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 of Group I (claims 1-2, 5, 12, 16-17, 20-23, and 43-45) as well as (A): SEQ ID NOs: 29 and 10 in the reply filed on 24July2026 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Claims 24, 36, 47-48, 52-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group of invention and/or species, there being no allowable generic or linking claim.
This Subject Matter Was Already Examined and Allowed
Further to the Obvious-type Double Patenting rejection herein below, claims nearly identical to these and encompassing the elected sequences SEQ ID NOs: 29 and 10 were already examined and allowed in parent application 17413743 (now US Pat. No. 12285019). Please note the rejoinder of species within the nonfinal action dated 29August2023 and the Notice of Allowance dated 20May2024.
Status of the Claims
The claims filed 24July2026 are acknowledged and have been fully considered. Claims 1-2, 5, 12, 16-17, 20-24, 36, 43-45, 47-48, 52-54 are pending. Claims 3-4, 6-11, 13-15, 18-19, 25-35, 37-42, 46, 49-51, 55-57 are canceled. Following the restriction requirement mailed 05June2026 and Applicant’s election dated 24July2026, claims 24, 36, 47-48, 52-54 are withdrawn as being directed toward a non-elected group and/or species (rejoinder currently being inappropriate).
Claims 1-2, 5, 12, 16-17, 20-23, 43-45 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 62780808 filed 17December2018]; 35 U.S.C. 365(c) [national stage of PCT/US19/64826 filed 06December2019]; and 35 U.S.C. 121 [17413743 filed 14June2021] is acknowledged. Claims 1-2, 5, 12, 16-17, 20-23, 43-45 have an effective filing date of 17December2018.
Claim Rejections - 35 USC § 112 - Indefiniteness
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, 12, 16-17, 20-23, 43-45 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.
These claims refer to an amino/nucleic acid sequence that has “at least 80% to at least 99% sequence identity” to a list of SEQ ID NOs. The phrase “at least 80% to at least 99% sequence identity” makes these claims indefinite because it is unclear whether the encompassed sequences have only between 80% and 99% identity to the referenced list of SEQ ID NOs (i.e., not including those having 100% identity to the SEQ ID NOs) or whether the encompassed sequences include the list of SEQ ID NOs themselves (i.e., does include those having 100% identity to the SEQ ID NOs). Especially in view of claim 2 (which depends upon claim 1), it is assumed that Applicant intended to include 100% sequence identity in this claim language and so the claims have been interpreted for the purpose of examination in the latter aspect (i.e., that this phrase includes those sequences having 100% sequence identity to the SEQ ID NOs).
An amendment to recite simply “at least 80% sequence identity to any one of SEQ ID NOs: …” would be remedial of this issue. In view of the Written Description discussion below, however, an amendment to “at least 95% sequence identity to any one of SEQ ID NOs: …” is recommended.
Claims 1, 2, 12 (and, therefore, 5, 16-17, 20-23, 43-45 which refer thereto without correcting the issue) 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.
These claims recite “with any of” or “of any of” a list of SEQ ID NOs: SEQ ID NOs: 1-17 or 18-40. At least because the recited sequences encompass both “SMIP1Aa” and “SMIP2Aa” sequences, the phrase “any of” makes these claims indefinite because it is unclear whether the claimed sequence is a “SMIP1Aa” sequence or an “SMIP2Aa” sequence or whether the claimed subject matter is somehow both of those.
It is recommended that “any of” be amended to “any one of”.
Claim 20 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.
The phrase “the transgenic plant cell of claim 17” lacks antecedent basis (note claim 17 is directed toward a host cell).
Claim Rejections - 35 USC § 112 – Written Description
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 1-2, 5, 12, 16-17, 20-23, 43-45 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.
Executive Summary of the Issues:
These claims recite an amino/nucleic acid sequence with as little as 80% sequence identity to SEQ ID NOs: 1-17 and/or 18-40 that is supposedly “toxic to an insect pest”, but (i) the claims do not clarify whether the sequences still comprise or encode a mutation (note SEQ ID NOs: 1 and 17 are naturally occurring1) and, even if the claims specified “mutant, insecticidal” amino/nucleic acids, (ii) all of the insecticidal sequences in this specification (which is unaided by the prior art) have at least 95% sequence identity to each other (see screenshot hereinbelow), and (iii) not all of the recited amino/nucleic sequences are insecticidal (note SEQ ID NOs: 11, 15, and 16 are not insecticidal). RE (a): please consider amending the claims to recite “mutant, insecticidal” nucleic acid molecules comprising a sequence with at least 95% sequence identity to “any one of” SEQ ID NOs: 21-29, 31-33” and “mutant, insecticidal” proteins comprising a sequence with at least 95% sequence identity to “any one of” SEQ ID NOs: 2-10, 12-14”.
These claims recite “fragments” of an amino/nucleic acid molecule that is supposedly toxic to an insect pest. (i)-(iii) from (a) above are also relevant here with respect to “fragments”. RE (b): please consider deleting the “fragment” concept from the claims.
and
Certain claims suggest that the mutant, insecticidal amino/nucleic acid molecule is useful within any host cell (claims 17 and 43) or within any [transgenic] plant cell (claims 20-22, 44-5), but the specification (which is unaided by the prior art) only shows that such molecules are useful within bacterial host cells and [transgenic] maize plants/plant parts. RE (c): please consider amending these claims to specify that the host cells are bacterial host cells and that the plants/plant parts are maize plants/plant parts.
The specification only shows that the mutant “SMIP1Aa” proteins comprising one of SEQ ID NOs: 2-10, 12-14 are insecticidal against Western Corn Rootworm (Diabrotica virgifera virgifera) when constitutively expressed (e.g., via the maize ubiquitin constitutive promoter) in maize/corn.2 To be clear, the specification does not describe even one (RE (a)) insecticidal amino/nucleic acid molecule having a sequence with as little as 80% sequence identity to SEQ ID NOs: 18-40 or 1-17, respectively, or even one (RE (b)) toxin-encoding fragment. For further clarity, there appears to be no evidence in the specification that mutant “SMIP1Aa” proteins comprising SEQ ID NO: 11, 15, or 16 have insecticidal activity (noting that SEQ ID NOs: 1 and 17 are not mutant sequences). Please note that all SMIP1Aa amino acid sequences 1-16 have at least 95% sequence identity to each other (see alignment screenshot provided hereinbelow and note that SEQ ID NO: 17 is a naturally occurring, non-mutant SMIP2Aa sequence). In addition, (RE (c)) the specification does not demonstrate that even molecules comprising (i.e., 100% identical to) one of SEQ ID NOs: 2-10, 12-14, 21-29, 31-33 would be useful within a non-bacterial host cell or within a non-maize plant/plant part.
The prior art does not (and, in fact, cannot) supplement the deficiencies of this specification at least because Applicant appears to be the first to describe (what it calls) “SMIP1Aa” proteins comprising one of SEQ ID NO: 1-16 (and their corresponding nucleic acid sequences) and the “SMIP2Aa” protein comprising SEQ ID NO: 17 (and its corresponding nucleic acid sequence(s)).
The limited structure::function description provided by this specification does not span the breadth of the present claims and does not appear to be supplemented by knowledge within the prior art. Without more, there is neither a description of a sufficient number of species within the claimed genus that are ‘representative of the full variety and scope of the genus’ nor the establishment of ‘a reasonable structure::function correlation’ sufficient for a skilled artisan at the time of filing to reasonably believe Applicant was in possession of the full metes and bounds of these claims. See MPEP § 2163(II)(A)(3)(a)(ii). Please consider the claim amendments suggested above.
The alignment below which is the sequence search results file “20260824_155455_us-19-089-698-10.rapbm” dated 24August2026):
PNG
media_image1.png
293
695
media_image1.png
Greyscale
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 1-2 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature without significantly more. See MPEP § 2106.
Step 1: These claims are directed toward a statutory category (e.g., compositions of matter). In particular, these claims are directed toward or encompass nucleic acid molecules encoding, or a protein comprising, SEQ ID NOs: 1 or 17. According to the specification, SEQ ID NOs: 1 and 17 are naturally occurring proteins encoded by naturally occurring nucleic acid molecules.3
Step 2A: The Court has previously held that a claim directed toward isolated DNA, without more, is directed toward a judicial exception/law of nature.4 There is no evidence of record to show that the analysis regarding the claimed nucleic acid molecules or proteins would be materially different than that by the Court for “isolated DNA”. Therefore, these claims are directed toward a judicial exception/law of nature.
Step2B: These claims do not recite additional elements (individually or in combination) beyond the judicial exception. In particular, the additional text within these claims provide non-limiting intended uses of the nucleic acid molecules and/or proteins. Therefore, the claims do not recite additional elements that amount to “significantly more” than the recited judicial exception/law of nature itself. These claims are directed toward subject matter that makes them patent ineligible.
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 1-2, 5, 12, 16-17, 20-23, 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,285,019 (issued from parent Appl. No. 17413743). Although the claims at issue are not identical, they are not patentably distinct from each other.
As stated above, please note the rejoinder of species within the nonfinal action dated 29August2023 and the Notice of Allowance dated 20May2024.
Claims 1-12 of US Pat. No. 12,285,019 teach a species of this application’s claims 1-2, 5, 12, 16-17, 20-23, and 43-45. Specifically:
Claim(s) __ of US Pat. No. 12,285,019 teach
Claim(s) __ of this application
1
1-2
2
5
3
12
4
16
5
17
6
20-23
8
43
9
44
10
45
The claims of US Pat. No. 12,285,019 are:
PNG
media_image2.png
300
871
media_image2.png
Greyscale
PNG
media_image3.png
303
424
media_image3.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad ABRAHAM can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA STEPHENS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
1 Example 1 at ¶160 on page 48 of the specification.
2 Tables 3-6 at pages 51-52 of the specification.
3 Example 1 at ¶160 on page 48 of the specification.
4 MPEP §§ 2106.04(I) 2106.04(b)(I) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013)).
Prosecution Insights