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
In response to previous restriction requirement, applicant has chosen to elect Group I for examination, consisting of claims 1-14, 16-17 and 21-23, with traverse.
Claim Status
Claims 1-2, 5-14, 16-17, 22 & 24 are under examination on the merits.
Claim 20 is withdrawn.
Claims 3-4, 15, 18-19, 21 & 23 are canceled.
Priority
Claims 1-2, 5-14, 16-17, 22 & 24 receive the U.S. effective filing date of 06-03-2020. Acknowledgement is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy of Application No. PCT/IB/2020/000519, filed 06-03-2020 has been received.
Previous objection to the specification for inclusion of hyperlinks is withdrawn in view of Applicant’s amendments to the specification.
Previous objection to claims 5-6 & 14 is withdrawn in view of Applicant’s amendments to the claims.
Previous rejection of claims 1-14, 16-17 & 21-23 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claims 21 & 23 under 35 U.S.C. 112(d) is withdrawn due to Applicant’s cancelation of the claims.
Previous rejection of claims 5 & 6 under 35 U.S.C. 112(a) for lacking enablement is withdrawn due to Applicant’s amendment of the claims.
Previous rejection of claims 1, 4, 14 & 21 under 35 U.S.C. 112(a) for reference to ‘vat analogs’ is withdrawn in view of Applicant’s amendment to the claims.
Previous rejection of claim 14 under 35 U.S.C. 101 as directed to description of natural phenomena without significantly more, is withdrawn in view of Applicant’s amendment to the claim.
Previous rejection of Claims 1-4, 7-12, 13, 14, 16-17, 21, 22 & 23 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to the claims.
Deposit Requirement
In response to previous enablement rejection, Applicant has provided affidavit regarding perfection of deposit of C. melo line MTYVVC721, NCIMB 44317.
Upon review of amended claims, it is Examiner’s position that the deposit is necessary for all claims, including claim 1. This is required to satisfy enablement because Applicant’s invention is a new plant requiring a specific genetic structure. Such a plant would require starting material(s) possessing all relevant QTL associated with the specific genetic signature claimed and thus require the starting material of the deposited line MTYVVC721. The starting materials or germplasm used at to arrive at MTYVVC721 are not in the specification or otherwise in the public domain.
As such, deposit of MTYVVC721, NCIMB 44317, is necessary for all claims of the instant application.
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.
Claim 24 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.
The claim is drawn to use of a plant selected via molecular markers and recites ‘breeding the plant…as a breeding partner in a breeding program’. It is unclear what is meant by methods of using ‘as a breeding partner’, and this is non-standard terminology in the art. Referring to specification for a definition of ‘a breeding partner’, none is found. Because common meaning of ‘partner’ is an object generally used with or complementary to another object, it is not clear if this is limiting use to a direct parent, distant relative, donor of particular DNA sequences, hybrid tester or other ‘partner’ to the plant breeding process.
Because this terminology is unclear and differing interpretation of what partner means would impact the scope of the subject matter encompassed, claim 24 is rejected.
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 1-2, 5-14, 16-17, 22 & 24 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 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.
Due to Applicant's amendment of the claims, the rejection is modified from that set forth in the Office action mailed 30 Dec 2025, as previously applied to claims 1-14, 16-17 & 21-23. Applicant's arguments filed 30 March 2026 have been fully considered but they are not persuasive.
Regarding independent claims 1 & 14; these are drawn to optional markers associated with QTL regions on chromosomes 2 (LG2) & 5 (LG5), encompassing multiple genes. Broadest reasonable interpretation of these claims is they encompass a genus. Said genus comprises unknown structures (QTLs) in melon having the function of multiple disease resistances as instantly claimed, and mapped on LG2 & LG5. The exact genetic composition of the QTL is not defined. Applicant presents a series of markers, from which only a single marker is required (i.e. ‘and/or’) to meet the limitation of the claimed QTL region.
However, Applicant has only described limited variant(s) of such genetic diversity in the form of a single germplasm accession deposited (i.e. C. melo ‘MTYVVC721’). This represents one breeding line, naturally limited by alleles, QTL, and chromosomes contributed by parental lines. Referring to the specification, we see that the parental material consists of only five genotypes from the many thousands of C. melo lines used in melon breeding.
As amended, claims recite a series of optional QTL-associated markers of which a single marker can be used for each QTL. Because QTL comprise genomic regions (i.e. loci), rather than specific points (i.e. ‘a marker’), one would need to know at least two markers to delineate or determine the endpoints of the genomic region encompassed (i.e. QTL). Preferably, one would have several markers spanning multiple regions of a described QTL to describe the intended region (i.e. a haplotype). Because the scope of claims 1 & 14 changes relative to the genomic or chromosomal region limited by the recited markers, or composition of the ‘QTLs conferring resistance’, the unambiguous assignment of markers defining the limits of a claimed QTL (i.e. more than one) is critical information.
However, Applicant does not specify which markers are required to determine the bounds of each of their individual claimed QTL region(s). One skilled in the art reading claims which included an option of a single marker, unbounded by another flanking marker to define a specific QTL, could interpret this to encompass the entirety of sequences physically linked to either side of the marker (i.e. the entire chromosome). Applicant does not describe representative examples of all genetic variations that may be observed on chromosomes of LG2 & LG5, or their combinations.
Further, Applicant does not recite that the QTL haplotypes claimed are restricted to the pool of breeding material, and the highly specific breeding lines, which they have described in the specification. There is no description of assessment or characterization of the claimed genetic combinations or QTL in alternate, varied breeding populations or via assessment in wider germplasm diversity panels. There is no description or assessment of the potentially variable QTL in material unrelated to Applicant’s particular breeding lines.
As such, broadest reasonable interpretation of claims includes plants with potentially different QTL regions or comprising fundamentally different linked resistance genes than those described by Applicant. As written, it would also encompass or those not derived from their described breeding material and is merely identical-by-state for singular markers. It is reasonable one could arrive at disease resistant watermelons with fundamentally different linked QTL regions, yet carrying singular markers recited by Applicant due to recombination.
Thus, Applicant’s claim language is drawn to known multi-genic disease resistance regions, in potentially all watermelon germplasm, which they claim via a highly reduced set of singular markers. Such a claim would encompass a wide variety of germplasm and potential haplotypes. However, Applicant’s written description only describes highly specific QTL haplotypes (i.e. multiple markers comprising QTL region) in highly specific germplasm (i.e. comprising or derived from watermelon line ‘MTYVVC721’).
As such, claims 1 & 14 are rejected for failure to describe representative species. Dependent claims are also rejected because they fail to overcome the deficiencies of the parent claims.
Applicant is advised to amend and limit claims to specific accession(s) or germplasm reflective of the written description. Applicant is advised to limit claims to clearly defined QTL regions, bounded by distinct molecular markers.
Response to Arguments
Applicant urges rejection of claims 1-14, 16-17 & 21-23 is improper due to amendment of the claims, that now recite a combination of four QTLs and the Vat gene [Remarks, p.12, ¶3, l.1-2]. Applicant argues that description of particular allelic combinations among the four different QTL is defined [p.13, ¶2]. Applicant further argues that the deposited line ‘MTYVVC721’ is representative of all variations of the claimed QTL combinations due to presence of specific QTL on linkage groups 2 & 5 [p.13, ¶3]. For these reasons, Applicant argues the amended claims are not directed to a broad family of unknown QTL structures.
Arguments are unconvincing for two reasons.
First, the previous rejection is not based on deficiency regarding there being four distinct QTL and the Vat gene included in the disease resistant watermelon per se (i.e. a five-gene stack). The rejection, as repeated here, is grounded on the fact that Applicant has not described each of the individual QTL, that remain undefined due to lack of claiming distinct boundary/flanking markers. For example, the description of a haplotype comprising four QTL regions, or four distinct chromosome regions, would require at least eight specific marker combinations, wherein two markers are required to define the bounds of each of the four QTL (i.e. 4 QTL regions x 2 flanking markers = 8 specific markers). Applicant does not provide such boundaries with respect to each QTL region presented in claims because their amendments optionally allow use of a single defining marker for each QTL.
Second, there is no limitation with respect to the germplasm in which the marker is assayed or detected, meaning breadth of the claims includes plants unrelated to Applicant’s germplasm, and would also potentially encompass watermelons arrived at by mutation, gene editing, or otherwise merely identical-by-state based on markers.
It is reasonable that the singular markers recited would have a high probability of carrying the linked QTL or nearby genes, if required they are derived from ‘MTYVVC721’. However, claim language does not require this, and as such broadly encompasses marker identities not derived from germplasm related to Applicant’s ‘MTYVVC721’. Rather than clarify the relationship of the QTL, linkage blocks, or associated markers with respect to breeding history, claims 1 & 14 do not recite the line ‘MTYVVC721’ at all.
Combined, these factors indicate that the broad possession claimed requires describing a representative sample of watermelon plants with representative variation in DNA linked to the singular, unbounded, markers claimed. One skilled in the art would reasonably expect Applicant to provide at least some characterization of genetic diversity surrounding regions linked to the listed markers outside of their own specific breeding population. Because the germplasm used is unspecified and the QTL regions are unbounded the amended claims, as currently written, remain drawn to a potentially very broad family of unknown QTL structures. Such a broad genus of plants is not described or demonstrated to be in possession of Applicant.
For this reason, previous rejection of claims 1 and 14, as well as their dependents is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 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, 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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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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