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 3-13, 15-20, 22-28, 32, 34-37, 39-50 have been amended. Claims 1-50 are pending and examined on the merits.
Information Disclosure Statement
The reference presented in the IDS filed 7/17/2023 has not been considered because it is without a publication date.
Claim Objections
Claims 7, 11, 12, 14, 18, 19, 22, 23, 26 and 27 are objected to because of the following informalities:.
Claim 7 is objected to for the misnumbering of the sub-section: “(xxvi) an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73” rather than ---(xxiv) an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73---
Claim 11 is objected to for mis-labeling subsections: on page 10 of 67, there are two sub-sections labeled “(n)”.
Claim 11 is objected to for missing parenthesis: page 10/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Claim 11 is objected to for the word-processing error of “wherein X at position 103178 of SEQ ID NO: 119 is Ser or Cys” rather than --- wherein X at position 178 of SEQ ID NO: 119 is Ser or Cys---.
Claim 12 is objected to for mis-labeling subsections: on page 18 of 67, there are two sub-sections labeled “(n)”.
Claim 12 is objected to for missing parenthesis: page 18/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Claim 12 is objected to for the word-processing error on page 19/67 of “(v) a β chain comprising the amino acid sequence of SEQ ID NO: 119, wherein position 103178 of SEQ ID NO: 119 is Ser or Cys” rather than --- wherein position 178 of SEQ ID NO: 119 is Ser or Cys---.
Claim 14 is objected to for the misnumbering of the sub-section on page 24 of 67: “(xxvi) an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73” rather than ---(xxiv) an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73---.
Claim 18 is objected to for mis-labeling subsections: on page 29 of 67, there are two sub-sections labeled “(n)”.
Claim 18 is objected to for missing parenthesis: page 29/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Claim 19 is objected to for mis-labeling subsections: on page 37 of 67, there are two sub-sections labeled “(n)”.
Claim 19 is objected to for missing parenthesis: page 37/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Claim 19 is objected to for the word-processing error on page 38/67 of “(v) a β chain comprising the amino acid sequence of SEQ ID NO: 119, wherein position 103178 of SEQ ID NO: 119 is Ser or Cys” rather than --- wherein position 178 of SEQ ID NO: 119 is Ser or Cys---.
Claim 22 is objected to for the misnumbering of the sub-section on page 43 of 67: “(xxvi) a second polypeptide chain comprising an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73” rather than ---(xxiv) a second polypeptide chain comprising an amino acid sequence at least 99% identical to the amino acid sequence of SEQ ID NO: 73---.
Claim 23 is objected to for the misnumbering of the sub-section on page 44 of 67: “(xxvi) a second polypeptide chain comprising an amino acid sequence of SEQ ID NO: 73” rather than ---(xxiv) a second polypeptide chain comprising an amino acid of SEQ ID NO: 73---.
Claim 26 is objected to for mis-labeling subsections: on page 48 of 67, there are two sub-sections labeled “(n)”.
Claim 26 is objected to for missing parenthesis: page 48/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Claim 27 is objected to for mis-labeling subsections: on page 56 of 67, there are two sub-sections labeled “(n)”.
Claim 27 is objected to for missing parenthesis: page 56/67, the first section “(n”) refers to “h)” rather than “(h)”; the second section “(n)” refers to “1)” rather than “(l)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7, 11-15, 19, 26 and 27 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 7 states, in part, that the isolated or purified TCR of claim 1 comprises “both (xv) and (xvii)”, “both (xviii) and (xxii)”, and “both (xx) and (xxii)”. The specification teaches that (xv) and (xvii) are both α chains; (xviii) and (xxii) are both β chains; (xx) and (xxii) are both β chains. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 7, in part, fails to include all the limitations of claim 1 because it is directed to species characterizing the TCR as having two alpha chains or two beta chains rather than an alpha chain, a beta chain or an alpha and a beta chain.
Claim 11 states, in part, that the isolated or purified TCR of claim 1 comprises “both (yyy) and (aaaa)” which are defined by the claim on page 15 and 16 as α chains. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain,, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 11, in part, fails to include all the limitations of claim 1 because it is directed to specie characterizing the TCR as having two alpha chains rather than an alpha chain, a beta chain or an alpha and a beta chain.
Claim 12 states, in part, that the isolated or purified TCR of claim 1 comprises “both (yyy) and (aaaa)” which are defined by the claim on page 22 as α chains. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain,, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 11, in part, fails to include all the limitations of claim 1 because it is directed to specie characterizing the TCR as having two alpha chains rather than an alpha chain, a beta chain or an alpha and a beta chain...
Claim 13 states an isolated and purified polypepide comprsing a functional portion of the TCR according to clam 1, wherein the functional portion comprises the amino acid sequences of SEQ IDX NO: 1-3, 4-6, 31-33, , 34-36, 64-66, 67-69, 1-6, 31-36 or 64-69. This fails to further limit claim 1 because claim 1 requires an isolated or purified T cell receptor comprising he same sequences.
Claim 14 states, in part, that the isolated or purified TCR of claim 13 comprises “both (xv) and (xvii)”, “both (xviii) and (xxii)”, and “both (xx) and (xxii)”. The specification teaches that (xv) and (xvii) are both α chains; (xviii) and (xxii) are both β chains; (xx) and (xxii) are both β chains. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 14, in part, fails to include all the limitations of claim 13 because it is directed to species characterizing the TCR as having two alpha chains or two beta chains rather than an alpha chain, a beta chain or an alpha and a beta chain..
Claim 15 states, in part, that the isolated or purified TCR of claim 13 comprises “both (xv) and (xvii)”, “both (xviii) and (xxii)”, and “both (xx) and (xxii)”. The specification teaches that (xv) and (xvii) are both α chains; (xviii) and (xxii) are both β chains; (xx) and (xxii) are both β chains. Claim 13 depends on claim 1. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 15, in part, fails to include all the limitations of claim 13 because it is directed to species characterizing the TCR as having two alpha chains or two beta chains rather than an alpha chain, a beta chain or an alpha and a beta chain.
Claim 19 requires, in part, the isolated or purified polypeptide of claim 13 comprising an α chain of (yyy) and an α chain of (aaaa). Claim 13 depends on claim 1. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 19, in part, fails to include all the limitations of claim 13 because it is directed to species characterizing the TCR as having two alpha chains rather than an alpha chain, a beta chain or an alpha and a beta chain...
Claim 26 states that the isolated or purified protein of claim 20 requires, in part both (yyy) and (aaaa) on page 54 of 67, which are both “first” polpeptides. Claim 20 depends on claim 13, which depends on claim 1. The disclosre defines (yyy) as an alpha chain and (aaaa) as an alpha chain. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 26, in part, fails to include all the limitations of claim 13 because it is directed to species characterizing the TCR as having two alpha chains, rather than an alpha chain, a beta chain or an alpha and a beta chain.
Claim 27 states, in part, that the isolated aor purified protein of claim 20 requires, in part both (yyy) and (aaaa) on page 62 of 67. Claim 20 depends on claim 13, which depends on claim 1. The disclosre defines (yyy) as an alpha chain and (aaaa) as an alpha chain. Claim 1 requires that the T cell receptor is characterized as comprising the hypervariable sequences of SEQ ID NO: 1-3, 31-33 or 64-66 within the α chain; or SEQ ID NO: 4-6, 34-36, or 67-69 within the β chain, or SEQ ID NO: 1-6, 31-36 or 64-69 which characterizes both the α chain and the β chain of the TCR. Thus, claim 27, in part, fails to include all the limitations of claim 13 because it is directed to species characterizing the TCR as having two alpha chains, rather than an alpha chain, a beta chain or an alpha and a beta chain..
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 9, 10, 14, 15, 22, 23, 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.
Claims 9 and 10 are vague and indefinite because they fails to end in a period and are thus incomplete and also appear to be missing SEQ ID NOs.
The recitations of “xxiv” in claim 14 on page 24, claim 15 on page 25, claim 22 on page 43 and claim 23 on page 45 lack specific antecedent basis within the claim.
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 1-20, 22-28, 32-50 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.
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).
Claims 1-20, 22-28, 32-50 are reliant on a the description of a genus of isolated and purified T cell receptors comprising an alpha chain comprising the hypervariable regions of SEQ ID NO: 1-3, an alpha chain comprising the hypervariable regions of SEQ ID NO: 6-13 , an alpha chain comprising the hypervariable regions of SEQ ID NO: 64-66, a beta chain comprising the hypervaraible regions of SEQ ID NO: 4-6, a beta chain comproising the hypervariable regions of SEQID NO: 34-36, a beta chain comprising the hypervariable region of SEQ ID NO: 67-69, an alpha chain and a beta chain comprising the hypervaraibole regions of SEQ ID NO:1-6, SEQ ID NO: 31-36 or SEQ ID NO: 64-69; the nucleic acids encoding the genus of T cell receptors; methods relaint on genus of T cell receptors and methods relaint on nucleic acids encoding the receptors.
It is well-know in the art, that both the alpha and beta chains of an αβ-TCR provide the binding surface to recognize an antigen displayd in the context of a MHC. Claims 1-20, 22-28, 32-50 admit in part a genus of TCR and nucleic acid encoding said TCR characterized by only an alpha chain or only a beta chain. Claim 1 specifies that the TCR has antigenic specificity for mutated RAS presented by a type I HLA, wherein the mutated RAS is KRAS, HRAS or NRAS. Given only the described alpha chains comprising SEQ ID NO: 1-3, SEQ ID NO: 6-13 , or SEQ ID NO: 64-66, one of skill in the art could not envisage a beta chain to from the binding surface to recognize mutated KRAS, HRAS or NRAS other than those described by the specification as comprising SEQ ID NO: 4-6, SEQ ID NO: 34-36 and SEQ ID NO: 67-69, respectively. Conversely, given only the described beta chains comprising SEQ ID NO: 4-6, SEQ ID NO: 34-36 and SEQ ID NO: 67-69, one of skill in the art could not envisage an alpha chain to form the binding surface to recognize mutated KRAS, HRAS or NRAS other than those described by the specification as comprising SEQ ID NO: 1-3, SEQ ID NO: 6-13 , or SEQ ID NO: 64-66, respectively. This, one of skill in the art would reasonably conclude that applicant was not in possession of the genus of TCR receptors characterized only by an alpha chain comprising SEQ ID NO: 1-3, SEQ ID NO: 6-13 , or SEQ ID NO: 64-66, wherein the TCR receptor recognized mutated KRAS, HRAS or NRAS; nor was applicant in possession of the genus of TCR receptors characterized only by a beta chain comprising SEQ ID NO: 4-6, SEQ ID NO: 34-36 and SEQ ID NO: 67-69 wherein the TCR receptor recognized mutated KRAS, HRAS or NRAS, at the time of filing.
Claims 44-50 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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).
(A)As drawn to the administration of the host cell of clam 37
Claim 44 is drawn to a method of inducing an immune response against a cancer in a mammal comprising the admisnitration of an effective amount of a host cell of claim 37 or a population thereof. Claims 45-50 are drawn to a method or treating or preventing cancer comprising the admisnitrtion of an effective amount of the host cell of claim 37 or a population thereof. The specification defines “host cell” as including a eukaryotic cell, e.g., plant, animal, fungi, or algae, or prokaryotic cell, e.g., bacteria or protozoa.
Clambrey et al (Journal of Molecular Medicine, 2014, Vol. 92, pp. 733-741) teach that the TCR heterodimer comprising the alpha chain and the beta chain is incapable of transducing a signal into the cell without close physical association with a complex of signal transduction proteins which are the CD3δ, CD3ε, CD3γ and the ζ chain (page 738, lines 1-66 of the 2nd paragraph under the heading “TCR specificities, signal transduction and the T cell response”). Clambrey et al teach that in order for a T cell to be fully activated, TCR signaling must occur in close spatial proximity to additional signaling transduction cascades such as the costimulatory molecules of CD28 and CD28-related proteins (page 738, lines 12-17 of the 2nd paragraph under the heading “TCR specificities, signal transduction and the T cell response”). Clambrey et al teach that activation through the TCR coupled with the integration of multiple signaling events rapidly elicits a specific T cell response that is characterized by proliferation and acquisition of effector functions including cytokine production or the ability to induce targeted cell killing (page 738-739). Thus, without the existence of the appropriate signal transduction proteins and additional signaling cascades in appropriate spatial proximity to the TCR to activate cytokine production or release of cytotoxic granules or other effector functions, the host cell population comprising the TCR of the claims will not have a function other than recognition of the cognate antigen in the context of HLA with no effect resulting from the recognition..
Regarding a NK cell as a host cell in instant claim 39, the art recognizes that killing by NK cells in vivo is due to low expression of HLA I on the target cell that normally prevents NK cell cytotoxicity . In the instant case of admisnitraton of the inventive host cells expressing the TCR which recognize mutated RAS in the contenxt of HLA class I is dependent on the expression of HLA class I on the target cells. , One of skill in the art would conclude that NK cell effector functioen which relies on recognizing cells expressing low level of HLA class I is at odds with carrying a T cell receptor which recognizes mutated RAS in the context of HLA class I on the target cells. One of skill in the art would not expect the invetive TCR to contribute to the efficacy of a NK cell because the NK cell would be active against target cells expreesing low MHC I or no MHC I versus the TCR which requires MHC I expression on the target cells.
Regarding a host cell which is a B cell, Clambrey et al (ibid)) teach that the TCR heterodimer comprising the alpha chain and the beta chain is incapable of transducing a signal into the cell without close physical association with a complex of signal transduction proteins which are the CD3δ, CD3ε, CD3γ and the ζ chain and that in order for a T cell to be fully activated, TCR signaling must occur in close spatial proximity to additional signaling transduction cascades such as the costimulatory molecules of CD28 and CD28-related proteins. Clambrey et al teach that activation through the TCR coupled with the integration of multiple signaling events rapidly elicits a specific T cell response that is characterized by proliferation and acquisition of effector functions including cytokine production or the ability to induce targeted cell killing. Thus, without the existence of the appropriate signal transduction proteins and additional signaling cascades in appropriate spatial proximity to the TCR to activate cytokine production or release of cytotoxic granules or other effector functions, a B cell population comprising the TCR of the claims will not have a function other than recognition of the cognate antigen in the context of HLA with no effect resulting from the recognition.
(B)As drawn to the induction of an immune response against a generic cancer in a mammal and a method of treatment of generic cancers
Claim 44 is drawn to a method of inducing an immune response against a cancer in a mamma and claims 45-50 are drawn, in part, to a method of treating cancer, both methods comprising the administratin of the inventive TCR expressed by an appropriate host cell capable of exerting effector functions, wherein the TCR which recognizes mutated RAS in the context of HLA class I. When given the bradest reasaobnle interpretation, “cancer” means any type of cancer without regard to the expression of mutated RAS. Claim 50 specifies the various histologies of the cancers treatable by the instant claims, but none of the claims require that the cancers express the required mutated RAS. One of skill in the art would be subjected to undue expereimtnation without reasonable expectation of success in order to induce an immune response aagasinst a generic cancer or treat any cancer by admisnitration of the inventive TCR expressed by the appropriate host cell.
(C)As drawn to the prevention of cancer
Claims 45-50 are drawn in part to a method of preventing cancer in a mammal comprising the admisnitration of an effective amount of a host cell expressing the inventive TCR expressed by an appropriate host cell capable of exerting effector functions, wherein the TCR which recognizes mutated RAS. When given the broadest reasonable interpretation, “a mammal” includes humans and non-experimental mammals. In order to prevent a cancer, the host cell expressing the inveitve TCR would have to be available in the human or non-experimental mammal at therapeutically effective levels at the time before the cancer actually occurred. It is noted that the host cell expressing the TCR would have a finite lifetime in circulation and the injected amount would likely decrease over time. Further, the mammal would have to be preseventing from developing a cancer characterized by mutated RAS so that recognition y the invetive TCR could occur and a subsequenct immune response against the cell would occur. The specification has not taght how to identify humans and non-experimental mammals who wll develop a cancer charcerized by mutant RAS, nor has the specification taught how to ascertain when this development will occur in order that the cell exprsssing the invetive TCR may be admisniter as prevention. One of skil in the art woud be subject to undue experimentation without rasoanble expectation of success in order to carryout the instant method as pertaining to the preventon of cancer.
Allowable Subject Matter
Claims 29-31 are allowed.
Claims 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/ Primary Examiner, Art Unit 1643