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
The information disclosure statement (IDS) submitted on 11/11/2025 is 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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: laser module in claims 2 and 12.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claims 7-9 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. In particular, the term “types” in claim 7 is not defined by the claim nor is it defined in the specification. Therefore, since claims 8-9 depend on claim 7 either directly or indirectly, they are also rejected under 112(b) for the reasons discussed above.
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.
Claims 1-3 and 5-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFarland et al. (US2025/0179404 A1-hereafter “McFarland”, has an earlier effective filing date as of the provisional application).
Regarding claim 1, McFarland discloses a system for mimicking cellular microenvironment (cell therapy manufacturing systems can include synthetic surfaces capable of mimicking of the function of dendritic cells, para. [0143]) comprising: a chip (microfluidic device 100, para. [0488], Fig. 1A); a microfluidic device or a nanofluidic device may be referred to herein as a “microfluidic chip” or a “chip”; or “nanofluidic chip” or “chip”, para. [0081]).
“a first carrier having a pore;”: McFarland discloses support structure 104, para. [0489], Fig. 1A, where structure 104 includes an opening, port 107, Fig. 1A; para. [0490], a pass-through hole).
“and a second carrier coupled to the first carrier;”: McFarland discloses cover 110, shown coupled to support structure 104 in Fig. 1A.
“a hydrogel disposed in the pore and comprising an extracellular matrix;”: McFarland discloses a cell matrix protein, which may be included in a coating material, can include, but is not limited to, a collagen, para. [0592]).
“and a cell in contact with the hydrogel.”: McFarland discloses an extracellular matrix (ECM) protein may be provided within the coating material for optimized cell adhesion to foster cell growth (para. [0592]).
Regarding claim 2, McFarland discloses the imaging device 194 can also include a mechanism for directing stimulating radiation and/or light beams into the microfluidic circuit 120 (para. [0497]; where circuit 120 is shown oriented on microfluidic device 100, Fig. 1A).
Regarding claim 3, McFarland discloses the cover 110 may comprise PDMS (para. [0495]) and support structure 104 may be transparent to light (para. [0495]).
Regarding claim 5, McFarland discloses various cell types (para. [0132]).
Regarding claim 6, , McFarland discloses various cell types (para. [0132]).
Regarding claim 7, McFarland discloses various cell types (para. [0132]).
Regarding claim 8, McFarland discloses surfaces of tumor cells (para. [0334]).
Regarding claim 9, McFarland discloses tumor cells such as CD19, CD20, CLL-1, TRP-2, LAGE-1, HER2, EphA2, FOLR1, MAGE-A1, mesothelin, SOX2, PSM, CA125, T antigen, etc. (para. 0334]); and McFarland discloses blood cells—non-tumor cells (para. [0120]).
Regarding claim 10, McFarland discloses a method for manufacturing a population of cells suitable for formulation as a cellular therapeutic and the method can include introducing a cell sample from a subject into the inlet port of a cartridge (para. [0005]; McFarland discloses the cell matrix may include growth factors (para. [0592]); the growth factors are stimulatory. Moreover, McFarland discloses analytical devices such as flow cytometers and microscopes can be used to evaluate cell surface markers and cell purity (para. [0173]).
Regarding claim 11, McFarland discloses growth factor stimulation (growth factors, para. [0592]). It should be noted that that the term “and/or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 12, McFarland discloses the imaging device 194 can also include a mechanism for directing stimulating radiation and/or light beams into the microfluidic circuit 120 (para. [0497]; where circuit 120 is shown oriented on microfluidic device 100, Fig. 1A); another illumination effect made possible by use of structured light patterns is selective curing, e.g., solidification of hydrogels within the microfluidic device (para. [0085]).
Regarding claim 13, McFarland discloses dye exclusion assays may be performed for cell viability (para. [0173]). It should be noted that that the term “and/or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 14, McFarland discloses cartridges for manufacturing a population of cells suitable for formulation as a cellular therapeutic are disclosed herein, along with systems and instruments for operating the cartridges and performing methods to generate the population of cells suitable for formulation as a cellular therapeutic (Abstract) and the system discussed above in claim 1. Moreover, McFarland discloses cell therapy effectiveness depend on having enough cells for administering to the subject (para. [0155]) and aspects of evaluating cell therapy products often include the use of potency assays (para. [0178]).
Regarding claim 15, McFarland discloses the cell matrix may include growth factors (para. [0592]); the growth factors are stimulatory.
Regarding claim 16, McFarland discloses growth factor stimulation (growth factors, para. [0592]). It should be noted that that the term “and/or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
Regarding claim 17, McFarland discloses cells (e.g., T-cells) can be contacted with growth stimulatory molecules, such as growth factors (para. [0141]).
Regarding claim 18, McFarland discloses aspects of cell therapy effectiveness depend on having enough cells for administering to the subjects (para. [0155]). Also, McFarland discloses dye exclusion assays may be performed for cell viability (para. [0173]). It should be noted that that the term “and/or” in the claim is being interpreted to indicate that one of the clauses needs to be met by the prior art in order to anticipate or render the instant claim obvious.
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. (US2025/0179404 A1-hereafter “McFarland”, has an earlier effective filing date as of the provisional application) as applied to claim 1 above, and further in view of Koh et al. (US2023/0266209 A1-hereafter “Koh”, has an earlier effective filing date as of the provisional application).
Regarding claim 4, McFarland discloses the invention discussed above in claim 1. However, McFarland does not explicitly disclose wherein the extracellular matrix comprises at least one selected from the group consisting of N-isopropyl acrylamide, gelatin methacrylate, and annealed graphene oxide.
For claim 4, Koh teaches compositions and methods for efficient transfer and analyses of cellular material, tissue samples, such as tissue sections, using carrier substrates (Abstract) and hydrogel polymers which may include N-isopropylacrylamide (para. [0076], which may include one or more crosslinkers).
Hence, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the device of McFarland and include a hydrogel including a crosslinker such as N-isopropylacrylamide as taught by Koh, since Koh teaches these materials allow for the formation of a three-dimensional network (para. [0076]) which allows for structural stability and strength of the hydrogel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. 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.
/LENORA A ABEL/Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
