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 .
Claims 1, 5, 8, 10, 12-15, 18-21 are under examination on the merits.
Claims 2-4, 6-7, 9, 11, 16-17 are canceled.
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 1, 5, 8, 10, 12-15 and 18-21 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. Claim 1 (and its dependent claims 5, 8, 10, 12-13) is directed to a genus of fungal cells deficient in 95% or higher homologs of SEQ ID NO:44 of no specific function and generic methods of use thereof see claim 14 ( and its dependent claims 15, 18), and claim 19 (and its dependent claims 20-21), respectively, wherein said genus or said methods of use of said genus are inadequately described in the disclosure in terms of function.
The court of Appeals for the Federal Circuit has recently held that such a general definition does not meet the requirements of 35 U.S.C. 112, first paragraph. “ A written description of an invention involving chemical genus, like a description of a chemical species, requires a precise definition, such as be structure, formula {or} chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). The court held that “ in claims involving chemical materials, generic formulae usually indicate with specificity what generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. accordingly, such a formula is normally an adequate description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian insulin cDNA,’ without more, is not an adequate written description of the genus because it does not distinguish it from others. One skilled in the art therefore cannot, as one can do with a fully described genus visualize the identity of the members of the genus”. Here, in claims 1, 5, 8, applicant is claiming a genus of recombinant fungal cells of no specific function by what the genus does not have rather than what it structurally has.
In claims 10 and 12-13, said genus of cells is recited to comprise a generic cassette for expressing a generic product (i.e., POI) wherein none of said products have been structurally defined.
Given the breadth of these product claims, it is impossible to distinguish instantly claimed products from other fungal cells which inherently lack SEQ ID NO:44 or homologs thereof (or DNA encoding all said products).
Regarding SEQ ID NO:44 (or DNA encoding it) on its own merits, it appears that said product was found by screening a deletion mutant library of T. reesei (Trichoderma reesei) cells (see Example 1 of the disclosure) and the exact function thereof is unidentified.
Applicant in claim 1 has referred to SEQ ID NO:44 (or DNA encoding it) as “a regulatory protein “but what said protein actually regulates has not been identified. Further a thorough search of SEQ ID NO:44 is commercially available databases does not show any sequences with homologies close to 95% or higher homologs of SEQ ID NO:44, which show “regulatory function”.
Further, in instant product claims, applicant not only claimed a genus of fungal cells that lack SEQ ID NO:44, but also cells that lack 95% or higher homologs of SEQ ID NO:44 (or DNA encoding them). The disclosure fails to explain which exact regions or amino acid domains are in charge of “regulatory function” of SEQ ID NO:44 (or DNA encoding it) and provides no examples of such regions or domains. Therefore, the lack of description support is even more serious with respect to fungal cells that lack homologs of SEQ ID NO:44.
Finally, with respect to generic phrase “fungal cell” recited in claim 1, claim 14 and 19 and their dependent claims, the disclosure merely provides information about T. reesei (Trichoderma ressei), which is a single species and said description is totally inadequate to support the genus of “fungal cells” claimed.
Therefore, given the scarcity of information provided and given the breadth of these product claims one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the filing of this application.
Since the products of claim 1, are inadequately described a method of use of said products (see claims 14, 18-21) are also inadequately described.
It is noted that in claim 15, applicant recites that the fungal cell of claim 1 further comprises another “regulatory protein”, namely SEQ ID NO:85 (or DNA encoding it) and 95% or higher homologs thereof.
However, it is unclear what the function of SEQ ID NO:85 (or DNA encoding it) is i.e. what is being regulated by said sequence), and again a thorough search of SEQ ID NO:85 is commercially available databases does not show any sequences with homologies close to 95% or higher homologs of SEQ ID NO:85 with similar “regulatory function”.
Again, in dependent claim 15, the disclosure fails to explain which exact regions or amino acid domains are in charge of “regulatory function” of SEQ ID NO:85 (or DNA encoding it) and provides no examples of such regions or domains can be found either. Therefore, the lack of description support is even more serious with respect to fungal cells that lack homologs of SEQ ID NO:85 as compared to its base claim. Since the fungal cells recited in claim 15 lack adequate written description, a method use of said products as claimed also lacks adequate written description support.
To summarize, given the scarcity of information provided and given the breadth of claim 15, one of skill in the art cannot reasonably conclude that applicant had full possession of the invention, before the filing of this application.
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 1, 5, 8, 10, 12-14, 18-21 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. Claim 1 (and its dependent claims 2, 5, 8, 10, 12-14, 18-21) is unclear. This is because it is unknown if SEQ ID NO:44 or homologs thereof are endogenous to the recombinant fungal cell or if the recombinant fungi cells are transfected/transformed to import exogenous SEQ ID NO:44 (or DNA encoding it).
In addition, it is unknown if the recombinant fungi cells are deletion mutants or if the expression of SEQ ID NO:44 (or DNA encoding it) in said recombinant fungi cells is suppressed by a modulatory factor such as an inhibitor etc.
Claims 5, 8, 10, 12-14, 18-21 are merely rejected for depending from claim 1.
Claims 13 is 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. Claim 13 depends from canceled claim 9, which is improper.
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, 5, 8, 10, 12-14, 18-21 are rejected under 35 U.S.C. 102(a)(2) as anticipated by “Ambrose” (US 2021/0076685, 3/2021) or, in the alternative, under 35 U.S.C. 103 as obvious over Ambrose .
Ambrose in in [0007], discloses the following:
[0007] The present invention is based on the discovery that a plant element (e.g., a whole plant, seedling, meristematic tissue, ground tissue, vascular tissue, dermal tissue, seed, leaf, root, shoot, stem, flower, fruit, stolon, bulb, tuber, corm, Kelis, shoot, bud) can be effectively augmented by associating its surface with a single endophyte strain or a plurality of endophytes in an amount that is not normally found on the plant element. Endophytes described herein can be isolated from inside the same plant or a different plant, or from inside a part or tissue of the same plant or different plant. The plant element thus associated with a single endophyte strain or a plurality of endophytes can be used to confer improved agronomic trait or traits to the seed or the plant that is grown or derived from the plant element.
In [0014], Ambrose recites: in some embodiments, the endophyte comprises a 16S rRNA or ITS rRNA nucleic acid sequence at least 95% identical to a nucleic acid sequence selected from the group consisting of SEQ ID NOs: 1-455. In some embodiments, the endophyte is capable of a function or activity selected from the group consisting of auxin production, nitrogen fixation, production of an antimicrobial compound, mineral phosphate solubilization, siderophore production, cellulase production (see also claims 8-9), wherein said cellulase is a POI and is an enzyme.
In [0167], according to Ambrose, “ An “endophyte” or “endophytic entity” or “endophytic microbe” is a symbiotic organism (e.g., a microorganism, e.g., a bacterium, e.g., a fungi) capable of living within a plant or is otherwise associated therewith, and does not cause disease or harm the plant otherwise, and confers one or more beneficial properties to the host plant.”.
The closest amino acid sequence disclosed in Ambrose to instant SEQ ID NO:44 is SEQ ID NO:2676, which only displays 45.8% identity thereto (see attachment 1, wherein the PCT application PCT/US15/68206 shown, corresponds to the parent case of Ambrose) and hence, Ambrose fungi lack 95% or higher homologs of instant SEQ ID NO:44 (or DNA encoding them).
In [0763-0766] and [0769-0771], the growth conditions of recombinant fungi in solid and liquid media, respectively, are discussed. Said recombinant fungi cells of Ambrose are inherently capable of producing increased amounts of cellulase relative to patent fungal cells under the same conditions.
Therefore, it is believed that the teachings of Ambrose anticipate this invention or as a whole, render it obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5, 8, 10, 12-14, 18-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 10, 24, ) 29, 31-32 of copending Application No. 18/578,223. Although the claims at issue are not identical, they are not patentably distinct from each other because: the recombinant fungal cell claims in said copending application are inherently deficient in regulatory proteins having at least 85% SEQ ID NO:44 and methods in said copending application (see claims 24, 29, 31-32) utilize said fungal cells being deficient in proteins having 95% or more identity to SEQ ID NO:44 by inherency.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651