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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been
timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR
1.114.
Applicant's submission filed on 13 August 2025 has been entered. Applicant indicates
on the Request for Continued Examination (RCE) Transmittal, 13 August 2025, that the
response of July 13 August 2025 be considered.
Claim status
In the reply filed 13 August 2025, Applicant has amended claims 1 and 13. Claims 27 and 28 are new. Claims 4, 11, 15, and 20 are cancelled and claims 22-26 are stand withdrawn.
Therefore, 1-3, 5-10, 12-14, 16-19, and 21-28 are herein pending.
Election/Restrictions
Applicant previously elected without traverse Group 1 claims 1-3, 5-10, 12-14, 16-19 and 21, drawn to a system in the reply filed on 06 January 2023.
Claims 22-26 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3, 5-10, 12-14, 16-19, 21, and 27-28 are herein under examination.
Withdrawn claim rejection 35 USC § 112(b)
The prior rejection of claims 1 and 13 under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention is withdrawn. The withdrawn is in light of Applicant’s amendment of claims 1 and 13 and to exclusively include “a single patient.” Therefore, this limitation in the claim overcome insufficient antecedent basis.
Maintained 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 1 and 13 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 “configured for” is 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 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 “configured for” 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 limitations are blood withdrawal device and infusion device in claims 1 and 13.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification “Blood withdrawal device 110 and cell therapy infusion device 150 can also be the same device, for example an apheresis device ([0021], [0022] and [0026])” 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.
Maintained and modified 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, 5-10, 12-14, 16-19, 21, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hauwaerts et al., (WO2018015561 A1, publication date: 25 January 2018; cited in PTO 892; hereinafter Hauwaerts), in view of Kenley et al. (US10471186 B2 Nov. 12, 2019; cited in PTO 892; hereinafter Kenley). This rejection is maintained for reasons of record and further explained below.
Regarding claims 1 and 13, Hauwaerts teaches a cell therapy production system for use with a single patient (p. 10 lines 31-32) at the bedside (p. 15 lines 20-22) comprising a cell separation device, a cell transduction apparatus, and a cell processing apparatus to produce cells for therapy.
Specifically, regarding claims 1(b, c, d), and 13 (b) ii-iv, Hauwaerts teaches a cell therapy production device comprising a fluidic cartridge (i.e., fluidly connected page 17, line 20) that comprises at least one input port, a separation chamber (i.e., cell separation device), an activation chamber, a transduction chamber (i.e., cell transduction apparatus), a cell culture chamber (i.e., a cell processing apparatus), and at least one output port (claims 18, 22, 27, 31 and Fig. 4-6, 8 and 9). Hauwaerts teaches that the cell transduction apparatus is an electroporation unit where genetic modification is done through transduction (p 24, lines 10-13). Furthermore, in regard to the elements being “fluidly connected”, Hauwaerts teaches the elements to produce CAR-T cells for therapy and to maintain their function in a 'functionally closed' sterile or aseptic processing environment. This way, the contamination risk of an automated system is essentially eliminated. (p 29, Line 15). Furthermore, in regard to the cell processing apparatus and cell transduction apparatus being fluidly connected to a patient, although Hauwaerts teaches the cells are autologous for direct administration to the patient (pgs. 1, 21, 27, see Claim 43), the Examiner has interpreted this limitation as being indirectly fluidly connected to the single patient via an infusion device.
Regarding claim 13 (b) i, Hauwaerts teaches that a cell processing device is an enclosed portable (i.e., housing) cell processing unit (Fig. 3, p11, lines 13-16)
However, regarding claims 1(a, e) and 13 (a, c), although Hauwaerts teaches apheresis (p. 10 lines 17-19) the cellular material is removed from the patient in the form of a bodily fluid (i.e. blood), the T-cells are then isolated and modified to express receptors on the cell surface specific to the particular form of cancer from which the patient is suffering, and then re-introduction to the patient, wherein the cells have the ability to target and kill cancer (p 1, line 21-24), with respect to claims 1(a, e), Hauwaerts is silent to preferred embodiment to use apheresis device.
Regarding claims 1(a, e) and 13 (a, c), Kenley teaches an apheresis device comprises an automated blood separation device that includes a blood inlet line that delivers blood from a single patient and consists of a blood outlet line that directly returns blood from the blood separation device to the patient (column 3, line 45 and column 8 lines 34-62).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to prepare the cell therapy product system of Hauwaerts comprising a cell separation device, a cell transduction apparatus, and a cell processing apparatus that are fluidly connected and combine the blood withdrawal and infusion device that are fluidly connected as taught by Kenley with a reasonable expectation of success. The ordinarily skilled artisan would have been motivated to do so as taught by Kenley, because a blood withdrawal that fluidly connected to a cell processing device to produce CAR-T cells for therapy and infusion device can maintain their function in a sterile or aseptic processing environment (p. 11, 3rd to 5th para., p. 29, 3rd para. of Hauwaerts, see also col 8, 6th para. of Kenley).
Additionally, Hauwaerts teaches that the cell therapy production system for use with a single patient (p. 10 lines 31-32) at the bedside (p. 15 lines 20-22) and the cell processing device is an enclosable portable (i.e., housing) cell processing unit (Fig. 3, p 11, lines 13-16), and a trolley could be used to collect the cell sample directly from the patient at the bedside (p 15, line 20-22). Furthermore, Kenley teaches a dialysis system that withdraws blood from the patient and infuses the purified blood into the patient (column 3, line 45, Fig. 1 and 4). Thus, it would have been obvious that this system collocated with the bed and located within the single patient's room.
Furthermore, Hauwaerts teaches that the cell therapy production system is a automated cell processing, with a computer control system and user interface for monitoring, and user operation procedure to control the cell processing device (cell separation, transduction, and cell culture) (p 4 lines 2-5; p. 8, 1st para., p 13, 2nd para., p.38, 1st para.).
Regarding claims 2, 3 and 14, Hauwaerts teaches a target cell population is T cells (p. 24, lines 1 and 5; p 49, lines 18-19; claim 44). Furthermore, Hauwaerts teaches that the cell separation device comprises a matrix, fluidic cartridge, or column made of beads, clouds, gels or has a surface that positively captures T cells (p. 24, lines 4-6, lines 16-17, lines 20-31).
Regarding claim 5, Hauwaerts teaches that the cell processing device is an automated (p. 15, line 17) cell processing (i.e., engineering) unit that includes a separation chamber, an activation chamber, a transduction chamber, a cell culture chamber contained within an automated cell engineering system (Fig. 3, claim 18).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to prepare an automated cell engineering system since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 6, Hauwaerts teaches that the cell processing device comprises a cell culture chamber.
Regarding claim 7, 10, and 19, Hauwaerts teaches an automated cell processing (i.e., engineering) system (claim 37, p. 15, line 17) is an enclosable portable (i.e., housing) cell processing unit (Fig. 3, p11, lines 13-16).
Regarding claims 8 and 16, Hauwaerts teaches a cell processing device wherein a single or more fluidic cartridge (i.e., fluidly connected page 17, line 20) comprises a cell culture chamber wherein the fluidics pathways provide recirculation (p 33, line 38), removal of waste (p 34 line 2) and homogenous gas exchange (p 35, line 14) and distribution of nutrients (p 33, line 10) to the cell culture chamber without disturbing cells (p 16 line 18).
Regarding claims 9 and 17, Hauwaerts teaches that the cell processing device comprises with one or more sensors (i.e., glucose monitors, oxygen sensors, optical cell counters) (p. 13, lines 15-17, p.16, lines 8-10).
Regarding claims 12 and 21, Hauwaerts teaches that the cell processing device is an enclosable portable (i.e., housing) cell processing unit (Fig. 3, p 11, lines 13-16), and a trolley could be used to collect the cell sample directly from the patient at the bedside (p 15, line 20-22). Furthermore, Kenley teaches a dialysis system that withdraws blood from the patient and infuses the purified blood into the patient (column 3, line 45, Fig. 1 and 4). Thus, it would have been obvious that this system collocated with the bed.
Regarding claims 27 and 28, Hauwaerts teaches that the cell processing device the cell separation device comprises magnetic separation devices (p. 33 lns 22-25) that use magnetic beads (p. 24 lns 4-6, 29-30).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 13 August 2025 are acknowledged.
First, Applicant discloses that independent claim 1 is amended to further recite the features previously presented in now-cancelled claims 4 and 11, and argues that Hauwaerts in view of Kenley fails to teach or suggest at least the above combination of features of present independent claim 1 when viewed as a whole. Independent claim 13 is amended to recite features similar to those recited in present independent claim 1 (and similarly recited in now cancelled claims 15 and 20).
See the remark p. 8 2nd ¶ and declaration listing no: 8-13, p. 4.
Applicant's arguments have been fully considered but they are not persuasive. The amended claims exclusively include the limitation of canceled claims, and those limitation was taught by the primary reference Hauwaerts. Therefore, for reasons of record in this maintained but modified rejection examiner further explained the teaching with citation in modified 103 rejection for independent claims 1 and 13. Additionally, dependent claims 2, 3, 5-10, 12, 14, 16-19, and 21 depend from and add further features to independent claims 1 and 13, and are therefore maintained the rejection over Hauwaerts in view of Kenley for at least the same reason presented above for present independent claims 1 and 13.
Conclusion
All claims are identical to, patentably indistinct from, or have unity of invention with the claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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, Christopher Babic can be reached on (571) 272-8507. 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.
/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633