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 .
Claims
Claims 1-27 are pending and are examined in this Office Action.
Duty to Disclose
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) The plants utilized in the breeding programs that arrived at the two parental varieties crossed to produce the instant hybrid variety (meaning the grandparent varieties), as well as the specific breeding steps/techniques used to arrive at these parent varieties, 2) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 3) if parental varieties that were crossed to arrive at the instantly claimed variety were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 4) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
It is noted that co-pending applications 18/905,279 and 18/905,304 are listed on the IDS received on Mar. 11, 2025. The Examiner has considered these two applications, but the Examiner cannot determine how the pepper plants taught and claimed in those applications are related to the instant pepper plants. If the pepper plants of these co-pending applications share a parent or grandparent plant with the instant pepper plant, Applicant should disclose this to the Examiner.
Specification
The disclosure is objected to because of the following informalities: there are numerous places in the specification where there are blank lines instead of an accession number for the seed deposit.
Appropriate correction is requested.
Claim Objections
Claims 1, 4, 6, 14, 17, 19, 20, and 23 are objected to because of the following informalities:
Claims 1, 4, 6, and 20 have a blank line where there should be an accession number.
Claim 4, in line 2, is awkward because it is unclear what has to have all of the characteristics. The Examiner believes Applicant wants the “plant regenerated from” to apply to both the plant part and the plant cell, but the current claim structure has the plant cell as the last choice rather than a plant regenerated from the plant cell as the last choice. Applicant is advised to replace “or the plant cell” with - - or a plant regenerated from the plant cell - - . This would address the issue.
Claim 6 has an unnecessary comma in line 2.
Claims 17 and 19 each recite crossing a plant “with itself” in parts (b) and (d). This is technically incorrect because “crossing” is taking pollen from one plant and transferring it to the stigma of a different plant. If the pollen from one plant is fertilizing its own female flowers, then this is referred to as “selfing” or “self-pollinating” (see, for example, instant claim 16).
In addition claims 17 and 19 recite “a second pepper plant” in both part (b) and part (d). Because these plants are not the same plant, the recitation in part (d) should use a different term other than “second pepper plant”.
Claim 23 recites “New Breeding Technique”, and it is not proper to have capital letters in a claim unless it is a proper noun or an acronym.
Appropriate correction is requested.
Warning – Duplicate Claims
Applicant is advised that should claim 7 be found allowable, claims 9 and 15 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof; and should claim 6 be found allowable, claim 14 will be objected to as 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).
Claim Rejections - 35 USC § 112
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.
Indefiniteness
Claims 1-27 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds, cells, parts, and plants of hybrid Capsicum annuum pepper designated HMC57092 and methods of using said seeds, cells, parts, and plants. The designation “HMC57092” has no art accepted meaning, and Applicant has not, yet, perfected their seed deposit. In addition, the two parents that are crossed to arrive at the claimed hybrid plant are unnamed “proprietary” inbred lines (Spec 52 ¶ 215). Without knowing the identity of the inbred parents and without the deposited seeds, the metes and bounds of the plants designated HMC57092 are not clear.
In claims 2, 4-6, 14, and 20 the recitation of Table 1 is not permitted. See MPEP 2173.05(s), which states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “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 be reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
There is no evidence that the information from Table 1 cannot be reproduced in the claims. Furthermore, the claims require having the characterstics in Table 1 “when grown under the same environmental conditions”. The specification does not disclose any particular environmental conditions, therefore, it is unclear what conditions the recited plants would need to be grown under to compare characteristics to those in Table 1. It is suggested the recitation of “listed in Table 1” be deleted.
With regard to claim 17, specifically, the method steps required by the claim do not necessarily arrive at the required “pepper plant derived from the pepper hybrid HMC57092” (claim 17 part (e)). Specifically, the last step recites “repeating step b) and/or c)”, and if one were to repeat step b) but NOT step c), then the end result would not be a pepper plant.
Claim 20 is directed to a pepper plant that “comprises a single locus conversion”, and this renders the claim indefinite because it does not specify what the locus conversion is relative to. Without defining the pepper plant having no locus conversions as the base starting material, there is no meaning to a plant that has a locus conversion. A locus conversion is a change in nucleotide sequence (insertion, deletion, substitution, etc.) at a specific spot in a chromosome relative to a non-converted chromosome. The non-converted plant must be defined (recited in the claim) for this to have any meaning.
Claim 22 has a similar issue because it requires a “mutated gene or nucleotide sequence” and it is unclear what the mutation would be relative to. What gene or sequence is the NON-mutated gene or sequence?
Claim 23 has a similar issue because it requires a gene that has been “modified” and it is unclear what the modification would be relative to. What gene is the NON-modified gene? In addition, the claim recites a “New Breeding Technique”, and it is unclear what is meant by this. The specification provides examples of techniques the inventors consider to be “new” (Spec 18-20 ¶ 76), but this does not constitute a definition.
Claim 20 recites “essentially" all of the physiological and morphological characteristics of hybrid pepper plant HMC57092 listed in Table 1.
See Nautilus, Inc. v. Biosig Instruments, Inc, No. 13-369, in which the Supreme Court held that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.
One skilled in the art understands that introducing a locus conversion is carried out by cross-pollinating the recipient plant with a different plant that has the desired locus/trait to be added. This produces an F1 hybrid which is subsequently cross-pollinated back to the original recipient plant in the technique called “backcrossing” (see Fehr, (Iowa State University, "Principles of Cultivar Development," Vol. 1 Theory and Technique and Vol. 2 Crop Species, Soybean, Macmillian Publishing Company, New York (1987) pp. 360-376). The amount of genomic DNA from each plant depends upon the number of generations of backcrossing that has been carried out (see Fehr, page 370, Table 28-2). It is possible to backcross enough times to arrive at a plant that has “almost 100% of its original genes” and also the newly added desired gene (see Fehr, page 362) or one can carry out a single backcross to arrive at a plant that, on average, would have only 75% of the original genes (see Fehr, Table 28-2). One skilled in the art also understands that sometimes additional genes are linked to the desired gene and the linked genes can introduce additional traits, referred to as “linkage drag” (see Fehr, page 371).
In this case, it is unclear what characteristics must be retained after back-crossing for a plant to have “essentially all” of the characteristics.
The Cambridge Dictionary defines “essentially” as “relating to the most important characteristics or ideas of something”. It is unclear which characteristics of a plant produced by locus conversion and/or back-crossing are considered the most important, and it is unclear how many of the characteristics would need to be present to satisfy the limitation that “essentially all” of the characteristics are present.
Within the US Patent literature, there are numerous examples of different interpretations of the word “essentially”, some are provided here:
US 2013/0291219 A1, paragraph 0011, which states “Essentially homogeneous corresponds to “at least about 97%” inbred seed.”, and this definition allows for about 3% variation.
US 2014/0072693 A1, paragraph 0007, which states "essentially homogeneous population of lettuce seed is exemplified to have at least about 97% of the total seed, including at least about 98%, 99%, or more of the seed", and this example allows for "about" 1%, 2%, or 3% variation.
US 2014/0228479 A1, paragraph 0039, which states ““essentially saturated” diene elastomers (low or very low content of units of diene origin, always less than 15%)”, and this allows for up to a 15% variation.
US 2014/0224707 A1, paragraph 0033, which states “essentially horizontal is defined as a variation of the slope of a plane or a straight line with respect to the vertical, or with respect to the horizontal, of an angle .alpha. of between +/- 5 degrees”, and this allows for 5.6% variation relative to 90 degrees, and 11% variation relative to 45 degrees.
US 2014/0223669 A1, paragraph 0020, which states “as defined herein, “essentially free of a component” means that no amount of that component is deliberately incorporated into the composition.”.
This limited sampling of US Patent publications demonstrates widely varying definitions for "essentially".
A review of the prosecution history did not shed any light on the meaning of the ambiguous language of “essentially all”. For these reasons, the claim is indefinite because one of skill in the art, in light of the specification and prosecution history, would not know with reasonable certainty what the scope of the claimed invention is.
Lack of Enablement
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 1-27 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are directed to seeds and plants of hybrid pepper plant HMC57092 or plant parts derived from said plant. Since the plant is essential to the claimed invention 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 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of the cultivar is considered sufficient for most plant species to ensure public availability. The specification does not disclose a repeatable process to obtain the plant. It is noted that Applicant has deposited seeds with the National Collection of Industrial, Food and Marine Bacteria (NCIMB) (Spec 59) but no date of deposit or accession number was disclosed; furthermore, they have not stated if the deposit was be made under the Budapest Treaty or not.
(a) If a deposit is made AND ACCEPTED under the terms of the Budapest Treaty, then the specification must include the street address of the depository and Applicant must provide a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over their 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, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) 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 effective life of the patent, whichever is longer, and the specification will include the street address of the depository;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
Inadequate Written Description
Claims 1-27 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
This rejection is based on the following analysis:
The MPEP requires:
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 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").
(MPEP § 2163 (I))
This is also referenced in the Enzo v. Gen-Probe decision.
Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002).
In the summary of the invention, Applicant provides an excellent description of
plant breeding and the processes to develop improved bell pepper germplasm in an inbred or hybrid plant.” (Spec 1-16).
The claims are directed to hybrid pepper plant named HMC57092. Aside from the deposit, this hybrid pepper is defined by both its traits as set forth in Table 1 (Spec 53-56), and by its genetics (undescribed).
In the instant application however, the specification only provides a phenotypic description of traits and overview of traits (Spec ¶223) with absolutely no description of the underlying genetics. The instant specification is silent regarding the breeding history of the two inbred parent plants that are crossed to produce the instant hybrid. Applicant provides no information regarding the genetics of the deposited seeds by way of disclosing parent and grandparent plants utilized for breeding the claimed hybrid pepper.
See Vas-Gath Inc. v. Mahurkar, which teaches that "the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] 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-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ).
None of the traits recited in Table 1 are unique to the claimed hybrid pepper. A hybrid pepper plant is not produced by selecting individual traits, it is produced by breeding. Thus, to protect an unintentional infringer, the breeding history is required.
Further, availability of the breeding history will expedite a full and through examination of the pending claims
To illustrate this point further, the breeding history features prominently in a recent decision by the Office’s Appeals Board.
In the McGowen decision, after analyzing the breeding history (p. 7 (btm)-8), the Board found the claimed plants to be obvious (p. 10). Ex Parte McGowen (PTAB 2020) (decision in appl. ser. no. 14/996,093). The decision provided extensive discussion of the traits (pp. 4-5 ¶¶ 5-8 & 12). These differences were cited by the applicant when comparing the prior art and the new plant variety. But the trait tables were insufficient to overcome the finding of obviousness. See, for example, McGowen, ¶¶ 6 & 8 (pp. 4-5). The decision, however, turned on the breeding history. (pp. 8 & 17). Because the breeding history was available, the phenotypic differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Thus the breeding history is necessary to aid in the determination of anticipation and/or obviousness and for resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
This applies both to the examination process and also for the purposes of determining possible infringement after the patent issues. Providing the breeding history begins to provide an artisan with the necessary information to be able to anticipate potential infringement.
Thus, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Since the breeding history, including the parents and the parents’ breeding history, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
In view of this variability, the breeding history is essential and is the least burdensome way to Applicant to provide genetic information needed by the Office and the public to adequately describe a newly developed plant.
To overcome this rejection, applicant should amend the specification/drawings to provide the breeding history used to develop the instant variety. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. If, for example, applicant’s breeding history uses proprietary line names, applicant should include in the specification all other names of the proprietary lines / varieties. This is particularly important in the case of publicly disclosed or patented lines / varieties. If the breeding history encompasses a locus conversion or a backcrossing process, applicant should clearly indicate the recurrent parent and the donor plant and specifically describe the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, applicant should provide the breeding history of the parent line as well (i.e. grandparents).
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.
Claims 1-4, 6-9, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
The instant specification states that the hybrid HMC57092 was realized for the first time in the spring of 2016, and the first evaluation was in Almerfa blocky pepper market with different growers in season 2016-2017 (Spec 53 ¶ 216). An internet search yielded the following definition for a “blocky pepper market”:
PNG
media_image1.png
187
653
media_image1.png
Greyscale
Because Applicant has admitted to providing the instant hybrid peppers to different growers in the blocky pepper market, this constitutes a public use or sale 7 years prior to the filing of the instant application. The specification did not state whether restrictions were placed on the multiple different growers who received the plants, therefore, this is considered a public use. The word “market” suggests sales as well.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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, Bratislav Stankovic can be reached at (571) 270-0305. 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.
CATHY KINGDON
Primary Examiner
Art Unit 1662
/CATHY KINGDON/Primary Examiner, Art Unit 1662
Prosecution Insights