Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-18 are pending.
Election/Restrictions
Applicant’s election of the invention of Group I, claims 1-15, and the species of:
a) Candida oleophila strain O;
b) sodium bicarbonate; and
c) a nutritional support comprising a gluconate salt.
in the reply filed on 7/7/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-18 are withdrawn as being drawn to a nonelected invention.
Claims 12, 14 and 15 are withdrawn as not being directed to the elected species of additional ingredients.
Claims 1-11 and 13 are under consideration to the extent that the composition comprises the elected species.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 8/5/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
Claims 1-11 and 13 are objected to because of the following informalities:
The preamble of claims 1-11 and 13 refers to both a “bio-control” combination and a “biocontrol” combination. For consistency and clarify, a single consistent wording should be used.
In Claim 3, line 1, “wherein” should be inserted between “claim 1,” and “the alkali”.
Claim 4 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claim 4 and claim 5, which depends from claim 4, have not been further treated on the merits.
Appropriate correction is required.
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 9 and 10 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 pre-AIA the applicant regards as the invention.
Claim 9 recites “the stabilizing amount of bicarbonate”, however claim 1 recites “a stabilizing amount of a bicarbonate or carbonate salt of an alkali or alkaline earth metal”. It is unclear if claim 9 is limiting both the amount and the type of stabilizing agent (to a bicarbonate only) or if the language was intended to read “the stabilizing amount of a bicarbonate or carbonate salt of an alkali or alkaline earth metal” and was shortened. If the former is correct, the following language is suggested, “The biocontrol combination as claimed in claim 1, wherein the bicarbonate or carbonate salt of an alkali or alkaline earth metal is a bicarbonate salt of an alkali or alkaline earth metal, and the stabilizing amount of bicarbonate salt of an alkali or alkaline earth metal is 0.1% to 10% w/v of the combination”, or similar. If the latter is correct, the following language is suggested, “The biocontrol combination as claimed in claim 1, wherein the stabilizing amount of bicarbonate or carbonate salt of an alkali or alkaline earth metal is 0.1% to 10% w/v of the combination”.
Claim 10 recites “the stabilizing amount of bicarbonate salt”, however claim 1 recites “a stabilizing amount of a bicarbonate or carbonate salt of an alkali or alkaline earth metal”. It is unclear if claim 10 is limiting both the amount and the type of stabilizing agent (to a bicarbonate salt only) or if the language was intended to read “the stabilizing amount of a bicarbonate or carbonate salt of an alkali or alkaline earth metal” and was shortened. If the former is correct, the following language is suggested, “The biocontrol combination as claimed in claim 1, wherein the bicarbonate or carbonate salt of an alkali or alkaline earth metal is a bicarbonate salt of an alkali or alkaline earth metal, and the stabilizing amount of bicarbonate salt of an alkali or alkaline earth metal is 1% to 5% w/v of the combination”. If the latter is correct, the following language is suggested, “The biocontrol combination as claimed in claim 1, wherein the stabilizing amount of bicarbonate or carbonate salt of an alkali or alkaline earth metal is 1% to 5% w/v of the combination”.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pujos (WO 2006/032530; cited in IDS) in view of Gamagae et al. (Crop Protection 22 (2003) 775-779).
Pujos teaches a composition for use against plant pathogens, comprising at least one antagonistic micro-organism and at least one salt (e.g. abstract). Pujos teaches that the at least one antagonistic micro-organism is Candida oleophila strain O (e.g. page 8, lines 5-9; Examples) and the at least one salt is a carbonate or bicarbonate, and may be sodium (e.g. page 2, line 21-page 3, line 16). Pujos teaches that the microorganism is present at 103 to 1011 cfu/ml, and the salt may be present at 0.005-5 g/L (i.e. 0.0005-0.5% w/v) (e.g. page 6, lines 6-14).
While the genus of salts disclosed by Pujos includes the elected species of sodium bicarbonate, it is not explicitly recited or exemplified.
Gamagae et al. investigated using the biocontrol agent Candida oleophila and sodium bicarbonate alone and in combination to reduce anthracnose caused by Colletotrichum gloeosporioides on papaya (Carica papaya L.) in storage (e.g. abstract). Gamagae et al. found the reduction of anthracnose severity was significantly (P<0.05) higher in fruits subjected to a combination treatment of 2% sodium bicarbonate and 2×108 cfu/mL of C. oleophila suspension compared to either agent alone (e.g. section 3.2; Fig 1). Gamagae et al. also found that naturally infected fruits subjected to the combination treatment revealed significantly (P<0.05) lower anthracnose incidence and severity than in fruits dipped in either sodium bicarbonate or C. oleophila suspension (e.g. section 3.3; Fig 2), and further that the overall quality of naturally infected fruits treated with combined application of sodium bicarbonate and C. oleophila were significantly (P<0.05) higher than fruits subjected to the either dip treatments alone (e.g. section 3.3; Fig. 3).
Regarding Claims 1-3, it would have been obvious to one of ordinary skill in the art at the time of filing to select the sodium bicarbonate of Gamagae et al. for use with the composition of Pujos. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both of the compositions and methods are directed to combinations of C. oleophilia and salts for use against plant pathogens, and Pujos discloses a genus of salts which includes sodium bicarbonate. One of ordinary skill would have been motivated in order to provide the benefits of significantly higher overall quality of infected fruits treated with combined application of sodium bicarbonate and C. oleophila, as taught by Gamagae et al.
Regarding the “biologically effective amount of Candida oleophila” and the “stabilizing amount of a bicarbonate or carbonate salt of an alkali or alkaline earth metal”, and Claims 6-10 and 13, Pujos teaches that the microorganism is present at 103 to 1011 cfu/ml, and the salt may be present at 0.005-5 g/L (i.e. 0.0005-0.5% w/v) (e.g. page 6, lines 6-14) and Gamagae et al. teach the combination treatment of 2% sodium bicarbonate and 2×108 cfu/mL of C. oleophila suspension, which overlap with the claimed ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). In addition, in combining the elements of Pujos and Gamagae et al. it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the concentrations through routine experimentation in order to optimize the resulting product. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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).
Regarding Claim 11, Pujos teaches the inclusion of “at least one salt” (i.e. can include multiple salts) and exemplifies the inclusion of calcium gluconate (e.g. Claim 11, Examples).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
Prosecution Insights