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 .
Response to Amendment
In light of the amendments, some of the previous 112(f) claim interpretation remains.
In light of the amendments, claims 11-12 are rejected under 35 U.S.C. 112(a).
In light of the amendments, claim 12 is rejected under 35 U.S.C. 112(b).
In light of the amendments, claims 11-12 are rejected under 35 U.S.C. 101.
Notice to Applicant
In the amendment dated 09/17/2025, the following has occurred: claims 1 and 11-12 have been amended; claim 2 was canceled; claims 3-10 remain unchanged; and claims 13-15 have been added.
Claims 1 and 3-15 are pending.
Effective Filing Date: 04/19/2023
Response to Arguments
Claim Interpretation:
Claim 12 was amended to remove the “input module”, but the “output module” remains. The claim language is confusing as there appears to be a black box between the display device and processor. Therefore, there this claim lacks a sufficient structure modification for performing the claimed functions. The claim states that there is a kit comprising 1) one or more hardware processors and then there is 2) an output module coupled to a display device via the processor. The structure is unclear as it seems there is a “black box” between the processor and the display device. Therefore, the claim lacks sufficient structure.
35 U.S.C. 101 Rejections:
Applicant argues that the amended claims overcome the 101. Examiner however disagrees that claims 11-12 overcome the 101 as these claims recite systems “providing” concoctions where the specification does not support an automated providing of concoctions. Examiner is interpreting that this claim is referring to a non-automated “providing”. The 101 was dropped for claims 1, 3-10, and 13-15 however.
Foreign Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Examiner Notes
Examiner believes that claim 12 is meant to be an independent claim, however it is written as a dependent claim. Examiner assumes this as the “providing” step of this claim is almost redundant to the limitation in claim 1, however in the case of claim 12 the kit is providing the concoction.
Examiner also suggests changing “one or more hardware processors” in the “collate” step of claim 11 to “the one or more hardware processors”
Claim Interpretation
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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: “an output module” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification outlines that the output module is a display device in paragraph [0167] while the input module is a carrier for samples in paragraph [0161].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 11-12 recite a “providing” step which is not supported in the specification. For example, the system and kit do not provide the concoction to the subject in an active manner. This assumes automation, which is not in the specification.
Claim Rejections - 35 USC § 112(b)
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.
Claim 12 is 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 12 recites “in any of claim 1 and claim 3 to claim 15”. The meaning of which is unclear. This can interpreted in two ways: 1) claim 11 tags on to claims 1 or claims 3-15 or 2) claim 11 tags on to claims 1 and claims 3-15. If scenario 2) plays out there would be a multiple dependency issue with the claims. Due to this lack of clarity this claim has been deemed indefinite. Examiner is interpreting the claim to mean 1) from above.
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 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 11-12 are drawn to a system/device which is within the four statutory categories. Claims 11-12 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 11 recites a system, comprising:
a) a memory storing instructions;
b) database; and
c) one or more hardware processors coupled to the memory wherein the one or more hardware processors are configured by the instructions to:
1) collect a saliva sample and a stool sample of the subject whose risk of PCOS disorder is to be assessed;
2) extract microbial deoxyribonucleic acid (DNA) sequences from each of the saliva sample and the stool sample, individually;
3) determine a quantitative abundance of: (i) each of a plurality of predetermined microbes associated with the saliva sample and (ii) each of a plurality of predetermined microbes associated with the stool sample, individually, from respective extracted DNA sequences, using a first set of probes and a second set of probes specific to each of the plurality of predetermined microbes associated with the saliva sample and the stool sample respectively, through a multiplex quantitative Polymerase Chain Reaction (qPCR) technique;
4) collate, via one or more hardware processors, the quantitative abundance of: (i) each of the plurality of predetermined microbes associated with the saliva sample and (ii) each of the plurality of predetermined microbes associated with the stool sample, to obtain a hybrid abundance matrix;
5) determine, via the one or more hardware processors, a model score based on the hybrid abundance matrix, using d) a pre-determined machine learning (ML) model;
6) perform, via the one or more hardware processors, risk assessment of the subject, based on the model score and a predefined threshold value; and
7) provide a designed personalized microbial concoction to the subject to enable amelioration of PCOS based on the risk assessment of the subject, wherein the designed personalized microbial concoction for the subject consisting of a specific composition of microbes employable for the subject assessed as having poly-cystic ovarian syndrome (PCOS) disorder for ameliorating the PCOS disorder.
Claim 11 recites, in part, performing the steps of 1) collect a saliva sample and a stool sample of the subject whose risk of PCOS disorder is to be assessed, 2) extract microbial deoxyribonucleic acid (DNA) sequences from each of the saliva sample and the stool sample, individually, 3) determine a quantitative abundance of: (i) each of a plurality of predetermined microbes associated with the saliva sample and (ii) each of a plurality of predetermined microbes associated with the stool sample, individually, from respective extracted DNA sequences, using a first set of probes and a second set of probes specific to each of the plurality of predetermined microbes associated with the saliva sample and the stool sample respectively, through a multiplex quantitative Polymerase Chain Reaction (qPCR) technique, 4) collate the quantitative abundance of: (i) each of the plurality of predetermined microbes associated with the saliva sample and (ii) each of the plurality of predetermined microbes associated with the stool sample, to obtain a hybrid abundance matrix, 5) determine a model score based on the hybrid abundance matrix, using a pre-determined model, 6) perform risk assessment of the subject, based on the model score and a predefined threshold value, and 7) provide a designed personalized microbial concoction to the subject to enable amelioration of PCOS based on the risk assessment of the subject, wherein the designed personalized microbial concoction for the subject consisting of a specific composition of microbes employable for the subject assessed as having poly-cystic ovarian syndrome (PCOS) disorder for ameliorating the PCOS disorder (in the capacity that the concoction is being provided). These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes a processing of providing a recommendation based on an individual’s data.
Claim 11 recites, in part, performing the steps of 4) collating the quantitative abundance of: (i) each of the plurality of predetermined microbes associated with the saliva sample and (ii) each of the plurality of predetermined microbes associated with the stool sample, to obtain a hybrid abundance matrix and 5) determining a model score based on the hybrid abundance matrix, using a model. These steps correspond to Mathematical Concepts.
The above abstract steps will be considered as a single abstract concept going forward.
Depending claim 12 includes all of the limitations of claim 11, and therefore likewise incorporate the above described abstract idea. Depending claim 12 further specifies elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claim 12 is nonetheless directed towards fundamentally the same abstract idea as independent claim 11 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a memory storing instructions, b) one or more hardware processors coupled to the memory wherein the one or more hardware processors are configured by the instructions, c) database (if hardware), and d) a pre-determined machine learning (ML) model to perform the claimed steps.
The a) memory storing instructions, b) one or more hardware processors coupled to the memory wherein the one or more hardware processors are configured by the instructions, and c) database in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraphs [0033] and [0034] where these components are generic, see MPEP 2106.05(f)).
Additionally, the d) pre-determined machine learning (ML) model in these steps generally links the abstract idea to a particular technological environment or field of use (such as machine learning, see MPEP 2106.05(h)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a memory storing instructions, b) one or more hardware processors coupled to the memory wherein the one or more hardware processors are configured by the instructions, c) database (if hardware), and d) a pre-determined machine learning (ML) model to perform the claimed steps amounts to no more than a general linking to a particular technological field and mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity or certain mathematical steps. Specifically, MPEP 2106.05(f) and MPEP 2106.05(h) recite that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)); and
Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
The current invention provides recommendations utilizing a) a memory storing instructions, b) one or more hardware processors coupled to the memory wherein the one or more hardware processors are configured by the instructions, and c) database, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Additionally, the d) pre-determined machine learning (ML) model generally links the abstract idea to a particular technological environment or field of use. The following represent an example that courts have identified as generally linking the abstract idea to a particular technological environment (e.g. see MPEP 2106.05(h)): Limiting the abstract idea data to a predetermined machine learning model, because limiting application of the abstract idea to machine learning is simply an attempt to limit the use of the abstract idea to a particular technological environment, e.g. see Electric Power Group, LLC v. Alstom S.A.
Mere instructions to apply an exception using generic computer components or a general linking to a particular technological field cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 11-12 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684