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 .
Applicants’ preliminary amendment filed on March 19, 2025, is acknowledged. Claims 1, 2, 4, 6, 9-11, 13, 16, 17, 19-23, 27, 31, 35, and 39 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 14, 2025 has been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim is directed to A recombinant rabies virus glycoprotein comprising a rabies virus glycoprotein having an amino acid sequence that has at least 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% sequence identity to SEQ ID NO:1 or SEQ ID NO:2.
Tordo et al. (PNAS, p. 3914-3918, 1986) teach a naturally occurring rabies virus glycoprotein having 98.9 identity with present SEQ ID NO: 2 (see sequence alignment below).
Query Match 98.9%; Score 2242; Length 524;
Best Local Similarity 99.0%;
Matches 416; Conservative 0; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KFPIYTIPDKLGPWSPIDIMHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 60
||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
Db 20 KFPIYTIPDKLGPWSPIDIHHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 79
Qy 61 CTGVVTEAETYTNFVGAVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 120
|||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||
Db 80 CTGVVTEAETYTNFVGYVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 139
Qy 121 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 140 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 199
Qy 181 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 200 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 259
Qy 241 VAMQTSNETKWCPPGQLVNLQDFRSDEIEHLVVEELVKKREECLDALELIMTTKSVSFRR 300
|||||||||||||||||||| ||||||||||||||||||||||||||| |||||||||||
Db 260 VAMQTSNETKWCPPGQLVNLHDFRSDEIEHLVVEELVKKREECLDALESIMTTKSVSFRR 319
Qy 301 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 320 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 379
Qy 361 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 380 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 439
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because a rabies glycoprotein having 98.9% identity with present SEQ ID NO: 2 is a naturally occurring viral protein.
Thus, present claim 9 is drawn to a judicial exception.
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 1, 2, 4, 10-11, 13, 16, 17, 19-23, 27, 31, 35, and 39 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 pre-AIA the applicant regards as the invention.
Claim 1 is drawn to A recombinant rabies virus glycoprotein comprising a rabies virus glycoprotein comprising one or more of the following mutations: His20Met, His261 Gln, Tyr77Ala, and Ser289Leu.
Claim 1 lacks reference to a specific SEQ ID NO: in which the mutations are present. Depending on the strain of the rabies virus, amino acid positions 20, 77, 261 and 289 may vary.
Applicant is required to recite specific SEQ ID NOs in which the mutations are present.
Correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 9 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jacob et al. (US Patent 6,673,601).
Jacob et al. disclose a rabies glycoprotein sequence having 99.2% identity with present SEQ ID NO: 1 and 98.9% identity with present SEQ ID NO: 2 (see SEQ ID NO: 24 in Jacob et al.). Thus, by this disclosure Jacob et al. anticipate the present claims.
Present SEQ ID NO: 1 and SEQ ID NO: 24 in Jacob et al.
Query Match 99.2%; Score 2251; Length 524;
Best Local Similarity 99.3%;
Matches 417; Conservative 0; Mismatches 3; Indels 0; Gaps 0;
Qy 1 KFPIYTIPDKLGPWSPIDIMHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 60
||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
Db 20 KFPIYTIPDKLGPWSPIDIHHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 79
Qy 61 CTGVVTEAETYTNFVGYVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 CTGVVTEAETYTNFVGYVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 139
Qy 121 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 140 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 199
Qy 181 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 200 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 259
Qy 241 VAMQTSNETKWCPPGQLVNLQDFRSDEIEHLVVEELVKKREECLDALELIMTTKSVSFRR 300
|||||||||||||||||||| ||||||||||||||||||||||||||| |||||||||||
Db 260 VAMQTSNETKWCPPGQLVNLHDFRSDEIEHLVVEELVKKREECLDALESIMTTKSVSFRR 319
Qy 301 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 320 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 379
Qy 361 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 380 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 439
Present SEQ ID NO: 2 and SEQ ID NO: 24 in Jacob et al.
Query Match 98.9%; Score 2242; Length 524;
Best Local Similarity 99.0%;
Matches 416; Conservative 0; Mismatches 4; Indels 0; Gaps 0;
Qy 1 KFPIYTIPDKLGPWSPIDIMHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 60
||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||
Db 20 KFPIYTIPDKLGPWSPIDIHHLSCPNNLVVEDEGCTNLSGFSYMELKVGYISAIKMNGFT 79
Qy 61 CTGVVTEAETYTNFVGAVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 120
|||||||||||||||| |||||||||||||||||||||||||||||||||||||||||||
Db 80 CTGVVTEAETYTNFVGYVTTTFKRKHFRPTPDACRAAYNWKMAGDPRYEESLHNPYPDYH 139
Qy 121 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 140 WLRTVKTTKESLVIISPSVADLDPYDRSLHSRVFPGGNCSGVAVSSTYCSTNHDYTIWMP 199
Qy 181 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 200 ENPRLGMSCDIFTNSRGKRASKGSETCGFVDERGLYKSLKGACKLKLCGVLGLRLMDGTW 259
Qy 241 VAMQTSNETKWCPPGQLVNLQDFRSDEIEHLVVEELVKKREECLDALELIMTTKSVSFRR 300
|||||||||||||||||||| ||||||||||||||||||||||||||| |||||||||||
Db 260 VAMQTSNETKWCPPGQLVNLHDFRSDEIEHLVVEELVKKREECLDALESIMTTKSVSFRR 319
Qy 301 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 320 LSHLRKLVPGFGKAYTIFNKTLMEADAHYKSVRTWNEIIPSKGCLRVGGRCHPHVNGVFF 379
Qy 361 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 380 NGIILGPDGNVLIPEMQSSLLQQHMELLVSSVIPLMHPLADPSTVFKNGDEAEDFVEVHL 439
Pertinent references
Tuli et al. (US Patent 7,901,691) disclose a chimeric recombinant rabies protein. They do not teach present His20Met, His261 Gln, Tyr77Ala, and Ser289Leu.
Smith et al. (US Patent Application Publication US 20140178419) disclose rabies glycoprotein sequences having 98.8% identity with present SEQ ID NO: 2 and 98.9% identity with present SEQ ID NO: 1.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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