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 are herein under examination.
Claims 1-13 are rejected.
Claims 1-13 are objected.
Priority
The instant application claims foreign benefit to Application No. IN202121024679 filed 06/03/2021. The claim to foreign benefit is not acknowledged for claims 1-13 because no foreign priority documents have been received. It is noted that an attempt to retrieve the foreign priority documents for 202121024679 failed on 11/03/2022. As such, the effective filing date for claims 1-13 is 06/02/2022.
Information Disclosure Statement
The IDS filed 06/02/2022 follows the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of the list of references cited from this IDS is included with this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “200” has been used to designate both Figure 2 and Figure 3A. It appears that Figure 3A should be labeled 300.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.” Although table 3 in para. [88] contains a column titled “Sequence Listing”, this is does not constituent as a sufficient Sequence Listing for the nucleotide sequenced in the table.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Table 3 in para. [88] contains nucleotide sequences longer than 10 with no SEQ. ID.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it uses implied phrases such as “The disclosure relates to” and “the disclosure also provides”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-13 objected to because of the following informalities:
Claims 1 and 12-13 contain a large spacing after the preamble which should be deleted.
Claim 1, pg. 64, line 12, and claim 12, pg. 70, line 11, and claim 13, pg. 74, line 15, recite the phrase “comprising of a” which should be “comprising a” to correct its grammar.
Claim 1, pg. 65, line 6, and claim 12, pg. 71, line 6, and claim 13, pg. 75, line 8, recite the phrase “comprising of the” which should be “comprising the” to correct its grammar.
Claim 1, pg. 65, line 12, and claim 12, pg. 71, line 12, and claim 13, pg. 75, line 14, recite the phrase “comprises of values” which should be “comprises values” to correct its grammar.
Claim 1, pg. 66, line 4, and claim 12, pg. 72, line 4, and claim 13, pg. 76, line 6, recite the phrase “the subset” which should be changed to “the predefined subset of rows” to clarify that it refers to the phrase “a predefined subset of rows” in claim 1, pg. 66, line 2, and in claim 12, pg. 72, line 2, and in claim 13, pg. 76, line 4.
Claim 1, pg. 66, line 8, and claim 12, pg. 72, lines 8-9, and claim 13, pg. 76, line 10, recite the phrase “the subset” which should be changed to “the predefined subset of rows” to clarify that it refers to the phrase “a predefined subset of rows” in claim 1, pg. 66, line 2, and in claim 12, pg. 72, line 2, and in claim 13, pg. 76, line 4.
Claim 1, pg. 66, line 8, and claim 12, pg. 72, line 8, and claim 13, pg. 76, line 10, recite the phrase “k-folds” which should be “k-fold”.
Claim 1, pg. 66, line 14, and claim 12, pg. 72, line 14, and claim 13, pg. 76, line 16, recite the phrase “progressively lesser” which should be changed to something similar to “progressively shorter” to correct its grammar.
Claim 1, pg. 67, line 3, and claim 12, pg. 73, line 6, and claim 13, pg. 77, line 6, recite the phrase “window the” which should be changed to something similar to “window, wherein the” to fix grammar of clause.
Claim 1, pg. 67, line 6, and claim 12, pg. 73, line 9, and claim 13, pg. 77, line 9, contain an unnecessary comma after “selecting” which should be deleted.
Claim 1, pg. 67, line 17, and claim 12, pg. 73, line 21, and claim 13, pg. 77, line 20, recite the phrase “comprising of data” which should be “comprising data”.
Claims 2-3 recite “claim 1 comprising” which should be “claim 1, further comprising”.
Claim 2 recites “of pregnant subject” which should be “of the pregnant subject”.
Claim 4, line 12, should recite “metrics” instead of “metrices”.
Claim 11, line 19, recites the phrase “data also” which should be “data is also”.
Claim 12, pg. 70, line 15, contains a comma after the word memories which should be removed.
Appropriate correction is required.
Claim Interpretation
35 USC 112(f)
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. Below are the limitations in claim 12 that recite means-plus-functions limitations:
Claim 12, pg. 70, lines 4-6 recites “a microbiome sample receiver for collecting a set of biological samples on a predefined set of days from the pregnant subject whose EDD is to be estimated”.
Claim 12, pg. 70, lines 7-10, recites “a microbiome characterization platform for performing microbiome profiling for each of the collected biological samples to obtain a microbiome profile data comprising of a plurality of metagenomic features”.
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 paragraphs below describe the corresponding structure of these means-plus-function limitations:
Neither the specification nor figures disclose a clearly linked corresponding structure for “a microbiome sample receiver”. Specification paras. [15] [41-42] [46] reiterate the sample receiver’s functions but do not disclose a structure. For examination purposes, any structure capable of collecting a biological sample will read on the microbiome sample receiver.
The structure for “a microbiome characterization platform” is being interpreted as any of the following recited in para. [42]: “sequencing platform, a microscopy platform, a nucleic acid hybridization platform, internet-enabled qPCR (Quantitative Polymerize Chain Reaction) machine or a cell sorting platform to obtain/generate the microbiome characterization.”
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
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 12-13 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.
Claim 12 fails to comply with the written description requirement because it does not adequately link or associate adequately described particular structure, material, or acts to perform the function recited in the claims identified to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Specifically, claim 12, pg. 70, lines 4-6, recites “a microbiome sample receiver”, which has been interpreted to invoke 35 U.S.C. 112(f). However, the specification does not provide a structure for the microbiome sample receiver. Therefore, in accordance with MPEP § 2181.IV, the instant specification does not provide written description support for the microbiome sample receiver because there is no corresponding structure disclosed in the specification.
Claim 13 fails to comply with the written description requirement. Claim 13 recites “instructions which when executed by one or more hardware processors cause: collecting a set of biological samples on a predefined set of days from the pregnant subject whose EDD is to be estimated”. This recitation claims a hardware processor configured to collect a physical sample. However, neither the drawings nor the specification describes a device with a hardware processor capable of collecting a physical sample from subjects on predefined days.
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.
Claims 1-13 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 1, pg. 64, lines 20-21, and in claim 12, pg. 70, line 21, and in claim 13, pg. 74, line 23 – pg. 75, line 1, recite the phrase “wherein the predefined set of days are pre-ascertained” which render the claims indefinite. It is unclear how limiting the already predefined set of days to be pre-ascertained affects the scope of the claims. It appears that both predefined and pre-ascertained indicate that the set of days are predetermined. To overcome this rejection, clarify how pre-ascertained further limits predefined.
Claim 1, pg. 64, line 21 – pg. 67, line 22, and in claim 12, pg. 70, line 22 – pg. 74, line 5, and in claim 13, pg. 75, line 1 – pg. 78, recite the following phrase that renders the claims indefinite: “the ensemble is built using the steps of: collecting … performing … training … reconstructing … constructing … training … computing … repeating … computing … identifying … selecting … retrieving … sorting … repeating … identifying … generating … selecting … and forming an ensemble using the selected subset of models.” It is unclear if this phrase requires an active step of building the ensemble as indicated by “is built”, or if it is a product by process that defines steps previously performed to derive “a prebuilt ensemble” as recited in claim 1, pg. 64, lines 16-17, and in claim 12, pg. 70, line 18, and in claim 13, pg. 74, line 20, respectively. To overcome this rejection, clarify how this phrase should be interpreted. For examination purposes, this phrase will be interpreted as a product by process limitation, and thus not required to be performed by the claims. See MPEP 2113.I regarding product by process limitations.
Claim 1, pg. 65, lines 4-5, and claim 12, pg. 71, lines 4-5, and claim 13, pg. 75, lines 6-7, recite the phrase “the collected biological samples” which render the claims indefinite. It is unclear if the phrase refers to the collected biological samples in claim 1, pg. 64, lines, 7-8, and in claim 12, pg. 70, lines 4-5, and in claim 13, pg. 74, line 11, or if the phrase refers to the collected biological samples in claim 1, pg. 65, lines 1-2, and in claim 12, pg. 71, lines 1-2, and in claim 13, pg. 75, line 3, respectively. To overcome this rejection, clarify which samples are being referenced. For examination purposes, this phrase refers to the samples collected from the plurality of pregnant subjects.
Claim 1, pg. 65, lines 7-8, and claim 12, pg. 71, line 8, and claim 13, pg. 75, line 10-11, recite the phrase “the obtained microbiome profile data” which render the claims indefinite. It is unclear which microbiome profile data is being referenced because there is “a microbiome data profile” recited in claim 1, pg. 64, line 12, and in claim 12, pg. 70, line 9, and in claims 13, pg. 74, line 15, as well as recited in claim 1, pg. 65, line 5, and in claim 12, pg. 71, line 5, and in claim 13, pg. 75, line 7, respectively. To overcome this rejection, clarify which one is being referenced. For examination purposes, this phrase is being interpreted as the microbiome profile data obtained from the collected biological samples from the plurality of pregnant subjects.
Claim 1, pg. 65, line 7, and claim 12, pg. 71, line 7, and claim 13, pg. 75, line 9, recite the phrase “training one or a combination of regressors”. Claim 1, pg. 65, line 9, and claim 12, pg. 71, line 9, and claim 13, pg. 75, line 11, also recite the phrase “using the trained regressors”. These phrases render the claim indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 12-13 recite both the broad recitation of “training one or a combination of regressors” and the narrower limitation of “using the trained regressors”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Specifically, it is unclear if there may be one regressor or if there must be at least two to have the “trained regressors”.
Claim 1, pg. 65, lines 11-12, and claim 12, pg. 71, lines 11-12, and claim 13, pg. 75, line 13, recite the phrase “the simulated microbiome profile” which render the claims indefinite. It is unclear which simulated microbiome profile is being referenced because there is a simulated microbiome profile for each patient, as recited in claim 1, pg. 65, lines 9-11, and in claim 12, pg. 71, lines 9-11, and in claim 13, pg. 75, lines 11-13, respectively. To overcome this rejection, clarify which simulated profile is being referenced.
Claim 1, pg. 65, line 14, and claim 12, pg. 71, line 14, and claim 13, pg. 75, line 16, recite the phrase “the pregnancy duration” which lacks antecedent basis. To overcome this rejection, amend the phrase to “the pregnancy period” to properly refer to the phrase “during a period of pregnancy” in claim 1, pg. 65, lines 2-3, and in claim 12, pg. 71, lines 2-3, and in claim 13, pg. 75, line 4-5, respectively.
Claim 1, pg. 65, line 15, and claim 12, pg. 71, line 15, and claim 13, pg. 75, line 17, recite the phrase “the pregnant subject” which render the claims indefinite. It is unclear if the phrase refers to “the pregnant subject” in claim 1, pg. 64, line 5, and in claim 12, pg. 70, line 5, and in claim 13, pg. 74, line 12, or if the phrase refers to a specific pregnant subject “among the plurality of pregnant subjects” recited in claim 1, pg. 65, line 10 and in claim 12, pg. 70, line 10, and in claim 13, pg. 75, line 12. To overcome this rejection, clarify which subject is being referenced.
Claim 1, pg. 65, line 16, and claim 12, pg. 71, lines 15-16, and claim 13, pg. 75, line 18, recite the phrase “the simulated microbiome profile” which render the claims indefinite. It is unclear which simulated microbiome profile is being referenced because there is a simulated microbiome profile for each pregnant subject, as recited in claim 1, pg. 65, lines 9-11, and in claim 12, pg. 71, lines 9-11, and in claim 13, pg. 75, lines 11-13. To overcome this rejection, clarify which simulated profile is being referenced.
Claim 1, pg. 65, line 18, and claim 12, pg. 71, line 18, and claim 13, pg. 75, line 20, recite the phrase “the multi-variate matrix” which render the claims indefinite. It is unclear which multi-variate matrix is being referenced because there is a multi-variate matrix for each metagenomic feature, as recited in claim 1, pg. 65, lines 16-17, and in claim 12, pg. 71, lines 16-17, and in claim 13, pg. 75, lines 18-19. To overcome this rejection, clarify which matrix is being referenced.
Claim 1, pg. 65, lines 16-20, and claim 12, pg. 71, lines 16-20, and claim 13, pg. 75, lines 18-22, recite the phrase “constructing … a multi-variate matrix for each of the metagenomic features, wherein the multi-variate matrix refers to the microbiome profile of the metagenomic feature observed in each of the pregnant subjects across entire duration of pregnancy” which render the claims indefinite. It is unclear (i) if there is a multi-variate matrix for each metagenomic feature, as indicated by “a multi-variate matrix for each of the metagenomic features”, or (ii) if there is a multi-variate matrix only for each metagenomic feature that is observed in each pregnant subject across an entire duration of pregnancy, as indicated by “wherein the multi-variate matrix refers to … the metagenomic feature observed in each of the pregnant subjects across entire duration of pregnancy”. To overcome this rejection, it is suggested to clarify which interpretation should be used.
Claim 1, pg. 65, line 18, and claim 12, pg. 71, line 18, and claim 13, pg. 75, line 20, recite the phrase “the microbiome profile” which lacks antecedent basis. There is recitation of “microbiome profile data” and “simulated microbiome profile” but not of “a microbiome profile” in claims 1 and 12-13. To overcome this rejection, provide antecedent basis for the phrase or clarify what it should refer to.
Claim 1, pg. 65, lines 18-20, and claim 12, pg. 71, lines 19-20, and claim 13, pg. 75, lines 21-22, recite the phrase “the metagenomic feature observed in each of the pregnant subjects across entire duration of pregnancy” which lacks antecedent basis. To overcome this rejection, provide antecedent basis for the phrase or clarify what the phrase refers to.
Claim 1, pg. 66, lines 3-5, and claim 12, pg. 72, lines 3-5, and claim 13, pg. 76, lines 5-7, recite the phrase “the metagenomic feature … belonging to the subset of the multi-variate matrix” which render the claims indefinite. It is unclear which metagenomic feature in which matrix is being referenced because each matrix corresponds to one metagenomic feature, as recited in claim 1, pg. 66, lines 1-3, and in claim 12, pg. 72, lines 2-3, and in claim 13, pg. 76, lines 4-5. To overcome this rejection, clarify which metagenomic feature of which matrix is being referenced.
Claim 1, pg. 66, line 6, and claim 12, pg. 72, line 6, and claim 13, pg. 76, line 8, recite the phrase “the target variable” which lacks antecedent basis. To overcome this rejection, change the phrase to “a target variable”.
Claim 1, pg. 66, line 9, and claim 12, pg. 72, line 9, and claim 13, pg. 76, line 11, recite the phrase “the multi-variate matrix” which render the claims indefinite. It is unclear which matrix is being referenced because there is a matrix for each metagenomic features, as recited in claim 1, pg. 66, lines 2-3, and in claim 12, pg. 72, lines 2-3, and in claim 13, pg. 76, lines 4-5. To overcome this rejection, clarify which is being referenced.
Claim 1, pg. 66, line 15, and claim 12, pg. 72, lines 15-16, and claim 13, pg. 76, line 17, recite the phrase “the previous or the next pregnancy window” which lacks antecedent basis. To overcome this rejection, it is suggested to amend the phrase to “a previous or a subsequent pregnancy window”.
Claim 1, pg. 66, lines 22-23, and claim 12, pg. 73, line 3, and claim 13, pg. 77, lines 2-3, recite the phrase “the maximum number of times” which lacks antecedent basis. To overcome this rejection, change the phrase to “a maximum number of times”.
Claim 1, pg. 67, line 3, and claim 12, pg. 73, line 3, and claim 13, pg. 77, line 6, recite the phrase “the regressor model” which render the claims indefinite. It is unclear which regressor model is being referenced because there is a repeated step of training the regressor model in claim 1, pg. 67, line 2, and in claim 12, pg. 72, line 10, and in claim 13, pg. 76, line 12. To overcome this rejection, clarify which regressor is being referenced.
Claim 1, pg. 67, lines 17-18, and claim 12, pg. 73, lines 21-22, and claim 13, pg. 77, line 20, recite the phrase “the numeric values” which lacks antecedent basis. There is recitation of values but they have not previously been specified to be numeric.
Claim 1, pg. 67, line 18, and claim 12, pg. 73, lines 22-23, and claim 13, pg. 77, line 21, recite the phrase “the identified specific subset of days” which lacks antecedent basis. There is recitation of “identifying and selecting, from amongst the specific set of days occurring in the selected pregnancy window, a predefined number of days” in claims 1 and 12-13. However, there is no mention of a subset of days. To overcome this rejection, provide antecedent basis or clarify what the phrase should refer to.
Claim 1, pg. 67, line 20, and claim 12, pg. 74, lines 2-3, and claim 13, pg. 77, line 23, recite the phrase “the lowest prediction error” which lacks antecedent basis. To overcome this rejection, change the phrase to “a lowest prediction error”.
Furthermore, claims 2-11 are also rejected because they depend on claim 1, which is rejected, and because they do not resolve the issue of indefiniteness.
Claim 3, line 6, recites the phrase ‘weekly predicted emergency burden (wPEB)’ which renders the claim indefinite. It is unclear if the single quotation marks impart some yet unspecified limitation into the claim. To overcome this rejection, the quotation marks should be deleted.
Claim 3, line 7, recites the phrase “the healthcare unit” which lacks antecedent basis. To overcome this rejection, change the phrase to “a healthcare unit”.
Claim 3, lines 7-8, recites the phrase “the healthcare emergency” which lacks antecedent basis. To overcome this rejection, change the phrase to “a healthcare emergency”.
Claim 3, lines 6-8, recites the phrase “metrics associated with the healthcare unit which are critical to handle the healthcare emergency”, which renders the claim indefinite. It is unclear how to clearly distinguish between a critical metric versus a non-critical metric used to handle a healthcare emergency. To overcome this rejection, specify which metrics are critical or remove the phrasing regarding criticality of the metrics.
Claim 3, lines 8-9, recites the phrase “the registered pregnant subject’s information” which lacks antecedent basis. To overcome this rejection, change the phrase to “a registered pregnant subject’s information”.
Furthermore, claim 4 is rejected because it depends on claim 3, which is rejected, and because it does not resolve the issue of indefiniteness.
Claim 6, lines 19-20, recites the phrase “the microbiome samples” which lacks antecedent basis. To overcome this rejection, change the phrase to “biological samples”.
Claim 8 is indefinite because it is unclear if it is part of an active step of building an ensemble or if it is part of the process previously performed to derive the prebuilt ensemble in claim 1. For examination purposes, claim 8 is being interpreted as part of the product by process limitation in claim 1.
Claim 8, line 6, recites the phrase “the pregnancy duration”, which renders the claim indefinite. It is unclear if the phrase refers to “during a period of pregnancy” in claim 1, pg. 65, lines 2-3; to “specific days of the pregnancy duration” in claim 1, pg. 65, lines 13-14; to “across entire duration of pregnancy” in claim 1, pg. 65, line 20; or to “a pregnancy duration” in claim 1, pg. 66, lines 14-15. To overcome this rejection, specify what the phrases refers to.
Claim 8, lines 6-7, recites the phrase “the boundaries of obtaining microbiome characterization data” which lacks antecedent basis. To overcome this rejection, provide antecedent basis.
Claim 9, lines 9-10, recites the phrase “the plurality of microbial and biological features” which lacks antecedent basis. For examination purposes, this phrase is being interpreted as “the plurality of metagenomic features”.
Claim 10 is indefinite because it is unclear if it is part of an active step of building an ensemble or if it is part of the process previously performed to derive the prebuilt ensemble in claim 1. For examination purposes, claim 10 is being interpreted as part of the product by process limitation in claim 1.
Claim 11, lines 18-19, recites the phrase “the microbiome profile data” which renders the claim indefinite. It is unclear which microbiome profile data is being referenced because claim 1, on both pg. 64, lines 10-14, and pg. 65, lines 4-6, a microbiome profile data. To overcome this rejection, it is suggested to clarify which microbiome profile data is being referenced.
Claim 11, line 21, recites the phrase “the pregnant subject” which renders the claim indefinite. It is unclear which pregnant subject is being referenced because claim 1, pg. 64, line 9, recites “the pregnant subject” and claim 1, pg. 65, lines 1-2, recites “a plurality of pregnant subjects”. To overcome this rejection, clarify which subject is being referenced.
Claim 12, pg. 70, line 13, recites the phrase “the one or more first hardware processors” which lacks antecedent basis. To overcome this rejection, change the phrase to “the one or more hardware processors”.
Claim 12, pg. 70, lines 4-5, recites the phrase “the one or more first memories” which lacks antecedent basis. To overcome this rejection, change the phrase to “the memory” or provide antecedent basis for the phrase.
Claim 13, pg. 74, line 12, recites the phrase “the pregnant subject” which lacks antecedent basis. To overcome this rejection, change the phrase to “a pregnant subject”.
Claim 13, pg. 74, line 13, recites the phrase “via the one or more hardware processors” which renders the claim indefinite. It is unclear if the phrase refers to the one or more hardware processors on pg. 74, line 9, or on pg. 74, line 13. To overcome this rejection, clarify what the phrase refers to.
Claim 13, pg. 74, line 21, recites the phrase “via the one or more hardware processors” which renders the claim indefinite. It is unclear if the phrase refers to the one or more hardware processors on pg. 74, line 9, or on pg. 74, line 13. To overcome this rejection, clarify what the phrase refers to.
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 and a natural phenomenon without significantly more.
Step 2A, Prong 1:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomena (Step 2A, Prong 1). In the instant application, claims 1-11 recite a method, claim 12 recites a system, and claim 13 recites a product. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claims 1 and 12-13 recite “… to obtain a microbiome profile data comprising of a plurality of metagenomic features; predicting … a set of expected delivery dates for the pregnant subject by providing the microbiome profile data as input to a set of models present in a prebuilt ensemble; and calculating … a central tendency value of the predicted set of expected delivery dates to determine the EDD of the pregnant subject, wherein the predefined set of days are pre-ascertained, and the ensemble is built using the steps of: collecting biological samples from a plurality of pregnant subjects at predefined time points during a period of pregnancy; performing microbiome profiling for each of the collected biological samples to obtain a microbiome profile data comprising of the plurality of metagenomic features; training one or a combination of regressors using the obtained microbiome profile data; reconstructing, using the trained regressors, for each pregnant subject among the plurality of pregnant subjects, a simulated microbiome profile, wherein the simulated microbiome profile comprises of values in original microbiome profile data and reconstructed values of all metagenomic features for specific days of the pregnancy duration when biological samples were not collected from the pregnant subject; constructing, using the simulated microbiome profile, a multi-variate matrix for each of the metagenomic features, wherein the multi-variate matrix refers to the microbiome profile of the metagenomic feature observed in each of the pregnant subjects across entire duration of pregnancy, wherein each matrix comprises a unique participant ID corresponding to each pregnant subject in rows and each day of pregnancy, in which the microbiome profile of the metagenomic feature is observed, as columns; training a regressor model with a k-fold cross validation on a predefined subset of rows in the multi-variate matrix for each metagenomic feature, wherein values of the metagenomic feature across the entire pregnancy duration belonging to the subset of the multi-variate matrix forms independent variables and corresponding date of delivery forms the target variable; computing prediction errors of the regressor models generated during k-folds cross validation performed on the subset of the multi-variate matrix; repeating the step of training the regressor model with k-fold cross validation for a particular metagenomic feature, each time using input data corresponding to one of a plurality of pregnancy windows, wherein each pregnancy window corresponds to a pregnancy duration that is progressively lesser by one week as compared to the previous or the next pregnancy window; computing corresponding prediction errors for input data corresponding to each pregnancy window; identifying, for each metagenomic feature, a predefined number of top pregnancy windows which resulted in the smallest prediction errors; selecting, from amongst identified predefined number of top pregnancy windows, a pregnancy window that occurs the maximum number of times across all metagenomic features; retrieving, for each metagenomic feature, the respective regressor model corresponding to the selected pregnancy window the regressor model comprises a plurality of temporal features; sorting the plurality of temporal features of the regressor model based on their importance scores and selecting, a set of top scoring temporal features, wherein the selected set of temporal features refer to a specific set of days within the selected pregnancy window; repeating the steps of retrieving and sorting for each of the metagenomic features in microbiome profile data; identifying and selecting, from amongst the specific set of days occurring in the selected pregnancy window, a predefined number of days that are associated to the metagenomic features; generating, for each metagenomic feature, a feature- specific regressor model with a k-fold cross validation on a custom multi-variate matrix comprising of data pertaining to the numeric values of the features on the identified specific subset of days; selecting a subset of models out of the models trained, wherein the selected models have the lowest prediction error; and forming an ensemble using the selected subset of models.”
Claim 2 recites “planning and managing healthcare emergency services in a healthcare unit using the expected delivery date of pregnant subject.”
Claim 3 recites “computing 'weekly predicted emergency burden (wPEB)' metrics associated with the healthcare unit which are critical to handle the healthcare emergency, based on the registered pregnant subject's information submitted to the healthcare unit.”
Claim 4 recites “wherein the wPEB metrices comprises Bed wPEB, Medicine wPEB, Doctor wPEB and nursing staff wPEB.”
Claim 5 recites “wherein the central tendency value is one of a mean or a median of the predicted set of expected delivery dates.”
Claim 8 recites “wherein Day 1 and Day 280 of the pregnancy duration serve as the boundaries of obtaining microbiome characterization data.”
Claim 7 recites “wherein the plurality of metagenomic features comprises one or both of microbial features and host features.”
Claim 9 recites “wherein the plurality of microbial and biological features comprises a microbial genus- level abundance profile, a microbial family-level abundance profile, a microbial sequence cluster profile, a microbial diversity profile and a normalized genus abundance table.”
Claim 10 recites “wherein the subset size of the rows is more than 50 percent of the original size.”
Claim 11 recites “wherein the microbiome profile data also obtained from a plurality of non- microbiome sources comprising physiological data, biochemical data, and host-specific data corresponding to the pregnant subject.”
Limitations reciting a mental process.
Claims 1-5 and 11-13 are recited at such a high level of generality that they equate to a mental process because they are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), which the courts have identified as concepts that can be practically performed in the human mind. The sentences below discuss the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mental process:
Regarding claims 1, 5 and 12-13, the BRI of calculating a central tendency, which may be mean or median, to determine the EDD includes a human performing calculations using pen and paper.
Regarding claim 2, the BRI of planning includes making determinations.
The BRI of claims 3-4 includes the performing the calculations of the formula in para. [76] on pen and paper.
Regarding claim 11, the BRI of obtaining physiological data of a subject and compiling it into a mycobiome profile data includes collecting data and organizing data, which a human could do with pen and paper.
Limitations reciting a mathematical concept.
Claims 1, 3-5, 7, 9 and 12-13 recite mathematical concepts because they are similar to the concepts of organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)), which the courts have identified as mathematical concepts. The paragraphs below discuss the BRI of the limitations in these claims that recite a mathematical concept:
Regarding claims 1 and 12-13, the BRI of predicting delivery dates by inputting microbiome profile data into a prebuilt ensemble includes performing the calculations of an ensemble of linear regressions, then using the numerical outputs of each linear regression to determine a set of delivery dates. This equates to a mathematical calculation and function. This interpretation is evidenced by specification paras. [33] [70].
Regarding claims 1, 5 and 12-13, calculating a central tendency, such as mean or median, equates to a mathematical equation and calculation.
Regarding claims 3-4, the BRI of computing wPEB metrics includes performing calculations using the formula recited in para. [76].
Regarding claims 1, 7, 9 and 12-13, the BRI of obtaining a microbiome profile that contains metagenomic features includes the metagenomic features being microbial features such as a normalized genus abundance table. The BRI of a normalized genus abundance table includes “dividing the number of sequences assigned to each genus by the median 16S gene copy number found in genomes of all the strains corresponding to said genus”, as recited in specification para. [92]. This equates to a mathematical calculation.
Limitations reciting a natural phenomenon.
Claims 1 and 12-13 equate to a natural phenomenon because they are similar to the concept of a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017), which the courts have established as a natural phenomenon. Claims 1 and 12-13 correlate a pregnant subject’s metagenomic features to an expected delivery date, which is a natural phenomenon.
Limitations reciting organizing human activity.
Claim 2 equates to organizing human activity because it is similar to managing personal behavior or relationships or interactions between people (MPEP 210604(a)(2).II.C). The BRI of managing in claim 2 includes a doctor directing nurses in a labor and delivery unit.
Limitations included in the judicial exception.
As discussed in 35 USC 112(b), the following limitation in claims 1 and 12-13 equates to product by process limitation: “the ensemble is built using the steps of: collecting … performing … training … reconstructing … constructing … training … computing … repeating … computing … identifying … selecting … retrieving … sorting … repeating … identifying … generating … selecting … forming an ensemble using the selected subset of models.” This limitation defines the process previously performed to acquire the “prebuilt ensemble”, wherein the prebuilt ensemble performs the abstract idea of “predicting … a set of expected delivery dates”. As such, this limitation in claims 1 and 12-13 is being interpreted as part of the “prebuilt ensemble”, and thus also part of the recited judicial exception of “predicting … a set of expected delivery dates”.
As discussed in 35 USC 112(b), claims 8 and 10 are also part of the product by process limitation in claim 1 because they further limit the pregnancy duration and subset of rows. As such, claims 8 and 10 are considered part of the judicial exception of the prebuilt ensemble predicting a set of expected delivery dates in claim 1.
As such, claims