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 .
Claims 1, 7-10, 15, 18, 24, 28 and 29 have been amended. Claims 1-15, 18, 24, and 28-30 are pending and under consideration.
The rejection of claims 13 and 14 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s amendment of claim 1 to require administration of at least one isolated subpopulation of T cells.
The rejection of claims 7-9, and 28-30 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The rejection of claims 1, and 3-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for lacking enablement for prevention is withdrawn in light of applicant’s deletion of a “method for preventing” in claim 1.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 1-15, and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained for reasons of record. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
The instant cans are reliant upon the description of a genus of T cells recognizing one or more peptide epitopes of HPIV3.
The specification fails to provide a written description of the portion of the T cell receptor responsible for recognition of the HPIV3 peptide epitopes in the context of HLA. When given the broadest reasonable interpretation, “T cells” are interpreted in accord to common usage, as αβ-T cells. It is well known in the art that a heterodimer of the α and β subunits of the TCR form the recognition unit of the receptor, wherein the N-terminal domains of both the α and β subunits encompassing sequence variability akin to the variable domains of immunoglobulins, including areas of relatively greater variability corresponding to CDR regions of immunoglobulins. The specification has not provided a written description of the N terminal domains of activated T cells that selectively recognize HPIV3 peptide epitopes. The findings in Amgen v. Sanofi of October 5, 2017, wherein it was concluded that a description of an antibody only by reciting the antigen to which the antibody binds is insufficient for the written description requirement of 112, first paragraph pertains to the instant T cells. The specification provides no written description for the T cells except the desired ability to selectively recognize HPIV3 in the context of HLA. The T cells are further described as recognizing peptides 84, 83, 82, 59, 85, 60, 76, 78, 38, 77, 39 or 50, in claims 10-12, 18, 24, and 28-30 which are identified by the specification by SEQ ID Nos. on page 67. One of skill in the art could not envisage the hypervariable regions of the alpha and beta chains of a T cell responsible for the recognition of the required peptides in the context of HLA because it is not possible to relate epitope binding to the structure of the T cell receptor.
Applicant has amended claims 1 to specify the specific peptide epitopes recognized by the T cells in claims 1, 10, and 15. This fails to describe the genus of a T cell subpopulation, or subpopulations, because it is not possible to construe the sequence of the TCR receptor based on recognition of a peptide epitope. This is analogous to the antibody art, wherein a description of an antigen bound by an antibody fails to provide an adequate written description of the antibody.
Claims 28-30 are not included with this rejection because claim 28 has been amended to delete reference to T cells recognizing the peptide epitope contained within peptides 84, 83, 82, 59, 85, 60, 76, 78, 38, 77, 39 or 50.
Applicant argues that because the claims are drawn to a method of treatment not a genus of T cell products as such, that the written description requirement does not apply. This has been considered but not found persuasive. Firstly, claims 15 and 18 are drawn to a composition, and therefore a genus of T cell products. Secondly, claims 1-14 are method claims reliant on a genus of T cell products so the written description of said products must comply with 35 U.S.C. 112(a). As stated in Section 2163 of the M.P.E.P.:
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.
In the instant case, there is no correlation between the structure of the TCR on the T cells in the subpopulation and the recognition of the particular epitopes in the context of HLA..
If the genus of biomolecules lacks written description, a method of treatment using the same said genus of biomolecule also lacks written description.
The rejection of claim 15 under 35 U.S.C. 102(a)(1) as being anticipated by McLaughlin et al (Cytotherapy, 2016, Vol. 18, pp. 1515-1524) is withdrawn in light of applicant’s amendment requiring that the subpopulation of T cells recognizes the peptides of SEQ ID NO: 8, 9, 11, 13-19, 21 or 24.
New Grounds of Rejection
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.
Claim 29 is 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.
The recitation of “at least one subpopulation of T-cells” in claim 29 is vague and indefinite because it is unclear if this refers to the subpopulation of claim 28 or the subpopulation of claim 24. Amendment of claim 29 to state “contacting the isolated at least one subpopulation of T cells” would overcome this rejection.
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.
Claims 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by the abstract of Harris et al (Blood, November 13, 2019, Vol.134, supplement 1, page 3251, reference of the IDS filed 6/9/2022).
The abstract discloses at subpopulations of virus-specific T cells occurring after ex vivo priming with a 15-mer peptide library encompassing the HPIV3 matrix peptide epitopes. (second paragraph). The abstract discloses that 13 novel immunodominant peptides were identified in 9 tested virus specific T cell populations , wherein the majority of the peptides were HLA class II restricted (3rd paragraph)., which meets the limitation of “one or more restricted peptide epitopes of PPIV3 in claim 15 The abstract discloses that the peptides included Peptide 39, identical to SEQ ID NO: 8, Peptide 50, identical to SEQ ID NO: 9, Peptide 60, identical to SEQ ID NO: 11, Peptide 76, identical to SEQ ID NO: 13, Peptide 77, identical to SEQ ID NO: 14, Peptide 78, identical to SEQI NO: 15, Peptide 82, identical to SEQ ID NO: 16, Peptide 83, identical to SEQ ID NO: 17, Peptide 84, identical to SEQ ID NO: 18 and Peptide 85, identical to SEQ ID NO: 19, which meets those specific limitations in claim 15.
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.
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 24 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over the abstract of Harris et al (Blood, November 13, 2019, Vol.134, supplement 1, page 3251). In view of the abstract of Lazarski et al (Cytotherapy, 2019, Vol. 21, No. 5, suppl, page s17).
Harris et al teach a method of priming a subpopulation of T cells recognizing HPIV3 epitopes comprising contacting T cell of a subject ex vivo with 15-mer peptides from HPIV3 matrix, Harris et al teach the identification of Peptide 84, Peptide 83, Peptide 82, Peptide 59, Peptide 85, Peptide 60, Peptide 76, Peptide 78, Peptide 38, Peptide 77, Peptide 39 and Peptide 50 as immunodominant epitopes within the matrix protein, which mees the limitations of claim 30. Harris et al teach that these results facilitate the development of clinical studies using “off the shelf” virus-specific T cell therapeutics (4th paragraph).
It would have been prima facie obvious at the time prior to the effective filing date to administer Peptide 84, Peptide 83, Peptide 82, Peptide 59, Peptide 85, Peptide 60, Peptide 76, Peptide 78, Peptide 38, Peptide 77, Peptide 39 or Peptide 50 to a healthy subject in order for the T cells of that subject to be primed and expanded in vivo, and subsequently to isolate a subpopulation of T cells that recognize the administered peptide. One of skill in the art would have been motivated to do so by the abstract of Harris et al on the adoptive transfer of virus-specific T cells targeting HPIV3 and the suggestion of the abstract that the disclosed immunodominant peptides can be used to develop an “off the shelf” virus-specific T cell therapeutic. One of skill in the art would be motivated to isolate and characterize the T cells elicited from the priming and expansion in vivo in order to potentially create an off the shelf T cell product for administration, thereby fulfilling the requirement of claim 28.
Regarding claim 29, the abstract of Lazarski et al teaches that expansion of T cells by culture in medium comprising Il-4 and Il-7 is the standard approach for manufacture of T cells.
It would have been prima facie obvious at the time prior to the effective filing date to expand the T cells isolated from the subject in claim 28 by culture in medium comprising both Il-4 and Il-7. One of skill in the art would have been motivated to do so by the teachings of the abstract of Lazarski et al on the standard method for manufacturing T cells for adoptive transfer.
All other rejections and/or objections as set forth in the prior Office action are withdrawn.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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, Julie Wu can be reached at 571-272-5205. 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.
KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights