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
Applicant’s election of Group I (claims 1-7) and species (A)(i) (SEQ ID NOs: 1-3, 10, 29-30) in the reply filed on 01June2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group of invention, there being no allowable generic or linking claim. Furthermore, the species encompassed by the following language at claim 4 are also withdrawn as being directed toward a nonelected species: “… or a functional variant or homolog thereof, wherein the functional variant or homolog has at least 80% overall sequence identity to SEQ ID NO: 1 to 3 or 29 to 30”.
Election was made without traverse in the reply filed on 01June2026.
Status of the Claims
The claims filed 01June2026 are acknowledged. Claims 1-9 are pending. Claims 4 and 8-9 are currently amended while claims 1-3 and 5-7 are original. Claims 8-9 are withdrawn. Claims 1-7 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) [GB1815672.9 filed 26September2018], 35 U.S.C. 365(c) [national stage of PCT/GB2019/062727 filed 26September2019], and 35 U.S.C. 120 [divisional application of 17279978, now US Pat. No. 12209248] is acknowledged. Claims 1-7 have an effective filing date of 26September2018.
Claims
As was discussed of record for parent application 17279978 (now US Pat. No. 12209248), Applicant may wish to consider amending claim 4 to remove nonelected species (recited at lines 3-5 and quoted above) and add some percent identity language (something like “… at least 90% sequence identity across the full length of one or more of SEQ ID NOs: 1, 2, 3, 10, 29, and 30.”).
Claim Objections
Claim 3 is objected to because of the following informalities: there is a comma within “… size distribution, within a grain or seed …” that adds confusion to the claim. If appropriate, please remove the claim (otherwise please clarify the claim).
Claim 6 is objected to because of the following informalities: “MRC” appears to be missing at line 3 of the claim (as in “… of at least one MRC nucleic acid ….” Appropriate correction is required.
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.
Claims 3-7 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.
Claims 3, 6, and 7 (therefore, all of claims 3-7) recite several phrases that, without clarification, make the metes and bounds of the claimed subject matter unclear. (1) Claims 3, 6, and 7 recite the phrase “grain or seed”. While these terms are generally accepted in the art as having slightly different meanings (“grain” is “seed” and “seed” may be “grain”), this situation is different because the specification tells us to interpret these terms “interchangeably” (see line 32 at page 17 of the specification “The terms ‘seed’ and ‘grain’ as used herein can be used interchangeably.”). Without a clear statement from Applicant confirming their intention to be a “lexicographer” and interpret these terms in a manner that is inconsistent with their well-recognized meaning in the art; it is not clear whether the phrase “grain or seed” in the claims is intended to mean that “grain” and “seed” are distinct things. Note that “as used herein can be used” in the specification is, itself, a confusing phrase and not enough to confirm Applicant as a “lexicographer”. Please pick one term (perhaps “grain”) and amend the claims so that only one is being recited. Alternatively, please explain on the record how “grain” and “seed” have different scopes and should be interpreted differently for the purpose of examination. (2) Similarly, claims 3 and 6 recite the phrase “compared to a wild-type or control” but because a “control” is generally understood to encompass a wild-type comparator, it is not clear from the current record why both are being recited in the claims and whether the duplication is meaningful. Absent Applicant using these terms in a manner that is different from their well-recognized meaning, it is recommended that “wild-type” be removed from the claims (i.e., just recite “compared to a control grain”) because, again, “control” in this context is usually understood to encompass wild-type comparators (“control” is broader than “wild-type”).
Claims 6-7 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.
Claim 6 (and, therefore, claim 7 which refers thereto without correcting the issue) is indefinite for additional reasons. Claim 6 refers back to claim 3 and purports to add the requirements that (1) the plant part is “grain or seed” and that the (2) “grain or seed” is “obtained or obtainable” from the plant part of claim 3; also that (3) the “grain or seed” has increased expression of at least one MRC [sic] nucleic acid or increased activity of an MRC polypeptide compared to a “control or wild-type” “grain or seed”. Requirements (2) and (3) are already required by claim 3: the plant part is already a “part thereof” (see the language of claim 3) and claim 3 already requires that the plant part has increased MRC nucleic acid expression or increased MRC polypeptide activity. Without more information, it is unclear how, if at all, requirements (2) and (3) add subject matter to what is already required of the plant part introduced at claim 3. Based on the current record, it is recommended that everything after “seed” at line 2 of claim 6 be deleted because it is redundant to what is already recited in claim 3. As said elsewhere herein, it is still recommended that “grain or a seed” at line 2 of claim 6 be amended to just “grain”. Taken together then, it is recommended that claim 6 simply say something like “The plant part of claim 3, wherein said plant part is grain.”
Claim Rejections - 35 USC § 112 – Written Description
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 2-7 (and, therefore, also claim 1 to which claim 2 refers) 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.
Claims 2-7 require (and, therefore, claim 1 encompasses) shifting starch granule size toward larger granules via a gain-of-function mutation within a Myosin-Resembling Chloroplast (MRC) gene or protein. Claims 1-4 encompass any non-Arabidopsis plant and, as elected, claim 5 recites that the non-Arabidopsis plant may be wheat, barley, rye, maize, potato, sorghum, or rice and claim 4 (as elected) requires that the plant be wheat (sequences SEQ ID NOs: 1-3, 29-30) or barley (SEQ ID NO: 10).
The specification only describes three gain-of-function mutations (all amino acid substitutions) which are able to shift starch granule size distribution towards larger granules and the specification only describes such mutations in the context of wheat: at Example VI at pages 88-89 the Kronos2485 (A625T), Kronos2096 (P681S), and Kronos775 (L394F) are described as being gain-of-function, substitution mutations capable of shifting wheat starch granule sizes toward larger granules. For clarity of the record, and as discussed within the record for parent application 17279978, these results in wheat appear to be reasonably extrapolated to barley (i.e., SEQ ID NO: 10).
Materially, as confirmed by lines 15-20 at page 89 of the specification: the phenotypic impact of an MRC mutation depends on the type of MRC mutation:
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The prior art does not supplement the deficiencies of the specification at least because this Applicant appears to be the first to describe a non-Arabidopsis MRC and, with this specification, a gain-of-function mutation which may shift starch granule size distribution toward larger granules.
Therefore, based on the current record, a skilled artisan would not reasonably believe Applicant was in possession of the full metes and bounds of these claims at the time the application was filed. In particular, and as evidenced by the statements within the specification itself, a skilled artisan would not reasonably believe that the results obtained via the Kronos2485 (A625T), Kronos2096 (P681S), and Kronos775 (L394F) mutations may be extrapolated out to every possible gain-of-function mutation within any one or more MRC nucleotide/polypeptide within any non-Arabidopsis plant. Please amend these claims so that they require the gain-of-function mutation to be (1) a Kronos2485 (A625T), Kronos2096 (P681S), or Kronos775 (L394F) mutation (such as by reciting that “… the at least one mutation is a gain of function mutation comprising a leucine to phenylalanine substitution at the position corresponding to residue 394 of SEQ ID NO: 1, an alanine to threonine substitution at the position corresponding to residue 625 of the sequence SEQ ID NO: 1, or a proline to serine substitution at the position corresponding to residue 681 of the sequence SEQ ID NO: 1 ….” with the understanding that “corresponding to” is the residue that aligns to the stated position and may therefore have a different residue number but not be materially different). Please also amend the claims so that the plant/plant part is (2) a wheat or barley plant/plant part.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by LETERRIER et al. (“Cloning, characterization and comparative analysis of a starch synthase IV gene in wheat: functional and evolutionary implications” 2008 BMC Plant Biology 8:98, 21 total pages, doi:10.1186/1471-2229-8-98).
Claim 1 is very, very broad: it encompasses increasing or decreasing the expression or activity of any one or more MRC nucleic acid/protein within any non-Arabidopsis plant.
Wheat MRC is now (post-filing) believed to interact with a number of proteins including the enzyme Soluble Starch Synthase 4 (abbreviated “SS4” or ”SSIV” in the art).1 Therefore, modulation of SS4/SSIV expression or activity within wheat, for example, is believed to modulate the expression or activity of MRC within wheat.
LETERRIER et al. teach modulation of SS4/SSIV expression or activity within wheat by adjusting light conditions.2 Therefore, and absent evidence to the contrary, LETERRIER et al. necessarily modulated the expression or activity of MRC (which interacts with SS4/SSIV) [claim 1].
As suggested within the Double Patenting rejection hereinbelow, please delete claim 1 (= amend claim 2 to be the first independent claim).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,209,248 (from parent application 17279978). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8 of the referenced patent recite a species within the genus of this application’s claim 1.
Claim 1 is very, very broad: it encompasses increasing or decreasing the expression or activity of any one or more MRC nucleic acid/protein within any non-Arabidopsis plant. For clarity, please also note that “for altering starch granule size distribution in a plant” within the preamble of claim 1 is non-limiting and, even if it were limiting, is also extremely broad.
Claims 1-8 of US Pat. No. 12209248 are generally directed toward shifting the starch granule size distribution of a wheat or barley plant toward smaller granules via introducing a partial or complete loss-of-function mutation into an MRC polynucleotide or polypeptide. Therefore, the subject matter of claims 1-8 of US Pat. No. 12209248 falls within claim 1 of this application (= anticipate the subject matter of this application’s claim 1).
As suggested within the anticipation rejection hereinabove, please delete claim 1 (= amend claim 2 to be the first independent claim).
Conclusion
The closest prior art is considered to be that describing Arabidopsis MRC(s) (also called “Protein Involved In Starch Initiation1”, “PII1”) and altering starch granule size distribution in Arabidopsis (an exemplary publication being VANDROMME et al. (of record IDS 25November2024). For clarity, there is no evidence of record showing that the prior art had described a wheat or barley MRC or altering starch granule size distribution toward larger granules in wheat or barley by modulating the expression or activity of an MRC/PII1 nucleic acid or polypeptide, respectively, and (specifically) doing so by introducing a gain-of-function mutation thereinto.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 See ABT & ZEEMAN “Evolutionary innovations in starch metabolism” 2020 Current Opinion in Plant Biology 55:109-117 at Figure 1 on page 110.
2 LETERRIER et al. at pages 4, 6, 11-12.
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