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, 8-15, 18, 19, 21-27, 29, 44, 45, 47-50 have been amended. Claims 20 and 46 have been canceled. Claims 1-19, 21-45, 47-50 are pending and under consideration.
The rejection of claims 7, 11-15, 19, 26 and 27 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it depends, or for failing to include all the limitations of the claim upon which it depends for reasons of record, is withdrawn in light of applicant’s arguments.
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 14-19 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. Claim 13 has been amended to delete all reference to a functional TCR. Thus, amended claim 13 now requiring all of SEQ ID NO: 1-6, all of SEQ ID NO: 31-36 or all of SEQ ID NO: 64-69 reads on a single polypeptide comprising SEQ ID NO: 1-6, SEQ ID NO: 31-36 or SEQ ID NO: 64-69, which differs from the original claim because one of skill in the art would understand that a TCR is made up of the alpha chain polypeptide and the beta chain polypeptide. Claims 14-19 fail to include all the limitations of claim 13 because none of the polypeptide chains of SEQ ID NO: 7, 8, 90, 91, 37, 38, 92, 93, 70, 71, 132, 133, 47, 48, 94, 85, 95, 49, 50, 96, 87, 97, 72, 73, 88 or 89 comprise all of SEQ ID NO: 1-6, all of SEQ ID NO: 31-36 or all of SEQ ID NO: SEQ ID NO: 64-69. Further section (xxvii) requires two paired polypeptide sequence which is outside the scope of claim 13 limited to a single polypeptide sequence. Claims 18 and 19 dependent on claim 13 require separate alpha chains and beta chains and therefore fail to include all the limitations of claim 13is limited to a single polypeptide sequence which comprises all of SEQ ID NO: 1-6, all of SEQ ID NO: 31-36 or all of SEQ ID NO: 64-69. 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.
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 13-19 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.
The recitation of “the functional portion” in claims 14 and 15 ack specific antecedent basis in claim 13.
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.
Claims 13, 14, 16, 17, 18, 19, 21, 22, 24-27 are rejected 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. 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.
Claim 13 has been amended to delete reference to a TCR receptor of claim 1. One of skill in the art would understand that the TCR receptor is made up of two polypeptides: an alpha chain and a beta chain and that three of the require hypervariable sequences are part of the alpha chain and the remining three are part of the beta chain. Claim 13 now reads on a polypeptide comprising all of SEQ ID NO: 1-6, SEQ ID NO: 31-36 and SEQ ID NO: 64-69. Claim 1 has a provision that the TCR has antigenic specificity for a peptide presented by HLA I which is kRAS, hRAS or nRAS. Thus, this specificity requires that the hypervariable regions of SEQ ID NO: are in an appropriate configuration to recognize the immunogenic epitopes of mutated RAS in the context of HLA-I. Claim 13 has no requirement for recognition of a mutated Ras peptide in the context of HLA-I, thus the required six sequences can be anywhere in the polypeptide. The specification lacks written description for genuses of single polypeptides minimally comprising SEQ ID NO: 1-6, SEQ ID NO: 31-36 and SEQ ID NO: 64-69 because the specification only describes these sequences in terms of a hypervariable region for a TCR alpha chai and a TCR beta chain, wherein the combination of the alpha and beta chains enables the recognition of the mutated Ras immunogenic epitopes I the context of HLA-I. Further the specification fails to describe the genus of polypeptides comprising 99% variants of SEQ ID NO: 7, 8, 90, 91, 37, 38, 92, 93, 70, 71, 132, 133, 47, 48, 94, 85, 95, 49, 50, 96, 87, 97, 72, 73, 88 or 89 as in claim 14(i) to (xxvii) because there is no correlation between the structural deviation and a functional attribute outside of appropriately paired alpha chains and beta chains that serve to recognize kRAS, hRas and nRas immunogenic peptides presented in the context of MHC I. Section (xxvii) of claim 14 is rejected because there is no correlation with recognize kRAS, hRas and nRas immunogenic peptides presented in the context of MHC I.
Claim 21 is reliant on (a) a genus of first polypeptide chains comprising SEQ ID NO: 1-3 and a genus of second polypeptide comprising SEQ ID NO: 4-6; (b) a genus of a first polypeptide chain comprising SEQ ID NI: 31-33 and a second polypeptide chain comprising 34-36; and (c) a genus of a first polypeptide chain comprising SEQ ID NO: 64-66 and a genus of a second polypeptide chain comprising SEQ ID NO: 67-69.
When given the broadest reasonable interpretation the required sequences can be located at any position within the first and second polypeptides of claim 21, The specification fails to describe any polypeptide other than appropriately spaced within a TCR alpha chain and a TCR beta chain, wherein the combination of the alpha and beta chains enables the recognition of the mutated Ras immunogenic epitopes I the context of HLA-I. Further the specification fails to describe the genus of polypeptides comprising 99% variants of SEQ ID NO: 7, 8, 90, 91, 37, 38, 92, 93, 70, 71, 132, 133, 47, 48, 94, 85, 95, 49, 50, 96, 87, 97, 72, 73, 88 or 89 as in claim 22(i) to (xxvii) because there is no correlation between the structural deviation and a functional attribute outside of appropriately paired alpha chains and beta chains that serve to recognize kRAS, hRas and nRas immunogenic peptides presented in the context of MHC I. Section (xxvii) of claim 22 is rejected because there is no correlation with recognize kRAS, hRas and nRas immunogenic peptides presented in the context of MHC I. One of skill in the art would reasonably conclude that applicant was not in possession of the required genuses at the time of filing.
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.
Claims 13-19, 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a TCR comprising (a) a first polypeptide chain comprising SEQ ID NO: 1-3 and a second polypeptide chain comprising SEQ ID NO: 4-6, (b) a first polypeptide chain comprising SEQ ID NO: 31-33 and a second polypeptide chain comprising SEQ ID NO: 34-36 and (c) a first polypeptide chain comprising SEQ ID NO: 64-66 and a second polypeptide chain comprising SEQ ID NO: 64-66 and a second polypeptide chain comprising SEQ ID NO: 67-69, wherein the first and second polypeptide together form the TCR, and the TCR recognizes hRas, kRas and nRas immunogenic peptides presented in the context of HLA-I, does not reasonably provide enablement for an isolated or purified peptide comprising all of SEQ ID NO: 1-6, SEQ ID NO: 31-36 or SEQ ID NO: 64-69, isolated 99% sequence variants of SEQ ID NO: 7, 8, 90, 91, 37, 38, 92, 93, 70, 71, 132, 133, 47, 48, 94, 85, 95, 49, 50, 96, 87, 97, 72, 73, 88 or 89, isolated polypeptides comprising the single chains of SEQ ID NO: 7, 8, 90, 91, 37, 38, 92, 93, 70, 71, 132, 133, 47, 48, 94, 85, 95, 49, 50, 96, 87, 97, 72, 73, 88 or 89. . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
It is well-known in the art, that both the alpha and beta chains of an αβ-TCR provide the binding surface to recognize an antigen displayed in the context of a MHC. Claim 13 specifies a single polypeptide having certain hypervariable regions. Claim 13 does not specify the location of the hypervariable regions in the polypeptide or any function resulting from appropriately located hypervariable rejection. Claim 14 requires 99% sequence variants of the polypeptide of claim 13. Claim 14 sections (i)-(xxvi) encompass single polypeptide chains and does not specify the preservation of any particular function within the 99% structural variants. Claim 14 section xxvii encompasses paired variant polypeptide chains but does not specify the preservation of any particular function within the paired 99% structural variants. Claim 15 specifies single polypeptide chains (i)-(xxvi) .
Claim 21 specifies (a) first polypeptide chains comprising SEQ ID NO: 1-3 and a second polypeptide comprising SEQ ID NO: 4-6; (b) a first polypeptide chain comprising SEQ ID NO: 31-33 and a second polypeptide chain comprising SEQ ID NO: 34-36; and (c) a first polypeptide chain comprising SEQ ID NO: 64-66 and a second polypeptide chain comprising SEQ ID NO: 67-69. The hypervariable regions recited in the claim can be at any location with the first or second polypeptides. The claims does not specify any specific function attributable to the presence of the hypervariable regions at specific locations within the polypeptide.
Claim 22 sections (i)-(xxvi) encompass single polypeptide chains and does not specify the preservation of any particular function within the 99% structural variants. Claim 22 section xxvii encompasses paired variant polypeptide chains but does not specify the preservation of any particular function within the paired 99% structural variants. Claim 23 specifies single polypeptide chains (i)-(xxvi) but does not attribute any particular function to the single polypeptide chains.
One of skill in the art would not be able to use the first and second polypeptide chains of claim 21 comprising (a) a first polypeptide chain comprising SEQ ID NO: 1-3 and a second polypeptide chain comprising SEQ ID NO: 4-6, (b) a first polypeptide chain comprising SEQ ID NO: 31-33 and a second polypeptide chain comprising SEQ ID NO: 34-36 and (c) a first polypeptide chain comprising SEQ ID NO: 64-66 and a second polypeptide chain comprising SEQ ID NO: 64-66 and a second polypeptide chain comprising SEQ ID NO: 67-69; the appropriately paired 99% variants in claim 22, section (xxvii); and the paired chains of claim 23, section (xxvii) other than for formation of a TCR wherein the TCR recognizes hRas, kRas and nRas immunogenic peptides presented in the context of HLA-I because the specification has not taught any alternative use for the peptides.
One of skill in the art would not be able to use the polypeptides of claims 13, the appropriately paired 99% variants in claim 14, section (xxvii); and the paired chains of claim 15, section (xxvii) other than for formation of a TCR wherein the TCR recognizes hRas, kRas and nRas immunogenic peptides presented in the context of HLA-I because the specification has not taught any alternative use for the peptides.
Thus, one of skill in the art would be subject to undue experimentation in order to make and use the polypeptides which were outside the scope of forming a TCR which recognizes hRas, kRas and nRas immunogenic peptides presented in the context of HLA-I.
All other rejections and/or objections as set forth in the prior Office action are withdrawn in light of applicant’s amendments.
Allowable Subject Matter
Claims 1-12, 28-45 and 47-50 are allowed.
Conclusion
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 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