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 with traverse of basil variety “OCB-011” in the reply filed on 11August2026 is acknowledged. The traversal is on the ground(s) that the species/varieties of the now-amended claims are all F2 siblings generated from a cross of “CB15” plants and “Rutgers Obsession DMR” plants. Please note that the claim amendments 11August2026 removed reference to parent variety “CB15” from the claims.
This is found persuasive. The Office thanks Applicant for the clarification. To ensure a clear record, Applicant’s response also clarifies ¶9 and ¶11 at pages 4-5 of the specification. Therefore, the Election of Species within the Requirement for Restriction/Election dated 11March2026 is withdrawn and all of the species/varieties within the claims are examined together.
Regarding the claimed varieties, it is understood that all are F2 basil varieties which were generated via a cross of ‘Rutgers Obsession DMR’ to ‘CB15’ and have the characteristics of pre- and post-harvest chilling tolerance as well as aroma (sweet or Thai) as determined by linalool, estragole, and/or eucalyptol levels in leaves (see below screenshot from the “Miscellaneous Incoming Letter” dated 11August2026 (pages 3-4). If the Office’s understanding is incorrect, Applicant should please correct or further clarify the record.
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Status of the Claims
The amendments and arguments filed 11August2026 are acknowledged and have been fully considered. Claims 17, 30-31 are canceled. Claims 32-34 are new. Claims 1-16, 18-29, and 32-34 are examined on the merits herein. Claims 1-3, 6-7, 13-16, 18-26 are currently amended. Claims 4-5, 8-12, 27-29 are original.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63500208 filed 04May2023] is acknowledged. Claims 1-16, 18-29, and 32-34 have an effective filing date of 04May2023.
Claim Objections
Claim 5 is objected to because of the following informalities: is “stein” meant to be “stem”? Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “low or high soil” is unnecessary at line 2 at least because a person with ordinary skill in the art would understand that pH tolerance is to either “low” or “high” pH and such person would also understand that pH tolerance is not just relevant in the context of soil (pH matters in all growth media). Please amend the claim to just say something like “… heat tolerance, Appropriate correction is required.
Claim 34 is objected to because of the following informalities: is “stein” meant to be “stem”? Appropriate correction is required.
Specification (RE Deposit Rejection)
The disclosure is objected to because of the following informalities: further to the Deposit Rejection below and the indefiniteness rejection thereafter, ¶13 at page 5 of the specification is objected to for not containing complete deposit information (please see the Deposit Rejection below for the specific information required and the timelines for perfecting the deposit).
Appropriate correction is required.
Deposit Rejection
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, 18-29, 32-34 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 claims contain 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.
Since seed deposited with the American Type Culture Collection (ATCC) is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public (35 U.S.C. 112). If a seed, or seed of the claimed plant is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112 (37 C.F.R. § 1.802). The specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. Therefore, a deposit thereof is believed to be necessary.
If the deposit of the seed is made, or will be made, under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating “the deposit has been made, or will be made, under the Budapest Treaty and ‘all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent’” (see 37 C.F.R. § 1.808(a)(2)) would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number that:
access to the deposit will be available during pendency of the patent application upon request to, and approval from, the Director (37 C.F.R. § 1.808(a)(1));
all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent (37 C.F.R. § 1.808(a)(2));
the deposit will be maintained in a public depository for a term of at least thirty (30) years or at least five (5) years after the most recent request for the furnishing of a sample of the deposit was received by the depository, whichever is longer (37 C.F.R. § 1.806);
the viability of the biological material will be tested at the time of the deposit and a corresponding viability statement has been or will be filed if the deposit is not being made under the Budapest Treaty (37 C.F.R. § 1.807); and
the deposit will be replaced if it should ever become unviable (37 C.F.R. § 1.805).
The information at 13 on page 5 of the specification is acknowledged, but Applicant has not provided several requisite details including whether the deposit is made under the Budapest Treaty, the Accession numbers, and dates of deposit. Please also note the statements/assurances which are required to perfect a deposit (the language of which is very particular): ¶13 of the specification does not refer to “all restrictions” being “irrevocably removed” upon “the granting of the patent”, for example.
Given the particularity of the deposit language rules, it is highly recommended that Applicant simply copy/paste the statement(s) provided above at a.-e. into their signed reply and, for this and future applications, that Application recites (e.g., in their reply and/or in the specification of a future application) a “catch all” phrase such as “In any event, all of the requirements set forth in 37 C.F.R. §§ 1.801-1.809 have, or will be, complied with.” Such phrase, if present within the as-filed specification, will ordinarily negate a Deposit Rejection (i.e., a “But-for” paragraph will be provided within an office action but not an actual rejection).
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 1-16, 18-29, 32-34 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 all recite or refer to an ATCC Accession number without providing that number. After the deposits have been perfected, please update the claims (and specification) with the corresponding accession number information. Please review the specification objection and Deposit Rejection above for further details regarding perfecting a deposit, amending the claims and specification, as well as the deadlines for doing so.
Claim 18 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.
This claim recites a single locus that “confers a … site-specific genetic recombination … trait” into the basil plant, but “site-specific genetic recombination” is not a trait. For at least this reason, it is not clear what is within (or outside of) the claim because it is not clear what the quoted phrase means.
Claims 21-22 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.
This claim refers to “collecting or producing” a “commodity plant product” by the steps of “collecting or producing and then producing a commodity plant product”. (1) As an initial matter, the repeated use of “producing” in the claim is confusing such that it is unclear how to practice the method (what, exactly, are the steps of this method?). (2) Further, what constitutes a “commodity plant product” is not given a limiting definition within the specification and does not have a well-recognized meaning in the prior art. For example, does “commodity plant products” include plant parts? How about a whole plant? Please clarify the claim.
Claim 22 is included here because of the issue with (1) “producing” but is definite with respect to (2) what “commodity plant product” means.
Applicant may wish to consider (RE (2)) brining claim 22 up into claim 21 and (RE (1)) amending claim 21 to say something like “obtaining a commodity plant product from the plant of claim 1, or a plant part thereof, wherein the commodity plant product comprises protein concentrate, protein isolate, a leaf, extract, or oil.”
Claim 25 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.
This method claim recites producing a genetically modified basil plant comprising “introducing a genetic modification in the plant of claim 1 by using a gene editing system and/or transforming the plant with a transgene. (1) As an initial matter, the period at the end of claim 25 appears to have been (accidentally) deleted. (2) Further, the term “using” is a non-limiting “intended use” reference under United States’ patent laws and rules. Therefore, it is not clear whether this method requires a gene editing system or “transforming” step. To explain by example, as currently written the method of claim 25 appears to encompass chemical mutagenesis (e.g., EMS mutagenesis) introducing a genetic mutation into the plant of claim 1.
Applicant may wish to consider amending the method to something like “A method of producing a genetically modified basil plant, comprising introducing into the plant, or plant part thereof, of claim 1 an expression construct encoding a site-specific nuclease and/or transgene, or a complement thereof .” Please note that “site-specific nuclease” would encompass TALEN, zinc-finger nuclease, and CRISPR gene editing approaches and that “complement thereof” is intended to capture the realities of transformation to add a transgene into a plant/part as well as using gene-editing to add a transgene into a plant/part. Applicant is always welcomed to propose their own claim language.
Claim 34 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.
This claim recites “modified essential seed amino acid characteristics” which is not given a limiting definition in the specification and does not have a well-recognized meaning within the prior art. It is unclear what this phrase means—for example, what is “essential” versus non-essential and what is a “characteristic”? Does Applicant perhaps mean to say something like “altered seed amino acid composition” (as is recited in claim 18)?
Claim Rejections - 35 USC § 112 – Failure to Further Limit + Proposed Claim Amendments
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.
Claim 2 (and, therefore, also claims 3-6 which refer thereto without correcting the issue) is/are 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 2 is directed toward a plant part of the whole plant of claim 1 (to which claim 2 refers), because a plant part is broader subject matter than a whole plant (e.g., one may have a plant part of claim 2 without having the whole plant of claim 1); claim 2 is improperly dependent for failing to include all of the limitations of claim 1 (namely, a whole plant).
Perhaps claim 1 may be amended to something like “A plant, or plant part thereof, of basil variety ….” and then claim 2 may be amended to something like “The [[A]]plant part of as encompassing both whole plants and plant parts (if there were such a definition, claim 1 would not need amendment to explicitly recite plant parts and claim 2 could just be amended as suggested). Please also note that if Applicant intends “plant parts” to encompass seeds , then perhaps claim 7 may be amended to refer back to claim 1 and say something like “The plant part of claim 1, wherein the plant part is a [[A]] seed of basil variety ….”? Alternatively, claim 1 could just explicitly recite “seed” as in “A plant, or plant part thereof, or seed of basil variety ….”? If amendments are made to claim 1 so that “plant part(s)” are recited, please review the entire claim set to ensure all is correct (e.g., some claims, such as claims 14 and 21, refer to “plant parts” whereas others do not—perhaps add a reference to “or a plant part thereof” at the last line of claim 15 and at the second line of claim 25 as in “… modification in the plant, or plant part thereof, of claim 1 ….”? Also, perhaps then claims 27-28 could just say a container/nanoparticle “comprising the plant part of claim 1”?).
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 § 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.
Claim 13 is 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.
This claim is directed toward any seed that is produced by the method of claim 11. The method of claim 11 encompass any number of crosses (no upper limit) of the plant of claim 1 with any “second basil plant”. This means that claim 13 encompasses a seed of any downstream generation from the varieties listed in claim 1 (e.g., F10, F15, F20+ generation). Note, for example, that the seed of claim 13 need not be of the F1 generation or grow into a plant that has “all of the physiological and morphological characteristics of the plant of claim 1 when grown in the same environmental conditions.”
The specification only describes plants/parts of the F2 basil varieties recited in claim 1 (F0 or F1 generations).
Given the nature of plant breeding, a skilled artisan could not reasonably expect, with reasonable certainty, what the physiological and morphological characteristics of a plant grown from the seed of claim 13 may be (= the claimed subject matter is so far removed from the varieties listed in claim 1 that the characteristics of the plants grown from the claimed seed cannot be reasonably surmised). Said another way, the claimed subject matter is not tethered to novel starting materials (MPEP § 2116) by being limited to the F0 or F1 generation (such as by reciting “F1” in claim 13 or requiring no more than one outcross in the method of claim 11) or by requiring that a plant grown from the claimed seed “comprises all of the physiological and morphological characteristics of the basil variety when grown in the same environmental conditions”. This claim encompasses any downstream seed which grows into a plant having any physiological and morphological characteristics (= the characteristics of those downstream plants cannot be reasonably known until after they are actually made).
Put simply, a skilled artisan (in view of the specification and knowledge in the art) would have absolutely no idea what characteristics/traits a plant grown from the claimed seed would have and, in that way, could not meaningfully distinguish the claimed seed from any other basil plant.
Without more information from Applicant, a skilled artisan at the time this application was filed would not reasonably recognize Applicant as being in possession of the full metes and bounds of these claims.
It would be remedial of this rejection to (I) explain (on the record, e.g., in remarks) how the specification (in view of the prior art) evidences possession of the full metes and bounds of the claimed plants; or (II) to amend the claim so that it only encompasses (a) seed of the F0 or F1 generation (MPEP § 2116) or (2) seed that grows into a plant that “comprises all of the physiological and morphological characteristics of the basil variety when grown in the same environmental conditions”.
Claim Rejections - 35 USC § 102
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.
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 24 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by SIMON et al. (US Pat. No. 10159212).
Claim 24 is directed toward extract or oil obtained from the plant, or plant part thereof, of claim 1. Oil has been separated from cellular components and does not otherwise contain any genomic material. Further, and unless otherwise defined, “extract” need not contain any cellular or genomic material either. Therefore, this product-by-process claim is anticipated by any prior art teaching a basil extract or oil, such as that taught by SIMON et al. at, for example, lines 23-32 of column 9 and claims 21-24. Please note that SIMON et al. teaches the plants and plant parts of parent plant variety ““Rutgers Obsession DMR”.
Conclusion
The following is a statement of reasons for the indication of allowable subject matter: plants and plant parts (F0 and F1 generations) of the varieties listed in claim 1 appear to be novel and nonobvious over the prior art at least because no prior art plants appear to have the same tolerance to low temperatures and aroma profile and no prior art plants appear to have the same parentage (noting that “CB15” is, according to Applicant, a confidential variety). The closest prior art may be identified as KUNZEMANN (US2019/0350152 published 21November2019) regarding plants/parts of basil variety “EMMA”, but plants/parts of the “EMMA” variety are materially different in at least genomic structure (as evidenced by having a materially different breeding history) and cold tolerance profile.
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 at (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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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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