DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions that are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-10, drawn to a method of controlling a cell culture process.
Group II, claims 11-16, drawn to one or more non-transitory, computer-readable media.
Group III, claims 17-22, drawn to a system.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature obtaining current values,( During run-time operation of system 100, Raman analyzer 106 and Raman probe 108 are used to scan (i.e., generate Raman scan vectors for) a biopharmaceutical process in bioreactor 102, and the Raman scan vector(s) is/are then transmitted from Raman analyzer 106 to computer 110. Raman analyzer 106 and Raman probe 108 may provide scan vectors to support predictions (made by JITL predictor application 130) according to a predetermined schedule of monitoring periods, such as once per minute, or once per hour, etc.), predicting, by processing hardware, one or more future values (via JITL predictor application, Fig. 1:130. 1:144 ), and controlling, by the processing hardware applying the one or more future values (via computer 110.) this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Tulsyan WO 2020/086635 as discussed in at least paragraphs 31-47.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Robert Jacobson on 09/23/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-22 have withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/31/2023 and 09/18/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by 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 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: processing hardware in claims 1 and 4.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: the “processing hardware” according to the applicant’s specification may comprises a programmable microprocessor, an application-specific integrated circuits (ASICs), or a field-programmable gate arrays (FPGAs) (see applicant’s specification paragraph 27).
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 § 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.
Claims 1-5 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tulsyan WO 2020/086635 as cited in the ids dated 03/31/2023.
Regarding claim 1, Tulsyan discloses a method of controlling a cell culture process, the method comprising, for one or more time intervals during the cell culture process (Depending on the frequency at which Raman analyzer 106 generates such scan vectors, JITL predictor application 130 may predict analytical measurements on a periodic or other suitable time basis.) as discussed in at least paragraphs 31, 42, and 43: obtaining current values, from manual sampling or a simulation, of one or more cell culture attributes associated with a cell culture (analytical instrument(s) 104 may measure one or more media component concentrations, such as nutrient and/or metabolite levels (e.g., glucose, lactate, glutamate, glutamine, ammonia, amino acids, Na+, K+, etc.) and media state parameters (pH, pC02, p02, temperature, osmolality, etc.). Additionally, or alternatively, analytical instrument(s) 104 may measure osmolality, viable cell density (VCD), titer, critical quality attributes, cell state (e.g., cell cycle) and/or other characteristics or parameters associated with the contents of bioreactor 102.) as discussed in at least paragraphs 24, 26 and 27; predicting, by processing hardware, one or more future values of a particular cell culture attribute associated with the cell culture, at least by applying (i) the current values of the one or more cell culture attributes, and (ii) an earlier value, obtained from manual sampling or a simulation at an earlier time interval, of at least one of the one or more cell culture attributes, as inputs to a data-driven predictive model (Computer 110 is coupled to Raman analyzer 106 and analytical instrument(s) 104, and is generally configured to analyze the Raman scan vectors generated by Raman analyzer 106 in order to predict one or more analytical measurements of the biopharmaceutical process. For example, computer 110 may analyze the Raman scan vectors to predict the same type(s) of analytical measurement(s) that are made by analytical instrument(s) 104.) as discussed in at least paragraphs 22-24, 27-28, 31, 35, 46 and 98; and controlling, by the processing hardware applying the one or more future values as inputs to a model predictive controller, one or more physical inputs to the cell culture process as discussed in at least paragraphs 46-47. Also see claims 12 and 20.
Regarding claim 2, Tulsyan discloses wherein the data-driven predictive model is a regression model as discussed in at least paragraphs 4 and 10.
Regarding claim 3, Tulsyan discloses wherein: obtaining the current values includes obtaining the current values during a current time interval; and predicting the one or more future values of the particular cell culture attribute includes, for a first cell culture attribute of the one or more cell culture attributes, applying (i) the current value of the first cell culture attribute, (ii) a value of the first cell culture attribute that was obtained during a first previous time interval that occurred prior to the current time interval, and (iii) a value of the first cell culture attribute that was obtained during a second previous time interval that occurred prior to the first previous time interval, as inputs to the data-driven predictive model (Computer 110 is coupled to Raman analyzer 106 and analytical instrument(s) 104, and is generally configured to analyze the Raman scan vectors generated by Raman analyzer 106 in order to predict one or more analytical measurements of the biopharmaceutical process. For example, computer 110 may analyze the Raman scan vectors to predict the same type(s) of analytical measurement(s) that are made by analytical instrument(s) 104. As a more specific example, computer 110 may predict glucose concentrations, while analytical instrument(s) 104 actually measure glucose concentrations.) as discussed in at least paragraphs 27, 31-32, 34-38, 42 and 46.
Regarding claim 4, Tulsyan discloses wherein for one or more additional time intervals that occur prior to the one or more time intervals: obtaining additional current values of the one or more cell culture attributes during a current time interval; predicting, by the processing hardware, an additional one or more future values of the particular cell culture attribute, at least by applying (i) the additional current values of the one or more cell culture attributes, (ii) an additional value of the first cell culture attribute that was obtained as an input to a different regression model; and controlling, by the processing hardware applying the additional one or more future values as inputs to the model predictive controller as discussed in at least paragraphs 27, 31-32, 42 , 45-46, 61-62 and 72.
Regarding claim 5, Tulsyan discloses wherein the data-driven predictive model is a neural network as discussed in at least paragraph 41.
Regarding claim 7, Tulsyan discloses wherein obtaining the current values of the one or more cell culture attributes associated with the cell culture includes: obtaining one or more Raman spectroscopy measurements of the cell culture; and determining the current value of at least one of the one or more cell culture attributes based on the one or more Raman spectroscopy measurements discussed in at least paragraphs 26-27 and 34-35.
Regarding claim 8, Tulsyan discloses wherein: the one or more cell culture attributes include one or more of (i) one or more metabolite levels, (ii) viable cell density, (iii) total cell density, (iv) viability, or (v) added feed volume; and the particular cell culture attribute is one of (i) a metabolite level, (ii) viable cell density, (iii) total cell density, or (iv) viability as discussed in at least paragraphs 7, 24 and 31.
Regarding claim 9, Tulsyan discloses wherein predicting the one or more future values of the particular cell culture attribute includes predicting a future value for each of at least two different days as discussed in at least paragraphs 73, 84, 86 and 89.
Regarding claim 10, Tulsyan discloses wherein controlling the one or more physical inputs to the cell culture process includes controlling an amount of glucose introduced into the cell culture (Control unit 152 is configured to control a glucose pump 154, i.e., to cause glucose pump 154 to selectively introduce additional glucose into the biopharmaceutical process within bioreactor 102.) as discussed in at least paragraphs 15-16 and 46-47.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tulsyan WO 2020/086635 as applied to claims 1-5 and 7-10 above, and further in view of Bharti et al. (hereinafter Bharti) CA 3094078.
Regarding claim 6, Tulsyan does not explicitly disclose that the neural network is a feedforward neural network.
Bharti discloses a feedforward neural network (Deep Neural Network 600) as discussed on at least page 20, lines 8-16. Also see page 19.
It would have been obvious to one of ordinary skill in the art to modify the neural network of Tulsyan to include a feedforward neural network as taught by Bharti since feedforward neural networks are typically more computationally efficient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached on (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796
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