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 .
DETAILED ACTION
Claim Status
Claims 1, 4-5, 11-13 and 15-18 are pending. Claims 2-3, 8-10, 14, 20, 24-25 and 31 have been canceled. Claims 1 and 12 have been amended. Claims 1, 4-5, 11-13 and 15-18 are being examined in this application. In the response to the restriction requirement, Applicants elected Invention I, encephalopathy, flavivirus, and dexamethasone.
Claim Rejections - 35 USC § 112
The rejection of claim 14 under 35 USC 112(d) is withdrawn in view of the amendments to the claims.
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.
This is a new rejection.
Claims 17-18 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 17 recites the limitation "the anti-viral agent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the anti-inflammatory agent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The rejection of claims 1-5 and 8-14 under 35 U.S.C. 102(a)(1) as being anticipated by Galipeau et al. is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 1, 4-5, 12-13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Echols (US 2003/0100498).
With respect to claims 1, 4-5 and 13, Echols teaches a method for inducing an increase in the number of CD4+ T-lymphocytes in an HIV-infected patient comprising administering human granulocyte-macrophage stimulating factor (GM-CSF) to the patient in an amount and for a time sufficient to induce a clinically significant increase in the patient's CD4+ T-lymphocyte count (claim 1).
It is noted that once the GM-CSF is administered to a patient, it would inherently prevent the instantly claimed viral infection-related conditions.
With respect to claim 12, Echols teaches that the human GM-CSF is recombinant GM-CSF (claim 2).
With respect to claim 15, Echols does NOT teach that the patient is treated with anti-inflammatory agents.
With respect to claim 16, Echols teaches that the GM-CSF is administered concurrently with at least one antiretroviral agent (abstract; paras [0007], [0014]).
This rejection has been modified.
Claims 1, 4-5, 11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shams (US 2014/0193506).
With respect to claims 1, 4-5 and 13, Shams teaches a method of protecting a subject against influenza infection, comprising administering to the lungs of a subject in need thereof an effective amount of a source of hGM-CSF, thereby protecting said subject (claim 1).
It is noted that once the GM-CSF is administered to a patient, it would inherently prevent the instantly claimed viral infection-related conditions.
With respect to claim 11, Shams teaches administering the composition by inhalation (paras [0160], [0232]).
With respect to claim 15, Shams does NOT teach that the patient is treated with anti-inflammatory agents.
Claim Rejections - 35 USC § 103
The rejection of claims 1-5, 8-14 and 17 under 35 U.S.C. 103 as being unpatentable over Galipeau et al. in view of Wang et al. is withdrawn in view of the amendments to the claims.
The rejection of claims 1-5, 8-14 and 17-18 under 35 U.S.C. 103 as being unpatentable over Galipeau et al. in view of Harvard Health Publishing is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 1, 4-5, 11-13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-14, 16-18 and 21-24 of copending Application No. 18/238261 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1, 4-5 and 13, '261 teaches a method of reducing the risk of, preventing, or treating a pathologic entity of Type 2 diabetes in a subject, the method comprising administering to the subject a composition comprising granulocyte macrophage colony stimulating factor (GM-CSF) or an mRNA construct encoding GMCSF, recombinantly produced molecule thereof, or biologically active fragment thereof, or an analog thereof wherein the subject has or is suspected of developing a pathologic entity of Type 2 diabetes (claim 1).
It is noted that once the GM-CSF is administered to a patient, it would inherently prevent the instantly claimed viral infection-related conditions.
With respect to claim 11, '261 teaches administering the composition by inhalation (claim 11).
With respect to claim 12, '261 teaches that the subject is human (claim 12), and further teaches that GM-CSF is recombinantly produced (claim 14).
With respect to claim 15, '261 does NOT teach that the patient is treated with anti-inflammatory agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection has been modified.
Claims 1, 4-5, 13 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 76-94 of copending Application No. 18/837235 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1, 4-5 and 13, '235 teaches a method for treating or preventing a neurodegenerative or neurological disease or disorder comprising administering a GMCSF agent (claim 76).
It is noted that once the GM-CSF is administered to a patient, it would inherently prevent the instantly claimed viral infection-related conditions.
With respect to claim 15, '235 does NOT teach that the patient is treated with anti-inflammatory agents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658