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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 2/6/26 is acknowledged.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention II, there being no allowable generic or linking claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a mass spectrometry process for acquiring…” in claim 1;
“a determination process for determining…” in claim 1;
“a dataset creation process for creating a dataset…” in claim 1;
“a database construction process for performing…” in claim 1; and
“a re-determination process for reading…” in claim 1.
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.
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 § 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 1-3 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract without significantly more. The claims recite four separate abstract ideas directed to mental processes and a mathematical concepts:
1) the determination process, which is the abstract idea of mathematically matching data to a library. Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea);
2) the dataset creation process, which is the abstract idea of labeling one type of data with another type of data. The courts have held that the steps of collecting and comparing information are abstract ideas, where, as here, they can be practically performed in the human mind. Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011);
3) the database construction process, which is the abstract idea of accumulating data in an ordered set. Such a step is again analogous to the abstract idea organizing information from Digitech; and
4) the re-determination step, which is the abstract idea of checking a collection of data for relevant information, which is again the abstract idea of comparing information noted in Classen.
Going forward, these abstract ideas are considered together as a general abstract idea of organizing and using data.
This judicial exception of organizing and using data is not integrated into a practical application at least because the claimed process does not yield a result or claim an application. Without any result or application associated with the claim, one cannot reasonably find any application of the claimed invention, let alone a practical application.
The only limitation of the instant claims that is not an abstract idea per se is the recitation of “a mass spectrometry process for acquiring mass spectrometry data by performing a scan measurement over a predetermined m/z range on a determination-target sample by a mass spectrometer.” This limitation, alone or taken together the other elements of the claim, does not include additional elements that are sufficient to amount to significantly more than the judicial exception. This is because the recitation of “performing a scan measurement over a predetermined m/z range on a determination-target sample by a mass spectrometer” is a claim to mass spectrometry analysis at a high level of generality. Further, the specification makes it clear that the mass spectrometry process at issue is conventional by listing a number of prior art techniques by which the analysis may take place. Accordingly, such analysis is a well understood, routine, and conventional activity in the analytical arts, and as such, is insignificant extra-solution activity akin to the analytical determinations of biomarkers in Mayo Collaborative Servs. V. Prometheus Labs., Inc, 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 and Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017).
Furthermore, the dependent claims, taken alone or as an ordered combination, fail to add a practical application or any limitation that could conceivably be significantly more than just the abstract idea.
Accordingly, the claims are directed to an abstract idea without significantly more or a practical application, and are rejected under 35 USC 101 for being directed to nonstatutory subject matter.
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 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. Claim 1 recites, “determining, for each of re-determination target compounds, whether or not the re-determination target compound was contained in the sample to be subjected to the re-determination, based on the mass spectrometry data included in the dataset, where the re-determination target compounds are one or more compounds including a compound which is none of the already-determined compounds identified from the dataset.” It is unclear whether the above limitation requires that at least one re-determination compound be different than the already-determined compounds, or that the determination step only occurs if at least one re-determination compound is different than the already-determined compounds. Looking to the original disclosure, it appears that either interpretations is possible. However, from the perspective of a practitioner looking to avoid infringement, the scope of these two interpretations is quite different. If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993). In the instant case, a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, because it is unclear which of the above noted interpretations is correct. As such, the claims are rejected as indefinite.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WYATT A STOFFA whose telephone number is (571)270-1782. The examiner can normally be reached M-F 0700-1600 EST.
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881
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