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 Status
1. Applicant’s response filed July 27, 2026 to the Office Action of January 28, 2026 is acknowledged and has been entered. Claims 1-2, 4, 6, and 8 have been amended. Claims 18 and 20 have been cancelled. Claims 21 and 22 are new. Claims 1-17 and 21-22 are currently pending and under examination.
Withdrawn Rejections
2. The Office Action of January 28, 2026 rejected claims 18 and 20 under 35 U.S.C. 112(b) as being directed to intended use claims. In response, Applicant cancelled these claims making the rejection moot. Thus, the rejection is withdrawn.
3. The Office Action of January 28, 2026 rejected claims 4, 6, and 8 under 35 U.S.C. 112(d) for improper dependent form. In response, Applicant has amended claims 4, 6, and 8 to remove the “or” and place the claims in proper dependent form. Thus, the rejection is withdrawn.
4. The Office Action of January 28, 2026 rejected claims 1, 3-10, 12-15, 17-18, and 20 under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Lai et al. (US2010/0172906 as cited in IDS filed on 4/1/2024). In response, Applicant has amended claim 1 to incorporate a limitation from claim 2. Thus, the rejection is withdrawn.
5. The Office Action of January 28, 2026 rejected claims 2, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lai in further view of Bauer et al. (Virology, 2017, 512:194-200). As discussed above, Applicant amended claim 1 to make the 102 rejections over Lai moot. Thus, the rejection is withdrawn.
New Rejection
(based on new considerations)
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.
6. Claims 1-2, 9-17, and 21-22 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 claims 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. This is a written description rejection.
The claims are drawn to a method of treating recurrent HSV infection by administering an anti-HSV antibody that specifically binds the glycoprotein D (gD) of HSV-1 and HSV-2.
Thus, the claims identify the antibody by the function of binding the gD of HSV-1 and HSV-2. Thus, the claims encompass a vast genus of antibody variants comprising variable amino acid sequences that function to bind the gD of HSV-1 and HSV-2
The instant specification discloses three distinct antibodies, E317, E245, and Y571 on pages 13-15 in Table 1 that include the complete amino acid sequences for the heavy and light chains including the heavy and light variable regions and the HC CDR1, HC CDR2, HC CDR3, LC CDR1, LC CDR2, and LC CDR3 sequences.
Thus, the instant specification discloses making three structurally distinct antibodies with the complete heavy chain including the HC CDR1, HC CDR2, and HC CDR3 and complete light chain including the LC CDR1, LC CDR2, and LC CDR3 sequences. The specification fails to disclose any other sequence variants that possess the function of binding the gD of HSV-1 and HSV-2.
To provide adequate written description and evidence of possession of the claimed antibody genus, the instant specification can structurally describe representative antibody variants that function to bind the gD of HSV-1 and HSV-2 and inhibit viral transmission, or describe structural features common to the members of the genus, which features constitute a substantial portion of the genus. Alternatively, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.). A disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product.
In this case, the only factor present in the claims is a recitation of the antibody function “binds to the gD of HSV-a and HSV-2”. The instant specification fails to describe structural features common to the members of the antibody genus, which features constitute a substantial portion of the genus because the instant specification fails to disclose representative antibody variant sequences that function as claimed. A definition by function does not suffice to define the genus because it is only an indication of what the antibody does, rather than what it is. Other than the antibodies disclosed in Table 1, the specification fails to provide the HC CDR1, HC CDR2, HC CDR3, LC CDR1, LC CDR2, and LC CDR3 structural features coupled to the claimed functional characteristics. The instant specification fails to describe a representative number of antibody variants for the genus of antibodies that function as claimed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus required to make the claimed antibodies.
The claims broadly encompass any antibody comprising any sequence variant that functions to bind the gD of HSV-1 and HSV2 and inhibit viral transmission. Applicants have not established any reasonable structure function correlation with regards to the sequences in the CDRs that can be altered and still maintain binding to the gD of HSV-1 and HSV-2. Sela-Culang (Frontiers in Immunol., 2013, 4:302) teaches that antibody CDRs have a unique set of contact preferences, favoring certain amino acids over others. (See Sela-Culang, pgs. 5-6). Given the well-known high level of polymorphism of antibody CDR sequences and structure, the skilled artisan would not have been in possession of the vast repertoire of antibodies encompassed by the claimed invention. One could not reasonably or predictably extrapolate the structure of a single anti-HSV antibody to the structure of any variants required to bind gD of HSV-1 and HSV-2 as broadly claimed. Therefore, one could not readily envision members of the broadly claimed genus.
Although Applicants may argue that it is possible to screen for antibodies that bind the gD of HSV-1 and HSV-2 and function as claimed, the court found in (Rochester v. Searle, 358 F.3d 916, Fed Cir., 2004) that screening assays are not sufficient to provide adequate written description for an invention because they are merely a wish or plan for obtaining the claimed chemical invention. “As we held in Lilly, “[a]n adequate written description of a DNA … ‘requires a precise definition, such as by structure, formula, chemical name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.” 119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies just as well to non-DNA (or RNA) chemical inventions.” Knowledge of screening methods provides no information about the structure of any future antibodies yet to be discovered that may function as claimed. The gD antigen provides no information about the structure of an antibody that binds to it.
Given the lack of representative examples to support the full scope of the claimed variant antibodies, and lack of reasonable structure-function correlation with regards to the unknown variable sequences in the CDRs that provide gD-binding function, the present claims lack adequate written description. Thus, the specification does not provide an adequate written description of antibody variants that bind gD of HSV-1 and HSV-2 that is required to practice the claimed invention.
Examiner Suggestion: Examiner suggests amending claim 1 to recite the CDR sequences listed in claims 3, 5, and 7.
New Rejection
(necessitated by 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.
7. Claim 21 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 21 recites the limitation "the recurrent period" in line 1. There is insufficient antecedent basis for this limitation in the claim.
New Rejections
(Necessitated by Amendments)
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8. Claims 1-10, 12-17, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (US 2010/0172906 as cited in IDS filed on 04/01/2024) in view of Whitley et al. (Lancet, 2001, 357:1513-1518).
Regarding claim 1, Lai discloses a method for treating herpes simplex virus (HSV)- including HSV-1 and HSV-2, infection comprising administering to a subject in need thereof an anti-HSV antibody, wherein the anti-HSV antibody specifically binds to the glycoprotein D (gD) of herpes simplex virus-1 (HSV-1) and herpes simplex virus-2 (HSV-2). (See pg. 1 [0004] and [0007]).
Regarding claims 3 and 4, Lai discloses an anti-HSV antibody comprising a VH region comprising SEQ ID NO: 15 which comprises a CDR1 of SEQ ID NO: 2, a CDR2 of SEQ ID NO:4, and a CDR3 of SEQ ID NO:6; and a VL region comprising SEQ ID NO: 16 which comprises a CDR1 of SEQ ID NO:9, a CDR2 of SEQ ID NO:11, and a CDR3 of SEQ ID NO:13. (See pg. 3, SEQ ID NOs: 1 and 2 underlined portions, also see alignments below).
Regarding claims 5 and 6, Lai discloses an anti-HSV antibody comprising a VH region comprising SEQ ID NO: 30 which comprises a CDR1 of SEQ ID NO: 18, a CDR2 of SEQ ID NO:20, and a CDR3 of SEQ ID NO:22; and a VL region comprising SEQ ID NO:31 which comprises a CDR1 of SEQ ID NO:24, a CDR2 of SEQ ID NO:26, and a CDR3 of SEQ ID NO:28. (See pg. 3, SEQ ID NOs: 3 and 4 underlined portions, also see alignments below).
Regarding claims 7 and 8, Lai discloses an anti-HSV antibody comprising a VH region comprising SEQ ID NO: 40 which comprises a CDR1 of SEQ ID NO:2, a CDR2 of SEQ ID NO:33, and a CDR3 of SEQ ID NO:6; and a VL region comprising SEQ ID NO: 41 which comprises a CDR1 of SEQ ID NO:35, a CDR2 of SEQ ID NO:11, and a CDR3 of SEQ ID NO:38. (See pg. 4, SEQ ID NOs: 41 and 42 underlined portions also see alignments below).
Regarding claim 9, Lai discloses the antibody is an antigen-binding fragment thereof. (See pg. 1 [0008] lines 3-4).
Regarding claim 10, Lai discloses the antibody is humanized. (See pg. 3 [0022] lines 6-7).
Regarding claim 12, Lai discloses the subject is a patient having a weakened immune system. (See pg. 1 [0002] lines 7-10).
Regarding claim 13, Lai discloses the anti-HSV antibody is administered to the subject in a single dose. (See pg. 9 [0075]).
Regarding claim 14, Lai discloses the anti-HSV antibody is administered to the subject at an early stage of the infection. (See pg. 10 [0077] lines 5-9).
Regarding claim 15, Lai discloses administering the antibody in an effective amount to reduce symptoms caused by HSV infection. (See pg. 10 [0077] lines 5-9).
Regarding claim 17, Lai discloses the anti-HSV antibody is administered to the subject after symptoms occur. (See pgs. 9-10 [0076]-[0077]).
Regarding claim 22, Lai discloses that a single dose in vivo to mice infected with HSV was enough to achieve 100% survival rate. (See Lai, Example 4 [0074]).
Lai does not disclose a method of specifically treating recurrent HSV infection or that the anti-HSV antibody is effective at neutralizing drug-resistant HSV, inhibiting viral transmission, or delaying recurrent incidences. Lai does not disclose administration of the antibody during the recurrent period.
Lai does teach that the antibody binds to the gD portion of the cell membrane, which is required for viral entry of HSV into the cells. (See Lai, pg. 2 [0019]). Lai also teaches that the antibody can be used for treating or preventing an infection of HSV without making a distinction between primary or latent infection. (See Lai pg. 1 [0010]).
Whitley teaches that both HSV-1 and HSV-2 are known to establish latent infections and cause recurrent infections. (See Whitley, pg. 1 column 1, paragraph 1).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to use the antibodies disclosed in Lai for treating recurrent HSV infections as claimed in the present invention. It would have been obvious because Lai discloses the same functional structural sequences of the present claimed antibody for treating HSV infections and a person of ordinary skill in the art would understand treating HSV infections to include recurrent infections. It would have a reasonable expectation of success because the mechanism of action is taught by Lai to inhibit viral entry into cells which would affect transmission of the virus at any phase of infection- primary or recurrent. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to use the antibodies disclosed in Lai with a reasonable expectation of success at treating recurrent HSV infection as claimed in the present invention.
SEQ ID NOs: 2, 4, and 6 100% match SEQ ID NO: 1 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 1; 31pp; English.
Query Match 88.9%; Score 196.4; Length 124;
Best Local Similarity 46.5%;
Matches 40; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 GGTLRTYGVS--------------RTIPLFGKTDYAQKFQG------------------- 27
|||||||||| |||||||||||||||||
Db 28 GGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKTDYAQKFQGRVTITADKSMDTSFMELTS 87
Qy 28 -------------DLTTLTSYNWWDL 40
|||||||||||||
Db 88 LTSEDTAVYYCARDLTTLTSYNWWDL 113
SEQ ID NOs: 9, 11, and 13 100% match SEQ ID NO: 2 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 2; 31pp; English.
Query Match 80.9%; Score 104.3; Length 110;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQSVTSSQLA---------------GASNRAT-------------------------- 19
|||||||||||| |||||||
Db 24 RASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIPDRFSGSGSGTDFTLTISRLEPED 83
Qy 20 ------QQYGSSPT 27
||||||||
Db 84 FAVYYCQQYGSSPT 97
SEQ ID NO: 15 is 100% identical to SEQ ID NO: 1 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 1; 31pp; English.
Query Match 100.0%; Score 652; Length 124;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAQVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAQVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKT 60
Qy 61 DYAQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DYAQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLV 120
Qy 121 TVSS 124
||||
Db 121 TVSS 124
SEQ ID NO: 16 is 100% identical to SEQ ID NO: 1 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 2; 31pp; English.
Query Match 100.0%; Score 563; Length 110;
Best Local Similarity 100.0%;
Matches 110; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
Qy 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKRAA 110
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKRAA 110
SEQ ID NOs: 18, 20, and 22 100% match SEQ ID NO: 3 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 3; 31pp; English.
Query Match 88.4%; Score 187.4; Length 124;
Best Local Similarity 46.5%;
Matches 40; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 GGTLRTYALS--------------RIIPMFGKTDYAQKFQG------------------- 27
|||||||||| |||||||||||||||||
Db 28 GGTLRTYALSWVRQVPGQGFEWMGRIIPMFGKTDYAQKFQGRLSITADKSMDTGFMELTS 87
Qy 28 -------------DLTTLTSYNWLDI 40
|||||||||||||
Db 88 LTSEDTAVYYCARDLTTLTSYNWLDI 113
SEQ ID NOs: 24, 26, and 28 100% match SEQ ID NO: 4 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 4; 31pp; English.
Query Match 81.1%; Score 106.3; Length 110;
Best Local Similarity 36.5%;
Matches 27; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQSVSSNYLA---------------GASSRAT-------------------------- 19
|||||||||||| |||||||
Db 24 RASQSVSSNYLAWYQKKPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTINRLEPED 83
Qy 20 ------QQYGRSPT 27
||||||||
Db 84 FAVYYCQQYGRSPT 97
SEQ ID NO: 30 is 100% identical to SEQ ID NO: 3 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 3; 31pp; English.
Query Match 100.0%; Score 647; Length 124;
Best Local Similarity 100.0%;
Matches 124; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MAQVQLQQSGAGVKKPGSSVRVSCSASGGTLRTYALSWVRQVPGQGFEWMGRIIPMFGKT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MAQVQLQQSGAGVKKPGSSVRVSCSASGGTLRTYALSWVRQVPGQGFEWMGRIIPMFGKT 60
Qy 61 DYAQKFQGRLSITADKSMDTGFMELTSLTSEDTAVYYCARDLTTLTSYNWLDIWGQGTLV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DYAQKFQGRLSITADKSMDTGFMELTSLTSEDTAVYYCARDLTTLTSYNWLDIWGQGTLV 120
Qy 121 TVSS 124
||||
Db 121 TVSS 124
SEQ ID NO: 31 is 100% identical to SEQ ID NO: 4 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 5; SEQ ID NO 4; 31pp; English.
Query Match 100.0%; Score 571; Length 110;
Best Local Similarity 100.0%;
Matches 110; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ETTLTQSPGTLSLSPGERATLSCRASQSVSSNYLAWYQKKPGQAPRLLIYGASSRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ETTLTQSPGTLSLSPGERATLSCRASQSVSSNYLAWYQKKPGQAPRLLIYGASSRATGIP 60
Qy 61 DRFSGSGSGTDFTLTINRLEPEDFAVYYCQQYGRSPTFGQGTKVEIKRAA 110
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DRFSGSGSGTDFTLTINRLEPEDFAVYYCQQYGRSPTFGQGTKVEIKRAA 110
SEQ ID NOs: 2, 33, and 6 100% match SEQ ID NO: 41 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 14; SEQ ID NO 41; 31pp; English.
Query Match 88.9%; Score 197.4; Length 122;
Best Local Similarity 46.5%;
Matches 40; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 GGTLRTYGVS--------------GTIPLFGKTDYAQKFQG------------------- 27
|||||||||| |||||||||||||||||
Db 26 GGTLRTYGVSWVRQAPGQGLEWLGGTIPLFGKTDYAQKFQGRVTITADKSMDTSFMELTS 85
Qy 28 -------------DLTTLTSYNWWDL 40
|||||||||||||
Db 86 LTSEDTAVYYCARDLTTLTSYNWWDL 111
SEQ ID NOs: 35, 11, and 38 100% match SEQ ID NO: 42 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 14; SEQ ID NO 42; 31pp; English.
Query Match 81.8%; Score 111.3; Length 109;
Best Local Similarity 37.3%;
Matches 28; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 RASQSVGSVNLA---------------GASNRAT-------------------------- 19
|||||||||||| |||||||
Db 24 RASQSVGSVNLAWYQQRPGQAPRLLIHGASNRATGIPDRFSGVGSGTDFTLTINRLEPDD 83
Qy 20 ------QQYGTSPIT 28
|||||||||
Db 84 FAVYYCQQYGTSPIT 98
SEQ ID NO: 40 is 100% identical to SEQ ID NO: 41 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 14; SEQ ID NO 41; 31pp; English.
Query Match 100.0%; Score 644; Length 122;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQSGAEVKKPGSSVKVSCKASGGTLRTYGVSWVRQAPGQGLEWLGGTIPLFGKTDY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQSGAEVKKPGSSVKVSCKASGGTLRTYGVSWVRQAPGQGLEWLGGTIPLFGKTDY 60
Qy 61 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 120
Qy 121 SS 122
||
Db 121 SS 122
SEQ ID NO: 41 is 100% identical to SEQ ID NO: 42 (Lai):
US2010172906-A1.
XX
CC PD 08-JUL-2010.
XX
CC PF 31-DEC-2009; 2009US-00651325.
XX
PR 05-JAN-2009; 2009US-00348550.
XX
CC PA (LAIJ/) LAI J.
CC PA (CHAN/) CHAN W.
XX
CC PI Chan W, Lai J;
XX
DR WPI; 2010-H99176/46.
XX
CC PT New isolated human antibody binding to glycoprotein-D of herpes simplex
CC PT virus-1 and -2, useful for treating, preventing or diagnosis of herpes
CC PT simplex virus-1 infection and herpes simplex virus-2 infection.
XX
CC PS Claim 14; SEQ ID NO 42; 31pp; English.
Query Match 100.0%; Score 570; Length 109;
Best Local Similarity 100.0%;
Matches 109; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ETTLTQSPGILSLSPGDRATLSCRASQSVGSVNLAWYQQRPGQAPRLLIHGASNRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ETTLTQSPGILSLSPGDRATLSCRASQSVGSVNLAWYQQRPGQAPRLLIHGASNRATGIP 60
Qy 61 DRFSGVGSGTDFTLTINRLEPDDFAVYYCQQYGTSPITFGQGTRLEIKR 109
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DRFSGVGSGTDFTLTINRLEPDDFAVYYCQQYGTSPITFGQGTRLEIKR 109
9. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (US 2010/0172906 as cited in IDS filed on 04/01/2024) and Whitley et al. (Lancet, 2001, 357:1513-1518) as applied to claims 1-10, 12-17, and 21-22 above, and further in view of Bauer et al. (Bauer et al., 2017 Virology 512:194-200).
The limitations of claims 1-10, 12-17, and 21-22 are disclosed by Lai as discussed above.
Lai does not disclose the anti-HSV antibody is effective in a subject who is susceptible or is infected with a drug-resistant HSV strain.
Bauer teaches the administration of an anti-HSV antibody as an effective response to patients infected with acyclovir-resistant ocular herpes simplex virus infections. (abstract). Bauer teaches that acyclovir has been used for more than two decades and has led to the development of drug-resistant strains which require new treatments for treating infections- including recurrent infections. (See Bauer, pg. 194 column 1 lines 5-7, also column 2 line 12-13 and pg. 195 column 1 lines 11-16).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date to use the antibody of Lai with the teachings of Bauer to treat drug-resistant HSV strains during recurrent infections. It would have been obvious because treating a drug-resistant strain of a virus would require using a different treatment mechanism of action like the antibodies of Lai and Bauer teaches administration of antibodies for another HSV infection had success in treating drug-resistant HSV infection. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to use the antibodies of Lai to treat drug-resistant HSV with a reasonable expectation of success based on the teachings of Bauer for the present claimed invention.
Response to Arguments
10. Applicant points to the Lynn declaration filed under 37 C.F.R. 1.132 and argues that the present claimed invention is not predictable from the prior art of Lai and Bauer. In particular, the Lynn declaration and the Applicant point to Example 10 of the present application that provides an example of a guinea pig model of infection that manifests both acute disease and spontaneous recurrences of infection that differs from mouse models that only demonstrate acute infection. Applicant argues that Bauer does not teach a proper model of recurrent HSV infections as the present invention does and this makes the reference not applicable to the present claimed invention. Applicant argues that the antibody’s ability to bind to the gD of the HSV-1 and HSV-2 are effective in treating HSV recurrence and argue this effect is unpredictable from the prior art. The declaration and Applicant’s arguments are all directed to the results of treatment with antibody UB-621.
11. Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Applicants argue that the cited prior art does not provide a reasonable expectation of success, or predictability, for the UB-621 antibody to treat recurrent HSV infection because they do not demonstrate using the same animal model as in the instant specification, and do not demonstrate treating spontaneous recurrent infection. Applicants have argued limitations not recited in the claims. Claim 1 does not recite treatment by administering antibody UB-621 antibody and does not recite treating a spontaneously recurrent HSV infection. Therefore, Applicants are arguing unpredictability for limitations not recited in the claims (see MPEP 716.02(d) - the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support).
As stated above, Applicant argues that the present claimed antibody’s ability to treat recurrent HSV infections is an unpredictable effect. In particular, Applicant points to the antibody’s ability to bind to the gD of HSV-1 and HSV-2 in the response on page 2 lines 18-22 and page 3 lines 28-29. As discussed above in the 103 rejection, Lai discloses this exact mechanism of action for the antibodies it discloses, which represent the same functional structural sequences of the present claimed invention. Further, Lai teaches that the binding of the gD portion prevents entry of the HSV into the cell, which would inhibit proliferation and transmission of the virus during primary and recurrent infection. Therefore, contrary to arguments, the cited prior art provides a reasonable expectation of success to treat HSV infection as claimed and by administering the same claimed antibody, including during a recurrent period as recited in new claim 21.
Further, while Applicant argues that treatment of the antibody for recurrent infection would be unpredictable, they provide no evidence to support the conclusion that the antibody of the prior art demonstrated to successfully treat a primary HSV infection would not also treat a recurrent infection by the same virus (see MPEP 716.02). As discussed above, Lai teaches the antibody is useful for treating and preventing any infection of HSV without distinguishing between a primary or latent infection and Whitley states that recurrent infections are known to occur in HSV infections. Therefore, a person of ordinary skill in the art would have a reasonable expectation of success at predicting a similar antibody to treat or prevent a recurrent HSV infection.
Regarding Bauer, the Applicant assumes because the study does not provide an animal model of recurrent infection that the treatment could not predictably be used for recurrent infections. Again, they provide no support that an antibody could not be predictably used for recurrent treatment in drug-resistant HSV strains. Therefore, the present claimed invention is considered unpatentable over Lai and Bauer as discussed in the rejections above and according to these arguments.
Conclusion
12. Claims 1-17 and 21-22 are rejected.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/Examiner, Art Unit 1642 /Laura B Goddard/Primary Examiner, Art Unit 1642
