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 .
RCE
The request filed on 11/30/2025 for a request for continued examination (RCE) under 37 CFR 1.114 (d) is acceptable and a RCE has been established. An action on the RCE follows.
Remark
The amendment and response filed on 11/05/2025 have been amended.
Claims 1, 5, 15, 17, 19, 33, 34 have been amended.
New claims 35-36 have been added.
Claims 3-4, 6-13, 22-28, 30 and 32 were canceled.
Claims 1, 2, 5, 14-21, 29, 31 and 33-35 are pending.
Claims 1, 2, 5, 14-21, 29, 31, 33-36 with elected species of BHV-1, SEQ ID NO: 23 and two mutations are pending based on the originally election made on 9/16/2023 on the merit. Please amend the claims to reflect the examination on the merit upon to response to the current office action.
Claim Rejections - 35 USC § 102
The rejection of Claims 1, 2, 5, 9-12, 14-15 are rejected under 35 U.S.C. 102 (a) (1) anticipated as being anticipated by Schwyzer et al. (Veterinary Microbiology, published in 1996, Vol. 53, pp67-77) has been withdrawn necessitated by Applicants’ amendment.
Claim Rejections - 35 USC § 103
The rejection of Claims 1, 2, 5, 9-12, 14-15, 17-21, 24 and 29 under 35 U.S.C. 102((a) (1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fulton et al. (Vaccine, 2013, Vol. 21, pp. 1271-1479) and in view of US Patent No. 10,105, 404B2 to Mohr et al. has been withdrawn necessitated by Applicants’ amendment.
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.
The rejection of claims 2 and 35-36 are moot in view of a new ground of rejection.
Claim 1, 2, 5, 14-21, 29, 31, 33-36 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.
In the instant case, Claims 1, 15, 17, 19, 33, 34 are vague and confusing because it is unclear if the amino acid residue at position 362 is D or Q for the claimed SEQVID NO: 23 prior to the mutation. Moreover, it is unclear how the SEQ ID NO: 22 and SEQ ID NO: 23 are corresponding each from other because there is only one amino acid residue 362 are numerically corresponding each other in SEQ ID NO: 22 and 23, wherein other mutated amino acid residues cited in SEQ ID NO: 23 are not corresponding to the mutated positions of SEQ ID NO: 22.
This rejection affects all depended claims 2, 5, 14,16-21, 29, 31, 35 and 36 are affected.
Claim Rejections - 35 USC § 112
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.
Claim 2 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. In the instant case, as an independent claim 1, which cites that the polypeptide comprising at least 87% identity to the sequence of SEQ ID NO: 23 which further comprises mutations at positions Q324, D363, R365, H421 and H435 in SEQ ID NO: 22, however, late in the claim such as i) that cites the positions become Q362, D405, Q408, Q464 and H468. Apparently, the positions are not the positions corresponding to the SEQ ID NO: 22 required by the claim described . Please explain this discrepancy . 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.
Moreover, claim 2 is an depended claim of claim 1, how the claimed virus particle cited in claim 2 comprising the SEQ ID NO: 22 and SEQ ID NO: 23 if the independent claim comprise the limitation(s) of mutations of SEQ ID NO: 22 and SEQ ID NO: 23. If possibly, please provide the sequence alignment. It would be very clear how the positions Q362, D405 , Q484, Q464 and H468 of SEQ ID NO: 23 are correspond to the Q324, D362. R365, H421 and H425 of SEQ ID NO: 22.
Claim Rejections - 35 USC § 112
The rejection of Claims 19-20, 23-24, 29 and 31 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, has been moot in a new ground of rejection necessitated by Applicants’ amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 14-15,-21, 29, 31, 33-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, Applicants had no possession of innumerable numbers of variant herpesviruses or alphaherpes viruses particles
Claims 1, 5, 14-15,-21, 29, 31, 33-34 are drawn to innumerable numbers of variants of bovine herpesviruses or alphaherpes viruses particles because the variants of bovine herpesviruses or alphaherpes viruses comprise a variants of UL37 proteins comprising of SEQ ID NOs: 22-27, 29-3 3, and 36 that comprise mutations in the R2 region at positions Q324, D362, R365, H421, and H425 in SEQ ID NO: 22, or mutations at the corresponding positions in the R2 region of one of SEQ ID NOs: 23-27, 29-33, and 36:or b) a polypeptide having at least 87% identity to the sequence of one of SEQ ID NOs: 22-27, 29-3 3, and 36, wherein the polypeptide of UL37 further comprises mutations corresponding to i) 0362, D405, 0408, 0464, and H468 in SEQ ID NO: 23:ii) 0370, Y422, 0425, 0481, and R485 in SEQ ID NO: 24, iii) 0366, E419, 0422, 0478, and H482 in SEQ ID NO: 25, iv) 0372, D425, 0428, 0484, and R488 in SEQ ID NO: 26,Application No. 17/93 2,320 v) 0363, D413, 0416, 0472, and R476 in SEQ ID NO: 27:vi) 0376, D424, 0427, 0476, and R480 in SEQ ID NO: 29;vii) 0376, D423, 0426, 0481, and R485 in SEQ ID NO: 30;viii) 0398, D444, 0447, 0503, and H507 in SEQ ID NO: 31:ix) 0469, E518, 0521, 0577, and R581 in SEQ ID NO: 32:x) 0487, E537, 0540, 0596, and R600 in SEQ ID NO: 33: and xi) 0435, E494, 0497, 0553, and R557 in SEQ ID NO: 36, wherein said virus particle exhibits reduced neuro-invasiveness relative to a virus particle lacking said mutation, and wherein the ability of the virus particle to replicate in peripheral tissues is retained. Because there are 23 amino acids different amino acids that can be used for substituted for the originally one at 5 cited mutation positions. Hence there are innumerable combinations of mutations for these 5 locations of the amino acid mutations in different combinations and the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed variants.
However, neither factual evidence of an actual reduction to practice has been disclosed by Applicants in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of enough numbers of the mutations of the sequences of the claimed polypeptide variants when the current Application was originally filed; nor has Applicant described distinguishing characteristics of the claimed vicariants sufficiently showing that Applicant were in possession of the claimed invention at the time the application was filed, such that the specification might reasonably convey to the skilled artisan that Applicant had possession of the claimed invention at the time the application was filed. While it seems as if Applicant has one species of the claimed polypeptide variants can be substituted with alanine (A) in all positions cited supra, molecules that are deemed capable of directing transcription, and no other information provided, one skilled in the art could not immediately recognize or distinguish members of the genus of claimed polypeptide that are deemed capable of exhibiting the same biological herpesvirus particles.
MPEP § 2163.02 states, "[a] n objective standard for determining compliance with the written description requirement is “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’ ". The courts have decided: The purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
The invention is, for purposes of the "written description" inquiry, whatever is now claimed. See Vas-Cathy, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, "'Written Description” Requirement (66 FR 1099-1111, January 5, 2001) states, "possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104).
Because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of the members of the genus of nucleic acid molecules, the skilled artisan could not immediately recognize or distinguish members of the claimed genus of nucleic acid sequences. Moreover, since the specification has not identified which nucleic acid molecules of the genus of sequences, one skilled in the art would not recognize that Applicant had possession of the claimed invention at the time the application was filed. There is insufficient support the generic claims as provided by the Interim Written Description Guidelines published in the June 15, 1998 Federal Register at Volume 63, Number 114, pages 32639-32645.
The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1648