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 .
Claims 22-37 are pending as amended 3/25/24 and are considered herein.
Drawings
The drawings are objected to because figure 5 contains two sequences requiring sequence identifiers. The drawings themselves do not contain the sequence identifiers required. The brief description for the drawings provides for SEQ ID NO: 15, but does not clearly link the same to the protein sequence in Figure 1. The brief description of the drawings does not provide any sequence identifier for the nucleic acid sequence requiring a sequence identifier, either. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 28 be found allowable, claim31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 31 requires the composition of Claim 28 to be a form suitable for a markush of administration forms, however, there is no form of composition of pharmaceutical composition of Claim 28 which is not also found in Claim 31. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112
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.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 27 is drawn to a nucleic acid encoding the peptide of Claim 26. However, nucleic acids are completely different chemical structure from that of a peptide. Thus, the scope of Claim 27 is completely outside the scope of Claim 26. 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 § 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.
Claim(s) 22-23, 25-28 and 30-37 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 10,695,438 to Durrant, et al.
Claim 22: Durrant claims several sequences that are immunogenic peptides of SEQ ID NO: 15. For Example, Claim 1 of Durrant claims SEQ ID NO: 1, which contains the sequence VIGMDVAASEFFcitSGKYDLD, each peptide of the two peptides connected through citrulline, being a sequence found in presently-claimed SEQ ID NO: 15. Moreover, the specification teaches these may be encoded by constructs for the making of the proteins (e.g., paragraph 30).
Claim 23: the polyadenylation sequence being so-linked is taught in, e.g., paragraph 33.
Claim 25: paragraph 30 teaches the coding sequence may be found in a plasmid.
Claim 26: As shown above, Durrant claims several sequences that are immunogenic peptides of SEQ ID NO: 15. For Example, Claim 1 of Durrant claims SEQ ID NO: 1, which contains the sequence VIGMDVAASEFFcitSGKYDLD, each peptide of the two peptides connected through citrulline, being a sequence found in presently-claimed SEQ ID NO: 15.
Claim 27: the specification teaches these may be encoded by constructs for the making of the proteins (e.g., paragraph 30).
Claim 28: paragraph 46 teaches the encoded polypeptide may be in a composition containing a carrier.
Claim 30: The use of poly I:C and imiquimod are taught (e.g., paragraph 107).
Claim 31: Paragraph 47 teaches many of the same administration routes.
Claim 32: paragraph 12 teaches the peptides may be used to raise an immune response.
Claim 33: paragraph 43 teaches pancreatic ductal adenocarcinoma.
Claim 34: treatment includes humans (e.g., paragraph 46).
Claim 35: paragraph 21 teaches mammals.
Claim 36: paragraph 51 teaches the additional administration of chemotherapeutics.
Claim 37: paragraph 43 teaches pancreatic ductal adenocarcinoma.
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.
Claim(s) 22-28 and 30-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,695,438 to Durrant, et al., as applied to Claims 22-23, 25-28 and 30-37, above, and further in view of U.S. Patent No. 7,329,649 to Fisher, et al.
As shown above, the base claims are anticipated by, and thus, are also novel over, Durrant. However, the aspect of using a recombinant expression vector that is unable to replicate in a mammalian cell is not taught.
On the other hand, Fisher teaches replication defective adenoviruses that are unable to replicate in normal cells, can be used to deliver MDA-7, in pancreatic cancer.
Thus, at the time of invention, it was obvious to make the invention by modifying the invention of Durrant with the replication defective adenovirus of Fisher. The Artisan would do so to treat cancer. The Artisan would expect success, as the components are utilized for their art-recognized purposes.
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.
Claim(s) 22-23, 25-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 10,695,438 to Durrant, et al., as applied to Claims 22-23, 25-28 and 30-37, above, and further in view of U.S. Patent No. 11,607,391 to Murphy, et al.
As shown above, the base claims are anticipated by, and thus, are also novel over, Durrant. However, the aspect of utilizing PLG microspheres for delivery of the protein or nucleic acid is not taught.
On the other hand, Murphy teaches PLG microspheres with adsorbed nucleic acid for delivery of the same (e.g., Claims 1, 3-5). Such is taught for delivery for treating, e.g., cancer (e.g., paragraph 67).
Thus, at the time of invention, it was obvious to make the invention by modifying the invention with the PLG microsphere delivery vehicles of Murphy. The Artisan would do so to treat cancer. The Artisan would expect success, as the components are utilized for their art-recognized purposes.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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