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 .
Election/Restrictions
Applicants’ election of Group I (claims 1-28, 43-46, and 54-57) in the reply filed on March 2, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 29-42 and 47-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 2, 2026.
Applicants’ further elected the following species on July 30, 2026: GRP78 target protein; the GRP78 variant (comprising unclaimed mutations R261Q and H265Q); and the B4 antibody (including unclaimed CDRs having SEQ ID NOS: 1-6). As above, because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Because the GRP78 variant and anti-GRP78 antibody elected are not specifically claimed, the election is deemed to encompass any GRP78 variant and any anti-GRP78 antibody.
Claims 13-14, 27-28, 45-46, and 56-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 30, 2026.
Therefore, claims 1-12, 15-26, 43-44, 54-55, and newly filed 58-59 are under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Sequences are present in paragraph [0104] without sequence identifiers.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers at Figure 4 in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The use of the terms TALEN at paragraphs [0022], [0084]-[0085], [0088], and [0097]-[0102]; PIGGYBAC at paragraph [0109]; SLEEPING BEAUTY at paragraph [0109]; ILLUMINA at paragraph [0113]; OXFORD NANOPORE TECHNOLOGIES at paragraph [0113]; GENSCRIPT at paragraphs [0226], [0241] and [0253]; and FORTEBIO at paragraphs [0236] and [0249]; which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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 Rejections - 35 USC § 112
Claims 1-12, 15-26, 43-44, 54-55, and 58-59 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.
At claim 1, lines 2 and 7, it is not clear what is meant by the phrase “modified cell line.” Are there any particular features, such as nucleic acid or amino acid sequences, growth characteristics and/or requirements, protein expression levels and types, that must be different from a parent cell line in order to be considered a modified cell line?
Claim 1 recites the limitation "the cell" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the modified cell" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-12 and 58-59 depend from claim 1, and are therefore included in these rejections.
Claim 4 recites the limitation "the native target protein" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the endoplasmic reticulum" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the Golgi apparatus" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
At claim 15, lines 2, 4-5, and 7, it is not clear what is meant by the phrase “modified mammalian cell line.” Are there any particular features, such as nucleic acid or amino acid sequences, growth characteristics and/or requirements, protein expression levels and types, that must be different from a parent cell line in order to be considered a modified mammalian cell line?
Claims 16-26 depend from claim 15, and are therefore included in this rejection.
Claim 17 recites the limitation "the secretory pathway" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is not clear if there is only a single secretory pathway available to cells or if there are alternative secretory pathways.
Claim 22 recites the limitation "the endoplasmic reticulum" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the Golgi apparatus" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
At claim 43, lines 3, 4, and 7, it is not clear what is meant by the phrase “modified mammalian cell line.” Are there any particular features, such as nucleic acid or amino acid sequences, growth characteristics and/or requirements, protein expression levels and types, that must be different from a parent cell line in order to be considered a modified mammalian cell line?
Claim 43 recites the limitation “the target epitope” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 depends from claim 43, and are therefore included in this rejection.
At claim 54, lines 2, 4, and 7, it is not clear what is meant by the phrase “modified mammalian cell line.” Are there any particular features, such as nucleic acid or amino acid sequences, growth characteristics and/or requirements, protein expression levels and types, that must be different from a parent cell line in order to be considered a modified mammalian cell line?
Claim 55 depends from claim 54, and is therefore included in this rejection.
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 1-3, 6-12, 15-17, 20-26, 43-44, and 54-55 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by 1-3, 6-12, 15-17, 20-26, 43-44, and 54-55 Gill (U.S. Patent Application Publication No. 2018/0094054, published April 5, 2018), and cited in the Information Disclosure Statement filed March 2, 2026).
Regarding claims 1, 15, 43, and 54, Gill discloses production of antibodies to GRP78, which have a high affinity for GRP78 (abstract). Gill discloses that the GRP78 protein can be a variant of GRP78 (paragraphs [0047] and [0108]). Gill discloses that the variant can have an addition, deletion, or substitution of any amino acid present at a given position in the 650 amino acid sequence of GRP78 (paragraph [0108]). Gill discloses expression of GRP78 variants in 293T cells (paragraph [0251]). Gill discloses production of anti-GRP78 antibodies by propagation of a hybridoma in cell culture, so that the antibody is produced (paragraph [0109]).
Regarding claims 2, 16, 44, and 55, Gill discloses that the antibody can be purified from the cell culture (paragraph [0109]).
Regarding claims 3 and 17, Gill discloses that GRP78 is a protein that is an intracellular protein that is generally found as an endoplasmic reticulum lumenal protein (paragraph [0006]).
Regarding claims 6 and 20, Gill discloses that GRP78 is a stress protein (paragraphs [0004]-[0005]).
Regarding claims 7-8 and 21-22, Gill discloses that GRP78 is a protein that is an intracellular protein that is generally found as an endoplasmic reticulum lumenal protein (paragraph [0006]).
Regarding claims 9 and 23, Gill discloses that GRP78 is an endoplasmic reticulum chaperone (paragraph [0005]).
Regarding claims 10 and 24, Gill discloses that GRP78 is heat shock protein in the HSP70 family (paragraphs [0005] and [0224]).
Regarding claim 11-12 and 25-26, Gill discloses that the target protein is GRP78 (paragraphs [0005]-[0007]).
Gill discloses each and every limitation of claims 1-3, 6-12, 15-17, 20-26, 43-44, and 54-55, and therefore, Gill anticipates claims 1-3, 6-12, 15-17, 20-26, 43-44, and 54-55.
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.
Claims 1-2, 6-12, 16-26, 43-44, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,060,415.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘415 patent claims an isolated monoclonal antibody that specifically binds to GRP78 and the instant application claims a method of making an antibody that binds to GRP78.
Regarding claims 1, 15, 43, and 54, the ‘415 patent claims an isolated monoclonal antibody that specifically binds to GRP78 (claims 1 and 5).
Regarding claims 6-12 and 17-26, the ‘415 patent claims that the antibody specifically binds to GRP78, which is a protein that is a stress protein, expressed on the endoplasmic reticulum as an endoplasmic reticulum chaperone, which can be a protein that is GRP78 (claims 1 and 5).
While the ‘415 patent does not claim a method of preparing the antibody to a mutant GRP78, because the anti-GRP78 antibody is a recombinant monoclonal antibody, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that, in order to have an isolated monoclonal antibody that specifically binds to GRP78 according to the ‘415, one would have had to express the antibody in a modified cell, culture the modified cell, and purify the antibody, thus obtaining the isolated recombinant anti-GRP78 antibody to a mutant GRP78 that retains the function of an unmutated GRP78, as claimed in the instant application.
Claims 1-2, 6-12, 16-26, 43-44, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,103,966.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘966 patent claims an isolated monoclonal antibody that specifically binds to GRP78 and the instant application claims a method of making an antibody that binds to GRP78.
Regarding claims 1, 15, 43, and 54, the ‘966 patent claims an isolated monoclonal antibody that specifically binds to GRP78 (claims 1 and 5).
Regarding claims 6-12 and 17-26, the ‘966 patent claims that the antibody specifically binds to GRP78, which is a protein that is a stress protein, expressed on the endoplasmic reticulum as an endoplasmic reticulum chaperone, which can be a protein that is GRP78 (claims 1 and 5).
While the ‘966 patent does not claim a method of preparing the antibody to a mutant GRP78, because the anti-GRP78 antibody is a recombinant monoclonal antibody, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that, in order to have an isolated monoclonal antibody that specifically binds to GRP78 according to the ‘966, one would have had to express the antibody in a modified cell, culture the modified cell, and purify the antibody, thus obtaining the isolated recombinant anti-GRP78 antibody to a mutant GRP78 that retains the function of an unmutated GRP78, as claimed in the instant application.
Claims 1-2, 6-12, 16-26, 43-44, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12,180,269.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘269 patent claims an isolated monoclonal antibody that specifically binds to GRP78 and the instant application claims a method of making an antibody that binds to GRP78.
Regarding claims 1, 15, 43, and 54, the ‘269 patent claims an isolated monoclonal antibody that specifically binds to GRP78 (claims 1 and 5).
Regarding claims 6-12 and 17-26, the ‘269 patent claims that the antibody specifically binds to GRP78, which is a protein that is a stress protein, expressed on the endoplasmic reticulum as an endoplasmic reticulum chaperone, which can be a protein that is GRP78 (claims 1 and 5).
While the ‘269 patent does not claim a method of preparing the antibody to a mutant GRP78, because the anti-GRP78 antibody is a recombinant monoclonal antibody, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that, in order to have an isolated monoclonal antibody that specifically binds to GRP78 according to the ‘269, one would have had to express the antibody in a modified cell, culture the modified cell, and purify the antibody, thus obtaining the isolated recombinant anti-GRP78 antibody to a mutant GRP78 that retains the function of an unmutated GRP78, as claimed in the instant application.
Claims 1-2, 6-12, 16-26, 43-44, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,577,301.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘301 patent claims an isolated monoclonal antibody that specifically binds to GRP78 and the instant application claims a method of making an antibody that binds to GRP78.
Regarding claims 1, 15, 43, and 54, the ‘966 patent claims an isolated monoclonal antibody that specifically binds to GRP78 (claims 1-3).
Regarding claims 6-12 and 17-26, the ‘301 patent claims that the antibody specifically binds to GRP78, which is a protein that is a stress protein, expressed on the endoplasmic reticulum as an endoplasmic reticulum chaperone, which can be a protein that is GRP78 (claims 1-3).
While the ‘301 patent does not claim a method of preparing the antibody to a mutant GRP78, because the anti-GRP78 antibody is a recombinant monoclonal antibody, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that, in order to have an isolated monoclonal antibody that specifically binds to GRP78 according to the ‘301, one would have had to express the antibody in a modified cell, culture the modified cell, and purify the antibody, thus obtaining the isolated recombinant anti-GRP78 antibody to a mutant GRP78 that retains the function of an unmutated GRP78, as claimed in the instant application.
Claims 1-12, 15-26, 43-44, 54-55, and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-20, 23-38, 41-44, and 46-48 of copending Application No. 18/311,227 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘227 application and the instant application claim a method of recombinant production of an antibody in a modified cell line.
Regarding claims 1, 15, 43, and 54, the ‘227 application claims expression of a nucleic acid encoding an antibody in a modified cell line, where the antibody specifically binds to a target epitope on a protein, the nucleic acid comprises a mutation of one or more amino acid residues of the target epitope, followed by initiating transcription and translation of the antibody under conditions that the antibody is produced (claims 9 and 27).
Regarding claims 2, 16, 44, and 55, the ‘227 application claims isolation of the antibody (claims 10 and 28).
Regarding claims 3 and 17, the ‘227 application claims that the target protein that is natively expressed is an intracellular protein in the secretory pathway of the cell line (claims 11, 23, 29, and 41).
Regarding claims 4 and 18, the ‘227 application claims that the mutation is an inert mutation that retains the structure and function of the native target protein in the cell (claims 12, 24, 30, and 42).
Regarding claims 5 and 19, the ‘227 application claims that the mutation reduces or abrogates binding of the antibody to the target epitope on the target protein (claims 13, 25, 31, and 43).
Regarding claims 6 and 20, the ‘227 application claims that the target protein is a stress protein (claims 14, 26, 32, and 44).
Regarding claims 7 and 21, the ‘227 application claims that the target protein is expressed on an organelle of the cell line (claims 15 and 33).
Regarding claims 8 and 22, the ‘227 application claims that the organelle is the endoplasmic reticulum or the Golgi apparatus (claims 16 and 34).
Regarding claims 9 and 23, the ‘227 application claims that target protein is an endoplasmic reticulum chaperone (claims 17, 35, and 46).
Regarding claims 10 and 24, the ‘227 application claims that the endoplasmic reticulum chaperone is a calreticulin, a heat shock protein or an isomerase (claims 18 and 36).
Regarding claims 11-12, 25-26, and 44, the ‘227 application claims that the target protein is glucose-regulated protein 78 (GRP78), HSP47, PDI, calreticulin or GP94 (claims 19-20 and 37-38).
Regarding claims 58-59, the ‘227 application claims that the variant GRP78 can comprise an H265Q mutation, which is a mutation found in instant claims 58-59 as SEQ ID NO: 27 (claims 47-48).
Therefore, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-12, 15-17, 20-26, 43-44, and 54-55are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-36 and 38-42 of copending Application No. 18/311,235 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘227 application and the instant application claim a method of recombinant production of an antibody in a modified cell line.
Regarding claims 1, 15, 43, and 54, the ‘227 application claims expression of a nucleic acid encoding an antibody in a modified cell line, where the antibody specifically binds to a target epitope on a protein, the nucleic acid comprises a mutation of one or more amino acid residues of the target epitope, followed by initiating transcription and translation of the antibody under conditions that the antibody is produced (claim 33).
Regarding claims 2, 16, 44, and 55, the ‘227 application claims isolation of the antibody (claim 34).
Regarding claims 3 and 17, the ‘227 application claims that the target protein that is natively expressed is an intracellular protein in the secretory pathway of the cell line (claim 35 and 47).
Regarding claims 6 and 20, the ‘227 application claims that the target protein is a stress protein (claim 36).
Regarding claims 7 and 21, the ‘227 application claims that the target protein is expressed on an organelle of the cell line (claim 38).
Regarding claims 8 and 22, the ‘227 application claims that the organelle is the endoplasmic reticulum or the Golgi apparatus (claim 39).
Regarding claims 9 and 23, the ‘227 application claims that target protein is an endoplasmic reticulum chaperone (claim 40).
Regarding claims 10 and 24, the ‘227 application claims that the endoplasmic reticulum chaperone is a calreticulin, a heat shock protein or an isomerase (claim 41).
Regarding claims 11-12, 25-26, and 44, the ‘227 application claims that the target protein is glucose-regulated protein 78 (GRP78), HSP47, PDI, calreticulin or GP94 (claim 42).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The prior art appears to fail to disclose or suggest that the variant target protein comprises or consists of SEQ ID NO: 27.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rauschert et al. (88 Laboratory Investigation 375-386 (2008)) disclose that the chaperone GRP78 is a member of the heat-shock protein 70 (HSP70) that provides for cellular homeostasis by preventing stress-induced apoptosis (abstract). In addition, Rauschert et al. disclose that GRP78 is expressed in all cells of the body (abstract). Rauschert disclose that GRP78 can be present on cancer cells in a variant form, which can potentially be a target for antibody-based cancer therapy (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NEIL HAMMELL can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
