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 .
Claim Status
Claims 1-15 are pending.
Claims 1-15 are examined on the merits.
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.
Claims 1-15 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.
Claim 1 is rejected as indefinite for the recitation in step (c), “generating a wound at or near at least one of the graft junctions”. The term “near” is a relative term and the claim does not provide an objective boundary for determining how close the wound must be to the graft junction.
This ambiguity is material because the wound location affects the subsequent shoot formation and selection steps. In particular, step (d) requires allowing the wounded grafted union to form shoots, and step (e) requires selecting a shoot comprising cells derived from the callus. A wound made in the callus, at the callus/scion junction, at the callus/rootstock junction, or merely somewhere “near” the junction may involve different tissues and may result in shoot having different cellular origins. Therefore, the metes and bounds of the claimed wound location, and consequently the scope of the selected callus-derived shoot, are unclear.
Dependent claims 2-15 are included in this rejection because they do not include additional limitations to resolve the ambiguity.
Claims 1 and 6 are rejected unclear as indefinite. Claim 1 recites “generating a wound at or near at least one of the graft junctions”, while claim 6 further recites that “the wounding of step (c) is removal of the shoot apical meristem by decapitation”. The scope of claim 6 is unclear because the shoot apical meristem is generally located at the shoot apex, whereas claim 1 requires the wound to be at or near a graft junction formed between the callus and the scion/rootstock. Thus, it is unclear whether claim 6 requires decapitation at or near the graft junction, removal of a scion shoor apex remote from the graft junction, or removal of a shoot apical meristem from a callus-derived shoot. Accordingly, the metes and bounds of the claimed wounding step are unclear.
Claim 5 is rejected unclear as indefinite because the phrase “a similar plant” lacks objective boundaries. The claim does not define the degree or type of similarity required between the scion and rootstock plants, such as whether similarity is based on species, variety, genotype, phenotype, or graft compatibility.
Claim Rejections - 35 USC § 112
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.
Written Descriptions
Claims 1-15 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.
The Federal Circuit has clarified the application of the written description requirement. The court stated 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". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
Claim 1 broadly recites a method of generating and selecting a shoot of a plant comprising: intergrafting a callus between a scion and a rootstock, forming graft junctions between the callus and each of the scion and rootstock, generating a wound at or near the graft junction, allowing the wounded grafted union to form a shoot, and selecting a shoot comprising cells derived from the callus. The claim is not limited to any particular plant species, genus, family, callus source, graft combination, regeneration system, graft compatibility relationship, or developmental condition.
The specification, however, provides only limited working examples involving particular Solanum and Capsicum materials under specific experimental conditions (p41-42, Examples 1-3). Example 1 employs RUBY-marked tomato callus intergrafted between stock and scion tissues of a highly regenerative tomato genotype. Example 2 employs transgenic Capsicum annuun cv. Maor callus intergrafted between stock and scion tissues of a particular tomato hybrid. The specification does not provide representative examples spanning the full breadth of plants encompassed by claim 1.
The breadth of claim 1 is not commensurate with the disclosure. Graft-based regeneration and chimera formation are known to depend upon plant species, genotype, graft compatibility, callus behavior, wound response, vascular reconnection, and regeneration capacity. Melnyk (Charles W. Melnyk, Plant grafting: insights into tissue regeneration, Regeneration 2017;4:3–14) teaches that callus formation associated with graft unions may be species-specific, that graft-associated callus biology remans incompletely understood, and that graft compatibility differs substantially among plant species (p7, left and right column; p11, left column, pa1; p11, Concluding Remarks). Melnyk further explains that the relationship between graft formation and callus development remains unresolved and that the cellular origin of graft-junction callus remains uncertain (p3, Introduction).
Zhou (Yiling Zhou, A thesis presented to the graduate school of the University of Florida (2016), pp1-57) reports that successful graft-mediated chimera formation depends on donor selection, grafting methodology, regeneration conditions, and compatibility between plant materials (p35; p45, pa1). Zhou further teaches that synthetic graft chimeras have been achieved only in limited plant system and that additional work is required to improve existing methods (p26)
Accordingly, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the claimed method across the full scope of “a plant” as recited in claim 1. The disclosure demonstrates possession of particular embodiments employing specific tomato and pepper materials under particular experimental conditions.
Dependent claims 2-15 are included in this rejection because they do not include additional limitations to resolve the ambiguity.
Scope of Enablement
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specifications, while being enabling for intergrafting the specifically disclosed callus material between the specifically disclosed scion and rootstock under the described culture and regeneration conditions, does not reasonably provide enablement for the full scope of the claimed method, which encompasses intergrafting a callus between plant parts of broadly recited “a plant”, generating a wound at or near a graft junction, and recovering a shoot comprising cells originating from the callus, without limitation as to plant species, graft compactivity, callus source, grating methodology, wound location, or regeneration condition. 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/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
Claim 1 broadly encompasses methods performed in any plant and is not limited to particular species, genera, families, graft-compatible combinations, callus sources, regeneration systems, or developmental conditions.
To practice the full scope of claim 1, a person of ordinary skill in the art would need to determine, for each plant species or genotype, whether a callus can survive intergrafting, whether functional graft junctions form between the callus and both graft partners, whether vascular reconnection occurs, whether wounding at or near the graft junction induces shoot regeneration, whether regenerated shoots contain callus-derived cells, and whether such shoots can be recovered and propagated. The specification provides no guidance establishing that these requirements can be achieved across plants generally.
The amount of experimentation required would be undue because the relevant art demonstrates that these variable are highly unpredictable. Melnyk teaches that wound-induced callus formation, graft healing, and vascular reconnection involve complex developmental processes, that graft-associated callus biology remains incompletely understood, and that graft compatibility differs substantially among plant species (p7, left column; p11, left column, pa1; p3, Introduction).
Zhou provides additional experimental evidence that graft-mediated chimera formation depends upon donor selection, grafting method, regeneration conditions, and compatibility between plant materials (p35; p45, pa1). Zhou reports that successful chimera formation occurred only in particular graft combinations and that numerous graft combinations failed to produce chimeric shoots (p26, Rationale and Objectives). Zhou further reports that regeneration efficiency did not reliably predict chimera formation, demonstrating the unpredictability of the process (p21-22, pap45).
The specification contains only a small number of working examples, involving specific tomato and pepper materials (instant application, p41-42, Example 1-3). Those examples do not provide sufficient guidance to permit a person of ordinary skill in the art to practice the claimed invention across the full scope of plants encompassed by claim 1 without extensive trial-and-error experimentation to identify suitable plant materials, graft combinations, callus sources, regeneration conditions, and selection methods.
Claims 2-15 are not enabled for at least the same reasons because they depend from claim 1 and further require successful practice of the broadly claimed intergrafting and regeneration method across the full scope of plants encompassed by claim 1. Although the specification describes embodiments involving germline progenitor cells, vegetative propagation, transgenes, mutations, and programmed genome editing, the disclosure does not enable such embodiments across the full breadth of plant species and graft combinations encompassed by claim1.
Accordingly, the specification does not enable the claimed invention commensurate with its full scope without undue experimentation.
Conclusion
No claims are allowed.
The closest prior art appears to be Noguchi (Brassica T. Noguchi et. al., Theoretical and Applied Genetics (1992) 83:727-732). Noguchi teaches approach-grafting seedlings followed by in vitro culture of the grafted plants, excision of graft-union tissues, and regeneration of chimeric shoots from cross-cut sections of the graft union (Summary; Fig 1; p728-730). In particular, Noguchi teaches that chimeric shoots were regenerated mainly from cross-cut sections of the graft union near the apical meristem (p730, left column). However, Noguchi does not teach or suggest intergrafting a separately prepared callus between a scion and a rootstock, generating shoots comprising cells derived from the intergrafted callus, or selecting shoots based on the presences of callus-derived cells. Therefore, while the closest prior art shows that graft-mediated chimera formation and regeneration from graft-union tissues were generally know, it does not teach or reasonably suggest the specific claimed method of intergrafting a separately prepared callus between scion and a rootstock, generating a wound at or near a graft junction, and selecting a shoot comprising cellos originating from the intergrafted callus.
Accordingly, the closest prior art does not anticipate or render obvious the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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 A Abraham can be reached at (571)272-7058. 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.
/YANXIN SHEN/Examiner, Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
Prosecution Insights