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
Applicant’s election without traverse of Group I, claims 1, 8, 9, 12, 13 and 18-21 in the reply filed on 5/11/2026 is acknowledged.
Claims 23, 30, 31, 34, 35 and 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5/11/2026.
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, 8, 9, 12, 13 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11, 832,601. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed genetically modified arthropod of claim 1 comprises the same genetic modification(s) and phenotype (reduction in viable offspring) as the genetically modified arthropod in claims 1-4 of ‘601.
The instant application was filed as a CON and the court has found that safe harbor does not apply when the continuing application is filed as CON. The court found that safe harbor from an ODP rejection only applies when a continuing application is filed as a DIV. See AMGEN INC., v. F. HOFFMANN-LA ROCHE LTD. 580 F.3d l340; 2009 U.S. App, LEXIS 20409; 92 U.S.P.Q.2D (BNA) 1289.
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, 8, 9, 12, 13 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.
When the claims are analyzed in light of the specification, the instant invention encompasses genetically modified arthropod comprising a bacterial operon encoding a sequence that is at least 60% identical to amino acid sequences SEQ ID NO: 2 (WD0631), SEQ ID NO: 4 (WD0632), SEQ ID NO: 6 (CidAwPip) and SEQ ID NO: 8 (CidBwPip) and said arthropod has a reduction in viable offspring in comparison to a corresponding wild-type arthropod.
Regarding function, the claims recite that the claimed arthropod has a reduction in viable offspring in comparison to a corresponding wild-type arthropod. However, the specification provides no description of any sequences other than the full-length sequence set forth in SEQ ID NOs, 2, 4, 6 and 8, that would indicate possession at the time of filing for a genetically modified arthropod that exhibits a reduction in viable offspring as claimed.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their structure. In the instant case, only SEQ ID NOs: 2, 4, 6 and 8 (amino acid) are sufficiently described to indicate possession of a genetically modified arthropod that exhibits decreased viability of offspring. The specification does not provide any disclosure as to what the complete structure would be of any amino acid sequence other than the one disclosed in the specification other than the full-length sequences as set forth in SEQ ID NOs: 2, 4, 6 and 8. The specification teaches no structural analysis for a nucleic acid sequence or the protein encoded in SEQ ID NOs: 2, 4, 6 and 8. This is significant since the claims recite a function for the produced protein.
However, the only disclosed protein(s) that function to reduce viability in offspring as claimed, are the ones disclosed in SEQ ID NOs: 2, 4, 6 and 8. As of the filing date, there was no known or disclosed correlation between a structure other than SEQ ID NOs: 2, 4, 6 and 8 and a reduction in viability of offspring. There is no general knowledge in the art about regarding the activity of an WD0631, WD0632, CidAwPip and CidBwPip to suggest that general similarity of structure confers the activity.
Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e. other than nucleotide or amino acid sequence), specific features and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only characteristic described, is that the proteins set forth in SEQ ID NOs: 2, 4, 6 and 8 reduce viability of offspring when expressed in an arthropod. The specification does not teach any other identifying characteristics such as domains relating to function/activity or any other related sequences that would guide the artisan to contemplate other amino acid sequences which are less than the full sequences set forth in SEQ ID NOs, 2, 4, 6 and 8 and exhibit the claimed function.
The specification teaches in Table 6 the full-length sequences for SEQ ID NOs: 2, 4, 6 and 8 and in Example 2 teach that expression of CidB and CidA in a transgenic D. melanogaster can lead to a reduction in offspring viability. However, again this function of the protein is related to its structure, which as stated above, the specification has only disclosed the full-length sequences for SEQ ID NO: 2, 4, 6 and 8 and any reduction in viability of offspring as embraced by the claims. However, the claims are not limited to only the full-length amino acid sequence, but rather a sequence which is at least 60% identical to SEQ ID NO: 2, 4, 6 and 8. In this regard, the art teaches the reduced viability, i.e. cytoplasmic incompatibility that results from expressing WD0631, WD0632, CidAwPip or CidBwPip is dependent on the sequence of the protein (see Beckman et al., 2013, Insect Biochemistry and Molecular Biology, Vol. 43, pgs. 867-878 and Wang et al., 2022, Nature Communications, Vol. 12:1608, pgs. 1-9).
The skilled artisan could not rely upon the disclosure in the specification such that the specification would sufficiently describe that Applicant was in possession of variants and functional fragments of SEQ ID NOs: 2, 4, 6 and 8 at the time of filing. While the structure and function of the full-length human WD0631, WD0632, CidAwPip and CidBwPip proteins and nucleotide sequence are known, the specification has not described any other structural characteristics of a nucleic acid sequence that encodes an amino acid sequence that results in a reduction in offspring viability when expressed in a transgenic arthropod.
Applicants' attention is directed to the decision in Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, which clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
With the exception of the sequences referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides, and therefore conception is not achieve regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The nucleic acid itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only the amino acid sequences set forth in SEQ ID NOs: 2, 4, 6 and 8, meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
In conclusion, this limited information is not deemed sufficient to reasonably convey to one skilled in the art that applicant is in possession of the genus of amino acid sequences encoding WD0631, WD0632, CidAwPip and CidBwPip, variants and fragments thereof as embraced by the claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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