DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Status
1. Claims 32-49 as filed on 19 January 2023 are examined herein.
Examiner’s Notes & Claim Interpretation
Examiner’s Notes
2. Citations to Applicant’s specification are abbreviated herein “Spec.”
Occasionally, “SIN:” may be used as an abbreviation “SEQ ID NO:” herein.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
1) 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
a) In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
b) In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
i) the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
c) In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
d) In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
2) When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
a) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
b) If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
3. Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
No SEQ ID NOs are present in “Appendix 3” which begins at page 49 of the specification.
Also, as noted below, two drawings appear to be deficient.
Specification
4. The specification is objected to because of the requirements under the sequence rules, above.
Appropriate correction is required.
Drawings
5. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the following reasons.
Figure 9 is not clear. Between the graph and the word “Samples” appear to be a number of nucleotide sequences. They are not legible. Additionally, they need to be labelled in accordance with the sequence rules.
Figure 10 is not clear. Near the bottom, there appears to be a line of text. That text is not clear. Pease explain if it is just a different shade of stippling. If this is a sequence, then it must be identified by a SEQ ID NO. Also, there is a hanging label that ends in .22X. The rest is unclear.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 32, 35, 37, 39, 40, 41, 42, 43, 46, 48 and 49 are objected to because of the following informalities.
6. Claims 32 and 46 are objected to because it the species names are not in italics. They are also objected to because these species names are in parentheses. The use of the parentheses raises a potential issue as to whether the parenthetical term has the same meaning as the preceding term.
7. Claims 35, 37, 39, 40, 41, 42 and 43 are objected to because they use the parenthetical term (ToBRFV) following the spelled out-name. Again, this raises a potential issue as to whether the spelled-out term and the abbreviation have identical meanings.
It is completely acceptable practice to use a parenthetical to establish the meaning of an abbreviation in the claims. Thus claim 32 is not objected-to because it establishes the meaning of “ToBRFV” for subsequent use in the claims.
8. Claims 35, 37 and 43 are all drawn to “genetic makers” and thus are reasonably interpreted as having the same scope. If found to be allowable, two of the three will be objected to as being drawn to the same subject matter and thus the duplicate claims would not be allowable under 35 USC 101.
Similarly, claims 42, 48 and 49 appear similar to claims 32, 33 and 34.
Appropriate correction is requested.
35 USC § 112(b)-Based Claim Rejections
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 32-49 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.
9. Claims 32 and 46 recite the limitations:
LA0107 (S. corneliomulleri), LA0361, LA1918, LA2650 (S. habrochaites), LA1938, LA1969, LA2748, LA2755 and LA2931 (S. chilense) [quoted text from OCR of claim set].
The “LA” terms lack general art-accepted meanings and appear to be some form of accession number.
Applicant does not explicitly define the terms in the specification. Furthermore, the limitations, except for the species names, appears to be essential matter to understand the scope of the claim.
It is impermissible to incorporate essential matter by reference except by reference to US patent documents.
The meaning of these terms could additionally change to designate something different or new during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Additionally the Markush group lists three species names, each in parentheses. It is indefinite as to whether the parenthetical term is the species of the prior listed accession or whether it is an alternative member.
10. 36, 38 and 45 are additionally rejected because they reference appendices.
. Where possible, claims are required to be complete in themselves. Incorporation by reference to something like the referenced appendices "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
These claims are also rejected because they recite various alphanumeric limitations such as “BCl 2 L2 15031000.” The terms appears to reference a database but have no intrinsic meanings.
Again, t is impermissible to incorporate essential matter by reference except by reference to US patent documents.
The meaning of these terms could additionally change to designate something different or new during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
11. Claims 32-49 are additionally rejected for using an insufficiently defined functional limitation.
The claims are drawn to a tomato plant with a “partially dominant resistance gene or genes to tomato brown rugose fruit virus.” That represents genetic information providing resistance to tomato brown rugose fruit virus but that genetic information is not provided.
Many dependent claims refer back to this gene.
Thus this language imposes a limit on the claim, the boundaries are unknown because a structure needed to accomplish the recited function is not taught. The specification fails to set forth what genetic information is associated with the phenotype.
The teachings, or lack thereof, of Applicant's specification are discussed in greater detail in the rejections under 35 U.S.C. 112(a), infra. As pointed out, Applicant does not teach anything about the gene other than its approximate chromosomal location and an assortment of markers plus its phenotype.
Applicant does not teach the sequence of the gene. Nor does Applicant provide a definitive location or presence in any particular tomato plant.
Thus, although an active gene is required, the instant claim language imposes no limits as to the structure needed for the claimed function to be performed. Further, no deposit is associated with the claims.
Applicant is reminded that while functional limitations may be properly used in claims, the boundaries imposed by a functional limitation must be clearly defined under 35 U.S.C. 112(b). Claim language that merely states a result to be obtained without providing boundaries on the claim scope is unclear. See e.g. "Enhancing Clarity By Ensuring That Claims are Definite Under 35 U.S.C. 112(b)," 20 May 2016 (available at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/examinationguidance-and-training-materials).
As a result, the metes and bounds of the claims are indefinite.
12. Additionally, claim 32 is indefinite because, in lines 2-4, it reads on crossing wild tomato plants, but in the last line, the plant has to be the non-wild, cultivated tomato. Crossing two wild tomato plants which is explicitly an embodiment would create plant which would be rejected under 35 USC 101. However, the last lines prevents a rejection under 35 USC 101. Therefore the claim contradicts itself.
13. Claim 41 is additionally rejected because it uses the limitation “and/or to an excessive degree and also recites the limitation “QTL to tomato brown rugose fruit virus.” This “QTL” appears to read on that QTL in any genetic context. The QTL itself is undefined but this claim structure appears to raise potential rejections under 35 USC 102, 103 or even 101.
Dependent claims are included in the above rejections because none provide limitations obviating the rejection(s).
35 USC § 112(a) based Claim Rejections
The following is a quotation of 35 U.S.C. 112(a):
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
14. Claims 32-49 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 claims contain 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention as broadly as claimed.
The Federal Circuit held that a written description of an invention "’requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials." Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405 (Fed. Cir. 1997) (quoting Fiers v. Revel, 984 F.2d 1164, 1171, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993)). The court also stated "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material." Id., 119 F.3d at 1568, 43 USPQ2d at 1406. The court held that “[a] description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” Id., 119 F. 3d at 1569, 43 USPQ2d at 1406.
Claim 32 is drawn to a tomato plant harboring a partially dominant resistance gene or genes to tomato brown rugose fruit virus (ToBRFV).
This plant is further required to be an offspring of a wild tomato plant that is resistant with a susceptible plant. Under the product-by-process analysis required by the MPEP (MPEP § 2133), however, the composition is evaluated as a tomato plant harboring a partially dominant resistance gene or genes to ToBRFV.
Claim 32 is rejected under 35 USC 112(b) on multiple grounds, but requires the presence of a “partially dominant resistance gene” or “genes.” Several sources potential sources are listed – they appear to be accessions but my also be merely species.
No actual genes are taught.
Dependent claim 33 is drawn to a seed. Dependent claim 34 is drawn to, e.g. a seed. Dependent claim 36 localizes to chromosome 2.
Independent claim 37 is drawn to genetic markers.
Independent claim 35 is drawn to genetic markers.
Dependent claim 38 lists some putative genetic markers.
Independent claim 37 is again drawn to genetic markers.
Dependent claim 38 focuses on chromosome 11.
Dependent claim 39 uses the markers of claim 35 in a method. Dependent claim 41 again uses the markers of claim 35 in a method.
Dependent claim 40 uses the markers of claim 37 in a method.
Independent claim 41 encompasses vast genera because of its frequent use of “and/or” plus the undefined “QTL” can be reasonably interpreted in a vast number of contexts.
Claim 42 is drawn to a tomato plant with “partially dominant resistance gene or genes is on chromosome 2, said sensitivity gene or genes is on chromosome 11.” All “gene or genes” are undefined and, of course, “gene or genes” broadens the scope. Dependent claim 46 recites various accessions and species.
Independent claim 43 is again drawn to genetic markers. Dependent claim 44 recites chromosomal locations. Dependent claim 45 is rejected under 35 USC 112(b) on multiple grounds. Dependent claim 47 specifies that one of the plants is S. Lycopersicum. Dependent claims 48 and 49 are drawn to, e.g. seeds.
The claims thus encompass vast genera of tomato plants, resistance genes and markers.
In contrast, Applicant provides limited written description.
Figure 5 depicts a ToBRFV-resistant tomato leaf asserted to be of the instant invention.
Example 1 describes screening about 50 accessions. Spec., p. 18. In Example 3, one cross with a resistant accession was further developed. Id., , p. 19 et seq. Part of this includes more detailed DNA analysis. QTL analysis was performed. Id., p. 33 et seq.
Example 8 describes “sequences that could be used as molecular markers.” Id., p. 35 et seq. These sequences are listed beginning on page 49.
The prior art teaches a gene providing resistance to ToBRFV in tomatoes. Hamelink et al.; WO 2019/110130 A1 (e.g. abstract). Hamelink et al.’s abstract also teaches it is on chromosome 11 (compare to instant specification, p. 6, l. 5).
Applicant reviews the prior art on pages 2 and 3, citing to Hamelink et al.
Applicant also cites to the publication of Allersma et al. U.S. Patent Publication No. 2020/0048655 A1 (also PCT WO 2020/0178783 A1 (23 Jan. 2020); also Ashkenazi et al. (U.S. 2020/0077614 A1); also Ykema et al. (WO 2020/148021 A1) (priority to 2019).
Therefore such resistance genes were known in the prior art but not defined as to the gene or protein sequence in these publication.
However, see, Ishibashi et al. (2009) Proc Natl Acad Sci 106(21):8778 83, which teaches a 754 amino acid resistance protein (just before “RESULTS” section) which can be transgenically expressed in tobacco. The protein was found in S. habrochaites.
See Vas-Cath Inc. v. Mahurkar which held that the purpose of the written description is, inter alia,
for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 USPQ2d 1111, 1115 (Fed. Cir., 1991) (quoting Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 434, 5 L.Ed. 472 (1822),
In this case, a practitioner is not provided sufficient description to be able to determine if any particular tomato plant with the appropriate resistance phenotype is infringing the instant claims. Therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Given the large amount of data provided in the appendices versus the lack of concrete structure / activity relationships provided, Applicant’s specification resembles a research plan. The Federal Circuit, however, held that merely providing a research plan does not satisfy the written description requirement.
Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d [1336] at 1353. (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and ... cover any compound later actually invented and determined to fall within the claim's functional boundaries.").
AbbVie Deutsch/and GmbH & Co. v. Janssen Biotech, lnc.,759 F.3d 1285, 1300, 11 UIS.P.Q.2d 1790 (Fed. Cir. 2014).
Therefore Applicant fails to satisfy the written description requirement for the pending claims. Further, under the Lilly test, Applicant fails to describe a representative number of species, and Applicant also fails to adequately describe the structure / activity relationship.
15. Claims 32-49 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.
The invention requires novel plants; with the lack of written description it requires deposited seeds. For example, claim 32 cites to eight accessions and three species. There is no evidence in the record that the claimed resistance gene is present in all plants of the recited species.
Thus the plant is essential to the claimed invention thus it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability.
The specification does not disclose a repeatable process to obtain the plant / gene and thus it is not apparent if the plant is readily available to the public with respect to this application. The specification does not teach such a process. Therefore Applicant must deposit seeds to comply with 35 USC 112(a). If a deposit is made, the deposit must be accepted under the terms of the Budapest Treaty or the results or a viability test must be provided.
Also, a statement, affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, is required to satisfy the deposit requirement made herein.
Dependent claims are included in this rejection.
The specification mentions a deposit on the top of page 10, but see above and also the claims do not recite the deposit’s accession number.
16. The claims are also rejected because other than the putatively deposited seeds and the gene found in the deposited seeds, the disclosure not reasonably provide enablement for the full scope of the claimed invention which is much broader than any putatively deposited seeds.. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Federal Circuit in In re Wands lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. In re Wands, 858 F2d 731, 8 USPQ2d 1400, 1406 (Fed. Cir. 1988). These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims. Id.
The scope of the claims is discussed above and is incorporated by reference herein. The invention requires tomato plants with novel characteristics. Also various markers.
The teachings of the specification are also incorporated by reference herein.
Applicant provides a large amount of data regarding QTLs, but lacks direct guidance as to how to move from the vast number of QTLs to the required gene.
The disclosure lacks adequate guidance.
Further,
The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point-where specific benefit exists in currently available form, there is insufficient justification for permitting an application to engross what may prove to be a broad field
Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695 (1966). Additionally, “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. "[A] patent system must be related to the world of commerce, rather than to the realm of philosophy. . . ." Id., 383 U.S. at 536, 148 USPQ at 696 (quoting In re Ruschig, 52 CCPA 1238, 343 F.2d 965, 970, 145 USPQ 274, 279).
Conclusion
17. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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 571-270-0708. 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.
/RUSSELL T BOGGS/Examiner, Art Unit 1663
Prosecution Insights