DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 January 2026 has been entered.
This Office Action is in response to Applicant’s Amendment and Remarks filed on 27 January 2026 in which claim 1 was amended to change the scope and breadth of the claims.
Claims 1-20 are pending in the current application. Claims 12-15 remain withdrawn as being drawn to a non-elected invention. Claims 1-11 and 16-20 are examined on the merits herein.
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 .
New Rejections
The following are new ground(s) or modified rejections.
Claim Rejections - 35 USC § 112(a), New Matter
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.
Claims 1-11 and 16-20 are 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.
Applicant’s amendment with respect to the amended claim 1 has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the range “wherein said arabinogalactan is present in an amount more than twice that of said hyaluronic acid”.
The specification as originally filed discloses the concentration of hyaluronic acid in the solutions ranges from 0.1% to 0.5% w/w (p.11), and the concentration of arabinogalactan ranges from 0.30% to 1.00% w/w (p.12). Relative to hyaluronic acid, arabinogalactan is present in amounts 2-10 times the amount of hyaluronic acid.
The specification fails to disclose the claimed composition “wherein said arabinogalactan is present in said composition in an amount more than twice that of said hyaluronic acid”. The recitation “at least” causes the claim to read literally on embodiments outside the 2-10 times limitation, which does not have support in the instant specification.
See MPEP 2163.05, section III: "With respect to changing numerical range limitations, the analysis must take into account which ranges one skilled in the art would consider inherently supported by the discussion in the original disclosure. In the decision in In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), the ranges described in the original specification included a range of “25%- 60%” and specific examples of “36%” and “50%.” A corresponding new claim limitation to “at least 35%” did not meet the description requirement because the phrase “at least” had no upper limit and caused the claim to read literally on embodiments outside the “25% to 60%” range, however a limitation to “between 35% and 60%” did meet the description requirement.””
The court of In re Curtis held that “a patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when… the evidence indicates ordinary artisans could not predict the operability …..of any other species.” (see In re Curtis 354 F.3d 1347, 69 USPQ2d 1274, Fed. Cir. 2004).
Consequently, there is nothing within the instant specification which would lead the artisan in the field to believe that Applicant was in possession of the invention as it is now claimed. See Vas-Cath Inc. v. Mahurkar, 19 USPQ 2d 1111, CAFC 1991, see also In re Winkhaus, 188 USPQ 129, CCPA 1975.
Response to Arguments
Applicant's arguments filed 27 January 2026 have been fully considered but they are not persuasive.
As noted in the previous Remarks, while the data provided in DiMola et al. and Silvani et al. show a 3:1 ratio of arabinogalactan to hyaluronic acid showed unexpected results, there is no data to support the entire range of “wherein said arabinogalactan is present in said composition in an amount more than twice that of said hyaluronic acid”, let alone 2-10 times as supported by the claimed range.
There is only one data point showing unexpected results from combining hyaluronic acid and arabinogalactan. More data would be needed to show unexpected results across the entire claimed range. See MPEP 716.02(d), “The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof.”.
Applicant contends the combination of HA and AG results in an unexpected synergistic property. Applicant has previously pointed to data presented in Di Mola et al. (Molecules, 2021, vol. 26, pp. 7246), and Silvani et al. (Experimental Eye Research, 2020, vol. 196, pp. 108058).
The data presented in Di Mola et al. and Silvani et al. appear to demonstrate the combination of hyaluronic acid and arabinogalactan have significant and unexpected properties, however, the results are not commensurate in scope with the present claims.
Silvani et al. tested arabinogalactan at 0.4% w/v, and hyaluronic acid at 0.15% w/v (Table 1). AG alone reduced the concentration of uric acid by 27% (Table 2). HA had no effect on uric acid concentration. However, the combination of polysaccharides reduced the formation of uric acid by 38.2%. This increased reduction is significant and surprising since hyaluronic acid had no effect on reducing the concentration of uric acid.
Di Mola et al. also suggest the relative concentrations of AG to HA is critical. A 1:1 ratio of AG to HA seems to have no effect on retaining water. However, a 3:1 ratio of AG to HA suggested the two polysaccharides form a complex and increase the retention of water (see Tables 1, 2, Figures 4 and 5). Di Mola et al. teach the data demonstrates the mixture displays enhanced mucoadhesive properties, decreased mobility of water and decreased viscosity (abstract). The data suggests the combination can be more effective and provide long-lasting hydration to certain tissues (including dry eye), (abstract).
The combination of Silvani et al. and Di Mola et al. demonstrate the combination of HA and AG have significant and unexpected properties. And they show the concentration of these polysaccharides are critical to observing these results.
Silvani et al. only demonstrated unexpected results for a single concentration of AG in combination with a single concentration of HA. On the other hand, the present claims are directed to a range of concentrations for each polysaccharide, which would also include combinations where the two polysaccharides are present in 1:1 ratios. However, Di Mola et al. show 1:1 ratios of the two polysaccharides are no better than each polysaccharide alone.
According to MPEP 716.02(d)(I), “The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof.”.
There is no evidence of record that would suggest the unexpected result from Silvani et al. could reasonably extend to the both claimed ranges.
The rejection is hereby maintained.
Maintained 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.
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) 1-11 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. (WO 2009/018060, cited in previous Office Action) in view of Luyckx et al. (Clinical Ophthalmology, 2011, vol. 5, 577-581, cited in previous Office Action) and Wong et al. (US Patent No. 9,474,736, cited in previous Office Action).
Burke et al. teach an ophthalmic composition formulated as an eye drop to comfort irritated eyes, comprising one or more natural polymers selected from the group consisting of hyaluronic acid (HA), alginate, guar gum, fructan, arabinogalactan or any salt or derivative thereof (abstract). The concentration of natural polymers is from 0.01% w/v to 0.5% w/v, or from 0.05% w/v to 0.2% w/v (p.3, penultimate para). The composition can further comprise panthenol, in an amount of 0.2% to 0.3% w/v or from 0.5% to 1.0% w/v (p.12-13, bridging para). The compositions are useful for treating a patient with dry eye, relieving eye irritation or dryness, and providing lubrication (p.16, second para). The composition further comprises allantoin (i.e. a pharmacologically active substance for the treatment of dry-eye syndrome). Also see additional ingredients listed in tables 1-7 (i.e. a pharmacologically active substance for the treatment of dry-eye syndrome). The composition also comprises 0.05-1.0 wt.% poloxamer 407 (Table 2; i.e. a gelling agent per p.7 of the present Specification).
Burke et al. disclose a combination of one or more natural polymers selected from a group of five polysaccharides including HA and alginate. Each polymer is present in concentrations from 0.01% w/v to 0.5% w/v, or from 0.05% w/v to 0.2% w/v, i.e. synergistic amounts suitable for use in the treatment of dry-eye syndrome. The composition can further comprise panthenol, an additional agent for treating dry-eye, and a gelling agent.
Burke et al. do not expressly disclose trehalose or TGPS (present claims 3, 8 and 16).
Luyckx et al. teach the use of trehalose in ophthalmology treating dry eye (p.579-580). Trehalose protects desiccated cultured corneal cells from death (p.579). In a murine dry eye model, topical administration of 30 mg/mL trehalose ophthalmic solution improved the ocular surface (cornea and conjunctiva), including reduction of corneal fluorescein staining area, decrease of ruffling and desquamating cells on the apical corneal epithelium, as well as decrease the number of apoptotic cells in the ocular surface epithelium compared to controls (p.579, Trehalose in ophthalmology).
Wong et al. teach an eyedrop comprising 0.5% tocopherol-PEG 1000 succinate (TPGS), (claim 7; 17). The stable eyedrops are useful for the treatment of dry eye, and delivering the active agent (claims 9, 10, 18, 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate an ophthalmic composition comprising hyaluronic acid (HA), arabinogalactan (AG), panthenol, trehalose and TGPS.
According to MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As discussed above, Burke et al. already teach HA, AG and panthenol can be formulated together for treating dry eye. The ordinary artisan would have been motivated to formulate hyaluronic acid (HA), arabinogalactan (AG), panthenol with trehalose because the prior art also recognize an ophthalmic solution having trehalose improved the ocular surface in a murine dry eye model. Specifically, trehalose was beneficial in reducing corneal fluorescein staining area, decreasing ruffling and desquamating cells on the apical corneal epithelium, and decrease the number of apoptotic cells in the ocular surface epithelium compared to controls.
The ordinary artisan would have been motivated to formulate hyaluronic acid (HA), arabinogalactan (AG), panthenol with trehalose and TGPS, because TGPS was useful for delivering active agents when formulated as an eye drop for the treatment of dry eye.
With respect to concentration, the amount of HA, AG and panthenol taught by Burke et al. overlaps with the present claims. The amount of poloxamer 407, a gelling agent, taught by Burke et al. also overlaps with present claim 11.
As noted above, Burke et al. teach a combination of one or more natural polymers selected from a group of five polysaccharides including HA and alginate. Each polymer is present in concentrations from 0.01% w/v to 0.5% w/v, or from 0.05% w/v to 0.2% w/v, i.e. synergistic amounts suitable for use in the treatment of dry-eye syndrome.
One having ordinary skill in the art would have been motivated to optimize the amount of TGPS upon combining it with additional other active ophthalmological ingredients as discussed above. See MPEP 2144.05 (II)(A), “Generally, 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."
The recitation “wherein the ophthalmic composition is filterable and sterilizable at 0.2 microns” in claim 9 is a property of the composition.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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