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 .
2. Applicant’s amendment filed on 07/01/2026 is acknowledged.
3. Claims 115-129 and 132-135 are pending and under consideration as they read on a composition comprising the peptide of SEQ ID NO:4143.
4. Applicant’s IDS filed on 07/07/2026 has been considered.
5. The following rejections are necessitated by the amendment filed on 07/01/2026.
6. 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.
7. Claims 115-129 and 132-135 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 115 is directed to “A pharmaceutical composition comprising:(a) a tissue-specific antigen peptide comprising an epitope sequence HPEYNRPLL (SEQ ID NO: 4143) encoded by KLK4; wherein the tissue-specific antigen peptide has less than 250 amino acid residues and the tissue-specific antigen peptide further comprises an accessory sequence flanking the epitope sequence; wherein KLK4 has an expression level in a diseased cell of a target tissue of a human subject that is at least 2 fold higher than a KLK4 expression level in cells of each non-target tissue of the human subject, wherein the tissue-specific antigen peptide is specific to a non-essential tissue, and wherein the non-essential tissue is a tissue not required for survival of a human; and (b) a pharmaceutically acceptable carrier of claim 115;
It is unclear if the “tissue-specific antigen peptide” which “further comprises an accessory sequence flanking the epitope sequence” is encoded by KLK4 or if only the peptide of SEQ ID NO:4143 is encoded by KLK4.
The recitation of “wherein KLK4 has an expression level in a diseased cell of a target tissue of a human subject that is at least 2 fold higher than a KLK4 expression level in cells of each non-target tissue of the human subject” is unclear.
The Examiner does not know what is meant by “diseased cell”, “target tissue” or “non-target tissue” and the specification does not provide definitions for any of these terms.
The recitation of “wherein the tissue-specific antigen peptide is specific to a non-essential tissue, and wherein the non-essential tissue is a tissue not required for survival of a human” is unclear. The following definitions of essential and non-essential make absolutely no sense.
[00225] In some embodiments, the tissue-specific antigen is specific to a target tissue other than in an essential tissue. In some embodiments, the target tissue is a non-essential tissue. As provided herein, an essential tissue can refer to a tissue in a living body, whose function in the maintaining the life of the body cannot be substituted by an internal or external support. As provided herein, a non-essential tissue can refer to a tissue in a living body, whose function in the maintaining the life of the body can be substituted (e.g., function of the tissue can be at least partially performed by some other tissue in the body or performed by tissue transplant or an artificial device) or foregone (e.g., function of the tissue is not required for survival of the body). In some embodiments, an essential tissue comprises brain or colon tissue. In some embodiments, an essential tissue comprises bone marrow. In some embodiments, a non-essential tissue comprises thyroid, pancreas, adrenal, fallopian, prostate, breast, ovary, or cervical tissue.
The recitation of “wherein KLK4 is expressed by a cancer” of claim 118 and wherein the cancer comprises prostate cancer of claim 119 are unclear. The Examiner does not know how these recitations relate to the recitations of KLK4 in claim 1. The claim is directed to a pharmaceutical composition.
The recitation of “wherein the human subject does not have the non-essential tissue or the function of the non-essential tissue is substituted” of claim 122 is unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein the human subject has the non-essential tissue” of claim 123 is unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein the tissue- specific antigen peptide comprising the epitope sequence HPEYNRPLL (SEQ ID NO: 4143 expressed in a target tissue and not expressed in each tissue of a plurality of non-target tissues that are different than the target tissue” of claim 124 is unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein the diseased cell is a tumor cell of the target tissue” of claim 125 is unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein an mRNA expression level of KLK4 is at most about 5 mRNA transcripts in a non-target essential tissue per one million total mRNA transcripts in each respective non-target tissue of a human subject; and wherein an mRNA expression level of KLK4 is at least about 100 mRNA transcripts per one million total mRNA transcripts in a target tissue” of claim 126 is unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein (i) the human subject is a female subject, and the tissue-specific antigen is specific to a non-essential tissue selected from the group consisting of: Bulbourethral gland, epididymis, penis, prostate, scrotum, seminal vesicle, testicle, and any combination thereof;(ii) the human subject is a male subject, and the tissue-specific antigen is specific to a non- essential tissue selected from the group consisting of: Bartholin's gland, fallopian tube, ovary, Skene's gland, uterus, cervix, vagina, and any combination thereof;(iii) the human subject is a Type I diabetes patient, and the tissue-specific antigen is specific to pancreas; or (iv) the human subject has an auto-immune thyroid condition, and the tissue- specific antigen is specific to thyroid” of claim 127; and “wherein the human subject is a female subject, and the tissue-specific antigen is specific to prostate” of claim 128 are unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The recitation of “wherein the non-essential tissue is prostate” of claim 132; “wherein the target tissue comprises cancerous tissue” of claim 133; and “wherein the target tissue comprises prostate tissue” of claim 134 are unclear. The Examiner has no idea how this relates to the recitations in claim 115. The claim is directed to a pharmaceutical composition.
The claims are unclear and need to be amended to recite a pharmaceutical composition with all of the components of the composition specifically recited.
Correction is required.
8. 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.
9. Claims 115-129 and 132-135 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. This is a New Matter rejection for the following reasons.
Applicant' s amendment asserts that no New Matter has been added and points to “throughout the application as originally filed” for example at paragraphs [0094], [0200], [0263]-[0299] and [0524] for support for the newly added limitations “A pharmaceutical composition comprising:(a) a tissue-specific antigen peptide comprising an epitope sequence HPEYNRPLL (SEQ ID NO: 4143) encoded by KLK4; wherein the tissue-specific antigen peptide has less than 250 amino acid residues and the tissue-specific antigen peptide further comprises an accessory sequence flanking the epitope sequence; wherein KLK4 has an expression level in a diseased cell of a target tissue of a human subject that is at least 2 fold higher than a KLK4 expression level in cells of each non-target tissue of the human subject, wherein the tissue-specific antigen peptide is specific to a non-essential tissue, and wherein the non-essential tissue is a tissue not required for survival of a human; and (b) a pharmaceutically acceptable carrier of claim 115”. However, the specification does not appear to provide an adequate written description of claim 115. There is no support for a less than 250 amino acid tissue antigen peptide comprising SEQ ID NO:4143 further comprising an accessory sequence flanking the epitope sequence that is encoded by KLK4 and is specific to non-essential tissue which is not required for survival of a human. The specification does not provide support for such a tissue antigen peptide “expressed in a target tissue and not expressed in each tissue of a plurality of non-target tissues that are different from the target tissue” of claim 124; “wherein the non-essential tissue is prostate” of claim 132; “wherein the target tissue comprises cancerous tissue” of claim 133; and “wherein the target tissue comprises prostate tissue: of claim 134. The instant claims now recite limitations which were not clearly disclosed in the specification and claims as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in the present claims, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C. 112.
Obviousness is not the standard for the addition of new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). New Matter is a written description issue.
The concept of the invention has changed. When an explicit limitation in a claim in not present in the written description whose benefit is sought it must be shown that a person of ordinary skill would have understood at the time the patent application was filed that the description required that limitation. The description must convey with reasonable clarity to those skilled in the art that as of the filing date sought applicant was in possession of the invention. Purdue Pharma L.P.v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481,1486 (Fed. Cir. 2000). The court noted that with respect to In re Ruschig 379 F.2d 990, 154 USPQ 118 (CCPA 1967) that "Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say "here is my invention". In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.
Applicant is required to cancel the New Matter in the response to this Office Action. Alternatively, Applicant is invited to clearly point out the written support for the instant limitations.
10. Claims 115-129 and 132-135 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.
Applicant is in possession of: a pharmaceutical composition comprising the peptide of SEQ ID NO:4143.
Applicant is not in possession of: a pharmaceutical composition comprising:(a) a tissue-specific antigen peptide comprising an epitope sequence HPEYNRPLL (SEQ ID NO: 4143) encoded by KLK4; wherein the tissue-specific antigen peptide has less than 250 amino acid residues and the tissue-specific antigen peptide further comprises an accessory sequence flanking the epitope sequence; wherein KLK4 has an expression level in a diseased cell of a target tissue of a human subject that is at least 2 fold higher than a KLK4 expression level in cells of each non-target tissue of the human subject, wherein the tissue-specific antigen peptide is specific to a non-essential tissue, and wherein the non-essential tissue is a tissue not required for survival of a human; and (b) a pharmaceutically acceptable carrier of claim 115; further comprising an adjuvant of claim 116; wherein the epitope sequence binds to or is predicted to bind to a protein encoded by an HLA-B07:02 allele expressed by the human subject of claim 117; wherein KLK4 is expressed by a cancer of claim 118; wherein the cancer comprises prostate cancer of claim 119; wherein the pharmaceutical composition is formulated for parenteral administration of 120; comprising from about 100 pg to about 5000 pg of the antigen peptide per dose of the pharmaceutical composition of claim 121; wherein the human subject does not have the non-essential tissue or the function of the non-essential tissue is substituted of claim 122; wherein the human subject has the non-essential tissue of claim 123; wherein the tissue- specific antigen peptide comprising the epitope sequence HPEYNRPLL (SEQ ID NO: 4143 expressed in a target tissue and not expressed in each tissue of a plurality of non-target tissues that are different than the target tissue of claim 124; and wherein the diseased cell is a tumor cell of the target tissue of claim 125; wherein an mRNA expression level of KLK4 is at most about 5 mRNA transcripts in a non-target essential tissue per one million total mRNA transcripts in each respective non-target tissue of a human subject; and wherein an mRNA expression level of KLK4 is at least about 100 mRNA transcripts per one million total mRNA transcripts in a target tissue of claim 126; wherein (i) the human subject is a female subject, and the tissue-specific antigen is specific to a non-essential tissue selected from the group consisting of: Bulbourethral gland, epididymis, penis, prostate, scrotum, seminal vesicle, testicle, and any combination thereof;(ii) the human subject is a male subject, and the tissue-specific antigen is specific to a non- essential tissue selected from the group consisting of: Bartholin's gland, fallopian tube, ovary, Skene's gland, uterus, cervix, vagina, and any combination thereof;(iii) the human subject is a Type I diabetes patient, and the tissue-specific antigen is specific to pancreas; or (iv) the human subject has an auto-immune thyroid condition, and the tissue- specific antigen is specific to thyroid of claim 127; wherein the human subject is a female subject, and the tissue-specific antigen is specific to prostate of claim 128; wherein the tissue- specific antigen peptide of (a) is an isolated peptide, a purified peptide, a synthetic peptide or any combination thereof of claim 129; wherein the non-essential tissue is prostate of claim 132; wherein the target tissue comprises cancerous tissue of claim 133; wherein the target tissue comprises prostate tissue of claim 134; and comprising at least 2% of the antigen peptide by weight of claim 135.
The claims encompass tissue specific antigen peptides of less than 250 amino acids in length which comprise SEQ ID NO:4143 and “an accessory sequence flanking the epitope sequence” and wherein the tissue specific antigen peptide “is encoded by KLK4” and pharmaceutical compositions thereof.
Claim 115 recites “wherein KLK4 has an expression level in a diseased cell of a target tissue of a human subject that is at least 2 fold higher than a KLK4 expression level in cells of each non-target tissue of the human subject” which has no bearing on the limitations of the claim so it is unclear why this recitation is included in the claim at all.
The rest of the claims go on to recite additional functions that are not described in the specification. The specification has not described any tissue specific antigen peptides with the functions of “wherein the tissue-specific antigen peptide is specific to a non-essential tissue, and wherein the non-essential tissue is a tissue not required for survival of a human” of claim 115; “wherein the epitope sequence binds to or is predicted to bind to a protein encoded by an HLA-B07:02 allele expressed by the human subject” of claim 117; “wherein the tissue- specific antigen peptide comprising the epitope sequence HPEYNRPLL (SEQ ID NO: 4143 expressed in a target tissue and not expressed in each tissue of a plurality of non-target tissues that are different than the target tissue” of claim 124; “the tissue-specific antigen is specific to a non-essential tissue selected from the group consisting of: Bulbourethral gland, epididymis, penis, prostate, scrotum, seminal vesicle, testicle, and any combination thereof ;(ii) the human subject is a male subject, and the tissue-specific antigen is specific to a non- essential tissue selected from the group consisting of: Bartholin's gland, fallopian tube, ovary, Skene's gland, uterus, cervix, vagina, and any combination thereof;(iii) the human subject is a Type I diabetes patient, and the tissue-specific antigen is specific to pancreas; or (iv) the human subject has an auto-immune thyroid condition, and the tissue- specific antigen is specific to thyroid” of claim 127; “wherein the human subject is a female subject, and the tissue-specific antigen is specific to prostate” of claim 128; “wherein the non-essential tissue is prostate” of claim 132; “wherein the target tissue comprises cancerous tissue” of claim 133; and “wherein the target tissue comprises prostate tissue” of claim 134.
The recitations of “wherein KLK4 is expressed by a cancer” of claim 118; “wherein the cancer comprises prostate cancer” of claim 119; “wherein the human subject does not have the non-essential tissue or the function of the non-essential tissue is substituted” of claim 122; “wherein the human subject has the non-essential tissue” of claim 123; and “wherein the diseased cell is a tumor cell of the target tissue” of claim 125; and “wherein an mRNA expression level of KLK4 is at most about 5 mRNA transcripts in a non-target essential tissue per one million total mRNA transcripts in each respective non-target tissue of a human subject; and wherein an mRNA expression level of KLK4 is at least about 100 mRNA transcripts per one million total mRNA transcripts in a target tissue” of claim 126 are also not described but as discussed supra it is unclear why these recitations are even in the claims because they are not limiting the tissue specific antigen peptide at all and they are only making the claims more confusing. That being said, all of these functional recitations are not described either but they are not the main focus of this rejection because they are not functional recitations of the tissue specific antigen peptide or the pharmaceutical composition thereof.
The skilled artisan cannot envision all the tissue specific antigen peptide and pharmaceutical composition possibilities recited in the instant claims.
Consequently, conception cannot be achieved until a representative description of the structural and functional properties of the claimed invention has occurred, regardless of the complexity or simplicity of the method.
The specification must set forth the structural features that allow one of ordinary skill in the art to identify and produce the recited tissue specific antigen peptides. In the instant case, definition by function does not suffice to define the genus because it is only an indication of what the tissue specific antigen peptides do, rather than what they are.
Given the lack of guidance in the specification, it is unpredictable which tissue specific antigen peptides with which structures would exhibit the recited functions of being encoded by KLK4 and being specific to a non-essential tissue which is not essential for survival and the other functions recited in the claims. The specification does not describe a correlation between the structure of the tissue specific antigen peptides themselves and their functions such that a skilled artisan would have known what tissue specific antigen peptide structures possess the claimed functions.
"Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features" Ex parte Kubin (83 U.S.P.Q.2d 1410 (BPAI 2007)), at page 16. In this instant case, Applicants have not provided the requisite identifying structural features of the tissue specific antigen peptide encompassed. "Without a correlation between structure and function, the claim does little more than define the claimed invention by function" supra, at page 17.
The specification has not described any “accessory sequences”, much less any tissue specific antigen peptides of less than 250 amino acids which comprise SEQ ID NO:4143 and any accessory sequence, particularly when the tissue specific antigen peptide is encoded by KLK4.
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the ... claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the applicant had possession at the time of invention of the claimed invention. regarding description of the claimed invention, the specification does not provide an adequate written description of the invention claimed herein. See The Regents of the University of California v. Eli Lilly and Company, 43 USPQ2d 1398, 1404-7 (Fed. Cir. 1997). In University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d 1225 (Fed. Cir. 1995) the inventors claimed a genus of DNA species encoding insulin in different vertebrates or mammals, but had only described a single species of cDNA which encoded rat insulin. The court held that only the nucleic acids species described
in the specification (i.e. nucleic acids encoding rat insulin) met the description
requirement and that the inventors were not entitled to a claim encompassing a genus
of nucleic acids encoding insulin from other vertebrates, mammals or humans, id. at
1240. The Federal Circuit has held that if an inventor is "unable to envision the detailed
constitution of a gene so as to distinguish it from other materials . . . conception has not
been achieved until reduction to practice has occurred", Amgen, Inc. v. Chugai
Pharmaceutical Co, Ltd., 18 U.S.P.Q.2d 016 (Fed. Cir. 1991). Attention is also directed
to the decision of The Regents of the University of California v. Eli Lilly and Company
(CAFC, July 1997) wherein is stated: "The description requirement of the patent statute
requires a description of an invention, not an indication of a result that one might
achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369,
372-373 (Fed. Cir. 1984) (affirming rejection because the specification does "little more
than outlin[ e] goals appellants hope the claimed invention achieves and the problems
the invention will hopefully ameliorate."). Accordingly, naming a type of material
generally known to exist, in the absence of knowledge as to what that material consists
of, is not a description of that material. Thus, as we have previously held, a cDNA is not
defined or described by the mere name "cDNA," even if accompanied by the name of
the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." See Fiers, 984
F.2d at 1171, 25 USPQ2d at 1606.
The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or U.S.C 112, I 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical
and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
The claims are not supported by a description that satisfies 35 U.S.C. § 112(a) or 35 U.S.C. § 112, first paragraph. "[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Phanns., Inc. V. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane).
A "sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Id. at 1350. "[A]n adequate written description requires 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." Id.
"[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function." Id. "But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id.
"A sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) (emphasis added).
The specification only discloses one example of a tissue specific antigen peptide comprising SEQ ID NO:4143 and that is SEQ ID NO:4143.
With respect to representative number of species, see AbbVic Deutschland GmbH & Co.V. Janssen Biotech, Inc. (Fed. Cir. 2014). Also, see MPEP 2163 II(A)(3)(a))(ii):
"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. 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 Abb Vie 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.")."
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. 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) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., Koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
In the instant case, one example of a structure with the function is given, which does not sufficiently represent the broad genus of tissue specific antigen peptides of less than 250 amino acid residues and comprising SEQ ID NO:4143 with these recited functions.
Given the broadly claimed class of structures with the recited functions, and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed class of tissue specific antigen peptides encompassed by the claims, the patentee must establish "a reasonable structure-function correlation" either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutschland GmbH & Co. V. Janssen Biotech, Inc. (Fed. Cir. 2014), MPEP 2163.
In the instant case, Applicant has not provided sufficient structure identifying characteristics or a reasonable structure-function correlation between the tissue specific antigen peptide’s sequence and the recited functions other than to list one specific structure with this function. The instant specification provides no guidance on how to generate other tissue specific antigen peptides with the recited functions or how to distinguish between tissue specific antigen peptides with these functions from ones without. Other than the recited SEQ ID NO: 4143 undue experimentation would be required to produce the invention commensurate with the scope of the claims from the written disclosure alone.
As such, there is insufficient written description of the required kind of structure
identifying information about the corresponding makeup of the claimed tissue specific antigen peptides and pharmaceutical compositions thereof to demonstrate possession.
11. 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.
12. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
13. Claims 115-129 and 132-135 are rejected under 35 U.S.C. 102(a)(1) as being as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Klar et al. (PTO-892 mailed on 04/01/2026; Reference U).
Klar et al. teaches measuring reactivity of TCR 2.5D6 against a panel of HLA-B*07:02 ligands. To analyze crossreactivity against a panel of 58 HLA-B*07:02 ligands reactivity of TCR 2.5D6 transduced PBMC against T2-B7 cells pulsed with peptide pools was analyzed (In particular, Figure 3.15, page 80, whole document) . As shown in figure 3.15, no reactivity against the peptide pools could be observed neither by untransduced nor TCR 2.5D6 transduced PBMC could be observed. A detailed list of the peptide pools is shown in table E.1 on page
Klar et al. teaches measuring reactivity of TCR transduced PBMC against naturally presented HLA B*07:02 ligands. 58 HLA-B*07:02 ligands were divided into eight peptide pools and were pulsed on T2-B7 cells at a concentration of 1µmol/l for each peptide (table E.1). As a positive control, T2-B7 cells pulsed with 1µmol/l of the MPO5 peptide were used. PBMC either untransduced or transduced with the TCR 2.5D6 were coincubated with target cells for 20 hours. Supernatants were harvested and IFN-γ was measured by ELISA. (In particular, page 80, whole document).
The reference teaches that the panel of HLA-B*07:02 ligands includes the peptide “HPEYNRPLL” from KLK4 (In particular, Table E.1 page 118, whole document).
All of the functional recitations of claims 115-129 and 132-135 are encompassed by the composition comprising the peptide of “HPEYNRPLL” from KLK4. Applicant is reminded that no more of the reference is required than that it sets forth the substance of the invention. The claimed functional limitations would be inherent properties of the referenced sequences. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999) “Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art... However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”.
The reference teachings anticipate the claimed invention.
Absent evidence to the contrary the term “accessory sequence flanking the epitope sequence” encompasses any amino acids added onto the sequence. It would have been obvious to have added a tag onto the epitope for visualization or purification.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
14. Claims 115-129 and 132-135 are rejected under 35 U.S.C. 102(a)(1) as being as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO 2015/014820 (PTO-892 mailed on 04/01/2026; Reference N) as evidenced by the attached translation from the WIPO site.
WO 2015/014820 teaches compositions comprising the “HPEYNRPLL” peptide of reference SEQ ID NO:19 (which is 100% sequence identical over length and sequence to instant SEQ ID NO:4143) for use in immunotherapy of prostate cancer. (In particular, claims, page 13, page 17, whole document).
All of the functional recitations of claims 115-129 and 132-135 are encompassed by the composition comprising the peptide of “HPEYNRPLL” from KLK4. Applicant is reminded that no more of the reference is required than that it sets forth the substance of the invention. The claimed functional limitations would be inherent properties of the referenced sequences. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999) “Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art... However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”.
The reference teachings anticipate the claimed invention.
Absent evidence to the contrary the term “accessory sequence flanking the epitope sequence” encompasses any amino acids added onto the sequence. It would have been obvious to have added a tag onto the epitope for visualization or purification.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
15. Claims 115-129 and 132-135 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2001/051633 (PTO-892 mailed on 04/01/2026; Reference O).
WO 2001/051633 teaches a composition comprising the 166 P703P His tag fusion protein of reference SEQ ID NO:695 (which comprises instant SEQ ID NO:4143 at amino acids 17-25) for treating prostate cancer. (In particular, page 499-500, claim 8, whole document). WO 2001/051633 teaches a composition comprising the 159 amino acid P703P-DE1 protein of reference SEQ ID NO:172 (which comprises instant SEQ ID NO:4143 at amino acids 10-18) for treating prostate cancer (In particular, pages 284-285, claim 2, whole document).
All of the functional recitations of claims 115-129 and 132-135 are encompassed by the composition comprising the peptide of “HPEYNRPLL” from KLK4. Applicant is reminded that no more of the reference is required than that it sets forth the substance of the invention. The claimed functional limitations would be inherent properties of the referenced sequences. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999) “Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art... However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”.
The reference teachings anticipate the claimed invention.
16. No claim is allowed.
17. 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 extension fee 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 date of this final action.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 17, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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