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 11-19 are pending and have been examined on the merits.
Claim Rejections - 35 USC § 102
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) 11-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braithwaite et al (WO 2017/189919 A2; IDS).
The instant claims are drawn to a process of administering a composition, comprising administering a plasma fraction to a subject, for the intended purpose of treating a liver disorder in a subject (claims 11-15) or improving recovery from liver resection or transplant surgery (claims 16-17 and 18-19 respectively).
Braithwaite et al WO ‘919, however, anticipates the claims by teaching administering to a subject an effective amount of a plasma product, specifically reciting a “method comprising administering an effective amount of a blood plasma product to a subject” (e.g. see ‘919 at claims 1-6 and 11; as required of instant claims 11-19). The process is further taught as useful for treating liver in a patient having an organ or tissue disorder, for example liver cancer (e.g. ‘919 at claim 11; broadly, a liver disorder or (acutely/chronic) failing liver), and wherein the method comprises administering the same composition (plasma fraction). Although reference does not expressly recite that the administration provides a benefit to certain liver diseases (e.g. as in instant claims 13-6 and 18), the invention as instantly claimed does not require the diagnosis to be the effect elicited (e.g. versus “treating a liver disorder in a subject diagnosed therewith….administering to said subject in an effective amount therefor..”, or similar phrasing), and thus remains inclusive of the prior art effects and subjects. See also MPEP 2112.02 at Ex parte Novitski (and Dart cited therein) regarding reference-silent bioaffecting features still being anticipating over the claimed process, including where the instant invention may appreciate that such effects are present upon administering the compositions. Additionally, Braithwaite et al teaches that the composition may be administered in an amount sufficient to treat the disease and over a sufficient period of time, such as one week or longer,…1 year or longer, etc, so as to evidence a reduction in the condition” see at §11. Administration; broadly pulse dosing as required of instant claim 12 and of timeframes as in claims 16-19).
Claim Rejections - 35 USC § 102/103
The relevant portions of 35 U.S.C. 102 that form the basis for the rejections under this section as of record above.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Braithwaite et al (WO 2017/189919 A2; IDS).
The claims and teaching of the cited refence of Braithwaite et al WO ‘919 are as of record above.
The cited reference discloses a administering to a subject an amount of a composition comprising a plasma fraction, which appears to be identical to the presently claimed composition and process since it is materially identical as claimed and the same produces biological effect inherent to the compositions. Consequently, the instant claims appears to be anticipated by the reference.
In the alternative, even if the process and composition is not identical to the referenced composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of the claimed composition, particularly in view of the similar characteristics which they have been shown to share (e.g. liver-beneficial effects). Thus, the claimed composition and administration to a subject would have been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a). Furthermore, where the same liver-treating composition is provided by the prior art to a subject having liver disease, selecting for the finite number of alternative liver conditions (liver failure, liver surgery recovery) would have been obvious or in the alternative at least obvious to have tried, particularly where the instant claims merely require administering the same composition.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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 11-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent Nos. 11660316 (claims 1-8), 11484551 (claims 1-15), and 12053489 (claims 1-12).
The instant claims are drawn to a process of administering a plasma fraction to a subject, optionally for the intended use to one suffering from liver disorder, failure, or surgical recovery (from resection or transplant). Although not identical the claims are not patentably distinguished because the reference patents are each drawn to the same plasma fraction administered to a subject and are inclusive of the inherent and liver-treating effects, including based upon the shared disclosures among the instant and ‘316, ‘551, and ‘489 reference patents. Further each reference patent (each at claim 2) recites providing a Pulse Dose regimen, the same diseases (‘316 at claims 1,3-5; ‘551 at claims 1,3-8 10,11,13,14; ‘489 at claims 1,3-5,7,8,10,11) - such that practicing at least one of the instant (or conflicting patents’) invention as claimed would at least have 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.
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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.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
