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 .
Applicant’s amendment and reply filed February 25, 2026 have been received and entered into the case. Claims 30 – 35 are added; claims 15 and 17 – 35 are pending; claim 27 is withdrawn; claims 15, 17 – 26 and 28 – 35 have been considered on the merits. All arguments have been fully considered.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 15, 17 – 26 and 28 – 35 in the reply filed on February 25, 2026 is acknowledged.
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 15, 17 – 26 and 28 – 35 remain and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 and its dependents remain indefinite because the claim still fails to recite any particular correlation of “determining bacteriophage sensitivities” to the “determining an adapted order.” The claims recite active steps of culturing a food product with a set of bacteria (subset 1 and 2); collecting a sample of subset 1; and exposing a sample of subset 2 to the sample of subset 1. No additional active steps are recited. It is unclear if subset 1 and subset 2 are cultured together or separately. It is unclear whether bacteriophages must be present in the various cultures, and how they may be introduced into the process. It is unclear how one practicing the method determines an adapted order, as no specific step or correlation is recited such that one knows how to make the determination, or what result directs order or culturing a food product.
Claim 15 remains indefinite for reciting “to determine bacteriophage sensitivities” and also “determining an adapted order” since no active steps are recited to carry out the mental step of determining. The claim remains indefinite because the claim fails to positively state that any “adapted order” is applied to the method. Moreover, the claim merely recites a mental step of “determining” an adapted order with nothing more. For purposes of examination, the limitations are regarded as mental steps only and do not require any particular active step for these determinations.
Claim 15 remains indefinite for not producing any fermented food product. Rather, the method steps appear drawn to mental steps of determining an order of adding bacterial strains to a process and nothing more.
Claim 18 remains indefinite because the phrase “employed dynamically” remains unclear as to what must be carried out to meet the limitation. The claim on which 18 depends does not recite any active step for culturing a food product with the adapted order. It is further indefinite because it is unclear what constitutes “employed dynamically” and whether this step intends to alter the order of steps alluded to in claim 15. Note that claim 15 does not specifically enumerate any active steps other than successively culturing a food product with a set of bacterial cultures.
Claim 19 remains indefinite as no active step is recited for “determining the bacteriophages sensitivities.”
In claim 22, the recitation of “is selected” continues to render the claim indefinite as selection is a mental step only with no active steps recited that must be carried out. For purposes of examination, the claim is limited to mental processes only and no active steps.
Claim 23 remains indefinite for reciting “determining…by determining” and no active steps for carrying out any active step. For purposes of examination, the claim is limited to mental processes only and no active steps. The claim is further confusing for reciting “determining a value indicative for a number of bacteriophages” as it is unclear what the phrase intends to convey let alone any active method step that must be performed.
Claim 26 remains indefinite for reciting “determining…by detecting and/or identifying” and no active steps for carrying out any active step. For purposes of examination, the claim is limited to mental processes only and no active steps.
Claim 29 and 35 remain/is indefinite for reciting “providers” as the term is not adequately defined by the claim language or specification. Clarification is required. Applicant indicates the term is defined by the specification; however, the specification fails to define the term. While the specification recites “a food producer may use bacterial cultures coming from two or more providers, such as for instance bacterial culture providers,” this is not a definition of the term such that the scope of the claim may be clearly defined and understood by one practicing the claimed method.
Claims 31, 33 and 34 are rendered indefinite because no active steps are recited that must be carried out thereby rendering it impossible to determine the scope of the claims. Instead, only mental steps of “determining” are recited. For purposes of examination, the claims are interpreted to include only mental steps of determining an adaptive order; looking at a compatibility matrix (or reference chart); or number of bacteriophages.
Claim 32 is rendered indefinite for reciting “used in a rotation” as the phrase attempts to claim a process without setting forth any steps involved in the process.
Response to Arguments
Applicant argues the claims have been amended to clarify their scope, however in light of the maintained and new rejections above, this argument and the amendments fail to overcome the rejections.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15, 17 – 26 and 28 – 35 are rejected under 35 U.S.C. 103 as being unpatentable over Klaenhammer et al. (US 5593885) in view of Marcó et al. (2012).
Regarding claims 15, 30 – 33 and 35, Klaenhammer teaches a method for fermenting food products (abstract, col.6 line 50 – 55) wherein a product is successively fermented with a first and second set of bacterial cultures (abstract) (or is carried out with an initial order of bacteria); wherein the substrate (food product) to be fermented originates from the same stock and a first culture is replaced with a second culture (rotated); or one or more strains in the original composite could be removed and replaced by a second strain (col.5 – 6). This is interpreted as exposing a second bacterial culture to a process sample cultured by the first bacterial subset. Although the reference does not indicate this step determines bacteriophage sensitivities of the second bacterial culture, the reference does teach that the first and second bacterial cultures have different phage defense mechanisms (abstract). In this regard, one has determined bacteriophage sensitivities of the second bacterial culture based on the original substrate/food product/process (or a sample of the first bacterial culture fermentation) (abstract, col.2 line 20 – 44) and has also determined an order of bacterial cultures used in the method, based on the difference in phage defense mechanisms, or bacteriophage sensitivities (or generated a compatibility matrix there between).
Klaenhammer does not teach the method wherein the first and second bacterial cultures are unknown and known, respectively. However, the methods of Klaenhammer are intended to reduce bacteriophages during fermentation of food products (col.1 line 15 – 20, col.6 line 50-55). Marcó teaches methods for reducing bacteriophages in fermenting food products wherein undefined (unknown cultures with unknown bacteriophage information) raw starter cultures are rotated with known, direct multi-strain cultures (DSC) (p.155, left col.). Specifically, Marcó teaches this rotation results in efficient phage control by avoiding recontamination by the same phage and build up of high phage levels in a dairy plant (p.155, left col.). Marcó teaches that the unknown starter cultures are considered highly tolerant to phage infection, leading to phage resistant and phage tolerant strains with high performance while the DSC (known strains) allow for highly reproducible results (p.155, left col.). At the time the claims were filed, one of ordinary skill in the art would have been motivated to use unknown then known starter cultures in the methods of Klaenhammer for their known advantages as discussed by Marcó and with a reasonable expectation for successfully producing a fermented food product.
Regarding claim 17, the limitations appear to be drawn to an intended use of the resulting food product. In this regard, the limitation appears to not further limit the process for producing a food product.
Regarding claim 18, the bacterial cultures are added in successive or alternate cycles, where new strain cultures and intervals can be used, removed and/or replaced with various strains (col.6 line 1 – 30) or wherein the order of strains are used “dynamically.”
Regarding claims 19 – 21, each of the bacterial strains are exposed to the bacteriophages within the culture process (col.5 – 6).
Regarding claim 22, Klaenhammer and Marcó both teach the methods for reducing bacteriophages in culture (Klaenhammer, abstract; Marcó, p.155).
Regarding claim 23 – 24, 26 and 34, Klaenhammer does not teach the method wherein bacteriophage numbers are determined. However, Marcó teaches common methods for quantifying bacteriophages include qPCR (p.150, right col.) and that these methods are used in detecting and monitoring phages during fermentation (p.152, left col.). Marcó additionally teaches that early detection of bacteriophages at any point during fermentation is extremely helpful to minimize the detrimental consequences of phage attacks in dairy factories and that several characteristics must be taken into account when selecting a particular phage detection method such as the volume product, the type of fermentation process, the starter culture used, the diversity of the phage population, the risk or frequency of phage infections, the requirement for rapid results, the quantification limit, and the cost of the assay (p.152). In this regard, when following the teachings of Marcó, one of ordinary skill in the art would have been motivated to optimize the method of detecting and determining presence of bacteriophages for the disclosed and known advantages early detection. Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to apply the claimed quantification methods in the methods of Klaenhammer as a matter of routine practice and procedure when fermenting food products.
Regarding claims 25 and 30, Klaenhammer teaches the methods wherein the food product is cheddar, cottage cheese (col.6 line 55 – 60) or milk (dairy product) (example 4, claim 11).
Regarding claims 28 - 29, Klaenhammer teaches the methods wherein at least 2 or 3 strains are used in the methods (abstract, col.2, col.6, example 1) and that the strains are different (different providers) (Table 1).
Regarding claim 30, Both Klaenhammer and Marcó teach fermentation processes of fermented food products (Klaenhammer, col.6-8; Marcó, entire document).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 15, 17 – 16 and 28 – 35 remain and are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4 – 6 and 14 of copending Application No. 17/794,346 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for culturing a food product with a first and second bacterial culture, wherein one set determines the order of culture and sensitivities to bacteriophage.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the rotation strategy of Klaenhammer is different from applicant in that the prior art requires isogenic bacterial strains having the same bacteriophage binding characteristics and different internal phage defense mechanisms; whereas the claimed invention requires different “bacteriophage sensitivities.” Applicant argues that the strains of Klaenhammer have the same bacteriophage binding properties and therefore necessarily also have the same bacteriophage sensitivities; and do not differ in susceptibility to phage binding and infection. Applicant states that the claimed method arranges bacterial cultures such that successive cultures do not have the same bacteriophage sensitivities.
However, while Klaenhammer teaches bacteria with the same bacteriophage binding properties, this is not the same as having the same bacteriophage sensitivity. Instead, Klaenhammer specifically states that the strains have different defense mechanisms (col.2 line 20 – 30) indicating the strains are different in their sensitivity to the bacteriophages. As acknowledged by applicant, “bacteriophage sensitivities” may refer to the ability of a bacterial culture or a bacterial strain to be infected by a specific bacteriophage (p. 4, applicant’s specification), which includes defense mechanisms.
Regarding their isogenic description, isogenic bacteria may be defined as different strains, particularly in that the strains of Klaenhammer have different mechanisms of defense against bacteriophages, or difference bacteriophage sensitivities (abstract, col.2 – 4).
Regarding the argument that the claimed method arranges bacterial cultures such that successive cultures do not have the same bacteriophage sensitivities, Klaenhammer specifically states that the cultures do not share the same defense mechanisms (col.3 - 4) or have different sensitivities to bacteriophages.
Applicant argues that the prior art does not teach including unknown bacterial cultures, but requires known cultures and known phage defense mechanisms prior to fermentation; and that the prior art does not teach or suggest using cultures with unknown phage sensitivities.
However, as stated in the rejection above, Marcó suggests rotating unknown raw starter cultures with known cultures results in efficient phage control by avoiding recontamination by the same phage and build up of high phage levels in a dairy plant (p.155, left col.). Marcó further teaches that the unknown starter cultures are considered highly tolerant to phage infection, leading to phage resistant and phage tolerant strains with high performance while the known strains allow for highly reproducible results (p.155, left col.). Thus, the combination of Klaenhammer and Marcó does teach and suggest using unknown cultures with unknown phage sensitivities and rotating the cultures during fermentation.
Applicant argues that the prior art does not teach exposing a culture sample of the second bacterial subset to a process sample to determine bacteriophage sensitivity of the second subset; and that using the same substrate or stock is not the same as successive fermentation by exposing a second bacterial culture to a process sample. Applicant further argues that the prior art does not teach an exposing step that characterizes bacteriophage sensitivities of the known strains to phages collected during culture of the unknown strains.
Initially, it is noted that the only active step recited for “determining bacteriophage sensitivity” is exposing a second bacterial culture to a process sample. In this regard, Klaenhammer teaches successive fermentation wherein a first culture is replaced with a second culture; or one or more strains in the original composite could be removed and replaced by a second strain (col.5 – 6). This is interpreted as exposing a second bacterial culture to a process sample cultured by the first bacterial subset.
Regarding the argument that the prior art does not teach an exposing step that characterizes bacteriophage sensitivities of the known strains to phages collected during culture of the unknown strains, it is noted that the method does not recite any active step beyond exposing a known bacterial culture to a sample of the fermentation process with the unknown bacterial culture. In this regard, the argument is not commensurate in scope with the claimed invention. Notwithstanding, it is reiterated that the teachings obtained by the combined references teaches and suggests successive fermentation wherein a first culture is replaced with a second culture; or one or more strains in the original composite could be removed and replaced by a second strain (col.5 – 6) which is interpreted as exposing a second bacterial culture to a process sample cultured by the first bacterial subset.
Applicant argues that Marcó teaches away from combining unknown and known cultures because it indicates that whey products using natural undefined starters should not be added to processes driven by defined starters.
However, this statement does not suggest undefined and defined strains cannot be used together to successfully produce a fermented food product. Rather, the statement suggests products produced with natural undefined strains may introduce risk to products if recycling whey protein concentrates (WPC) are recycled therein. Moreover, the claims are not directed to recycling whey protein concentrates or recycling whey products into later fermentation processes. Thus, applicant appears to argue a teaching away that is irrelevant to the claimed method. With regards to the claimed method, Marcó expressly teaches the rotating natural starters (undefined culture) and defined cultures effects the “main basis for an efficient phage control program” which results in “avoiding recontamination by the same phage and build up of high phage levels” which “provides a relatively simple way to minimize fermentation failures due to phages” (p.155, left col.). As such, it is maintained that the combined references teach and suggest combining unknown and known cultures as claimed.
Applicant argues there is no motivation to combine the references because the references solve different problems with different approaches in that Klaenhammer uses isogenic strain with known phage defense mechanisms while the claimed method is drawn to determining optimal culturing order when using bacterial cultures from different providers and bacteriophage sensitivities are unknown.
However, both references are drawn to solving the same problem of phage defense in fermentation of dairy products and are therefore analogous art to each other and also the claimed method of producing fermented food products (e.g., dairy products, page 7 of the specification). Insofar as the references use different approaches, it is reiterated that the combined teachings of the references arrive at the claimed invention as explained in the rejection above. Marcó teaches methods for reducing bacteriophages in fermenting food products wherein undefined (unknown cultures with unknown bacteriophage information) raw starter cultures are rotated with known, direct multi-strain cultures (DSC) (p.155, left col.). Specifically, Marcó teaches this rotation results in efficient phage control by avoiding recontamination by the same phage and build up of high phage levels in a dairy plant (p.155, left col.). Marcó teaches that the unknown starter cultures are considered highly tolerant to phage infection, leading to phage resistant and phage tolerant strains with high performance while the DSC (known strains) allow for highly reproducible results (p.155, left col.). Therefore, it is maintained that at the time the claims were filed, one of ordinary skill in the art would have been motivated to use unknown then known starter cultures in the methods of Klaenhammer for their known advantages as discussed by Marcó and with a reasonable expectation for successfully producing a fermented food product.
Regarding the argument that the claimed method is drawn to determining optimal culturing order when using bacterial cultures from different providers and bacteriophage sensitivities are unknown, the claims do not require any active steps for carrying out these argued mental steps. In this regard, the argument is not commensurate in scope with the claimed invention. Further, claim 15 does not require “different providers” as argued, nor does the claim or specification define what a “provider” is such that one practicing the invention would even know to what this refers. Moreover, from where a bacterial culture is obtained does not materially change the claimed method of producing fermented food products, as it does not contribute to any claimed active step in the claimed method.
Applicant states that a terminal disclaimer has been filed to overcome the provisional nonstatutory double patenting rejection, however no such filing has been received or entered into the case.
No claims are allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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