DETAILED ACTION
Claims 1-12 and 14-20 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 .
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 the second paragraph of 35 U.S.C. 112:
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 1-12 and 14-20 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 5 is indefinite in its recitation of “comprising the single locus conversion … having otherwise all the physiological and morphological characteristics of hybrid maize X08V068”. It is not clear what the physiological and morphological characteristics of hybrid maize X08V068 are. The specification only describes physiological and morphological characteristics of X08V068 with one or more unspecified locus conversions for insect control and/or herbicide tolerance (Table 1, “Wherein X08V068 has one or more locus conversion(s) for insect control and/or herbicide tolerance”).
The specification recites the following with respect to locus conversions:
[148] Traits may be used by those of ordinary skill in the art to characterize progeny. Traits are commonly evaluated at a significance level, such as a 1%, 5% or 10% significance level, when measured in plants grown in the same environmental conditions. For example, a locus conversion of X08V068 may be characterized as having essentially the same or essentially all of the phenotypic traits or physiological and morphological traits or characteristics as X08V068. By essentially all of the phenotypic characteristics or morphological and physiological characteristics, it is meant that all of the characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than an occasional variant trait that might arise during backcrossing or direct introduction of a transgene or genetic modification. The traits used for comparison may be those traits shown in Table 1 as determined at the 5% significance level when grown under the same environmental conditions.
The definition of “essentially all of the phenotypic characteristics or morphological and physiological characteristics” above indicates that an “occasional variant” is encompassed. The specification does not indicate how a “occasional variant”, which by the use of the word “occasional” is something that happens at some times and not at other times, applies to a product, i.e., the claimed plant. The specification indicates in ¶258 that “an” reads on more or more. Given that, “an occasional variant” means one or more.
It is not clear if the locus converted X08V068 in Table 1 has the same or if it only has “essentially all” of the phenotypic traits or physiological and morphological traits as X08V068 without those locus conversions(s); if the latter it is not clear how many “occasional variants” are in the plant of Table 1.
Further, the discussion in ¶148 states “The traits used for comparison may be those traits shown in Table 1”. However, the traits in Table 1 are X08V068 has one or more locus conversions. As locus converted X08V068 may have only “essentially all” of the phenotypic traits or physiological and morphological traits as X08V068, the discussion of locus converted X08V068 in ¶148 indicating that comparison may be made to a locus converted X08V068 becomes circular discussion, making the claims further indefinite
It is thus not clear what the single locus conversion is in relation to - X08V068 without locus conversions or the locus converted X08V068 as in Table 1.
It is also thus unclear what the physiological and morphological characteristics of hybrid maize X08V068 are.
Claims 1, 11, and 18 recite “representative seeds of the maize lines SSH65 and PH2F59 have been deposited under ATCC Accession Numbers PTA-12581 and PTA-123681”. It is unclear how the seed are “representative”. Even though the claims have been amended to recite that SSH65 and PH2F59 are lines not varieties, it is not clear if these seeds are the ones that produce the locus converted X08V068 in Table 1 or X08V068 without locus conversions.
It is thus unclear in what way the deposited seeds are “representative”.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 14-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims all require seed of hybrid maize X08V068 or its parents SSH65 and PH2F59.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant has deposited seeds for SSH65 and PH2F59 at the ATCC. However, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds was made and accepted under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
If the deposit was not made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
It is noted that Applicant has not provided evidence regarding viability of the biological material at the time of deposit, as required for deposits not made and accepted under the Budapest Treaty.
Claims 1-12 and 14-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
A. The specification fails to provide a description of hybrid maize X08V068.
There is no description of X08V068 in the specification. Table 1 only describes X08V068 with one or more unspecified locus conversions for insect control and/or herbicide tolerance (Table 1, “Wherein X08V068 has one or more locus conversion(s) for insect control and/or herbicide tolerance”).
While parents SSH65 and PH2F59 are deposited, this is not a deposit of X08V068. Further, a deposit is not a substitute for a description of the claimed invention. See MPEP 2163I:
An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of certain biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ("reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material"); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) ("The requirement for a specific identification is consistent with the description requirement of the first paragraph of 35 U.S.C. 112, and to provide an antecedent basis for the biological material which either has been or will be deposited before the patent is granted." Id. at 34,876. "The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.) Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art."). (emphasis added)
B. The specification fails to describe the full scope of hybrid maize X08V068 seed and plants further comprising a transgene
Claim 4 is drawn to a seed produced by introducing a transgene into either or both SSH65 and PH2F59 by backcrossing or genetic transformation.
Both backcrossing and genetic transformation can introduce numerous changes in the physiological and morphological characteristics of a plant. Backcrossing may be done only once, for example, and genetic transformation can introduce off-site effects.
There is no requirement that the seed in claim 4 grows onto a plant with the transgene and otherwise all the physiological and morphological characteristics of hybrid maize X08V068.
Thus, claim 4 and the claims dependent upon it encompass seed and plants with numerous changes in the physiological and morphological characteristics relative to hybrid maize X08V068.
The structural features that distinguish X08V068 further comprising a transgene, as claimed, from other hybrid maize lines are not described in the specification.
Hence, Applicant has not, in fact, described the claimed seeds and plants, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4 and 14-20 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 is drawn to the seed of claim 1 further comprising a transgene. Parent claim 1 is drawn to a seed of hybrid maize X08V06 produced by crossing maize lines SSH65 and PH2F59, where maize lines SSH65 and PH2F59 have been deposited under ATCC Accession Numbers PTA-12581 and PTA-123681.
If the seed of claim 1 is limited to the genetics contributed by maize lines SSH65 and PH2F59, then addition of a transgene, as in claim 4, changes those genetics.
Further, the seed in claim 4 was produced by introducing a transgene into either or both SSH65 and PH2F59 by backcrossing or genetic transformation. There is no requirement that the seed in claim 4 grows onto a plant with the transgene and otherwise all the physiological and morphological characteristics of hybrid maize X08V068. As both backcrossing and genetic transformation can introduce numerous changes in the physiological and morphological characteristics of a plant, the claim encompasses seed with numerous changes in the physiological and morphological characteristics relative to seed claim 1.
Claim 4 thus fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § § 102, 103
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 4 and 14-20 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 Bing et al (2017, US 9,675,025).
The claims are interpreted as detailed in the indefiniteness and written description rejections above and incorporated herein.
Bing et al describes hybrid corn variety 2847130 (Table 1), which shares parent SSH65 with instantly claimed hybrid maize X08V068. Bing et al claims 2847130 seed and plants further comprising a transgene, including where the transgene confers a property s male sterility, herbicide tolerance, insect resistance, disease resistance, waxy starch, modified fatty acid metabolism, modified phytic acid metabolism, modified carbohydrate metabolism or modified protein metabolism (claims 5-8 and 19). Thus, the seed and plants claimed in Bing et al appear to be the instantly claimed seed and plants produced by crossing SSH65 and PH2F59 into which a transgene into either or both by backcrossing or genetic transformation.
It would be obvious to one of ordinary skill in the art to apply a seed treatment onto these seeds as Bing et al suggests for hybrid corn variety 2847130 seed (column 6, lines 19-30) as this can increase resistance to the plants grown from the seed to stress.
It would be obvious to one of ordinary skill in the art to produce nucleic acids from the plants, as this is a common method performed in backcrossing.
It would be obvious to one of ordinary skill in the art to produce a commodity plant product, as products like starch, syrup, silage, fat and protein are what farmers grow and sell the seeds and other plant parts to be used for.
It would be obvious to one of ordinary skill in the art to cross the plant with another maize plant to pass its traits into other plants or to further backcross it with a parent plant.
Claims 4 and 14-20 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 Fischer et al (2018, US 9,861,059).
The claims are interpreted as detailed in the indefiniteness and written description rejections above and incorporated herein.
‘059 describes hybrid corn variety X08H842 (Table 1), which shares parent PH2F59 with instantly claimed hybrid maize X08V068. ‘059 claims X08H842 seed and plants further comprising a transgene, including where the transgene confers a property s male sterility, herbicide tolerance, insect resistance, disease resistance, waxy starch, modified fatty acid metabolism, modified phytic acid metabolism, modified carbohydrate metabolism or modified protein metabolism (claims 5-6 and 9). Thus, the seed and plants claimed in ‘059 appear to be the instantly claimed seed and plants produced by crossing SSH65 and PH2F59 into which a transgene into either or both by backcrossing or genetic transformation.
‘059 claims this seed further comprising a seed treatment (claim 7) and a method of producing nucleic acids from the seed (claim 8), which ‘059 defines as a plant (column 11, lines 36-40).
‘059 claims applying plant breeding techniques to the plant to produce a second plant (claim 10) and crossing the plant with another maize plant (claim 11).
It would be obvious to one of ordinary skill in the art to produce a commodity plant product, as products like starch, syrup, silage, fat and protein are what farmers grow and sell the seeds and other plant parts to be used for.
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 4 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-11 of U.S. Patent No. 9,861,059. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims are interpreted as detailed in the indefiniteness and written description rejections above and incorporated herein.
‘059 describes hybrid corn variety X08H842 (Table 1), which shares parent PH2F59 with instantly claimed hybrid maize X08V068. ‘059 claims X08H842 seed and plants further comprising a transgene, including where the transgene confers a property s male sterility, herbicide tolerance, insect resistance, disease resistance, waxy starch, modified fatty acid metabolism, modified phytic acid metabolism, modified carbohydrate metabolism or modified protein metabolism (claims 5-6 and 9). Thus, the seed and plants claimed in ‘059 appear to be the instantly claimed seed and plants produced by crossing SSH65 and PH2F59 into which a transgene into either or both by backcrossing or genetic transformation.
‘059 claims this seed further comprising a seed treatment (claim 7) and a method of producing nucleic acids from the seed (claim 8), which ‘059 defines as a plant (column 11, lines 36-40).
‘059 claims applying plant breeding techniques to the plant to produce a second plant (claim 10) and crossing the plant with another maize plant (claim 11).
It would be obvious to one of ordinary skill in the art to produce a commodity plant product, as products like starch, syrup, silage, fat and protein are what farmers grow and sell the seeds and other plant parts to be used for.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1663
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