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 .
Claim Objections
Claims 5-23 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 5-23 have not been further treated on the merits.
Claims Summary
Claim 1 is directed to a recombinant yeast cell comprising:
A heterologous, regulatable promoter operably linked to a nucleic acid sequence encoding a cell wall permeabilizing agent; and
A heterologous promoter operably linked to a nucleic acid sequence encoding a therapeutic protein.
Claim 2 is directed to a further embodiment, wherein the cell further comprises a heterologous promoter operably linked to a nucleic acid sequence encoding a VLP-forming protein sequence, preferably wherein the VLP-forming sequence comprises a capsid protein, a matrix protein, a GAG protein, a GAG-homology protein, an envelope protein, functional fragments thereof, or combinations thereof. It is understood that a functional fragment of a VLP-forming protein sequence is a fragment that is capable of VLP-formation. The nucleic acid sequence encoding the therapeutic protein further comprises an IRES element inactive in yeast. Optionally, the IRES element is represented by SEQ ID NO: 6. SEQ ID NO: 6 is 587 nucleotides in length.
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.
Claims 2-4 are 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.
Regarding claim 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase is part of the claimed invention. See MPEP § 2173.05(d). Claims 3 and 4 are included in this rejection because they depend from claim 2.
Claim 3 recites, “a GAG-homology protein”. The specification offers some examples of such proteins, but the degree of homology to GAG is not clearly set forth such that the metes and bounds can be determined. The structure of the homologous protein relative to the original GAG protein is not clear.
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.
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Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 and 28 of copending Application No. 17/612,179 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending product claims (claims 1-20) are a species of the instantly claimed genus. The copending method claims (method of making the product, claims 21-26, and method of administering the product, claim 27) render obvious the instantly claimed product. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 4 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 and 28 of copending Application No. 17/612,179 (reference application) as applied to claims 1-3 above, and further in view of Walch al. (Gene Therapy, 2012, 19:237-245, “Walch”). Claim 4 is directed to an embodiment wherein the nucleic acid sequence encoding the therapeutic protein further comprises an IRES element inactive in yeast. The copending claims do not require the presence of an IRES element inactive in yeast. However, it would have been obvious to have claimed this embodiment with a reasonable expectation of success. The copending claims are directed to vaccine compositions for oral administration, thus the vaccines are for subjects that include mammalian subjects. Walch discloses yeast cells as a delivery vehicle for nucleic acids to mammalian APCs, wherein the nucleic acids are expressed in the cytosol of APCs, which is advantageous for an immune response in mammalians, compared to expression in yeast (see page 237, left column, top portion of the paragraph, and right column, last paragraph). Walch designed the vector to have a IRES upstream of the protein of interest that is nonfunctional in yeast but functional in mammalian cells (see page 238, left column, first full paragraph). Therefore, it would have been obvious to have claimed this embodiment, motivated by the advantage of improving the immune response of the vaccine in mammalian subjects. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure:
Wen et al. (US 20180133303A) disclose recombinant yeast cells expressing two or more viral proteins on separate vectors with inducible promoters, the proteins forming a VLP (see paragraph [0009]). Wen et al. teach the use of a cell wall digesting enzyme to produce a spheroplast to allow for budding of the VLPs (see paragraph [0010]). However, there is no teaching or fair suggestion to engineer the yeast cell to express the enzyme.
Smith and Pushko (WO 2008/005777 A2) disclose recombinant yeast cells expressing VLPs (see page 14, lines 9-18). In Example 2, chitinase signal peptides are used to shuttle the VLP proteins out of the yeast cell, but there is no teaching or fair suggestion to use the enzyme in the construct. The signal peptide would not be expected to permeabilize the cell wall. Even if shuttling the protein out of the cell is considered a form of permeabilizing the cell wall, there is no teaching or fair suggestion to have a promoter linked to the signal peptide, and another promoter linked to the therapeutic protein (VLP protein). One would expect that the promoter would be linked to the signal peptide which would be directly linked to the therapeutic protein with no additional promoter being needed for the therapeutic protein.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672