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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 November 2025 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on 20 November 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,028,407 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Status of the claims
Claims 34, 43-44, and 47-51 are pending and examined herein.
The rejection of claims 34, 44 and 47-49 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-8, and 10 of U.S. Patent No. 11,028,407 B2 is withdrawn in light of Applicant’s filing of a terminal disclaimer.
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.
Written Description
Claims 34, 43-44, and 47-51 remain 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 claims contain 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. Due to Applicant's amendment of the claims, this rejection is modified from the rejection set forth in the Final Rejection mailed 15 August 2025. Applicant' s arguments filed 20 November 2025 have been fully considered but they are not persuasive.
Claims 34, 43-44, and 47-51 require a polypeptide with 97% identity to SEQ ID NO: 798, wherein
said polypeptide has insecticidal activity against Lepidopteran insects.
Polypeptides with 97% identity to the 877 amino acid long SEQ ID NO: 798 encompass polypeptides with 26 amino acid substitutions relative to SEQ ID NO: 798. Polypeptides with 35 amino acid substitutions relative to SEQ ID NO: 798 encompass more than 2026 (6.71 X 1033) unique polypeptides.
The specification discloses SEQ ID NO: 798 (page 87, lines 12-15). It does not disclose any polypeptides with at least 97% identity to SEQ ID NO: 798 and which have the claimed function of insecticidal activity against Lepidopteran insects.
The prior art does not teach sequences with at least 97% identity to SEQ ID NO: 798, with or without the claimed function.
Thus, the specification describes a single species of the vast claimed genus. The prior art fails to disclose any additional species.
The specification does not offer any description or disclosures related to the function or structure of SEQ ID NO: 798 beyond the amino acid sequence. The specification does not disclose any structural features of SEQ ID NO: 798 that would provide the claimed functions. The specification teaches that SEQ ID NO: 798 is a PtIP-83 protein, but does not disclose the type of PtIP-83, which have different structures and insecticidal activities (page 87, lines 12-15; Table 2; Table 12), and some of which have no function at all against Lepidopteran insects.
Post-filing Jimenez-Juarez et al 2023 (US 20230340522 A1) describes two sequences, SEQ ID NOs: 798 and 968, with 100% identity to the instant application’s SEQ ID NO: 798 (alignment not included in office action). Jimenez-Juarez et al further discloses: said sequences are PtIP-83Gb proteins; PtIP-83Gb has activity against Fall Armyworm, Corn Earworm, Soybean Looper, and European Corn Borer; PtIP-83Gb does not share BBMV binding sites with PtIP-83Aa/SEQ ID NO: 1 (paragraph 0012; Table 12; paragraph 0496; and Table 26).
Other, post filing art discloses that the polypeptide of SEQ ID NO: 798 is also known as IPD083Gb and has insecticidal activity against Corn Earworm and, further, that IPD083 proteins bind to Corn Earworm brush border membrane vesicles (BBMV)( Liu et al 2019, Toxins 11: 383; Page 5, Table 1, IPD0883Gb; page 6, Figure 3; page 9, paragraphs 1-2; page 14, paragraph 2; NCBI 2019, GenBank Accession Number: KY558381).
Neither of the post filing references, however, describe any structural characteristics of PtIP-83Gb proteins.
The specification describes several conserved sequence motif’s present in other PtIP-83 proteins, but does not describe which, if any, of said motifs are present in PtIP-83Gb/SEQ ID NO: 798 (Table 2). The specification does not disclose the relationship between these structures and the various insecticidal activity of said other PtIP-83 proteins. The specification does not disclose which motifs are necessary and sufficient for insecticidal activity or which, if any, are necessary and sufficient for pest specificity.
Moreover, there is variability among the various PtIP-83 proteins in terms of presence/absence of the disclosed motifs—some PtIP-83 proteins lack certain motifs. Further SEQ ID NOs: 9, 11 and 13 (PtIP-83Cc, PtIP-83Cd, and PtIP-83Ce, respectively) all possess the full complement of motifs, but differ in their pest specificity (Table 2 and Table 12). Thus, not only does the specification fail to disclose a structure-function relationship, but there also appears to be variability in the relationship between the disclosed motifs and the insecticidal activity and pest specificity of PtIP-83 proteins.
Thus, the specification has not adequately described the structural features that distinguish insecticidal proteins that have activity against Lepidopteran insects from other polypeptides with at least 97% identity to SEQ ID NO:798 but which lack the claimed function.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly diverse, SEQ ID NO: 798 is insufficient to describe the claimed genus.
Hence, Applicant has not, in fact, described insecticidal proteins that have insecticidal activity against Lepidopteran insects over the full scope of claims 34, 43-44, and 47-51 and the specification fails to provide adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Response to Applicant’s Remarks filed 20 November 2025 in response to the previous 112(a) written description rejection:
Applicant argues that the amendment of independent claims 34, 47, and 50 to recite 97% sequence identity to the amino acid sequence of SEQ ID NO: 798 overcomes the written description rejection. Applicant argues that, in light of the amendment to the claims, the specification provides sufficient description to support claimed invention. Applicant cites case law drawn to the interpretation of the written description requirement in support of their argument.
This is not found persuasive.
As a first matter, as set forth above in the modified rejection in more detail, the genus of amino acid sequences encompassed by polypeptides with at least 97% sequence identity to SEQ ID NO: 798 is still exceedingly vast and, given Applicant’s failure to describe the common attributes that identify members of the genus (i.e. the structure-function relationship), SEQ ID NO: 798 is insufficient to describe the claimed genus and show that Applicant was in possession of the claimed genus. As set forth above, Applicant does not disclose the activity of SEQ ID NO: 798 (or any other PtIP-83Gb protein) nor does Applicant describe which, if any, of the identified motifs are present in PtIP-83Gb/SEQ ID NO: 798. Additionally, there appears to be significant variability in the relationship between the arrangement and presence/absence of these motifs and insecticidal activity and specificity. Applicant’s amendment to narrow the scope of the claimed genus of polypeptides does not overcome these deficiencies.
Applicant argues that the written description requires only a description of a representative number of species or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus (Remarks, page 4, paragraph 5 and citations therein). Applicant argues that size alone cannot be the basis of a written description rejection and that disclosed species are representative when they reflect the diversity of the genus (Remarks, page 6, first paragraph, and citations therein). In the instant case Applicant has not disclosed either a representative number of species or structural features common to the members of the genus. The rejection is not based solely on the size of the genus, but rather on the both of these deficiencies. Applicant describes a single species out of a genus of 6.71 X 1033 polypeptides--this cannot be considered representative. Further, as explained in the rejection above, applicant has not disclosed a structure-function relationship and such a relationship is not taught in the prior art.
Applicant argues on that a perfect correspondence between the members of the genus and the asserted structural features does not need to be perfect and the written description analysis must take into account the state of the art (Remarks, pages 5-6, bridging paragraph, and citations therein). The written description rejection sets forth why the disclosure of motifs and activity in Tables 2 and 12 is insufficient. Applicant’s own disclosure demonstrates that proteins comprising the same complement of motifs can have different insecticidal activities and specificities. Applicant discloses that 4 of the 21 PtIP-83 polypeptides assayed, have no insecticidal activity at all (nearly 20%). Thus, there is no clear disclosure of a structure-function relationship and substantial evidence of variability in any relationship between the presence of the discloses motifs and any functional activity. Thus, one of skill in the art would not be able to envision or predict which members of the claimed genus have the required function and which do not. Indeed, even identifying a polypeptide as member of the broad class of PtIP-83 polypeptides may be insufficient to predict if said polypeptide has any insecticidal activity against Lepidopterans at all. The prior art does not remedy this deficiency as explained above because it provides no teachings directed to the structure-function relationship of the claimed genus of polypeptides.
Applicant argues that the written description requirement does not demand either examples or an actual reduction to practice (Remarks, pages 5-6, bridging paragraph, final line). Applicant has not elaborated on this argument or provided any nexus between this statement and the written description rejection of claims of 34, 43-44, and 47-51. Examiner notes that the rejection is based on the failure of Applicant to disclose either a representative number of species or structural features common to members of the claimed genus such that one of skill in the art would recognize members of the genus.
For the reasons above, the rejection is maintained.
Enablement
Claims 34, 43-44, and 47-51 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Due to Applicant's amendment of the claims, this rejection is modified from the rejection set forth in the Final Rejection mailed 15 August 2025. Applicant' s arguments filed 20 November 2025 have been fully considered but they are not persuasive.
Claims 34, 43-44, and 47-51 are broadly drawn to polynucleotides encoding an insecticidal polypeptide with 97% identity to SEQ ID NO: 798, transgenic plants and insecticidal compositions comprising said polypeptide, and methods of using said polypeptide to control insect pests.
However, the specification does not teach how to use sequences with 97% identity to SEQ ID NO: 798 as insecticidal polypeptides against Lepidopterans.
As explained above in the rejection for failing to comply with the written description requirement above, the genus encompassed by polypeptides with 97% identity to SEQ ID NO: 798 is vast.
The specification only teaches SEQ ID NO: 798. It does not teach any other sequences with 97% identity to SEQ ID NO: 798. The prior art does not rectify this shortcoming. The sequence with the highest identity to SEQ ID NO: 798 is derived from the fern Osmunda regalis and has just 45.1% sequence identity to the instant sequence (UniProt, 2019, Accession A0A3S6ZRD7).
The specification does offer any teachings regarding the insecticidal activity or pest specificity of SEQ ID NO: 798 or PtIP-83Gb polypeptides.
The specification does not teach any structures that provide the function of insecticidal activity to SEQ ID NO: 798/PtIP-83Gb or other PtIP-83 polypeptides.
The specification teaches several conserved sequence motif’s present in other PtIP-83 proteins, but does not teach which, if any, of said motifs are present in PtIP-83Gb/SEQ ID NO: 798 (Table 2). The specification does not teach the relationship between these structures and the various insecticidal activity of said other PtIP-83 proteins. The specification does not teach which motifs are necessary and sufficient for insecticidal activity or which, if any, are necessary and sufficient for pest specificity. The specification does not teach which, if any, motifs confer the function of insecticidal activity against Lepidopterans.
Moreover, there is substantial unpredictability in the relationship between the disclosed motifs and the insecticidal activity and pest specificity of PtIP-83 proteins. SEQ ID NOs: 9, 11 and 13 (PtIP-83Cc, PtIP-83Cd, and PtIP-83Ce, respectively) all possess the full complement of motifs, but differ in their pest specificity (Table 2 and Table 12).
Thus, not only does the specification fail to teach the function of SEQ ID NO: 798, or the function of any polypeptides with 97% identity to said sequence, it does not provide a way to determine the function from structural features of said polypeptides.
At the time of filing of the instant application’s priority document, the prior art did not provide any teachings regarding the claimed function, activity or structure.
As such, a person of skill in the art would be forced to develop and evaluate polypeptides with 97% or more identity to SEQ ID NO: 798 to determine their insecticidal activity. Doing so for even a representative number of polypeptides would constitute undue trial and error experimentation.
The specification provides worked examples of transgenic plants and insecticidal compositions comprising SEQ ID NO: 1/PtIP-83Aa, and methods of using said polypeptide to control insect pests (Examples 1-13). However, the specification does not provide any worked examples of transgenic plants and insecticidal compositions comprising SEQ ID NO: 798/PtIP-83Gb, or methods of using SEQ ID NO: 798/PtIP-83Gb to control insect pests.
Given the vastness of the genus, the lack to guidance in the specification, the unpredictability in the art, and the lack of worked examples, a person having ordinary skill in the art would not have been able make and/or use the instant invention at the time the application was filed without undue experimentation. Thus, the instant invention is not enabled.
Response to Applicant’s Remarks filed 11 December 2024 in response to the previous 112(a) enablement rejection:
Applicant argues that the amendment of independent claims 34, 47, and 50 to recite 97% sequence identity to the amino acid sequence of SEQ ID NO: 798 overcomes the enablement rejection. Applicant argues that, in light of the amendment to the claims, the specification provides reasonable enablement to support the claimed invention without resorting to undue experimentation (Remarks, page 7). Applicant cites case law and USPTO guidelines for assessing enablement.
This is not found persuasive.
As set forth in detail in the previous and current enablement rejections, the specification does not provide sufficient teachings, guidance or worked examples that would allow a person having ordinary skill in the art to make or use the claimed genus of insecticidal polypeptides given the size of the claimed genus and the level of unpredictability regarding any structure-function relationship . As explained above, there are no teachings in the specification relating to the function of SEQ ID NO: 798 as an insecticidal polypeptide nor any teachings directed to the structures which would provide said function. There are no examples reduced to practice regarding how to use SEQ ID NO: 798 as an insecticidal polypeptide or how to make polypeptides with at least 96% sequence identity to SEQ ID NO: 798 that have function of insecticidal activity against Lepidopteran insects.
Applicant has not provided any arguments drawn to the substance of the enablement rejection set forth above. Applicant merely provides a summary of the guidelines for assessing enablement and citations from case law. Furthermore, applicant has not provided any nexus between the case law cited and the merits of the enablement rejection. Applicant cites from case law drawn to general principles of assessing enablement, for example: “considerable amount of experimentation is permissible, if it is merely routine or if the specification provides a reasonable amount of guidance” (Remarks, pages 7, 3rd paragraph; citation of Cephalon). However, in the instant case, as explained above, there is no guidance in the specification drawn to using or making SEQ ID NO: 798 as an insecticidal polypeptide with activity against Lepidopteran insects. There are only prophetic statements such as (Specification, page 87, lines 12-15):
“In some embodiments polynucleotides are provided encoding a PtIP-83 polypeptide
comprising an amino acid sequence having at least 80%, at least 85%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98% or at least 99% sequence identity to any one of SEQ ID NO: 786-888.
Applicant reminds Examiner that one must establish, on the record, a reasonable basis for questioning the adequacy of the disclosure. However, Applicant does not provide any arguments drawn to the adequacy of the rejection or refuting any of the points raised by Examiner.
Applicant cites from Amgen and USPTO Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., Federal Register / Vol. 89, No. 7 (Jan. 10, 2024) to argue that not all embodiments of the claimed genus must be described and that describing a subset of embodiments can suffice if some general shared quality is disclosed that give said genus a “peculiar fitness for the particular function”. Again, however, Applicant has not provided any arguments drawn to Examiners position that the specification is not enabling for the claimed genus of polypeptides—Applicant does not provide an example of the described subset of embodiments that enable the invention or the disclosure of a shared quality (i.e. structure-function relationship) that provide reasonable enablement of the claimed genus of polypeptides with insecticidal activity against Lepidopteran insects.
Examiner reminds Applicant that the USPTO Guidelines for Assessing Enablement in Utility Applications and Patents (as cited above) make clear that in their Amgen decision the court affirmed previous Federal Circuit decisions that held that synthesizing and screening billions of compounds to determine if they were functional would indeed constitute undue experimentation (see for example , page 1564, paragraph bridging columns 2-3; page 1564, column 3, first paragraph; page 1565, column 3, first paragraph, and final paragraph). Thus, developing and evaluating polypeptides with 97% or more identity to SEQ ID NO: 798 (a genus of extraordinary size) to determine their insecticidal activity, for even a representative number of polypeptides, would likewise constitute random trial and error experimentation and thus constitutes unreasonable experimentation outside the bounds allowed by 35 U.S.C 112(a).
For the reasons above, the rejection is maintained.
Subject Matter Free of the Prior Art
Claims 34, 43-44, and 47-51 are free of the prior art, given the failure of the prior art, to teach or suggest a polynucleotide encoding a polypeptide having at least 97% identity relative to SEQ ID NO: 798. The closest prior art made of record is Markham et al (2006, International Journal of Plant Sciences 167:111-117). Markham et al teaches polypeptides isolated from fern and moss that display insecticidal activity against Lepidopteran pests (Figures 3-4). However, Markham does not reasonable teach or suggest a polypeptide having at least 97% identity relative to SEQ ID NO: 798 nor does it suggest screening or using Adiantum raddianum as a source of insecticidal polypeptides.
Conclusion
No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEKSANDAR RADOSAVLJEVIC whose telephone number is (571)272-8330. The examiner can normally be reached Monday--Friday 8-5:30.
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/ALEKSANDAR RADOSAVLJEVIC/ Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
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