DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 6/12/2026 have been received and entered into the case. Claim1 has been canceled, and Claims 30-31 have been added. Claims 2-31 are pending, Claims 8-16, 18-19, 22-23 and 25-29 have been withdrawn, and Claims 2-7, 17, 20-21, 24, and 30-31 have been considered on the merits, insofar as they read on the elected species of Escherichia coli and a nitrogen fertilizer. All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 2-7, 17, 20-21 and 24 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Sabbadini et al (US 2015/0218254 A1; 8/6/2015. Cited on IDS) as evidenced by Sachs et al (J. Membrane Biol. 2006;212:71-82.) are withdrawn in view of applicant’s amendments.
Rejections under nonstatutory double patenting are withdrawn in view of applicant’s amendments.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 2-7, 17, 20-21 and 24 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Sabbadini et al (US 2015/0218254 A1; 8/6/2015. Cited on IDS) as evidenced by Sachs et al (J. Membrane Biol. 2006;212:71-82.).
The instant claims recite an agricultural composition, comprising: a minicell having encapsulated within said minicell a fertilizer.
Sabbadini teaches compositions and methods for the production and use of minicells (para 0014) comprising Escherichia coli (a prokaryotic cell, a gram-negative bacterium, para 0205) (para 0244), at least one carrier including lactose and mannose (an agriculturally acceptable carrier) (para 0968, 0970, 0977), and urea (a nitrogen fertilizer) (para 0977), wherein said compositions can be formulated as liquid, dry composition, or powder (para 0972, 0977), and said minicells can be used in agricultural studies (para 0672). Before the effective filing date of the claimed invention, it was well-known in the art that urea moves through bacterial membranes by passive diffusion, as evidenced by Sachs (p.72 col right – para 4). Since urea moves through biological membranes via passive diffusion, said minicells of Sabbadini can contain urea. Urea moves in and out of minicells, the minicells exhibit a burst release rate due to the rapid, initial discharge of urea outside of the minicells.
The limitation of “agricultural” in the preamble is regarded as an intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
Therefore the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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 of this title, 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 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Sabbadini et al (US 2015/0218254 A1; 8/6/2015. Cited on IDS) as evidenced by Sachs et al (J. Membrane Biol. 2006;212:71-82.) as applied to claims 2-7, 17, 20-21 and 24 above.
References cited above do not teach the claimed amount of the fertilizer (claim 30), and the claimed weight ratio of fertilizer:minicell (claim 31).
However, Sabbadini does teach compositions and methods for the production and use of minicells (para 0014) comprising urea (a nitrogen fertilizer) (para 0977).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount / ratio of a fertilizer and a minicell based on desirable outcomes. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to optimize the amount / ratio of a fertilizer and a minicell with a reasonable expectation for successfully obtaining a composition.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-7, 17, 20-21, 24, and 30-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7, 33 and 49-56 of U.S. Patent No 11,649,265 (referred to as the ‘265 patent) in view of Sabbadini et al (US 2015/0218254 A1; 8/6/2015. Cited on IDS) as evidenced by Sachs et al (J. Membrane Biol. 2006;212:71-82.).
Claims 1-7, 33 and 49-56 of the ‘265 patent recite an anucleated cell composition comprising: an intact anucleated cell having encapsulated within said cell at least one non-expressed agricultural compound. The minicell composition further comprises at least one agriculturally acceptable carrier, wherein the minicell is derived from Escherichia coli, and the minicell exhibits a burst release rate of the agricultural compound. The minicell composition is formulated as a liquid, dry composition, powder, granule, seed coating, drench, in-furrow composition, or foliar spray.
The limitation of “agricultural” in the preamble is regarded as an intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
‘265 patent does not teach the agricultural compound is a nitrogen fertilizer including urea (claims 21 and 24).
However, ‘265 patent does teach a minicell composition. Sabbadini teaches compositions and methods for the production and use of minicells (para 0014) comprising urea (a nitrogen fertilizer) (para 0977). Before the effective filing date of the claimed invention, it was well-known in the art that urea moves through bacterial membranes by passive diffusion, as evidenced by Sachs (p.72 col right – para 4). Since urea moves through biological membranes via passive diffusion, said minicells of Sabbadini can contain urea.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate urea (a nitrogen fertilizer), since ‘265 patent and Sabbadini both disclose a minicell composition, Sabbadini and Sachs disclose the minicell composition can contain urea (a nitrogen fertilizer). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to incorporate urea (a nitrogen fertilizer) with a reasonable expectation for successfully obtaining a minicell composition.
References cited above do not teach the claimed amount of the fertilizer (claim 30), and the claimed weight ratio of fertilizer:minicell (claim 31).
However, Sabbadini does teach compositions and methods for the production and use of minicells (para 0014) comprising urea (a nitrogen fertilizer) (para 0977).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount / ratio of a fertilizer and a minicell based on the desirable outcome. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to optimize the amount / ratio of a fertilizer and a minicell with a reasonable expectation for successfully obtaining a composition.
Claims 2-7, 17, 20-21, 24, and 30-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 16-19 and 21 of U.S. Patent No 11,970,518 B2 (referred to as the ‘518 patent) in view of Sabbadini et al (US 2015/0218254 A1; 8/6/2015. Cited on IDS) as evidenced by Sachs et al (J. Membrane Biol. 2006;212:71-82.).
Claims 1-6, 16-19 and 21 of the ‘518 patent recite a minicell composition comprising a minicell having encapsulated within said minicell an agrochemical. The minicell composition further comprises at least one agriculturally acceptable carrier, wherein the minicell is derived from Escherichia coli, and the minicell exhibits a burst release rate of the agrochemical. The minicell composition is formulated as a liquid, dry composition, powder, granule, seed coating, drench, in-furrow composition, or foliar spray.
The limitation of “agricultural” in the preamble is regarded as an intended use limitation. The claiming of a new use, function or unknown property does not necessarily make the composition patentable. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103. (MPEP 2112)
‘518 patent does not teach the agrochemical is a nitrogen fertilizer including urea (claims 21 and 24).
However, ‘518 patent does teach a minicell composition comprises a minicell having encapsulated within said minicell an agrochemical. Sabbadini teaches compositions and methods for the production and use of minicells (para 0014) comprising urea (a nitrogen fertilizer) (para 0977). Before the effective filing date of the claimed invention, it was well-known in the art that urea moves through bacterial membranes by passive diffusion, as evidenced by Sachs (p.72 col right – para 4). Since urea moves through biological membranes via passive diffusion, said minicells of Sabbadini can contain urea.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate urea (a nitrogen fertilizer), since ‘518 patent and Sabbadini both disclose a minicell composition, Sabbadini and Sachs disclose the minicell composition can contain urea (a nitrogen fertilizer). Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to incorporate urea (a nitrogen fertilizer) with a reasonable expectation for successfully obtaining a minicell composition.
References cited above do not teach the claimed amount of the fertilizer (claim 30), and the claimed weight ratio of fertilizer:minicell (claim 31).
However, Sabbadini does teach compositions and methods for the production and use of minicells (para 0014) comprising urea (a nitrogen fertilizer) (para 0977).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the amount / ratio of a fertilizer and a minicell based on the desirable outcome. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to optimize the amount / ratio of a fertilizer and a minicell with a reasonable expectation for successfully obtaining a composition.
Response to Arguments
Applicant argues that Sabbadini does not teach each element of the agricultural compositions as presently claimed. The preamble of the present claims has been amended to reflect and emphasize this distinction.
These arguments are not found persuasive because the limitation of “agricultural” in the preamble is regarded as an intended use limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Sabbadini does teach a composition comprises a minicell having encapsulated within said minicell urea (a fertilizer). In addition, other disclosed carriers (in the same para 0977) such as lactose, gum acacia, mannose, gelatin, mannitol, for example, are well-known components used in agricultural applications.
Applicant argues that Sabbadini does not disclose an agricultural composition comprising a minicell encapsulating a fertilizer, and that Sabbadini mentions the pharmaceutical carrier urea once in a list of at least 17 such carriers, including: "glucose, lactose, mannose, gum acacia, gelatin, mannitol, starch paste, magnesium trisilicate, talc, corn starch, keratin, colloidal silica, potato starch, urea, medium chain length triglycerides, dextrans, and other carriers suitable for use in manufacturing preparations, in solid, semisolid, or liquid form." Sabbadini at para. [0977], emphasis added.
These arguments are not found persuasive because the rejected independent claim 2 recites a fertilizer, which is a genus that encompasses a wide array of components. In other words, applicant’s claims encompass a wide array of components. Furthermore, Sabbadini does teach a composition comprises a minicell having encapsulated within said minicell urea (a fertilizer).
Applicant argues that inherency may not be established by probabilities or possibilities, and that Sabbadini simply does not disclose an agricultural composition comprising minicells encapsulating urea.
These arguments are not found persuasive because Sabbadini explicitly teaches a composition comprises a minicell having encapsulated within said minicell urea (a fertilizer) (para 0977).
Applicant argues that new claims 30 and 31, reciting particular ratios and weight percentages of components, are not anticipated by Sabbadini. However, these arguments are moot in light of the new rejections above in view of applicant’s amendments.
Applicant argues that Double Patenting rejections do not constitute a proper obviousness-type double patenting rejection. The Examiner has not explained why the presently rejected claims are an obvious variant of the '265 Patent or '518 Patent claims, without relying on combination with the disclosure of a secondary reference.
These arguments are not found persuasive because claims are rejected on the ground of nonstatutory obviousness-type double patenting. The ‘265 patent recites an anucleated cell composition comprising an intact anucleated cell having encapsulated within said cell at least one non-expressed agricultural compound and at least one agriculturally acceptable carrier, and the ‘518 patent recites a minicell composition comprising a minicell having encapsulated within said minicell an agrochemical and at least one agriculturally acceptable carrier. In addition, Sabbadini does teach a composition comprises a minicell having encapsulated within said minicell urea (a fertilizer). Therefore, before the effective filing date of the claimed invention, a skill in the art would incorporate urea (a fertilizer) in a minicell composition with a reasonable expectation of success, since urea is an agriculturally acceptable carrier.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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