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
Claims 1-13 are currently pending and under exam herein.
Priority
The instant Application is the National Stage filing of PCT/EP2021/072482, filed 12 August 2021 which claims the benefit of Foreign priority to EP2019/0823.3, filed 13 August 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Each of claims 1-13 herein enjoy the priority to the EFD of 13 August 2020.
Information Disclosure Statement
The Information Disclosure Statement filed 30 April 2021 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The Drawings filed 10 February 2023 are accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US2023/0288393.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 recites a series of steps that include “the computer program product being configured to monitoring…monitoring…submitting…receiving…and controlling” wherein the recitation of words ending in “ing” herein are grammatically incorrect and should be amended to recite, instead: “ the computer program product being configured to monitor…monitor…submit…receive…and control”. Appropriate correction is required.
Claim Interpretation
A. With respect to the recitation of “bacteriophage pressure” in the instant claims, the Specification fails to specifically define this phrase and thus under the Broadest Reasonable Interpretation (BRI) as would be understood by one of skill in the art, said phrase is interpreted herein to mean the bacteriophage burden on a particular system.
B. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
Claim 12:
Controller is configured to operate…to perform
monitoring milk fermentation process performance data
monitoring a value indicative for a number of bacteriophages
submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model
receiving from the model an instruction to control bacteriophage pressure
controlling the bacteriophage pressure
Claim 13:
computer program product configured to:
monitoring milk fermentation process performance data
monitoring a value indicative for a number of bacteriophages
submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model
receiving from the model an instruction to control bacteriophage pressure
controlling the bacteriophage pressure
The instant Specification provides that the invention relates to a system that includes a controller at [0014]; The Specification further includes that the controller is configured to operate the system to perform steps of monitoring; submitting; receiving; and controlling [0084]. However the Specification fails to include a definite meaning for the structure of the claimed “controller” and one of skill in the art would not have a clear understanding of what “controller” mechanism corresponds to said recitation. See TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259-60, 85 USPQ2d 1787, 1789 (Fed. Cir. 2008) ("Sufficient structure exists when the claim language specifies the exact structure that performs the function in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure."); see also Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir. 2003). See also Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1376, 58 USPQ2d 1801, 1806 (Fed. Cir. 2001); Cardiac Pacemakers, Inc. v. St. Jude Med., Inc., 296 F.3d 1106, 1115-18, 63 USPQ2d 1725, 1731-34 (Fed. Cir. 2002).
Because this claim limitation are being interpreted under 35 U.S.C. 112(f) they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. In the instant Specification, however, there is a lack of corresponding structure for each of the above. See rejections below that are informed herein by the claim interpretation under 112(f).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
A. Written Description based on the Claim Interpretation under 112(f) above
(i) Claims 12-13 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Claims 12-13 are interpreted under 112(f), as above. As such, the Specification should provide support for the recited “means” in the claims. However, the instant Specification fails to provide adequate support for the description of the sufficient structure to perform the claimed functions. The specification, instead, provides only that said operations are generically performed on a computer, but does not provide any description of a “controller” as claimed.
Claim Rejections - 35 USC § 112(b)-Indefiniteness
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.
A. Rejections under 112(b) as pertain to the Claim Interpretation under 112(f) above:
(i) Claims 12-13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 12-13 recite, “controller configured to operate the system to perform [or in claim 13 a computer program product being configured to]monitoring milk fermentation…monitoring a value; submitting the milk fermentation process performance data and ta value indicative of the number of bacteriophages to a model; receiving from the model an instruction to control bacteriophage pressure; and controlling the bacteriophage pressure” wherein said claim step is indefinite with respect to the structure of “controller” or any particular algorithm by which said operations function and further, one of skill in the art is not apprised of the definition for such a “controller”. See for example: Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1242 [The specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to a special purpose computer so that a person of ordinary skill in the art can implement the disclosed algorithm to achieve the claimed function]. Clarification is requested through clearer claim language.
As the above claim limitations are interpreted to invoke 35 U.S.C. 112(f) and are subject to the written description rejection above, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, claims 1-12 are directed to a method and system for monitoring and controlling bacteriophage pressure in a milk fermentation process.
With respect to claim 13, the claims are not directed to a proper class of invention and are rejected herein for failing the Step 1 analysis because the claim recites “a computer program product”. Therefore the claims read on carrier waves which are non-statutory which read on transitory propagating signals which are not proper patentable subject matter because they do not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006). It is noted that the recitation of a "non-transitory computer-readable medium" would overcome the rejection with respect to this aspect of claim 13.
For purposes of compact prosecution, claim 13 will be further analyzed with assumption that non-transitory will be amended into the claim.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information).
The claim steps to abstract ideas are as follows:
Claim 1:
monitoring milk fermentation process performance data; (b) monitoring a value indicative for a number of bacteriophages; (c) submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model, wherein steps directed to “monitoring” are those that are mere observations of data in a process and mental steps of providing that data to a model (i.e., seemingly using the data in a model process). One of skill in the art can perform said operations mentally with the aid of pen and paper or a computer as s tool. There are no steps beyond in the claim that suggest or are interpreted under the broadest reasonable interpretation (BRI) of the claim as otherwise.
Claim 6: the model is a statistical model, wherein the model is further defined to be a mathematical model that can be implemented by human mental processes, save for no other steps set forth in the claim and further as pertains to the BRI of the instant claim.
Claim 7: the model is an artificial intelligence model, wherein the model is further defined to be a mathematical model that can be implemented by human mental processes, save for no other steps set forth in the claim and further as pertains to the BRI of the instant claim.
Claim 12: monitoring milk fermentation process performance data; (b) monitoring a value indicative for a number of bacteriophages; (c) submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model, wherein steps directed to “monitoring” are those that are mere observations of data in a process and mental steps of providing that data to a model (i.e., seemingly using the data in a model process). One of skill in the art can perform said operations mentally with the aid of pen and paper or a computer as s tool. There are no steps beyond in the claim that suggest or are interpreted under the broadest reasonable interpretation (BRI) of the claim as otherwise.
Claim 13: monitoring milk fermentation process performance data; (b) monitoring a value indicative for a number of bacteriophages; (c) submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model, wherein steps directed to “monitoring” are those that are mere observations of data in a process and mental steps of providing that data to a model (i.e., seemingly using the data in a model process). One of skill in the art can perform said operations mentally with the aid of pen and paper or a computer as s tool. There are no steps beyond in the claim that suggest or are interpreted under the broadest reasonable interpretation (BRI) of the claim as otherwise.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance in the mind (calculations by hand or pen and paper or with the aid of a computer to perform abstract ideas). There are no specifics as to the methodology involved and thus, under the BRI, one could simply, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said calculations. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claim 1: receiving from the model an instruction to control bacteriophage pressure; and (e) controlling bacteriophage pressure
Claim 12: system; controller; receiving from the model an instruction to control bacteriophage pressure; and (e) controlling bacteriophage pressure
Claim 13: computer program product; receiving from the model an instruction to control bacteriophage pressure; and (e) controlling bacteriophage pressure
Dependent claims further limit the computer (server); times to access milk; and data as pertain to the input in the claims.
Further with respect to the above additional elements in the instant claims, those steps directed to data gathering, such as “receiving an instruction” perform functions of collecting the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further, the system, computer, and program are part of a general purpose computer system and there are no details herein wherein of how the specific computer structures are used to implement the judicial exceptions beyond generic computing operations, i.e., the computer elements of the claims do not provide improvements to the functioning of the computer itself (see: DDR Holdings, LLC v. Hotels.com LP); they do not provide improvements to any other technology or technical field (see: Diamond v. Diehr); nor do they utilize a particular machine (see: Eibel Process Co. v. Minn. & Ont. Paper Co.). Hence, these are mere instructions to apply the judicial exception using a computer, and therefore the claim does not provide integration into a practical application of any judicial exception.
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the prior art to Gernaey et al. (Trends in Biotechnology (2010) Vol. 28, No. 7:346-354) disclose that steps of receiving instruction for control in the fermentation environment are routine and well-known operations (see page 346). Gernaey et al. disclose that in fermentation processes, for example models are implemented wherein process control is achieved by measuring critical process variables and adjusting the process operation accordingly (page 346, col. 2; p. 347, col. 1 as applied to the food industry specifically). As such, said laboratory steps as disclosed herein encompass steps that are routine, well-understood and conventional in the art.
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)II.): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
With respect to the recitation of generic computing elements, the instant specification discloses that computer processors and systems, as example, are generic computing systems [0101]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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.
The factual inquiries 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.
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.
1. Claims 1-6, 8, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Krysiak-Baltyn et al. (Crit. Rev. Microbiol. (2016) Vol. 42(6):942-968) in view of US20090215027 to Houlberg (IDS reference).
Claim 1 is directed to:
A computer implemented method for monitoring and controlling bacteriophage pressure in a milk fermentation process using a bacterial culture, said method comprising [Krysiak-Baltyn et al. disclose monitoring and controlling in a culture system [page 946, col. 1-2, e.g.]:
(a) monitoring milk fermentation process performance data;
(b) monitoring a value indicative for a number of bacteriophages [Krysiak-Baltyn et al. disclose a three-component system by which to monitor the number of bacteriophage in a system at Figure 1, B; page 943, col. 2; page 945, col. 2];
(c) submitting the milk fermentation process performance data and a value indicative for the number of bacteriophages to a model [Krysiak-Baltyn et al. disclose performance data, e.g., number of bacteria in a culture {specifications of the bacterial culture}and phage numbers; page 945, col. 2; page 947 at Table 4; page 952, col. 1];
(d) receiving from the model an instruction to control bacteriophage pressure; and
(e) controlling bacteriophage pressure.
Krysiak-Baltyn et al. do not teach the implementation of modeling into milk fermentation specifically or to control of bacteriophage pressure. However, the prior art to Houlberg discloses monitoring properties of milk fermentation products [0002]. Houlberg discloses the correlation of signal parameters from products for the ultimate control of fermentation procedures [Figure 1 description beginning [0085-0097]. Houlberg is concerned with assessing fermentation condition values by computer-implemented monitoring for purposes, in part, of control of bacteriophage infection in cultures [0002; 0056]. Houlberg further discloses that the computer-implemented system may operate to obtain information and provide ultimate control over system operation by, for example, display of information and further instruction to return to an “addition of Sample” step or to terminate in a “Stop” step, as such exercising control over bacteriophage, for example [0097].
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have included the modeling data for performance and bacteriophage data as described in the prior art to Krysiak-Baltyn et al. with the system implementation as described by Houlberg because each of said references is specifically concerned with mitigating bacteriophage contamination in fermentation environments. Further, Krysiak-Baltyn et al. motivate the use of said modeling for dairy production in particular (page 962, col. 2) and the issue of, for example, pH shifts that contribute to a switch in the lytic cycle, which significantly alters the dynamic behavior of said populations. This fosters the need for accurate modeling that is difficult to obtain by experimental study alone (page 965, col. 2). As such, one would have had a reasonable expectation of success in combining the two references herein.
With respect to claims 12 and 13, said claims include the system and programs of the above recited method. The prior art to Houlberg discloses computing programs and systems for said operation at least at [0103]-[0104].
With respect to claim 2, Houlberg discloses computing systems [0103-0104].
With respect to claim 3, Houlberg discloses taking multiple samples [0070].
With respect to claim 4, the prior art to Krysiak-Baltyn et al. disclose specifications of a bacterial culture at least at Table 1 [page 943].
With respect to claim 5, Houlberg discloses instruction to return to an “addition of Sample” at [0097].
With respect to claim 6, the models disclosed by Krysiak-Baltyn et al. include statistical models [see, e.g., page 963].
With respect to claim 8, Houlberg disclose a value indicative of bacteriophage from a sample at [0131].
With respect to claim 11, Houlberg discloses that a measurement kit includes pH indicators for one well in a microtiter plate, providing disclosure of a “code” for each sample.
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Krysiak-Baltyn et al. (Crit. Rev. Microbiol. (2016) Vol. 42(6):942-968) in view of US20090215027 to Houlberg (IDS reference), as applied to claim 1 above and in further view of Li et al. (Front. Inform. Technol. Electron. Eng. (2017) Vol. 18(1):86-96).
The prior art to Krysiak-Baltyn et al. in view of Houlberg disclose the limitations above as pertain to claim 1.
With respect to claim 7, neither Krysiak-Baltyn et al. nor Houlberg specifically disclose an artificial intelligence mode. However, the prior art to Li et al. discloses the use of artificial intelligence in manufacturing processes for intelligent manufacturing system architecture (abstract).
It would have been prima facie obvious to have combined the references to Krysiak-Baltyn et al. and Houlberg, as indicated above and to further include the implementation of an artificial intelligence model as disclosed by Li et al. for a more robust and data-driven analysis of bacteriophage in said systems for the direct implementation in computer-controlled systems. The prior art to Krysiak-Baltyn et al. specifically employs computation modeling whereby the leap to include artificial intelligence for said models is obvious, as artificial intelligence provides for customized and flexible systems for production facilitation using model-driven paradigms (Li et al. at page 87; 95). As such, one of skill in the art would have had a reasonable expectation of success in building such a platform.
3. Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Krysiak-Baltyn et al. (Crit. Rev. Microbiol. (2016) Vol. 42(6):942-968) in view of US20090215027 to Houlberg (IDS reference) as applied to claims 1 and 8 above and in further view of Richter et al. (Drug Discovery Today (2018) Vol. 23(2)448-455).
The prior art to Krysiak-Baltyn et al. in view of Houlberg disclose the limitations above as pertain to claims 1 and 8.
With respect to claims 9 and 10, neither Krysiak-Baltyn et al. nor Houlberg specifically disclose assessing bacteriophage using either DNA/RNA quantification methods or plaque assay. However, the prior art to Richter et al. disclose numerous methods by which to detect bacteriophage numbers, such as PCR and plaque assay (page 450, Table 1).
It would have been prima facie obvious to have combined the references to Krysiak-Baltyn et al. and Houlberg, as indicated above and to further include the count methods as disclosed in Richter et al., as is disclose din Richter et al. here are numerous laboratory methods in which to assess bacteriophage count. Said routine laboratory analysis would have been obvious in the systems and methods as disclosed by Krysiak-Baltyn et al. and Houlberg, as said references are also expressly directed to such determinations. One of skill in the art would have had a reasonable expectation of success in so doing as including of multiple methods as in Richter et al. provide for more robust count methodology and all references are in the same field of endeavor.
Conclusion
No claims are allowed.
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