DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 11-14 in the reply filed on 13 May 2025 is acknowledged. The traversal is on the ground(s) that all the claims can be examined together without serious search and examination burden and citing MPEP 803 (See Remarks, p. 6, last paragraph). This is not found persuasive because the MPEP at 803 recites that there must be a showing that there is a serious search and/or examination burden. A serious search burden can be demonstrated by a showing of different classification which will result in a divergent search. This holds true here, wherein as demonstrated in the previous Office action, the first Group has a classification of C12N 9/52 and elected Group II has a classification of A61K 38/48.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Status of Application
The instant application is being examined under the accelerated examination Track One program.
Claims 1-14 are pending; Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 11-14 are subject to examination on the merits.
Priority
The instant application is a CON of PCT/CN2023/129169 filed 01 November 2023 which claims benefit of foreign priority document CN202211358492.2 filed 01 November 2022 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04 March 2025 has been considered by the examiner. See initialed and signed PTO/SB/08.
Claim Rejections - 35 USC §101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) appear not to fall within at least one of the four categories of patent eligible subject matter because it is unclear if “Use of a serine protease selectively degrading mucins in preparing a drug…….” is a process, machine, manufacture or composition of matter. In addition, should these claims be interpreted as a process claim, they are deemed an improper definition of a process within the context of 35 U.S.C. 101. See MPEP 2173.05(q).
It is noted, claim interpretation of these claims for the remainder of this Office action will be that they are attempting to claim a process.
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.
Claims 11-14 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or join inventor regards as the invention.
This is because the claims attempt to recite a process without setting forth any steps involved in the process. Specifically, the claims recite “Use of a serine protease selectively degrading mucins in preparing a drug….”, and “Use of pharmaceutical composition in preparing a drug…..” However, it is unclear what the process steps are supposed to be which results in an actually making a drug preparation/composition comprising SEQ ID NO: 2 or having at least 90% identity thereto. It is noted, the recitation of a “use” without any active, positive steps delimiting how the use is practiced is deemed indefinite. See MPEP 2173.05(q).
It is further noted, the intended use of the prepared drug preparation/composition, e.g. intended to be used to treat various diseases, does not cure the deficiency of actually making a drug preparation/composition. Claims 11-14 are not considered method of treatment claims (which, notably, would have been restricted from the other two groups).
Claims 11-14 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 11 and 13 are deemed indefinite for recitation of improper Markush groupings, e.g. “wherein the mucus related disease is selected from a group consisting of chronic obstructive pulmonary disease…..peritoneal cancer……ovarian cancer, adenocarcinoma…..”; and then in the same sentence, “the ovarian cancer comprises mucinous ovarian cancer and the peritoneal cancer comprises peritoneal pseudomyxoma”.
In the first instance, it is noted the general format of a Markush claim is “selected from the group consisting of” followed by a list of alternatives (e.g. A, B and C).
In the second instance, the claims are deemed indefinite because it is unclear whether or not the additional recitation of “; the ovarian cancer comprises mucinous ovarian cancer and the peritoneal cancer comprises peritoneal pseudomyxoma” are required as part of the selection of the Markush group or not. Or rather, any type of ovarian or peritoneal cancers are sufficient (regarding claim 11). With regards to claim 13, it is unclear if which level of Markush group is required, the first and/or the second, with regards to the “additional reagent”. This is because on the one hand the additional reagent is selected from the group consisting of chemotherapeutic and radiotherapeutic reagent, an enzyme, and a chemical salt. But on the other hand, the claim recites additional Markush groups with specific reagents for each one (e.g. the of chemotherapeutic and radiotherapeutic reagent is further selected from the group consisting of gemcitabine, cisplatin, adriamycin, fluorouracil, taxodone, paclitaxel, and oxaliplatin; the enzyme is further selected from the group consisting of N-acetylgalactosidase, galactosidase, glucosidase, sialidase and specific endomucinase; and the chemical salt reagent is selected from the group consisting of sodium bicarbonate, carbocysteine, N-acetylcysteine and ambroxol). This is similar to reciting a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim). See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language/Markush groups are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) are required feature of the claims.
In the third instance, a Markush group is to be a closed group of alternatives. It must not recite an open-ended list, which it does here because the ovarian cancer comprises mucinous ovarian cancer and the peritoneal cancer comprises peritoneal pseudomyxoma cancer. Thus, this is interpreted that additional unrecited elements may be a part of the group but is unclear what those unrecited elements are.
This same pattern as recited above in the first and second instances are repeated in claims 12 and 14, wherein the administration route is “selected from a group consisting of injection administration, oral administration and spray administration, and the injection administration is intraperitoneal injection”. It is unclear whether or not intraperitoneal is to be considered as a required alternative in the Markush group or not.
See both MPEP 2173.05(b) and 2117.
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.
Claim(s) 11-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fleckenstein, J.M. (WO 2016/115328 – cited on IDS).
The claims are interpreted as utilizing a protein having at least 90% identity to SEQ ID NO: 2 which results in a drug comprising said protein. The intended use of the drug, e.g. for treating various muscle-related diseases are not taken into consideration because the claims are not methods of treatment claims.
With regard to claims 12 and 14, the claims are interpreted that the prepared drug composition must be in form suitable for injection, oral administration or spray administration.
Fleckenstein teaches:
Regarding claims 11 and 13, a vaccine composition comprising an active ingredient of a protein comprising SEQ ID NO: 2 which is EatA having serine protease activity, comprising the passenger domain and having 100% sequence identity to instant SEQ ID NO: 2 – See Supplemental Content, 20250414_104411_us-19-069-321-2.rag file, Result #1; also see Claims 1 and 8. Said EatA degrades mucins (See paragraph 0023).
Further regarding claims 11 and 13, EatA serine protease comprising SEQ ID NO: 2 is found in a composition which is pharmaceutically acceptable – See paragraphs 0042 and 0044.
With regard to the additional reagent selected from a chemotherapeutic and radiotherapeutic, enzyme and a chemical salt reagent; the pharmaceutical composition further comprises chemical sodium salts (See paragraph 0052). As noted above in the 112(b) rejection, there is a question of doubt as to whether the more narrow Markush groupings are required or not. As such, the claim is interpreted as minimally requiring the first recited Markush group of the additional regent being selected from chemotherapeutic and radiotherapeutic reagent, an enzyme, and a chemical salt.
Regarding claims 12 and 14, the EatA pharmaceutical formulations comprising SEQ ID NO: 2 are in lyophilized or liquid form, wherein the liquid form is readily utilizable as an injectable (See paragraphs 0045-0046). Alternatively, the pharmaceutical composition is prepared for other routes of administration including parental administration including intramuscular, intraperitoneal, intradermal, intravenously, subcutaneous, or other means such as topical, transdermal, etc. – See paragraph 0060. While there are several formulation routes detailed and to choose from, one skilled in the art can immediately envisage any or all of them and as such, the disclosure of Fleckenstein is taken as anticipatory over the claimed invention (See MPEP 2131.02(III)).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 22 May 2025