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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 May 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a Divisional of Application 16/981623 (currently abandoned), which is a national stage entry of PCT/EP2019/057215 filed 22 March 2019. Claims 1-13 are currently pending and examined on the merits within.
Examiner’s Note: The current Application has been filed as a Divisional of Application 16/981623. However, a restriction was not made in the parent case. Filing as a Divisional is improper and instead the Application should be filed as a Continuation of Application 16/981623.
Claim Objections
3. Claim 7 is objected to because of the following informalities: “method according to claim 2” should instead recite “The method according to claim 2”. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 112(a) New Matter
4. 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.
5. Claims 1-13 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.
6. Claim 1 recites “A method for treatment to facilitate or accelerate wound closure comprising: providing 2.5 weight % to 15 weight % of a molecule with formula (I) as depicted below or a pharmaceutical salt thereof and water, which has a temperature lower than 40C…cooling the molecule with formula (I) to 20C to form a homogenous hydrogel; and using the homogenous hydrogel to facilitate or accelerate wound closure at a temperature lower than 40C.” The specification states “For example the gelation point for the 2.5% Gly hydrogel was determined to be 40°C while the gelation point for the 5% Gly hydrogel was determined to be at 45°C (see Example 1 in this application). See page 9. Another portion of the specification states that hydrogel formation begins to occur at 37C. See page 29. There is no explicit support for formation of a homogenous hydrogel when the molecule is cooled to 20C or using the homogenous hydrogel to facilitate or accelerate wound closure at a temperature lower than 40C since it appears that gelation does not occur until 37 or 40C. Claim 2 is included in this rejection for the same deficiencies.
7. Claims 8-9 recite “wherein the hydrogel is stable at a temperature of at least 37C.” The specification however states that gelation can occur at values such as 37 and 40C as stated above. The specification also states “It is essential that the degelation point of the hydrogel is higher than the body temperature of the mammal to be treated for a wound otherwise the hydrogel will become liquid when applied onto the wound.” See page 10. Thus, at certain temperatures, the hydrogel will turn back into liquid, i.e., unstable. Therefore, there is no explicit written description for stability at all temperatures of 37C or above.
Since this Application is a Divisional (or child) of Application 16/981623, wherein there is no support for these amendments in the instant application or parent application, the effective filing date of claims 1-13 becomes 17 May 2024, the date of which the claims with these amendments were filed in this application.
Claim Rejections – 35 U.S.C. 112(b)
8. 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.
9. Claims 1-13 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.
10. Claim 1 recites “A method for treatment to facilitate or accelerate wound closure comprising: providing 2.5 weight % to 15 weight % of a molecule with formula (I) as depicted below or a pharmaceutical salt thereof and water, which has a temperature lower than 40C…cooling the molecule with formula (I) to 20C to form a homogenous hydrogel; and using the homogenous hydrogel to facilitate or accelerate wound closure at a temperature lower than 40C.”
First, the preamble is directed to a method of treatment, however the body includes method of making steps. Is the claim directed to a method of making the hydrogel or a method of treating. Clarification is requested.
Second, the body of the claim additionally adds the step of “using the homogenous hydrogel” however there is no active step of how the hydrogel is used. Is it applied? Clarification is requested.
Thus in the claimed method of treatment, the only active step is “cooling the molecule with formula (I) to 20C to form a homogenous hydrogel.”
The claim also recites providing the molecule and water, which has a temperature lower than 40C and cooling the molecule to 20C. What has a temperature lower than 40C? The molecule of formula (I), the water, or both? How does it have a temperature lower than 40C? Is this a storage condition? If both are provided, are they provided together in a mixture or in two individual vessels? This question arises because the claim appears to only reduce the temperature of the molecule of the compound of formula (I) and not the combination of water and the compound of formula (I). Thus the claims are unclear as to what is occurring and if details or steps are missing.
In addition, the specification states “For example the gelation point for the 2.5% Gly hydrogel was determined to be 40°C while the gelation point for the 5% Gly hydrogel was determined to be at 45°C (see Example 1 in this application). See page 9. Another portion of the specification states that hydrogel formation begins to occur at 37C. See page 29. It is unclear how cooling to 20C forms a homogenous hydrogel and how the combination would be a hydrogel if applied at a temperature less than 40C? Clarification is requested.
Claim 2 is included in this rejection for the same deficiencies.
11. Claims 10-13 are directed to isotopes of R1 and R2. Do all elements have isotopes? It is unclear what this limitation means. Is it referring to labeled isotopes? Clarification is requested.
Claim Rejections – 35 U.S.C. 102
12. 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.
13. Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iwakiri et al. (EP3275447A1).
Regarding instant claims 1-9, Iwakiri et al. disclose a gel type local anesthetic agent consisting of a local anesthetic having a tertiary amine and glycyrrhizic acid. See abstract. The aqueous glycyrrhizic acid solution is a homogenous solution with a concentration of 200 mg/ml or less. See paragraph [0033]. This equates to 20% or less of glycyrrhizic acid in water. 20% or less of glycyrrhizic acid reads on values of 2.5% to 15% and 2.5% to 20%. Iwakiri et al. teach that mixing of a homogenous solution of glycyrrhizic acid with an aqueous solution of local anesthetic having an amine can be carried out at 0 to 60°C. Only by mixing the two liquids at room temperature a gel can be formed. See paragraph [0035]. Thus Iwakiri envisions water and glycyrrhizic acid at temperatures below 40°C. Since Iwakiri et al. teach the same two ingredients in the claimed amount, the resultant product should have the same viscosity, temperature, function in wound care, de-gelation point, and stability. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding instant claims 10-13, isotopes should be naturally occurring and present.
Thus the instant claims are anticipated by Iwakiri et al.
Claim Rejections – 35 U.S.C. 103
14. 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.
15. Claim(s) 1-13 is/are rejected under 35 U.S.C. 103 as obvious over Iwakiri et al. (EP3275447A1) in view of Zhang et al. (U.S. Patent Application Publication No. 2012/0053141).
Regarding instant claims 1-9, Iwakiri et al. teach a gel type local anesthetic agent consisting of a local anesthetic having a tertiary amine and glycyrrhizic acid. See abstract. The aqueous glycyrrhizic acid solution is a homogenous solution with a concentration of 200 mg/ml or less. See paragraph [0033]. This equates to 20% or less of glycyrrhizic acid in water. 20% or less of glycyrrhizic acid reads on values of 2.5% to 15% and 2.5% to 20%. Iwakiri et al. teach that mixing of a homogenous solution of glycyrrhizic acid with an aqueous solution of local anesthetic having an amine can be carried out at 0 to 60°C. Only by mixing the two liquids at room temperature a gel can be formed. See paragraph [0035]. Thus Iwakiri envisions water and glycyrrhizic acid at temperatures below 40°C. Since Iwakiri et al. teach the same two ingredients in the claimed amount, the resultant product should have the same viscosity, temperature, function in wound care, de-gelation point, and stability.
Regarding instant claims 10-13, isotopes should be naturally occurring and present. However, if applicant is referring to labelled isotopes, the prior art of Zhang et al. has been applied to make obvious this limitation.
Zhang et al. teach novel uses of glycyrrhizic acid comprising the compound of the invention and a pharmaceutically acceptable carrier. See abstract. Zhang et al. teach preparing radiolabeled isotopes of the compound of the invention to determine structures of metabolites. The isotopes include 14C and 3H (higher atomic mass). See paragraph [0062].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use an isotope of R1 or R2 for analysis to determine metabolites of the compound.
Conclusion
16. No claims are allowed at this time.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615