DETAILED ACTION
Formal Matters
Claims 2-6, 11, 18, and 21-27 are cancelled. Claim 28 is new. Claims 1, 7-10, 12-17, 19-20 and 28 are pending. Claims 1, 14-16, 20 and 28 are withdrawn. Claims 7-10, 12, 13, and 17 and 19 are pending and under examination.
New claim 28 is found on the first page of the applicant’s arguments/remarks from 6/19/2026.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/TR2022/050872 filed on 8/17/2022, which claims priority to TR2021/013738 filed on 9/1/2021.
There appears to be no certified copy of the foreign priority document in either this application file or with the PCT application. Priority will be considered as of the date of the filing of the PCT application, which is 8/17/2022. If applicant desires benefit of priority to the Turkish application filed on 9/1/2021, then applicant should file a copy of the certified priority document.
Information Disclosure Statements
The information disclosure statement (IDS) filed on 02/29/2024 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 7-10, 12, 13, 17 and 19) in the reply filed on 6/19/2026 is acknowledged. Claim 19 is added here as the dependency of claim 17 was corrected and claim 19 is dependent on claim 17. The election is treated as without traverse as applicant does not traverse the restriction requirement.
Claims 1, 14-16, 20 and 28 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/19/2026.
Newly submitted claim 28 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The elected method is a process while claim 28 is to a composition using product by process format.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 28 is also withdrawn from consideration as being directed to a non-elected invention.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.
Claim Objection
Claim 7 is objected to for “on this mixture” where “on” might be more correct as “to”.
Claim 19 is objected to for use of commas instead of “.” in the values of the ranges.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(b)
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 7-10, 12, 13, 17 and 19 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.
Claim 7 is indefinite for the phrase “A formulation production method that absorbs quickly from the skin, renews the skin, eliminates redness, and accelerates the wound healing process effectively, resulting in scar free healing” as this preamble makes it uncertain whether the claim is to be toward a method of using on skin or if the method is truly to a process of production/making. As the steps set forth in the method are to steps in a process of making a formulation, the claim will be treated as such for the purpose of compact prosecution. Applicant may amend the recitation to say “A formulation production method for making a formulation that absorbs quickly from the skin, renews the skin, eliminates redness, and accelerates the wound healing process effectively, resulting in scar free healing” if they desire to keep these intended use phrases. Another option is to amend the preamble to “A process of making a formulation comprising….” Applicant should note that group II in the restriction/election requirement was seen as toward a process of making (production method) and a switch to a process of using/treating would be a shift in invention.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 recites the limitation "the skin" in the first line of the claim. There is no introduction of skin for “the skin” to refer back to. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend the first recitation to say “quickly from skin”.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for “hyaluronic acid and boric acid with a molecular weight of 500 KDa or less” as it is unclear based on this claim structure if the molecular weight refers to the hyaluronic acid, the boric acid or the combination of both as some type of complex. If applicant means the molecular weight to refer to the hyaluronic acid, then applicant might consider “hyaluronic acid with a molecular weight of 500 kDa or less and boric acid” for clarity.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for “molecular weight” as there is no indication in the specification how the molecular weight is measured in terms of this invention. There are different types of molecular weights including weigh average molecular weight, number average molecular weight and viscosity average molecular weight and each can provide a different value based on the differing procedures to obtain them. If applicant has support for the more specific type of molecular weight used for hyaluronic acid within the confines of the original disclosure, then applicant should amend the claim to reflect it while providing where these recitations were found in the original disclosure.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for “on this mixture, and mixing the same” as it is unclear which “this mixture” or “the same” is being referred back to. The dispersed gelling agent in water can be one mixture or the other mixture could also result after the addition of the hyaluronic acid and boric acid. Applicant should specify the mixture being referred to and also specify what “the same” is.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claims 7 and 8 are indefinite for “20% NaOH” as there are no units provided for this percentage. % may be w/w or w/v or mol/v or mol/mol, etc. Applicant should add the units for the percent to offer meaning to the percentage.
Claims 9-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 recites the limitation "the reaction medium" in part c) of the claim. There is no introduction of a reaction medium to refer back to. There is insufficient antecedent basis for this limitation in the claim. If applicant means to refer to the formulation from step c), then applicant may say “solution to the formulation obtained from step c)”
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for “the resulting mixture” in step d) as it is unclear if the resulting mixture is that of step a), step b) or step c). Applicant should clarify this in the claim.
Claims 8-10, 12, 13, and 17 and 19 are rejected as being dependent on an indefinite claim.
Claim 7 is indefinite for “appropriate pH” as it is unclear what “appropriate” would be considered. This could refer to a number of pH values or pH ranges. Applicant should define what pH or pH range they desire or simply saying “and adjusting the pH of the…” if they desire it to be broadly read.
Claims 8-10, 12, and 17 and 19 are rejected as being dependent on an indefinite claim.
Regarding claim 9, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
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 pre-AIA 35 U.S.C. 103(a) 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 7-10, 13, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Asgharian US20050129771A1, Oreste WO2021209975A1 and Gupta (Int J App Pharm, 2018, volume 10, pages 123-130).
Asgharian teaches topical ophthalmic compositions to form a gel (abstract). Asgharian teaches a polysaccharide/borate gelling system (abstract). Asgharian teaches using pH adjusting agents including sodium hydroxide, solubilizing agents like Tween 80, and suitable preservatives such as polyquaternium-1 and polyhexamethylene biguanide (paragraph 30). Asgharian teaches gelling systems of different types (paragraph 29). Asgharian teaches one or more surfactants to remove deposits (paragraph 28). Asgharian teaches 0.1 to 5% w/v of one or more polysaccharides and 0.05 to 5% w/v of borate compound (paragraph 27). Asgharian teaches a composition with Konjac glucomannan (gelling agent) at 0.25% and boric acid added at 1% along with polyquaternium-1 at 0.0005% and adjusting pH with sodium hydroxide to 6.5 to 7 (paragraph 37). The composition of paragraph 37 also has purified water. Asgharian teaches “The above composition is prepared in two parts. Konjac glucomannan is dispersed in 40% of the volume water and allowed to hydrate. The polymer solution is polish filtered and autoclaved at 122° C. for 30 minutes. The resulting solution (“Part I”) is then autoclaved at 121° C. for 35 minutes, and mixed while cooling. A second part (“Part II”) is prepared by dispersing the remaining ingredients in 40% of the batch volume of purified water and allowing the ingredients to dissolve and then adjusting the pH to near the target pH.” (paragraph 37-38). Asgharian teaches carbomers may be used in the gelling system (paragraph 29). The amount of water in example 2 would be between 98 and 99% of the formulation. However, it is noted that Asgharian provides for Qs to 100 with water, which means the amount of water is dictated by the amount of other ingredients used and concentrations desired.
Asgharian does not teach the addition of hyaluronic acid/hyaluronan with boric acid. Asgharian does not provide for keeping at 4C for 24 hours.
Oreste teaches ophthalmic liquid compositions with linear low molecular weight hyaluronic acid (90 kda to 120 kda) (abstract and claim 1 of Oreste). Oreste teaches 1.1 to 2% of hyaluronic acid (claim 2 of Oreste) and 1% LMWHA in example 7. Oreste teaches its carrier may be boric acid buffer (claim 6 of Oreste and page 4). Oreste teaches “the reaction can be stopped by neutralisation, for example adding a solution of a base, like NaOH until pH 7” (top of page 5). Boric acid can be from 0.5 to 2% w/v of the composition (page 7). Oreste allows for other actives and/or conventional excipients (page 7 lines 15-19). Oreste notes that use of higher molecular weight HA would cause excessive viscosity (page 7, line 10). Oreste also teaches a base of sodium hydroxide to achieve a pH of 7 (page 6).
Gupta teaches making and optimizing a thermosensitive in situ ocular drug delivery system (abstract). Gupta teaches using Carbopol as one of the gelling agents (abstract). Gupta teaches making the composition by dispersing the gelling agent (carbomer, pluronic and gellan gum) then adding benzalkonium chloride (preservative) solution, adjusting pH to 7-7.5 by adding sodium hydroxide, sterilizing and then refrigeration at 4 C (Preparation of in-situ hydrogel and drug loading).
One of ordinary skill in the art before the time of filing would have provide low molecular weight hyaluronic acid of Oreste with boric acid in making an ophthalmic formulation as in Asgharian which also recognizes adding a boric acid composition to gelling polymer when making an ophthalmic gel composition. Gupta provides that such formulations would be kept at 4C after the pH adjusting step had been done. Although Gupta does not provide for the time kept at approximately 24 hours, this would be determined based on how long the formulation was going to be stored before use. In regard to the order of adding/combining ingredients such as surfactants and preservatives, it would be obvious to change the order of addition and still obtain formulations with the functions of the surfactant and preservative (see MPEP 2144.04 VI C). Thus, there was a reasonable expectation of success in combining the teachings of the references to product an ophthalmic formulation in a manner of applicant’s current claims.
Claims 12 and 19 in addition to Claims 7-10, 13, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Asgharian US20050129771A1, Oreste WO2021209975A1, Gupta (Int J App Pharm, 2018, volume 10, pages 123-130) and Shawer US20160213609.
Asgharian, Oreste and Gupta teach the claims as discussed above.
Asgharian, Oreste and Gupta do not teach the amount of preservative or surfactant that can be used.
Shawer teaches a suspension with ophthalmic ingredient to treat ophthalmic conditions (abstract). Shawer teaches surfactants (paragraph 75). Shawer teaches preservatives from 0.001 to 1% w/w (paragraph 78). Shawer also teaches surfactant from 0.01 to 5% (paragraphs 80-82). Shawer teaches pH of 6-8 and 6.3 to 7 and sodium hydroxide (paragraphs 81-83). Shawer teaches carbomers as suspending agent (paragraph 68).
One of ordinary skill in the art before the time of filing would have routinely adjusted amounts of surfactants and preservatives in ophthalmic formulations by the teachings of Shawer as Asgharian recognizes use of these components in its ophthalmic formulations and Shawer provides for amounts that would be used in ophthalmic formulations. Therefore, there was a reasonable expectation of success of working within the ranges taught by Shawer and obtaining formulations with concentrations of surfactant and preservative of applicant’s claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/
Examiner, Art Unit 1613
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