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
A request for continued examination under 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR § 1.114, and the fee set forth in 37 CFR § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 08 April 2026 has been entered.
Claims 1-15 were originally filed.
Claims 4, 9, and 14 are canceled.
Claims 16-18 are newly added.
Claims 1, 5-6, 10-11, and 15 are currently amended.
Claims 1-3, 5-8, 10-13, and 15-18 are currently pending and have been examined herein.
RESPONSE TO APPLICANT’S AMENDMENTS/ARGUMENTS
– Double Patenting –
Claims 1-15 were rejected on grounds of nonstatutory double patenting in the previous Office Action.
In Applicant’s Remarks, Applicant chose to defer addressing the rejections. Accordingly, the rejections are maintained, but held in abeyance.
– 35 USC § 112(f) –
Re the Examiner’s interpretation that claims 6-15 invoked 35 USC §112(f), Applicant only generally asserts that such position is not conceded, but fails to address the merits of the interpretation. As such, the Examiner maintains this interpretation.
– 35 USC § 112(a) –
Claims 1-3, 5-8, 10-13, and 15 were rejected under 35 USC § 112(a) in the previous Office Action.
In the Remarks, Applicant respectfully disagrees and purports that “the Specification provides a detailed, multi-step algorithmic framework that, taken as a whole, gives one of ordinary skill in the art clear and sufficient disclosure of how to implement the claimed invention.” While the Examiner does not necessarily disagree with this statement, it appears the Applicant is conflating the sufficiency requirements for enablement and possession, separate inquiries under 35 USC § 112(a). Specifically, the Examiner agrees with Applicant’s contention that the statement supports the enablement of the claimed invention. However, the lack of specificity, particularly at the point of novelty of the claimed invention, is what is not sufficient to meet the possession standard. The Applicant’s assertion that one of ordinary skill in the art would know how to implement the claimed invention precisely demonstrates that the Applicant did not have possession of such algorithm. While the Examiner concedes that Applicant’s disclosure generally speaks of machine learning models, the Examiner asserts that the disclosure is not of sufficient detail to ensure the Applicant had proper possession of the particular algorithm(s) to perform the claimed features. Particularly because machine learning algorithms are largely mathematical, with nearly infinite manipulations possible, it is essential that Applicant’s disclosure provide specific algorithms above general mentions of machine learning techniques (e.g., a Bayesian model or recurrent neural network). Furthermore, the Examiner re-asserts that Applicant’s contention that “one of ordinary skill in the art in the field of liquid chromatography and mass spectrometry instrument diagnostics would understand how to implement machine learning models for classification and prediction tasks” may be construed as an admission that such claimed features were old and well-know. Accordingly, Applicant’s arguments are not persuasive and the Examiner maintains the rejections on the remaining claims. Newly added claims 16-18 fail to cure this deficiency.
– 35 USC § 112(b) –
Claims 6-8, 10-13, and 15 were rejected under 35 USC § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Re claims 6-8, 10-13, and 15, Applicant argues the claim was amended to avoid interpretation under §112(f). The Examiner respectfully disagrees. Accordingly, Applicant’s arguments are not persuasive and the Examiner maintains the rejections on the remaining claims.
– 35 USC § 101 –
Claims 1-15 were rejected under 35 USC § 101 as being directed to an abstract idea without significantly more.
Applicant disagrees and asserts the newly amended feature describing the accessed information as “…sampled at a rate of at least 10 Hz” sufficiently integrates the judicial exception into a practical application. The Examiner respectfully disagrees. While the Examiner concedes the features of the claims are generally tied to a technological environment, they are not sufficiently integrated into a practical application nor do they represent significantly more than the abstract idea itself. More specifically, the claims merely set forth information that is accessed. The claims do not require an active sampling of data at a rate of at least 10 Hz as implied by the Applicant. Furthermore, whether the detection model is backward looking or forward looking, the analysis is the same. Absent sufficient integration into a practical application, as is the case here, the claims are ineligible. Accordingly, the rejections are maintained on the currently pending claims.
– 35 USC § 102 –
Claims 1-3, 5-8, 10-13, and 15 were rejected under 35 USC § 102 as being anticipated by CARNEIRO.
Without acquiescing to the merits of Applicant’s arguments, the Examiner finds them moot in view of the new grounds of rejection, necessitated by the substantial amendments to the claimed invention.
– Additional Remarks –
Applicant is reminded that in order to be entitled to reconsideration or further examination, the applicant or patent owner must reply to the Office action. The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims, be held in abeyance until allowable subject matter is indicated. The Applicant’s or patent owner’s reply must appear throughout to be a bona fide attempt to advance the application or the reexamination proceeding to final action. A general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references does not comply with the requirements of this section1.
Should the Applicant believe that a telephone conference would expedite the prosecution of the instant application, Applicant is invited to call the Examiner.
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 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.
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 paragraph2:
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;
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
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: “instructions that… perform operations comprising… accessing…applying…displayin…” in claim 6 and claim 11.
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:
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
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.
DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-8, 10-13, and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,836,617. Although the claims at issue are not identical, they are not patentably distinct from each other because they clearly represent a substantially similar, but broader scope.
CLAIM REJECTIONS - 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 1-3, 5-8, 10-13, and 15-18 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, for failing to disclose a sufficient algorithm to satisfy the written description requirement.
Re claim 1, Applicant’s recitation does not comply with the written description requirement because it sets forth a computer-implemented feature without an algorithm disclosed for achieving the particular computer-implemented feature. This rejection applies regardless of whether § 112(f) is invoked.3
Particularly, claim 1 recites the following computer-implemented feature:
“applying a machine learning model to the information…configured to detect predict…”
Applicant is respectfully reminded, for computer-implemented claims, “examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.” MPEP § 2161.01(I).
Applicant’s specification does not describe an algorithm that performs application of a machine learning model to detect errors/readiness in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. For example, Applicant’s specification discloses various machine learning models in [0042-0043]. However, such disclosure is not an algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed feature in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.
Applicant is also reminded, “[i]f the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 USC 112(a) or pre-AIA 35 USC 112, first paragraph, for lack of written description must be made.” MPEP § 2161.01(I).
Therefore, because an algorithm for the computer-implemented feature is not disclosed in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter, and in accordance with MPEP § 2161.01, claim 1 is rejected for lack of written description.
Dependent claims 2-3, 5, and 16-18 fail to cure this deficiency of independent claim 1 (set forth directly above) and are rejected accordingly.
Claims 6-8, 10-13, and 15 contain language similar to claims 1-3, 5, and 16-18 as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 6-8, 10-13, and 15 are also rejected under 35 USC § 112(a) as failing to comply with the written description requirement.
CLAIM REJECTIONS - 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.
Claims 1-3, 5-8, 10-13, and 15-18 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.
Re claim 1, Applicant recites, “the machine learning model configured to detect predict…” While this appears to be an inadvertent grammatical error associated with the amendment, nevertheless, the nature of the error gives rise to multiple claim scopes, thus rendering the claim indefinite. For the purposes of examination, the Examiner will assume “detect” was meant to be deleted. Similarly in the last line of the claim, Applicant recites, “is predicted to occur has occurred.” Appropriate correction is required.
Re claims 2-3, 5, and 16-18 they fail to cure the deficiencies of claim 1, from which they depend, and are thus rejected accordingly.
Re claims 6-8, 10-13, and 15, Applicant recites claims with the same deficiencies as outlined above with respect to claims 1-3, 5, and 16-18. Accordingly, claims 6-8, 10-13, and 15 are rejected in the same or substantially the same manner as claims 1-3, 5, and 16-18
Further re claim 6, as mentioned above, the limitation “instructions that…perform operations comprising… accessing… applying… displaying…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Further re dependent claims 7-8 and 10, such claims fail to cure the deficiencies of independent claim 6 (set forth directly above) and are rejected accordingly.
Further re claims 11-13 and 15 contain language similar to claims 6-8 and 10, as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 11-13 and 15 are also rejected under 35 USC § 112(b) as 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 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, 5-8, 10-13, and 15-18 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to an abstract idea without significantly more.
Following the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence (89 FR 58128 and MPEP § 2106, hereinafter 2024 GUIDANCE), the claim(s) appear to fall into one of the enumerated statutory categories and recites at least one judicial exception, as explained in the Step 2A, Prong I analysis below. Furthermore, the judicial exception(s) does/do not appear to be integrated into a practical application as explained in the Step 2A, Prong II analysis below. Further still, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s) as explained in the Step 2B analysis below.
STEP 2A, PRONG I:
Step 2A, prong I, of the 2024 GUIDANCE, first looks to whether the claimed invention recites any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activities such as a fundamental economic practice, or mental processes).
Re claim 1, Applicant recites the following limitations:
applying a machine learning model to the information, the machine learning model configured to detect predict (sic) one or more of a future instrument error condition or a future instrument readiness condition, wherein the future instrument error condition or the future instrument readiness condition comprises one or more of an equilibrated/not equilibrated state, a pressure seal leak, a degasser failure, a clogged inject valve, a partially clogged needle, a fouled column, a column that is chemically and/or thermally equilibrated, or a detector that is stable and/or not drifting
These steps are directed to a mathematical concept, such as determining a mathematical relationship or performing a mathematical calculation and/or mental process. The 2024 GUIDANCE expressly recognizes such mathematical relationships/calculations and/or mental processes as constituting patent-ineligible abstract ideas. Accordingly, these limitations can reasonably be characterized as reciting a patent-ineligible abstract idea.
STEP 2A, PRONG II:
Step 2A, prong II, of the 2024 GUIDANCE, next analyzes whether the claimed invention recites additional elements that individually or in combination integrate the judicial exception into a practical application. In particular, the 2024 GUIDANCE identifies various considerations indicative of whether an additional element or combination of elements integrate the judicial exception into a practical application, such as an additional element reflecting an improvement in the functioning of a computer or an improvement to other technology or technical field.
Re claim 1, in addition to reciting the above-noted abstract idea(s), the judicial exception recited in the claim is not integrated into a practical application because the additional elements recited, namely “accessing information for an analytical chemistry instrument…; displaying, on a display, a notification that the future error condition or future readiness condition has occurred”, fail to integrate the judicial exception into a practical application. Specifically, these additional elements merely reflect insignificant extra-solution activity. Here, the “accessing” step merely represents data gathering while the “displaying” step merely represents insignificant post-solution activity. Furthermore, nothing in the claim reasonably indicates that anything other than generic computer elements needs to be used to carry out the abstract idea.
STEP 2B:
Step 2B of the 2024 GUIDANCE, next analyzes whether the claimed invention adds any specific limitations beyond the judicial exception that, either alone or as an ordered combination, amount to more than “well-understood, routine, conventional” activity in the field.
Re claim 1, the additional limitation(s) recited above only generally link the judicial exception to a particular technological field. Furthermore, these additional elements do not appear to be sufficient to amount to significantly more than the judicial exception because they again merely reflect insignificant extra-solution activity (i.e., accessing and displaying data) while only generally linking the judicial exception to a particular technological field (i.e., analytical chemistry instrument). Further still, this/these additional limitation(s) does/do not, as an ordered combination, amount to more than “well-understood, routine, conventional” activity in the field.
Accordingly, claim 1 is rejected under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter for at least these reasons.
Re claims 2-3, 5, and 16-18 these claims do not cure the deficiencies noted above with regard to claim 1, from which they depend, as they merely add further mathematical processing steps and/or other extra-solution activity. Accordingly, they are rejected under the same or substantially similar analysis, as outlined above.
Re claims 6-8, 10-13, and 15, Applicant recites language similar to claims 1-3 and 5, as discussed in the preceding paragraphs, and for reasons similar to those discussed above, claims 6-8, 10-13, and 15 are also rejected under 35 USC § 101 as failing to recite patent-eligible subject matter.
CLAIM REJECTIONS - 35 USC § 103
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.
Claims 1-3, 6-8, 11-13, and 16-18 are rejected under 35 U.S.C. § 103 as being unpatentable over Carneiro et al., US20200387790 (hereinafter “CARNEIRO”) in view of Quint et al., US20210063361 (hereinafter “QUINT”).
Re claim 1, CARNEIRO discloses a computer-implemented method comprising,
accessing information for an analytical chemistry instrument [0012];
applying a machine learning model to the information, the machine learning model configured to detect/predict one or more of an instrument error condition or an instrument readiness condition [0011-0012], [0016], wherein the instrument error condition or the instrument readiness condition comprises one or more of an equilibrated/not equilibrated state, a pressure seal leak, a degasser failure, a clogged inject valve, a partially clogged needle, a fouled column, a column that is chemically and/or thermally equilibrated, or a detector that is stable and/or not drifting [0056-0060]; and
displaying, on a display, a notification that the future error condition or future readiness condition is predicted to occur has occurred [0056]
CARNEIRO fails to explicitly disclose the information comprising instrument diagnostic signal data sampled at a rate of at least 10 Hz.
However, QUINT, in the same or similar field of endeavor, teaches a condition readiness system which samples instrument diagnostic signal data at a rate of at least 10 Hz [0048]
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing of the instant invention, to modify CARNEIRO to include the particular sampling specs of instrument diagnostic signal data as in QUINT. One would have been motivated to do so in order to secure that certain changes are reflected in the time series data to allow the identification of multiple conditions (see at least QUINT at [0048]). Further still, the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007) provided that combining prior art elements according to known methods to yield predictable results may render a claimed invention obvious over such combination. Here, QUINT merely teaches that it is well-known to sample diagnostic data at a rate of at least 10 Hz. Since both CARNEIRO and QUINT disclose similar instrument diagnostic systems, one of ordinary skill in the art would recognize that the combination of elements here has previously been executed according to known methods, thereby evidencing that such combination would yield predictable results.
Re claim 2, CARNEIRO/QUINT renders obvious the method of claim 1, as shown above. CARNEIRO further discloses,
wherein the analytical chemistry instrument is a liquid chromatography (LC) device [0012]
Re claim 3, CARNEIRO/QUINT renders obvious the method of claim 1, as shown above. CARNEIRO further discloses,
wherein the information is one or more of instrument diagnostic signal data or a chromatogram generated based on an output of the analytical chemistry instrument [0023]
Re claims 6-8 and 11-13, Applicant recites limitations of the same or substantially the same scope as claims 1-3. Accordingly, claims 6-8 and 11-13 are rejected in the same or substantially the same manner as claims 1-3. Furthermore, CARNEIRO, in at least [0028-0029], discloses the additional computer elements recited, namely a non-transitory computer readable medium, a computer, a processor, and a memory storing instructions.
Re claim 16, CARNEIRO/QUINT renders obvious the method of claim 1, as shown above. CARNEIRO further discloses,
wherein displaying the notification comprises displaying a context-specific action based on the type of error or readiness condition detected [Fig.22 and associated text]
Re claim 17, CARNEIRO/QUINT renders obvious the method of claim 1, as shown above.
CARNEIRO fails to explicitly disclose performing, at the analytical chemistry instrument, an automatic action in response to detecting the future error or future readiness condition
However, QUINT, in the same or similar field of endeavor, teaches a condition readiness system which performs, at an analytical chemistry instrument, an automatic action in response to detecting a future error or future readiness condition [0095]
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing of the instant invention, to modify CARNEIRO to include the automatic response mechanism of QUINT. One would have been motivated to do so in order to increase productivity of an instrument with an automatic response (see at least QUINT at [0003]). Further still, the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007) provided that combining prior art elements according to known methods to yield predictable results may render a claimed invention obvious over such combination. Here, QUINT merely teaches that it is well-known to provide an automatic response to a diagnostic signal. Since both CARNEIRO and QUINT disclose similar instrument diagnostic systems, one of ordinary skill in the art would recognize that the combination of elements here has previously been executed according to known methods, thereby evidencing that such combination would yield predictable results.
Re claim 18, CARNEIRO/QUINT renders obvious the method of claim 17, as shown above.
CARNEIRO fails to explicitly disclose wherein the automatic action comprises automatically beginning a queued sample analysis run without requiring further input from the user or automatically terminating a current analysis run
However, QUINT, in the same or similar field of endeavor, teaches a condition readiness system which perform, at an analytical chemistry instrument, an automatic action in response to detecting a future error or future readiness condition [0095] wherein the automatic action comprises automatically beginning a queued sample analysis run without requiring further input from the user or automatically terminating a current analysis run [Fig.7 and associated text]
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing of the instant invention, to modify CARNEIRO to include the particular automatic response mechanism of QUINT. One would have been motivated to do so in order to increase productivity of an instrument with an automatic response (see at least QUINT at [0003]). Further still, the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007) provided that combining prior art elements according to known methods to yield predictable results may render a claimed invention obvious over such combination. Here, QUINT merely teaches that it is well-known to provide an automatic response to a diagnostic signal. Since both CARNEIRO and QUINT disclose similar instrument diagnostic systems, one of ordinary skill in the art would recognize that the combination of elements here has previously been executed according to known methods, thereby evidencing that such combination would yield predictable results.
Claims 5, 10, and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Carneiro/Quint in further view of OFFICIAL NOTICE.
Re claim 5, CARNEIRO/QUINT renders obvious the method of claim 1, as shown above.
CARNEIRO fails to explicitly disclose wherein the machine learning model comprises one or more of a Bayesian hierarchical model or a gradient boosted tree
However, the Examiner takes OFFICIAL NOTICE that Bayesian hierarchical models and gradient boosted trees are old and well-known machine learning models
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing of the instant invention, to modify CARNEIRO to include such well-known algorithms. One would have been motivated to do so in order to process large data sets to reveal patterns, trends, and associations between data channels for diagnostic services (see at least CARNEIRO at [0012]. Further still, the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007) provided that combining prior art elements according to known methods to yield predictable results may render a claimed invention obvious over such combination. Here, OFFICIAL NOTICE merely teaches well-known machine learning models. Since both CARNEIRO and OFFICIAL NOTICE disclose similar instrument diagnostic systems, one of ordinary skill in the art would recognize that the combination of elements here has previously been executed according to known methods, thereby evidencing that such combination would yield predictable results.
Re claims 10 and 15, Applicant recites limitations of the same or substantially the same scope as claim 5. Accordingly, claims 10 and 15 are rejected in the same or substantially the same manner as claim 5.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS M HAMMOND III whose telephone number is (571)272-2215. The Examiner can normally be reached on Mon-Fri 0800-1700.
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Respectfully,
/Thomas M Hammond III/Primary Examiner, GAU 2855
1 37 C.F.R. § 1.111(b)
2 MPEP § 2181, subsection I
3 This rejection does not rely on 35 USC § 112(f) being invoked. See MPEP § 2161.01 (“[C]laims with computer-implemented functional claim limitations may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. […]. Even if a claim is not construed as a means-plus-function limitation under 35 U.S.C. 112(f), computer-implemented functional claim language must still be evaluated for sufficient disclosure under the written description and enablement requirements of 35 U.S.C. 112(a).” (emphasis added)).
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