DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is claiming the benefit as a 35 U.S.C. 371 national phase application from, and claims priority to, International Application No. PCT/US22/16142, filing date 02/11/2022, which claims the benefit of the prior-filed United States Provisional Patent Application Nos. 63/151,229 (filing date 02/19/2021) and 63/148,969 (filing date 02/12/2021).
Status of Application/Claims
The preliminary amendment, filed 02/09/2024, is acknowledged. Claims 4, 7, 10, 12-15, 17, 22-24, and 26 are currently amended. Claims 1-27 are currently pending and are examined on the merits herein.
Information Disclosure Statement
An information disclosure statement (IDS) was not submitted with the application.
Specification
The use of the terms Invitrogen, Inovio, GenScript, Aggilent Technologies, Roche, R&D Systems, Cell Signaling Technology, Mabtech, BioLegend, ThermoFisher, Li-Cor, The Jackson Laboratory, Graphpad Prism, eBioscience, Sigma-Aldrich, Biotek, Alexa Fluor, Fluoroshield, Abcam, and Nikon which are trade names or marks used in commerce, have been noted in this application. The terms should be in all caps wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 recites, “…wherein the nucleic acid molecule is an expression vector and sequences encoding said one or more proteins are operable linked to regulatory elements,” which is grammatically incorrect. The examiner suggests the following correction: “…wherein the nucleic acid molecule is an expression vector; wherein, the expression vector comprises nucleotide sequences encoding said one or more proteins that are operably linked to regulatory elements”. Appropriate correction is required.
Claims 15 and 17 are objected to because of the following informalities: Claims 15 and 17 each recite, “…a nucleic acid molecule of claim 1…”, which should be corrected to “…the nucleic acid molecule of claim 1…”.
Claims 16 and 18 are objected to because of the following informalities: Claims 16 and 18 each recite, “…a composition of claims 14…”, which should be corrected to “…the composition of claim 14…”.
Claims 24 and 26 are objected to because of the following informalities: Claims 24 and 26 each recite, “…a protein of claim 19…”, which should be corrected to “…the protein of claim 19…”.
Claims 25 and 27 are objected to because of the following informalities: Claims 25 and 27 each recite, “…a composition of claims 23…”, which should be corrected to “…the composition of claim 23…”.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 6, 9, 20-22, 24, and 26 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 2 recites the limitation "a), b), c), d), e), f), g), h), i), j), k), and l)" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the following limitations: "a) or b)”, “c) or d)”, “e) or f)”, “g) or h)”, “i) or j)”, and “k) or l)" in lines 3-8; and, recites the limitation “elements” in lines 3-8 (6 instances). There is insufficient antecedent basis for these limitations in the claim.
[AltContent: textbox ([img-media_image1.png])]Further, claim 3 is rendered indefinite for the following reason: Claim 3 recites the following: The phrase “one or more” and the recitations of “at least one selected from either…” render the claim indefinite. It is unclear whether only one protein/element is required from groups i) – vi) or if one protein/element is required from each of groups i) – vi). For further examination, the claim is interpreted to mean that only one protein from any of groups i) – vi) is required.
Claim 6 recites the following limitations: "a) or b)”, “c) or d)”, “e) or f)”, “g) or h)”, “i) or j)”, and “k) or l)" in lines 3-8; and, recites the limitation “elements” in lines 3-8 (6 instances). There is insufficient antecedent basis for these limitations in the claim.
[AltContent: textbox ([img-media_image2.png])]Further, claim 6 is rendered indefinite for the following reason: Claim 6 recites the following:
The phrase “one or more” and the recitations of “at least one selected from either…” render the claim indefinite. It is unclear whether only one nucleotide sequence is required from groups i) – vi) or if one nucleotide sequence is required from each of groups i) – vi). For further examination, the claim is interpreted to mean that only one from any of groups i) – vi) is required.
[AltContent: textbox ([img-media_image3.png])]Claim 9 is rendered indefinite for the following reason: Claim 6 recites the following:
The phrase “one or more” and the recitations of “at least one selected from either…” render the claim indefinite. It is unclear whether only one nucleotide sequence is required from groups i) – vi) or if one nucleotide sequence is required from each of groups i) – vi). For further examination, the claim is interpreted to mean that only one from of groups i) – vi) is required.
Claim 20 recites the limitation "a), b), c), d), e), f), g), h), i), j), k), and l)" in line 2. There is insufficient antecedent basis for this limitation in the claim.
[AltContent: textbox ([img-media_image4.png])]Claim 21 recites the following limitations: "a) or b)”, “c) or d)”, “e) or f)”, “g) or h)”, “i) or j)”, and “k) or l)" in lines 3-8. There is insufficient antecedent basis for these limitations in the claim. Further, claim 21 recites the following:
The phrase “one or more” and the recitations of “at least one selected from either…” render the claim indefinite. It is unclear whether only one protein is required from groups i) – vi) or if one protein is required from each of groups i) – vi). For further examination, the claim is interpreted to mean that only one from of groups i) – vi) is required.
Claims 20-22, 24, and 26 are rendered indefinite for the following: Claims 20-22, 24, and 26 are dependent on claim 19. Claim 19 recites “A protein comprising one or more proteins…”. Thus, the first instance of “protein” can be interpreted encoding one or multiple proteins. Thus, each recitation of the term “protein” in claim 19 can have a different meaning. Claims 20-22, 24, and 26 reference the term “protein”. Further, claims 20-22 reference the term “protein” multiple times. Thus, the meaning of the term “protein” is unclear in each instance. For further examination, the claims are interpreted as follows:
Claim 19: “A polypeptide comprising one or more peptides…”
Claim 20: “The polypeptide of claim 19, wherein the peptide(s) is/are selected from…”Claim 21: “The polypeptide of claim 19, wherein the polypeptide comprises one or more peptides selected from…”
Claim 22: “The polypeptide of claim 19, wherein the polypeptide comprises one or more peptides selected from…”
Claim 24: “A method… comprising administering the polypeptide…”
Claim 26: “A method… comprising administering the polypeptide…”
Claim Interpretation:
Regarding claims 1, 5, and 19: Claims 2-3, 6, and 20-21 make references to “groups a), b), c), d), e), f), g), h), i), j), k), and l)” which lack proper antecedent basis as described in the above U35 U.S.C. 112(b) rejections. Claims 2-3 are dependent on claim 1; claim 6 is dependent on claims 1 and 5; and, claims 20-22 are dependent on claim 19. For further examination, the limitations of “a through i” are considered to refer to the following limitations/SEQ ID NOs of claims 1 and 19 (for protein/peptide SEQ ID NOs), and of claim 5 (for nucleotide SEQ ID NOs) as shown [AltContent: textbox ([img-media_image5.png])]in the figures below:
[AltContent: textbox ([img-media_image6.png])]
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3, 6, 9, and 20-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 3 are dependent on claim 1. Claim 1 recites “A nucleic acid molecule comprising a coding sequence encoding one or more proteins selected from the group consisting of: a)…; b)…; c) …; d) …; e) …; f) …; g) …; h) …; i) …; j) …; k) …; and l)...” Claim 2 recites “The nucleic acid molecule of claim 1, wherein the nucleic acid molecule encodes one or more proteins selected from the group consisting of: a), b), c), d), e), f), g), h), i), j), k), and l)”, which refers to the SEQ ID NO limitations of claim 1. Claim 3 recites “The nucleic acid molecule encodes one or more proteins selected from the group consisting of: …a) or b); …c) or d); …e) or f); …g) or h); …i) or j); and …k) or l). As only one protein from a) through l) is interpreted to be required (see 112(b) rejection and claim interpretation above), the limitations are effectively the same as that stated in claim 1. Therefore, claims 2 and 3 fail to further limit claim 1.
Claim 6 is dependent on claim 5. Claim 5 recites “The nucleic acid molecule of claim 1, wherein the nucleic acid molecule comprises one or more nucleotide sequences selected from the group consisting of: a)…; b)…; c) …; d) …; e) …; f) …; g) …; h) …; i) …; j) …; k) …; and l)...” Claim 6 recites “The nucleic acid molecule of claim 5, wherein the nucleic acid molecule comprises one or more nucleotide sequences selected from the group consisting of: …a) or b); …c) or d); …e) or f); …g) or h); …i) or j); and …k) or l). As only one protein from a) through l) is interpreted to be required (see 112(b) rejection and claim interpretation above), the limitations are effectively the same as that stated in claim 5. Therefore, claim 6 fails to further limit claim 5.
Claim 9 is dependent on claim 8. Claim 8 recites “A nucleic acid molecule comprising one or more nucleotide sequences selected from the group consisting of: a)…; b)…; c) …; d) …; e) …; f) …; g) …; h) …; i) …; j) …; k) …; and l)...” Claim 9 recites “The nucleic acid molecule of claim 8, wherein the nucleic acid molecule comprises one or more nucleotide sequences selected from the group consisting of: …a) or b); …c) or d); …e) or f); …g) or h); …i) or j); and …k) or l). As only one protein from a) through l) is interpreted to be required (see 112(b) rejection and claim interpretation above), the limitations are effectively the same as that stated in claim 8. Therefore, claim 9 fails to further limit claim 8.
Claim 20 is dependent on claim 19. Claim 19 recites “A protein comprising one or more proteins selected from the group consisting of: a)…; b)…; c) …; d) …; e) …; f) …; g) …; h) …; i) …; j) …; k) …; and l)...” Claim 20 recites “The protein of claim 1, wherein the protein is selected from the group consisting of: a), b), c), d), e), f), g), h), i), j), k), and l)”, which refers to the SEQ ID NO limitations of claim 19 Thus, the claims recite the same limitations. Claim 21 recites “The protein of claim 19, wherein the protein comprises one or more proteins selected from the group consisting of: …a) or b); …c) or d); …e) or f); …g) or h); …i) or j); and …k) or l). As only one protein from a) through l) is interpreted to be required (see 112(b) rejection and claim interpretation above), the limitations are effectively the same as that stated in claim 19. Therefore, claims 20 and 21 fail to further limit claim 19.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
Claims 1-14 and 19-23 are rejected under 35 U.S.C. 101 because the claimed
invention is directed to a natural phenomenon judicial exception without significantly
more. The claims are drawn to naturally occurring nucleic acids and proteins. The judicial exceptions are not integrated into practical application because the claims read on natural phenomena. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions.
The claims are evaluated using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106.III.
Step 1: Is the claim drawn to a process, machine, manufacture or composition of matter?
Yes. The claims are drawn to compositions of matter (i.e., nucleic acids and proteins) and methods of use thereof (i.e., processes) and each fall under one of the four statutory categories.
Step 2A, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes. Claims 1-14 are drawn to nucleic acids that are natural products. Claims 19-23 are drawn to proteins that are natural products. Claims 2-7 and 12-14 are dependent upon claim 1. Claims 9-11 are dependent upon claim 8. Claims 20-23 are dependent upon claim 19.
Claims 1, 4, 11, 19, and 22 are drawn to the following proteins which are natural products; claims 2-3, 5-7, 12-14 are dependent upon and thus also include the natural product limitation of claim 1:
SEQ ID NOs: 2 and 4 represent the amino acid sequence and a fragment thereof, respectively, of human PPAP (prostatic acid phosphatase protein; see Uniprot.org, P15309 PPAP-Human. 03/01/1992, p.9).
SEQ ID NOs: 6 and 8 represent the amino acid sequence and a fragment thereof, respectively, of human PARM1 (prostate androgen-regulated mucin-like protein 1; see Uniprot.org, Q6UWI2 PARM1-Human. 07/05/2004, p.7).
SEQ ID NOs: 10 and 12 represent the amino acid sequence and a fragment thereof, respectively, of human PCTA (prostate carcinoma tumor antigen-1; see Fisher and Ruoquian – US6811972B1. Development of DNA probes and immunological reagents specific for cell surface-expressed molecules and transformation-associated genes. p.34, col8, para.1 and Fig.18A. Patent date: 11/02/2004; Publication date: 07/18/1996).
SEQ ID NOs: 14 and 16 represent the amino acid sequence and a fragment thereof, respectively, of human PSCA (prostate stem cell antigen; see Uniprot.org, O43653 PSCA-Human. 10/10/2018, p.7).
SEQ ID NOs: 18 and 20 represent the amino acid sequence and a fragment thereof, respectively, of human PSP94 (prostate secretory protein of 94 amino acids; see Uniprot.org, P08118 MSMB-Human. 08/01/1988, p.7).
SEQ ID NOs: 22 and 24 represent the amino acid sequence and a fragment thereof, respectively, of human STEAP1 (six-transmembrane epithelial antigen of the prostate-1; see Uniprot.org, Q9UHE8 STEA1-Human. 05/01/2000, p.8).
Claims 5, 7-8, and 10 are drawn to the following nucleic acids which are natural products; claim 6 is dependent upon and thus also includes the natural product limitation of claim 5; claims 11-12 and 20-23 are dependent upon and thus also include the natural product limitation of claim 8:
SEQ ID NO: 1, which is the nucleic acid sequence encoding PAP (i.e., PAPP) amino acid SEQ ID NO: 2.
SEQ ID NO: 3, which is the nucleic acid sequence encoding a fragment of PAP (i.e., PAPP) amino acid SEQ ID NO: 4.SEQ ID NO: 5, which is the nucleic acid sequence encoding PARM1 amino acid SEQ ID NO: 6.
SEQ ID NO: 7, which is the nucleic acid sequence encoding a fragment of PARM1 amino acid SEQ ID NO: 8.SEQ ID NO: 9, which is the nucleic acid sequence encoding PCTA amino acid SEQ ID NO: 10.
SEQ ID NO: 11, which is the nucleic acid sequence encoding a fragment of PCTA amino acid SEQ ID NO: 12.
SEQ ID NO: 13, which is the nucleic acid sequence encoding PSCA amino acid SEQ ID NO: 14.
SEQ ID NO: 15, which is the nucleic acid sequence encoding a fragment of PSCA amino acid SEQ ID NO: 16.
SEQ ID NO: 17, which is the nucleic acid sequence encoding PSP94 (i.e., MSMB) amino acid SEQ ID NO: 18.
SEQ ID NO: 19, which is the nucleic acid sequence encoding a fragment of PSP94 (i.e., MSMB) amino acid SEQ ID NO: 20.
SEQ ID NO: 21, which is the nucleic acid sequence encoding STEAP1 (i.e., STEA1) amino acid SEQ ID NO: 22.
SEQ ID NO: 23, which is the nucleic acid sequence encoding a fragment of STEAP1 (i.e., STEA1) amino acid SEQ ID NO: 24.
Therefore, the claims encompass naturally occurring phenomena.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into an application?
Regarding claims 1-14 and 19-23 [Wingdings font/0xE0] No. There are no recited additional elements that integrate the judicial exceptions into a practical application:
Claims 1-4, 11 recite a nucleic acid molecule encoding amino acids of SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24, and do not integrate the judicial exception into an application.
Claims 5-10 recite a nucleic acid molecule encoding nucleic acids of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23, and do not integrate the judicial exception into an application.
Claim 12 recites that the nucleic acid molecule is a plasmid and does not integrate the judicial exception into an application.
Claim 13 recites that the nucleic acid molecule is an expression vector of nucleic acids operably linked to regulatory elements and does not integrate the judicial exception into an application.
Claim 14 recites a composition comprising at least one of the nucleic acid molecule of claim 1 and does not integrate the judicial exception into an application.
Claims 19-22 recite a protein of SEQ ID NOs: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24, and do not integrate the judicial exception into an application.
Claim 23 recites a composition comprising at least one protein of claim 19 and does not integrate the judicial exception into an application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Regarding claims 1-14 and 19-23 [Wingdings font/0xE0] No. There are no additional recited elements that amount to significantly more than what is found in the naturally occurring phenomena.
Therefore, the claims encompass a naturally occurring phenomenon that is not markedly different in structure from a naturally occurring product; or, are dependent upon claims that encompass a naturally occurring phenomenon that is not markedly different in structure from a naturally occurring product.
Without any evidence to the contrary, the peptide functionality and structure
would not be markedly different from that of the naturally occurring CPNE4. Because
there is no difference in the characteristics (structural, functional, or otherwise) between
the claimed and naturally occurring proteins, the claimed invention does not have
markedly different characteristics from what exists in nature. See, e.g., MPEP 2106).
Accordingly, the claims are directed to a judicial exception. Because the claim
does not include any additional features that could add significantly more to the
exception, the claim does not qualify as eligible subject matter under 35 U.S.C §101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 12, 14, and 19-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dendreon Corportation – US6210662B1 (patent date: 04/03/2001; effective filing date: 12/28/1995; herein referred to as Dendreon).
Dendreon teaches therapeutic compositions and methods for inducing cytotoxic T cell responses in vitro and in vivo; wherein antigen presenting cells are activated by contact with a polypeptide complex construct that comprise tumor antigens and dendritic cell stimulator protein GM-CSF (abstract; p.10, col.4). Dendreon teaches that malignant tumors express a number of proteins that can serve as target antigens for an immune attack, and antigens include prostatic acid phosphatase (PAP; p.11, col 5-6). Dendreon further teaches that PAP is a secreted molecule that has been identified as a serum tumor marker that is specific to prostate cancer; and, that PAP can serve both as an inducer of CTL and as a target in prostate cancer cells when combined with the dendritic cell binding protein GM-CSF (p.12, col.7). Dendreon teaches that the immunostimulatory peptides include tissue-specific tumor antigen human PAP of amino acid SEQ ID NO: 2, which overlaps with instant SEQ ID NO: 2 at 100% identity (p.10, cols.3-4; p.14, cols.11-12; Fig.1; see alignment below); and, that these antigens can be isolated, synthesized, or recombinantly expressed according to known methods in the art (p.11, col.6). As, instant SEQ ID NO: 2 comprises instant SEQ ID NO: 4, Dendreon SEQ ID NO: 2 also teaches instant SEQ ID NO: 4 at 100% identity (see alignment below). Dendreon further teaches plasmid expression vectors and systems for producing the polypeptides, as well as substantially purified nucleic acid molecules that encode them (abstract; p.10, col.4; p.15, col.14). Dendreon teaches tumor cell killing testing in vitro using a novel prostate carcinoma cell line HLA A2.1 cells (p.10, col.4). Dendreon further teaches that their invention enables introduction of an exogenously added protein into the class I pathway of a mature dendritic cell (p.13, col.9). Dendreon teaches that the antigenic peptide complex can be administered directly to an individual as a vaccine in order to stimulate the individual’s cellular immunity pathways in vivo and that the response in the subject can be measured by monitoring the induction of cytolytic T-cell responses, a helper T-cell response, and antibody response towards the antigen in peripheral blood mononuclear cells by methods well known in the art (p.14, col.11).
[AltContent: textbox (Instant PAP SEQ ID NO: 2 vs Dendreon human PAP SEQ ID NO: 2
[img-media_image7.png]
Instant PAP SEQ ID NO: 2 vs instant PAP SEQ ID NO: 4
[img-media_image8.png])]
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 17-18 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Dendreon, as applied to claims 1 and 19 above; and, further in view of Dendreon.
Dendreon teaches nucleic acid molecules encoding the human PAP protein of instant SEQ ID NOs: 2 and 4 to induce an immune response, as applied to instant claims 1 and 19 above.
Dendreon does not explicitly teach an embodiment wherein the nucleic acid molecule expressing the PAP protein is used in a method of inducing an immune response in a subject (i.e., in vivo).
Dendreon does, however, teach that the antigenic proteins expressed and administered in the method of inducing immune response in immune cells can be used in vitro and in vivo (see abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to further combine the teachings of Dendreon by using a nucleic acid molecule expressing human antigenic PAP protein (taught by Dendreon) in order to induce an immune response by administering the nucleic acid molecule via in vivo administration (also taught by Dendreon) of immune cells activated with the immunogenic PAP protein. One of ordinary skill would be motivated to do so and would have a reasonable expectation of success because Dendreon teaches that administration of PAP nucleic acid that expresses PAP protein can be used to induce an immune response and Dendreon teaches the human PAP amino acid sequences SEQ ID NO: 2 and 4.
Claims 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dendreon; and, further in view of University of Waikato. The genetic code. Science Learning Hub Pokapu Akoranga Putaiao (2014), internet, p.1 (herein referred to as UW).
Dendreon teaches nucleic acid molecules encoding the human PAP protein of instant SEQ ID NOs: 2 and 4 using nucleic acid plasmid expression vectors, as applied to instant claim 1 above.
Dendreon does not explicitly teach the nucleotide sequence for the human PAP protein of instant SEQ ID NO: 1 (instant claims 5-11).
UW teaches the genetic code for amino acids that correspond to nucleic acid codons.
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Dendreon with the teachings of UW by performing a reverse translation of the human PAP amino acid SEQ ID NO: 2 (also taught by Dendreon) by using the genetic code taught by UW, in order to arrive at the instantly claimed invention, because the combination of prior art elements results in the predictable result of obtaining nucleic acids encoding the polypeptides (taught by UW) for the PAP antigen protein (taught by Dendreon). One of ordinary skill in the art would have a reasonable expectation of success because UW teaches codons for expression of amino acids/proteins.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Dendreon; and, further in view of Prazeres and Monteiro. Plasmid biopharmaceuticals. Microbiology Spectrum – American Society for Microbiology Press (2014), 2:6, p.1-18 (herein referred to as Prazeres).
Dendreon teaches nucleic acid molecules encoding the human PAP protein of instant SEQ ID NOs: 2 and 4 using nucleic acid plasmid expression vectors, as applied to instant claim 1 above.
Dendreon does not explicitly teach that the expression vector comprises sequences encoding protein that are operably linked to regulatory elements (instant claim 13).
Prazeres teaches that plasmids are indispensable molecular tools in science research and biotechnology industry, supporting production of pharmaceutical proteins, antibodies, vaccines, industrial enzymes, and molecular diagnostics; and, have exhibited improvements in the context of gene therapy and DNA vaccination interventions (abstract, p.1). Prazeres teaches plasmid-based gene therapy and DNA vaccination rely on effective delivery and expression of the transgene to target cells; and, include the therapeutic gene and regulatory elements required for expression in eukaryotic cells (p.5; Fig.3).
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Dendreon with the teachings of Prazeres to employ the regulatory elements in an expression vector (taught by Prazeres) to drive expression of the PAP protein (taught by Dendreon), to arrive at the instantly claimed invention, because the combination of prior art elements results in a predictable result of regulatory element driven expression of a PAP protein from a DNA plasmid expression vector. One of ordinary skill in the art would have a reasonable expectation of success because Dendreon teaches expression vectors and the sequence for the PAP protein of instant SEQ ID NOs: 2 and 4.
Claims 15-16 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dendreon; and, further in view of Provenge: Package insert/prescribing info. Drugs.com.. 08/25/2019. Internet – Wayback Machine. p.1-16 (herein referred to as Provenge).
Dendreon teaches nucleic acid molecules encoding the human PAP protein of instant SEQ ID NOs: 2 and 4 to induce an immune response in the context of cancer including prostate cancer, as applied to instant claims 1 and 19 above.
Dendreon does not explicitly teach an embodiment wherein the nucleic acid molecule expressing the PAP protein is used in a method of treating a subject diagnosed with prostate cancer (i.e., an in vivo treatment).
Provenge teaches package insert and prescribing information for sipuleucel-T which is an autologous cellular immunotherapy for prostate cancer; wherein T cells are activated with a construct comprising PAP protein (p.2, para.2). Provenge teaches intravenous infusion administration to patients (p.3, para.11). Provenge teaches that the drug consists of activation of the T cells using recombinant prostatic acid phosphatase (PAP), which is an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune activator (p.8, para.3). Provenge teaches that the drug is designed to induce an immune response targeted against PAP (p.8, para.7).
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Dendreon with the teachings of Provenge by using the nucleic acid molecule expressing the human PAP protein (taught by Dendreon) in a method of treating a subject diagnosed with prostate cancer because Provenge teaches that sipuleucel-T comprises PAP antigen and is an immunotherapy indicated for the treatment of prostate cancer. One of ordinary skill in the art would have a reasonable expectation of success because Provenge teaches dosage and administration of sipuleucel-T for treatment of prostate cancer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US11045535B2
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US11045535B2 (herein referred to as Pat’535). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat’535 teaches methods for treating prostate cancer and for generating an immune response in an individual comprising administering a composition comprising one or more nucleic acid molecule encoding one or more proteins, and nucleotide sequences thereof, selected from a group that includes STEAP1 (SEQ ID NOs: 11-12; instant SEQ ID NOs: 21-22 and 23-24) and PSCA (SEQ ID NOs: 13-14; instant SEQ ID NOs: 13-14 and 15-16) (Pat’535 claims 1-7; instant claims 1-4, 11, 14-27). Pat’535 also teaches expression vectors wherein the sequences encoding the proteins are operably linked to regulatory elements (Pat’535 claims 8-9; instant claims 12-13).
US11980659B2
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. US11980659B2 (herein referred to as Pat’659). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat’659 teaches methods for treating prostate cancer and for generating an immune response in an individual comprising administering a composition comprising one or more nucleic acid molecule encoding one or more proteins, and nucleotide sequences thereof, selected from a group that includes STEAP1 (SEQ ID NOs: 10-12; instant SEQ ID NOs: 21-22 and 23-24) and PSCA (SEQ ID NOs: 13-14; instant SEQ ID NOs: 13-14 and 15-16) (Pat’659 claims 1-9 and 12-19; instant claims 1-4, 11, 14-27). Pat’659 also teaches expression vectors wherein the sequences encoding the proteins are operably linked to regulatory elements (Pat’659 claims 10-11; instant claims 12-13).
US9399056B2
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. US9399056B2 (herein referred to as Pat’056). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat’056 teaches methods for treating prostate cancer and for generating an immune response in an individual comprising administering a composition comprising one or more nucleic acid molecule encoding one or more proteins, and nucleotide sequences thereof, selected from a group that includes STEAP1 (SEQ ID NOs: 10-12; instant SEQ ID NOs: 21-22 and 23-24) and PSCA (SEQ ID NOs: 13-14; instant SEQ ID NOs: 13-14 and 15-16) (Pat’056 claims 1-9 and 12-16; instant claims 1-4, 11, 14-27). Pat’659 also teaches expression vectors wherein the sequences encoding the proteins are operably linked to regulatory elements (Pat’056 claims 10-11; instant claims 12-13).
Conclusion
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/JAMI MICHELLE GURLEY/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647