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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, see 10-14, filed 8/14/2, with respect to 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of claims 1-6, 8, 9, 11, and 25-27 has been withdrawn.
Claim Status
Claims 1, 3, 5, 6, 8, 9, 11, 13-18, 20, 23, 25, and 27 are pending. Claims 13-18 and 20 are withdrawn as non-elected inventions. Claims 1, 3, and 27 are currently amended. Claims 6, 8, 9, 11, and 25 were previously presented.
Priority
The Application is the 371 of PCT/US2020/053758, filed 10/1/2020, which claims priority to the provisional application 62/910,998, filed 10/4/2019. The priority date of 10/4/2019 is acknowledged.
Claim Objections
Claim 25 is objected to because of the following informalities: the claim recites that the solid particle displays “at least one transport peptide of claim 1” and currently claim 1 only recites one transport peptide. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 9 is 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 9 recites the solid particle of claim 5 which further comprises a biologically active molecule. The instant specification does not define a “biologically active molecule,” thus rendering the scope of this claim indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 recites the transport peptide of claim 1, which consists essentially of SEQ ID NO: 2. As recited in the previous Office Action, it is noted that for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., Pg 156 F.3d at 1355, 48 USPQ2d at 1355 (MPEP 2111.03). The instant specification provides no such teaching or guidance, thus supporting the interpretation of "consisting essentially of' as equivalent to "comprising." Thus, per this interpretation, claim 3 does not further limit claim 1 from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 3, 5, 6, 8, 9, 11, 25, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10-13, 20, 24, 25, 35, 37, 40, 42, 44, and 46 of copending Application No. 18/004,517 (‘517 reference application; claim set filed 1/6/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of copending Application No. ‘517 recites an immunogenic composition comprising an effective amount of a therapeutic engineered phage and a pharmaceutically acceptable carrier, wherein the therapeutic engineered phage comprises one or more fusion polypeptides comprising an antigenic polypeptide and a phage coat protein.
Dependent claims include the therapeutic engineered phage further comprises a fusion polypeptide comprising a tissue-targeting polypeptide and a phage coat protein (claim 2); the tissue-targeting polypeptide targets lung tissue (claim 10); the lung tissue targeting polypeptide comprises SEQ ID NO: 4 and 28 (wherein SEQ ID NO: 4 and the instant SEQ ID NO: 2 are identical; claim 11); the tissue-targeting polypeptide is an integrin-binding domain (claim 12); the integrin-binding polypeptide comprises SEQ ID NO: 4, 5, and 86 (claim 13); the therapeutic engineered phage is an AAVP and further comprises a viral gene (claim 20); the therapeutic engineered phage further comprises a fusion polypeptide comprising an aerosol delivery polypeptide that targets lung tissue and acts as a transcytosis domain and phage coat protein (claim 24); the aerosol delivery peptide comprises the amino acid sequence of SEQ ID NO: 4 (claim 25); a method of stimulating an immune response in a subject comprising administering to the subject one or more of the immunogenic compositions of claim 1 (claim 35); a method of treating, ameliorating, or preventing a coronavirus infection (claim 37); a method of promoting gene delivery to a virally-infected cell comprising contacting the cell with a therapeutically engineered phage comprising a fusion protein comprising a ligand-binding polypeptide and a phage coat protein (claim 40); the ligand-binding polypeptide is selected from the group comprising SEQ ID NO: 1-5, 28-30, and 86 (claim 42); a method of treating, ameliorating, or preventing a viral infection comprising administering to the subject an effective amount of a therapeutic engineered phage comprising a fusion protein comprising a ligand-binding polypeptide and a phage coat protein, thereby treating, ameliorating, or preventing the viral infection in the subject claim 44); the ligand-binding polypeptide is SEQ ID NO: 1-5, 28-30, and 86 (claim 46).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
SEQ ID NO: 2 is free of the art. The closest prior art is Mazhar et al.(Mazhar S, Altermann E, Hill C, McAuliffe O. Draft Genome Sequences of the Type Strains of Six Macrococcus Species. Microbiol Resour Announc. 2019 May 9;8(19):e00344-19.), as cited in the previous office action, which discloses a peptide comprising or encompassing “CAKSMGDIV” as part of a larger peptide sequence. Mazhar does not provide any teachings, suggestions, or motivations to insert a Cys residue after the “CAKSMGDIV” sequence in the peptide taught, thereby resulting in the claimed SEQ ID NO: 2. Therefore, SEQ ID NO: 2 is novel and non-obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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