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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 27 April 2026 has been entered.
Status of the Claims
Applicant' s submission filed 27 April 2026 has been entered. Claims 98, 128, 132-146, and 148-154 are pending. Claim 98 has been amended, while claims 129-131 have been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 98, 128, 132-146, and 148-154. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 98, 128-146, 148, and 152-154 under 35 USC 103 over Maeurer as evidenced by Pistoia et al in view of Gattinoni et al
The cancellation of claims 129-131 renders the rejection moot for those claims. For the
remaining claims, Applicant’s arguments filed 27 April 2026 have been fully considered but they are not persuasive.
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 27 April 2026 that Maeurer fails to teach a composition that is less than 10% CD4+ T cells and which comprises at least 108 CD8+ T cells that are specific for three to ten target peptide antigens, instead teaching a composition that comprises a very substantial number of CD4+ T cells as well as double negative T cells. In response, the Examiner respectfully submits that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, even nonpreferred embodiments. See MPEP § 2123: Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989); Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). In the instant case, Maeurer teaches embodiments of the invention wherein the population primarily comprises CD8+ T cells and a smaller percentage of CD4+ T cells. See, for example, Examples 7, 22, 31-32 and Figures 22a, 23 of Maeurer. Therefore, the ordinary artisan would have recognized that the disclosure of Maeurer does not teach away from a population comprising a large percentage of CD8+ T cells. It is also of note that Maeurer teaches that a patient suffering from cancer can be administered 90x106 cells/kg, and that the clinically relevant, antigen edited are polyclonal and respond to multiple antigens, including twelve different target antigens. See, for example, Paragraphs [0027]-[0028], [0124]-[0125], [0129]-[0131], [0170]-[0171], [0193]-[0197], [0200], [0202], [0278]-[0279] of Maeurer. Therefore, the ordinary artisan would have understood that the composition can be tailored to comprise 108 CD8+ T cells that are specific for three to ten target peptide antigens.
Applicant has further traversed the rejection, asserting in Pages 7-8 of the Remarks filed 27 April 2026 that Maeurer fails to teach that the antigen-specific CD8+ T cells are expanded using IL-2, IL-4, IL-6, IFN-γ, and IL-1β, which allows for the generation of the claimed composition. In response, the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the secondary reference of Ohno et al was relied upon to teach the culture of the CD8+ T cell in the presence of IL-2, IL-4, IL-6, IFN-γ, and IL-1β. Furthermore, in regards to the novelty of the claimed composition in culturing the antigen-specific CD8+ T cells with the recited cytokines, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Therefore, the rejection of record is maintained and amended to encompass the claims as currently written.
New/Maintained Grounds of Rejection
Claim Objections
Claim 149 is objected to because of the following informalities:
Regarding claim 149: The instant claim is objected to for reciting “INF-γ” for the abbreviation of interferon-gamma instead of “IFN-γ”.
Appropriate correction is required.
Claim Interpretation
Instant claims 132-133 recite limitations separated by the conjunction “and/or”. Unless
otherwise specified, the Examiner is interpreting these limitations as alternatives, wherein only one limitation that is separated by an “and/or” conjunction is required.
Furthermore, claims 149-151 further define the method by which the isolated cell composition of claim 98 is obtained. These are product-by-process limitations. Product-by-process limitations are considered only in so far as the method of production affects the structure of the final product. In the instant case, there is no evidence that the CD8+ T cells enriched from source cells imparts any particular structure or significance to the CD8+ T cells. Thus, the claim will be interpreted as if the expansion of the CD8+ T cells in the presence of IL-2, IL-4, IL-6, INF-γ, and IL-1β fulfills the enrichment step that is required by instant claim 149 and its dependents thereof.
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 98, 128, 132-146, and 148-154 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.
Regarding claim 98: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the instant case, claim 98 recites the narrow recitation “at least 108 CD8+ T cells that are specific for three to ten target peptide antigens”, and the claim also recites “wherein at least 10% of the CD8+ T cells in the composition are specific for a target peptide antigen”, which is the broader statement of the limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the sake of compact prosecution, the instant claim will be interpreted as if it is required for at least 108 CD8+ T cells to be specific for three to ten target peptide antigens.
Instant claims 128, 132-146, and 148-154 are included within the rejection because they fail to correct the deficiencies of the parent claim.
Appropriate correction is required.
Regarding claims 138-139: The instant claims each recite the limitation "the one or more antigens" in Line 2. There is insufficient antecedent basis for this limitation in the claim, as there is no prior recitation of “one or more antigens” and the CD8+ T cells of parent claim 98 are required to be specific for three to ten target peptide antigens. It is of note that a claim is indefinite when it contains words or phrases whose meaning is unclear. In re Packard, 751 F.3d 1307, 1314, 110 USPQ2d 1785, 1789 (Fed. Cir. 2014). The lack of clarity could arise where a claim refers to "said lever" or "the lever," where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference. Similarly, if two different levers are recited earlier in the claim, the recitation of "said lever" in the same or subsequent claim would be unclear where it is uncertain which of the two levers was intended. See MPEP § 2173.05(e).
Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 138-139 and 146 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 138-139: The instant claims each recite the limitation "the one or more antigens" in Line 2. However, parent claim 98 requires the CD8+ T cells to be specific for three to ten target peptide antigens. Therefore, dependent claims 138 and 139 fail to further limit the parent claim given the interpretation presented in the 35 USC 112(b) rejection of independent claim 98, as the recitation of “one or more antigens” is broader than “three to ten target peptide antigens”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 146: The instant claim recites the limitation “wherein the cell composition is less than 10% CD4+ T cells”. This fails to further limit the method of parent claim 98, as the parent claim requires the composition to comprise “less than 10% CD4+ T cells”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 98, 128, 132-146, 148, and 152-154 remain rejected under 35 U.S.C. 103 as being unpatentable over Maeurer (US 2017/0107490 A1, of record on IDS filed 12 December 2019) as evidenced by Pistoia et al (Front Immunol, 2018, of record) in view of Gattinoni et al (Nat Med, 2011, of record).
Maeurer et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Gattinoni et al and Pistoia et al are considered prior art under 35 USC 102(a)(1).
Regarding claims 98, 134-141, 143-144, 146, and 148: Maeurer discloses a method of preparing a population of clinically relevant, antigen edited lymphocytes using a composition of predefined cytokines (Paragraphs [0001], [0019]). Maeurer further discloses that the prepared population is formulated into a composition with a pharmaceutically acceptable carrier and administered to subject in need thereof, including a subject suffering from cancer or an infectious disease (Paragraphs [0027]-[0028], [0193]-[0197], [0200]). With that, Maeurer further discloses that at least about 90x106 cells per kilogram of body weight of the clinically relevant lymphocytes can administered to the subject (Paragraph [0202]). It is of note that “at least about 90x106 cells” is merely close to “at least 108 cells”, especially considering that is per kilogram of the subject’s body weight. See MPEP § 2144.05(I).
As such, Maeurer discloses that the clinically relevant lymphocytes are mixed populations comprising, at least, CD8+ effector cells, central memory T cells (TCM-cells), peripheral – or effector – memory T cells (TPM-cells/TEM-cells), stem cell memory T cells (TSCM), T cell precursors (naïve T cells), and gamma-delta T cells (Paragraphs [0075], [0164]-[0166], [0179]-[0191]). Maeurer further discloses the clinically relevant lymphocytes are mixed populations comprising, at least 2% effector memory T cells (TEM-cells), at least 1% T cell precursors, and at least 1% gamma-delta T cells (Paragraphs [0179], [0187]-[0188], [0191]). Maeurer further discloses the clinically relevant lymphocytes are produced by culturing autologous or allogenic lymphocytes in vitro with cytokine cocktails and one or more expansion antigens in order produce the clinically relevant, antigen edited lymphocytes (Paragraphs [0065]-[0068], [0073]-[0075], [0088]-[0092], [0102]-[0144]). Maeurer exemplifies expanded populations of lymphocytes, following culturing in cytokines and antigenic stimulation, wherein at least 50%, 60%, and 70% are CD8+ central memory T cells (TCM-cells, CD8+, CCR7+, CD45RA-), at least 30%, 40%, and 40% effector memory T cells (TEM-cells and TEMRA-cells, CD8+, CCR7-, CD45RA-), and at least 1% CD8+ memory precursors (CD8+, CCR7+, CD45RA+) (Examples 7, 22, 31-32; Figures 22a, 23). Maeurer further discloses an experimental embodiment wherein the clinically relevant, antigen edited lymphocytes are 94% CD8+ T cells and only about 4% CD4+ T cells (Figure 16). It is of note that the methods and compositions of Maeurer do not include recombinant T cell receptors (TCRs) or chimeric antigen receptors (CARs).
Maeurer further discloses that the clinically relevant, antigen edited lymphocytes are polyclonal and respond to multiple antigens, including twelve different target antigens (Paragraphs [0124]-[0125], [0129]-[0131], [0170]-[0171], [0278]-[0279]).
Maeurer does not specifically disclose the exact percentages of T memory stem cells, as required by instant claim 98.
Gattinoni et al, however, disclose enriched CD8+ T cells, wherein the percentages of central and effector memory T cell, T memory stem cell, and naïve T cell subsets are analyzed within samples following antigenic stimulation (Title; Page 7, Discussion; Page 9, Generation of mesothelin-specific T cells; Figure 2E). More specifically, Gattinoni et al disclose an enriched population of CD8+ T cells comprising about 80% central and effector memory cells, about 20% T memory stem cells, and about 2% naïve cells (Figure 2E).
Therefore, it would have been prima facie obvious to have modified the method of Maeurer such that the percentage of central and effector memory T cells and T memory stem cells is at least 95% of the composition while the percentage of naïve T cells comprised within the composition is less than 5%, as suggested by Gattinoni et al. One of ordinary skill before the effective filing date of the invention would have been motivated to have a composition comprising an enriched population of CD8+ memory cells, as they allow for the fast delivery of immune effector functions upon administration into a subject while also providing for long-term immunological memory, and would have had a reasonable expectation of success based on the disclosure of Maeurer (Paragraphs [0012]). See MPEP § 2143(I)(G). With that, it also would not have been outside the skillset of the ordinary artisan to tune the composition for particular percentages of CD8+ central and effector memory T cells, T memory stem cells, and naïve T cells. More specifically, it would not have been outside the skillset of the ordinary artisan to provide a composition of CD8+ T cells comprising about 80% central and effector memory cells, about 15% memory stem cells, and about 5% naïve cells – as is necessarily suggested by Figure 2E of Gattinoni et al. See MPEP § 2144.05(II). It also would not have been outside the skillset of the ordinary artisan to tune the composition such that at least 108 CD8+ cells are polyclonal and respond to only three to ten target antigens, as Maeurer teaches an embodiment wherein the cells can respond to twelve different antigens.
Consequently, Maeurer as modified by Gattinoni et al render obvious a method of treating cancer or an infectious disease, wherein a subject is administered a population of clinically relevant, antigen edited lymphocytes comprised in a pharmaceutically acceptable carrier, wherein the clinically relevant, antigen edited lymphocytes are gamma-delta T cells – which inherently consist of a proportion of Vδ2 T cells and Vδ1 T cells (claim 148; See Pistoia et al, Page 2) – and at least about 90x106 CD8+ T cells capable of binding to three to ten target antigens, which are comprised of about 80% central and effector memory T cells (claims 138-141), about 15% T memory stem cells (claims 134-136), and less than 5% naïve T cells (claims 143-144). See MPEP § 2144.05(I). As this composition of clinically relevant, antigen edited lymphocytes comprised in a pharmaceutically acceptable carrier comprises CD8+ T cells having greater than 95% of a memory phenotype (claim 137) – which the Examiner arrived to by combining the above subset percentages of at least 80% central and effector memory T cells and at least 15% T memory stem cells – and less than 10% CD4+ T cells (claim 146), and is silent to the inclusion of recombinant T cell receptors or chimeric antigen receptors, this modified method therefore renders obvious the method of instant claim 98.
Regarding claims 128 and 152: Following the discussion of claim 98, Maeurer further discloses that the target peptide antigens are tumor associated antigens (claim 128), including Survivin (claim 152)(Paragraphs [0072], [0109], [0144]; Example 7). This therefore reads on the method of the instant claims.
Regarding claim 132-133 and 153-154: Following the discussion of claims 98 and 128, Maeurer further discloses that, in addition to the tumor associated antigens, the clinically relevant lymphocytes can also be specific for a pathogen associated antigen – or antigens related to bacteria, viruses and other microorganism (claim 132) – including EBV (claims 133, 153-154)(Paragraphs [0068], [0070], [0147]-[0148]). This therefore reads on the method of the instant claims.
Regarding claim 142: Following the discussion of claim 98, Maeurer further discloses that the percentage of terminally differentiated T cells is at least 1% (Paragraphs [0013], [0189]-[0190]). Therefore, since “at least 1%” also includes 1%, less than 10% of the CD8+ T cells will be terminally differentiated. This therefore reads on the method of the instant claim.
Regarding claim 145: Following the discussion of claim 98, Maeurer further discloses that about 40% of the CD8+ T cells are polyfunctional when activated in vitro (Paragraphs [0132], [0153]-[0156], [0170], [0278]-[0279]; Example 25; Figure 16). This therefore renders obvious the method of the instant claim. See MPEP § 2144.05(I).
Claims 98, 128, 132-146, 148-149, and 152-154 are rejected under 35 U.S.C. 103 as being unpatentable over Maeurer (US 2017/0107490 A1, of record on IDS filed 12 December 2019) as evidenced by Pistoia et al (Front Immunol, 2018, of record) in view of Gattinoni et al (Nat Med, 2011, of record), and further in view of Ohno et al (US 5874307 A, of record) as evidenced by Krumm et al (The Protein Society, 2014, of record).
The discussion of Maeurer as evidenced by Pistoia and as modified by Gattinoni et al regarding claim 98 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Maeurer as evidenced by Pistoia et al as modified by Gattinoni et al render obvious claims 98, 128, 132-146, 148, and 152-154. Ohno et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2) and Krumm is considered prior art under 35 USC 102(a)(1).
Regarding claim 149: The instant claim includes product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and included herein.
Accordingly, following the discussion of claim 98, Maeurer further discloses that the clinically relevant lymphocytes – which include CD8+ T cells – can be cultured or incubated in the presence of one or more cytokines. As such, Maeurer discloses that the one or more cytokines include IL-2, IL-4, and IL-1β (Paragraph [0090]).
The combination of Maeurer and Gattinoni et al fail to teach the culturing of the CD8+ T cells in the presence of IL-2, IL-4, IL-6, INF-γ, and IL-1β, as required by instant claim 149.
Ohno et al, however, disclose culture methods of CD8+ cytotoxic T lymphocytes that allow for the downstream use for clinical treatments of tumors, or adoptive immunotherapies (Abstract).
As such, Ohno et al disclose the culture of the cytotoxic T lymphocytes in medium comprising IL-1, IL-2, IL-4, IL-6, and INF-γ (Column 5, Lines 10-15). It is of note that IL-1 inherently comprises IL-1β (Krumm et al, Page 527, IL-1).
Therefore, it would have been prima facie obvious to have modified the combined method of Maeurer as evidenced by Pistoia et al and in view of Gattinoni et al to include IL-1β, IL-2, IL-4, IL-6, and INF-γ within the culture medium, as taught by Ohno et al as evidenced by Krumm et al. One of ordinary skill before the effective filing date of the invention would have been motivated to culture the CD8+ T cells in a culture medium known to enhance tumor killing capabilities, and would have had a reasonable expectation of success based on the disclosure of Ohno et al (Columns 4-6, Example 1). See MPEP § 2143(I)(G).
Consequently, Maeurer as evidenced by Pistoia et al as modified by Gattinoni et al and further in view of Ohno et al as evidenced by Krumm et al render obvious a method of treating cancer or an infectious disease, wherein the clinically relevant CD8+ T cells are cultured in the presence of IL-1β, IL-2, IL-4, IL-6, and INF-γ. This therefore renders obvious the method of the instant claim.
Claims 98, 128, 132-146, and 148-154 are rejected under 35 U.S.C. 103 as being unpatentable over Maeurer (US 2017/0107490 A1, of record on IDS filed 12 December 2019) as evidenced by Pistoia et al (Front Immunol, 2018, of record) in view of Gattinoni et al (Nat Med, 2011, of record) and Ohno et al (US 5874307 A, of record) as evidenced by Krumm et al (The Protein Society, 2014, of record), and further in view of Almaasbak et al (US 2019/0062706 A1, of record on IDS filed 12 December 2019).
The discussion of Maeurer as evidenced by Pistoia et al and as modified by Gattinoni et al regarding claim 98, and the discussion of Maeurer as evidenced by Pistoia et al in view of Gattinoni et al and Ohno et al as evidenced by Krumm et al regarding claim 149 can be observed above and are each relied upon herein, the content of which is incorporated in its entirety. Maeurer as evidenced by Pistoia et al and modified by Gattinoni et al render obvious claims 98, 128, 132-146, 148, and 152-154. Maeurer as evidenced by Pistoia et al and taken in view of Gattinoni et al and Ohno et al as evidenced by Krumm et al render obvious claims 98, 128, 132-146, 148-149, and 152-154. Almaasbak et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 28 October 2015.
Regarding claims 150-151: The instant claim includes product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and included herein.
Accordingly, following the discussion of claim 149, Maeurer further discloses that the clinically relevant, antigen edited lymphocytes are stimulated with peptides or peptide fragments of the clinically relevant antigens, and then allowed to expand in culture for seven days (Paragraphs [0029], [0066]-[0069], [0121]-[0125], [0132]). Maeurer further discloses that the clinically relevant antigen can also include an MHC class I molecule (Paragraph [0125]).
None of Maeurer as evidenced by Pistoia et al as modified by Gattinoni et al, or Maeurer as evidenced by Pistoia et al as modified by Gattinoni et al and Ohno et al as evidenced by Krumm et al teach that the clinically relevant antigens are attached to paramagnetic aAPCs having an MHC class I ligand and a co-stimulatory ligand, nor that the cells and aAPCs are incubated in the presence of a magnetic field for at least one minute, as required by instant claims 150-151.
Almaasbak et al, however, disclose compositions of expanded T cell populations, methods for the expansion of T cell populations, and methods for using such populations of cells (Abstract).
As such, Almaasbak et al disclose contacting and enriching T cells with aAPCs, which include peptides presented by the major histocompatibility complex (MHC) class I proteins on the surface of the aAPCs (Paragraphs [0002], [0004], [0061], [0064]). Almaasbak et al further disclose that the aAPCs are paramagnetic beads which have a CD28 co-stimulatory ligand attached, and that the paramagnetic aAPCs and T cells are incubated in the presence of a magnetic field for 30 minutes (Paragraphs [0064], [0113], [0123]-[0124], [0139]-[0142], [0151]-[0157], [0162]-[0167], [0174]-[0177]).
Therefore, it would have been prima facie obvious to have substituted the MHC/peptide antigen presentation complex of Maeurer for the paramagnetic aAPCs of Almaasbak et al, as doing so would have been a simple substitution of one antigen presentation technique for another. See MPEP § 2143(I)(B). One of ordinary skill before the effective filing date of the invention would have recognized that the two techniques – and complex/aAPC therein – are functionally comparable, and thereby would have been able to substitute the techniques with predictable results.
Consequently, Maeurer as evidenced by Pistoia et al as modified by Gattinoni et al, Ohno et al as evidenced by Krumm et al, and Almaasbak et al render obvious a cancer or infectious disease treatment method wherein the clinically relevant, antigen edited T lymphocytes are enriched with a paramagnetic aAPC comprising MHC class I and CD28 co-stimulatory ligands (claim 150) for 30 minutes in the presence of a magnetic field, and then expanded in culture for seven days (claim 151). This therefore renders obvious the method of the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
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