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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-4, 6, 13-14, 18-19, 21, 27-32, 39-41, and 43 have an effective filing date of 23NOV2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/12/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 4/10/2026, Applicant elected, without traverse:
Group I, claims 1-4, 6, 13-14, 18-19, 21, and 27-32
Species
CD25 on Tregs as distinct species of common gamma chain
TCR as the distinct gene product
CRISPR-Cas9 as distinct species of gene editing system
Status of Claims
Claims 1-4, 6, 13-14, 18-19, 21, 27-32, 39-41, and 43 are currently pending.
Claims 39-41, and 43 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 6, 13, 18-19, 21, and 27 are amended.
Claims 5, 7-12, 15-17, 20, 22-26, 33-38, 42, and 44-46 are canceled.
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.
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 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.
Claims 1-4, 13-14, 21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bilbao Cortes et al (US 20140286906 A1, IDS 9/12/2023).
In regards to claims 1, 14, and 27, Bilbao Cortes et al a method for expansion of naïve lymphocyte population [0100]. Bilbao Cortes et al further teaches naïve Treg cells [0149]. Bilbao Cortes et al further teaches the Treg cell expansion culture conditions IGF-1 is added [0100]. Bilbao Cortes et al further teaches a method of adding IL-2 [0102].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Bilbao Cortes’s method of expanding naïve lymphocyte population comprising culturing cells with IGF-1 and common gamma chain. It would have been prima facie obvious to use Bilbao Cortes’s method for a method for expansion of a naïve lymphocyte population comprising culturing lymphocytes with IGF-1 and common gamma chain, because Bilbao Cortes teaches expanding naïve lymphocyte populations comprising IGF-1 and common gamma chain for the treatment of diseases.
In regards to claim 2, Bilbao Cortes et al teaches cell proliferation [0100].
In regards to claim 3, Bilbao Cortes et al teaches maintaining a naïve phenotype of the lymphocyte population [0149].
In regards to claims 4 and 13, Bilbao Cortes et al teaches the cells may be attained from the subject to which the treatment will be applied [0095].
With regards to the Treg population is cultured for about 9-11 days, the growth factors are replenished after 3 or 7 days, and wherein optionally the IGF1 has a concentration of about 100 ng/mL and IL-2 has a concentration of about 10IU/mL, the amount and timing of adding growth factors is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1-4, 13-14, 18, 21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bilbao Cortes et al (US 20140286906 A1, IDS 9/12/2023) as applied to claims 1-4, 13-14, 21, and 27 above, and further in view of Walker et al (De novo generation of antigen-specific CD4 CD25 regulatory T cells from human CD4 CD25 cells, PNAS, Vol. 102, No. 11, 2005, IDS 9/12/2023).
The teachings of Balboa Cortes et al are discussed above.
Balboa Cortes et al does not specifically teach biological material removed from cells. However, this deficiency is made up in the teachings of Walker et al.
In regards to claim 18, Walker et al teaches De novo generation of antigen-specific CD4+ CD25+ regulatory T cells from human CD4+ CD25- cells [Abstract].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Bilbao Cortes’s method of expanding naïve lymphocyte population comprising culturing cells with IGF-1 and common gamma chain, with Walker’s method of de novo generation of antigen-specific CD4+ CD25+ regulatory T cells from human CD4+ CD25- cells. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Bilbao Cortes and Walker’s method for a method for expansion of a naïve lymphocyte population comprising culturing lymphocytes with IGF-1 and common gamma chain, because Bilbao Cortes teaches expanding naïve lymphocyte populations comprising IGF-1 and common gamma chain for the treatment of diseases, wherein the CD4+ T cells are obtained by removing cells that contain CD8, CD14, CD16, CD19, CD20, CD25, CD36, CD56, CD61, CD66b, CD123, HLA-DR, TCR γ/ δ, and glycophorin A.
Claims 1-4, 13-14, 19, 21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bilbao Cortes et al (US 20140286906 A1, IDS 9/12/2023) as applied to claims 1-4, 13-14, 21, and 27 above, and further in view of Khaitan et al (FOXP3+Helios+ regulatory T cells, immune activation and advancing disease in HIV infected children, J Acquir Immune Defic Syndr., 72(5), pgs. 474-484, 2016, IDS 9/12/2023).
The teachings of Balboa Cortes et al are discussed above.
Balboa Cortes et al does not specifically teach naïve FOXP3+Helios+ regulatory T cells. However, this deficiency is made up in the teachings of Khaitan et al.
In regards to claim 19, Khaitan et al teaches naïve FOXP3+Helios+ regulatory T cells [First Paragraph, pg. 5].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Bilbao Cortes’s method of expanding naïve lymphocyte population comprising culturing cells with IGF-1 and common gamma chain, with Khaitan’s method of expansion of T cells using FOXP3+Helios+ regulatory T cells. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Bilbao Cortes and Khaitan’s method for a method for expansion of a naïve lymphocyte population using FOXP3+Helios+ regulatory T cells comprising culturing lymphocytes with IGF-1 and common gamma chain, because Bilbao Cortes and Khaitan teach the expansion of T cells from treating diseases.
Claims 1-4, 13-14, 21, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Bilbao Cortes et al (US 20140286906 A1, IDS 9/12/2023) as applied to claims 1-4, 13-14, 21, and 27 above, and further in view of Quintarelli et al (WO 2020021045 A2, IDS 9/12/2023).
The teachings of Bilboa Cortes et al are discussed above.
In regards to claims 28-30, Quintarelli et al teaches a method of using vector for stable integration into a cell genome [Line 31, pg. 42]. Quintarelli et al further teaches the modification occurring for cell expansion [Line 24, pg. 41].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Bilbao Cortes’s method of expanding naïve lymphocyte population comprising culturing cells with IGF-1 and common gamma chain, with Quintarelli’s method of expanding cell comprising vectors. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Bilbao Cortes and Quintarelli’s methods for a method for modifying a lymphocyte population comprising transducing a vector in a lymphocyte that promotes homeostatic expansion of the naïve lymphocyte, because teaches expanding naïve lymphocyte populations comprising IGF-1 and common gamma chain for the treatment of diseases and Quintarelli teaches modifying expanding cell populations using vectors.
In regards to claim 31, Quintarelli et al teaches the expression of T cell receptor [Line 5-25, pg. 49].
In regards to claim 32, Quintarelli et al teaches the gene editing system CRISPR-Cas 9 [Line 1, pg. 42].
Claims 1-4, 6, 13-14, 21, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bilbao Cortes et al (US 20140286906 A1, IDS 9/12/2023) as applied to claims 1-4, 13-14, 21, and 27 above, and further in view of Ramsey et al (The Lymphopenic Environment of CD132 (Common gamma chain) Deficiency Hosts, The Journal of Immunology, pgs. 5319-5326, 2008).
The teachings of Bilboa Cortes et al are discussed above.
Balboa Cortes et al does not specifically teach subjecting the population to the growth factor common gamma chain CD132. However, this deficiency is made up in the teachings of Ramsey et al.
In regards to claim 6, Ramsey et al teaches homeostatic proliferation of naïve T cells by administering the common gamma-chain (CD132) family of cytokines [Abstract].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Bilbao Cortes’s method of expanding naïve lymphocyte population comprising culturing cells with IGF-1 and common gamma chain, with Ramsey’s method of homeostatic expansion of naïve T cells by administering the common gamma-chain (CD132) family of cytokines. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Bilbao Cortes and Ramsey’s methods for a method for expansion of a naïve lymphocyte population comprising culturing lymphocytes with CD132, because Bilbao Cortes teaches expanding naïve lymphocyte populations comprising IGF-1 and Ramsey teaches T cell homeostatic proliferation by utilizing the common gamma-chain (CD132) family of cytokines.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
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