DETAILED ACTION
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 .
Election/Restrictions and Claim Status
Applicant’s election of Group 1 and SEQ ID NO:1 with L353A, M351V and M358V in the reply filed on 9/9/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-13, 15 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 9/9/26.
The elected variant polypeptides is L353A, M351V and M358V (not any particular sugar modifications) so claim 7 is drawn to a non-elected species.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/9/26.
Claim 14 has been canceled.
Claims 1-6 and 16-18 are being examined.
Priority
The priority information is found in the filing receipt of 9/6/24.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/11/24 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
37 CFR 1.831(c) recognizes that each sequence presented in a drawing must include the sequence identifier in the drawing or brief description of the drawing. Instant figure 5 recites sequences but does not include the sequence identifier in the drawing or brief description of drawing.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 2-3 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure/disclosure of drawings:
Claims 2-3 recite functional properties or combinations of functional properties.
Claims 2-3 depend on claim 1 which recites 90% identity to SEQ ID NO:1. SEQ ID NO:1 is 394 amino acids in length and 10% identity allows for at least 39 substitutions.
When 39 of the positions are varied to any of the 20 common amino acids there are at least 2039 (i.e. 549,755,813,888,000,000,000,000,000,000,000,000,000,000,000,000,000 different possible sequences). As such, the genus is large.
Claim 2 recites protease and is not limited to any particular protease.
The examples are limited to specific mutations at specific positions.
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Claim 1 is not included in the instant rejection because claim 1 does not recite any functional properties.
Claims 2-3 recite functional properties or combinations of functional properties.
As set forth above, the genus of claim 1 includes at least 549,755,813,888,000,000,000,000,000,000,000,000,000,000,000,000,000 different possible sequences. There is no specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims. There is not an adequate correlation between which specific position can be modified and how it can be modified to result in the functions or combination of functions as recited in claims 2-3. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus.
(5) Method of making the claimed invention/actual reduction to practice:
The specification (pages 19-20) describes make proteins. However, mere making of a protein does not show that it would have the functionalities claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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)(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) 1-6 and 16-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Weiner MP (US 2023/0212271; ‘Weiner’).
Weiner teach rhA1At with M351V/M358V/L353A (section 0220).
Weiner claims priority to provisional application 63/248,908 (September 27, 2021) which also recites rhA1AT with M351V/M358V/L353A (section 00178).
In relation to the variant of claims 1-6 and 16-18 Weiner teach rhA1AT with M351V/M358V/L353A (section 0220) which corresponds to the elected species and contains the triple mutation M351V/M358V/L353A.
Claim Rejections - 35 USC § 103
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.
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) 1-6 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (WO 2019/148848; as cited with IDS 4/11/24) in view of Blaurock et al. (‘C-terminal alpha-1 antitrypsin peptide: a new sepsis biomarker with immunomodulatory function’ Mediators of Inflammation 2016 pages 1-13; ‘Blaurock’) in view of Park et al. (US 2021/0155913; ‘Park’).
Lin et al. (WO 2019/148848; as cited with IDS 4/11/24) is not in the English language. All references herein will be to the English language equivalent US 2020/0354433 (as cited with IDS 4/11/24; LinTranslation).
LinTranslation teach that alpha-1-antitrypsin (AAT) is relatively unstable and easily oxidized and in order to make a better drug for clinical application the sensitivity to oxidation and in vivo half life need to be improved (section 0007). Figure 1 shows the sequence of the protein. LinTranslation teach that the double mutant M351V/M358V confers a substantial increase in oxidation resistance (section 0012 and figure 6). LinTranslation teach methods of making the protein (page 7).
LinTranslation does not teach the L353A mutation.
Blaurock teach alpha-1-antitrypsin (AAT) (page 1 first paragraph of introduction). Blaurock teach cleavage of AAT by matrix metalloproteases specifically cleavage between Phe353-Leu353 which leads to a loss of activity (page 1 2nd paragraph of introduction).
Park teach protein engineering and specific modifications to a particular protein including L353A (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of LinTranslation because LinTranslation teach that alpha-1-antitrypsin (AAT) is relatively unstable and easily oxidized and in order to make a better drug for clinical application the sensitivity to oxidation and in vivo half life need to be improved (section 0007). Since Blaurock teach cleavage of AAT by matrix metalloproteases specifically cleavage between Phe353-Leu353 which leads to a loss of activity (page 1 first paragraph of introduction) one would have been motivated to modify the protein to avoid such cleavage and improve the protein half-life. Since Park teach protein engineering and specific modifications to a particular protein including L353A (abstract) one would have been motivated to make such modification. Since LinTranslation teach that the double mutant M351V/M358V confers a substantial increase in oxidation resistance (section 0012 and figure 6) one would have been motivated to use such variant as the base protein to be further modified with L353A. One would have had a reasonable expectation of success since LinTranslation teach methods of making the protein (page 7).
In relation to the variant of claims 1-6 and 16-18, the triple mutation M351V/M358V/L353A discussed above corresponds to the elected species and contains the triple mutation M351V/M358V/L353A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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