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 .
Claims
Applicant’s preliminary amendment of 10/11/24 fails to incorporate Claim 6, which was present in the original filing, and fails to provide any status for the claim. Technically, it is a non-responsive amendment, but the office accepted it. The Examiner feels he can examine the claims, in the interest of compact prosecution. Claim 6 is included, in the interest of compact prosecution, as it was originally present. The following is the presently-considered-pending claims of record:
Claim 1. (Original) A method for reducing one or more symptoms of disease in a mammalian subject, comprising administering a therapeutically effective amount of the vector of claim 46 to a mammalian subject in need of therapy.
Claim 2. (Original) The method of claim 1, further comprising detecting the presence of at least a portion of the vector in a cell of the treated subject.
Claim 3. (Original) The method of claim 1, wherein the recombinant nucleotide sequence further comprises a heterologous polynucleotide sequence operably linked to a first adeno-associated virus inverted terminal repeat (AAV ITR).
Claim 4. (Original) The method of claim 3, wherein the heterologous polynucleotide sequence comprises a therapeutic sequences.
Claim 5. (Original) The method of Claim 3, wherein the therapeutic sequences encodes one or both of a disease associated polypeptide and an antigen polypeptide.
Claim 6. (Original) The method of Claim 5, wherein the therapeutic sequence encodes an antigen polypeptide, and the method further comprises detecting an immune response by the subject to the antigen polypeptide.
Formalities:
The specification of 4/8/25 is accepted.
The drawings of 10/11/24 are objected to for containing sequences not properly identified.
At this point, Applicant has filed no IDS statements.
The priority is recognized to be:
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Drawings
The drawings are objected to because Figure 8 contains a sequence requiring a sequence identifier, that being the ITR contained therein. (see also PTO-2301). 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
Claims 4-5 are objected to because of the following informalities:
Claim 4 recites “a therapeutic sequences”. The antecedent basis of “a” does not go with a plural “therapeutic sequences”, in proper English.
Claim 5 recites “the therapeutic sequences encodes one or both …”. Proper English is “therapeutic sequences encode one or both…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1, 3, and 6 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 1 recites “the vector of claim 46”. There is no Claim 46 of record. Thus, the scope of the vector is not clear.
Claim 3 recites “a heterologous polynucleotide sequence operably linked to a first adeno-associated virus inverted terminal repeat (AAV ITR)”. It is not clear how a heterologous sequence is “operably linked” to an AAV ITR. The ITR does not code a protein, and thus, being in frame is not relevant. Is Applicant claiming simply that there is an AAV ITR in the polynucleotide? The scope of the claim is not clear.
Claim 6 recites “the therapeutic sequence” of Claim 5. There is insufficient antecedent basis for this therapeutic sequence”. Is Applicant referring to one specific sequence in the therapeutic sequences of Claim 5, or is this another sequence?
Non-Statutory Double Patenting
For the record, both patents 10,214,730 and 10,947,514 were considered for NSDP rejections. However, they do not claim therapy, pharmaceuticals, or therapeutic aspects. As such, they have use in laboratory use, and therefore are not considered to be NSDP with the present claim.
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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,623,107. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claims 2 and 10 teach reducing a symptom of a disease (locomotor function after spinal cord injury) in a subject in need, comprising administering AAV10-NG2Ab, Claim 10 teaches the additional administration of AAV10-NT3.
Claim 2: observing the improvement inherently detects that the vector(s) entered the cell(s) of the subject.
Claim 3: AAV10 requires the presence of AAV ITRs, as they are the defining piece of a vector. They are linked to the coding sequences, making it an AAV vector, and thus are so-operably linked.
Claim 4: the NG2Ab and NT3 are both therapeutic sequences.
Claim 6: the antigen polypeptide may be considered to be NG2Ab or NT3, and the immune response may be found in the improved locomotor function.
Thus, in light of the patent, the invention is obvious. The Artisan would make it and expect success, as it is claimed.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,478,536. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 teaches treating IOP associated conditions (diseases) in a subject. The method comprising administration of tPA therapeutic agent which may be nucleic acid encoding tPA/variants/RNA regulators of expression or activity. Claim 8 is similar but directed specifically increasing outflow facility in the subject.
Claim 2: detection of the presence of the vector in a cell is taught by the observation of the improvement in the conditions of the subject.
Claim 3: Claims 3 and 10 teach it may be an AAV vector, which necessarily requires the AAV ITRs to be so-operably linked.
Claim 4: the encoded tPA/variants/RNA regulators may be considered therapeutic sequences.
Claim 5: the encoded regulators are necessarily antigens, and disease-associated polypeptides, as they treat the disease.
Claim 6: in addition to the above, the detected immune response is found by observing the improvement in the patient.
Thus, in light of the patent, the invention is obvious. The Artisan would make it and expect success, as it is claimed.
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.
Claim(s) 1-6 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2004/0242528 A1 to Hagstrom, et al.
Claim 1: Claim 1 teaches delivering a polynucleotide into a vein of a mammal limb of a mammal. The gene may encode an antigen and a therapeutic polypeptide (e.g., Claim 15). Calim 23 teaches it may be done to treat a disease chosen from a markush of diseases, thus meeting the requirement for a subject in need of therapy.
Claim 2: Claim 23, in teaching treatment of a Markush of diseases, means that observation of the improvement would be a way of detecting the presence of at least of portion of the vector in a cell of the subject.
Claim 3: Claim 11 teaches AAV viruses, which necessarily includes the defining ITRs.
Claim 4: Claim 15 teaches encoding a Markush of proteins, including therapeutic polypeptides.
Claim 5: Claim 15 teaches therapeutic polypeptide and an antigen.
Claim 6: in addition to the above, the detection of the improvement of the diseae(s) would necessarily indicate detection of the proper immune response.
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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