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
1. The Office acknowledges the receipt of Applicant’s amendment filed October 31, 2025. Claims 1-4, 6-8, 10-12, 18, 20-22, 24-26, 28 and 30 are pending and are examined.
Applicant’s request for an interview is noted. Applicant may contact the examiner to set up a mutually convenient time to discuss Applicant’s interview agenda.
All previous rejections not set forth below have been withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is made FINAL.
Information Disclosure Statement (IDS)
2. Applicant’s IDS filed October 31, 2025 has been considered. A signed copy is attached.
Claim Objections
3. Claim 28 is objected to because of the following:
In claim 28, line 2, “of variety 72-MP0033 RZ” should be inserted before “has been deposited”.
In claim 28, in the obtaining step, “RZ” should be inserted after “72-MP0033”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. Claims 7, 21, 22, 24-26, 28 and 30 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.
In claim 7, it is unclear what is retained in the “derived” product. It is suggested “derived” be amended to “obtained”.
In claim 21, line 1, “the” should be inserted after “from” for proper antecedence.
In claim 22, a plant having all the morphological and physiological characteristics of hybrid tomato variety 72-MP0033 RZ comprising at least one new trait cannot be produced by introducing a mutation or transgene conferring the at least one new trait into a plant of hybrid tomato variety 72-MP0033 RZ, because introducing a mutation or transgene into a plant of hybrid tomato variety 72-MP0033 RZ would alter the morphological and physiological characteristics of hybrid tomato variety 72-MP0033 RZ.
In claim 24, “plant according to claim 1” should be amended to “the plant according to claim 2” for proper antecedence.
In claim 28, in the obtaining step, the first plant and the reference plant are the same plant. The recitation of “said plant” refers to the plant of tomato variety 72- MP0033 RZ in the preamble, and “the reference plant is a tomato plant of tomato variety 72-MP0033 RZ of claim 2” also refers to a plant of tomato variety 72-MP0033 RZ. Additionally, it should be noted that the preamble recites “a first generation progeny thereof”, but none of the steps addresses the first generation progeny thereof.
In claim 30, “a tomato fruit according to claim 26” should be amended to “the tomato fruit according to claim 26” for proper antecedence.
Dependent claims are included.
Correction and/or clarification is required.
Applicant does not address the above rejections. Accordingly, the rejection is maintained.
Claim Rejections - 35 USC § 112(a)
5. Claims 1-4, 6-8, 10-12, 18, 20-22, 24-26, 28 and 30 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 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.
Since the seed 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 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.
The deposit statement in paragraph [0036] of the specification and Applicant’s statement filed October 31, 2025 do not address (e) above. It is suggested Applicant provides a signed statement indicating “the deposit will be replaced if it should ever become unviable.”
6. Claim 8 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 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.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
With regard to claim 8, the tissue culture of claim 6 encompasses haploid cells such as anther and ovule (contains haploid cells). The haploid cells are formed during meiosis when the diploid genome segregates during sexual hybridization. Variety 72-MP0033 RZ is a hybrid, whereby its genome is heterologous at every locus. The tomato genome has about 35,000 genes (US Pub. No. 20240415127 (previously cited), [0002]). When its diploid genome segregates to form haploid cells, it is highly unpredictable which combination of alleles from each of the 35,000 genes are present in the haploid cells. There is no disclosure as to the genetic makeup of these haploid cells and how they can be used to produce a plant expressing all the physiological and morphological characteristics of hybrid variety 72-MP0033 RZ. Applicant has no working examples and provides no guidance as how the haploid cells can produce a plant having all or selected physiological and morphological characteristics of hybrid variety 72-MP0033 RZ.
Given the state of the prior art, the lack of guidance, the lack of working examples, and the unpredictability in the art, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue.
Applicant’s Traversals
Applicant traverses primarily that ovules and anthers are diploid structures of the parent plant and do not undergo any form of segregation.
Response to Applicant’s Traversals
Applicant’s traversal has been considered but is deemed unpersuasive for the following reasons. Ovules and anthers contain haploid cells (Cermak et al., US Pat. No. 11,926,835 (A), col. 55, lns. 12-16). Accordingly, the rejection is maintained.
7. Claims 4, 6, 7 and 28 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.
Variety 72-MP0033 RZ is a hybrid, whereby its genome is heterologous at every locus. With regard to claims 4, 6 and 7, as stated above, the anther and ovule (contains haploid cells) are haploid cells formed during meiosis, whereby the diploid genome segregates during sexual hybridization. From the about 35,000 genes present in a tomato genome (US Pub. No. 20240415127 (previously cited), [0002]), it is highly unpredictable which combination of alleles from each of the 35,000 genes are present in the haploid cells. There is no disclosure as to the genetic makeup of these haploid cells. The claimed haploid cells as a plant part or in tissue culture are not described phenotypically or genetically. Accordingly, the plant parts and tissue culture cells comprising these plant parts lack adequate written description.
Claim 28 is not adequately described because Applicant does not disclose the plurality of polymorphisms which are indicative of and/or give rise to the expression of the morphological and physiological characteristics of hybrid variety 72-MP0033 RZ. Applicant does not indicate which nucleic acids obtained from hybrid variety 72-MP0033 RZ correlate to which morphological and physiological characteristics of said variety. No polymorphism or gene sequence of hybrid variety 72-MP0033 RZ has been disclosed or correlated to any morphological and physiological characteristic of hybrid variety 72-MP0033 RZ. Additionally, it is unclear what results can be obtained from the detecting step, as there is no disclosure as to what the target sequences are. Thus, the plurality of polymorphisms which are indicative of and/or give rise to the expression of the morphological and physiological characteristics of hybrid variety 72-MP0033 RZ lacks adequate written description.
For the above reasons, the claimed invention lacks adequate written description under current Written Description Guidelines, see
https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Applicant’s Traversals
To the extent Applicant’s traversals apply to the rejection above, Applicant traverses primarily that ovules and anthers are diploid tissue of the parent plant which do not undergo any form of segregation and merely contain the gametes which are not part of those tissues.
Response to Applicant’s Traversals
Applicant’s traversals have been considered but are deemed unpersuasive for the following reasons. The claims recite ovule and anther, which contain haploid cells (Cermak et al., US Pat. No. 11,926,835 (A), col. 55, lns. 12-16). The claims are not limited to diploid cells of hybrid variety 72-MP0033 RZ. None of the disclosed characteristics in the specification describes the morphological and physiological characteristics of an ovule or an anther of hybrid variety 72-MP0033 RZ. While an inbred plant has two identical copies of each chromosome, hybrid variety 72-MP0033 RZ does not. The deposit of seeds of tomato hybrid variety 72-MP0033 RZ is not representative of these haploid cells because the claimed haploid cells are not required to be identical to the haploid cells present in the deposit. In fact, the haploid cells of the seeds in the deposit population, when grown into plants, are genetically and phenotypically distinct from each other. It is unpredictable which combinations of dominant and recessive alleles are present in each haploid cell. Accordingly, the rejection is maintained.
Conclusion
8. No claim is allowed.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
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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/PHUONG T BUI/Primary Examiner, Art Unit 1663