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 .
Information Disclosure Statement
Applicant has not addressed the issue raised in the last Office Action mailed on 4 September 2025 on page 1 with respect to the invalid reference number on the Information Disclosure Statement, either through Remarks or by submitting a correction.
The issue has been reproduced from the previous Office Action mailed on 4 September 2025 below for convenience:
An invalid reference number was identified on the Information Disclosure Statement submitted on 9 October 2024. See section “FOREIGN PATENT DOCUMENTS”, line item #8, listing WO 02090965, published on 2022-11-14 and assigned to Spectrumedix Corporation. However, no such reference exists.
WO 2002090965 with the same assignee, Spectrumedix Corporation, was found instead. However, this was published on 2002-11-14, not 2022-11-14 as stated in the IDS. Therefore, it is unclear whether WO 2002090965 was the intended reference, or some other reference.
Non-Compliant Amendments
Claim 8’s status was indicated as being “Currently Amended”, yet no amendments were presented. Claim 14’s status was indicated as being “Previously Presented”; however, amendments were presented. The claim statuses are therefore not compliant under 37 CFR 37 CFR 1.121.
However, despite not being in compliance with 37 CFR 1.121, the claims have been examined on the merits. The “Introductory Remarks” section reflects the actual proper claim statuses, not the claim statuses presented by Applicant.
Introductory Remarks
In response to communications filed on 3 December 2025, claims 1-7 and 10-14 are amended per Applicant's request. No claims were cancelled. No claims were withdrawn. No new claims were added. Therefore, claims 1-14 are presently pending in the application, of which claim 1 is presented in independent form.
The previously raised 112(a), lack of enablement rejections of claims 3 and 12-13 are withdrawn in view of the amendments to the claims.
The previously raised 112(a), lack of enablement rejection of claim 4 has been withdrawn in view of the amendments to the claims. A new ground(s) of rejection has been issued.
The previously raised 112(a), lack of enablement rejection of claim 14 is partially maintained in view of the amendments to the claims.
The previously raised 112(b), indefiniteness rejection of the pending claims is partially maintained for claims 1-14 in view of the amendments to the independent claims.
The previously raised 112(b), indefiniteness rejection of claim 3 is withdrawn in view of the amendments to the claim.
The previously raised 112(b), indefiniteness rejection of claim 4 is withdrawn in view of the amendments to the claims. A new ground(s) of rejection has been issued.
The previously raised 112(b), indefiniteness rejections of claims 12-13 are withdrawn in view of the amendments to the claims.
The previously raised 112(b), indefiniteness rejections of claim 14 is partially maintained in view of the amendments to the claims.
The previously raised 101 rejections of the pending claims are maintained.
The previously raised prior art rejection of the pending claims is withdrawn in view of the amendments to the claims. A new ground(s) of rejection has been issued.
Response to Arguments
Applicant’s arguments filed 3 December 2025 with respect to the objection of claims 2-7 and 8-13 (see Remarks, p. 5) have been fully considered. However, there are still objections to claims 3 and 8. See below for further detail.
Applicant’s arguments filed 3 December 2025 with respect to the rejection of the claims under 35 U.S.C. 101 (see Remarks, p. 5-6) have been fully considered but are not persuasive.
Applicant’s Remarks have not addressed the 101 rejection of claims 2-4 and 9-13 as being directed to a non-statutory subject matter, nor has Applicant amended the claims to address this issue. Therefore, the 101 rejection of these claims have been maintained.
Applicant’s arguments with respect to the 101 Alice rejection of claims 1-14 (see Remarks, p. 5-6) are unpersuasive. Applicant argues that “Claim 1 assessed as a whole is not directed to a mental process”, pointing to the claim limitation “separating one or more chemical constituents of a fluid sample and measuring data relating to the separated chemical constituents during or after the chemical separation thereof”, and thus does not constitute a mental process. However, not all limitations must be a recitation of a mental process for the entire claim to be directed to an abstract idea. Rather, there must be a recitation of an abstract idea; additional steps such as those cited by Applicant are insignificant extra-solution activities, which do not move the claims outside the realm of abstract ideas. Therefore, claim 1 still recites mental tasks or processes, with such steps being nothing more than insignificant extra-solution activities. Therefore, Applicant is improperly conflating Step 2A, Prong One with Step 2A, Prong Two.
Applicant’s arguments that the claims are directed to an improvement (see Remarks, p. 5-6) is unpersuasive. Firstly, Applicant is citing limitations that are not in Claim 1 itself. Therefore, such arguments are moot, as Applicant is improperly importing limitations from the Specification into the claims. Secondly, to be an improvement, merely reciting what the intended improved result/goal/effect, is not enough; rather, there must be a concrete embodiment that reflects that improvement. Claim 1 does not contain such limitations.
Thus, Applicant’s argument that “the claim as a whole has demonstrable improvements to the art” (see Remarks, p. 6) is unpersuasive for similar reasons as indicated above, i.e., patent eligibility is not determined based on an intended improvement, but rather that the claims represent a concrete embodiment, i.e., a reflection of that improvement.
Thus, for at least the aforementioned reasons and those set forth in the 101 rejection below, the 101 rejection has been maintained.
Applicant’s arguments filed 3 December 2025 with respect to the rejection of the claims under 35 U.S.C. 112(a), lack of enablement (see Remarks, p. 6) have been fully considered. They are persuasive with respect to all the previously raised issues (i.e., that the amendments render the 112(a), lack of enablement rejection moot), except with respect to claims 4 and 14. The 112(a), lack of enablement rejection for claim 4 has been withdrawn in view of the amendments to the claim; however, a new ground(s) of rejection has been raised (as well as a 112(a), lack of written description rejection). Part of the 112(a), lack of enablement rejection for claim 14 has been withdrawn; however, the other part has been maintained.
Applicant’s arguments filed 3 December 2025 with respect to the rejection of the claims under 35 U.S.C. 112(b), indefiniteness (see Remarks, p. 6-7) have been fully considered but are not persuasive.
Applicant argues that reading the claims in light of the Specification renders the claimed steps clear, e.g., with respect to separating the one or more chemical constituents of the fluid sample, one of ordinary skill in the art would have recognized that this is done using chromatography as seen in, e.g., Specification, [0019]. However, this is unpersuasive, as there are multiple steps in claim 1, and Applicant has not provided explanations for what is performing the rest of the steps, e.g., steps b-g, which involve measuring, recording, data processing and analysis. Obviously, these are not done “using chromatography”.
Simply providing one example does not mean that the vast majority of the claims (the other 6 steps) are definite, and Applicant has not provided any explanation with respect to the other 6 steps. It is obvious the rest of the 6 steps are different from the first and only example provided by Applicant. Implication is not enough to render the claims definite, nor has Applicant been able to provide any showing how/by what the rest of the claimed steps are performed “in light of the Specification”.
Applicant has not addressed the rest of the 112(b), indefiniteness remarks. Therefore, the 112(b), indefiniteness rejection has been maintained/withdrawn and possibly new ground(s) raised, depending on the claims; see the Introductory Remarks section above for a summary.
Applicant’s arguments filed 3 December 2025 with respect to the rejection of the claims under 35 U.S.C. 103 (see Remarks, p. 7-8) have been fully considered but are not persuasive.
Applicant’s characterization of Paschke is incorrect. Applicant argues that Paschke does not teach both factors, i.e., comparing the amount of the separated constituents and comparing the profiles. However, this was explicitly cited in the rejection below, where the position (“spatial or time separation profile”) and relative intensities of peaks (i.e., “the amount of said separated constituents”) in the measured spectrum are used to match to those of a reference spectrum (Paschke, [0129-0130] and [0132]). A score of this identification indicates the degree of agreement of the measured spectrum (comprising the profile and amount) with a database spectrum (Paschke, [0132] and [0168]). Therefore, Paschke does indeed disclose comparing both factors as claimed.
Thus, the rest of Applicant’s arguments are moot, as they are based on an incorrect characterization of Paschke.
Claim Objections
Claim 3 is objected to because of the following informalities: there are two instances of “a” in front of “biopharmaceutical manufacturing process”. There should only be one. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the claim recites “A method according to claim 1”. This should be “The” method. Appropriate correction is required.
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.
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 method for classifying a fluid sample, which method comprises the steps of:…” in claim 1;
“…wherein those two data sets are processed by an algorithm to provide a two-dimensional sample data set for each sample which is used in steps d. to g.” in claim 2, and
“A biopharmaceutical manufacturing plant configured to implement the method as defined in claim 1 to check and/or control a biopharmaceutical manufacturing process” in claim 14.
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 § 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.
Claim 4 is 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 claim recites “wherein the presence, or absence, of samples in different groups informs changes to one or more parameters in a biopharmaceutical manufacturing process”.
The closest paragraph to be found appears to be in Specification, [0005], where “One advantage is that [the disclosed] analysis method allows for a fast, non-operator dependent, classification scheme, in which limits for grouping samples can be easily set for automated analysis. This method allows for decisions to be made, for example, if the manufacturing process is working satisfactory, or if separation parameters need to be changed”.
However, the “presence, or absence, of samples in different groups” is different from “limits for grouping samples”. Thus, the use of the ”presence, or absence, of samples in different groups” for “inform[ing] changes to one or more parameters in a biopharmaceutical manufacturing process” is not supported.
Additionally, even if the limitation were to be interpreted such that the data “informs changes to one or more parameters”, this is not supported by the Specification. This language appears to imply that there is a recommendation or suggestion scheme in the method; however, the most that is provided by the Specification is that certain information appears to be implicitly communicated to a user, who then makes the decisions as to whether such changes need to occur. However, the data itself does not “inform changes”, but rather this is a step that is performed by the user.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claim recites “wherein the presence, or absence, of samples in different groups informs changes to one or more parameters in a biopharmaceutical manufacturing process”.
In addition to there not being support for the use of the “presence, or absence of samples in different groups” being used to “inform[] changes in one or more parameters in a biopharmaceutical manufacturing process” as claimed, there is a lack of enablement with such a limitation, as one of ordinary skill in the art could not make or use the invention based on what is disclosed, e.g., how, simply the presence or absence of samples in different groups, is able to inform changes in one or more parameters in a biopharmaceutical manufacturing process.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claim recites “A biopharmaceutical manufacturing plant configured to implement the method as defined in claim 1”.
Firstly, as noted in the 112(f) invocation above, there is no corresponding structure for performing the acts of claim 1. Therefore, one of ordinary skill in the art would not be able to make or use the claimed invention (i.e., somehow being able to link the claimed biopharmaceutical manufacturing plant, with no corresponding structure, to the steps of claim 1, which also have no corresponding structure).
Lastly, because there are no limitations within the claim, nor details within the Specification, confining the biopharmaceutical manufacturing plant to any particular details, as a result one of ordinary skill in the art would not be able to configure the claimed biopharmaceutical manufacturing plant to the steps of the claimed method.
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 1-14 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.
Independent Claim 1 recites only a method for performing the steps. As noted in the 112(f) invocation above, the method does not provide sufficient structure to perform the recited functions. For example, there is no structure for performing separation of the one or more chemical constituents of the fluid sample (step a), no structure for measuring and recording various data (steps b-c), no structure for performing comparison steps (steps d-e), no structure for performing the assigning of a similarity score to the sample based on certain factors (step f), and no structure for providing a classification of the sample based on the similarity score (step g). Therefore, it is unclear what structures are performing the disclosed steps, and whether the same or different structures are involved at each step.
Similarly, dependent claim 2 recites “…wherein those two data sets are processed by an algorithm to provide a two-dimensional sample data set for each sample which is used in steps d. to g.” Yet claim 1, which claim 2 depends upon, makes no reference to any sort of structure, including a computer, in which an algorithm may operate within. Thus, there is no sufficient structure to provide the recited functions.
Furthermore, although dependent Claims 9-13 pertain to a computer program, it does not make sense that the computer program would be involved in step (a) of “at least partially separating one or more of the chemical constituents of the fluid sample” (which appears to be outside the realm of computer programs), as well as steps (b) and (c) which perform measuring of certain data (which also appear to be outside the realm of computer programs).
The rest of the dependent claims are rejected for at least by virtue of their dependency on claim 1 (and claim 9), and for failing to cure the deficiencies of their respective parent claims.
Claim 4 is 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 claim recites “wherein the presence, or absence, of samples in different groups informs changes to one or more parameters in a biopharmaceutical manufacturing process”.
It is unclear the metes and bounds of such a limitation, as the active step involves an implied determination step (e.g., the presence or absence of samples in different groups). However, with the limitation that this “informs changes to one or more parameters in a biopharmaceutical manufacturing process”, it is unclear the metes and bounds of “informing changes” are, e.g., if it is simply to provide information, or whether it is an active step.
Although Specification, [0005] appears to be the closest paragraph, it should be noted that (1) the analysis method pertains to “limits for grouping samples”, not to the “presence, or absence of samples in different groups” as claimed.
Secondly, the method appears to “allow for decisions to be made, for example if the manufacturing process is working satisfactory, or if separation parameters need to be changed”. However, “informing changes to one or more parameters in a biopharmaceutical manufacturing process” thus appears to be directed to how a user is intended to utilize the information; however, the language is unclear with respect to what is meant to be claimed with respect to this limitation, e.g., an intended decision-making process, a certain conveying of information, etc. However, note that the information being conveyed are not recommendations. In other words, the data itself does not “inform changes”, but rather this is a step that is performed by the user; however, the claim language is not clear with respect to this, and appears to be actively claiming a step that was an intended use by a user.
For purposes of examination, the interpretation that this is an intended use of the presence/absence of different groups, has been taken.
Claim 14 is 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 claim recites “A biopharmaceutical plant configured to implement the method as defined in claim 1”. There is insufficient structure for a biopharmaceutical plant to implement the claimed method steps of at least: measuring and recording various data relating to the separated fluid sample (steps b and c), performing comparisons of the amount of the separated constituents to one or more reference samples (step d), comparing the spatial or time separation profile to the corresponding profile of the or each reference sample (step e), assigning a similarity score to the sample based on the similarity of the amount or the profile comparisons of the separated constituents, as performed under steps d and e above, or both, with the equivalent amount and/or profile of the or each reference sample respectively (step f), and providing a classification of the sample based on the similarity score (step g). As also noted in claim 1 above, it is unclear what structures within a biopharmaceutical plant are performing the disclosed steps, and whether the same or different structures are involved at each step.
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 2-4 and 9-13 are rejected under 35 U.S.C. 101 because the claims are directed to a non-statutory subject matter. Claim 2 recites processing two datasets by “an algorithm” (with claims 3-4 depending on claim 2). Claims 9-13 are directed to a “computer program”, which is software per se. While the claimed “algorithm” (when taking broadest reasonable interpretation) and “computer program” causes a computer to execute the claimed steps (i.e., for claims 9-13, it was stated in claim 9 that the program was “run on a computer”), the computer is not claimed as part of the “product” (i.e., the algorithm (in claims 2-4) and the computer program (in claims 9-13)). Products which do not have a physical or tangible form (such as the claimed algorithm and computer program), i.e., that do not have any structural recitations, are software per se, and do not fall within at least one of the four categories of patent eligible subject matter. See MPEP § 2106.03(I).
Claims 1-14 are rejected under 35 U.S.C. 101 because the claims are directed to a judicial exception (i.e., an abstract idea) without significantly more.
Independent Claim 1 recites comparing an amount of separated constituents to one or more reference samples, and comparing the spatial or time separation profile to the corresponding profile of the or each reference sample, assigning a similarity score to the sample based on the similarity of the amount or the profile comparisons of the separated constituents, as performed under the aforementioned comparison steps, or both, with the equivalent amount and/or profile of the or each reference sample respectively, and providing a classification of the sample based on the similarity score. These encompass an evaluation, observation, and/or judgment, which falls under the “Mental Processes” grouping of abstract ideas.
Dependent Claim 2 recites processing two data sets to provide a two-dimensional sample data set for each sample. This falls under the “Mental Processes” grouping of abstract ideas (e.g., being able to create a two-dimensional vector/tuple, a table with two dimensions, a matrix, etc. is capable of being performed in the human mind).
Dependent Claim 3 recites that different groups of samples represent pass or fail results in a biopharmaceutical manufacturing process. Similarly, dependent Claim 4 recites that the presence, or absence, of samples in different groups informs changes to one or more parameters in a biopharmaceutical manufacturing process. These encompass an evaluation, observation and/or judgment (the implicit determination of a pass/fail result; the determination of a presence/absence of samples), which falls under the “Mental Processes” grouping of abstract ideas, as well as “Certain Methods of Organizing Human Activity” grouping of abstract ideas (with regards to the resulting quality control of / changes in a biopharmaceutical manufacturing process).
Dependent Claim 8 recites calculating the similarity score using a Pearson correlation function. This falls under the “Mathematical Concepts” grouping of abstract ideas.
Dependent Claims 10-12 recite a user interface for user selection and/or presentation of various data (claim 10), which enables a user to perform various specific functions including manipulation of data by setting certain limits of what data to include within the analysis or grouping of samples (claims 11-12). Such limitations encompass managing personal behavior or relationships between a person and a computer, which falls under “Certain Methods of Organizing Human Activity”.1 See also, e.g., Intellectual Ventures I LLC v. Capital Bascom Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016) finding that “filtering content is an abstract idea because it is a long-standing, well-known method of organizing human behavior, similar to concepts previously found to be abstract” with regards to claims 11-12).
Dependent Claims 12-13 recite presenting certain types of data for aiding in tracking a protein purification process. Similarly, dependent Claim 14 recites implementing claim 1 to check and/or control a biopharmaceutical manufacturing process. Such limitations encompass managing personal behavior or relationships between a person and a computer, which falls under “Certain Methods of Organizing Human Activity”.
Because the claims recite limitations that fall under “Certain Methods of Organizing Human Activity” and “Mental Processes” groupings of abstract ideas (but for the recitation of generic computer components), accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application of the idea. Claims 9-13 recite that the steps are implemented by a computer program, which are recited at a high level of generality and recited so generically that they represent no more than mere instructions to apply the judicial exception on a computer (see MPEP 2106.05(f)). Similarly, dependent Claim 2 recites that the two provided data sets are processed by an “algorithm”. Similarly, Claims 10-13 attempt to claim the use of graphical user interfaces for implementing the disclosed steps of receiving user inputs and presenting information. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(h)).
Independent Claim 1 recites partially separating one or more of the chemical constituents of a fluid sample (step (a)), measuring and recording an amount of the separated chemical constituents of the sample during, or after, the chemical separation, such as an amount thereof (step (b)), and measuring and recording the spatial or time separation profile of sample constituents, during or after separation (step (c)). These are insignificant pre-solution activities that can be regarded as a form of “gathering data”.2 Furthermore, the fact that these data pertain to separation of chemical constituents, including, e.g., the chemical separation being electrophoresis or chromatography (dependent claims 5-6), and spatial or time separation profile of those sample constituents, are nothing more than insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result.
Independent Claim 1 recites providing a data set of step (c). Similarly, dependent claim 2 recites providing a data set of the amount of the or each separated constituent for each of the samples, and providing a data set of the spatial separation profile or time separation profile for each sample. These are insignificant extra-solution activities. The specific data that is involved is nothing more than insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result.
Other insignificant field-of-use limitations include:
the type of data involved in resulting in a quality control of a biopharmaceutical manufacturing process involve different groups of samples representing pass or fail (dependent claim 3);
the type of data involved in informing changes to one or more parameters in a biopharmaceutical manufacturing process involves the presence or absence of samples in different groups, and that the presence/absence of samples “informs changes to one or more parameters in a biopharmaceutical manufacturing process” (dependent claim 4);
that chromatography run data is used for the classification of samples (dependent claim 7);
the graphical user interface is provided for user selection and/or presentation of reference profiles and/or regions of interest for analysis and/or data, and/or electrophoresis lanes and/or chromatograms and/or a two-dimensional scatter plot (dependent claim 10);
the type of data points being removed from analysis have reached a maximum limit of a detector (dependent claim 11);
that a two-dimensional scatter plot is used (dependent claim 12);
that trend lines and/or colour gradients are presented (dependent claim 13); and
that a biopharmaceutical manufacturing plant is configured to implement the method of claim 1 (dependent claim 14).
Dependent Claim 14 recites a biopharmaceutical manufacturing plant configured to implement the method as defined in claim 1. This is nothing more than mere instructions to implement an abstract idea or other exception. As noted above, the fact that certain types of data are involved or that a biopharmaceutical manufacturing plant is involved, are nothing more than insignificant field-of-of use limitations, describing the context rather than a particular manner of achieving the result.
Lastly, dependent Claim 8 recites that the similarity score is calculated using the Pearson correlation function. However, narrow embodiments of ineligible matter, are still ineligible.3 Thus, such limitations are nothing more than insignificant field-of-use limitations, describing the context rather than a particular manner of achieving the result.
Accordingly, these additional elements do not integrate the abstract idea into a practical application, because they do not impose any meaningful limits on practicing the abstract idea.
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements reciting the use of various computing software and hardware components (including, e.g., a computer algorithm, computer program running on a computer, and graphical user interfaces) amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept.
The steps of gathering data / collecting data, can be viewed as, for example, a form of electronic recordkeeping, in which data is measured and gathered, and later retrieved for analysis. However, such steps are well-understood, routine, and conventional. See MPEP § 2106.05(d)(II) (“Electronic recordkeeping” and “Storing and retrieving data from memory”).
When considering the claims separately and as an ordered combination, i.e., as a whole, the claims do nothing more than recite the abstract steps at a high level of generality and not a specific technical mean or process by which the claimed steps are performed other than those which can be performed mentally in the mind of a person, and/or represent certain methods of organizing human activity by allowing a user to manipulate certain information.
The most detail that could be found was with respect to the claimed GUI steps. However, as previously noted by the Federal Circuit court in Electric Power Group4, “Merely requiring the selection and manipulation of information—to provide a ‘humanly comprehensible’ amount of information for others…by itself does not transform the otherwise-abstract process of information collection and analysis” (Id. at p. 9). Similarly, in BSG Tech, allowing users to consider historical usage information while inputting data was still found to be abstract. Thus, in a similar vein, the present claims which enable a user to view and even select/manipulate the information, is still abstract.
The majority of the claim limitations attempt to narrow the type of data, the type of application to a particular process/environment, and type of user manipulations to elements slightly more detailed than what is generic. However, as a matter of law, narrowing or reformulating an abstract idea does not add “significantly more” to it.5 What is needed is an inventive concept in the non-abstract application realm. Limitation of the claims to a particular field of information does not move the claims out of the realm of abstract ideas.6 Similarly, limitation of the claims to a particular technological environment does not amount to significantly more.
Furthermore, in combination, the claims do no more than recite a series of high-level steps together. There is, in short, nothing “inventive” about any claim details, individually or in combination, that are not themselves in the realm of abstract ideas. Adding one abstract idea to another abstract idea, does not make a claim non-abstract. See RecogniCorp, LLC v. Nintendo Co., Ltd. (Fed. Cir. 2017) at p. 8.
Essentially, the claims only recite generic functional language to achieve the purported solutions, without integrating the claims into a practical application of that idea. In other words, the claims do not recite any sort of technical steps for carrying out the claimed steps. “Generally, a claim that merely describes ‘an effect or result dissociated from any method by which [it] is accomplished’ is not directed to patent-eligible subject matter” (Apple Inc. v. Ameranth Inc., 842 F.3d 1229 (Fed. Cir. 2016), quoting Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348 (Fed. Cir. 2015)). See also Intellectual Ventures, 838 F.3d 1307, 1316 (Fed. Cir. 2016) (quoting Internet Patents Corp.), where the court found claims directed to email filtering to be abstract and patent ineligible when there is “no restriction on how the result is accomplished…[and] [t]he mechanism…is not described.”
A desired goal (i.e., result or effect) absent structural or procedural means for achieving that goal is an abstract idea. In this case, the claims are directed to an abstract idea for failing to describe how—whether by particular process or structure—the goal is accomplished. Even with the additional elements, the claim limitations fail to restrict how the goal is accomplished.
Therefore, for at least the aforementioned reasons, the claims are rejected under 35 U.S.C. 101 being directed to a judicial exception without significantly more.
A Note on Intended Use
The Examiner notes there are multiple elements in the claims that will be interpreted as intended use. A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see MPEP 2114 (II) and Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). “Language that suggest or makes optional but does not require steps to be performed does not limit a claim to a particular structure, nor limits the scope of a claim or claim limitation”, see MPEP 2111.04. The Examiner notes the recited prior art has the capability to perform the limitations indicated as intended use.
An incomplete list of the limitations that could be interpreted as intended use is as follows:
Claim 3 recites that the pass or fail results are in/of “a biopharmaceutical manufacturing process”; and
Claim 4 recites that the presence or absence of samples in different groups “informs changes to one or more parameters in a biopharmaceutical manufacturing process”.
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.
Claims 1-2, 4, 6-7, and 9 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Paschke et al. (“Paschke”) (US 2017/0154169 A1).
Regarding claim 1: Paschke teaches A method for classifying a fluid sample, which method comprises the steps of:
a. at least partially separating one or more of the chemical constituents of the fluid sample (Paschke, [0086], where the step of acquiring data includes performing liquid chromatography or (differential) ion mobility separation or any other physical separation. See also Paschke, [0126], where the sample measured may comprise tissues from different body fluids);
b. measuring and recording an amount of the separated chemical constituents of the sample during, or after, the chemical separation; c. measuring and recording the spatial or time separation profile of sample constituents, during or after separation, and providing a data set of the same (Paschke, [0122], where instrument interface 22 sends data and receives data from the mass spectrometer 1 and/or the ion source comprising the liquid chromatography setup. The mass spectrometer communicates with instrument interface 22 to set voltages on one or more of the ion-optical elements of the mass spectrometer and/or receive signals from detectors or sensors in the mass spectrometer. The control unit may contain a processor unit for performing pre-processing of the measured signals, including peak identification, mass calculation, peak annotation (e.g., with exact mass, area, elemental composition, etc.) (i.e., “measuring and recording an amount of the separated chemical constituents of the sample during, or after the chemical separation, such as an amount thereof; measuring and recording the spatial or time separation profile of sample constituents, during or after separation”). See Paschke, [0129], where spectrum files containing one or more mass spectra in one or more mass ranges are obtained from the storage unit (i.e., “providing a data set of the same”). See also, e.g., Paschke, [0124], where the storage unit 24 stores raw measurement data (from which the initial data vectors were derived), e.g., in the form of individual files (i.e., “providing a data set of the same”));
d. comparing the amount of said separated constituents to one or more reference samples; e. comparing the spatial or time separation profile to the corresponding profile of the or each reference sample (Paschke, [0132], where the selected mass spectra, derived from the received spectrum files (see Paschke, [0129-0130]) are compared to reference spectra in a database. When position (i.e., “spatial or time separation profile”) and relative intensities of peaks (i.e., “the amount of said separated constituents”) in the measured spectrum match those of a reference spectrum from a known peptide or protein within a certain tolerance, it can be concluded that the sample contains a particular peptide or protein, i.e., that peptide or protein is identified);
f. assigning a similarity score to the sample based on the similarity of the amount and the profile comparisons of the separated constituents, as performed under steps d and e above, or both; and g. providing a classification of the sample based on the similarity score (Paschke, [0132] and [0168], where the table “Peptides” indicates the score of the identification, e.g., the degree of agreement (i.e., “similarity score”) of the measured spectrum with a database spectrum, the selected mass spectra having been compared to reference spectra in a database, the position and relative intensities of peaks in the measured spectrum matching those of a reference spectrum from a known peptide or protein with a certain tolerance (i.e., “based on the similarity score”)), resulting in the conclusion that the sample contains a particular peptide or protein, i.e., that peptide or protein is identified).
Regarding claim 2: Paschke teaches The method according to claim 1, wherein plural samples are classified (Paschke, [0066], where the disclosed system acquires initial data vectors of a plurality of samples by a mass spectrometry),
wherein step b. includes providing a data set of the amount of the or each separated constituent for each of the samples, wherein step c. includes providing a data set of the spatial separation profile or time separation profile for each sample, and wherein those two data sets are processed by an algorithm to provide a two-dimensional sample data set for each sample which is used in steps d. to g. (Paschke, [0122], where pre-processing is performed on the measured signals, including peak identification, mass calculation, peak annotation (e.g., with exact mass, area, elemental composition, accuracy information for intensity and mass, etc.). See Paschke, [0129], where spectrum files containing one or more mass spectra in one or more mass ranges are obtained from the storage unit (i.e., “providing a data set of the amount of the or each separated constituent for each of the samples”). See also Paschke, [0134-0135], where spectrum files obtained from the acquired data include peaks that are defined with respect to a time axis of elution time of the liquid chromatography setup (i.e., “spatial separation profile or time separation profile”) and the mass axis of the mass spectrometer (i.e., “amount of the or each separated constituent for each of the samples”). Note that the spectrum files containing these two forms of data imply that such datasets were generated, and the spectrum file itself implying the generation of a “two-dimensional sample data set” containing these two sets of data. See claim 1 above with respect to steps d through g, which were based on the spectrum files obtained from storage (see Paschke, [0129-0130])).
Regarding claim 4: Paschke teaches The method according to claim 2, wherein the presence, or absence, of samples in different groups informs changes to one or more parameters in a biopharmaceutical manufacturing process (Paschke, [0106], where one exemplary view is a simple array of color coded markers for the presence or non-presence of an analytical feature in a sample, or conversely for an analytical feature the study variables or samples for which this is true. The analytical feature may, for example, be presence of a certain protein or metabolite or the presence of a compound that is specific to a certain metabolic pathway or organism. See also Paschke, [0107], where the disclosed system enables ad hoc definition of relationships between samples and grouping of samples (i.e., “samples in different groups”), as well as applications to proteomics).
The Examiner notes that the presence or absence of samples in different groups “informs changes to one or more parameters in a biopharmaceutical manufacturing process” has been considered as an intended use/result, and is not afforded patentable weight.
The Examiner notes that “A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); see also MPEP § 2114. The recited prior art has the capability to perform these intended use limitations, and therefore, the prior art meets the claimed limitations. See MPEP § 2111.02; see also In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997).
Because Paschke disclose all the claimed features, the claimed invention does not distinguish over the prior art since Paschke would confer the same intended use/result as claimed.
Regarding claim 6: Paschke teaches The method according to claim 1, wherein the chemical separation is chromatography (Paschke, [0086], where the step of acquiring data includes performing liquid chromatography or (differential) ion mobility separation or any other physical separation).
Regarding claim 7: Paschke teaches The method according to Claim 6 where chromatography run data is used for the classification of samples (Paschke, [0129], where spectrum files are read from the storage unit (i.e., “chromatography run data”; see, e.g., Paschke, [0072-0081], where the initial data that was stored in the storage unit was derived from performing liquid chromatography on the sample, and then performing analysis on the obtained data), where these files may contain one or more mass spectra in one or more mass ranges. A number of mass spectra were measured at subsequent times, and the raw data thus contains both the information of a chromatogram, i.e., intensity against elution time, as well as that of a mass spectrum, i.e., intensity against mass-to-charge ratio. See Paschke, [0130-0132], where this information is analyzed and compared to reference spectra in a database for identification of proteins present in a particular tissue (see also Paschke, [0072])).
Regarding claim 9: Paschke teaches A computer program, comprising program code for performing the method of claim 1 when the program is run on a computer (Paschke, [0123], where the disclosed data processing device can be realized as a single computer, where functions for processing the data are implemented in an object-oriented programming language (i.e., “computer program”)).
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 3, 5, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Paschke et al. (“Paschke”) (US 2017/0154169 A1).
Regarding claim 3: Paschke teaches The method according to claim 2, wherein different groups of samples represent pass or fail results in a a biopharmaceutical manufacturing process (Paschke, [0106], where one exemplary view is a simple array of color coded markers for the presence or non-presence of an analytical feature in a sample, or conversely for an analytical feature the study variables or samples for which this is true. The analytical feature may, for example, be presence of a certain protein or metabolite or the presence of a compound that is specific to a certain metabolic pathway or organism. See also Paschke, [0107], where the disclosed system enables ad hoc definition of relationships between samples and grouping of samples (i.e., “different groups of samples”)).
Although Paschke does not appear to explicitly state that “different groups of samples represent pass or fail results” (but rather that samples are grouped each indicated with the presence/non-presence of certain compounds), the claimed invention does not distinguish over the prior art because the differences in the claim limitations and the prior art’s disclosure are only found in the nonfunctional descriptive material and are not functionally involved in the steps recited. The steps of claim 2 would have been performed the same regardless of the specific data involved (i.e., different groups of samples representing pass or fail, or some other data). Thus, this descriptive material will not distinguish the claimed invention from the prior art in terms of patentability. See In re Gulack, 703 F.2d 1381, 1385, 217 USPQ2d 401, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994).
Therefore, it would have been obvious to a person of ordinary skill in the art to have referred to Paschke’s teachings in making the claimed invention, because such data does not functionally relate to the steps in the method claimed and because the subjective interpretation of the data does not patentably distinguish the claimed invention over the prior art.
The Examiner notes that the pass or fail results are in/of “a biopharmaceutical manufacturing process” has been considered as an intended use/result, and is not afforded patentable weight.
The Examiner notes that “A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.” Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987); see also MPEP § 2114. The recited prior art has the capability to perform these intended use limitations, and therefore, the prior art meets the claimed limitations. See MPEP § 2111.02; see also In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed.Cir. 1997).
Because Paschke disclose all the claimed features, the claimed invention does not distinguish over the prior art since Paschke would confer the same intended use/result as claimed.
Regarding claim 5: Paschke teaches The method according to claim 1, wherein the chemical separation is electrophoresis (Paschke, [0086], where the step of acquiring data includes performing liquid chromatography or (differential) ion mobility separation or any other physical separation).
Although Paschke does not appear to explicitly state that electrophoresis is utilized for the separation, Paschke states that “any other physical separation” may be utilized. Therefore, one of ordinary skill in the art would have found it obvious to have modified Paschke to explicitly include electrophoresis with predictably equivalent operating characteristics, which is that data is gathered and analyzed. One of ordinary skill in the art would have been motivated to do so in order to take advantage of pre-existing technologies with their various advantages (e.g., only a small sample size required, efficient and rapid separation of molecules, etc.).
Regarding claim 10: Paschke teaches The computer program according to claim 9, further operable to provide a graphical user interface (GUI) for user selection and/or presentation of reference profiles and/or regions of interest for analysis and/or data, and/or electrophoresis lanes and/or chromatograms and/or a two-dimensional scatter plot (Paschke, [0125], where operation of the mass spectrometry setup is preferably controlled via a graphical user interface. See also Paschke, [0060], where the user can view and edit workflows with a graphical user interface. See Paschke, [0024], where the provided visualization may comprise scatter plots).
Although Paschke does not appear to explicitly state that the scatter plot is two-dimensional as claimed, one of ordinary skill in the art would have found it obvious to have explicitly included two-dimensional scatterplots with predictably equivalent operating characteristics, which is to enable the visualization of relevant data. One of ordinary skill in the art would have found it obvious to do so in the cases where only two dimensions are utilized, e.g., there is no point is rendering a 3D scatter plot when the data is only two-dimensional.
Regarding claim 11: Paschke teaches The computer program according to claim 10, wherein the GUI is further configured to enable a user to remove data points from an analysis which have reached a maximum limit of a detector (Paschke, [0182], where a list of identified peptides and proteins are filtered based on a threshold of confidence so that only peptides and/or peptide groups and/or proteins which are identified with sufficient reliability will be taken into account. Additionally, the filtering may be carried out so that known contaminants are not processed any further. See also Paschke, [0184], where a property for the exclusion state may be added so that any module in the workflow may change the content of the column in order to filter out undesired peptides and/or proteins. See also, e.g., Paschke, [0068], where the system selects data vectors for which the item of additional data has a predefined value).
Although Paschke does not appear to explicitly state that these filtering of the data is performed by “a user” that is enabled to manually perform such steps using “the GUI” (and that the filtering occurs after all the processing and visualization had already taken place), one of ordinary skill in the art would have found it obvious to have allowed users to manually configure this with the motivation of allowing users to manipulate/customize data according to their requirements/needs (i.e., greater flexibility), and to display the resulting data to the user for further modification and manipulation with the motivation of allowing users to see the system-rendered analysis/presentation first prior to manipulating the data (and seeing the results afterwards, e.g., greater informativity), as well as presenting on a GUI for easier navigation.
Furthermore, although Paschke does not appear to explicitly state that the filtered out data pertains to “data points…which have reached a maximum limit of a detector” as claimed, one of ordinary skill in the art would have found it obvious to have included excluding such types of data because such data points (that have reached a maximum limit of a detector, as claimed) are not reliable for analysis. Therefore, one of ordinary skill in the art would have found it obvious to have modified Paschke to explicitly exclude such data with predictably equivalent operating characteristics, which is that both the claimed invention and Paschke result in only retaining the identified data with sufficient reliability to take into account for the analysis. One of ordinary skill in the art would have been motivated to do so in order to enable greater accuracy and efficiency in data processing/analysis (i.e., less data to consider).
Regarding claim 12: Paschke teaches The computer program according to claim 10, wherein the GUI is configured to present a two-dimensional scatter plot (Paschke, [0125], where operation of the mass spectrometry setup is preferably controlled via a graphical user interface. See also Paschke, [0060], where the user can view and edit workflows with a graphical user interface. See also Paschke, [0024], where the visualization may comprise scatter plots. See also Paschke, [0107], where the disclosed system enables ad hoc definition of relationships between samples and grouping of samples, where this data set may then be used for further grouping, processing, visualization, etc.).
Although Paschke does not appear to explicitly state that a two-dimensional scatter plot is utilized, one of ordinary skill in the art would have found it obvious to have utilized a two-dimensional scatter plot for performing the disclosed with the motivation of enabling users to more easily visualize data having relationships/correlations with one another, making a user’s data manipulations more intuitive relative to the data presented to them.
Regarding claim 13: Paschke teaches The computer program according to claim 12, wherein the GUI is configured to present trend lines and/or colour gradients (Paschke, [0024], where the visualization may comprise user-configurable tables, scatter plots, histograms, bar charts, pie charts and/or Venn diagrams. See also Paschke [0106], where one exemplary view is a simple array of color coded markers for the presence or non-presence of an analytical feature in a sample, or conversely for an analytical feature the study variables or samples for which this is true. The analytical feature may, for example, be the presence of a certain protein or metabolite or the presence of a compound that is specific to a certain metabolic pathway or organism).
Although Paschke does not appear to explicitly state that color “gradients” are utilized or that “trend lines” are displayed, one of ordinary skill in the art would have found it obvious to have modified Paschke to explicitly include such limitations as claimed with predictably equivalent operating characteristics, which is data is somehow visualized to a user. One of ordinary skill in the art would have found it obvious to do so with the motivation of enabling users to track different types of data conferred by the color “gradients” and “trend lines”, e.g., being able to more easily track intensities over time (via a trend line), as well as seeing continuous changes through visual representations as opposed to representing information discretely (e.g., through the use of color gradients), both of which may provide better information to a user with respect to certain applications.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Paschke et al. (“Paschke”) (US 2017/0154169 A1), in view of Grossman et al. (“Grossman”) (US 2018/0059011 A1).
Regarding claim 8: Paschke teaches A method according to claim 1, wherein the spatial or time separation profile similarity score is calculated … (Paschke, [0164-0168], [TABLE 2], and [TABLE 6], where the result files of the first workflow include various types of information, including identified peptides, proteins, and modifications, as well as quantification information. A SequestScore is included in [TABLE 2], which indicates a score as to the degree of agreement between a measured spectrum and the identified peptide or protein. In [TABLE 6], the dynamic table “Peptides” is shown with schematic values for the sequence of peptides identified in the first workflow, indicating also the score of the identification, e.g., the degree of agreement of the measured spectrum with a database spectrum. Thus, Paschke’s “degree of agreement” corresponds to the claimed “similarity score”.
Recall from Paschke, [0131-0132], with respect to the “spatial or time separation profile”), i.e., where the mass spectra, which includes a position and intensity (i.e., “spatial or time separation profile”), are compared to reference spectra in a database, where when position and relative intensities of peaks in the measured spectrum measure those of a reference spectrum from a known peptide or protein within a certain tolerance, it can be concluded that the sample contains a particular peptide or protein).
Paschke does not appear to explicitly teach [calculating the similarity score] using the Pearson correlation function.
Grossman teaches [calculating the similarity score] using the Pearson correlation function (Grossman, [0097], where the correlation between the spectra of the sample and the reference is performed using the Pearson correlation formula).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Paschke and Grossman with the motivation of utilizing a Pearson correlation formula which is advantageous for being non-dependent on the vertical scales of the compared spectra (Grossman, [0099]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Paschke et al. (“Paschke”) (US 2017/0154169 A1), in view of Goix (“Goix”) (US 2004/0036870 A1).
Regarding claim 14: Paschke teaches the method as defined in claim 1 (see Paschke above in claim 1).
Paschke does not appear to explicitly teach A biopharmaceutical manufacturing plant configured to implement [the method of detecting microparticles in fluid samples] (Goix, [0002] and [0004], where the disclosed system pertains to a method and apparatus for detecting microparticles in fluid samples (thus overlapping with Paschke), where detection of microorganisms present at low concentration in fluids is critical to better manage quality control processes in drug manufacturing plants (implying that detecting microparticles in fluid samples may be relevant, i.e., applied, to drug manufacturing plants). See Paschke in claim 1 above with respect to the implementation of the disclosed steps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Paschke and Goix with the motivation of better managing quality control processes in drug manufacturing plants, and providing scientists with a powerful and easy to use analytical research tools (Goix, [0004]).
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 IRENE BAKER whose telephone number is (408)918-7601. The examiner can normally be reached M-F 8-5PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boris Gorney can be reached at (571) 270-5626. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRENE BAKER/Primary Examiner, Art Unit 2154
19 May 2026
1 Similar cases falling under “Certain Methods of Organizing Human Activity” (managing personal behavior in a claim) involved tracking data to determine whether they exceed a pre-set spending limit (see, e.g., Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015), and considering historical usage information while inputting data (BSG Tech. LLC v. Buyseasons, Inc., 899 F.3d 1281, 1286, 127 USPQ2d 1688, 1691 (Fed. Cir. 2018))
2 See, e.g., MPEP § 2106.05(g) under “Mere Data Gathering” (vi. Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App’x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)).
3 SAP America, Inc. v. InvestPic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed. Cir. 2018) at p. 12 (“Dependent method claims 2-7 and 10 add ‘limitations…[that] require[] the resampling method to be a bootstrap method.’ SAP, 260 F. Supp. 3d at 715. Likewise, ‘[c]laims 8 and 9 add limitations that the statistical method is a jackknife method and a cross validation method.’ Id. at 716. Because bootstrap, jackknife, and cross-validation methods are all “particular methods of resampling,” those features simply provide further narrowing of what are still mathematical operations. They add nothing outside the abstract realm. See Mayo, 566 U.S. at 88-89 (stating that narrow embodiments of ineligible matter, citing mathematical ideas as an example, are still ineligible); buySAFE, 765 F.3d at 1353 (same)”).
4 Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016)
5 See SAP Am., Inc. v. InvestPic, LLC, No. 2017-2081, slip op. at 14 (2018)
6 See BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281 (Fed. Cir. 2018) at p. 17-18.
Prosecution Insights