since sheared gels are less rigid. Since Grover’s hydrogel is made via shearing, and employing gellan microgel particles made from gellan and N+ ions in view of Wu, the reasonable assumption is that the elastic modulus G’ will be at the lower end of this range, e.g. 5-200 Pa.
2. The present claims do not necessarily exclude a surfactant. Grover’s hydrogel neither requires a surfactant for stability, nor excludes a surfactant that may provide enhanced stability. At any rate, Wu is merely a secondary reference being relied on for disclosing that gellan microgel particles, such as disclosed in Grover, can be made specifically from 0.1-1 wt% gellan, and up to about 3 wt% NaCl, e.g. 0.1-3 wt% NaCl. Grover provides that gellan microgel particles are suitable, and no surfactant is required, for a hydrogel that can be applied to tissues to treat disease. Wu’s hydrogel, which also includes gellan microgel particles, and also a surfactant, likewise are suitable for application to tissues to treat disease. It would thus appear that the surfactant is not necessary for a hydrogel containing gellan microgel particles to be applied to tissue to treat disease. Hence, employing Wu’s gellan microgel particles (i.e. gellan with Na+ ions) in Grover, either with or without the surfactant, would reasonably be expected to result in a hydrogel that can be applied to tissues to treat disease. The surfactant would not frustrate the purpose of Grover.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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