DETAILED ACTION
Claims 17-30 are pending in the present reissue application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
The present application is a reissue application of 14/373,877, issued as USPN 9,757,460. The present application is also a CON of 17/155,058, issued as USPN RE 49,758, which is a reissue application of 14/373,877, issued as USPN 9,757,460.
The specification of the present reissue application has been amended so as to recite a cross reference to the prior reissue applications for the ‘460 patent, i.e., Serial No. 17/155,058. However, the 17/155,058 specification has not been amended so as to recite a cross reference to the present application. 37 CFR 1.177(a) requires that all multiple reissue applications resulting from a single patent must include as the first sentence of their respective specifications a cross reference to the other reissue application(s). The present specification is objected to due to the lack of cross references in the two other applications. See MPEP 1451(I). Since the 17/155,058 application has issued as a reissue patent, the amendments to the specification should be taken care of by Applicant by certificate of correction.
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 17-22, 24-26, and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,273,298. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claim 1 of the ‘298 patent claims a composition comprising an antigen binding protein or polypeptide and a semi-fluorinated alkane that forms a suspension. Dependent claim 11 of the ‘298 patent specifies that the semi-fluorinated alkane is F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, and F6H10. Dependent claim 5 of the ‘298 patent claims that the antigen-binding polypeptide or protein has a molecular mass of at least 90 kDa. Therefore, claim 17 is anticipated.
With respect to claim 18, the ‘298 patent defines the mass of antigen binding protein or polypeptide to be at least 10 kDa. See column 7, lines 56-66. Therefore, claim 18 is rendered obvious as the ranges overlap.
With respect to claims 19-21, claim 12 of the ‘298 patent specifies that the composition consists essentially of antigen-binding polypeptide or protein and semi-fluorinated alkane. Therefore, the resultant product would be free of preservatives and necessarily be microbiologically stable due to the ingredients present. Also, the product is a suspension, which requires that solid particles be suspended in the semi-fluorinated alkane. Therefore, claims 19-21 are anticipated.
With respect to claims 22 and 24, the claim is rendered obvious for the same reasons as claim 18.
With respect to claim 25, the ‘298 patent defines the compositions can comprise further pharmaceutical excipients to include acids, bases, antioxidants, stabilisers, synergists, coloring agents, and thickening agents. See column 13, lines 1-13. Therefore, claim 25 is rendered obvious.
With respect to claim 26, the claim is anticipated for the same reasons as claim 17.
With respect to claim 28, the claim is rendered obvious for the same reasons as claim 25.
With respect to claims 29 and 30, the formation of the suspension composition of the ‘298 patent would necessarily involve suspending solid particles of a bioactive protein or polypeptide of a preferred size in the liquid vehicle. Therefore, claims 29 and 30 are rendered obvious.
Claims 17-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. RE49,758. Although the claims at issue are not identical, they are not patentably distinct from each other because the following reasons.
Claim 31 of the ‘758 patent claims a liquid suspension composition comprising a bioactive polypeptide or protein having a molecular mass of at least 1,500 Da and a liquid semifluorinated alkane vehicle selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, and F6H10. Therefore, claim 17 is anticipated.
With respect to claim 18, claim 32 of the ‘758 patent is dependent on claim 31 and further specifies that the molecular mass of the protein is between 2,000 to 60,000 Da. Therefore, claim 18 is anticipated.
With respect to claim 19, claim 33 of the ‘758 patent specifies that the composition is preservative-free and microbiologically stable. Therefore, claim 19 is anticipated.
With respect to claims 20 and 21, claim 34 of the ‘758 patent specifies that the composition consists of the bioactive polypeptide or protein and one or more semi-fluorinated alkanes including F6H8. As the composition is a suspension, the bioactive polypeptide or protein is necessarily in the form of solid particles. Therefore, claims 20 and 21 are anticipated.
With respect to claims 22 and 24, the claim is anticipated for the same reasons as claim 17.
With respect to claim 23, claim 26 of the ‘758 patent claims a liquid suspension composition comprising a recombinant human insulin and a liquid semifluorinated alkane vehicle selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, and F6H10. Therefore, claim 23 is anticipated.
With respect to claim 25, the ‘758 patent defines the compositions to comprise further pharmaceutical excipients including acids, bases, antioxidants, stabilisers, synergists, coloring agents, and thickening agents. See column 11, lines 33-45. Therefore, claim 25 is rendered obvious.
With respect to claim 26, the claim is anticipated for the same reasons as claim 17.
With respect to claim 27, the claim is anticipated for the same reasons as claim 23.
With respect to claim 28, the claim is rendered obvious for the same reasons as claim 25.
With respect to claim 29, claim 7 of the ‘758 patent claims a method of preparing a liquid suspension composition by suspending a bioactive polypeptide or protein having a molecular mass of at least 1,500 Da in a liquid semifluorinated alkane vehicle selected from F4H5, F4H6, F4H8, F6H4, F6H6, F6H8, and F6H10. Therefore, claim 29 is anticipated.
With respect to claim 30, the solid particles are of a preferred size, and it would be obvious to one of ordinary skill in the art to grind or mill the particles to the preferred size before incorporating into the suspension. Therefore, claim 30 is rendered obvious.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 9,757,460 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
Claims 17-30 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/Alan Diamond/ /Patricia L Engle/
Patent Reexamination Specialist SPRS, Art Unit 3991
Central Reexamination Unit 3991