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 .
Applicant’s election without traverse of Group II, claims 3-14 in the reply filed on 28 May 2026 is acknowledged. The election/restriction requirement is deemed proper and is therefore made FINAL. An Action on the merits of claims 3-14 is contained herein.
Group I, claims 1-2 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
This application claims foreign priority to CHINA 202311708752.9 filed 12/13/2023, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in the instant application.
Drawings
The drawings are objected to because in Fig. 1 what parameter is plotted in the X-axis is missing. Even though para 0042 in the specification teaches what they are, Fig. 1 should also indicate this on they X-axis. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The Information Disclosure Statement filed 04/30/2025 indicates that an English translation has been provided for all the foreign documents cited (all boxes to the right checked). However, only the English translation of the Abstract is seen. English translation of the whole document was not provided.
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 3-14 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 3, 5, 7, 9, 11, and 13 are drawn to application of a pharmaceutical composition including hyaluronic acid or a salt thereof, an excipient, and glycosylglycerol or a derivative thereof in a preparation of a drug for treating skin diseases. Claims 4, 6, 8, 10, 12, and 14 are drawn to application of a pharmaceutical composition including hyaluronic acid or a salt thereof in a preparation of a drug for treating skin diseases. It is not clear if applicant is claiming a method of preparation of a drug using the recited component(s), or if applicant intends a method of treating a skin disease using a composition including hyaluronic acid and glycosylglycerol as active agents in claims 3-14. From the claim recitation it is not clear if the drug is derived from hyaluronic acid and glycosylglycerol, and if so it’s composition/structure. Since this is unclear the claims are examined as drawn to a method of treating thymic stromal lymphocyte mediated skin diseases as in claims 5-14 using a composition comprising hyaluronic acid or a salt thereof and glycosylglycerol or a derivative thereof as active agents. The term ‘including’ should be replaced by ‘comprising’. Claims 3 and 4 should recite ‘in a human in need thereof’. The claims also do not recite the steps for the treatment.
Claim 3 recites ‘low molecular weight’. The term “low molecular weight” in claim 3 is a relative term which renders the claim indefinite. The term “low molecular weight” is not defined by the claim. Even though the specification, at para 0009, defines low molecular weight HA has molecular weight in the range 10Da-50kDa, limitations from the specification cannot be carried into the claims. In Claim 3 it is not clear what microbial fermentation of the hyaluronic acid means. For the purpose of prosecution, the said recitation is interpreted as hyaluronic acid obtained by fermentation. The said recitation is also seen in claim 4.
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.
Claim(s) 3-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Woo et al (WO 2018101517, Machine English Translation, pages 1-13).
Woo’s invention is drawn to an anti-inflammatory composition which regulates the expression of inflammatory skin disease-associated mediators (Abstract; page 3, lines 1-2). The composition is for treatment of inflammatory skin disease (page 3, lines 12-13). The skin diseases treated are atopic dermatitis, eczema, psoriasis and allergies like urticaria and insect allergy (page 8, second para from bottom; limitations of claims 3-4: thymic stromal lymphocyte mediated skin disease; and skin disease recited in claims 5-8, and 11-14).
The composition used for the treatment of the skin disease comprises hyaluronic acid and glyceryl glucoside (same as glycosyl glycerol as in claim 3). Salts of hyaluronic acid can also be used. The molecular weight of hyaluronic acid used can be low molecular weight of less than 500kDa. The hyaluronic acid can be obtained by a fermentation method (page 4, second para from bottom; page 5, second full para: limitation of claims 3-4). The composition can have the active agents in an amount of 0.01-20.0wt% (page 6, sixth full para; limitation of claim 3-regarding amount of hyaluronic acid and glycosyl glycerol). The composition may include at least one excipient (page 8, second and third full paras; as in claim 3).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings a composition comprising hyaluronic acid or its salts and glucosylglycerol is shown to be anti-inflammatory and is suggested as useful for treating thymic stromal lymphocyte mediated skin diseases. Thus, it is obvious to arrive at the claimed invention in view of the teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the teachings of the prior art. The artisan would be motivated to apply the claimed composition in a method of treating thymic stromal lymphocyte mediated skin diseases since Woo teaches that the composition comprising the instant active agents has excellent anti-inflammatory effect and is not toxic to cells, and has no skin side effects (page 10, paras 7 and 9; page 11, para above sub-title: Formulation Example 1).
Claim(s) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Woo et al (WO 2018101517, Machine English Translation, pages 1-13) in view of Weisshaar et al (Acta Derm Venerol, 2003, suppl 213, 5-32).
The teachings of Woo are set forth above. Woo does not expressly teach the application of its composition for treating pruritus as in claims 9-10.
It can be seen from Weisshaar that pruritus is associated with atopic dermatitis, and psoriasis (page 7, right col., sub-title: Mediators of pruritus; page 9, left col., under sub title: Cytokines; page 11, right col., sub-title: Pruritus in Dermatologic Disease through page 13).
From this teaching of Weisshaar and that of Woo it would be obvious to one of ordinary skill in the art to apply the composition of Woo for treating pruritus.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings a composition comprising hyaluronic acid or its salts and glucosylglycerol is shown to be anti-inflammatory and is suggested as useful for treating thymic stromal lymphocyte mediated skin diseases which are related to pruritus. Thus, it is obvious to arrive at the claimed invention in view of the combined teachings of the prior art.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the teachings of the prior art. The artisan would be motivated to apply the claimed composition in a method of treating thymic stromal lymphocyte mediated skin diseases including pruritus since Woo teaches that the composition comprising the instant active agents are useful for treating skin diseases like psoriasis and urticaria which are related to pruritus (Weisshaar). According to Woo the composition has excellent anti-inflammatory effect and is not toxic to cells, and has no skin side effects (page 10, paras 7 and 9; page 11, para above sub-title: Formulation Example 1). The artisan would have a reasonable expectation of success in treating pruritus in view of Woo and Weisshaar.
Conclusion
1. Elected claims 3-14 (Group II) are rejected.
2. Group I, claims 1-2 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693
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