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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed XXX. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Election/Restrictions
Newly submitted claim 8-11 (Group 2) are directed to an invention that is independent or distinct from the invention originally claimed (Group 1, previous claims 1-4 and current claims 5-7) for the following reasons:
Groups 1 is directed towards a computer-implemented method for identifying Multiple Sclerosis in a subject, classified in A61B 5/4076.
Group 2 is directed towards a computer implemented method for identifying Multiple Sclerosis and recommending treatment for a subject, classified in A61K 35/74.
Inventions 1 and 2 are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different effect, are mutually exclusive, and are not obvious variants. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and/or
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 8-11 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: the initial positive recitation of “MS”. For the initial recitation, the examiner respectfully notes and encourages Applicant to instead recite “Multiple Sclerosis (MS)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 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 6 positively recites the limitation "the pre-trained machine learning model" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 positively recites the limitation "the pre-trained machine learning model" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann (US 2021/0201199 A1).
For claim 5, Neumann discloses a computer-implemented (104) method for identifying MS in a subject (Fig 1) ([0015-0092]), the method comprising inter alia:
a. obtaining a blood sample and a fecal sample from the subject ([0019-0021, 0033-00346]);
b. determining an immune profile based on the blood sample ([0019-0021]), the immune profile comprising at least one percentage of at least one immune cell type ([0019-0021]);
c. determining a blood metabolome profile based on the blood sample ([0021, 0025, 0031, 0041, 0057-0059]), the blood metabolome profile comprising at least one concentration of at least one blood metabolite ([0021, 0025, 0031, 0041]);
d. determining a gut microbiome profile based on the fecal sample ([0031, 0033-00346]), the gut microbiome profile comprising at least one relative abundance of at least one microbiome taxa ([0031, 0033-00346]);
e. receiving the immune profile, the blood metabolome profile and the gut microbiome profile at a non-volatile computer-readable memory of a computing device (116) (Fig 1) ([0061]);
f. transforming, using a machine learning model (140) (Fig 1) operating on the computing device (Fig 1), at least one of the immune profile, the blood metabolome profile, the gut microbiome profile, and any combination thereof into a classification of the subject as a healthy control or an MS patient (Fig 1) ([0068, 0079, 0083]); and
g. displaying (148) (Fig 1) ([0091]), using the computing device, the classification of the subject to a practitioner ([0068, 0079, 0083]).
For claim 6, Neumann discloses the method of claim 5, wherein a pre-trained machine learning model (140) ([0061-0092]) is selected from a random forest (RF) model, an elastic net regularized linear regression (ENL) model, or an elastic net regularized support vector machine (SVM) ([0079]).
For claim 7, Neumann discloses the method of claim 5, wherein a pre-trained machine learning model (140) is trained using a training set (136) ([0077-0080]) comprising a plurality of clinical datasets, each clinical dataset comprising a training immune profile, a training blood metabolome profile, a training gut microbiome profile, and a classification of control or MS obtained from a training subject ([0077-0080]).
Response to Arguments
Applicant’s arguments, see pages 5-9, filed 12/18/25, with respect to the amendments obviating the 112, 101, and 102 rejections have been fully considered and are persuasive. The prior rejections of the claims have been withdrawn.
Applicant’s arguments with respect to claim(s) 5-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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