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 .
Claim Rejections 35 USC 103
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.
Claim(s) 17-28 are rejected under 35 U.S.C. 103 as being unpatentable over McCormack, F. (WO2002/006301).
McCormack teaches compositions and methods for treating oxidative lung injury by using lung surfactant proteins, including the hydrophilic surfactant proteins A (SP-A) and D (SP-D), and the hydrophobic surfactant proteins B (SP-B) and C (SP-C) (p. 1, lines 5-25). This reference teaches derivatives of SP-A are used to treat tissue injury, such as oxidative lung injury, macrophage-independent microbial proliferation in mammals with lung infection or injury, and acute lung injury, including adult respiratory distress syndrome and hyperoxic lung injury (p. 3, lines 1-10). McCormack teaches various SP-A, B, C and D sequences that are used to treat lung injuries, including SP-A active portions (SEQ ID NOs: 2, 16) and their derivatives, SEQ ID NOs: 12-15. Each of these comprise sequences identical to those of instant claims 17-19 and 22-24. These therapeutic SP-A peptides comprise the following sequences:
Active head and CRD portions rat SP-A (148 aa), SEQ ID NO 2: AYLDEELQTELYEIKHQILQTMGVLSLQGSMLSVGDKVSTNGQSVNFDTIKE MCTFRAGGNIAVPRTPEENEAIA SIAKKYNNYVYLGMIEDQTPGDFFYLDGA SVNYTNWYPGEPRGQGKEKCVEMYTDGTWNDRGCLQYRLAVCEF, which comprises sequences 100% identical to the claimed SEQ ID NOs: 2, and 5-7.
Theis reference also teaches active human SP-A portion that comprise the following underlined portions:
Active region of human SP-A-Neck and CRD of human SP-A (148 aa), SEQ ID NO 5: AHLDEELQATLHDFRHQILQTRGALSLQGSIMTVGEKVFSSNGQSITFDAIQEA CARAGGRIAVPRNPEENEAIA SFVKKYNTYAYVGLTEGPSPGDFRYSDGTPV NYTNWYRGEPAGRGKEQCVEMYTDGQWNDRNCLYSRLTICEF (SEQ ID NO:5), which comprises a sequence that is 100% identical to the claimed SEQ ID NO: 1.
McCormack further teaches that the SP-A peptides may be encapsulated in liposomes for delivery (p. 22, lines 1-15). This reference further teaches that method of administration include parenteral, transdermal, subcutaneous, intravenous injection, oral and intratracheal (p. 25, lines 15-32). This reference teaches that the preferred method of delivery is intratracheal administration with an inhaler or nebulizer (p. 25, lines 19-22).
McCormack also teaches that the SP-a peptide of the invention can be used to treat systemic infections comprise disease states characterized by the infection in the blood stream or major body cavities or organs, including treatment for systemic infections (sepsis) and prophylaxis in preventing sepsis (p. 22, lines 3-17).
The difference between the prior art and the instant claims is that the prior art does not reduce to practice a method of administering the SP-A peptide to a patient for treatment of lung injury or sepsis.
However, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to have administered the composition of McCormack to a subject for treating or preventing acute lung injury and sepsis because McCormack teaches the exact same proteins in the exact same method of administration, which McCormack teaches aids as an antimicrobial and surfactant in treating these conditions. There is a reasonable expectation of success that the peptides of McCormack will be effective when administered to any subject as a prophylactic measure and also for treating lung injuries and sepsis.
Note that the specification states that “treatment or treating encompasses prophylaxis and/or therapy. Accordingly the compositions and methods of the present invention are not limited to therapeutic applications and can be used in prophylactic ones. Therefore "treating" or "treatment" of a state, disorder or condition includes: (i) preventing or delaying the appearance of clinical symptoms of the state, disorder or condition developing in a subject that may be afflicted with or predisposed to the state, disorder or condition but does not yet experience or display clinical or subclinical symptoms of the state, disorder or condition” (p. 10, lines 13-19).
As such, the subject can be any subject that could experience acute lung injury or sepsis in the future, not those that already have the condition.
These teachings rendering obvious treatment of sepsis and acute lung injury sufficiently cover the prevention of sepsis by teaching the administration of SEQ ID NO: 4 to a subject that may get one of these conditions in the future, as well as to treat those that have either sepsis or acute lung injury. As such, claims 17-19 and 22-24 are met. Claims 20 and 25 are met because McCormack teaches liposome carriers. Claims 21 and 26 are met because McCormack teaches intratracheal and intravenous administration. Claims 27 and 28 are met because McCormack teaches SEQ ID NO: 5 as one of the peptides used in treatment, which comprises a sequence identical to instant SEQ ID NO: 1.
As such, claims 17-28 are rendered obvious over the prior art.
Nonstatutory 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 17-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,070,483. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-6 of ‘483 teach a polypeptide “consisting of” SEQ ID NOs: 1-4, which are more narrow embodiments of the claimed polypeptide sequences, which read “comprising,” and are not limited by length. Claims 7-10 of ‘483 teach the same method of treating acute lung injury with the same polypeptide consisting of SEQ ID NOs: 1-7, which anticipates instant claims 17-19. Instant claims 20 and 21 are met by claims 10 and 11 of ‘483, which teach liposome carriers and a method of intravenous or intratracheal administration.
Claims 12-14 of ‘483 teach the same method of treating sepsis with the same polypeptide consisting of SEQ ID NOs: 1-7, which anticipates instant claims 12-14. Instant claims 25 and 26 are met by claims 15 and 16 of ‘483, which teach liposome carriers and a method of intravenous or intratracheal administration. Instant claims 27 and 28 are met because ‘483 teaches methods of treating cute lung injury and sepsis with SEQ ID NO: 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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