The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 4-9-2025 is acknowledged. Claims 1, 12-14, 16-17, 20-22, 28-29, 34-36, 38 and 101-102 have been amended. Claim 15 has been canceled. Claim 103 has been added. Claims 1-5, 7-8, 12-14, 16-17, 20-22, 25-29, 32, 34-36, 38, 49, 51-52 and 101-103 are pending. Claims 2-5, 7-8, 32, 49 and 51-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 12-14, 16-17, 20-22, 25-29, 34-36, 38 and 101-103 are currently under examination. Claims 2, 49 and 51-52 have improper claim status identifiers. Claims are either “withdrawn” or “previously presented”. Additionally, claim 49 is listed as being “previously presented” wherein it has been withdrawn from consideration. Said claim status identifiers need to be corrected in order for any response to this action to be deemed fully responsive.
Information Disclosure Statement
The Information Disclosure Statements filed on 10-9-2025 and 12-5-2025 have been considered. Initialed copies are attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
The objection to claims 1, 12-14, 17, 20-22, 25-29, 34-36, 38 and 102 for reciting claim language drawn to non-elected inventions is maintained for reasons of record. Applicant’s request that this objection be held in abeyance until allowable subject matter is reached is noted.
Claim Rejections Withdrawn
The rejection of claim 13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement (biological deposit) requirement is withdrawn in light of the amendment thereto.
The rejection of claim 101 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement (biological deposit) requirement is withdrawn.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…one or more Klebsiella bacteria…” is withdrawn in light of the amendment thereto.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the term “stability” is withdrawn.
The rejection of claim 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the term “stability” is withdrawn.
The rejection of claim 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the term “stability” is withdrawn.
Claim Rejections Maintained
35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 12-14, 16-17, 20-22, 25-29, 34-36, 38 and 101-103 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 for the reasons set forth in the previous Office action in the rejection of claims 1, 12-14-17, 20-22, 25-29, 34-36, 38 and 101-102. Cancellation of claim 15 has rendered the rejection of that claim moot. 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.
Applicant argues:
1. The genus Klebsiella only comprises about 13 species (in contrast to other bacteria genera like Bacillus, which by some reports has at least 266 species). Additionally, it is well known in the art that species of Klebsiella bacteria share numerous common structural features, including, but not limited to, Gram-negative cell wall, non-motile rod morphology (bacilli shape, lack of flagella), facultative anaerobic metabolism, and conserved genetic markers (16S rRNA, rpoB, and gyrA sequences). Thus, Applicant respectfully submits that the claims as amended herein do not correspond to hundreds of diverse species, but rather a small genus of bacteria with common structural features.
2. Claim 1 has been amended to recite that the polymer is polyvinylpyrrolidone-vinyl acetate (PVP-VA) and that the composition is a solid or a liquid.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Points 1 and 2, while the various members of the genus Klebsiella share some structural features, the specification is silent with regard to what specific phenotypical feature is required in order for the PVP-VA to confer the recited effect (which would constitute the common structural feature that would allow the skilled artisan to recognize the encompassed genus). Moreover, the specification is equally silent with regard to which Klebsiella species possess said phenotype. Consequently, the specification does not identify a common structural feature that would allow the skilled artisan to predict whether a given Klebsiella species would have increased stability when treated with PVP-VA.
The instant claims are drawn to compositions comprising one or more Klebsiella bacteria and polyvinylpyrrolidone-vinyl acetate (PVP-VA) wherein the PVP-VA is between 5% and 20% by weight to volume of the composition and wherein the Klebsiella bacteria exhibit an increased stability compared to compositions lacking said polymers. The claims optionally require:
the Klebsiella bacteria comprises Klebsiella variicola (claim 12);
the Klebsiella bacteria comprises Klebsiella variicola 137-1036 strain (claim 13);
the composition further comprises one or more polymers selected from: polyvinylpyrrolidone (PVP), carboxymethyl cellulose (CMC), hydroxypropyl methylcellulose, alginate, and combinations thereof (claim 14);
the polymer composition further comprises an electrospun polymer (claim 16);
the polymer composition further comprises a copolymer (claim 17);
the stability of the one or more isolated Klebsiella bacteria exhibit an increase when stored for at least 30 days, as compared to a control composition comprising one or more isolated bacteria lacking the one or more polymers (claim 20);
the stability of the one or more isolated Klebsiella bacteria exhibit an increase when stored in liquid culture (claim 21);
the composition is a solid (claim 22);
the microbial composition is a seed coat present on a plant seed or other plant propagation material (claim 25);
the microbial composition is a seed coat present on a corn seed that has an insecticide, herbicide, fungicide, or nematicide present on said seed (claim 26);
the microbial composition is an in furrow formulation (claim 27);
wherein the isolated Klebsiella bacteria are endophytic, epiphytic, or rhizospheric (claim 28);
the isolated Klebsiella bacteria are wild type bacteria, transgenic bacteria, or non-intergeneric remodeled bacteria (claim 29);
the isolated Klebsiella bacteria are non-intergeneric remodeled bacteria capable of fixing atmospheric nitrogen in the presence of exogenous nitrogen (claim 34);
the isolated Klebsiella bacteria are non-intergeneric remodeled bacteria comprising: at least one genetic variation introduced into at least one gene, or non-coding polynucleotide, of the nitrogen fixation or assimilation genetic regulatory network (claim 35);
each of the isolated Klebsiella bacteria comprises an introduced control sequence operably linked to at least one gene of the nitrogen fixation or assimilation genetic regulatory network (claim 36);
each of the isolated Klebsiella bacteria comprises at least one genetic variation introduced into a member selected from the group consisting of: nifA, nifL, ntrB, ntrC, glnA, glnB, glnK, drat, amtB, , glnD, glnE, nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifV, nifW, nifZ, nifM, nifF, nifB, nifQ, , bcsii, bcsiii, yjbE, FhaB, pehA, otsB, treZ, glsA2, and combinations thereof (claim 38);
the isolated Klebsiella bacteria are non-intergeneric remodeled bacteria selected from the group consisting of a bacterium deposited as NCMA 201712001, a bacterium deposited as NCMA 201712002, a bacterium deposited as NCMA 201708001, progeny or derivatives thereof, and combinations thereof (claim 101);
the isolated Klebsiella bacteria comprise a nucleic acid sequence that shares at least about 90%/o, 95%, or 99% sequence identity to a nucleic acid sequence selected from SEQ ID NOs: 191-210, and 458-469 (claim 102); and
wherein each of the isolated Klebsiella bacteria comprises at least one genetic variation introduced into a member selected from the group consisting of: a polynucleotide encoding glutamine synthetase, a polynucleotide encoding glutaminase, a gene associated with biosynthesis of a nitrogenase enzyme, and combinations thereof (claim 103).
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of microbial compositions, Applicant must adequately describe which combination of Klebsiella species and polymers resulting in a composition with increased “stability”. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of microbial compositions to which the claims are drawn, such as a correlation between the structure (i.e. phenotype/components) of said composition and its recited function (i.e. increased stability), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of antibodies. The specification fails to disclose what combination of Klebsiella species and PVP-VA (as well as other additional polymers) polymers so that the resultant compositions have the claimed biological properties. Therefore, the specification fails to adequately describe at least a substantial number of members of the genus of microbial compositions to which the claims refer. The specification is limited to the disclosure of solid and liquid compositions comprising PVP-VA and Klebsiella variicola wherein the addition of PVP-PA increases the “stability” of both culture types (see Example 3). This limited disclosure cannot be extrapolated to the full genus of compositions which can comprise any and all Klebsiella species, PVP-VA and optionally additional polymers.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by 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 applicant 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); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); 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"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Consequently, only solid and liquid compositions comprising PVP-VA and Klebsiella variicola but not the full breadth of the rejected claims are properly described as required by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 14, 16-17, 20-22, 25-29, 34-36, 38 and 102-103 are rejected under 35 U.S.C. 102(a)(1) as being anticipated or, in the alternative, under 35 U.S.C. 103 as obvious over by Temme et al. (U.S. Patent Application Publication US 2018/0002243 – IDS filed on 12-17-2021) for the reasons set forth in the previous Office action in the rejection of claims 1, 14, 16-17, 20-22, 25-29, 34-36 and 38.
Applicant argues:
1. Temme does not teach or suggest PVP-VA is a microbial protectant.
2. Temme et al. does not teach or suggest any concentration ranges for PVP-VA.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, Temme et al. clearly disclose that the bacteria of their compositions can be mixed with an agriculturally acceptable carriers can confer a variety of properties, such as increased stability, wettability, or dispersibility (see paragraph [0135]) and that PVP-VA is an example of said agriculturally acceptable carriers.
With regard to Point 2, as set forth in the rejection, while Temme et al. doesn’t disclose the specific concentration of said polyvinylpyrrolidone-vinyl acetate, it is well settled where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
As outlined previously, Temme et al. disclose bacterial compositions comprising non-intergenic bacteria comprising genetic variation introduced into one or more genes or non-coding polynucleotides of the bacteria’s nitrogen fixation or assimilation regulatory network such that said bacteria are able to fix atmospheric nitrogen in the presence of exogenous nitrogen (see abstract). Temme et al. further disclose said bacteria can be Klebsiella (see paragraph [0127] for example); that said one or more genes or non-coding polynucleotides of the bacteria's nitrogen fixation or assimilation genetic regulatory network are selected from the group consisting of: nifA, nifL, ntrB, ntrC, polynucleotide encoding glutamine synthetase, glnA, glnB, glnK, drat, amtB, polynucleotide encoding glutaminase, glnD, glnE, nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifF, nifB, and nifQ (see paragraphs [0020] and [0026]-[0030] for example); that the modified bacteria can be endophytic, epiphytic or rhizospheric (see paragraphs [0012], [0019], [0029] and [0030] for example); that said compositions can comprise polyvinylpyrrolidone-vinyl acetate (see paragraph [00139]) and that the addition of said polyvinylpyrrolidone-vinyl acetate can confer a variety of properties, such as increased stability, wettability and dispersibility (see paragraph [0135]; that said composition can comprise a fungicide, herbicide insecticide or a nematicide (see paragraph [0134]; that said composition can be in liquid form (see paragraph [0142]) or solid form (see paragraph [0143]); and that said composition can be a seed coat or applied directly to furrows (see paragraphs [0132]-[0134] for example). With regard to the limitations drawn to “increased stability” in claims 1 and 20-21, Temme et al. disclose bacterial compositions comprising polyvinylpyrrolidone-vinyl acetate. Consequently, both the compositions disclosed by Temme et al. and those of the instant claims would have the same chemical, biological and immunological properties. This would include the ability to increase stability of the composition. Since the Office does not have the facilities for examining and comparing the product of the instant invention with the product disclosed in the prior art, the burden is on Applicant to show a novel or unobvious difference between the claimed product (bacterial composition comprising polyvinylpyrrolidone-vinyl acetate) and the product of the prior art. See In re Best 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
The MPEP states:
A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THEPRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THEPRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTICWhere applicant claims a composition in terms of a function, property or characteristicand the composition of the prior art is the same as that of the claim but the function is notexplicitly disclosed by the reference, the examiner may make a rejection under both 35U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent inconcurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA1977). This same rationale should also apply to product, apparatus, and process claimsclaimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103rejection is appropriate for these types of claims as well as for composition claims.
2112.01 Composition, Product, and Apparatus ClaimsPRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURERECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TOTHAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS AREPRESUMED TO BE INHERENTWhere the claimed and prior art products are identical or substantially identical instructure or composition, or are produced by identical or substantially identicalprocesses, a prima facie case of either anticipation or obviousness has been established.In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTOshows a sound basis for believing that the products of the applicant and the prior art arethe same, the applicant has the burden of showing that they are not.” In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima faciecase can be rebutted by evidence showing that the prior art products do not necessarilypossess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ773 (Fed. Cir. 1985).COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLYTHE SAME, IT MUST HAVE THE SAME PROPERTIES“Products of identical chemical composition can not have mutually exclusive properties.”A chemical composition and its properties are inseparable. Therefore, if the prior artteaches the identical chemical structure, the properties applicant discloses and/or claimsare necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658(Fed. Cir. 1990).
While Temme et al. doesn’t disclose the specific concentration of said polyvinylpyrrolidone-vinyl acetate, it is well settled where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Claims 1, 14, 16-17, 20-22, 25-29, 34-36, 38 and 102-103 are rejected under 35 U.S.C. 102(a)(2) as being anticipated or, in the alternative, under 35 U.S.C. 103 as obvious over by Temme et al. (U.S. Patent Application Publication US 2018/0002243 – IDS filed on 12-17-2021) for the reasons set forth in the previous Office action in the rejection of claims 1, 14, 16-17, 20-22, 25-29, 34-36 and 38.
Applicant argues:
1. Temme does not teach or suggest PVP-VA is a microbial protectant.
2. Temme et al. does not teach or suggest any concentration ranges for PVP-VA.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, Temme et al. clearly disclose that the bacteria of their compositions can be mixed with an agriculturally acceptable carriers can confer a variety of properties, such as increased stability, wettability, or dispersibility (see paragraph [0135]) and that PVP-VA is an example of said agriculturally acceptable carriers.
With regard to Point 2, as set forth in the rejection, while Temme et al. doesn’t disclose the specific concentration of said polyvinylpyrrolidone-vinyl acetate, it is well settled where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
As outlined previously, Temme et al. disclose bacterial compositions comprising non-intergenic bacteria comprising genetic variation introduced into one or more genes or non-coding polynucleotides of the bacteria’s nitrogen fixation or assimilation regulatory network such that said bacteria are able to fix atmospheric nitrogen in the presence of exogenous nitrogen (see abstract). Temme et al. further disclose said bacteria can be Klebsiella (see paragraph [0127] for example); that said one or more genes or non-coding polynucleotides of the bacteria's nitrogen fixation or assimilation genetic regulatory network are selected from the group consisting of: nifA, nifL, ntrB, ntrC, polynucleotide encoding glutamine synthetase, glnA, glnB, glnK, drat, amtB, polynucleotide encoding glutaminase, glnD, glnE, nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifF, nifB, and nifQ (see paragraphs [0020] and [0026]-[0030] for example); that the modified bacteria can be endophytic, epiphytic or rhizospheric (see paragraphs [0012], [0019], [0029] and [0030] for example); that said compositions can comprise polyvinylpyrrolidone-vinyl acetate (see paragraph [00139]) and that the addition of said polyvinylpyrrolidone-vinyl acetate can confer a variety of properties, such as increased stability, wettability and dispersibility (see paragraph [0135]; that said composition can comprise a fungicide, herbicide insecticide or a nematicide (see paragraph [0134]; that said composition can be in liquid form (see paragraph [0142]) or solid form (see paragraph [0143]); and that said composition can be a seed coat or applied directly to furrows (see paragraphs [0132]-[0134] for example). With regard to the limitations drawn to “increased stability” in claims 1 and 20-21, Temme et al. disclose bacterial compositions comprising polyvinylpyrrolidone-vinyl acetate. Consequently, both the compositions disclosed by Temme et al. and those of the instant claims would have the same chemical, biological and immunological properties. This would include the ability to increase stability of the composition. Since the Office does not have the facilities for examining and comparing the product of the instant invention with the product disclosed in the prior art, the burden is on Applicant to show a novel or unobvious difference between the claimed product (bacterial composition comprising polyvinylpyrrolidone-vinyl acetate) and the product of the prior art. See In re Best 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
The MPEP states:
A REJECTION UNDER 35 U.S.C. 102/103 CAN BE MADE WHEN THEPRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THEPRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTICWhere applicant claims a composition in terms of a function, property or characteristicand the composition of the prior art is the same as that of the claim but the function is notexplicitly disclosed by the reference, the examiner may make a rejection under both 35U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent inconcurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA1977). This same rationale should also apply to product, apparatus, and process claimsclaimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103rejection is appropriate for these types of claims as well as for composition claims.
2112.01 Composition, Product, and Apparatus ClaimsPRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURERECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TOTHAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS AREPRESUMED TO BE INHERENTWhere the claimed and prior art products are identical or substantially identical instructure or composition, or are produced by identical or substantially identicalprocesses, a prima facie case of either anticipation or obviousness has been established.In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTOshows a sound basis for believing that the products of the applicant and the prior art arethe same, the applicant has the burden of showing that they are not.” In re Spada, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima faciecase can be rebutted by evidence showing that the prior art products do not necessarilypossess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ773 (Fed. Cir. 1985).COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLYTHE SAME, IT MUST HAVE THE SAME PROPERTIES“Products of identical chemical composition can not have mutually exclusive properties.”A chemical composition and its properties are inseparable. Therefore, if the prior artteaches the identical chemical structure, the properties applicant discloses and/or claimsare necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658(Fed. Cir. 1990).
While Temme et al. doesn’t disclose the specific concentration of said polyvinylpyrrolidone-vinyl acetate, it is well settled where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Conclusion
No claims is 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.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 February 11, 2026