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 .
Status of the Application
1. Claims 1-3, 8, 16, 19-24, 28-31, 33-35, and 38-39 are pending and subject to examination on the merits. Claims 1-3, 8, 16, 19-24, and 28-31 are withdrawn from consideration as being drawn to non-elected subject matter. Claims 33-35 and 38-39 are currently under examination.
Priority
2. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 63/476,393 filed 21 December 2022.
Election/Restrictions
3. Group III, claims 33-35 and 38-39, was elected. Claims 1-3, 8, 16, 19-24, and 28-31 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Additionally, SEQ ID NO: 99 is the elected species. Election was made without traverse in the reply filed on 05 February 2026.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 07 September 2021 and 12 July 2022 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Rejections - 35 USC § 112(a)
5. 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:
6. Claims 33-35 and 38-39 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.
The claims are drawn to a method of modifying a target nucleic acid in any cell or particularly a plant cell, wherein the method comprises introducing an expression cassette, comprising a polynucleotide encoding a promoter sequence, and a polynucleotide encoding a polypeptide that has at least 70% or more sequence identity to SEQ ID NO: 99, where the method further comprises regenerating the plant cell comprising the modified target nucleic acid to produce a plant comprising the modified target nucleic acid.
MPEP 2163(1):
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en bane); Vas-Gath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description"). The written description requirement has several policy objectives. "[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The 'written description' requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent's term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Gath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
7. The claims are drawn to a method of modifying a target nucleic acid in any cell or specifically, a plant cell, wherein the method comprises introducing an expression cassette, comprising a polynucleotide encoding a promoter sequence, and a polynucleotide encoding a polypeptide that has at least 70% or more sequence identity to SEQ ID NO: 99, where the method further comprises regenerating the plant cell comprising the modified target nucleic acid to produce a plant comprising the modified target nucleic acid. The variability in all cells, prokaryotic and eukaryotic, and specifically, plant cells, coupled with generating an actual plant from the plant cells is enormous. It is unknown which cell or cells should be used to accomplish this feat or what kind of plant is to be used, and gene targeting in plants remains challenging due to low efficiency in homologous recombination, promoter, sgRNA, target genome (diploid or polyploid), and transformation methods as taught by Zaman et al (Zaman et al., 2024, Trends in Biotechnology—cited herein; p. 568-569, “Limitations of the CRISPR system”). The specification does not describe any method of introducing an expression cassette to modify a target nucleic acid in a plant cell. At most, the specification describes the use of an expression cassette utilizing SEQ ID NO: 99 in HEK293T cells. However, how an expression cassette targets and introduces changes into a specific cell, i.e. HEK293T cells, is not predictive in how the method would work or not work in any cell or plant cell, and further, how said plant cell would generate an entire modified plant is also unknown. Here the specification is incomplete and it mandates that those skilled in the art must then figure out the aimed invention. Thus, the claims do not find adequate support in any place in the specification to show that possession of methods for modifying a plant cell and subsequently generating a modified plant. The courts have established:
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336 (Fed. Cir. 2013):
A patent, however, "is not a reward for the search, but compensation for its successful conclusion." Ariad, 598 F.3d at 1353 (quoting University of Rochester, 358 F.3d at 930 n.10). For that reason, the written description requirement prohibits a patentee from "leaving it to the ... industry to complete an ufinished invention.” Id.
Claim Rejections - 35 USC § 112(b)
8. 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.
9. Claims 38-39 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.
Regarding claim 38, the phrase "at least about" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention; specifically, it is unclear where “at least” is delineated, i.e. 70% or less or more due to the presence of “about.” It is recommended to delete either “at least” or “about.” For examination purposes, the claim will be broadly but reasonably interpreted as “about 70% or more.” See MPEP § 2173.05(d). Claim 39 is included in the instant rejection, since it does not mitigate the issue.
Claim Rejections - 35 USC § 112(d)
10. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
11. Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 39 introduces the limitation “wherein the polypeptide is the polypeptide of claim 1;” however, claim 1 recites the identical limitation recited in claim 38 (from which claim 39 depends) in regards to the polypeptide. Specifically both claims recite “a polypeptide that has at least about 70% or more sequence identity to one or more of SEA ID NOs: 96-133.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
12. 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.
13. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
14. Claims 33-35 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Bothmer et al (Bothmer et al., 2021, WO 2021/178720 A2—cited herein; front page and pertinent cited pages included due to file size). Regarding claims 33-35 and 38-39, drawn to a method of modifying a target nucleic acid in any cell, specifically, a plant cell to produce a plant comprising the modified target nucleic acid (claim 34), wherein the method comprises introducing an expression cassette (claim 33) consisting of a CRISPR-Cas effector protein, a polypeptide that has about 70% or more sequence identity to SEQ ID NO: 99, and an extended guide nucleic acid (claims 38-39), and wherein the introducing is carried out at a temperature of about 20-42oC, Bothmer et al. teaches novel compositions, systems, and methods for altering a genome at one or more locations in a host cell in vivo or in vitro (p. 2, Summary of Invention). Specifically, Bothmer et al. teaches the utilization of Gene Writer systems to modify a plant or plant part to increase the fitness of a plant, where the plant is contacted by the Gene Writer™ system, encoded by a vector, wherein nucleic acid are introduced into a plant or a part of plant (p. 1286-1287, “A. Delivery to a Plant”). Bothmer et al. continues to teach that the Gene Writer™ system can be delivered to a part of the plant or to a plant embryo, resulting in a plant with the genetic alteration (p. 1292, paragraph 3). Bothmer et al. teaches that the system or components of the system may be delivered to the cells utilizing a vector, a plasmid or virus, containing a retrotransposase, template nucleic acid, and a ribonuclear protein (p. 1294), where the retrotransposase may be SEQ ID NO: 8003, also termed “AVIRE_P03360_3mut,” which shares 99.8% sequence identity to SEQ ID NO: 99 of the instant claims (See Supplemental file: 20260226_082634_us-18-391-959-99.rag, result 2, entry 8 (duplicate 7); Bothmer et al., p. 1022, Table 44). Notably, the Gene Writer™ polypeptide may comprise a CRISPR-associated endonuclease domain that binds a template RNA, comprising a gRNA, which binds a DNA sequence (p. 1056, “Endonuclease domain”). Lastly, Bothmer et al. teaches some embodiments, where the Gene Writer™ polypeptide system is introduced to a host cell at room temperature (25oC) and then further incubated at 37oC for 3 days (p. 1110, last paragraph).
Bothmer et al., does not teach the specific transfection of a plant cell with a gene expression cassette encoding CRISPR/Cas effector protein system, SEQ ID NO: 99 polypeptide, and a guide nucleic acid (claim 38) and at a temperature of about 20-42oC.
Nonetheless, it would be obvious to one of ordinary skill in the art to utilize the system taught by Bothmer et al. to transfect a plant cell to produce a plant utilizing a CRISPR/Cas ribonuclear protein, guide RNA, and SEQ ID NO: 99 at a temperature of about 20-42oC because Bothmer et al. teaches all of these components in detail, where a skilled artisan would need only to choose to put these components in combination. One skilled in the art would be motivated to combine these reagents to transfect a plant seed to produce a transgenic plant to increase the fitness of the plant as taught by Bothmer et al (p. 1287, “A. Delivery to a Plant,” first paragraph). Specifically, an increase in fitness could be manifested in a number of ways, e.g. better production of the plant, improved yield, improved vigor, improved pre- or post-harvest traits, and/or improvement of traits beneficial to humans, i.e. decrease in allergen production (p. 1288, second paragraph). There would be a reasonable expectation of success in transfecting a plant cell to produce a plant utilizing a method involving contacting a plant cell with a gene expression cassette comprising a guide RNA, CRISPR/Cas protein, and SEQ ID NO: 99 to produce a plant, since Bothmer et al. teaches all aspects of this specific combination in various embodiments, and one would only need to merely optimize well-known reagents and methods in the art to deduce this specific methodology.
Conclusion
15. All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656