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 .
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Status of Application and Claims
US Patent 11,642,408 issued from underlying application 17/057,378 on 5/9/23 with claims 1-12. This reissue application was filed 5/1/25; it amends claims 1-3 and adds new claims 13-25. Claims 1-25 are pending and under examination.
Specification
The 5/1/25 amendment to the specification fails to comply fully with 37 CFR 1.173(d) because it does not underline the new paragraph that discusses the sequence listing.
Claim Objections
Claims 15 and 23 are objected to for misspelling the word “cells” at line 2 of each claim (see “W138 cekks”).
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 15-17, 21, and 23 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.
Claim 15 recites “monkey kidney cells (COS-7 cells)” at lines 1-2. This is confusing because numerous types of monkey kidney cells were known in the art as of the claims’ effective filing date, e.g. Vero cells and MA-104 cells. (See US 20030165814, reference A, at paragraph 50.) It is unclear whether claim 15 intends to limit the monkey kidney cells to COS-7 cells or whether the material in parentheses is merely a preference or an example. See MPEP 2173.05(d) (examples and preferences in claims can be indefinite). Clarification is required. Claim 23 suffers a similar deficiency and is rejected for the same reason.
Claim 16 refers to “[t]he vaccine composition of claim 14.” Claim 14 recites a method, not a vaccine composition. Claim 13, the independent claim, does not recite a vaccine composition either. The antecedent basis for claim 16 is unclear. See MPEP 2173.05(e).
Claim 17 depends from claim 13 and refers to “the gene” as comprising a particular nucleotide sequence. Claim 13 does not recite a gene; nor does claim 3. There is insufficient antecedent basis for “the gene” in claim 17. See MPEP 2173.05(e).
Claim 21 depends from claim 20, which indicates that if amino acid 536 is present, it is leucine. Claim 21 requires that amino acid 536 is leucine. It is unclear whether claim 21 intends to require that amino acid 536 is present.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 3, 5, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales et al. (US 20060121052; reference B) taken in view of Li et al. (2007, Journal of Virology 81: 8525-8532; reference U). This rejection addresses the embodiment of claims 15 and 23 in which the monkey kidney cells are CV1/EBNA cells.
Sotelo-Morales teaches Varicella zoster virus (VZV) glycoprotein E (gE) having SEQ ID NO: 3. (Figure 3; paragraph 23.) Within Sotelo-Morales’s SEQ ID NO: 3, the amino acid residue at position 40 is threonine and the amino acid residue at position 536 is leucine:
MGTVNKPVVGVLMGFGIITGTLRITNPVRASVLRYDDFHTDEDKLDTNSVYEPYYHSDHA
ESSWVNRGESSRKAYDHNSPYIWPRNDYDGFLENAHEHHGVYNQGRGIDSGERLMQPTQM
SAQEDLGDDTGIHVIPTLNGDDRHKIVNVDQRQYGDVFKGDLNPKPQGQRLIEVSVEENH
PFTLRAPIQRIYGVRYTETWSFLPSLTCTGDAAPAIQHICLKHTTCFQDVVVDVDCAENT
KEDQLAEISYRFQGKKEADQPWIVVNTSTLFDELELDPPEIEPGVLKVLRTEKQYLGVYI
WNMRGSDGTSTYATFLVTWKGDEKTRNPTPAVTPQPRGAEFHMWNYHSHVFSVGDTFSLA
MHLQYKIHEAPFDLLLEWLYVPIDPTCQPMRLYSTCLYHPNAPQCLSHMNSGCTFTSPHL
AQRVASTVYQNCEHADNYTAYCLGISHMEPSFGLILHDGGTTLKFVDTPESLSGLYVFVV
YFNGHVEAVAYTVVSTVDHFVNAIEERGFPPTAGQPPATTKPKEITPVNPGTSPLLRYAA
WTGGLAAVVLLCLVIFLICTAKRMRVKAYRVDKSPYNQSMYYAGLPVDDFEDSESTDTEE
EFGNAIGGSHGGSSYTVYIDKTR
(Relevant residues bolded and underlined.)
Sotelo-Morales does not teach a variant of VZV gE comprising a carboxy-terminal (C-terminal) truncation starting at any one of the amino acid residues of positions 534, 535, 536, 537, 538, or 540. Regarding claim 2, Sotelo-Morales does not teach the amino acid sequence of SEQ ID NO: 5.
Li teaches that amino acids 1-537 of VZV gE constitute the protein’s extracellular domain. (Page 8526, column 1.) Li teaches that VZV gE interacts with its receptor, insulin-degrading enzyme. (Abstract.) Li teaches that antibodies to VZV gE can neutralize virus infectivity. (Page 8525, column 2.) Li teaches purifying the extracellular domain from the supernatant of CV1/EBNA (African green monkey kidney) cells containing a plasmid expressing amino acids 1-537 of VZV gE. (Page 8527, column 1 (construct gEt).)
It would have been obvious to produce the extracellular domain of Sotelo-Morales’s VZV gE protein (e.g., truncated at residue 537) because Li teaches that this portion of the protein retains its receptor-binding activity. The person of ordinary skill in the art would have been motivated to make the truncated extracellular domain of Sotelo-Morales’s VZV gE protein in order to study interactions of that domain with the VZV receptor.
Claims 1, 2, 8, 10, 18, 19, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales in view of Li as applied to claims 3, 5, and 13-15, above, and further in view of Didierlaurent et al. (2017, Expert Review of Vaccines 16: 55-63; reference V).
The teachings of Sotelo-Morales and Li are relied upon as above.
Sotelo-Morales and Li do not teach a composition comprising a VZV gE protein and an adjuvant.
Didierlaurent teaches that adjuvants were well-known in the art for improving the presentation of protein antigens to the immune system for the production of antibodies. (Page 55, column 2.) Didierlaurent teaches a vaccine composition comprising VZV gE protein and adjuvant AS01 for preventing herpes zoster by inducing an immune response to the virus. (Page 56, column 2, through page 57, column 1.)
It would have been obvious to combine the VZV gE ectodomain of Sotelo-Morales in view of Li with Didierlaurent’s AS01 adjuvant because Li teaches that antibodies to VZV gE can neutralize virus infectivity and Didierlaurent teaches that adjuvants improve the immune system’s response to antigens by increasing antibody production. The skilled artisan would have been motivated to make the combination in order to generate a vaccine for herpes zoster, as suggested by Didierlaurent.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales in view of Li as applied to claims 3, 5, and 13-15, above, and further in view of Baum (US 20080182793, reference C).
The teachings of Sotelo-Morales and Li are relied upon as above.
Sotelo-Morales and Li do not teach producing the VZV gE ectodomain in CHO cells.
Baum teaches that CV1/EBNA and CHO cells are both suitable for expressing recombinant polypeptides. (Paragraph 93.)
It would have been obvious to substitute Baum’s CHO cells for Li’s CV1/EBNA cells to produce the VZV gE ectodomain because Baum teaches that both of these cell types are useful for expressing recombinant polypeptides. Substituting art-recognized equivalents for the same purpose is prima facie obvious; see MPEP 2144.06(II).
Claims 20, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales in view of Li and Didierlaurent as applied to claims 1-3, 5, 13-15, 22, and 23, above, as evidenced by UniProt entry P09259 (available online at rest.uniprot.org/uniprotkb/P09259.txt; reference W) and Peters et al. (2012, Journal of Virology 86: 10695-10703; reference X).
The teachings of Sotelo-Morales, Li, and Didierlaurent are relied upon as above.
Sotelo-Morales, Li, and Didierlaurent do not specify that the VZV glycoprotein E is derived from a Clade 1 VZV glycoprotein.
Sotelo-Morales’s VZV gE protein is “derived from” a Clade 1 VZV glycoprotein because it is 100% identical to the Dumas strain of VZV glycoprotein E. UniProt P09259 is cited solely as evidence of the sequence of VZV glycoprotein E (Dumas strain). Peters is cited solely as evidence that the Dumas strain is within Clade 1. (Page 10696, column 2.) The amino acid at position 536 of UniProt P09259 is leucine.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sotelo-Morales in view of Li and Didierlaurent as applied to claims 1-3, 5, 13-15, 22, and 23, above, and further in view of Baum.
The teachings of Sotelo-Morales, Li, and Didierlaurent are relied upon as above.
Sotelo-Morales, Li, and Didierlaurent do not teach producing the VZV gE ectodomain in CHO cells.
Baum teaches that CV1/EBNA and CHO cells are both suitable for expressing recombinant polypeptides. (Paragraph 93.)
It would have been obvious to substitute Baum’s CHO cells for Li’s CV1/EBNA cells to produce the VZV gE ectodomain because Baum teaches that both of these cell types are useful for expressing recombinant polypeptides. Substituting art-recognized equivalents for the same purpose is prima facie obvious; see MPEP 2144.06(II).
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, 2, 8, 10, and 18-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 10,874,734. Although the claims at issue are not identical, they are not patentably distinct from each other.
The ’734 patent claims a vaccine for preventing or treating varicella or herpes zoster; the vaccine comprises an aluminum salt and a Varicella zoster virus surface protein gE (glycoprotein E) having the amino-acid sequence of SEQ ID NO: 1. (Claim 1.) SEQ ID NO: 1 of the ’734 patent is 100% identical to the first 537 amino acids of examined SEQ ID NO: 1 and contains a threonine at position 40 and a leucine at position 536. The ’734 patent discloses that the aluminum salt is inherently an adjuvant. (Abstract, e.g.) The ’734 patent further claims a method for preventing or treating Varicella or herpes zoster by administering the vaccine composition to a subject. (Claim 6.)
Examined independent claims 1 and 18 are product-by-process claims. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP 2113. The ’734 patent does not specify the source or manner of making its VZV gE protein. A protein, however, is defined by its amino-acid sequence, so the person of ordinary skill in the art would have understood that the structure implied by the process steps recited in examined claims 1 and 18 is the protein identified by the sequence features in those claims.
Allowable Subject Matter
Claims 4, 6, 7, 9, 11, 12, and 17 are objected to as being dependent upon a rejected base claim, but they would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-3, 5, 8, 10, 13-16, and 18-25 are rejected. Claims 4, 6, 7, 9, 11, 12, and 17 are objected to but are not rejected.
Maintenance Fees
Applicant is reminded of the requirement to pay all applicable maintenance fees on the original patent. See MPEP 1415.01.
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. 11,642,408 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lora E Barnhart Driscoll, whose telephone number is (571)272-1928. The examiner can normally be reached M-F 7:00-4:00 p.m. ET.
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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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/Lora E Barnhart Driscoll/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/KSO/
Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/
SPRS, Art Unit 3991
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