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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed August 12th, 2025. Claims 1, 2, and 7-10 are pending. Claims 3-6 are canceled.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The specification lacks antecedent basis for the amended claim recitations of claims 2 and 10.
The specification lacks antecedent basis for the amended claim recitation of claim 9 to “a standard solution containing known…”.
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 2 and 10 are directed towards transitory propagating signals, per se. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re ZIetz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101, Aug. 24, 2009; p. 2.
A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation " non-transitory " to the claim. Cf Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134F.3d 1473 (Fed. Cir. 1998).
Here, the claims provide “software for performing…” which, present recitations that cover non-transitory embodiments.
It appears that Applicant intends to non-transitory computer readable medium encoded with instructions to be executed by a processor to carry out said steps.
Examiner further asserts that the claims are drawn to a kit, in which physical components are provided that are to be combined at a time-of-use by a user.
Claim Rejections - 35 USC § 112
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 9 and 10 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.
The amendment to claim 9 to “a standard solution containing known concentrations of the selected synovial fluid metabolites for calibration of the quantification device” is drawn to new matter in the claims.
The specification is absent discussion thereto. Notably, paragraphs [0054,0055] of Applicant’s pre-grant publication US 2022/0244273 speak to “conditions for an instrument for GC/TOF MS,” but are absent discussion of calibrating the instrument, let alone discussion to calibrating with a “standard solution containing known concentrations of the selected synovial fluid metabolites…” recited herein.
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 2 and 10 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.
Claims 2 and 10 recite the limitation "the quantified synovial fluid metabolite data." There is insufficient antecedent basis for this limitation in the claim.
Examiner further notes that the claims do not require any active steps/processes of carrying out GC-TOF-MS, let alone GC-TOF-MS with synovial fluid and with respect to particular metabolites thereof and “metabolite data,” (wherein such terminology in and of itself is indefinitely defined in its metes and bounds as to the data correlated therewith and is not clarified by the disclosure), as in the recited Markush group given in respective independent claims 1/9.
The claims are drawn to a kit, which is a collection of parts wherein a user may assemble such for its usage, wherein the present recitation to the OPLS-DA software and reliance on quantified data are indefinitely provided for herein.
Claims 9 and 10 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.
The sought “standard solution” as in claim 9 is indefinitely understood in its metes and bounds. The recitation “…containing known concentrations of the selected synovial fluid metabolites…” is indefinitely understood in what metabolites are provided in the standard solution.
The claim recites a GC-TOF-MOS with functionality to measuring one or more of the recited metabolites, and the recitation to the standard solution provides “the selected synovial fluid metabolites…” in which the claim does not necessitate a selection, let alone a selection of a plurality of metabolites.
The present recitation to the standard solution “containing known concentrations of the selected metabolites…” is unclear in providing how many metabolites of initial listing of “one or more…” are to be within the final standard solution.
Does Applicant intend that the standard solution contains known concentrations of all of the metabolites listed (coinciding with the selected group as in the preceding recitation)?
Or, and as the claim is drawn to a kit, does Applicant intend to provide a standard solution for each of the recited metabolites in the Markush group listing such that a user would have access to each of the respective standard solutions and employ the necessary one(s) as deemed fit for their application at-hand?
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 7, and 8 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Ludemann et al. (US 2007/0141712), hereafter Ludemann.
Ludemann discloses analyzing metabolites (abstract). With regard to claim 1, Ludemann disclose a kit comprising a quantification device comprising a GC/TOF-MS for measuring a concentration of one or more synovial fluid metabolites selected as recited therein (pars.[0112]; and wherein the particular analysis of the recited metabolites is not necessitated by the claim but instead is drawn to the functionality of the GC/TOF-MS, wherein Ludemann provides a commensurate GC/TOF-MS that is fully capable of measuring a concentration of one ore more synovial fluid metabolites in as much as recited and required herein), and a reagent comprising methanol and at least one of methylhydroxyamine hydrochloride (methoxyamine hydrochloride herein) and N-methyl-N-(trimethysilyl)-trifluoroacetamide (MSTFA) for extracting and preparing a synovial fluid sample as recited herein (par.[0109], for example; and further noting that a synovial fluid sample is drawn to an intended workpiece that is not positively claimed and not afforded patentable weight, and Ludemann discloses a commensurate reagent as recited that is fully capable of extracting and preparing a prospective synovial fluid sample in as much as claimed and recited herein).
Further, the recitation to “wherein a patient is classified into a high disease activity group [and likewise with the moderate recitation that follows] when the concentration…” is drawn to a narrative discussion of an intended usage that is not afforded patentable weight. The claimed kit does not require any such active process steps of carrying out steps to ascertain a concentration (nor a relative increase/comparison therewith) of a particular metabolite.
This is likewise seen with respect to claims 7 and 8 as the recitations are drawn to prospective intended use recitations not afforded patentable weight.
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.
Claim(s) 2, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Ludemann in view of Jia et al. (US 2012/0040383), hereafter Jia.
Ludemann has been discussed above.
Ludemann does not specifically disclose software for performing OPLS-DA as recited in claim 2.
Jia discloses methods and kits related to metabolite biomarkers for colorectal cancer (abstract). Jia discloses utilizing GC-TOF-MS and including software for performing OPLS-DA to aid in the metabolomics in identifying and differentiating metabolites among sample groups in order to better assess and inform the metabolic biomarkers to the correlated disease/condition (pars.[0006,0050,0054,01540162,0163], for example).
It would have been obvious to one of ordinary skill in the art to modify Ludemann to provide software for performing OPLS-DA as recited in claim 2 such as suggested by the analogous art of Jia in order to provide an on-board tool for metabolomics in identifying and differentiating metabolites among sample groups in order to better assess and inform the metabolic biomarkers to the correlated disease/condition.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, and 7-10 have been considered but are moot because the new ground of rejection, as provided in view of the amendments to the claims, does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The claims are rejected as discussed above in the body of the action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schulzknappe et al. (US 2010/0167267) discloses mass spectroscopy quantitation that is relevant to Applicant’s field of endeavor.
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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, Jill Warden can be reached at 571 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798