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 .
Applicant’s amendment and response of 6/9/26 is entered.
Claims 1, 3, 5, 16, and 19 are amended.
Claim 20 is canceled.
Claims 1-3, 5, 7-11, 14, 16, 18-19, 36, 38, 56, 58, 60, 79, 106, and 108-109 remain pending.
Claim Status, Canceled Claim(s)
In light of the cancelation of Claim 20, all rejections/objections thereto, are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, as in present Claims 1-3, 5, 7-11, 14, 16, 18-19, 36, 38, and 56, in the reply filed on 2/2/26 was previously acknowledged.
Claims 58, 60, 79, 106, and 108-109 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/2/26.
Applicant’s election of the species of T cells specific for BKV, CMV, AdV, EBV, and HHV-6 virus antigens (element “(i)” from Claim 38), in the reply filed on 2/2/26 was previously acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-3, 5, 7-11, 14, 16, 18-19, 36, 38, and 56 are presently considered for the elected species.
Drawings
In light of the amended drawings of 6/9/26, the objection to the drawings is withdrawn.
Claim Objections
Applicant remains advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 2 limits the cell lines of Claim 1 to being clonal, oligoclonal, or polyclonal. These are, however, the only options. Thus, despite the slight difference in wording, these claims have substantially the same scope.
Applicant remains advised that should claim 1 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 16 requires one of the plurality of donors (the cells obtained) to match on at least two HLA alleles with the greatest number of patients in a prospective patient population. However, as the prospective patient population is not defined, it could be any population, and thus, the patient populations can be imaginary and have the required matches. Therefore, despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 18 requires a T cell match that on each HLA allele with a patient in a patient population. As the patient population is imaginary, the composition is not limited. Thus, despite a slight difference in wording, these claims have the same substantial scope.
Response to Argument – Double Patenting Warnings
Applicant’s argument of 6/9/26 has been considered but is not found persuasive.
Applicant argues that by importing the language of Claim 20 into Claim 1, the rejected claims are now distinguished from Claim 1 (p. 9, penultimate paragraph).
Such is not persuasive. I am not sure what to say, the amendment simply is tangiential to to the fact that these dependent claims limitations, which are non-limiting on the scope of Claim 1. The only claim that it addresses is Claim 20, due to the cancelation of the claim itself.
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.
In light of the amendment, the rejections of Claims 3, 5, 16, and 19 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, are withdrawn.
To wit, the multiple scopes within eachother have been removed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 7, 16, 18-19 and 56 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by both U.S. Patent Application Publication 2016/0296563 and U.S. Patent No. 10,357,515, each to Sourdive, et al. (It is noted that these are the same, the patent evolving from the application, but the application is referred to for description citations (as they are labelled by paragraph), and patent claims are cited were possible because the claims are patented.
Claims 1-2: the patent claims a method of generating a batch of T cells from different human donors, and pooling the same, where they may originate from 3-50 donors (e.g., Claim 1). Claim 4 indicates they may have different HLA types, and thus they differ in the alleles. Additionally, Claim 10 indicates allele differences. E.g., Paragraph 49 of the Application Publication indicates these T cells may be T cell lines.
Claim 2: being cell lines, they are clonal, and being multiple, and from 3-50 donors, they are oligoclonal and polyclonal. Additionally, paragraphs 26-28 of the Application Publication makes clear that the cells may be clonal, and transfected to express a CAR (e.g., paragraphs 26-28).
Claims 3, 5, 7: Paragraphs 15-19 of the Application Publication teaches where minimal numbers of donors is sought for limiting infectious disease, while providing sufficient diversity for engraftment, pooling 3-50 donors, each individual expressing a small number of HLA alleles, one each of HLA A, B, and C, and the three principal class II molecules, from each parent, thereby arriving at least two allele distinctions, for each.
Claims: 16, 18 and 20: the patient population being imaginary, absent reason to believe otherwise, it does so-meet the matches and has the structure of the composition where they pooled after generation.
Claim 19: 3 donors is taught (e.g., Claim 1).
Claim 56: the structure being there, the reactivity is assumed to be present.
Response to Argument – 102, Sourdive
Applicant’s argument of 6/9/26 has been considered but is not found persuasive.
Applicant argues that they have amended the claim, to now recite that the T cell lines are pooled together after they are assessed for identity, viability, sterility, phenotype, potency or alloreactive (p. 10, paragraphs 3-4).
Such is not persuasive. The way in which they put together does not alter the structure claimed. Similar to an outright product by process, it is properly rejected by the product made, regardless of the process.
Applicant argues that Sourdive’s method uses molecular biology to inactivate TCR genes, then the cells are pooled, with the intent to achieve “averaged potency”. On the other hand, Applicant’s method generates individual T cell lines from each donor first and pools the quantified cells, ensuring only cell lines that have met their criteria are used. Pp. 10-11, paragraphs bridging).
Such is not persuasive. There is no exclusion of the structure of Sourdive from the claimed limitations. Moreover, the assaying steps currently claimed are merely mental, there are no limitations on them, and there is no limitations regarding any molecular manipulations in Applicant’s claims. I cannot see where Sourdive does not infringe the claims.
Applicant recaps that sourdive fails to provide for the pooling after generation and assessment for a particular characteristic of the Markush (p. 11, paragraph 2).
Such is not persuasive. The claims are not distinct from encompassing what is taught in Sourdive, even taking Applicant’s argument. Moreover, the assessment requires nothing, it is as simple as looking at it and say it meets the Artisan’s criteria for any single characteristic of the Markush. The composition structures are infringed by Sourdive.
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.
Claim(s) 1-3, 5, 7-8, 14, 16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2016/0296563 and U.S. Patent No. 10,357,515, each to Sourdive, et al. (It is noted that these are the same, the patent evolving from the application, but the application is referred to for description citations (as they are labelled by paragraph), and patent claims are cited were possible because the claims are patented.
.As shown above, the base claims are anticipated by the base art, and thus, also makes obvious the same. However, the aspect of differing for at least one class II allele is not taught.
On the other hand, each reference teaches to provide diversity through multiple donors (e.g., paragraph 15 of the patent Application Publication), i.e., in situations where a miniumal number of donors is sought to reduce infectious disease risk, while providing diversity for high engraftment, sufficient HLA diversity can be obtained by pooling lymphocytes originating from at least three donors, preferable 3-50; each individual expressing only a relatively small number of HLA alleles, A, B, and C being class I from each parent, and one allele the class II molecules (DR DP and DQ) from each parent, with little/no crossover.
Given the diversity of donors, it would therefore have been obvious to provide the same diversity in HLA alleles and Class I and Class II alleles. The Artisan would do so to provide the adqueate diversity and being able to reduced infectious disease risk. The Artisan would expect success, as it is taught for its intended purposes.
Claim(s) 1-3, 5, 7-11, 14, 16, 18, 20 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2016/0296563 and U.S. Patent No. 10,357,515, each to Sourdive, et al., as applied to Claims 1-3, 5, 7-8, 14, 16, 18, 20, and 56 above, and further in view of WO 02/077030 to Jakobsen, et al.
As shown above, the base claims are obvious over the base art (the publication or the patent), however, the aspect of differing from the DPA1, DPB1, DQA1, DQB1, DRA and DRB1 is not taught.
Claims 9-11:
On the other hand, Avidex teaches the DRA and DRB1 class II alleles are associated with disease (e.g., p. 9, teaching the DRA is a clas II alpha chain, while the DRB1 is a class II beta chain, DR denoting the loci in which the DNA encoding the HLA class II molecule is located, the class II HLA loci being DM, DO, DP, DQ and DR. Each complete class II HLA containing alpha and beta chains, from the same loci. “A” and “B” denote the alpha or beta chain of an HLA, respectively. The remaining numbers follow the same rules. Class II disease associations are produced by antigen peptide specificity, which can be induced by alpha or beta chains of any given HLA molecule. By convention, these disease associations are listed by reference to the class II HLA chain associated with the disease. Generation of the cells of cells present HLA alles of distinct types is also taught: “modified molecules of a selected HLA type are caused to be presented by a cell. The modified molecules can be different subtypes.
Given that two HLA class II alleles are known and prominent in patients, it would have been obvious to the Artisan to use these alleles in the T cells, thus, making a population meeting the claim., and differences. The Artisan woudl do so to optimize the universal potential of the cells for distinct recipients. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claim(s) 1-3, 5, 7-11, 14, 16, 18, 20, 36, 38 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2016/0296563 and U.S. Patent No. 10,357,515, each to Sourdive, et al., as applied to Claims 1-3, 5, 7-8, 14, 16, 18, 20, and 56 above, and further in view of Siyahian, et al. (2018 July) “Prophylaxis for Hepatitis B Virus Reactivation after Allogeneic Stem Cell Transplantation in the Era of Drug Resistance and Newer Antivirals: A systematic Review and Meta-Analysis” Biological Blood Marrow Transplant, 24(7): 1483-89.
The various aspects are obvious over the base art, however, the aspect of targeting HBV is not taught, although Sourdive claims treating viral infection (e.g., Claim 19).
On the other hand, Siyahian teaches treating Hepatitis B reactivation after allogeneic stem cell transplant (e.g., ABSTRACT).
Thus, it would be obvious to use T cells for HBV, and follow that with further treatment if reactivation occurs. The Artisan would do so, as allogeneic T cell treatment was already known for HBV. The Artisan would expect success, as the components are utilized for their art-recognized purposes.
Response to Argument – 103 rejections
Applicant argues that Sourdive, in failing to meet its requirement under 102, and the teachings of Jakobsen and Siyahian do not make up for these deficiencies, the rejections under 103 must also fall (pp. 11-12).
Such is not persuasive. As shown above, Sourdive does not fail to meet the claimed invention.
Art Made of Record
Inventor Leen’s NPL: Melenhorst, et al. (2010) “Allogeneic virus-specific T cells with HLA alloreactivity do not produce GVHD in human subjects”, Blood, 116(22); 4700-02, which appears to be the first study to note that allogeneic T cells do not produce GVHD in humans.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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