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 .
Summary
1. Claims 1-22 are 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.
2. Claims 1-22 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.
3. Claims 1-22 are rejected under 35 U.S.C. 103 as obvious over Hoang (US 11,098,079 B2) in view of Lee (US 2010/0023307 A1).
Claim Objections
The examiner is appreciative of the applicant proactively correcting multiple dependency issues. Please kindly consider compacting certain dependent claim combinations to better reflect the contours of the independent claims. Namely, please combine:
-in the method: 2 and 3 (2/3); 4 and 5 (4/5); 6 and 7 (6/7).
-in the system: 13 and 14 (13/14); 15 and 16 (15/16); 17 and 18 (17/18).
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the GUI as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
1. Claims 1-22 are 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 claims are drawn broadly to cover any system or method that: (a) generates a principal component analysis (PCA) model from historical datasets of sterile filtration processes for protein molecules; (b) maps target process parameters into the PCA-defined model space; and causes sterile filter validation to be selectively bypassed or not bypassed based on whether the mapped values fall within a “normal operating region” and an associated error space. The claims encompass any combination of process parameters, formulation parameters, and intrinsic protein molecule parameters and any PCA-based model and decision criteria that would result in bypassing or not bypassing sterile filter validation.
However, the specification appears to disclose only a single or limited number of specific implementations of the claimed PCA-based approach. The disclosure lacks sufficient guidance for a person of ordinary skill in the art to practice the full breadth of the claimed invention across the wide variety of possible parameter sets, PCA model constructions, preprocessing methods, component-selection criteria, definitions of “normal operating region” and “associated error space,” measurement-system implementations, and threshold-setting procedures (e.g., thresholds for T2 and SPE) without undue experimentation. In particular, the specification does not adequately teach or exemplify:
• how to select, preprocess, normalize, or otherwise handle diverse parameter types (including but not limited to the wide range of process, formulation, and intrinsic protein parameters recited in the claims) so that PCA yields a valid and reliable model across all claimed embodiments;
• how to determine the number of principal components to retain or how to define the model space in a manner that applies across the full scope of the claimed parameter combinations;
• objective, reproducible methods for defining the claimed “normal operating region” and the “associated error space” for arbitrary protein molecules and process/formulation parameter combinations; and
• how to set, justify, and validate threshold values (e.g., T2 and SPE thresholds) so that the bypass decision is operable and reliable across the full range of species, process conditions, and instrumentation encompassed by the claims.
Given the breadth of the claims and the absence of adequate disclosure addressing the variations and parameters summarized above, the Examiner determines that undue experimentation would be required to practice the full scope of the claimed invention. Accordingly, claims 1–22 are not enabled.
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.
2. Claims 1-22 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.
The terms “selectively” and “normal” are relative terms which render the claims indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
How would the method and system proceed if the target values fall outside the normal operating region (of the model space and/or error space)? Would the filter validation be x) bypassed or y) not bypassed? Or, would the (final) causation feature just not occur at all? Equally, because certain phrases were contracted, it is unclear if the space(s) actually have any materiality in the causation aspect.
Claim Rejections - 35 USC § 103
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 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.
3. Claims 1-22 are rejected under 35 U.S.C. 103 as obvious over Hoang (US 11,098,079 B2) in view of Lee (US 2010/0023307 A1).
As per claims 1 and 12,
Hoang discloses:
The use of charged depth filtration to promote re‑oxidation of partially reduced antigen‑binding proteins in aqueous solution, decreasing the fraction of reduced species and stabilizing product quality.
-Applicable to antigen‑binding proteins broadly (antibodies, Fc‑containing proteins, peptibodies, fragments), with emphasis on IgG1/IgG2 antibodies.
-A practical, process‑integrated approach to repair or prevent partial reduction without changing the core unit operations drastically.
-More effective than aeration/chilling/sterile filtration in restoring disulfide integrity and reducing fragments/aggregates.
-Scales across a range of throughputs and process placements; the beneficial effect continues during post‑filter holds and can be synergistic with CEX.
Hoang, thereby, evinces a need to augment/improve/upgrade sterile filtration for proteins, including but not limited to upstream and/or downstream processing (see at least Abstract, Background, claim 1). Hoang , however, presents a particularized approach.
Lee, in the field of manufacturing and process control, teaches:
obtaining, by one or more processors, a plurality of historical datasets that each include respective values of a plurality of parameters associated with a respective process for a respective item, wherein the plurality of parameters includes one or more process parameters; generating, by one or more processors processing the plurality of historical datasets, a principal component analysis (PCA) model ([0008]-[0017] model) that includes a plurality of vectors, the vectors (i) each corresponding to a differently weighted combination of the plurality of parameters and (ii) collectively forming an uncorrelated orthogonal basis set that defines a model space ([0018]-[0019] space); obtaining, by one or more processors, a target dataset that corresponds to a process for a target and includes target values of the plurality of parameters; mapping, by one or more processors, the target values onto the model space ([0052]-[0110] mapping); determining, by one or more processors, whether the mapped target values fall within a normal operating region of the model space and an associated error space ([0008] “generating a confidence value by comparing the predicted feature space with a normal baseline distribution, a faulty baseline distribution, or a combination thereof; and providing a status of mechanical system based at least in part on the confidence value”).
It would have been obvious to one of ordinary skill in the art at the time of filing to improve sterile filtration for proteins with the mathematical techniques of Lee, and the results would have been predictable. One would have been motivated to make the combination to proactively replace filters, rather than have a reactive maintenance program.
As per claims 2-11 and 13-22,
Hoang fairly suggests the waterfront of filtration parameters for proteins, including but not limited to a process requiring sterility.
E.g., Hoang’s operating conditions include:
• Throughput examples range from ~150 to 850 L/m²; higher throughput slows early kinetics but reaches the same steady state re oxidation within ~24 h.
• Flow rates typically ≤200 LMH; pressure ≤50 psi.
• Temperature: room temperature or 2–8 °C; re oxidation proceeds under both.
• Effect often continues post filtration during a hold (hours to a few days) until a lower steady state level of reduced species is reached.
Therefore, the examiner finds that all of the variables of the dependent claims are known, and that it would have been obvious to arrange / analyze them according to the techniques of Lee, with the motivation of maintaining process integrity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL FUELLING whose telephone number is (571)270-1367.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL FUELLING/ Supervisory Patent Examiner,