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 1-30 are pending and have been examined on the merits.
Claim Objections
Claims 23-25 are objected to because of the following informalities:
In the claims (claims 23 at lines 2-3; claim 24 at line 3; and claim 25 at line 3), the phrased “from reconstituted plasma ranges” (claims 23, 24) and “reconstituted plasma” (claim 25) appear to be an inconsistent formatting or font and is unclear what is intended thereby. Appropriate correction is required.
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.
I. Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 9,545,379 (claims 1-20).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a formulation comprising plasma and a stable acidic substance, optionally from among ascorbic, citric, gluconic, lactic, oxalic, molybdic, phosphotungstic, tungstic, chromic, sulfamic, halogenated acetic, and/or arene sulfonic acids, glycine hydrochloride, and/or monosodium citrate (see instant claims 6, 9, 20, 27), and the spray dried (see instant claims 10+, 26+) and reconstituted (claim 30) compositions thereof; however, would have at least been rendered obvious in view of the reference patents which recite the same disclosed invention and as claimed the reference patents are drawn to providing and/or preparing the claimed formulations for spray drying and spray dried compositions. For example ‘;379 recites plasma and stable acidic substances including the acids instantly claimed (‘379 at claims 1, 16), providing a pH of 5.5-7.2 (‘945 at claim 16, see instant claims 1, 10, 17-22, 26, 30). Additionally, the features further instantly claimed depending directly from the independent claims are mutually claimed and/or disclosed as alternative embodiments within the broad generic “comprising” invention as claimed. Thus practicing at least one of the instant or conflicting patent would have at least rendered obvious the other invention as claimed.
II. Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,052,045 (claims 1-39).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a formulation comprising plasma and a stable acidic substance, optionally from among ascorbic, citric, gluconic, lactic, oxalic, molybdic, phosphotungstic, tungstic, chromic, sulfamic, halogenated acetic, and/or arene sulfonic acids, glycine hydrochloride, and/or monosodium citrate (see instant claims 6, 9, 20, 27), and the spray dried (see instant claims 10+, 26+) and reconstituted (claim 30) compositions thereof; however, would have at least been rendered obvious in view of the reference patents which recite the same disclosed invention and as claimed the reference patents are drawn to providing and/or preparing the claimed formulations for spray drying and spray dried compositions. For example ‘;045 recites plasma and stable acidic substances including the acids instantly claimed (‘045 at claims 1, 21), providing a pH of 5.5-7.2 (‘045 at claim 21, see instant claims 1, 10, 17-22, 26, 30). Additionally, the features further instantly including e.g. concentrations and features as claimed depending directly from the independent claims are mutually claimed and/or disclosed as alternative embodiments within the broad generic “comprising” invention as claimed. Thus practicing at least one of the instant or conflicting patent would have at least rendered obvious the other invention as claimed.
III. Claim 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,806,431 (claims 1-30).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a formulation comprising plasma and a stable acidic substance, optionally from among ascorbic, citric, gluconic, lactic, oxalic, molybdic, phosphotungstic, tungstic, chromic, sulfamic, halogenated acetic, and/or arene sulfonic acids, glycine hydrochloride, and/or monosodium citrate (see instant claims 6, 9, 20, 27), and the spray dried (see instant claims 10+, 26+) and reconstituted (claim 30) compositions thereof; however, would have at least been rendered obvious in view of the reference patents which recite the same disclosed invention and as claimed the reference patents are drawn to providing and/or preparing the claimed formulations for spray drying and spray dried compositions. For example ‘;431 recites plasma and stable acidic substances including the acids instantly claimed (‘431 at claims 1, 7, 16, 22), providing a pH of 5.5-7.2 (‘431 at claims 1, 16, see instant claims 1, 10, 17-22, 26, 30). Additionally, the features further instantly claimed depending directly from the independent claims are mutually claimed and/or disclosed as alternative embodiments within the broad generic “comprising” invention as claimed. Thus practicing at least one of the instant or conflicting patent would have at least rendered obvious the other invention as claimed.
IV. Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,064,518 (claims 1-26).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a formulation comprising plasma and a stable acidic substance, optionally from among ascorbic, citric, gluconic, lactic, oxalic, molybdic, phosphotungstic, tungstic, chromic, sulfamic, halogenated acetic, and/or arene sulfonic acids, glycine hydrochloride, and/or monosodium citrate (see instant claims 6, 9, 20, 27), and the spray dried (see instant claims 10+, 26+) and reconstituted (claim 30) compositions thereof; however, would have at least been rendered obvious in view of the reference patents which recite the same disclosed invention and as claimed the reference patents are drawn to providing and/or preparing the claimed formulations for spray drying and spray dried compositions. For example ‘;518 recites plasma and stable acidic substances including the acids instantly claimed (‘518 at claims 1, 16), spray drying/dried compositions (‘518 at claim 2), providing a pH of 5.5-7.2 (‘518 at claims 1, 3, 15-17, 23, 26, 27; see instant claims 1, 10, 17-22, 26, 30). Additionally, the features further instantly claimed depending directly from the independent claims are mutually claimed and/or disclosed as alternative embodiments within the broad generic “comprising” invention as claimed. Thus practicing at least one of the instant or conflicting patent would have at least rendered obvious the other invention as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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, Anand Desai can be reached at (571)272-0947. 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.
/AARON J KOSAR/Primary Examiner, Art Unit 1655
Prosecution Insights