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 .
Response to Amendment
The amendment filed 08/08/2025 has been entered. Claims 1-4, 11, 14-18 have been amended. Claims 1-23 remain pending in this application.
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 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: a sample processing module and a cell infusion module in claim 1.
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.
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 § 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 1-7, 9, 12-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon (Pat. No.: US 9,694,128 B1) in view of June et al. (Pub. No.: US 2004/0203155 A1) and further in view of Liberti et al. (Pub. No.: US 2018/0291364 A1).
Regarding claim 1, LeBerthon discloses (fig. 10) a device for immune therapy or causing a T cell response (abstract), the device comprising:
A sample processing module (IV type line 220), wherein the sample processing module obtains a blood sample from a subject (col. 9, ln. 51-53),
A cell incubation module (device 10a), wherein the cell incubation module:
Receives the blood sample (col. 9, ln. 51-55),
Introduces a substance into the cells of the blood sample (col. 9, ln. 57-col. 10, ln. 10); and
A cell infusion module (line 222), wherein the cell infusion module infuses at least a portion of the blood sample to the subject (col. 9, ln. 55-57);
Wherein the sample processing module is connected to the cell incubation module which is connected to the cell infusion module such that a portion of the blood sample flows from the subject through the device and back to the subject (fig. 10, col. 9, ln. 49-57).
Regarding the limitation of “the blood sample comprising T cells”, such limitation is inherent to the blood sample of LeBerthon as LeBerthon discloses that the blood sample is whole blood (the blood is received directly from the patient, col. 9, ln. 51-54).
Regarding the limitation of the “cell incubation module configured to…wash the blood sample to remove nontransduced vectors”, such limitation relates to the function of the cell incubation module. Since the cell incubation module of LeBerthon can receive a fluid such as a saline solution (col. 9, ln. 66-67), it is capable of being configured to wash the blood sample to remove nontransduced vectors.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
LeBerthon fails to disclose that the substance is one or more vectors and mixing the blood sample with the one or more vectors and an agent that activates T cells for introduction of the one or more vectors into the cells of the blood sample.
June teaches a method of immune therapy or causing a T cell response (abstract) and thus in the same field of endeavor, wherein one or more vectors is introduced into the cells of a blood sample by mixing the blood sample with the one or more vectors and an agent that activates T cells for introduction of the one or more vectors into the cells of the blood sample (¶ 0022, ¶ 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substance of LeBerthon such that it comprises one or more vectors and an agent that activates T cells, as taught by June, thereby configuring the cell incubation module to introduce one or more vectors into the cells of the blood sample by mixing the blood sample with the one or more vectors and an agent that activates T cells for introduction of the one or more vectors into the cells of the blood sample, in order to induce gene therapy (June ¶ 0005).
LeBerthon in view of June fail to disclose the cell incubation module comprising a rotating container, wherein the cell incubation module rotates the container to maintain cells of the blood sample in suspension for culture and/or growth.
Liberti teaches (fig. 1) a device for immune therapy (system 10, ¶ 0033) and thus in the same field of endeavor, comprising: a cell incubation module (chamber 20) comprising a rotating container (¶ 0033), wherein the cell incubation module rotates the container to maintain cells of the blood sample in suspension for culture and/or growth (¶ 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cell incubation module of LeBerthon in view of June such that it comprises a rotating container, as taught by Liberti, in order to improve incubation (Liberti ¶ 0059).
Regarding claim 2, LeBerthon discloses wherein the blood sample comprises substantially whole blood (the blood is received directly from the patient, col. 9, ln. 51-54). The limitation of “the portion of the blood sample infused into the subject comprises at least two of CD3+ cells, NK cells, myeloid cells, and neutrophil” is inherent to the blood sample of LeBerthon as LeBerthon discloses that the blood sample is whole blood (the blood sample comprising whole blood is received directly from the patient, col. 9, ln. 51-54, followed by being treated and then returned to the patient).
Regarding claim 3, LeBerthon in view of June and further in view of Liberti fail to disclose wherein the cell incubation module further removes one or more blood cells from the blood sample, the one or more blood cells comprise B cells.
June teaches removing one or more blood cells from the blood sample, the one or more blood cells comprise B cells (¶ 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cell incubation module of LeBerthon in view of June and further in view of Liberti such that it is further configured to remove one or more blood cells from the blood sample, the one or more blood cells comprise B cells, as taught by June, in order to obtain primary T cells from a subject (June ¶ 0048).
Regarding claim 4, LeBerthon in view of June and further in view of Liberti fail to teach wherein the cell incubation module further removes one or more blood cells from the blood sample using a bead conjugated with an antibody against a B cell marker.
June teaches removing one or more blood cells from the blood sample using a bead conjugated with an antibody against a B cell marker (¶ 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cell incubation module of LeBerthon in view of June and further in view of Liberti such that it is further configured to remove one or more blood cells from the blood sample using a bead conjugated with an antibody against a B cell marker, as taught by June, in order to obtain primary T cells from a subject (June ¶ 0048).
Regarding claim 5, the limitation of “the blood sample comprises peripheral blood mononuclear cells”, such is inherent to the blood sample of LeBerthon as LeBerthon discloses that the blood sample is whole blood (the blood is received directly from the patient, col. 9, ln. 51-54).
Regarding claim 6, LeBerthon in view of June and further in view of Liberti disclose an agent, as discussed above in claim 1. LeBerthon in view of June and further in view of Liberti further disclose wherein the agent comprises a T cell activator (June ¶ 0005).
Regarding claim 7, LeBerthon in view June and further in view of Liberti disclose an agent, as discussed above in claim 1. LeBerthon in view of June and further in view of Liberti further disclose wherein the agent comprises a bead conjugated with anti-CD3 and a bead conjugated with anti-CD28 (June ¶ 0041).
Regarding claim 9, LeBerthon in view of June disclose and further in view of Liberti one or more vectors, as discussed above in claim 1. LeBerthon in view of June and further in view of Liberti further disclose wherein the one or more vectors are in a form of a viral particle that comprises a membrane-bound T cell activation element on a surface of the viral particle (June ¶ 0055).
Regarding claim 12, LeBerthon further discloses wherein the device comprises a material comprising plastic (col. 9, ln. 29-32).
Regarding claim 13, LeBerthon further discloses wherein the plastic comprises polystyrol, polystyrene, polyvinylchloride, polycarbonate (col. 9, ln. 29-32), glass, polyacrylate, polyacrylamide, polymethylmethacrylate (PMMA), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), thermoplastic polyurethane (TPU), silicone, polyethylene (PE), collagen, chitin, alginate, hyaluronic acid derivative, polylactide (PLA), polyglycolide (PGA), or a combination thereof.
Regarding claim 16, LeBerthon further discloses wherein vein-to-vein time for blood flow from the subject and back to the subject is between 10 and 90 minutes (col. 6, ln. 39-46),
However, LeBerthon fails to explicitly disclose the vein-to-vein time being between about 30 minutes and 1 hour, about 1 hour and 72 hours, about 1 hour and 12 hours, about 1 hour and 24 hours, about 1 hour and 48 hours, about 12 hours and 24 hours, about 12 hours and 48 hours, or about 48 hours and 72 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vein-to-vein time for blood flow of LeBerthon such that it is between about 30 minutes and 1 hour, about 1 hour and 72 hours, about 1 hour and 12 hours, about 1 hour and 24 hours, about 1 hour and 48 hours, about 12 hours and 24 hours, about 12 hours and 48 hours, or about 48 hours and 72 hours, as applicant appears to have placed no criticality on the claimed range (see specification ¶ 00356 indicating the vein-to-vein time “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 17, LeBerthon discloses wherein the vein-to-vein time is between 10 and 90 minutes (col. 6, ln. 39-46).
However, LeBerthon fails to explicitly disclose the vein-to-vein time being between about 1 hours or about 12 hours and 24 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vein-to-vein time for blood flow of LeBerthon such that it is between about between about 1 hours or about 12 hours and 24 hours, as applicant appears to have placed no criticality on the claimed range (see specification ¶ 00356 indicating the vein-to-vein time “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon in view of June and further in view of Liberti, as applied to claim 1 above, and further in view of Lee et al. (Pub. No.: US 2020/0354677 A1).
Regarding claim 8, LeBerthon in view of June and further in view of Liberti fail to teach wherein the agent further comprises protamine sulfate.
Lee teaches a method of immune therapy or causing a T cell response (abstract) and thus in the same field of endeavor, comprising an agent that activates T cells for introduction of a vector (¶ 0249), wherein the agent further comprises protamine sulfate (¶ 0250).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the agent of LeBerthon in view of June and further in view of Liberti such that it comprises protamine sulfate, as taught by Lee, as protamine sulfate is suitable for reducing repulsion forces between cells and vectors and mediates contact and/or binding of the vector to the cell surface (Lee ¶ 0249-¶ 0250).
Claims 10-11, 18 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon in view of June and further in view of Liberti, as applied to claims 9 and 1 above, and further in view of Scharenberg et al. (Pub. No.: US 2021/0147871 A1).
Regarding claim 10, LeBerthon in view of June and further in view of Liberti fail to teach wherein the membrane-bound T cell activation element comprises anti-CD3.
Scharenberg teaches (fig. 1A) a vector for use in gene therapy (¶ 0039) and thus in the same field of endeavor, wherein the vector is in a form of a viral particle that comprises a membrane-bound T cell activation element on a surface of the viral particle, wherein the membrane-bound T cell activation element comprises anti-CD3 (fig. 1A, ¶ 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the membrane-bound T cell activation element of LeBerthon in view of June and further in view of Liberti such that it comprises anti-CD3, as taught by Scharenberg, in order to further enhance T-cell activation (Scharenberg ¶ 0011).
Regarding claim 11, LeBerthon in view of June and further in view of Liberti fail to teach wherein the viral particle further comprises a membrane-bound polypeptide that binds to CD28.
Scharenberg teaches (fig. 1A) a vector for use in gene therapy (¶ 0039) and thus in the same field of endeavor, wherein the vector is in a form of a viral particle that comprises further comprises a membrane-bound polypeptide that binds to CD28 (fig. 1A, CD28 ligand, ¶ 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify viral particle of LeBerthon in view of June and further in view of Liberti such that it comprises a membrane-bound polypeptide capable of binding to CD28, as taught by Scharenberg, in order to further enhance T-cell activation (Scharenberg ¶ 0011).
Regarding claim 18, LeBerthon in view of June and further in view of Liberti fail to teach wherein the one or more vectors comprise a polynucleotide encoding a chimeric antigen receptor (CAR) targeting a WBC antigen and a polynucleotide encoding a CAR targeting a solid tumor antigen.
Scharenberg teaches (fig. 1A) a vector for use in gene therapy (¶ 0039) and thus in the same field of endeavor, wherein the vector comprises a polynucleotide encoding a chimeric antigen receptor (CAR) targeting a WBC antigen (e.g., CD19, ¶ 0064) and a polynucleotide encoding a CAR targeting a solid tumor antigen (e.g., B7-H3, ¶ 0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vector of LeBerthon in view of June and further in view of Liberti such that it comprises a polynucleotide encoding a chimeric antigen receptor (CAR) targeting a WBC antigen and a polynucleotide encoding a CAR targeting a solid tumor antigen in order to target cells specific to a WBC antigens and solid tumor antigens (Scharenberg ¶ 0064).
Regarding claim 20, LeBerthon in view of June and further in view of Liberti fail to teach wherein the one or more vectors comprise a polynucleotide encoding a CAR targeting a solid tumor antigen. Scharenberg teaches (fig. 1A) a vector for use in gene therapy (¶ 0039) and thus in the same field of endeavor, wherein the one or more vectors comprise a polynucleotide encoding a CAR targeting a solid tumor antigen (¶ 0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vector of LeBerthon in view of June and further in view of Liberti such that it comprises a polynucleotide encoding a CAR targeting a solid tumor antigen, as taught by Scharenberg, in order to target cells specific to a solid tumor antigen (Scharenberg ¶ 0064).
Regarding claim 21 LeBerthon in view of June, Liberti and further in view of Scharenberg disclose a solid tumor antigen, as discussed above in claim 20. LeBerthon in view of June, Weneger and further in view of Scharenberg further disclose wherein the solid tumor antigen comprises tumor associated MUC1 (tMUC1), PRLR, CLCA1, MUC12, GUCY2C, GPR35, CR1L, MUC 17, TMPRSS11B, MUC21, TMPRSS11E, CD207, SLC30A8, CFC1, SLC12A3, SSTR1, GPR27, FZD10, TSHR, SIGLEC15, SLC6A3, KISS1R, CLDN18.2, QRFPR, GPR119, CLDN6, UPK2, ADAM12, SLC45A3, ACPP, MUC21, MUC16, MS4A12, ALPP, CEA, EphA2, FAP, GPC3, IL13-Ra2, Mesothelin, PSMA, ROR1, VEGFR-II, GD2, FR-a, ErbB2, EpCAM, EGFRvIII, B7-H3 (Scharenberg ¶ 0064), or EGFR.
Regarding claim 22, LeBerthon in view of June, Liberti and further in view of Scharenberg disclose a polynucleotide encoding a CAR. LeBerthon in view of June and further in view of Scharenberg further disclose wherein the CAR comprises an antigen binding domain (Scharenberg ¶ 0064), a transmembrane domain (Scharenberg ¶ 0070), a co-stimulatory domain (Scharenberg ¶ 0069), and a CD3 zeta domain (Scharenberg ¶ 0064).
Regarding claim 23, LeBerthon in view of June, Liberti and further in view of Scharenberg disclose a co-stimulatory domain, as discussed above in claim 22. LeBerthon in view of June, Weneger and further in view of Scharenberg further disclose wherein the co-stimulatory domain comprises an intracellular domain of CD27 (Scharenberg ¶ 0064), CD28, 4-1BB, OX40, CD30, CD40, PD-1, ICOS, lymphocyte function-associated antigen-1 (LFA-1), CD2, CD7, LIGHT, NKG2C, B7-H3, a ligand that binds CD83, or a combination thereof.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon in view of June and further in view of Liberti, as applied to claim 1 above, and further in view of Van Bruggen et al. (Pub. No.: US 2018/0264186 A1).
Regarding claim 14, LeBerthon in view of June and further in view of Liberti fail to teach wherein the device further comprises one or more sensors, wherein the one or more sensors detects a progress of separation of the blood sample by detecting formation of layers of the blood sample, a change in pH value of the blood sample, and/or a change in temperature of the blood sample.
Van Bruggen teaches a device for immune therapy or causing a T cell response (abstract) and thus in the same field of endeavor, wherein the device further comprises one or more sensors configured to detect a change in temperature of the blood sample (¶ 0151).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of LeBerthon in view of June and further in view of Liberti such that it further comprises one or more sensors configured to detect a progress of separation of the blood sample by detecting formation of layers of the blood sample, a change in pH value of the blood sample, and/or a change in temperature of the blood sample, as taught by Van Bruggen, in order to monitor a temperature of the blood (Van Bruggen ¶ 0151).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon in view of June and further in view of Liberti, as applied to claim 1 above, and further in view of Wegener et al. (Pub. No.: US 2017/0313968 A1).
Regarding claim 15, LeBerthon in view of June and further in view of Liberti disclose wherein the rotating container is disposable and/or has been sterilized.
Wegener teaches (fig. 1) a cell incubation module (in-process container 122, ¶ 0059) and thus in the same field of endeavor, wherein the cell incubation module comprises a container that is disposable and/or has been sterilized (¶ 0003).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rotating container of LeBerthon in view of June and further in view of Liberti, such that it is disposable and/or has been sterilized, as taught by Wegener, in order to maintain sterile operation.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over LeBerthon in view of June and further in view of Liberti, as applied to claim 1 above, and further in view of Honda et al. (Pub. No.: US 2022/0204608 A1).
Regarding claim 19, LeBerthon in view of June and further in view of Liberti fail to teach wherein the one or more vectors further comprise a polynucleotide encoding IL-12, a polynucleotide encoding IL-6, and/or a polynucleotide encoding IFNy.
Honda teaches a vector for immune therapy or causing a T cell response (abstract) and thus in the same field of endeavor, wherein the vector comprises a polynucleotide encoding IL-6 (¶ 0110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the vector of LeBerthon in view of June and further in view of Liberti such that the one or more vectors further comprise a polynucleotide encoding IL-12, a polynucleotide encoding IL-6, and/or a polynucleotide encoding IFNy, as taught by Honda, in order to treat cells affected by dysfunction of the Il-6 protein.
Response to Arguments
The amendment to claim 1 overcomes the claim objection and the objection is therefore withdrawn.
Regarding the claim limitations interpreted under 35 USC §112(f), the sample processing module and the cell infusion module remain interpreted under 35 USC §112(f).
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on LeBerthon in view of June, alone, for any teaching or matter specifically challenged in the argument. Amended claim 1 recites the cell incubation module comprising a rotating container. A new grounds of rejection is made citing Liberti, which teaches a rotating container.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wegener et al. (Pub. No.: US 2017/0315121 A1) discloses a cell incubation module comprising a rotating container.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781