Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 13-21 in the reply filed on 4/1/2026 is acknowledged. The traversal is on the ground(s) that i) the alleged inventions are all dependent claims that depend from independent method claim 13, and ii) the applied reference in Requirement for Restriction/Election filed 2/13/2026, i.e. Malmquist et al. (WO Pub. No. 2020/260073; hereinafter Malmquist; already of record), does not teach monitoring at least one product quality attribute (PQA) for a target product, identifying trends and/or deviations by comparing the monitored at least one PQA to the critical to quality (CTQ) profile of the target product, and controlling process parameters of the bioreactor based on the identified trends and/or deviations to maintain the target product within the CTQ profile.
This is not found persuasive because, regarding point i), MPEP 1850(II) states that, “The examiner should bear in mind that a claim may also contain a reference to another claim even if it is not a dependent claim as defined in PCT Rule 6.4. One example of this is a claim referring to a claim of a different category (for example, "Apparatus for carrying out the process of Claim 1 ...," or "Process for the manufacture of the product of Claim 1 ...")”. Therefore, claims 22-24, although they depend directly or indirectly from claim 13, are not considered dependent claims for purposes of lack of unity. See also Annex B, which states that “Unity of invention has to be considered in the first place only in relation to the independent claims in an international application and not the dependent claims. By "dependent" claim is meant a claim which contains all the features of another claim and is in the same category of claim as that other claim (the expression "category of claim" referring to the classification of claims according to the subject matter of the invention claimed － for example, product, process, use or apparatus or means, etc.).”. In this instance, all of claims 22-24 are drawn to different categories than claim 13, as claim 13 is drawn to a method, while claim 22 is drawn to a system, claim 23 to a computer program, and claim 24 to a computer-readable storage medium.
Further, regarding point ii), this is not found persuasive because Applicant’s arguments that Malmquist does not teach the claimed limitations are conclusory. Further, with regards to Applicant’s argument that Malmquist does not teach embodiments of the invention that use sensing to enable rapid control adjustments to be made in a bioreactor system, thereby enabling biologics yield to be maximized while providing accurate time-stamped manufacturing records for regulatory approval purposes, these arguments are not drawn to claimed features of the invention, and are therefore moot.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 13-24 are pending, with claims 13-21 being examined, and claims 22-24 deemed withdrawn. Claims 1-12 are canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) received on 7/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 21 is objected to because of the following informalities:
Regarding claim 21, Lns. 1-2 recite, “wherein the step of controlling process parameter…”, which is grammatically correct. To be grammatically correct and to be in agreement with claim 13, which recites, “controlling process parameters of the bioreactor…”, the Examiner suggests amending the above limitation to recite, “wherein the step of controlling process parameters…” to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 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.
Claim 17 recites the limitation "the at least second sensor system" in Ln. 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of compact prosecution, the claim has been examined as only requiring the at least first sensor system.
Examiner’s Note: in order to overcome a 112(b) rejection for claim 17, the claim must provide sufficient antecedent basis for both “the at least first sensor system” and “the at least second sensor system”.
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 13-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The subject matter eligibility test for the claims is shown below:
Step 1: Claim 13 is directed toward a device.
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract idea.
Claim 13 recites the abstract idea, “identifying trends and/or deviations by comparing the monitored at least one PQA [product quality attribute] to the CTQ [critical to quality] profile of the target product”. The act of identifying trends and/or deviations by comparing a measured property to a desired property is a determination/evaluation-type mental process that can be practically performed in the human mind. Further, the act of deciding how to alter process parameters based on the identified trends and/or deviations is a decision that can be practically performed in the human mind, and is a mental process. Independent claim 13 is therefore drawn to a mental process-type abstract idea.
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Independent claim 13 additionally recites, “monitoring at least one product quality attribute, PQA, for the target product”. This amounts to mere data gathering, and is insignificant extra-solution activity. See MPEP 2106.05(g). Independent claim 13 additionally recites, “controlling process parameters of the bioreactor based on the identified trends and/or deviations to maintain the target product within the CTQ profile”. As previously stated in Step 2A, Prong One, the act of deciding how to alter process parameters based on the identified trends and/or deviations is a decision that can be practically performed in the human mind, and is a mental process. The act of actually controlling process parameters of the bioreactor based on the identified trends and/or deviations amounts merely to “apply it”. See MPEP 2106.05(f).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claim 13 recites the additional element of a bioreactor. However, this additional element does not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(c) and MPEP 2106.05(d). Further, the recitation of a bioreactor merely generally links the use of the mental process-type judicial exception to a biochemical process field. See MPEP 2106.05(h).
Further, with regards to the generically recited bioreactor being nothing more than a well-understood, routine, and conventional components that are well-known in the art, the following prior art is relied upon to show that the above element is well-understood, routine, and conventional:
Webster et al. (US Pub. No. 2023/0204421; hereinafter Webster) teaches a bioreactor ([0007]).
Angelini et al. (US Pub. No. 2022/0056398; hereinafter Angelini) teaches a bioreactor ([0005]).
Hincapie et al. (US Pub. No. 2021/0087514; hereinafter Hincapie) teaches a bioreactor ([0085]).
Hyckenberg et al. (WO Pub. No. 2020/002713; hereinafter Hyckenberg) teaches a bioreactor (Pg. 2 Ln. 20-Pg. 3 Ln. 6).
Claims 14-19 merely further define the steps that go into data-gathering, and therefore do not integrate the judicial exception into a practical application, or contain additional elements that amount to significantly more than the judicial exception.
Claim 20 applies a generically recited “self-learning system” to analyze the at least one PQA for the step of identifying trends and/or deviations (which has been previously established as a mental process-type judicial exception). Mere instructions to implement an abstract idea on a computer do not amount to significantly more than the judicial exception. See MPEP 2106.05(A).
Claim 21 merely further defines the “apply it” step of “controlling process parameters…” previously described in claim 13, and does not integrate the judicial exception into a practical application, or contain additional elements that amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 13-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyckenberg.
Regarding claim 13, Hyckenberg discloses a method for controlling process parameters in a bioreactor when producing a target product with a pre-determined critical to quality, CTQ, profile (Pg. 7 Ln. 8-Pg. 8 Ln. 20, see Fig. 3). The method comprises:
monitoring at least one product quality attribute, PQA, for the target product (Pg. 7 Ln. 8-Pg. 8 Ln. 20, see Fig. 3).
Identifying trends and /or deviations by comparing the monitored at least one PQA to the CTQ profile of the target product (Pg. 7 Ln. 8-Pg. 8 Ln. 20, the measured quality attribute is compared to the desired characteristics of the target product, where the target characteristics are within a pre-determined range, see Fig. 3).
Controlling process parameters of the bioreactor based on the identified trends and / or deviations to maintain the target product within the CTQ profile (Pg. 7 Ln. 8-Pg. 8 Ln. 20, the cell culture process is controlled to meet the desired characteristics of the target product).
Regarding claim 14, Hyckenberg discloses the method according to claim 13, wherein the step of monitoring the at least one PQA further comprises obtaining PQA data from at least a first sensor system directly mounted to the bioreactor to establish the at least a first PQA (Pg. 12 Lns. 3-22, Raman spectroscopy is measured in-line).
Regarding claim 15, Hyckenberg discloses the method according to claim 14, wherein the PQA data is obtained by measuring selected parameters within the bioreactor (Pg. 5 Lns. 13-17, Pg. 12 Lns. 3-22).
Regarding claim 16, Hyckenberg discloses the method according to claim 13, wherein the step of monitoring the at least one PQA further comprises accessing a sample from the bioreactor and obtaining data from the sample by at least a second sensor system installed at-line or on-line to the bioreactor to establish the at least one PQA (Pg. 5 Lns. 13-17, Pg. 12 Lns. 3-22, LC-MS and MS-MS are measured at-line).
Regarding claim 17, Hyckenberg discloses the method according to claim 14, wherein each of the at least first sensor system and the at least second sensor system is based on spectroscopic methods, surface plasmon resonance, mass spectroscopy, light scattering or light absorbance (Pg. 5 Lns. 13-17, Pg. 12 Lns. 3-22).
Regarding claim 18, Hyckenberg discloses the method according to claim 13, wherein the at least one PQA of the target product is selected to be polypeptide sequence variations or posttranslational modifications or degradation of the target molecule (Pg. 6 Lns. 7-15).
Regarding claim 19, Hyckenberg discloses the method according to claim 13, wherein the step of monitoring at least one PQA is performed in real-time or near real-time (Pg. 6 Ln. 21-Pg. 7 Ln. 7, see Fig. 5).
Regarding claim 20, Hyckenberg discloses the method according to claim 19, wherein the step of identifying trends and /or deviations further comprises analyzing the at least one PQA in a self-learning system (Pg. 10 Lns. 19-28, see Fig. 6).
Regarding claim 21, Hyckenberg discloses the method according to claim 13 wherein the step of controlling process parameters further comprises adjusting one or more of the following process parameters in the bioreactor: pH, temperature, stirring rate, dissolved oxygen, partial pressure of carbon dioxide and nutrients (Pg. 12 Lns. 3-22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Primary Examiner, Art Unit 1798
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