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 May 24, 2026.
Amendments
Applicant's amendments, filed December 12, 2025, is acknowledged. Applicant has cancelled Claims 1-37 and 43-55, amended Claims 38, 40, and 57, withdrawn Claims 41-42, and 56, and added new claims, Claims 58-62.
Claims 38-42 and 56-62 are pending.
Election/Restrictions
Applicant has elected without traverse the invention of Group II, Claims 38-42, drawn to a method for treating a senescence-associated or an immune-inflammatory associated disease in a subject in need thereof, the method comprising the step(s) of:
a) obtaining information of a disease etiology of the subject;
wherein the disease etiology comprises a senescence-associated or an immune-inflammatory associated disease; and
(b)(i) administering to the subject cytotoxic CD4 T-cells (CD4-CTLs) and/or an agent capable of inducing CD4-CTLs differentiation and/or proliferation, thereby treating the senescence-associated disease; or
(b)(ii) administering an agent capable of inducing aTreg depletion and/or inhibition.
Within Group II, Applicant has elected without traverse the following species, wherein:
i) the alternative pharmaceutical composition is CD4 cytotoxic T-cells (CD4-CTLs);
iii) the alternative additional method step is isolating effector memory CD4 T-cells (EMs) from the subject and differentiating them into CD4-CTLs, as recited in Claim 40;
iv) the alternative biomarker is IL-6 during EM cultivations, and CD44 used for sorting the EMs, as recited in Claim 40; and
v) the alternative senescence-associated disease, immune-inflammatory associated disease, or autoinflammatory or autoimmune disease, is fibrosis, as recited in Claim 57.
Claims 38-42 and 56-62 are pending.
Claims 41-42 and 56 are pending but withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Newly submitted Claims 59-60 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: they are directed to non-elected disease (v) species.
Newly submitted Claim 61 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: they are directed to non-elected alternative biomarker (iv) species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 59-62 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 38-40 and 57-58 are under consideration.
Priority
This application is a 371 of PCT/IL2021/051047 filed on August 25, 2021. Applicant’s claim for the benefit of a prior-filed application provisional application 63/073,183 filed on September 1, 2020, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application Nos. 63/073,183 and PCT/IL2021/051047, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim(s) 38 has been amended to recite the step of administering to the subject self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
The Examiner is unable to find support for the amendment in 63/073,183 and PCT/IL2021/051047.
A search of “self-antigens” identifies a single mention in reference to regulatory CD4+ T cells (Tregs) (e.g. ‘183 pg 8, para 4); however, instant claims are directed to cytotoxic CD4+ T cells, which is recognized in the art to be different than Treg cells. ‘047 suffers the same deficiency.
The ‘183 specification is silent to “cancer-antigen naïve”. ‘047 suffers the same deficiency.
A search of “naïve” identifies reference to sampling CD4 T cells from a subject (e.g. ‘183 pg 7, Figure 6D legend; pg 19, Example 4, para 2); however, the specification is silent to instantly recited step of administering to the subject cancer-antigen naïve cytotoxic CD4+ T cells. ‘047 suffers the same deficiency.
Clear support for the new limitation(s) cannot be found in the instant application or priority documents. Accordingly, the amendment(s) to Claim 38 is considered to constitute new matter. See 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejection below.
Accordingly, the effective priority date of the instant application is granted as February 28, 2023, the filing date of the instant application.
If applicant believes the earlier applications provide support for this disclosure, applicant should point out such support with particularity by page and line number in the reply to this Action.
Specification
1. The prior objection to the disclosure is withdrawn in light of Applicant’s amendment to the specification to properly identify the trade name(s) and/or trade mark(s).
Claim Objections
2. The prior objections to Claims 38 and 40 are withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 101
3. The prior rejection of Claims 38-40 under 35 U.S.C. 101 is withdrawn in light of Applicant’s amendment to the claim cancelling recitation of “a) obtaining information”.
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.
4. The prior rejection of Claim 40 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of Applicant’s amendment to the claim to recite the isolated CD4+ effector memory (EM) T-cells are CD44-positive, which the Examiner finds persuasive.
New Matter
5. Claims 38-40 and 57-58 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(s) 38 has been amended to recite the step of administering to the subject self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
Clear support for the new limitation(s) cannot be found in the instant application or priority documents. Accordingly, the amendment(s) to Claim 38 is considered to constitute new matter.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application”. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Applicant fails to point with particularity where in the originally filed application support for the instantly recited limitations is/are found.
The Examiner is unable to find support for the amendment.
A search of “self-antigens” identifies a single mention in reference to regulatory CD4+ T cells (Tregs) (e.g. pg 14, para 4); however, instant claims are directed to cytotoxic CD4+ T cells, which is recognized in the art to be different than Treg cells.
The specification is silent to “cancer-antigen naïve”.
A search of “naïve” identifies reference to sampling CD4 T cells from a subject (e.g. pg 9, Figure 6D legend; pg 30, para 2), including sampling CD4 T cells from within a subject’s tumor (e.g. pg 12, Figure 13C legend); however, the specification is silent to instantly recited step of administering to the subject cancer-antigen naïve cytotoxic CD4+ T cells.
Alternatively, if Applicant believes that support for the step of administering to the subject self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells, as now recited in Claim 38, is present and clearly envisaged in the instant application or earlier filed priority documents, applicant must, in responding to this Office Action, point out with particularity, where such support may be found.
Declarations and new references cannot demonstrate possession of a concept after the fact.
Applicant does not indicate where these limitations are supported by the original specification, or how, as is Applicant's burden. See MPEP §714.02, last sentence of the third paragraph from the end and MPEP §2163.06 (I) last sentence.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim(s).
6. Claims 38-40 and 57-58 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.
Claim 38 is directed to a method of treating a senescence-associated disease in a subject in need thereof, including, but not limited to, the elected senescence-associated disease species fibrosis.
Claim(s) 38 has been amended to recite the step of administering to the subject self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
The phrase “an effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In reFredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954). MPEP 2173.05(c)
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
A “therapeutically effective amount” is a functional property that is dependent upon many different variable parameters, including, but not limited to:
the type of subject human or non-human animal to be treated [parameter 1];
the dosage administered [parameter 2];
the disease/disorder/condition to be treated [parameter 3]; and
the phenotypic response to be achieved [parameter 4].
The claim(s) also denote(s) that there is an amount of the pharmaceutical composition comprising the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells that, upon administration to the subject, is not, in fact, “a therapeutically effective amount” (syn. subtherapeutic amount), to necessarily and predictably achieve a real-world, clinically meaningful therapeutic effect, thereby treating a senescence-associated disease, including fibrosis.
Parameter 1
The claims are broad for reasonably encompassing an enormous genus of human and non-human animals, including mammals (pg 20, para 2).
The claims are broad for encompassing about 1,000,000 species of animals (Kingdoms of Life, waynesword.palomar.edu/trfeb98.htm, last visited April 8, 2021), wherein the mammalian sub-genus reasonably encompasses some 6,400 species (including humans), distributed in about 1,200 genera, about 152 families and about 29 orders (Mammal, en.wikipedia.org/wiki/Mammal, last visited August 31, 2022).
Parameter 2
The claims are broad for failing to recite the at least minimal dosage of the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells required to be administered to the 1x10^6 human and non-human animal subjects to necessarily and predictably achieve a real-world, clinically meaningful therapeutic effect, thereby treating a senescence-associated disease, including fibrosis.
While the specification discloses Examples of sampling different CD4+ T cell populations from a mouse subject, the specification is silent to an Example reducing to practice the step of administering self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells to the one or more human and non-human animal subjects to necessarily and predictably achieve a real-world, clinically meaningful therapeutic effect, thereby treating a senescence-associated disease, including fibrosis.
The specification is silent to the dosage of the cytotoxic CD4+ T cell, including self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
Parameter 3
The claims are broad for an enormously vast genus of etiologically and pathologically distinct diseases/disorders/conditions associated with senescence (syn. aging).
Espe (Malacards: The Human Disease Database, J. Medical Library Association 106(1): 140-141, DOI: dx.doi.org/10.5195/jmla.2018.253; January 2018) is considered relevant prior art for having taught that there are at least 26,000 known human diseases.
The term “fibrosis” is recited at a high level of generality; whereas, the specification discloses liver fibrosis (e.g. pg 11, Figure 9A legend; pg 32, Example 12, mouse model of liver fibrosis).
The specification is silent to administering self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells to a mouse model of liver fibrosis, thereby achieving a real-world, clinically meaningful therapeutic effect.
Parameter 4
It is understood that in order to meaningfully treat the subject, and thereby satisfy the requirements of 35 U.S.C. 101 (See MPEP 2107.01 III, Therapeutic or Pharmacological Utility), a therapeutically effective amount or dose of the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells must be administered to the subject, thereby achieving some real-world, clinically meaningful effect, and thereby being of “immediate benefit to the public”.
The claims are broad for reasonably encompassing an enormous genus of physiologically and phenotypically different results, which evokes the question: A therapeutically effective amount to do what?
The claim(s) also denote(s) that there is an amount of the pharmaceutical composition comprising the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells that, upon administration to the subject, is not, in fact, “a therapeutically effective amount” (syn. subtherapeutic amount), to necessarily and predictably achieve a real-world, clinically meaningful therapeutic effect, thereby treating a senescence-associated disease, including fibrosis.
The recitation implies a genus of unrecited and undisclosed phenotypes by which the therapeutically effective dose is to be determined and/or identified, thereby rendering the claim indefinite. A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
The specification discloses (e.g. pgs 19-20, joining para) the therapeutic effect includes, but is not limited to:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment.
The specification does not disclose a definition for “prevents” or “preventing”, and thus is interpreted according to its plain meaning, which is “to keep from happening or existing” (www.merriam-webster.com/dictionary/prevent; last visited March 4, 2025)
If there are multiple ways to measure “therapeutically effective dose”, then the claim may be indefinite because it is unclear which method step parameter(s) is/are to be performed, individually and/or in combination and/or subcombination thereof, and to achieve which phenotypic result(s) to determine infringement.
The claims encompass a genus of unrecited phenotypes by which the therapeutically effective dose is to be determined and/or identified, whereby the therapeutically effective amount of the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells administered is/are a result-effective variable dependent upon many different parameters, thereby rendering the claim indefinite.
See further discussion below in the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, rejections.
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 claims.
Appropriate correction is required.
When functional claim language is found indefinite, it typically lacks an adequate written description under §112(a), because an indefinite, unbounded functional limitation would cover a plurality of undisclosed structures and/or method steps of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention. Thus, in most cases, a §112(b) rejection that is based on functional language having unclear (or no) claim boundaries should be accompanied by a rejection under §112(a) based on failure to provide a written description for the claim. See MPEP 2173.05(g).
7. Claims 38-40 and 57-58 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 38 is directed to a method of treating a senescence-associated disease in a subject in need thereof, including, but not limited to, the elected senescence-associated disease species fibrosis.
Claim(s) 38 has been amended to recite the step of administering to the subject self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
The Examiner incorporates herein the above 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, rejection.
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 phrase “an effective amount” has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In reFredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954). MPEP 2173.05(c)
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
A “therapeutically effective amount” is a functional property that is dependent upon many different variable parameters, including, but not limited to:
the type of subject human or non-human animal to be treated [parameter 1];
the dosage administered [parameter 2];
the disease/disorder/condition to be treated [parameter 3]; and
the phenotypic response to be achieved [parameter 4].
The claim(s) also denote(s) that there is an amount of the pharmaceutical composition comprising the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells that, upon administration to the subject, is not, in fact, “a therapeutically effective amount” (syn. subtherapeutic amount), to necessarily and predictably achieve a real-world, clinically meaningful therapeutic effect, thereby treating a senescence-associated disease, including fibrosis.
Parameter 2
The specification is silent to the dosage of the cytotoxic CD4+ T cell, including self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells.
Parameter 3
The claims are broad for an enormously vast genus of etiologically and pathologically distinct diseases/disorders/conditions associated with senescence (syn. aging).
The specification is silent to administering self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells to a mouse model of liver fibrosis, thereby achieving a real-world, clinically meaningful therapeutic effect.
Parameter 4
It is understood that in order to meaningfully treat the subject, and thereby satisfy the requirements of 35 U.S.C. 101 (See MPEP 2107.01 III, Therapeutic or Pharmacological Utility), a therapeutically effective amount or dose of the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells must be administered to the subject, thereby achieving some real-world, clinically meaningful effect, and thereby being of “immediate benefit to the public”.
The claims encompass a genus of unrecited phenotypes by which the therapeutically effective dose is to be determined and/or identified, whereby the therapeutically effective amount of the self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells administered is/are a result-effective variable dependent upon many different parameters, thereby rendering the claim indefinite.
Zhou et al (CD4+ T cell activation and inflammation in NASH-related fibrosis, Frontiers Immunol. 13: e967410, 10 pages; doi.org/10.3389/fimmu.2022.967410, August 9, 2022) is considered relevant art for having taught that liver fibrosis diseases include nonalcoholic fatty liver disease (NAFLD) and nonalcholic steatohepatitis (NASH) (e.g. pg 1, Introduction).
Zhou et al taught that the art recognizes that CD4+ T cells are involved in the progression of NAFLD and NASH, including experimental animal models of adoptive transfer of CD4+ T cells (e.g. pg 4, col. 2, “CD4+ T cells were found to be crucial in promoting liver steatosis-fibrosis transition”). Rather, it is the depletion of CD4+ T cells that reduces proinflammatory cytokine production and fibrosis (e.g. pg 4, col. 2).
Thus, the prior art teaches the opposite result of what Applicant now claims.
Instant claims and specification fail to make up for the deficiencies of the global scientific community.
The claims fail to recite, and the specification fails to disclose, a first self-antigen specific cytotoxic CD4+ T cell dosage [parameter 2] administered to a first subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a pig, that is necessarily and predictably able to prevent development of [parameter 4] a senescence-associated disease [parameter 3], e.g. cancer, as opposed to a second self-antigen specific cytotoxic CD4+ T cell dosage [parameter 2] administered to a second subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a human, that is necessarily and predictably able to cause remission of [parameter 4] a senescence-associated disease [parameter 3], e.g. liver fibrosis, for example.
The claims fail to recite, and the specification fails to disclose, a first cancer-antigen naïve cytotoxic CD4+ T cell dosage [parameter 2] administered to a first subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a non-human primate, that is necessarily and predictably able to prevent disease spread of [parameter 4] a senescence-associated disease [parameter 3], e.g. chronic inflammation, as opposed to a second cancer-antigen naïve cytotoxic CD4+ T cell dosage [parameter 2] administered to a second subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a rabbit, that is necessarily and predictably able to cause prolongation of survival of [parameter 4] a senescence-associated disease [parameter 3], e.g. multiple sclerosis, for example.
The claims fail to recite, and the specification fails to disclose, how to transform or otherwise modify a first self-antigen specific cytotoxic CD4+ T cell dosage [parameter 2] administered to a first subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a pig, that is unable to prevent development of [parameter 4] a senescence-associated disease [parameter 3], e.g. cancer, into a second self-antigen specific cytotoxic CD4+ T cell dosage [parameter 2] administered to a second subject of the about 1x10^6 human and non-human animal subjects [parameter 1], e.g. a human, that is now necessarily and predictably able to cause remission of [parameter 4] a senescence-associated disease [parameter 3], e.g. liver fibrosis, for example.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”).
Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005).
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.” Such correlations may be established “by the inventor as described in the specification,” or they may be “known in the art at the time of the filing date.” See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014)
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function ... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is’).
In Amgen, Inc., v. Sanofi (872 F.3d 1367 (2017)
At 1375, [T]he use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper.
At 1377, [W]e questioned the propriety of the "newly characterized antigen" test and concluded that instead of "analogizing the antibody-antigen relationship to a `key in a lock,'" it was more apt to analogize it to a lock and "a ring with a million keys on it." Id. at 1352.
An adequate written description must contain enough information about the actual makeup of the claimed products — "a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials," which may be present in "functional" terminology "when the art has established a correlation between structure and function." Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. See, e.g., J.A. 1241 (549:5-
16) (Appellants' expert Dr. Eck testifying that knowing "that an antibody binds to a particular amino acid on PCSK9 ... does not tell you anything at all about the structure of the antibody"); J.A. 1314 (836:9-11) (Appellees' expert Dr. Petsko being informed of Dr. Eck's testimony and responding that "[m]y opinion is that [he's] right"); Centocor, 636 F.3d at 1352 (analogizing the antibody-antigen relationship as searching for a key "on a ring with a million keys on it") (internal citations and quotation marks omitted).
In the instant case, knowing that the initial pharmaceutical composition is to comprise self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells does not tell you anything at all about the enormously vast genus of structurally and functionally undisclosed doses of said self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells [parameter 2] to be administered to the enormously vast genus of about 1x10^6 human and non-human animal subjects [parameter 1], so as to necessarily and predictably achieve a real-world, clinically meaningful treatment of the enormously vast genus of senescence-associated diseases [parameter 3], including, but not limited to:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4].
In Amgen, Inc., v. Sanofi (U.S. Supreme Court, No. 21-757 (2023))
“Amgen seeks to monopolize an entire class of things defined by their function”.
“The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequence, but a “vast” number of additional antibodies that it has not.”
“It freely admits that it seeks to claim for itself an entire universe of antibodies.”
In the instant case, the record reflects that Applicant seeks to claim for themselves:
an enormously vast genus of structurally and functionally undisclosed doses of said self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells [parameter 2] to be administered to an enormously vast genus of about 1x10^6 human and non-human animal subjects [parameter 1], to treat an enormously vast genus of etiologically and pathologically distinct senescence-associated diseases [parameter 3], whereby the “therapeutically effective amount” and/or “effective amount” will depend on the condition to be treated, the severeness of disease, individual parameters of the patient, including age, physiological condition, size and weight, duration of treatment, type of accompanying therapy, specific route of administration, and dose, each of which are variable parameters, so as to necessarily and predictably achieve a real-world, clinically meaningful therapeutic result including, but not limited to:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4].
“They leave a scientist forced to engage in painstaking experimentation to see what works. 159 U.S., at 475.
This is not enablement. More nearly, it is “a hunting license”. Brenner v. Manson, 383 U.S. 519, 536 (1966).
“Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation”.
While the “roadmap” would produce functional combinations, it would not enable others to make and use the functional combinations; it would instead leave them to “random trial-and-error discovery”.
“Amgen offers persons skilled in the art little more than advice to engage in “trial and error”.
“The more a party claims for itself the more it must enable.”
“Section 112 of the Patent Act reflects Congress’s judg-ment that if an inventor claims a lot, but enables only a lit-tle, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the stat-utory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same.
Instant application fails to disclose a reduction to practice of the claimed invention.
The prior art teaches away from using cytotoxic CD4+ T cells to achieve, e.g.:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4], of a senescence-associated fibrotic disease such a liver fibrosis.
Rather, cytotoxic CD4+ T cell are recognized to be causal for liver fibrosis.
Instant claims and specification fail to make up for the deficiencies of the global scientific community.
Applicant is essentially requiring the ordinary artisans to discover for themselves that which Applicant fails to disclose.
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.
See further discussion below in the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, enablement rejection.
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)
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claims.
8. Claims 38-40 and 57-58 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 Examiner incorporates herein the 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, written description rejections.
In Amgen, Inc., v. Sanofi (872 F.3d 1367 (2017)
At 1375, [T]he use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper.
At 1377, [W]e questioned the propriety of the "newly characterized antigen" test and concluded that instead of "analogizing the antibody-antigen relationship to a `key in a lock,'" it was more apt to analogize it to a lock and "a ring with a million keys on it." Id. at 1352.
An adequate written description must contain enough information about the actual makeup of the claimed products — "a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials," which may be present in "functional" terminology "when the art has established a correlation between structure and function." Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. See, e.g., J.A. 1241 (549:5-
16) (Appellants' expert Dr. Eck testifying that knowing "that an antibody binds to a particular amino acid on PCSK9 ... does not tell you anything at all about the structure of the antibody"); J.A. 1314 (836:9-11) (Appellees' expert Dr. Petsko being informed of Dr. Eck's testimony and responding that "[m]y opinion is that [he's] right"); Centocor, 636 F.3d at 1352 (analogizing the antibody-antigen relationship as searching for a key "on a ring with a million keys on it") (internal citations and quotation marks omitted).
In the instant case, knowing that the initial pharmaceutical composition is to comprise self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells does not tell you anything at all about the enormously vast genus of structurally and functionally undisclosed doses of said self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells [parameter 2] to be administered to the enormously vast genus of about 1x10^6 human and non-human animal subjects [parameter 1], so as to necessarily and predictably achieve a real-world, clinically meaningful treatment of the enormously vast genus of senescence-associated diseases [parameter 3], including, but not limited to:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4].
In Amgen, Inc., v. Sanofi (U.S. Supreme Court, No. 21-757 (2023))
“Amgen seeks to monopolize an entire class of things defined by their function”.
“The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequence, but a “vast” number of additional antibodies that it has not.”
“It freely admits that it seeks to claim for itself an entire universe of antibodies.”
In the instant case, the record reflects that Applicant seeks to claim for themselves:
an enormously vast genus of structurally and functionally undisclosed doses of said self-antigen specific cytotoxic CD4+ T cells or cancer-antigen naïve cytotoxic CD4+ T cells [parameter 2] to be administered to an enormously vast genus of about 1x10^6 human and non-human animal subjects [parameter 1], to treat an enormously vast genus of etiologically and pathologically distinct senescence-associated diseases [parameter 3], whereby the “therapeutically effective amount” and/or “effective amount” will depend on the condition to be treated, the severeness of disease, individual parameters of the patient, including age, physiological condition, size and weight, duration of treatment, type of accompanying therapy, specific route of administration, and dose, each of which are variable parameters, so as to necessarily and predictably achieve a real-world, clinically meaningful therapeutic result including, but not limited to:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4].
“They leave a scientist forced to engage in painstaking experimentation to see what works. 159 U.S., at 475.
This is not enablement. More nearly, it is “a hunting license”. Brenner v. Manson, 383 U.S. 519, 536 (1966).
“Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation”.
While the “roadmap” would produce functional combinations, it would not enable others to make and use the functional combinations; it would instead leave them to “random trial-and-error discovery”.
“Amgen offers persons skilled in the art little more than advice to engage in “trial and error”.
“The more a party claims for itself the more it must enable.”
“Section 112 of the Patent Act reflects Congress’s judg-ment that if an inventor claims a lot, but enables only a lit-tle, the public does not receive its benefit of the bargain. For more than 150 years, this Court has enforced the stat-utory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same.
The Quantity of Any Necessary Experimentation to Make or Use the Invention
It is generally recognized in the art that biological compounds often react unpredictably under different circumstances (Nationwide Chem. Corp. v. Wright, 458 F. supp. 828, 839, 192 USPQ95, 105(M.D. Fla. 1976); Affd 584 F.2d 714, 200 USPQ257 (5th Cir. 1978); In re Fischer, 427 F.2d 833, 839, 166 USPQ 10, 24(CCPA 1970)). The relative skill of the artisan and the unpredictability of the pharmaceutical art are very high.
The courts have stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in patent application. 27 USPQ2d 1662 Exparte Maizel. In the instant case, in view of the lack of guidance, working examples, breadth of the claims, the level of skill in the art and state of the art at the time of the claimed invention was made, it would have required undue experimentation to make and/or use the invention as claimed.
If little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) ("Nascent technology, however, must be enabled with a 'specific and useful teaching.' The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee's instruction. Thus, the public's end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology." (citations omitted)).
As In re Gardner, Roe and Willey, 427 F.2d 786,789 (C.C.P.A. 1970), the skilled artisan might eventually find out how to use the invention after “a great deal of work”. In the case of In re Gardner, Roe and Willey, the invention was a compound which the inventor claimed to have antidepressant activity, but was not enabled because the inventor failed to disclose how to use the invention based on insufficient disclosure of effective drug dosage. The court held that “the law requires that the disclosure in the application shall inform them how to use, not how to find out how to use for themselves”.
Reliance on animal models is not predictive of clinical outcome. This has been complicated by the inability to extrapolate delivery methods in animals with those in humans or higher animals.
Mingozzi and High (Immune responses to AAV vectors: overcoming barriers to successful gene therapy, Blood 122(1): 23-36, 2013) demonstrate that the human findings are not recapitulated from the animal studies (page 26, col 2, “it seemed logical that one could model the human immune response in these animals, but multiple attempts to do so have also failed”). Hence, lessons learned from small animals such as the mice studies could not recapitulate the ability to deliver adequately in humans.
Kattenhorn et al (Adeno-Associated Virus Gene Therapy for Liver Disease, Human Gene Therapy 27(12): 947-961, November 28, 2016) taught concerns for translation lead to extensive analysis of the effects on clinical use. The use of AAV after initial promising results went on hiatus (pg 947, col. 2, “clinical hiatus in the field”) as the animal models were deficient (pg 953, col. 2, “Although animal models predicted many aspects of the human immune response…, they largely failed to predict responses to AAV capsid”; “Work done in nonhuman primates has not met with any additional success”).
Perrin (Make Mouse Studies Work, Nature (507): 423-425, 2014) taught that the series of clinical trials for a potential therapy can cost hundreds of millions of dollars. The human costs are even greater (pg 423, col. 1). For example, while 12 clinical trials were tested for the treatment of ALS, all but one failed in the clinic (pg 423, col. 2). Experiments necessary in preclinical animal models to characterize new drugs or therapeutic compounds are expensive, time-consuming, and will not, in themselves, lead to new treatments. But without this upfront investment, financial resources for clinical trials are being wasted and [human] lives are being lost (pg 424, col. 1). Animal models are highly variable, and require a large number of animals per test group. Before assessing a drug’s efficacy, researchers should investigate what dose animals can tolerate, whether the drug reaches the relevant tissue at the required dose and how quickly the drug is metabolized or degraded by the body. We estimate that it takes about $30,000 and 6–9 months to characterize the toxicity of a molecule and assess whether enough reaches the relevant tissue and has a sufficient half-life at the target to be potentially effective. If those results are promising, then experiments to test whether a drug can extend an animal’s survival are warranted — this will cost about $100,000 per dose and take around 12 months. At least three doses of the molecule should be tested; this will help to establish that any drug responses are real and suggest what a reasonable dosing level might be. Thus, even assuming the model has been adequately characterized, an investment of $330,000 is necessary just to determine whether a single drug has reasonable potential to treat disease in humans. It could take thousands of patients, several years and hundreds of millions of dollars to move a drug through the clinical development process. The investment required in time and funds is far beyond what any one lab should be expected to do. (pg 425, col.s 2-3). The human costs are even greater: patients with progressive terminal illnesses may have just one shot at an unproven but promising treatment. Clinical trials typically require patients to commit to year or more of treatment, during which they are precluded from pursuing other experimental options (pg 423, col.2 1-3).
Greenberg (Gene Therapy for heart failure, Trends in Cardiovascular Medicine 27: 216-222, 2017) is considered relevant prior art for taught that despite success in experimental animal models, translating gene transfer strategies from the laboratory to the clinic remains at an early stage (Abstract). The success of gene therapy depends on a variety of factors that will ultimately determine the level of transgene expression within the targeted cells. These factors include the vector used for delivery, the method and conditions of delivery of the vector to the [target tissue], the dose that is given and interactions between the host and the vector that alter the efficiency of transfection of [target] cells (e.g. pg 217, col. 1). Failure of therapeutic results may arise because the vector DNA levels were at the lower end of the threshold for dose-response curves in pharmacology studies, and/or only a small proportion of target cells were expressing the therapeutic transgene (e.g. pg 220, col. 1). Although the use of AAVs for gene therapy is appealing, additional information about the best strain of AAVs to use in human patients is needed. Experience indicates that there is a need to carefully consider the dose of the gene therapy vector; however, this has proved to be difficult in early phase developmental studies due to the complexity and cost of such studies (e.g. pg 221, col. 1).
Maguire et al (Viral vectors for gene delivery to the inner ear, Hearing Research 394: e107927, 13 pages, doi.org/10.1016/j.heares.2020.107927, 2020) is considered relevant post-filing art for taught that there are limitations to what experiments in mice can tell us about the true translation potential of a new therapeutic (e.g. pg 8, col. 2), e.g. species-related physiological differences between mice and humans (e.g. pg 9, col. 1).
Tobias (Mouse Study Used in Research, Multiple Sclerosis News Today, multiplesclerosisnewstoday.com/news-posts/2023/09/08/lets-not-get-overexcited-about-any-mice-study-used-research/; September 8, 2023) is considered relevant art for having taught that, “Mice exaggerate and monkeys lie, some researchers jokingly say. (Or is it the other way around?)” The odds of an experimental treatment making it from mouse or monkey to human are very low. Less than 8% of cancer treatments make it from animal studies into a clinical setting, where they’re tested on people, and only 10% of the medications in those clinical trials make it through to government approval. No wonder some researchers joke about mice and monkeys lying and exaggerating.
Instant application fails to disclose a reduction to practice of the claimed invention.
The prior art (e.g. Zhou et al, 2022; of record) teaches away from using cytotoxic CD4+ T cells to achieve, e.g.:
i) obtaining a beneficial or desired result, which themselves are arbitrary and subjective determinations;
ii) alleviation or amelioration of one or more symptoms;
iii) diminishment of disease extent;
iv) stabilization of disease state;
v) prevention of disease spread;
vi) prevention of the development of disease;
vii) delay, slow, or halt disease progression;
viii) amelioration or palliation of the disease state;
ix) remission of disease state; and
x) prolonging survival of the subject beyond that expected in the absence of treatment [parameter 4], of a senescence-associated fibrotic disease such a liver fibrosis.
Rather, cytotoxic CD4+ T cell are recognized to be causal for liver fibrosis.
Instant claims and specification fail to make up for the deficiencies of the global scientific community.
Applicant is essentially requiring the ordinary artisans to discover for themselves that which Applicant fails to disclose.
Thus, for the reasons outlined above, it is concluded that the claims do not meet the enablement requirements 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)
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claims.
Claim Rejections - 35 USC § 102
9. The prior rejection of Claim(s) 38-39 under 35 U.S.C. 102(a)(1) as being anticipated by Comoli et al (2002; of record) is withdrawn in light of Applicant’s amendment to Claim 38 to recite the step of administering cancer-antigen naïve cytotoxic CD4+ T cells, a limitation Comoli et al do not teach. The cytotoxic CD4+ T cells of Comoli et al are specific for EBV antigens, whereby EBV is art-recognized to be causal for cancer, and thus considered to be a cancer antigen.
10. The prior rejection of Claim(s) 38-39 under 35 U.S.C. 102(a)(1) as being anticipated by Hunder et al (2008; of record) is withdrawn in light of Applicant’s amendment to Claim 38 to recite the step of administering cancer-antigen naïve cytotoxic CD4+ T cells, a limitation Hunder et al do not teach. The cytotoxic CD4+ T cells of Hunder et al are specific for NY-ESO-1 cancer antigens.
11. The prior rejection of Claim(s) 38-39 under 35 U.S.C. 102(a)(1) as being anticipated by Bollard et al (2013; of record) is withdrawn in light of Applicant’s amendment to Claim 38 to recite the step of administering cancer-antigen naïve cytotoxic CD4+ T cells, a limitation Bollard et al do not teach. The cytotoxic CD4+ T cells of Bollard et al are specific for LMP-1 and LMP2 cancer antigens.
Claim Rejections - 35 USC § 103
12. The prior rejection of Claim(s) 40 under AIA 35 U.S.C. 103 as being unpatentable over Bollard et al (2013; of record), as applied to Claims 38-39 above, and in further view of Flaherty et al (April 2015; of record), Nish et al (2014; of record), and Longhi et al (2008; of record) is withdrawn for reasons discussed above.
Conclusion
13. No claims are allowed.
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.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
Prosecution Insights