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 .
Status of Claims
Claims 60-64 are under examination on the merits.
Claims 1-59 are withdrawn without traverse.
The objections to the specification are withdrawn in light of Applicant’s amendments.
The objections to claims 60-62 & 64-65 are withdrawn in light of Applicant’s amendments.
The provisional rejection of claims 60, 62 & 64 on the ground of nonstatutory double patenting as being unpatentable over claims 30-32 of copending Application No. 18/180,488 are withdrawn in light of Applicant’s amendments to Application No. 18/180,488.
Claim Rejections - 35 USC § 112
Indefiniteness
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 64 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/8/2025 as applied to claims 62 & 64. Applicant' s arguments filed 11/18/2025 have been fully considered but they are not persuasive.
In claim 64, the recitation “gene” implies a polynucleotide structure comprising a coding sequence and the associated promoter, terminator, enhancer and/or repressor regulatory encoding regions (see The Federal Register, Vol. 66, No. 4, Friday, January 5, 2001 at page 1108, left column, Endnote 13). In the instant case, claim 64 recites the gene is a polypeptide. Given that a gene is not a polypeptide, claim 64 is indefinite as to what is encompassed by the limitation.
Applicant urges claim 64 has been amended for clarification and correction (Remarks, page 16, paragraph 4).
This argument is unpersuasive, because amendments have not clarified what the definition of a “gene” encompasses if the “gene” of claim 64 is a polypeptide rather than a nucleotide sequence. Amendment to wording such as --the morphogenic gene encodes a Babyboom (BBM) and/or a Wuschel (WUS) polypeptide-- would clarify the indefiniteness in claim 64.
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.
Claim(s) 60-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon-Kamm et al US 2011/0167516 A1 (published 7/7/2011, hereafter Gordon-Kamm) taken with the evidence of Zhao et al (2008) Agricultural Sciences in China. 7(9): 1046-1051.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/8/2025 as applied to claims 60-65. Applicant' s arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Claims 60-64 are drawn to a method of expressing a morphogenetic gene in a plastid-transformed cell or sector to enable multiplying and/or regenerating the plastid-transformed cell.
Gordon-Kamm discloses that plastid transformation allows for engineering of plant cells that maintain a very high copy number of an introduced gene (paragraph [0098]). However, plastid transformation is not routine in important crop species. For example, plastid transformation frequency in soybean is low (paragraph [0099]). Gordon-Kamm discloses that the introduction and expression of polynucleotides encoding cell proliferation factors, including babyboom polypeptides, may enhance efficiency of plastid transformation (paragraph [0100]). Gordon-Kamm specifically teaches that plastid transformation is possible in rice (paragraph [0099]).
Gordon-Kamm discloses an example of using cell proliferation factors for enhancing chloroplast transformation in plants wherein cell proliferation factor genes under control of an inducible promoter are introduced in a species of interest by nuclear transformation, such as leaves of maize (paragraph [0276]). The leaves are placed on medium which activates the cell proliferation factor genes and induces an embryogenic tissue culture response. The leaves are bombarded with chloroplast transformation vectors carrying a selectable marker gene and trait gene prior to, during, or just after induction of the cell proliferation genes, one to seven days after bombardment with the transformation vector the tissue is placed in medium with spectinomycin, eight weeks after the tissue is further proliferated on 13152 medium comprising 2,4-D, and finally transgene presence is determined using PCR or Southern analysis, which reads on identifying plastid-transformed cell or tissue (paragraph [0276]).
Gordon-Kamm discloses an alternative approach wherein expression cassettes containing tetracycline-inducible BBM and WUS genes are co-bombarded along with chloroplast transformation vectors carrying an aadA gene for selection into leaf explants or green tissue callus. Tetracycline or doxycycline is added to the culture medium after bombardment which stimulates expression of BBM and WUS and callus growth to improve recovery of homoplastic transgenic events (paragraph [0277]).
Gordon-Kamm discloses that selectable marker genes suitable for plastid transformation are genes that confer resistance to a substance which inhibits protein synthesis by the plastids such that cells which have acquired the phenotype are selected for by contacting the cells with a substance which inhibits protein synthesis by the plastids. Gordon-Kamm discloses that genes which confer resistance to the effects of spectinomycin are suitable for the selection of plastid transformation events (paragraph [0105]).
Zhao provides evidence that 2,4-D is a plant growth regulator, specifically a strong auxin used in medium for induction and proliferation of callus from maize (page 1049, right column, paragraph 3).
The method of Gordon-Kamm anticipates a method of expressing a morphogenetic gene in a plastid transformed cell in maize to enable regenerating the plastid-transformed cell (instant claim 60) including wherein the cell or sector is derived from a leaf (instant claim 61), wherein introducing the morphogenic gene is prior to the identification of the plastid transformed cell or sector (instant claim 62). Because the medium for culturing the transformed tissue comprises 2,4-D, a plant growth regulator, and because the tissue is proliferated, the method of Gordon-Kamm reads on a method wherein the plastid-transformed cell or sector is placed on a medium containing plant growth regulators sufficient to enable cell multiplication or regeneration of the cell or sector (instant claim 63).
Gordon-Kamm’s approach of introducing expression cassettes containing tetracycline-inducible BBM and WUS genes into the plastid-transformed cells or calli anticipates a method wherein the morphogenic gene encodes a Babyboom (BBM) or Wuschel (WUS) polypeptide, which reads on instant claim 64.
Thus, Gordon-Kamm anticipates claims 60-64.
Applicant urges that the obviousness of the use of polynucleotides encoding babyboom in nuclear transformation does not extend to plastid transformation, including plastid transformation of monocot species. Applicant urges that Gordon-Kamm is directed to methods for nuclear transformation and does not disclose or enable methods where the plastid transformed cell or sector is a monocot cell (Remarks, page 16, paragraph 6-page 17, paragraph 3).
This argument is unpersuasive, because Gordon-Kamm discloses an example of plastid transformation in leaves of maize from plants transformed with cell proliferation factor genes. A working example is not required in the prior art or instant specification to show enablement.
Applicant urges that because Gordon-Kamm’s example of maize plastid transformation is prophetic, and because graminaceous monocots are known to be naturally resistant to spectinomycin, attempts to use spectinomycin for selection will fail; thus, Applicant urges Gordon-Kamm has not taught nor enabled plastid transformation in this species (Remarks, page 17, paragraph 4).
This argument is unpersuasive, because instant claims 60-64 do not require spectinomycin nor even selection. Identification of the plastid-transformed cell or sector, as in instant claim 62, reads on the PCR and Southern analysis in the method of Gordon-Kamm. The use or non-use of spectinomycin is irrelevant to the patentability of the instant claims or whether Gordon-Kamm discloses plastid transformation in a monocot.
Applicant urges that cell proliferation factors of Gordon-Kamm and strong auxins such as 2,4-D promote an embryogenic response in maize and other monocots. Applicant urges that because embryogenic cultures are routinely initiated in dark or low light conditions, they are not conducive to production and selection of plastid transformants. Applicant urges that because successful maize plastid transformation known in the art used different conditions, the work of Zhao and Gordon-Kamm would not be applicable to plastid transformation (Remarks, page 17, paragraph 5-page 18, paragraph 1).
This argument is unpersuasive, because claims 60-64 do not require dark or low light conditions or organogenic response, so those conditions are irrelevant to the rejection above. Moreover, instant claim 61 encompasses the method wherein the transformed cell or sector is derived from an embryogenic callus. Gordon-Kamm’s disclosed method comprises the initiation of embryogenic callus from maize leaves, which reads on the instantly claimed method of plastid-transformation in a monocot.
Applicant urges that stable plastid transformation leading to fertile plants has not been demonstrated in any monocotyledonous plant species despite decades of research because many steps must be successfully executed together to be successful. Applicant urges that the prior art lacks successful demonstration of plastid transformation from 2,4 D-induced and propagated embryogenic callus to monocot plants. Applicant urges that monocot plastid transformation in cereal crops such as maize has been a clear and unmet need for decades and requires extensive, time consuming, and expensive additional research on the many other factors with no guarantee of success (Remarks, page 18, paragraph 2-page 19, paragraph 1).
This argument is unpersuasive, because the instantly claimed method does not require additional, successfully executed steps not previously disclosed by the method of Gordon-Kamm. If all the positively recited limitations of the instantly claimed method, which have been previously disclosed by Gordon-Kamm, are not sufficient to enable stable plastid transformation, it would seem that the instant claims are not enabled over the full scope of the claimed invention.
With respect to Applicant’s arguments regarding providing a long-felt need, MPEP 716.04 makes clear that Applicant has not met the criteria for this argument. Establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967). Second, the long-felt need must not have been satisfied by another before the invention by applicant. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988) ("[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved".) Third, the invention must in fact satisfy the long-felt need. In re Cavanagh, 436 F.2d 491, 168 USPQ 466 (CCPA 1971).
However, Gordon-Kamm teaches that plastid transformation in rice, a monocot, was successful prior to the filing of the instant application (paragraph [0099]). In addition, Applicant states that the prior art of Sidorov demonstrates maize plastid transformation (Remarks, page 18, first paragraph). Therefore, Applicant does not meet all the criteria for the secondary consideration of long felt need.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 60-62 & 64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-24, 27, 36 & 39 of copending Application No. 18/203,875 (reference application, hereafter ‘875). Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations of claims 60-62 & 64 are obvious over the limitations of ‘875 claims 23-24, 27, 36 & 39.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/8/2025 as applied to claims 60-62 & 64-65. Applicant' s arguments filed 11/18/2025 have been fully considered but they are not persuasive.
‘875 claims 23-24 are drawn to a method of genetically modifying a monocotyledonous plant or plant part comprising introducing an exogenous nucleic acid sequence into cells comprising nucleic acid expression constructs expressing morphogenic genes and capable of regeneration and purifying heteroplasmic plastid-transformed leaf sectors to homoplasy via a second or multiple rounds of regeneration from leaf tissues.
This reads on instant claims 60 and 62 wherein a morphogenetic gene is expressed in a plastid-transformed monocot cell or sector to enable regenerating the plastid-transformed cell, prior to or after identification of the plastid-transformed cell or sector, because purifying leaf sectors reads on identification of the plastid-transformed cell or sector.
‘875 claim 27 is drawn to the method wherein the genetically modified plant comprises a genetically modified plastid or chloroplast genome. ‘875 claim 36 is drawn to the method wherein the morphogenic genes are from a list that includes monocot-derived BBM and WUS2. ‘875 claim 39 is drawn to the method wherein the monocot plant is a leaf tissue or an embryo tissue.
Although ‘875 claims 36 & 39 do not require that the genetically modified monocotyledonous plant cell be a plastid-transformed plant cell, it would be obvious that plastid-transformed plant cells are encompassed by ‘875 claim 23 given the limitations of ‘875 claims 27 and 24. Therefore, ‘875 claim 36 makes obvious instant claim 64 and ‘875 claim 39 makes obvious instant claim 61.
Applicant urges that the currently amended claims are not made obvious over one another because the claims of the ‘875 application are directed to morphogenes and the claims facilitate multiplication and regeneration. Applicant urges that it would not be obvious that morphogenes would be useful in wild-type backgrounds for plastid transformation (Remarks, page 19, paragraph 5-page 20, paragraph 2).
This argument is unpersuasive because the instant claims are drawn to a method of expressing a morphogenic gene in a transformed cell, including introducing the morphogenic gene into a plastid-transformed cell or sector (instant claim 62, line 1-2). The instant claims encompass backgrounds that are not wild-type. Likewise, the claims of ‘875 recite steps of introducing nucleic acid sequence stably expressing one or more morphogenic genes and incubating sufficient to regenerate a plant. The claims are therefore obvious over one another.
Claims 60-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23-24, 27, 36 & 39 of copending Application No. 18/203,875 (hereafter ‘875) in view of Okuzaki et al (2012) Plant Biotechnology. 29: 307-310 (published 6/6/2012, hereafter Okuzaki) taken with the evidence of Jahan et al (2019) Pak. J. Bot. 51(2): 451-459 (published 2019, hereafter Jahan).
This is a provisional nonstatutory double patenting rejection. Due to Applicant' s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9/8/2025 as applied to claims 60-65. Applicant' s arguments filed 11/18/2025 have been fully considered but they are not persuasive.
The claims of ‘875 are presented above. ‘875 does not include the limitation of placing the plastid-transformed cell or sector on a medium containing plant growth regulators sufficient to enable cell multiplication or regeneration.
Okuzaki teaches a method of plastid transformation wherein tobacco leaves were subjected to plastid transformation by bombardment with DNA and then placed on MSBN medium, which contained N6-benzyladenine and 1-naphthaleneacetic acid, from which adventitious shoots were recovered (page 308, right column, paragraph 1-page 309 left column, paragraph 1). Okuzaki teaches that the protocol, which includes pre-and post-bombardment treatment of the leaves, yielded more independent primary transformants effectively and stable (page 310, left column, paragraph 1).
Jahan provides evidence that 1-naphthaleneacetic acid is a plant growth regulator (abstract).
Before the filing date of the instant application, it would have been obvious to one of ordinary skill in the art to modify the method of ‘875 claims 23-24, 27, 36 & 39 to add a step of placing the plastid transformed cells on a medium supplemented with a plant growth regulator such as 1-naphthaleneacetic acid. One of ordinary skill would have been motivated to use the modifications suggested by Okuzaki including culture on a medium with a plant growth regulator in order to increase primary transformants. One of ordinary skill in the art would have had reasonable expectation of success, because both Okuzaki and ‘875 are methods of plastid transformation.
The mapping of claims 60-62 & 64 to ‘875 claims 23-24, 27, 36 & 39 is presented above. Thus, instant claims 60-64 are obvious over ‘875 claims 23-24, 27, 36 & 39 in view of Okuzaki.
Applicant urges that amended claims are not made obvious over one another because the instant application of ‘875 is directed specifically to the re-transforming of a genetically stable monocot which is distinct from currently amended claimed invention (Remarks, page 20, paragraphs 3-4).
This argument is unpersuasive, because the instantly claimed method of expressing a morphogenic gene in a plastid-transformed cell or sector encompasses a method of re-transforming via plastid transformation a genetically stable monocot expressing a morphogenic gene. The claim limitations are not distinct and are obvious over one another.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Victoria L DeLeo whose telephone number is (703)756-5998. The examiner can normally be reached M-F 8:00am-4pm EDT.
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/VICTORIA L DELEO/Examiner, Art Unit 1662
/Anne Kubelik/Primary Examiner, Art Unit 1663
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