DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-3 are pending.
Priority
This application is filed 09/27/2024, and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 9/27/2024 has been considered unless marked with a strikethrough.
Abstract
The abstract of the disclosure is objected to because the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. Currently, the abstract has 29 words.
The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The current submitted abstract is the front pages of PCT application. Examiner requests to bring in narrative form to satisfy the abstract requirement.
Correction is required. See MPEP § 608.01(b).
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
The phrase “an atopic dermatitis improving agent” in claim 1 should be treated as an intended use phrase because the phrase merely identifies the therapeutic purposes of the composition, and the other phrases, “an interleukin production inhibitor”, “configured to inhibit production of interleukin-33 and interleukin-1”, “an inhibitor of expression of interleukin gene”, and “configured to inhibit expression of interleukin-33 gene and interleukin-I gene”, should be treated as functional language because they characterize the biological function or mechanism of action of the claimed Formula (I). Accordingly, the structural limitation of claims 1-3 is the glyceryl ascorbic acid acylated derivative represented by formula (I).
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.
The rejections under this section are made when the scope of the claimed subject matter is not clear. (See MPEP 2173)
Claims 1-3 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.
Regarding claim1, the term " improving agent" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The term “improving agent” is not defined by the claim and specification that do not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear whether “improving agent” refers to treatment of atopic dermatitis, symptom alleviation or reduction of skin roughness. See MPEP § 2173.05(d).
Regarding claims 2-3, the phrase "configured to" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Specifically, the phrase “configured to inhibit production of interleukin-33 and interleukin-1” in claim 2, and the phrase “inhibit expression of interleukin-33 gene and interleukin-1 gene” in claim 3 do not provide any criteria for determining how the inhibitor achieve or configure the characterization of the biological function or mechanism of action as recited “inhibit production of interleukin-33 and interleukin-1” or “inhibit expression of interleukin-33 gene and interleukin-1 gene”. For example, the phrase “configured to inhibit production of interleukin-33 and interleukin-1” in claim 2 could be interpreted as configuring a particular structure conformation that interact with a molecular targets (i.e., interleukin-33 gene and interleukin-1 gene), or as functionally reducing/increasing the amount of interleukin-33 gene and interleukin-1 produced by a cell or gene, regardless of the substance’s structure, molecular target, or mechanism of action. Also, the phrase “inhibit expression of interleukin-33 gene and interleukin-1 gene” in claim 3 could be interpreted as configuring structure or conformation by interacting with a nucleic acid, protein or regulatory component involved in expression, or as functionally measuring in expression of those genes, including an indirect upstream pathway, or transcriptional regulation, regardless of the substance’s structure, or mechanism of action. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Masato et al. (US 2013/0204017 A1, pub’d 08/08/2013, IDS cited, hereinafter "Masato2013").
With respect to claims 1-3, Masato2013 teaches a glyceryl ascorbic acid acylated derivative, and 2-O-glyceryl-6-O-hexadecanoyl ascorbic acid that corresponds to the instant Formula (I) (Example 3). Masato2013 further teaches emulsion formulated compositions (paragraph [0166]-[0175]), and their use as skin cosmetics. As discussed in the claim interpretation above, the intended use and functional languages including “an atopic dermatitis improving agent“, “an interleukin production inhibitor”, “configured to inhibit production of interleukin-33 and interleukin-1”, “an inhibitor of expression of interleukin gene”, and “configured to inhibit expression of interleukin-33 gene and interleukin-I gene” are do not encompass any additional structural limitation of an agent/inhibitor of Formula (I), and they should be interpreted as an inherent functional property and/or intended use. They merely characterize the biological function or mechanism of action of the claimed Formula (I).
Accordingly, Under MPEP 2112 and 2114, although the prior art reference does not explicitly disclose the functional property for the instant application, the prior art compound is structurally identical to the claimed compound. A prior art compound that is structurally identical to the claimed compound is presumed to possess the same inherent properties as the claimed compound. The discovery of a previously unrecognized property of a prior art compound does not render the old compound patentable, and functional/ intended use languages are not limited to a specific structure does not avoid prior art where the prior art article is capable of inherently performing the recited function.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masato et al. (JP 2015/003894 A, pub’d 01/08/2015, IDS cited, hereinafter "Masato2015").
The rationale for the rejection of anticipation by Masato2013, as discussed above, also applies here.
Masato2015 teaches a glyceryl ascorbic acid derivative, and 2-O-glyceryl-6-O-hexadecanoyl ascorbic acid that corresponds to the instant Formula (I) (abstract, and paragraph [0095]-[0096]). Masato further teaches their use as antimicrobial agents and anti-acne agents (abstract).
Masato2015 teaches the Formula (I) and the claims do not encompass any additional structural limitation of an agent/inhibitor of Formula (I), and they should be interpreted as an inherent functional property and/or intended use. Accordingly, in view of the rationale of Masato2013’s anticipation, the claim interpretation and MPEP 2112/2114, claims 1-3 are anticipated by Masato2015.
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masato et al. (US 2013/0204017 A1, pub’d 08/08/2013, IDS cited, hereinafter "Masato2013"), in view of Ito et al., (US 6437002 B1, pub’d 08/20/2002, IDS cited).
As discussed in the claim interpretation and the rejection under 35 USC 102, the recited intended use language is not entitled to patentable weight and does not distinguish the claimed compound from the compound disclosed by Masato3013. Nevertheless, this rejection is made that, even if the intended use language is accorded patentable weight, the claimed subject matter would have been obvious to a person of ordinary skill in the art in view of the combined teaching of Masato2013 and Ito.
With respect to claim 1, the claim recites that an atopic dermatitis improving agent comprising a glyceryl ascorbic acid acylated derivative represented by formula (I).
As discussed 35 USC 102, Masato2013 teaches a glyceryl ascorbic acid acylated derivative, and 2-O-glyceryl-6-O-hexadecanoyl ascorbic acid that corresponds to the instant Formula (I). (see Example 3). Masato2013 further teaches emulsion formulated compositions (paragraph [0166]-[0175]), and their use as skin cosmetics. Masato2013 also teaches that such glyceryl ascorbic acid acylated derivatives have a whitening effect, a collagen production promoting effect, a moisturizing effect, high permeability and stability (paragraph [0028]).
Masato2013 fails to teach that the instant Formula (I), 2-O-glyceryl-6-O-hexadecanoyl ascorbic acid, has an atopic dermatitis improving activity.
Ito teaches an agent for preventing and treating skin diseases comprising as an active ingredient an ascorbic acid derivative (abstract). Ito does not directly teach the instant Formula (I) compound, but Ito’s Markush genus indicates that Ito’s Formula (I) may have R1 is glyceryl (i.e., ether bond with an aliphatic alcohol of 2 to 14 carbon atoms), R2/R3 are a hydroxyl group, and R4 is -OC(O)R wherein R is an alkyl group of 4 to 21 carbon atoms (column 7, lines 35-65). Thus, Ito’s Markush genus encompasses the instant Formula (I).
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Instant Formula (I) Ito’s Formula (I)
Ito further teaches the use of the agent is for treating atopic skin diseases during or after the treatment, and the pigmentation or cutaneous impression as an atopic skin disease vestige can be eliminated to recover the normal skin. (column 11, lines 5-9).
It would have been obvious to a PHOSITA at the time of the invention to use the 2-O-glyceryl-6-O-hexadecanoyl ascorbic acid of Masato2013 as the ascorbic acid derivative in the atopic skin disease treatment agent of Ito in order to obtain glyceryl ascorbic acid acylated derivatives having improved stability, permeability, moisturizing effect, and skin cosmetic suitability taught by Masato2013. Accordingly, combining the Masato2013’s glyceryl ascorbic acid acylated derivatives with Ito’s teaching of treating atopic skin diseases would have predictably resulted in an atopic dermatitis improving agent comprising the Formula (I) compound, with expected a moisturizing effect, high permeability and stability.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of 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.
Consistently, applying KSR example rationale (A) in the independent claim 1, it would have been prima facie obvious to combine known glyceryl ascorbic acid acylated derivatives including the instant Formula (I) taught by Masato2013 and treating atopic skin diseases using glyceryl ascorbic acid acylated derivatives taught by Ito, yielding predictable results with expected a moisturizing effect, high permeability and stability. (see MPEP 2141)
With respect to claims 2 and 3, the claim 2 recites that an interleukin production inhibitor comprising a glyceryl ascorbic acid acylated derivative represented by formula (I) and being configured to inhibit production of interleukin-33 and interleukin-1, and the claim 2 recites that an inhibitor of expression of interleukin gene, the inhibitor comprising a glyceryl ascorbic acid acylated derivative represented by formula (I) below and being configured to inhibit expression of interleukin-33 gene and interleukin-1 gene.
As discussed above in the claim interpretation and 35 USC 102 rejection, under MPEP 2114, the interleukin related functional language does not render claims 2 and 3 patentably distinct from the obvious Formula (I) compound containing agent resulting from the combination of Masato2013 and Ito.
Conclusion
Claims 1-3 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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