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 .
Claims 1-36, 39-44, and 46-190 are cancelled. Claims 191-209 are new.
Claims 37, 38, 45, and 191-209 are pending and examined on the merits.
Claim Objections
Claims 199-201 and 206 are objected to because of the following informalities:
Regarding claims 199-201, the word “mutation” should be inserted after the recitation “L114P” in line 2 of each of the claims for consistency which the other members of the group (e.g., “a R994H mutation” in claim 199).
The first letters of the words “Larvae” and “Pulvifaciens” in line 6 of claim 206 should be lowercase.
Claim 206 recites “Paenibacillus polymyxa” twice at lines 3 and 8. One of the two recitations should be deleted.
The recitation “Paenibacillus odorifier” in lines 9-10 of claim 206 is a misspelling of the known species Paenibacillus odorifer. See the abstract of Beno (mSphere. 2020. 5(1): e00739-19. Published January 22, 2020). The recitation “odorifier” should be replaced with “odorifer.”
Appropriate correction is required.
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 197-204 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 197-201 are each rendered indefinite by the recitation “or at a homologous amino acid position in a homologous GlnR protein.” The recitation in each of claims 197-201 is preceded by a list of amino acid substitutions at multiple amino acid positions. However, the recitation regarding a homologous amino acid position is directed to an amino acid substitution at a single amino acid position. It is unclear which one of the amino acid positions in SEQ ID NO: 16 is being referred to by said recitation. It is unclear whether said recitation is referring to preceding position. For instance, with respect to claim 198, it is unclear whether said recitation is referring to an amino acid substitution in a homologous GlnR protein at an amino acid position homologous to amino acid position 133 of SEQ ID NO: 16. Since claim 197 is indefinite, then its dependent claims, claims 198-204, are rendered indefinite. Thus, claims 197-204 are rejected under 35 U.S.C. 112(b).
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 37, 38, 191-195, 197-201, 203, and 205-209 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.
Claims 37 and 205-209 require the broad genus of one or more bacteria capable of fixing nitrogen irrespective of exogenous nitrogen levels at a rate at least equivalent to a rate of nitrogen fixation in a wild-type gram-positive diazotrophic bacterium in the absence of exogenous nitrogen. Though claims 38, 191-195, 197-201, and 203 more narrowly require that the one or more bacteria comprise one or more engineered gram-positive diazotrophic bacteria comprising a heterologous promoter operably linked to a nif operon and/or a mutant GlnR protein, the genus of the one or more bacteria is still broad. However, the specification as filed does not provide a representative number of species of the claimed genus to adequately describe the claimed genus, nor would one of skill in the art be able to visualize or recognize the identity of the members of the claimed genus.
With respect to the one or more bacteria of claim 38, Applicant describes the heterologous promoter linked to a nif operon at least in Figure 9 and paragraph [0091] (in particular, a heterologous promoter comprising a nucleic acid sequence selected from any one of SEQ ID NOs: 1-11). Applicant also describes the mutant GlnR protein at paragraph [0094] (in particular, a GlnR protein comprising an amino acid sequence selected from the group consisting of SEQ ID NO: 17-19). The bacteria engineered to comprise the heterologous promoter and mutant GlnR protein as described in paragraphs [0091] and [0094] are shown in Figure 10.
On the other hand, the claims recite a genus that is vast, encompassing any bacteria that can perform the recited nitrogen fixing, including bacteria that are normally not capable of performing the recited nitrogen fixing but have been genetically modified to do so. However, Applicant does not describe the structures that are required for obtaining the claimed function of fixing nitrogen irrespective of exogenous nitrogen levels at a rate at least equivalent to a rate of nitrogen fixation in a wild-type gram-positive diazotrophic bacterium in the absence of exogenous nitrogen. As such, one of ordinary skill in the art would not recognize bacteria that can perform the recited function from other bacteria that would not, based upon their structural composition.
In view of these teachings, Applicant appears to be claiming the invention on the basis of function alone. “A definition by function alone "does not suffice" to sufficiently describe a coding sequence "because it is only an indication of what the gene does, rather than what it is." Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharma. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). (MPEP 2163).
The limited number of species described by Applicant are insufficient to describe the recited genus by virtue of example.
Response to Arguments
Applicant’s arguments, filed September 24, 2025, have been fully considered and are persuasive with respect to the rejections of the last Office Action. Therefore, those rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of further consideration of the claimed subject matter and as necessitated by the amendments to the claims.
Conclusion
Claims 45, 196, 202, and 204 are allowed.
Claims 37-38,191-195,197-201,203 and 205-209 are not allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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