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
This action is in response to the papers filed March 24, 2026 and June 29, 2026.
Amendments
Applicant's amendments, filed March 24, 2026 and June 29, 2026, are acknowledged. Applicant has cancelled Claims 24-52, and amended Claims 2 and 15.
Claims 1-23 are pending.
Election/Restrictions
Applicant has elected without traverse the invention of Group I, claim(s) 1-5, 13-20, and 22-23, drawn to a composition comprising gamma delta (gd) T cells enriched for Vgamma9 Vdelta2 (Vγ9Vδ2; g9d2) T cells.
Within Group I, Applicant has elected without traverse the following species, wherein:
i) the alternative functional property is eliciting an immune response against a coronavirus when administered to a host, as recited in Claim 4; and
ii) the alternative first and second markers are CD11a and HLA-DR, as recited in Claim 12.
Claims 1-23 are pending.
Claims 5-13 and 18-23 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-4 and 14-17 are under consideration.
Priority
This application is a 371 of PCT/US2021/048897 filed on September 2, 2021. Applicant’s claim for the benefit of a prior-filed application provisional application 63/073,850, filed on September 2, 2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
Applicant has filed Information Disclosure Statements on March 1, 2023 and July 17, 2023 that have been considered.
The information disclosure statement filed March 1, 2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. Each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue.
See also MPEP 707.05(e) for electronic documents, including, but not limited to:
(D) reference to the unique Digital Object Identifier (DOI) number, or other unique identification number, if known.
Bibliographic information provided must be at least enough to identify the publication. author, title and date. For books, minimal information includes the author, title, and date. For periodicals, at least the title of the periodical, the volume number, date, and pages should be given.
NPL citations have been lined through for being defective of one or more requirements.
The signed and initialed PTO Forms 1449 are mailed with this action.
Claim Objections
1. The prior objection to Claims 2 and 15 is withdrawn in light of Applicant’s amendments to the claims to separate the ‘wherein’ clauses by line indentation.
Claim Rejections - 35 USC § 112
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 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.
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.
2. Claims 1-4 and 14-17 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 term “enriched” in Claim 1 is a relative term which renders the claim indefinite. The term “enriched” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Similarly, the term “purified” in Claim 15 is a relative term which renders the claim indefinite. The term “enriched” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The claim is considered indefinite because the claim fails to recite the reference composition and/or cell population from which the limitation “enriched” and/or “purified” is to be compared.
That which is/is not considered “enriched” and/or “purified” is an arbitrary and subjective determination.
While it is clear that the composition of Claim 15 is to comprise about 1x10^9 gd T cells (numerator), the claim fails to recite the total cells [denominator] present in the composition from which “purified” is to be determined.
The term "comprising" is open-ended and allows for additional, unrecited elements in the claims. MPEP 2111.03 specifically sets forth that the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). There is no upper limit to the number of cells in the claimed composition, within which about 1x10^9 cells are gd T cells.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
The Examiner suggests canceling recitation of “enriched”, and instead recite the objective minimal number or % of gamma/delta T cells that are to be present in the composition. See, for example, Claim 3.
3. Claims 2 and 15 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 phrase “specifically enriched” in Claims 2 and 15 is a relative term which renders the claim indefinite. The term “enriched” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The claim is considered indefinite because the claim fails to recite the reference composition and/or cell population from which the limitation “specifically enriched” is to be compared.
That which is/is not considered “specifically enriched” is an arbitrary and subjective determination.
While Claims 2 and 15 recite a reference (recited at a high level of generality), such is also a variable “reference” object, per MPEP §2173.05(b), and thus does not overcome the indefiniteness. That which is/is not a “reference” is an arbitrary and subjective determination.
While Claims 2 and 15 recite a control gamma/delta T cell composition (recited at a high level of generality), such is also a variable “control” object, per MPEP §2173.05(b), and thus does not overcome the indefiniteness. That which is/is not a “control gd T cell composition” is an arbitrary and subjective determination.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
The Examiner suggests canceling recitation of “enriched”, “reference”, and “control gd T cell composition”, and instead recite the objective minimal number or % of CD45RA-, CD27- effector memory (EM) cells and CD45RA-, CD27+ central memory (CM) cells that are to be present in the composition. See, for example, Claim 3.
4. Claim 15 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 claim twice recites “at least about”.
The metes and bounds of the term “at least about" are unclear because there are two limitations in this phrase: "at least" and "about".
The limitation "about" is broad, but not indefinite.
Similarly, the limitation "at least" is broad, but not indefinite.
However, "at least about" is indefinite because the metes and bounds of limitation "at least about" can not be determined.
“About” indicates values below 1x10^9 or 80%, respectively, which necessarily fails to meet the "at least" requirement.
The Examiner suggests amending the claim to recite either “at least” or “about”, but not both. Choose one. See, for example, Claims 2-3, “at least”.
5. Claim 14 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 phrase “allogeneic” in Claim 14 is a relative term which renders the claim indefinite. The term “allogeneic” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The claim is considered indefinite because the claim fails to recite the reference human and/or non-human animal species from which the limitation “allogeneic” is to be determined.
That which is/is not considered “allogeneic” is an arbitrary and subjective determination.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
6. Claim 14 is 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.
The Examiner incorporates herein the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
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.
7. Claim 17 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 17 recites the broad recitation “the composition comprises”, and the claim also recites exemplary limitations “optionally, a pharmaceutically acceptable carrier, diluent, adjuvant and/or additive”, which is the narrower statement of the range/limitation.
Claim 17 recites the broad recitation “diluent, adjuvant and/or additive”, and the claim also recites “a pharmaceutically acceptable carrier”, which is the narrower statement of the range/limitation. Those of ordinary skill in the art in biological research and/or clinical medicine have long-recognized that pharmaceutically acceptable carriers are an additive and dilute the agent and/or cells present in the composition, per natural law of physics and chemistry.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
8. Claim 17 is 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 16 recites a pharmaceutical composition comprising the gd T cells of Claim 1.
Claim 17, dependent upon Claim 16, recites wherein the pharmaceutical composition of Claim 16 comprises, optionally, a pharmaceutically acceptable carrier, diluent, adjuvant and/or additive.
Claim 17 fails to further limit Claim 16 because those of ordinary skill in the art of biological research and/or clinical medicine have long-recognized that it is axiomatic that a pharmaceutical composition comprising the gamma/delta T cells necessarily comprises a pharmaceutically acceptable carrier, diluent, adjuvant, and/or additive. It is the presence of the pharmaceutically acceptable carrier, diluent, adjuvant, and/or additive that renders the cellular composition a “pharmaceutical” composition.
Instant specification fails to disclose a pharmaceutical composition comprising the gd T cells of Claim 1 in the absence of a pharmaceutically acceptable carrier, diluent, adjuvant, and/or additive.
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.
9. Claim 17 is 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 16 recites a pharmaceutical composition comprising the gd T cells of Claim 1.
Claim 17, dependent upon Claim 16, recites wherein the pharmaceutical composition of Claim 16 comprises, optionally, a pharmaceutically acceptable carrier, diluent, adjuvant and/or additive.
Those of ordinary skill in the art of biological research and/or clinical medicine have long-recognized that it is axiomatic that a pharmaceutical composition comprising the gamma/delta T cells necessarily comprises a pharmaceutically acceptable carrier, diluent, adjuvant, and/or additive. It is the presence of the pharmaceutically acceptable carrier, diluent, adjuvant, and/or additive that renders the cellular composition a “pharmaceutical” composition.
Instant specification fails to disclose a pharmaceutical composition comprising the gd T cells of Claim 1 in the absence of a pharmaceutically acceptable carrier and/or diluent.
10. Claim 4 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.
Claim 4 recites wherein the cells of the composition are capable of eliciting an immune response against coronavirus when administered to a host.
The phrase “an immune response” in Claim 4 is a relative term which renders the claim indefinite. The term “immune response” is recited at a high level of generality, is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The claim is considered indefinite because the claim fails to recite the reference immune response from which the limitation “capable of eliciting” is to be compared.
That which is/is not considered “an immune response” is an arbitrary and subjective determination.
Those of ordinary skill in the art have long-recognized that gd T cells are, by definition, immune cells, and thus it is axiomatic that said cells are capable of inducing an immune response, however minor that might by, per natural law of cell biology.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
11. Claim 4 is 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 1 recites a composition comprising the g9d2 T cells.
Claim 4, dependent upon Claim 1, recites wherein the cells of the composition are capable of eliciting an immune response against coronavirus when administered to a host.
Either this is an inherent property of (that naturally flows from) the g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1, or it is not, and something of said g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1 must change.
To the extent it is an inherent property of (that naturally flows from) the product of the independent claim, then the instant claim fails to further limit the independent claim.
Furthermore, in regard to instant claims, it is noted that the “are capable of eliciting an immune response against coronavirus when administered to a host" clause does not recite any additional structure(s) of the composition of Claim 1, but simply states a characterization of the positively recited g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The phrase “are capable of eliciting an immune response against coronavirus when administered to a host” is an intended use limitation, which does not contain any further structural limitations with respect to claimed g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1 (see MPEP §2114).
Those of ordinary skill in the art have long-recognized that gamma/delta T cells are, by definition, immune cells, and thus it is axiomatic that said cells are capable of inducing an immune response, however minor that might by, per natural law of cell biology.
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
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.
12. Claim 4 is 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 1 recites a composition comprising the g9d2 T cells.
Claim 4, dependent upon Claim 1, recites wherein the cells of the composition are capable of eliciting an immune response against coronavirus when administered to a host.
Either this is an inherent property of (that naturally flows from) the g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1, or it is not, and something of said g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1 must change.
The claim denotes that not all g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1 have the functional properties recited in Claim 4.
To the extent it is not an inherent property of (that naturally flows from) the product of the independent claim, then the instant claim lack adequate written description for failing to recite the structural change(s) necessary and sufficient to predictably achieve the recited functional properties.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. The disclosure of a single species is rarely, if ever, sufficient to describe a broad genus, particularly when the specification fails to describe the features of that genus, even in passing. (see In re Shokal 113USPQ283(CCPA1957); Purdue Pharma L.P. vs Faulding Inc. 56 USPQ2nd 1481 (CAFC 2000).
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997).
The claim fails to recite, and the specification fails to disclose, a first population of g9d2 T cells and/or composition comprising the g9d2 T cells that do not have the functional property of being “capable of eliciting an immune response against coronavirus when administered to a host”, as opposed to a second population of g9d2 T cells and/or composition comprising the g9d2 T cells that necessarily and predictably have the functional property of being “capable of eliciting an immune response against coronavirus when administered to a host”.
Furthermore, in regard to instant claims, it is noted that the “are capable of eliciting an immune response against coronavirus when administered to a host" clause does not recite any additional structure(s) of the composition of Claim 1, but simply states a characterization of the positively recited g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1. Therefore, the "wherein" clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claims. See Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1171,26 USPQ2d 1018, 1023 (Fed Cir. 1993) ("A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim."). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.").
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The phrase “are capable of eliciting an immune response against coronavirus when administered to a host” is an intended use limitation, which does not contain any further structural limitations with respect to claimed g9d2 T cells and/or composition comprising the g9d2 T cells of independent Claim 1 (see MPEP §2114).
'Even if such a phrase did hold patentable weight, the phrase would likely be rejected under 35 USC 112(b) for being indefinite because such a phrase would amount to a 'functional limitation' whereby one of ordinary skill in the art would essentially need to 'guess' what steps must occur in the claim, in addition to the positively-recited method steps, in order to result in 'wherein the....' (the 'intended result' phrase in the claim).
Thus, for the reasons outlined above, it is concluded that the claims do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc)
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.
13. Claim(s) 1, 4, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sumida et al (Predominant Expansion of Vy9/Vδ2 T Cells in a Tularemia Patient, Infection and Immunity 60(6): 2554-2558, 1992; of record).
With respect to Claim 1, Sumida et al is considered relevant prior art for having taught a composition enriched for g9d2 T cells, e.g. about 33% (entire paper).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gamma/delta T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
Thus, Sumida et al anticipate the claims.
14. Claim(s) 1, 4, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poccia et al (CD94/NKC2 Inhibitory Receptor Complex Modulates Both Anti-Viral and Anti-Tumoral Responses of Polyclonal Phosphoantigen-Reactive Vgamma9/Vdelta2 T Lymphocytes, J. Immunol. 159: 6009-6017, 1997).
With respect to Claim 1, Poccia et al taught an enriched culture, e.g. 36%-68%, of expanded g9d2 T cells (e.g. Figure 3).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
Nevertheless, Poccia et al taught that g9d2 T cells display potent cytotoxic activity against virus-infected target cells (e.g. pg 6009, col. 2), and that g9d2 T cells display both lytic and proliferative activities against virus-infected cells, that g9d2 T cells stimulated with cells infected by a first virus, e.g. HIV, also have potent cytotoxicity against cells infected by a second virus, e.g. HBV, and thus, the anti-viral function of gd T cells is directed not against viral antigens, but rather, against a cellular ligand induced or modified by viral infection (e.g. pg 6015, col. 2).
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gamma/delta T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
Thus, Poccia et al anticipate the claims.
15. Claim(s) 1, 4, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poccia et al (Anti–Severe Acute Respiratory Syndrome Coronavirus Immune Responses: The Role Played by Vg9Vd2 T Cells, J. Infectious Diseases 193: 1244-1249, 2006).
With respect to Claim 1, Poccia et al taught an enriched culture of g9d2 T cells (e.g. Figure 1).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
Nevertheless, Poccia et al taught that g9d2 T cells exhibit one or more immune responses against a coronavirus (e.g. pg 1249, col. 1, “we observed that Vg9Vd2 T cells are able to exert a potent cytolytic activity against SARS-CoV–infected target cells” and “our results are compatible with the idea that Vg9Vd2 T cells contribute to anti-SARS innate immune responses by employing both cytotoxic and noncytolytic antiviral mechanisms”).
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gamma/delta T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
Thus, Poccia et al anticipate the claims.
16. Claim(s) 1, 4, 14, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siegers et al (Anti-Leukemia Activity of In Vitro-Expanded Human Gamma Delta T Cells in a Xenogeneic Ph+ Leukemia Model, PLoS ONE 6(2): e16700; 13 pages, doi:10.1371/journal.pone.0016700; February 2011).
With respect to Claim 1, Siegers et al taught an enriched culture of g9d2 T cells (e.g. Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells.
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
With respect to Claims 16-17, Siegers et al taught a pharmaceutical composition comprising the composition comprising g9d2 T cells (e.g. pg 3, col. 2, PBS and BSA).
See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
Thus, Siegers et al anticipate the claims.
17. Claim(s) 1, 4, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salot et al (Large scale expansion of γ9δ2 T lymphocytes: Innacell γδ™ cell therapy product, J. Immunol. Methods 326: 63-75, 2007).
With respect to Claim 1, Salot et al taught an enriched culture of g9d2 T cells (e.g. Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells (e.g. pg 64, col. 1).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
With respect to Claim 15, Salot et al taught a large-scale expansion process yielding an enriched culture of g9d2 T cells (e.g. Abstract, “1000-fold expansion”; Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells (e.g. pg 64, col. 1).
Salot et al taught the manufacturing process is “much simpler than most current cellular therapy approaches” (e.g. Abstract).
Salot et al taught the expansion manufacturing process (e.g. pg 66, col. 1, 2.3 Large scale amplification) yielded about 6.3x10^9 total cells (e.g. Figure 1a; pg 68, col. 1, “6.3 +/- 3.7 g9d2 T cells”), whereby the gd2 T cell population was about 80% (e.g. Figure 1b), and the process yielded a gd2 T cell enrichment of about 77% (e.g. pg 68, col. 2, “77 +/- 17%).
With respect to Claims 16-17, Salot et al taught a pharmaceutical composition comprising the composition comprising g9d2 T cells (e.g. pg 66, col. 2, 4% HA), and recognized cell therapies using the g9d2 T cells (e.g. pg 74, col. 1), for which it is axiomatically understood by the ordinary artisan in biological research and/or clinical medicine that cellular therapeutics inherently comprise at least a pharmaceutically acceptable carrier, diluent, or additive.
See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
Thus, Salot et al anticipate the claims.
18. Claim(s) 1-4, 14, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berglund et al (Expansion of Gammadelta T Cells from Cord Blood: A Therapeutical Possibility, Stem Cells International, Article 8529104, 15 pages, doi.org/10.1155/2018/8529104; available online March 7, 2018).
With respect to Claim 1, Berglund et al taught an enriched culture of g9d2 T cells (e.g. Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells (e.g. pg 1, col. 1).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
With respect to Claims 16-17, Berglund et al taught a pharmaceutical composition comprising the composition comprising g9d2 T cells (e.g. pg 9, col. 2, adoptive g9d2 T cell therapy), for which it is axiomatically understood by the ordinary artisan in biological research and/or clinical medicine that cellular therapeutics inherently comprise at least a pharmaceutically acceptable carrier, diluent, or additive.
See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 3, Berglund et al taught the composition comprises about 85%, or more, g9d2 T cells (e.g. Figure 3a).
With respect to Claim 2, Berglund et al taught the composition comprises about 85%, or more, g9d2 T cells (e.g. Figure 3a), are enriched for CD45RO+, CD27- effector memory (EM) and CD45RO+, CD27+ central memory (CM) (e.g. Figures 3a, 3e).
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Thus, while worded differently, those of ordinary skill in the art would have reasonably understood and/or inferred that Berglund et al taught CD45RA- CD27- effector memory (EM) and CD45RA-, CD27+ central memory (CM) cells (e.g. Figures 3a, 3e) because CD45RO+ cells cannot be CD45RA+ cells. CD45RO and CD45RA are distinct isoforms derived from the same CD45 gene, and thus it is axiomatic, per natural law of genetics and cell biology, that the CD45RO+, CD27- EM cells are CD45RA- CD27- EM cells (instant recitation), and CD45RO+, CD27+ CM cells are CD45RA-, CD27+ CM cells (instant recitation).
Thus, Berglund et al anticipate the claims.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
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.
19. Claims 1-4 and 14-17 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Berglund et al (available online March 7, 2018; of record) in view of Salot et al (2007; of record).
Determining the scope and contents of the prior art, and Ascertaining the differences between the prior art and the claims at issue.
With respect to Claim 1, Berglund et al taught an enriched culture of g9d2 T cells (e.g. Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells (e.g. pg 1, col. 1).
Berglund et al taught the composition comprises about 85%, or more, g9d2 T cells (e.g. Figure 3a).
Berglund et al do not teach ipsis verbis the composition comprises about 1x10^9 gdT cells, at least 80% of which are g9d2 T cells.
However, prior to the effective filing date of the instantly claimed invention, and with respect to Claim(s) 15, Salot et al taught a large scale expansion process yielding an enriched culture of g9d2 T cells (e.g. Abstract, “1000-fold expansion”; Figure 1). There is no objective evidence that g9 T cells were selectively removed from the enriched culture comprising gd2 T cells. Rather, those of ordinary skill in the art recognized that gd2 T cells almost exclusively express the Vg9 of the TCRgamma chain and represent over 75% of the peripheral gdT cells (e.g. pg 64, col. 1).
Salot et al taught the manufacturing process is “much simpler than most current cellular therapy approaches” (e.g. Abstract).
Salot et al taught the expansion manufacturing process (e.g. pg 66, col. 1, 2.3 Large scale amplification) yielded about 6.3x10^9 total cells (e.g. Figure 1a; pg 68, col. 1, “6.3 +/- 3.7 g9d2 T cells”), whereby the gd2 T cell population was about 80% (e.g. Figure 1b), and the process yielded a gd2 T cell enrichment of about 77% (e.g. pg 68, col. 2, “77 +/- 17%).
Resolving the level of ordinary skill in the pertinent art.
People of the ordinary skill in the art will be highly educated individuals such as medical doctors, scientists, or engineers possessing advanced degrees, including M.D.'s and Ph.D.'s. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell biology, immunology, and cellular therapeutics. Therefore, the level of ordinary skill in this art is high.
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at ___, 82 USPQ2d at 1396.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
The focus when making a determination of obviousness should be on what a person of ordinary skill in the pertinent art would have known at the time of the invention, and on what such a person would have reasonably expected to have been able to do in view of that knowledge. This is so regardless of whether the source of that knowledge and ability was documentary prior art, general knowledge in the art, or common sense. M.P.E.P. §2141.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). See also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MPEP §2144.
Prior to the effective filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to arrive at a cellular composition enriched for g9d2 T cells, said composition comprising about 1x10^9 gdT cells, and about 80% of which are g9d2 T cells, and wherein said cellular composition is enriched for CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells with a reasonable expectation of success because Salot et al taught a simple, large-scale expansion method to generate a therapeutic cellular composition of g9d2 T cells yielding 1000-fold expansion of g9d2 T cells, said composition comprising about 6.3x10^9 total cells (e.g. Figure 1a; pg 68, col. 1, “6.3 +/- 3.7 g9d2 T cells”), whereby Berglund et al taught the expanded g9d2 T cell composition comprising at least 85% g9d2 T cells are naturally enriched for CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells (e.g. Figures 3a, 3e).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close enough that one skilled in the art would have expected them to have the same properties. See M.P.E.P. §2144.05(I).
Instant specification fails to disclose an element of criticality for a composition comprising about 1x10^9 gdT cells, about 80% of which are g9d2 T cells, as opposed to the compositions comprising about 6.3 +/- 3.7x10^9 g9d2 T cells, whereby the gd2 T cell population was about 80% (e.g. Figure 1b), and the process yielded a gd2 T cell enrichment of about 77% (e.g. pg 68, col. 2, “77 +/- 17%) taught by Salot et al.
Instant specification fails to disclose an element of criticality for a composition comprising at least 70%, 75%, 80%, 95%, etc… g9d2 T cells, as opposed to the compositions comprising at least 60%, 65%, 70%, 75%, 80%, 95%, or 100% g9d2 T cells taught by Berglund et al (Figure 3a ranges).
Instant specification fails to disclose an element of criticality for a composition comprising enriched CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells, as opposed to the compositions comprising enriched CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells taught by Berglund et al (Figure 3a ranges).
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See the recent Board decision Ex parte Smith, —USPQ2d—, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925 .pdf).
With respect to Claim 4, capable of eliciting an immune response, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 14, allogeneic, such fails to further limit the independent claim. See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
Absent objective evidence to the contrary, it is considered axiomatic that every gd T cell is necessarily allogeneic to the species from which they were obtained, per natural law of biology.
With respect to Claims 16-17, Berglund et al taught a pharmaceutical composition comprising the composition comprising g9d2 T cells (e.g. pg 9, col. 2, adoptive g9d2 T cell therapy), for which it is axiomatically understood by the ordinary artisan in biological research and/or clinical medicine that cellular therapeutics inherently comprise at least a pharmaceutically acceptable carrier, diluent, or additive.
Salot et al taught a pharmaceutical composition comprising the composition comprising g9d2 T cells (e.g. pg 66, col. 2, 4% HA), and recognized cell therapies using the g9d2 T cells (e.g. pg 74, col. 1), for which it is axiomatically understood by the ordinary artisan in biological research and/or clinical medicine that cellular therapeutics inherently comprise at least a pharmaceutically acceptable carrier, diluent, or additive.
See the above 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, rejection.
To the extent Applicant argues otherwise, see above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
With respect to Claim 3, Berglund et al taught the composition comprises at least 85% g9d2 T cells (e.g. Figure 3a).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close enough that one skilled in the art would have expected them to have the same properties. See M.P.E.P. §2144.05(I).
Instant specification fails to disclose an element of criticality for a composition comprising at least 70%, 75%, 80%, 95%, etc… g9d2 T cells, as opposed to the compositions comprising at least 60%, 65%, 70%, 75%, 80%, 95%, or 100% g9d2 T cells taught by Berglund et al (Figure 3a ranges).
With respect to Claim 2, Berglund et al taught the composition comprises at least 85% g9d2 T cells (e.g. Figure 3a), are enriched for CD45RO+, CD27- effector memory (EM) and CD45RO+, CD27+ central memory (CM) (e.g. Figures 3a, 3e).
Thus, while worded differently, those of ordinary skill in the art would have reasonably understood and/or inferred that Berglund et al taught CD45RA- CD27- effector memory (EM) and CD45RA-, CD27+ central memory (CM) cells (e.g. Figures 3a, 3e) because CD45RO+ cells cannot be CD45RA+ cells. CD45RO and CD45RA are distinct isoforms derived from the same CD45 gene, and thus it is axiomatic, per natural law of genetics and cell biology, that the CD45RO+, CD27- EM cells are CD45RA- CD27- EM cells (instant recitation), and CD45RO+, CD27+ CM cells are CD45RA-, CD27+ CM cells (instant recitation).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close enough that one skilled in the art would have expected them to have the same properties. See M.P.E.P. §2144.05(I).
Instant specification fails to disclose an element of criticality for a composition comprising enriched CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells, as opposed to the compositions comprising enriched CD45RA- CD27- EM cells (syn. CD45RO+, CD27-) and/or CD45RA-, CD27+ (syn. CD45RO+, CD27+) CM cells taught by Berglund et al (Figure 3a ranges).
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, the invention as a whole is prima facie obvious.
Citation of Relevant Prior Art
20. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jacobavits et al (U.S. 2019/0119634; priority to May 12, 2017 and/or May 12, 2016) is considered relevant prior art for having disclosed cellular compositions comprising expanded and/or enriched gdT cells, including g9d2 T cells, and pharmaceutical compositions thereof comprising (e.g. [0005], “adoptive transfer of g9d2 T cells”; [0168]; [0376-377], “administration…enriched gd T-cell population”; pg 9, col. 2, adoptive g9d2 T cell therapy).
Huang (U.S. 2020/0230236; priority to at least April 1, 2020) is considered relevant prior art for having disclosed cellular compositions comprising expanded and/or enriched gdT cells, including g9d2 T cells.
Conclusion
21. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN K. HILL whose telephone number is (571)272-8036. The examiner can normally be reached 12pm-8pm EST.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
Prosecution Insights