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 .
DETAILED ACTION
Status of objections and rejections
1. Claims 1-6 are pending. Accordingly, claims 1-6 are examined on merits in the present Office action. Applicant’s response filed January 21, 2025 and August 14, 2025 is entered.
2. Objection to claim 6 is withdrawn in light of claim amendments filed in the papers of January 21, 2025.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. Rejection of claim 4 under 35 U.S.C 101 because claim is directed to a non-statutory subject matter is withdrawn in light of claim amendments filed in the papers of January 21, 2025.
Claim Objections
5. Claim 4 is objected to because of the following informalities:
Claim 4 is objected for reciting “use” in the method step. The term “use” is not an active
method step. It is suggested to change the recitation “comprising use of the plant of claim 2 in one or more crosses”” to ---comprising crossing the plant of claim 2 to other Cannabis plant in a plant breeding program ---.
This is objection is necessitated due to Applicant ‘s claim amendments filed in the papers of January 1, 2025.
Appropriate correction is required.
Specification
6. The disclosure is objected to because of the following informalities:
The disclosure remains objected to because of the blank and the deposit information throughout the specification is missing. See for example, page 5, paragraph [0033]. The deposit statement lacks ATCC Accession No. and the date deposit was made.
The specification is objected for not providing parents of “Harlequin” and Cannabis variety LPA004 in request for information under 37 CFR § 1.105.
The specification is objected for not providing “chemicals” used to screen for the production THCVA. It looks like Applicant refers to chemical mutagenesis of commercial variety “Harlequin”. If that is the case, Applicant must describe chemical mutagenesis in detail to create mutants in request for information under 37 CFR § 1.105.
New objections to the specification have been necessitated in response to the Applicant’s response and amendments to the specification filed in the papers of January 21, 2025 and August 14, 2025.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
7. Claims 1-6 remain rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention for the reasons of record stated in the Office action mailed July 19, 2024.
Claim 1 remains rejected under 35 U.S.C. 112(b), as being indefinite in its recitation “deposited under____” because the deposit information is missing.
Claim 1 remains rejected under 35 U.S.C. 112(b) as being indefinite in its recitation Cannabis plant designated ‘LPA004’ because the recitation does not clearly identify the claimed Cannabis plant cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name Cannabis plant designated ‘LPA004’ is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the Cannabis plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the ATCC deposit number.
Depending claims are also rejected because they fail to overcome the deficiency of parent claims.
Applicant in the papers filed January 21, 2025 states that rejection should be held in abeyance without presenting arguments to the issues raised in the rejection. Accordingly, rejection is maintained.
Claim Rejections - 35 USC § 112, 4th paragraph
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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.
8. Claims 2-6 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 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. In the instant case, the parent claim 1 requires genetically homogenous seed from Cannabis plant designated ‘LPA004’ whose seeds are to be deposited with specific accession number. In the dependent claim 2, Cannabis plant, plant part, tissue or cell obtained by growing seed of claim 1 will have to be genetically identical with the seed of claim 1. However, the recitation “descendant” in claim 2 reads on any plant of cannabis that may not be necessarily genetically identical and/or homogenous or homozygous with the genetic composition of seed of parent 1. Thus, claim 2, fails to limit the scope of parent 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. Claim2 fails the infringement test because claim 2 would conceivably be infringed by a “descendant” of Cannabis plant, plant part, tissue or cell obtained by growing seed of claim 1 which would not infringe claim 1. See MPEP § 608.01(n).
Dependent claims 3-6 are also rejected because they fail to overcome deficiencies of parent claim 2.
It may be noted that Applicant’s response (breeding history) filed in the papers of August 14, 2025 and earlier response filed in the papers of January 21, 2025 has necessitated this rejection. The papers filed in the papers of August 14, 2025 also fails to address the breeding history of descendant of claimed Cannabis plant.
9. Claims 1-6 remain rejected under 35 U.S.C. 112(a) 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 for the reasons of record stated in the Office action mailed July 19, 2024.
Since the seed of Cannabis plant designated ‘LPA004’ claimed 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. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. 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. If the deposit of the seed is 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 seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 (25 packets of 25 seeds each) 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 showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Applicant’s response filed January 21, 2025 fails to present any argument(s) in response to this rejection.
10. Claims 1-6 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 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 for the reasons of record stated in the Office action mailed July 19, 2024.
Claims are broadly drawn to a seed from Cannabis plant designated ‘LPA004’, a plant grown from the seed, a use of said plant, a part of said plant and a clonal descendent of said plant.
Applicant describes crossing seed or female parent ‘Harlequin’ with male or pollen parent stated as “unknown, posited to be African landrace” on page 10, paragraph [0041]. The specification at paragraphs [0010] -0014] says:
“The present invention relates to a new and distinct annual variety of C. sativa, which has been given the variety denomination of ‘LPA004’. ‘LPA004’ is intended for use as use as a medicinal herb for sale in Cannabis dispensaries. ‘Harlequin’ bag seed from circa 2008-2010 was germinated and chemically analyzed for lineages with unique cannabinoid profiles. Parental germplasms were selected from this screening and a number of self and sib crosses were performed (generally referred to as Fl, even though some were selfed and technically S1). Representative samples from these Fl were again germinated and screened chemically, keeping only those varieties that contained elevated levels of tetrahydrocannabivarin (THCV) compared to a non-producing control. Those meeting the criteria of producing significantly more THCV than non-producers were kept as germplasm for final evaluation. In this group, 3 classes of individual were identified: plants making less than 1% THCY, plants making between 1%-5% THCYV, and plants making greater than 5% THCV. The final class fell into a group that is known as 1:1 THCV:THC producer. Seed from the final class were selected and either selfed or sib crossed. The claimed variety is one of the germplasm identified chemically from a selfed population created from seed selected from the final class. “LPA004’ was selected due to its unique properties, and was thereafter clonally propagated. Selection criteria included THCV levels. The selection was subsequently evaluated for 2 years at Salinas, CA. Plants of the new variety differ from plants of the seed parent ‘Harlequin’ primarily in being highly sensitive to overwatering, highly sensitive to photoperiod changes, and production of moderate to high levels of the minor cannabinoid THCVA. Plants are generally very late finishing (very slow flower maturation) unless light deprivation is used. Plants are also very nutrient sensitive. Unmanicured (outdoor grown) plant height can reach over 12 feet. Plants show strong anthocyanin in stems and petioles when grown indoors using UV lights. Flower tends to be less dense than parental type. Pollen production from reversed females is generally lower than expected due to the slow maturation of the flower.”
It is noted that the specification does not provide any information pertaining to the deposit of biological material. Applicant describes characteristics of Cannabis plant designated ‘LPA004’ collected from asexual reproduction of the “original selection” (pages 10-11 of the Specification), but Applicant does not appear to describe any distinguishing characteristics of a plant grown from a stable seed line or a plant grown from a seed produced by a plant grown from a yet to be deposited seed. The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted. The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement. Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). See also 54 Fed. Reg. at 34,880.
It is also noted that Applicant’s Response to Request for information under 37 CFR § 1.105 states:
“Seeds of a commercial variety called ‘Harlequin’ (unpatented) were chemically screened
for the production of THCVA. Through such chemical screening, a single male plant was found that produced THCVA.”
As it is unclear what “chemically screened” means, the genus encompasses large number structures with undescribed or unknown 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 variant, incomplete description of Cannabis plant designated ‘LPA004’ is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Applicant’s response filed January 21 fails to present any argument(s) in response to this rejection.
Claim Rejections - 35 USC § 102
11. Claim(s) 1-6 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmes (US Patent NO.: US PP30,668 P3, Issued July 9, 2019) for the reasons of record stated in the Office action mailed January 21, 2025.
Holmes disclose Cannabis sativa variety ‘DD-CT-BR5’ plant, plant part, tissue or plant cell produced by growing said seed. Holmes further disclose cannabinoid and terpene profiles which is also encompassed and falls within the scope of instantly claimed cannabinoid and terpene profiles as set forth in Tables 1 and 2 of Cannabis plant designated ‘LPA004’. Holmes further disclose stems, trichomes, leaves and flower buds of Cannabis sativa variety ‘DD-CT-BR5’ plant. Holmes further describe that said Cannabis sativa variety ‘DD-CT-BR5’ plant is also maintained through vegetative and clonal propagation. See in particular, columns 1-6, abstract; Tables 5 and 6.
This rejection is made because of following reasons:
(a) Applicant admits at page 10 that male parent is unknown, and characteristics of female parent ‘Harlequin’ (arbitrary designation) are also unknown. Additionally, It is also noted that Applicant’s Response to Request for information under 37 CFR § 1.105 states:
“Seeds of a commercial variety called ‘Harlequin’ (unpatented) were chemically screened for the production of THCVA. Through such chemical screening, a single male plant was found that produced THCVA.”
(b) As it is unclear what “chemically screened” means, the genus encompasses large number structures with undescribed or unknown function.
(c) The recitation “descendant thereof” does not limit claims to one particular Cannabis plant because there is nothing either in instant claims or instant specification that would limit one of skilled in the art to exclude and/or include additional crosses using different plant breeding methods. In fact, claims read on any Cannabis plant.
(d) It is noted that neither claims nor the specification provide any information pertaining to the deposit of biological material.
Applicant’s response filed in the papers January 21, 2025 fails to argue why Homes disclosure does not anticipates instantly claimed invention. The reference discloses all the structural and functional elements as encompassed by the breadth and the scope of instantly claimed invention and thus anticipates the claimed invention.
Accordingly, Homes anticipated the instantly claimed invention.
Conclusion
12. Claims 1-6 remain rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/ Primary Examiner, Art Unit 1663