DETAILED ACTION
Claims 1-2, 6-9, 12-14, 16, and 22-25 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to claims 10-11 is withdrawn in light of Applicant’s cancellation of claims.
The rejection of claims 1-2, 6-16, and 22-25 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement and the Schardon Declaration filed 25 March 2026 stating that the NCMA can provide more than one 25-seed packet upon request for a Budapest Treaty deposit.
The rejection of claims 1-2, 6-9, 12-14, 16, and 22-25 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn as alfalfa variety C0515A3357 a collection of traits and genes and not a plant of fixed genetics.
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 1-2, 6-9, 12-14, 16, and 22-25 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 the rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The rejection is modified from the rejection set forth in the Office action mailed 26 September 2025 as applied to claims 1-2, 6-16, and 22-25, to remove portions overcome by Applicant’s amendment to the claims and the Schardon and 3rd Ma Declarations. Applicant’s arguments and the 3rd Ma Declaration, both filed 25 March 2026, have been fully considered but they are not persuasive.
Claim 1 is drawn to a population of seeds of alfalfa variety C0515A3357, wherein representative seed of said alfalfa variety have been deposited under NCMA Accession No. 202110001 and wherein a population of plants produced from the population of seeds has all of the physiological and morphological characteristics of said alfalfa variety C0515A3357.
It is unclear what it means for a population to have “all of the physiological and morphological characteristics of said alfalfa variety C0515A3357”.
C0515A3357 is a synthetic variety encompassing a diverse and very heterogeneous population of alfalfa plants resulting from crosses of 73 separate parent plants (¶16).
The specification describes some of the characteristics of the C0515A3357 population in Tables 1-14 and ¶14-19. ¶19 describes the C0515A3357 population as having high resistance to anthracnose (Race 1), bacterial wilt, fusarium wilt, verticillium wilt, Phytophthora root rot, Aphanomyces root rot (Race 1), and Aphanomyces root rot (Race 2), and has having resistance to pea aphid (¶19). In Tables 7-14, the specification indicates that “high resistance” means >50% of the plants in the population are resistant and that “resistance” means 31-50% of the plants in the population are resistant. Tables 7-14 provide both those general ratings for resistance for those traits as well as specific percentages; for example, Table 8 indicates that 72% of the C0515A3357 population is resistant to bacterial wilt. It is not clear if the C0515A3357 population must be merely resistant or highly resistant to these diseases and pests as summarized in ¶19 or if the population must have the exact resistance percentages listed in Tables 7-14.
It is not clear if the C0515A3357 population must have the exact total yield, annual yield, persistence, fall dormancy rating, winter survival rating, and multifoliate leaf expression, reported in Tables 1-6 or if it can have the more general rating presented in the Tables. It is not clear which standard the C0515A3357 population must have to have all the physiological and morphological characteristics of alfalfa variety C0515A3357.
Similarly, it is not clear if the C0515A3357 population must have the exact percentages of flower color listed in ¶16 or if any variation is permitted. It is also unclear what percentage a “trace” of variegated and white color is and how large the population must be to have those exact percentages. Note that 97% purple, 1% cream, and 1% yellow adds up to 99%; it is not clear what percent “trace” is.
If the C0515A3357 population must have the exact percentages and values listed in ¶17, Tables 1-14 and C0515A3357’s undisclosed phenotypic traits, it is not clear if one had a population of alfalfa seeds or plants with a percentage or value for one of these traits that differed, for example, by 1%, if that population would be encompassed by the claims. If one has a single C0515A3357 seed or plant or a C0515A3357 subpopulation that is too small to have all the physiological and morphological characteristics of alfalfa variety C0515A3357, it is not clear this the plant or subpopulation would be encompassed by the claims.
It is also not clear if “all of the physiological and morphological characteristics of alfalfa variety C0515A3357” only means the characteristics described in Tables 1-14 and ¶14-19 or if includes all the non-described characteristics of alfalfa variety C0515A3357, like detergent fiber concentration, relative feed value, and salt tolerance. It is also unclear what the values these are for C0515A3357.
It is unclear how many plants and seeds must be in the population to produce the exact percentages present in C0515A3357, and it is unclear if one had one fewer plant or seed than that if that population would be encompassed by the claim.
Therefore, the metes and bounds of the claims are indefinite.
Response to Arguments
Applicant urges that a "population" of alfalfa variety C0515A3357 has a customary, well-known technical meaning in the art that encompasses genetic structure and allele frequencies
(response pg 5).
This is not found persuasive because Applicant has not provided such a definition from the art. Applicant is reminded that evidence submitted after final will not be considered unless Applicant provides a showing of good and sufficient reasons of why they were necessary and not earlier presented.
The Declaration states and Applicant urges that alfalfa populations are characterized by their classification thresholds such as highly resistant, resistant, or susceptible, which is how alfalfa varieties are described (and marketed) in the art, e.g. by the Alfalfa and Miscellaneous Legumes Variety Review Board and how C0515A3357 is described in the specification (Declaration ¶7; response pg 6).
This is not found persuasive. The specification does not state that only the traits and thresholds described and marketed in the art are how C0515A3357 is described in the specification and does not limit its traits to those described by the Alfalfa and Miscellaneous Legumes Variety Review Board. ¶18 states that
All disease and pest tests of alfalfa variety C0515A3357 were conducted for the National Alfalfa and Miscellaneous Legume Variety Review Board AOSCA certification and were conducted by standard procedures and scoring systems as described in the NAAIC Standard Tests to Characterize Alfalfa Cultivars, which are maintained online on the NAAIC's website
A statement of how tests were run is not a limitation on the meaning of “all of the physiological and morphological characteristics of said alfalfa variety C0515A3357”.
It also does not clarify if the claimed population must have all of the other physiological and morphological characteristics of said alfalfa variety C0515A3357, like its detergent fiber concentration, relative feed value, salt tolerance and nitrogen fixing potential, and how close a percent match the values for each of these traits must be to what plants grown from the seeds in the deposit have.
It is noted that the plain meaning of “all of the physiological and morphological characteristics of … C0515A3357” means that it has each and every physiological and morphological characteristic of said alfalfa variety C0515A3357, including those not disclosed. The plain meaning would not be that the physiological and morphological characteristics of C0515A3357 only include those listed in the specification or only those listed in the specification but at a range varying from 50 to 100%, or only those traits discussed on a protocol list that is not part of the specification.
The Declaration states and Applicant quotes that interpreting the description to only describe a population with, e.g., exactly 72% of plants exhibiting resistance to Bacterial wilt is improper and unreasonable as NAAIC guidelines could indicate an Adjusted %R of 71% or 73%, rather than the 72% disclosed in the specification or any other percentage within the classification threshold that is classified as highly resistant to Bacterial wilt; a skilled artisan would not question this characteristic because an exact Adjusted %R of 72% was not obtained in a subsequent test (Declaration ¶8; response pg 6).
This is not found persuasive. An exact Adjusted %R of 72% not being obtained in a subsequent test mean the characteristic is affected by environmental conditions or that there is allelic variation from generation to generation. The former means that if plants are grown in environmental conditions such that Phytophthora root rot resistance, reported in Table 11 as having a 55% adjusted R, is now a 49% adjusted R, the population would be merely resistance and not highly resistant to Phytophthora root rot. These plants would not be encompassed the claims even though they have the same allelic distribution is in the deposit. One growing a population of alfalfa may infringe in some years and not others, without knowing beforehand which years they would be infringing.
The latter means that the distribution of alleles in C0515A3357 is not fixed. However, Ma, in the Declaration filed 1 August 2025 asserted that an alfalfa population is in Hardy-Weinberg equilibrium (2nd Declaration ¶7), which means that distribution of alleles in C0515A3357 does not change. It is thus not clear if the distribution of alleles in C0515A3357 is fixed or not.
It is still unclear how much variation from the reported percentages listed in Tables 1-16 is tolerated.
The Declaration states and Applicant urges that the interpretation that a population of plants of alfalfa variety C0515A3357 must have the identical numerical percentages disclosed in the specification is inconsistent with the record and fundamental practices in the art; the percentages reflect the test results obtained for the respective standardized tests, and these percentages establish the classification thresholds that characterize alfalfa variety C0515A3357 (Declaration ¶8; response pg 6).
This is not found persuasive. The interpretation that a population of plants of alfalfa variety C0515A3357 must have the identical numerical percentages disclosed in the specification is not inconsistent with the record as the Table disclose exact percentages. At no point in the specification does it state that C0515A3357 is only defined by ranges.
The Declaration states and Applicant urges that flower color is a descriptor rather than a defining classification criterion; 97% purple, 1% yellow, 1% cream with a trace of variegated and white" represents the variety's expected phenotypic distribution based on the underlying allele frequencies, but does not affect the variety's agronomic performance or commercial identity and would not be relied upon for identifying or distinguishing alfalfa variety C0515A3357 like NAAIC testing protocols for the variety's defining agronomic traits are (Declaration ¶9; response pg 6-7).
This is not found persuasive.
In the 1st Ma Declaration, filed 27 January 2025, the same Declarant relied on the flower color percentages to distinguish C0515A3357 alfalfa variety 510M374 (U.S. 10,674,696) cited as prior art (1st Ma Declaration ¶7), saying .
[T]he gene pool and allelic frequencies of the claimed and referenced alfalfa varieties are distinct. These genetic differences are also exhibited in the distinct phenotypes of the claimed and referenced varieties. For example, alfalfa variety 510M374 is classified as exhibiting flower colors that are 97% purple and 2% variegated with a trace of white, yellow, and cream, and a "5" fall dormancy class; whereas the claimed variety is classified as exhibiting flower colors that are 97% purple, 1% yellow, 1% cream, with a trace of variegated and white, and a "4" fall dormancy class. Such characteristics help define the claimed and referenced alfalfa varieties. (emphasis added)
Such a contradiction does not clarify which traits describe C0515A3357.
Applicant urges that whether a claim is indefinite requires a determination of whether those skilled in the art would understand in light of the specification, and those skilled in the art would understand the scope of “all of the physiological and morphological characteristics of said alfalfa variety C0515A3357”; it requires the population to be of sufficient size to manifest the characteristics described in the specification (response pg 7).
This is not found persuasive because the characteristics described in the specification are not “all of the physiological and morphological characteristics of … C0515A3357”. They are only a subset of them. Applicant has not provided evidence that those skilled in the art view only the traits in Tables 1-16 to be “all of the physiological and morphological characteristics of … C0515A3357”. Applicant is reminded that evidence submitted after final will not be considered unless Applicant provides a showing of good and sufficient reasons of why they were necessary and not earlier presented.
The Declaration states that a "population" of C0515A3357 has a technical meaning that encompasses genetic structure and allele frequencies; NAAIC guidelines define population-level testing, and the variety is stable across Syn1-Syn3 generations and the physiological and morphological characteristics of alfalfa variety C0515A3357 can be maintained over several generations (Declaration ¶11).
This is not found persuasive. Applicant has not provided evidence that “all of the physiological and morphological characteristics of said alfalfa variety C0515A3357” are limited to those for which there are NAAIC testing protocols. If these the physiological and morphological characteristics of alfalfa variety C0515A3357 can vary from one test to another, as Declarant indicated in ¶8, then they cannot be maintained over several generations.
It is also not clear if one had a subpopulation of C0515A3357 seeds or plants that differ in one of these traits from what is described in the specification or in some other trait of C0515A3357 as deposited, if that subpopulation of C0515A3357 seeds or plants would be encompassed by the claims. It is unclear how many plants and seeds must be in the population to produce the exact percentages present in C0515A3357, and it is unclear if one had one fewer plant or seed than that if that population would be encompassed by the claim.
The Declaration states that only routine effort is needed to obtain a population of first-generation progeny alfalfa seeds produced by inter-pollinating a population of plants of alfalfa variety C0515A3357, as well as a population of alfalfa plants produced by growing said seeds and such plants will predictably comprise all of the physiological and morphological characteristics of alfalfa variety C0515A3357, which are defined in the specification and verifiable using established sampling and statistical methods well known in the art. There is therefore no ambiguity in what constitutes the claimed populations, including a population of first-generation alfalfa seed and/or plants of alfalfa variety C0515A3357 (Declaration ¶11).
This is not found persuasive. This is not an enablement rejection. There is ambiguity in what constitutes the claimed populations for the reasons above.
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 6-9, 12-14, 16, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over McCaslin et al (2020, US Patent No. 10,687,505).
The rejection is repeated for the reasons of record as set forth in the Office action mailed 26 September 2025, as applied to claims 1-2, 6-16, and 22-25. Applicant’s arguments and the 2nd Ma Declaration, both filed 25 March 2026, have been fully considered but they are not persuasive.
McCaslin et al teach alfalfa variety 412A121. Both 412A121 and the instant population have yields that vary with the year and location grown, are very winterhardy, have fall dormancy ratings that place them in fall dormancy class 4, and have high resistance to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Races 1 and 2) (column 4, lines 36-47; Tables 1-14). McCaslin et al are silent regarding the resistance of 412A121 to pea aphid.
The population of 412A121 plants have a slightly different proportions of purple, cream, yellow, variegated and white flowers. However, the proportions of flower colors can change based on which population subset examined.
Thus, 412A121 appears to be identical to the instantly claimed alfalfa population.
The deposit of seeds (claim 1) would be a population of 412A121 seeds.
Bulking 412A121 to form breeder seeds (column 4, lines 23-24) is a method comprising crossing a population of 412A121 plants with itself and harvesting seed, and the seed produced is first generation progeny seed, where the population of plants grown from the seed have all the morphological and physiological characteristics of 412A121, and thus C0515A3357. Planting the population to produce that seed forms a composition of the seed in soil.
McCaslin et al teach vegetatively propagating 412A121 by collecting tissues the population of plants, cultivating the tissue to form shoots, rooting the shoots to obtain plantlets, and growing plants from the plantlets (column 23, lines 43-52).
McCaslin et al teach introducing a transgene into 412A121 to produce 412A121 with the transgene and otherwise all the morphological and physiological characteristics of 412A121 (column 15, line 1, to column 16, line 44). The transgene includes those that confer male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, improved digestibility, improved energy content, improved forage yield, improved seed yield, improved winterhardiness, improved nitrogen fixation, modified fatty acid metabolism, abiotic stress resistance, flowering time, altered seed amino acid composition, and modified carbohydrate metabolism (column 16, line 49, to column 23, line14). McCaslin et al also teach crossing the transformed plants to produce progeny plants and applying selection to the progeny population for the transgene (column 14, lines 16-33).
McCaslin et al teach intercrossing crossing 412A121 with another alfalfa variety or (column 9, lines 38-46). McCaslin et al teach producing sprouts, forage, hay, greenchop and silage from the plants (column 3, lines 338-47).
Response to Arguments
The Declaration states and Applicant quotes that alfalfa varieties are synthetic populations whose gene pool and allelic frequencies result from the founder parent plants; the 73 founder parent plants used in the development of the claimed variety are separate and distinct from the 110 founder parent plants used in the development of 412A121 (Declaration ¶13; response pg 26).
This is not found persuasive. Declarant has provided no evidence to support the assertion that the two sets of founder parents are separate and distinct, that they are nonobvious over one another, and they result in a different collection of genes. It is noted that the Applicant/assignee and one inventor are in common between ‘505 and the instant application, making it likely that such evidence is readily obtainable.
Applicant is reminded that evidence submitted after final will not be considered unless Applicant provides a showing of good and sufficient reasons of why they were necessary and not earlier presented.
The Declaration states and Applicant quotes that genetic differences between the claimed and prior art varieties are also exhibited in their agronomic characteristics (Declaration ¶13; response pg 26)
This is not found persuasive. See the analysis below.
The Declaration states and Applicant quotes that the absolute mean annual yield of the instant variety across 12 site-years and 58 total harvests was greater than that of HybriForce 3400 than was the absolute mean annual yield of the prior art variety across 12 site-years and 52 total harvests was greater than that of HybriForce 2400; although HybriForce 2400 (GEN-2) and HybriForce 3400 (GEN-3) are distinct commercial varieties and no direct, head-to-head yield comparison between C0515A3357 and 412A121 is available from the disclosed trial data, the absolute mean annual yield of C0515A3357 across 12 site-years at the same five geographic locations used for the 412A121 trials numerically exceeds that of 412A121 (8.47 T DM/acre across 12 site-years) and exceeds the yield of its Hybraforce check by a greater percent than does the prior art plant exceed the yield of its Hybraforce check. Thus, the yield performance of C0515A3357 is superior to that of 412A121 (Declaration ¶14; response pg 26).
This is not found persuasive. The yield data for the prior art variety was obtained in 2013-2015, while the yield data for the instant variety was obtained in 2016-2018. Mean yield is dependent upon the years tested, i.e., the environment. For example, in 2023/0240243 and the instant application, check varieties Hi-Gest 360, 54R02 and HybriForce 3400 were all grown in what appears to be the same locations (Table 1 of each). However, mean yield data shows that the difference in yield between varieties is dependent on the years grown. In ‘243, Hi-Gest 360 had a higher yield than 54R02, but in the instant application, 54R02 had a higher yield than Hi-Gest 360:
Variety
2023/0240243 Table 2
(2017-2019)
Instant Table 2
(2016-2018)
Hi-Gest 360
7.60
7.75
54R02
7.46
7.80
HybriForce 3400
6.98
7.42
The difference between HybriForce 3400 and Hi-Gest 360 was also dependent on the years grown.
Thus, mean yield is affected by environmental factors.
Since the mean yield of the prior art variety was compared to a different variety grown in different years (i.e., different environments) than was the instant variety, no conclusions can be made regarding any difference in mean yield between the prior art variety and the instant variety. Mean yields can only be compared when the varieties are grown side-by-side.
Declarant states that thus the instant variety is neither identical to or obvious in view of the prior art variety (Declaration ¶15).
This is not found persuasive because no conclusion that the varieties are not identical can be made for the reasons above. Further, obviousness is a legal determination, and unsupported legal conclusions in declarations are not entitled to any weight. Neither Declarant nor Applicant have made any showing that the instant variety is not obvious over the prior art variety.
It is noted that ‘243 is silent regarding the resistance of 412A121 to pea aphid and the instant application is regarding the resistance of C0515A3357 to stem nematode; a showing that the two varieties are not identical could have been made if evidence had been brought in showing that the prior art variety and the instant variety differ in resistance to pea aphid, stem nematode, or some other disease or pest. Applicant is reminded that evidence submitted after final will not be considered unless Applicant provides a showing of good and sufficient reasons of why they were necessary and not earlier presented.
It is also noted that the prior art variety and the instant variety differ in their proportions of purple, cream, yellow, variegated and white flowers, but Declarant stated that flower color proportion is not a defining characteristic of an alfalfa variety that a skilled artisan would rely upon for distinguishing the instant variety (Declaration ¶6).
It is also noted that the prior art variety and the instant variety differ slightly in their exact winterhardiness and fall dormancy scores and resistance percentages to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Races 1 and 2) resistance, as shown in the Table below:
Trait
Instant Tables 3-14 & 16
‘505 Tables 3-16
Persistence
100/87
100/83
fall dormancy class
4
4
Winterhardy
Very, 1.9-2.0
Very, 1.6-1.5
Multifolate
High, 3.11 MF 84%MF
High, 3.09 MF 85%MF
anthracnose (Race 1)
HR, 65% adjusted
HR, 56% adjusted
bacterial wilt
HR, 72% adjusted
HR, 67% adjusted
Fusarium wilt
HR, 70% adjusted
HR, 74% adjusted
Verticillium wilt
HR, 64% adjusted
HR, 66% adjusted
Phytophthora root rot
HR, 55% adjusted
HR, 60% adjusted
Aphanomyces root rot (Race 1)
HR, 63% adjusted
HR, 58% adjusted
Aphanomyces root rot (Race 2)
HR, 59% adjusted
HR, 56% adjusted
However, Declarant stated that alfalfa is only described by resistance class, e.g., “highly resistant”, not adjusted % resistance (Declaration ¶8). As 412A121 and C0515A3357 have the same resistance class for all these traits, 412A121 appears to have all the morphological and physiological characteristics of C0515A3357.
Thus, Applicant has not shown that the instant claims are not anticipated by or obvious over ‘505.
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 1-2, 6-9, 12-14, 16, and 22-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of prior U.S. Patent No. 10,687,505. Although the claims at issue are not identical, they are not patentably distinct from each other.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 26 September 2025, as applied to claims 1-2, 6-16, and 22-25. Applicant’s arguments filed 25 March 2026 have been fully considered but they are not persuasive.
‘505 claims alfalfa variety 412A121 (claims 1-2). Both 412A121 and the instant population have yields that vary with the year and location grown, are very winterhardy, have fall dormancy ratings that place them in fall dormancy class 4, and have high resistance to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Races 1 and 2) (column 4, lines 36-47; Tables 1-14). McCaslin et al are silent regarding the resistance of 412A121 to pea aphid.
The population of 412A121 plants have a slightly different proportions of purple, cream, yellow, variegated and white flowers. However, the proportions of flower colors can change based on which population subset examined.
Thus, 412A121 appears to be identical to the instantly claimed alfalfa population.
The deposit of seeds (claim 1) would be a population of 412A121 seeds and plants grown from the seeds would be a population of 412A121 plants.
‘505 claims a composition comprising seed of 412A121 in soil or a synthetic cultivation medium (claims 6-7). It would be obvious for that composition to comprise a population of seed of 412A121. As 412A121 is a mixture of plants and seeds, one of ordinary skill in the art would plant that population of seeds in soil to produce more plants.
‘505 claims crossing a plant of 412A121 with itself or another alfalfa plant (claims 8-9) and progeny seed and plants produced from a cross of 412A121 with itself (claims 10-11). It would be obvious to one of ordinary skill in the art to do that crossing with a population of plants as such crossing is routinely done in fields planted with populations of alfalfa plants.
‘505 claims vegetatively propagating a 412A121 plant by collecting tissues the plant, cultivating the tissue to form shoots, rooting the shoots to obtain plantlets, and growing a plant from the plantlets (claims 12-13). It would be obvious to one of ordinary skill in the art to do that with a population of 412A121plants to maintain the entire genetic variation within 412A121.
‘505 claims introducing a transgene into a 412A121 plant, including where the transgene confers male sterility, herbicide tolerance, insect resistance, pest resistance, disease resistance, improved digestibility, improved energy content, improved forage yield, improved seed yield, improved winterhardiness, improved nitrogen fixation, modified fatty acid metabolism, abiotic stress resistance, flowering time, altered seed amino acid composition, or modified carbohydrate metabolism (claims 14-17). It would be obvious to one of ordinary skill in the art to do that with a population of 412A121 plants so that the entire genetic variation within 412A121 has the transgene.
‘505 claims crossing transformed 412A121 plant with a population of alfalfa plants to produce a population of progeny plants where at least one progeny plant has the transgene and selecting progeny plants with the transgene (claims 22-23). It would be obvious to one of ordinary skill in the art to do that with a population of transformed 412A121 plants so that more of the progeny plants have the transgene.
‘505 claims combining a 412A121 seed with seed of a second alfalfa variety. It would be obvious to one of ordinary skill in the art to do that with a population 412A121 seeds so that an entire filed could be planted.
‘505 claims producing sprouts, forage, hay, greenchop or silage from a 412A121 plant (claims 25-27). It would be obvious to one of ordinary skill in the art to do that with a population 412A121 plants so that more sprouts, forage, hay, greenchop or silage could be produced.
Response to Arguments
Applicant urges that as discussed above the two varieties are not identical and have founder parents that differ phenotypically and genetically from each other (response pg 27).
This is not found persuasive. As discussed in the Response to Arguments in the 102/103 rejection above and incorporated herein, Applicant has not shown that the two varieties are not identical. Further, Applicant has not provided any evidence that the founder parents or each variety differ phenotypically and genetically from each other and that their crossing results in populations of plants that differ phenotypically and genetically from each other.
Applicant urges that the variety disclosed in ‘505 does not teach or suggest a population with all of the morphological and physiological traits of the claimed variety (response pg 27).
This is not found persuasive. The 2nd Ma Declaration, filed 25 March 2026, states that winterhardiness and fall dormancy scores and resistance percentages to anthracnose (Race 1), bacterial wilt, Fusarium wilt, Verticillium wilt, Phytophthora root rot, and Aphanomyces root rot (Races 1 and 2) resistance define and distinguish alfalfa varieties, that alfalfa is only described by resistance class, e.g., “highly resistant”, not adjusted % resistance (Declaration ¶8). As 412A121 and C0515A3357 have the same resistance class for all these traits, as shown in the 102/103 rejection above, 412A121 has all of the morphological and physiological traits of the claimed variety.
Conclusion
No claim is 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.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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