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 .
Specification
The Specification as amended on 26 June 2024 is objected to because incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 26, line 31, page 27, line 11, page 29, lines 3, 29 and 33, page 30, line 10, page 34, line 27, page 35, lines 26-27, and page 36, line 6. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located page 41, line 6.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Information Disclosure Statement
The listing of references on pages 51-54 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 1-16 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 Applicant’s claims are broadly directed to a method for reducing N2O production from the soil in a photosynthetic cell or plant, respectively, the method comprising the step of genetically modifying the photosynthetic cell or plant to express a cys-oleosin to reduce N2O. The claims are also broadly directed to a method for producing a photosynthetic cell or plant respectively, with increased CO2 assimilation, wherein the method comprises modifying the photosynthetic cell or plant with a cys-oleosin to reduce WSC (Claims 25 and 26). Photosynthetic cells that are included in the scope of the claims appear to include all photosynthetic cells species. Plants that are included in the scope of the claims appear to include all plant species and tissue types.
Applicant describes 17 oleosins (absent of an artificially introduced cysteine) suitable to be modified for use in the invention (both polynucleotide and polypeptide sequences), by their deposit numbers and species (Table 1, pages 15-16, SEQ ID NO: 13-24, 52, 54, 56, 58 and 60) and describes the listed oleosins as containing a central domain of approximately 70 non-polar amino acid residues (including a proline knot) uninterrupted by any charged residues, flanked by two hydrophilic arms. Applicant notes that typically oleosins do not contain cysteines (page 15, line 6), Applicant describes using a construct encoding the Cys-OLE of Winichayakul et al 2013 (instant SEQ ID NO: 49) comprising three engineered cysteine residues on each N- and C-terminal amphipathic arms in Example 1 on page 41.
Applicant does not describe the genus of methods for reducing nitrous oxide (N2O) production from the soil, the method comprising the step of genetically modifying the photosynthetic cell or plant to express a modified oleosin including at least one artificially introduced cysteine to reduce nitrous oxide production from the soil. Applicant does not describe a structure-function relationship between a modified oleosin including at least one artificially introduced cystine.
Winichayukal et al. (2013) discloses that modified cys-oleosin in combination with diacylglycerol O-acyltransferase in Arabidopsis led to a 24% increase in the CO2 assimilation rate and a 50% increase in leaf biomass as well as oil accumulation in the leaves and roots. Winichayukal et al. discloses that only the co-expression of DGAT1 and cys-oleosins enabled the long-term elevation of fatty acids in the leaf, and that only this embodiment could lead to an increase in CO2 assimilation.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
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 11-16 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.
Claims 11-14 are indefinite because it is unclear if the seed produced comprises the genetic modification. Hence, the metes and bounds of the claims are unclear.
At claim 11 is indefinite because at line 2, “plants produced” lacks proper antecedent basis in claim 1.
At claim 15, line 2, “A plant” and “for use” are indefinite because it is unclear which plant and what use the claim is directed to. Hence, the metes and bounds of the claim are unclears.
Claim 16 is indefinite because claim 11 is directed to a method of producing a seed, but the instant claim is directed to a method of using a plant. Hence, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winichayakul et al (2013, Plant Physiology 162: 626-639).
Winichayakul et al disclose modified oleosins that include at least one artificially introduced cystine in Figure 1 on page 628. Winichayakul et al disclose a plant genetically modified to express the modified oleosin “o1-3” containing four artificially introduced cystines and the triacylglycerol synthesizing enzyme DGAT1 (diacylglycerol O-acyltransferase) in Table 1 on page 629. Winichayakul et al disclose producing seed from the D1o3-3 plant on page 630, right column, 2nd paragraph. Winichayakul et al disclose planting the D1o3-3 plant in soil in Figure 3 on page 632. Hence, Winichayakul et al had previously disclosed the claimed invention.
See Integra LifeSciences I Ltd. V. Merck KGaA 50 USPQ2d 1846, 1850 (DC SCalif 1999), which teaches that where the prior art teaches all of the required steps to practice the claimed method and no additional manipulation is required to produce the claimed result, then the prior art anticipates the claimed method. Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
In the instant case, the claims are directed to an inherent property of the D1o3-3 plant without anything more. The inherent property includes the limitations of instant claims 5-10 because said claims do not recite anything more than what is disclosed by Winichayakul et al.
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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,987,551. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘551 disclose a subgenus of the instantly claimed genus. Practicing the invention of the claims of the ‘551 would inherently practice the invention of the instant claims. Essentially the instantly claimed invention would give the Applicant an improper timewise extension of the “right to exclude” others from practicing the invention of the ‘551 Patent.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,275,945. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘945 disclose a subgenus of the instantly claimed genus. Practicing the invention of the claims of the ‘945 would inherently practice the invention of the instant claims. Essentially the instantly claimed invention would give the Applicant an improper timewise extension of the “right to exclude” others from practicing the invention of the ‘945 Patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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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.
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/David H Kruse/
Primary Examiner, Art Unit 1663