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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 15, 2026 has been entered.
Claim Status
2. Claims 1, 3-9, and 19 are pending and under examination to the extent of the elected species of a first foreign sequence from Physaria fendleri from claim 3 and a second foreign gene sequence being from P. fendleri.
Claims 2 and 10-18 are cancelled.
Response to Arguments – Claim Objections
3. Applicant is advised that should claim 1 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The difference between claim 1 and claim 19 is that claim 1 in lines 4-5 recites, “inserting a first foreign gene sequence”, whereas claim 19 in line 4-5 recites, “inserting a single foreign gene sequence”. Applicants in the response filed 05/29/2026 (p. 5 under “New Claim”) indicate that new claim 19 requires that only a single foreign gene sequence is inserted, that gene sequence encoding a TAG lipase. However, the recitation, “a single”, in claim 19 does not limit the method to inserting only one foreign gene sequence. The instant specification on p. 15, paragraph [0082], recites, “It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.” It is unclear what type of context would “clearly dictate otherwise”. Further, claims 1 and 19, in line 3, recite the open transitional phrase, “comprising”, which does not exclude further method steps. Claims 1 and 19 therefore share the same scope.
Response to Arguments – Claim Rejections - 35 USC § 102
4. Applicant’s arguments and amendments and the signed affidavit under 37 CFR 1.132 filed May 29, 2026 have overcome the rejections of record. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 103.
Response to Arguments – Claim Rejections - 35 USC § 103
5. Claim 2 is cancelled by Applicant’s amendments filed May 29, 2026. However, said amendments have necessitated new grounds of rejection under 35 U.S.C. 103.
Claim Rejections - 35 USC § 103
6. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7. Claims 1, 3-9, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (FEBS Lett. 2009;583(13):2301-2307 (U)), in view of Browse et al. (US-2008/0282427-A1, published 11/13/2008 (previously cited)), and further in view of Bhandari and Bates (Plant Physiology. 2021; 187(2):799–815 (cited on Applicant’s IDS as “Bates et al.”)).
Genes associated with the production of lipase do not represent any art-recognized class of genes and Applicant does not provide a clear definition of such a class[0057]. Thus, the Office interprets “genes associated with the production of lipase” to comprise any and all genes that are active in a TAG metabolic pathway(s) comprising any lipase except for DGAT1 as explicitly excluded by Applicant.
Regarding claims 1 and 19, Seo teaches a transgenic method for TAG remodeling of an oil composition of an oil-producing species, comprising modifying one or more cells of a selected oil-producing species by inserting a foreign gene sequence associated with the production of lipase (i.e., At2g31690) into the one or more cells, wherein the foreign gene sequence encodes a TAG lipase (Abstract; p. 2301, third paragraph; p. 2302, “2.2 Subcellular localization”; p. 2306, “3.4. Substrate specificity of chloroplast-targeted DAD1-like acylhydrolases”, second paragraph).
Seo does not teach cultivating one or more organisms from the one or more modified cells; and selecting a specimen from the one or more organisms, wherein the selected specimen exhibits an increased concentration of a target fatty acid as compared to an unmodified control organism of the selected oil-producing species grown under substantially similar growth conditions.
However, Browse teaches a transgenic method for TAG remodeling of an oil composition of an oil-producing species, comprising modifying one or more cells of a selected oil-producing species by inserting a first foreign gene sequence associated with the production of lipase into the one or more cells[0005], [0168-0173] (e.g., LPAT, LACS, PDAT, and SEQ ID NOs:54-59; see: Table 2); cultivating one or more organisms from the one or more modified cells; and selecting a specimen from the one or more organisms (see: Example 3), wherein the selected specimen exhibits an increased concentration of a target fatty acid as compared to an unmodified control organism of the selected oil-producing species grown under substantially similar growth conditions[0013], [0015], [0192-0195] (Abstract; Claim 30).
Bhandari teaches the roles of TAG lipases (e.g., TAGL-like-1, SDP1) in TAG remodeling in Physaria fendleri (Abstract; p. 809, right column, last paragraph – p. 810, left column, first partial paragraph), discloses the likelihood of a TAG lipase-based mechanism in the production of 2HFA-TAG in TAG remodeling (p. 808, right column, first full paragraph; p. 809, Fig. 7), suggests that TAG lipase works in tandem with DGAT to produce hydroxy fatty acids during TAG remodeling (p. 809, right column, first full paragraph), and suggests TAG remodeling pathways as a useful strategy for the engineering of designer plant oil compositions (p. 811, left column, second full paragraph).
The level of ordinary skill in the plant biotechnology art is high as evidenced by Seo, Browse, and Bhandari. It would have been prima facie obvious for one of ordinary skill in the art to modify the teachings of Seo by the teachings of Browse and Bhandari to develop a method of TAG remodeling wherein the lipid composition of an oil-producing species is remodeled by the introduction of a TAG lipase into one or more cells of the species. One of ordinary skill in the art would have been motivated to do so because both Browse and Bhandari teach TAG lipases as involved in TAG and lipid remodeling, Bhandari teaches the role of TAG lipase in TAG remodeling, and Bhandari further suggests that TAG lipases are crucial components of TAG remodeling and function in conjunction with other genes associated with the production of lipase during said remodeling. In suggesting the engineering of TAG remodeling to produce industrially valuable plant oil compositions, Bhandari provides strong motivation for one of ordinary skill in the art to engineer a plant comprising a foreign TAG lipase and additional TAG metabolism genes such as DGAT, LPAT, LACS, and/or PDAT. One of ordinary skill in the art would have been motivated to modify an oil-producing plant with the TAG lipase taught by Seo, because Seo discloses that the enzyme encoded by At2g31690 exhibits catalytic activity against multiple lipids including TAG lipase. One of ordinary skill in the art would be motivated to introduce a lipase with activity towards multiple substrates to increase the availability of the products of lipase activity for lipid synthesis and remodeling. Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and with no surprising or unexpected results.
Regarding claim 3, Seo is silent to Ricinius communis. However, in addition to the teachings discussed above, Browse teaches R. communis gene sequences associated with the production of lipase [0005], [0168-0173] (e.g., LPAT, LACS, PDAT, and SEQ ID NOs:54-59; see: Table 2).
Regarding claim 4, Seo is silent to HFA. However, in addition to the teachings discussed above, Browse teaches wherein the target fatty acid is HFA (Abstract).
Regarding claim 5, in addition to the teachings discussed above, Seo teaches A. thaliana (Title; Abstract; p. 2302, “2.1. Real-time reverse transcription polymerase chain reaction (RT-PCR) analysis”).
Regarding claims 6-8, Seo is silent to the insertion of a second foreign gene sequence. However, in addition to the teachings discussed above, Browse teaches inserting a second foreign gene sequence from R. communis (i.e., oleoyl-12-hydroxylase, DGAT1, DGAT2, LPAT, LACS) associated with production of at least one TAG assembly enzyme into the one or more cells[0005] (Abstract; Claims 32-33; see: Example 5).
Regarding claim 9, Seo is silent regarding omega-3 fatty acids, omega-6 fatty acids, and saturated fatty acids as compared to an unmodified control organism. However, in addition to the teachings discussed above, the plant taught by Browse comprises increased omega-3 fatty acids, decreased omega-6 fatty acids, and reduced saturated fatty acids as compared to an unmodified control organism[0009] (see: Table 1).
Accordingly, one of ordinary skill in the art would have been motivated to produce the claimed invention with a reasonable expectation of success and with no surprising or unexpected results.
Conclusion
8. No claim is allowed.
Examiner’s Contact Information
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEQUANTARIUS J SPEED whose telephone number is (703)756-4779. The examiner can normally be reached M-F; 9AM-5PM ET.
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.
/DEQUANTARIUS JAVON SPEED/Junior Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
Prosecution Insights