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 .
DETAILED ACTION
Response to Arguments
Applicant's arguments filed 6/18/26 have been fully considered but they are not persuasive.
Applicant asserts, without any supporting remarks or evidence, that Izumi fails to disclose each and every feature of claim 1. The applicant doesn’t even identify which feature that Izumi supposedly fails to disclose. If the emphasized portion of the claims was even intended to indicate which feature was omitted by Izumi (vs emphasizing which feature was changed in the amendment), the applicant provided no actual indication of this or any support it might be true.
Election/Restrictions
Newly submitted claims 4-29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The claims are directed to subcombinations usable together but are not in scope with the data utilization rate of the originally claimed invention. Additional factors include, but are not limited to: 1. Separate classification. 2. Diverging subject matter requires diverging search strategies with results for one unlikely to be useful for another. Specifically, searching for specific feature(s) of one group isn't specifically likely to produce specific feature(s) of another group beyond mere coincidence, and thus requiring the examiner to construct and execute a search strategy that specifically investigates each feature separately and independently. 3. Diverging subject matter requires diverging art analysis strategies with results for one unlikely to be useful for another. Specifically, due to the diverging subject matter it is unlikely that a reference useful for analyzing the patentability of one group is would be significantly useful for analyzing another. Further certain combinations of reference that may be useful for analyzing one group may not be obvious to combine with references relevant to each of the other groups, thus requiring separate and independent consideration for each group. 4. Extreme breadth of claim subject matter makes the presentation of what subject matter the applicant regards as their invention or inventions unclear. Without knowledge of what the applicants consider their invention the examiner would be unable to provide a clear and comprehensive examination as examining multiple inventions and unrelated subject matter is prohibitively burdensome.
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 4-29 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.
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.
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 1-3 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. ‘[C]omprising or trained on more than 100 million unlabeled mass spectra’ is indefinite because it cannot be determined what acts qualify as ‘comprising’ or ‘training’ in light of the obtaining/processing steps in the claim. The ‘unlabeled mass spectra’ is unspecified and is reasonably confusable with an improper antecedent basis reference to the earlier raw mass spectra reference. Similarly, it could be an accumulation or reduction of the previously obtained mass spectra through obtainment or processing.
Claims 1-3 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 applicant’s reference describes that data sets of 100 million unlabled MS spectra exist, but does not describe it as a feature of the invention. The closest it comes is a reference to 100M molecules from a database, which is not the same as 100M mass spectra.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Izumi US 20190267222 A1 in possible view of Irwin et. al. “ZINC20-A Free Ultralarge-Scale Chemical Database for Ligand Discovery.”
Regarding Claim(s) 1-3, Izumi teaches: A method of analyzing a sample, the method comprising: introducing the sample to an inlet of a mass spectrometer; ionizing at least a portion of the sample; obtaining one or more raw mass spectra of the ionized portion of the sample using a mass spectrometer; processing the raw mass spectra of the ionized portion of the sample using a large spectral model comprising or trained on more than 100 million unlabeled mass spectra, to generate at least one predictive classifier associated with the sample; and outputting the at least one predictive classifier associated with the sample. wherein the large spectral model has a data utilization rate of at least 2%. wherein m/z values of the one or more raw mass spectra are not binned during or prior to the processing. (Izumi [0016],[0030],[0035]-[0036],[0043],[0049]-[0052],[0060]-[0061],[0070]-[0076],[0165],[0166] – The relationship in the amount of data used as currently claimed holds no meaningful patentable weight. One could interpret the raw mass spectra to be whatever quantity is desired to arbitrarily meet the other factors for data utilization rates, m/z values in the spectra that are not binned, etc. Similarly, ‘comprising or trained’ is vague to the point of including the data processed by the method, which by the underlying process is any and every arbitrary number.)
Izumi discloses large spectral models of arbitrary size, including that the model would incorporate new data for future analysis. One of ordinary skill in the art would already understand that the size of unlabeled mass spectra the model comprises or is trained on is already any available number, and would obtain any number through continued incorporation of new data as disclosed. Further, the evidence on record fails to suggest any criticality in the particular number ‘100 million’ as claimed. In cases like the present, where patentability is said to be based upon particular chosen dimensions or upon another variable recited within the claims, applicant must show that the chosen dimensions are critical. As such, the claimed dimensions appear to be an obvious matter of engineering design choice and thus, while being a difference, does not serve in any way to patentably distinguish the claimed invention from the applied prior art. In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990); In re Kuhle, 526 F2d. 553, 555, 188 USPQ 7, 9 (CCPA 1975). Even if it was demonstrated as critical, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include any model size, since it has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious. KSR International Co. v Teleflex Inc., 550 U.S.__, __, 82 USPQ2d 1385, 1395-97 (2007)
However, even if one of ordinary skill could arrive at the opinion that Izumi fails to adequately disclose this feature, Irwin et al. teaches a model ‘comprising or trained on more than 100 million’ of unlabeled mass spectrum. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the model of Irwin et al. for the model of Izumi because it has been held that the simple substitution of one known element for another to obtain predictable results is obvious and that the size or range of size of the model is predictable. KSR International Co. v Teleflex Inc., 550 U.S.__, __, 82 USPQ2d 1385, 1395-97 (2007); In re Aller, 105 USPQ 233 (CCPA 1955); In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980); In re Rose, 105 USPQ 237 (CCPA 1955); In re Stevens, 1010 USPQ 284 (CCPA 1954).
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 SEAN LUCK whose telephone number is (571)272-6493. The examiner can normally be reached 8-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Georgia Epps can be reached at (571) 272-2328. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SEAN LUCK
Examiner
Art Unit 2878
/SEAN LUCK/Examiner, Art Unit 2878
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