DETAILED ACTION
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 .
Claim Status
The amendment of 09/12/2025 has been entered. Claims 1, 3, 5-8, 10-20, 26-27 are pending (claim set as filed on 09/12/2025). Claims 14-20, 26-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election of invention Group I, drawn to a biocontrol composition, of ‘strawberry’ as the plant, seed, flower, or produce species, and of ‘Botrytis cinerea’ as the pathogen species, was made with traverse in the reply filed on 12/11/2024.
Claims 1, 3, 5-8, 10-13 are currently under examination and were examined on their merits.
Withdrawn Objections/Rejections
The rejection of claims 8 and 10 under 35 U.S.C. 112(b) as being indefinite
as set forth in the previous Office action is withdrawn in light of the amendment filed on
09/12/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-8, 10-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a combination of judicial exceptions without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that
these entities are not patentable subject matter. These judicial exceptions include
abstract ideas, laws of nature, and natural phenomena. The Office released guidance
on January 7, 2019 for the examination of claims reciting natural products under 35
U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d
1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S., 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims
must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the
product must (a) not be directed to a judicial exception or must (b) contain additional
elements that amount to significantly more than the judicial exception itself.
'Directed to a judicial exception' analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Base claim 1, from which all examined claims depend, recites microbes (“a biocontrol composition comprising at least two microbes, wherein the at least two microbes comprise: (a) an isolated Gluconobacter cerinus, and (b) an isolated Hanseniaspora uvarum”; see base claim 1, lines 1-4), which are a natural phenomenon. Base claim 1 further recites the elements ‘isolated’ and ‘co-cultured’. It is not evident from the claims or specification how an isolated microbe structurally differs from a non-isolated microbe. Co-cultures of microbes occur naturally. It is not evident from the claims or specification how co-culturing alters the structure of the microbes claimed. Claims 1, 3, and 5-6, recite the additional feature ‘product ratio’. A natural co-culture inherently comprises a ratio of the co-cultured microbes. The concentration of each judicial exception does not alter the structure of the exception.
Claim 7 recites a comparison (“wherein the biocontrol composition is capable of inhibiting a fungal disease incidence of 10% or more compared to a reference composition”; claim 7, lines 1-3), which is a mental step. It is not evident from the claims or the specification how the mental step is defined or performed.
Prong Two: Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Base claim 1 recites the additional elements ‘isolated’ and ‘co-cultured’, and dependent claims 8, 10-11, recite the additional element ‘culturing process’. The recited elements ‘isolated’ ‘co-cultured’, and ‘culturing process’ are product by process limitations. It is not evident from the claims and the specification how isolating alters the microbe, and how co-culturing versus combining individually cultured microbes alters the microbes and the products produced during culturing. Therefore, the product by process limitations do not structurally change the microbes. Dependent claims 11-13 recite the additional element ‘storage’. However, ‘storage’ relates to intended use and thus does not structurally change the judicial exceptions. Other than the product by process limitations and storage, the claims do not recite any additional elements related to the judicial exceptions ‘microbe’ and ‘mental step’.
Therefore, the additional elements do not integrate the judicial exceptions into practical applications.
'Significantly more' analysis:
The claims do not include additional elements that are sufficient to amount to
significantly more than the judicial exception because claim 7 does not include any
additional elements affecting the judicial exception ‘mental step’, and claims 1, 3, 5-8, 10-13 do not include additional elements that structurally alter the judicial exceptions ‘microbes’.
Therefore, claims 1, 3, 5-8, 10-13 are directed to subject matter that is not
patent-eligible and are rejected under 35 U.S.C. 101.
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, 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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-8, and 10-13 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Besoain Canales et al. (US 2019/0059387 A1, published on 02/28/2019), in view of Salas et al. (“Antifungal Microbial Agents for Food Biopreservation - A Review”, published on 07/08/2017, Microorganisms 2017, Vol. 5, 37, pages 1-35).
Besoain Canales et al.’s general disclosure relates to “a biological product useful for the control of fungal diseases in plants comprising bacteria of Gluconobacter genus and yeast of Hanseniaspora genus (see entire document, including abstract).
Regarding claim 1, pertaining to a biocontrol composition, Besoain Canales et al. teaches a biocontrol composition comprising two microbes, wherein the two microbes comprise: (a) an isolated Gluconobacter cerinus, and (b) an isolated strain of the genus Hanseniaspora (“The present invention relates to a biological product useful for the control of fungal diseases in plants comprising bacteria of Gluconobacter genus and yeast of Hanseniaspora genus”; “Gluconobacter may correspond to Gluconobacter cerinus”; paragraphs [0027], [0042] and [0046], see abstract).
Pertaining to the product ratio, Besoain Canales et al. teaches a product ratio of Gluconobacter and Hanseniaspora of 100:1 based on the disclosed cell concentrations (“Gluconobacter cerinus (G.c.) concentration, strain 515 was 1x106 [CFU/ml] and that of Hanseniaspora osmophila (H.o.) strain 337 was 1x104 [CFU/ml].”; paragraph [0042], see Fig. 9).
Additionally, Besoain Canales et al. teaches “wherein at least 1x106 [CFU/ml] of Gluconobacter spp. and at least 1x104 [CFU/ml] of Hanseniaspora spp. are mixed” (see claim 10).
Regarding claim 7, pertaining to inhibiting a fungal disease, Besoain Canales et al. teaches wherein the biocontrol composition is capable of inhibiting a fungal disease incidence by 10% or more compared to a reference composition comprising one or more of the at least two microbes cultured individually (“Example 2: Gluconobacter Spp. and Hanseniaspora Spp. Present a Synergistic Antifungal Effect Against Rhizopus Spp., Botrytis cinerea, Aspergillus Spp. and Penicillium Spp”; “the biological product of the disclosure (which comprises Gluconobacter cerinus+Hanseniaspora osmophila) has a clear enhanced synergistic effect in relation to the effect obtained by its individual parts (FIG. 1A). This is evidenced by the fact that Hanseniaspora osmophila evidently improves the antifungal properties of Gluconobacter cerinus, even though Hanseniaspora osmophila alone has no antifungal effect against Rhizopus spp. (FIG. 1A). The product of the disclosure also exerts an enhanced antifungal effect against Botrytis cinerea (FIG. 2A), Aspergillus spp. (FIG. 3A), and against Penicillium spp. (FIG. 4A).”; paragraph [0073], see Figures 1-4). Please note treatment 8 versus treatment 5 in FIG. 2A (Besoain Canales et al.) as an example for the biocontrol composition inhibiting a fungal disease incidence by 10% or more compared to a single strain.
Regarding claims 8 and 10-11, the claims are directed to a product claim and thus the method of making the product does not impart a structural limitation absent evidence to the contrary (see MPEP 2113 (I)). Further it is noted that Besoain Canales et al. teaches the synergy of the combination (“the present disclosure relates to an antifungal product comprising Gluconobacter and Hanseniaspora, which have a surprisingly synergistic and potentiated effect of antifungal activity”; paragraph [0048]).
Regarding claim 11, Besoain Canales et al. teaches wherein the biocontrol composition is subjected to a storage condition (“To obtain the product of present disclosure, it is necessary to mix Gluconobacter spp., …, with Hanseniaspora spp.”, “To administer the product of the disclosure, any means is suitable, including administrations in liquid vehicles (direct jet, spray, mixed with irrigated waters) or directly as powder in the case of being used lyophilized.”; paragraphs [0052]-[0053]). The Examiner notes that during the time between production of the composition and administering the composition, the product intrinsically is subjected to storage.
Regarding claims 12-13, it is noted that storage conditions are future intended use of the composition that does not structurally limit the claim.
Besoain Canales et al. does not teach
wherein the yeast of the genus Hanseniaspora is Hanseniaspora uvarum (instant claim 1),
wherein the Gluconobacter cerinus and the Hanseniaspora uvarum are co-cultured (instant claim 1),
wherein the product ratio of the Gluconobacter cerinus and the Hanseniaspora uvarum is between about 1:10 and 10:1 (instant claim 3),
wherein the product ratio of the Gluconobacter cerinus and the Hanseniaspora uvarum is between about 1:3 and 3:1 (instant claim 5),
wherein the product ratio of the Gluconobacter cerinus and the Hanseniaspora uvarum is between about 1:2 and 2:1 (instant claim 6).
Salas et al.’s general disclosure relates to “main fungal spoilers encountered in food products, the antifungal microorganisms tested for food bioprotection, and their mechanisms of action.” (see entire document, including abstract).
Regarding claim 1, pertaining to Hanseniaspora uvarum, Salas et al. teaches that Hanseniaspora uvarum is an antifungal microorganism isolated from strawberry and inhibits Botrytis cinerea (see Table 1, row 12, on page 11).
While modified Besoain Canales et al. does not teach wherein the yeast of the genus Hanseniaspora is Hanseniaspora uvarum (instant claim 1), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified Besoain Canales et al.’s biocontrol composition with Salas et al.’s teachings on H. uvarum, to establish a biocontrol composition comprising Gluconobacter cerinus and Hanseniaspora uvarum that are combined at a product ratio. One of ordinary skill in the art would have been motivated to do so, in order to develop a superior biocontrol composition since H. uvarum taught by Salas et al. has antifungal properties and the Besoain Canales et al. suggests the genus Hanseniaspora (see above). A skilled artisan would have reasonably expected success in combining Besoain Canales et al.’s and Salas et al.’s teachings, because both references are directed to microbial compositions with antifungal properties (see above).
Regarding the limitation of co-culturing, the instant claims are directed to the product and not the method of making the product. Therefore, the co-culturing limitations are product-by-process and the process claims are given patentable weight if they impart a structural limitation to the claims. In the instant case, the culturing of each individual microbe and combining both is considered to be the same as co-culturing both microbes absent evidence otherwise (see MPEP 2113 (I)). Besoain Canales et al. further teaches: “In order to mix the microorganisms of the disclosure, these may be suspended in culture medium” (see paragraph [0051]) indicating that individually grown microorganisms are not necessarily removed from the growth medium before being combined with the other microorganism. The resulting combination would have the same structure as co-cultured microorganisms.
While modified Besoain Canales et al. does not teach wherein the product ratio of the Gluconobacter cerinus and the Hanseniaspora uvarum is between about 1:10 and 10:1 (instant claim 3), between about 1:3 and 3:1 (instant claim 5), and between about 1:2 and 2:1 (instant claim 6), the instantly recited ranges would be within the realm of routine experimentation since modified Besoain Canales et al. teaches a product ratio of 100:1, and also wherein the cell count for each individual microorganism can be above a minimum cell count and therefore variable (see above). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine the optimal product ratio ranges of the biocontrol composition, in order to develop a composition with optimal antifungal effects. Further, one would expect success since modified Besoain Canales et al.’s teachings are directed to a biocontrol composition inhibiting different fungi (see above), and therefore manipulation of the product ratio based on the teachings of the reference would be within the purview of an artisan. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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 (CCPA1955). See MPEP § 2144.05 part II A.
Claims 1, 3, 5-8, and 10-13 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Besoain Canales et al. (US 2019/0059387 A1, published on 02/28/2019), in view of Salas et al. (“Antifungal Microbial Agents for Food Biopreservation - A Review”, published on 07/08/2017, Microorganisms 2017, Vol. 5, 37, pages 1-35), and in view of Nunes et al. (“Occurrence of Gray Mold in Stored Strawberries as Affected by Ripeness, Temperature, and Atmosphere”, published Jan 2012, Proc. Fla. State Hort. Soc., Vol. 125, pages 287-294).
The teachings of Besoain Canales et al. and Salas et al. have been set forth above. It is noted that storage conditions are intended use of the composition that does not structurally limit the claim. In the interest of compact prosecution, the examiner will make the following rejection. However, it is applicant’s burden to show the intended use provides a structural limitation on the product per se.
Modified Besoain Canales et al. does not teach wherein the storage condition comprises storage at a temperature between 4°C and 25°C (instant claim 12), or wherein the storage condition comprises a storage time of at least 7 days (instant claim 13).
Nunes et al.’s general disclosure relates to “the postharvest decay in strawberries in general and gray mold caused by Botrytis cinerea in particular” (see entire document, including abstract).
Regarding claim 12, pertaining to the storage temperature, Nunes et al. teaches wherein a storage condition for strawberries comprises storage at a temperature of 10 °C (“The objectives of this study were to evaluate the development of postharvest decay in strawberries in general and gray mold, caused by B. cinerea in particular, specifically: 1…; 2) the interaction of fruit ripeness and CA storage among fruit stored for 1 or 2 weeks at normal cold storage temperatures (4 or 10 °C) for commercial handling”; page 288, left column, paragraph 3).
Regarding claim 13, pertaining to the storage time, Nunes et al. teaches wherein a storage condition comprises a storage time of 7 days (“The objectives of this study were to evaluate the development of postharvest decay in strawberries in general and gray mold, caused by B. cinerea in particular, specifically: 1…; 2) the interaction of fruit ripeness and CA storage among fruit stored for 1 or 2 weeks at normal cold storage temperatures (4 or 10 °C) for commercial handling”; page 288, left column, paragraph 3).
Additionally, Nunes et al. teaches wherein the storage of strawberries at 10 °C for 7 days corresponds to commercial handling conditions (“The objectives of this study were to evaluate the development of postharvest decay in strawberries in general and gray mold, caused by B. cinerea in particular, specifically: 1)…; 2) the interaction of fruit ripeness and CA storage among fruit stored for 1 or 2 weeks at normal cold storage temperatures (4 or 10 °C) for commercial handling”; page 288, left column, paragraph 3).
While modified Besoain Canales et al. does not teach wherein the storage condition comprises storage at a temperature between 4°C and 25°C (instant claim 12), or wherein the storage condition comprises a storage time of at least 7 days (instant claim 13), It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified et al.’s biocontrol composition with Nunes et al.’s teachings on storage temperature and time, in order to develop a biocontrol composition, wherein the storage condition comprises storage at a temperature of 10 °C and a storage time of 7 days. One would have been motivated to do so, in order to provide a superior biocontrol composition that maintains potency during strawberry storage under commercial conditions. A skilled artisan would have reasonably expected success in the combination of modified Besoain Canales et al.’s and Nunes et al.’s teachings since both references are directed to preservation of postharvest fruit (see above).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 11,771,029 B2 in view of Salas et al. (Antifungal Microbial Agents for Food Biopreservation - A Review”, published on 07/08/2017, Microorganisms 2017, Vol. 5, 37, pages 1-35) and in view of Besoain Canales et al. (US 2019/0059387 A1, published on 02/28/2019). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for similar compositions comprising microbial biocontrol agents. ‘029 provides for a biocontrol composition comprising Gluconobacter cerinus and Hanseniaspora uvarum of the instant claims. However, ‘029 does not teach a co-culture and a product ratio. Salas et al. teaches co-culturing to stimulate antifungal activity (“Co-cultures can also positively stimulate antifungal activity”; page 19, paragraph 7), and Besoain Canales et al. teaches a Gluconobacter/ Hanseniaspora biocontrol composition comprising antifungal properties with a product ratio of Gluconobacter: Hanseniaspora of 100:1 (“present invention relates to a biological product useful for the control of fungal diseases in plants comprising bacteria of Gluconobacter genus and yeast of Hanseniaspora genus”; “Gluconobacter cerinus (G.c.) concentration, strain 515 was 1x106 [CFU/ml] and that of Hanseniaspora osmophila (H.o.) strain 337 was 1x104 [CFU/ml].”; paragraph [0042], see abstract and Fig. 9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the biocontrol composition provided by ‘029 with Salas et al.’s teachings on co-culture and Besoain Canales et al.’s teachings on product ratio of a biocontrol composition, in order to create a biocontrol composition wherein the at least two microbes are co-cultured, and wherein Gluconobacter cerinus and Hanseniaspora uvarum are co-cultured at a product ratio of 100:1. A skilled artisan would have been motivated to do so in order to develop a superior biocontrol composition with increased antifungal properties (see above).
Response to Arguments
Applicant has traversed the previous rejections of claims 1-3, 5-8, and 10-13 under 35 U.S.C. 101, of claims 1-3, 5-8, and 10-13 under 35 U.S.C. 103, and the double-patenting rejection of claim 1. Applicant's arguments filed on 9/12/2025 have been fully considered but they are not persuasive.
In Applicant’s reply, Applicant states that “[t]he Office asserts that co-culture of microbes occur naturally, but provides no evidence that a co-culture of Gluconobacter cerinus and Hanseniaspora uvarum microbes at a product ratio between about 1: 100 and 100: 1 occurs naturally”, and that “the functional difference of superior antifungal effects of the biocontrol composition of co-cultured Gluconobacter cerinus and Hanseniaspora uvarum rises to the level of a marked difference compared to a mixture of Gluconobacter cerinus and Hanseniaspora uvarum that was NOT co-cultured, Gluconobacter cerinus alone, and Hanseniaspora uvarum alone (remarks, pages 8-9).
The Examiner responds that the claimed composition is a combination of microbes that occur in nature and the combination itself does not appear to have a markedly different characteristic. While the specification presents experimental data, the impact of co-culture of the recited microbes on the antifungal activity of the composition is unclear since no statistical evaluation of the presented data in the instant application is provided (see specification, paragraphs [110]-[111] and Table 3), and, therefore, proper interpretation of the presented results is not possible (see MPEP 716.02(b) I). As such, the specification does not provide evidence that co-culturing of the recited microbes results in increased antifungal activity of the biocontrol composition.
In Applicant’s reply, Applicant describes that “claim 7 defines a comparison in terms of the capability of the claimed biocontrol composition, such that no mental step is set forth in claim 7. Moreover, the specification of the present application clearly defines fungal disease incidence as "the appearance of fungal growth on a fruit"(paragraph 0038 of the present application)”.
The Examiner responds that claim 7 recites a comparison which requires the mental step of comparing and is not further defined or described in the specification of claims. Thus, the comparison in claim 7 is considered a mental step (remarks, page 10).
Applicant explains that “none of the cited references teaches or suggests that a biocontrol composition comprising co-cultured microbes of Gluconobacter cerinus and Hanseniaspora uvarum would provide a superior antifungal activity compared to a mixture after sole culture of each of the microbes” (remarks, page 13), that therefore “the claimed biocontrol composition must be considered to exhibit an unexpected property, which further evidences the unobviousness of the claimed biocontrol composition in view of the cited references” (remarks, page 13), and that “the composition of co-cultured Gluconobacter cerinus and Hanseniaspora uvarum provides improved storage stability compared to either Gluconobacter cerinus or Hanseniaspora uvarum alone” (remarks page 14). Applicant further states that “the present invention as defined by claim 1 is not obvious in view of the claims of the '029 patent even when considered in view of Salas et al. and Besoain Canales et al., for at least the same reasons discussed above with respect to the obviousness rejections” (remarks, page 14).
The Examiner responds that the instant claims are directed to a product and not to the method of making the product. Therefore, the co-culturing limitations are product-by-process and the process claims are given patentable weight if they impart a structural limitation to the claims. In the instant case, the culturing of each individual microbe and combining both is considered to be the same as co-culturing both microbes absent evidence otherwise (see MPEP 2113 (I)). The impact of co-culturing of the recited microbes on the antifungal activity of the composition and on storage stability is unclear since no statistical evaluation of the presented data in the instant application is provided (see specification, Examples 1 and 3, paragraphs [110]-[111], [0119]-[0121], Tables 3 and 6), and as such, proper interpretation of the presented results is not possible (see MPEP 716.02(b) I).
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 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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/SANDRA ZINGARELLI/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653