DETAILED ACTION
Present claims 1-18 and 20 are currently pending and under examination in this 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 .
Priority
Application claims benefit from provisional application 63/403,408. Application claims subject matter that is disclosed in the provisional application. Therefore, application is granted the effective filing date of 09/02/2022.
Claim Interpretation
Claims 18 and 20 recite, “for use,” in the preamble. The use of the words “for use” is being interpreted as inciting a purpose or intended use for the product. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. (MPEP 2111.02(II)). In this case, the intended use of claims 18 and 20 add no structural limitations to the product, the anti-HSV antibody of claim 1, and is therefore given no patentable weight.
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, 9-18, and 20 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.
Claims 1 and 18 are drawn to an anti-HSV antibody that binds to glycoprotein D of herpes simplex virus-1 or 2. Claim 1 recites a method of administering the antibody to treat drug-resistant or recurrent HSV infection. Claim 18 is drawn to the anti-HSV antibody. Applying the broadest reasonable interpretation (BRI), these claims encompass the treatment of drug-resistant or recurrent HSV infection with any anti-HSV antibody that binds the glycoprotein D portion of HSV-1 or HSV-2. As described in the specification of the present application on page 20 [00094-000095], “drug-resistance” indicates that the virus is able to survive when exposed to one or more anti-viral agents, including acyclovir, famciclovir, penciclovir, valacyclovir, trifluridine, foscarnet, and cidofovir. Further, drug-resistant HSV strains are characterized as having mutations in the tyrosine kinase (TK) or DNA polymerase enzyme.
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Claims 1 and 18 define the present invention by its ability to treat drug-resistant HSV infections. The claims further identify the antibodies as binding to the glycoprotein D portion of HSV-1 or HSV-2. Drug-resistant HSV infections are characterized as HSV infection by strains that are able to evade the mechanism of action of nucleoside agents but not antibody neutralization. This would lead to the conclusion that any neutralizing antibody is capable of treating drug-resistant HSV infections.
Further, claims 1 and 18 define the antibody by its ability to bind glycoprotein D (gD) in HSV-1 and HSV-2 infection as the mechanism of action. Anti-HSV antibodies that bind gD are known in the art. For example, Nicola, et al., reported on an antibody for HSV that binds gD in 1998. (Nicole, A. et al., Journal of Virology, 1998 72(5):3595-3601). A person of ordinary skill in the art would not be able to determine that the applicant had a specific method for treating drug-resistant and recurring HSV infections based on the BRI of claims 1 and 18. Therefore, the claims lack adequate written description and are rejected under 35 U.S.C. 112(a).
Claims 9-17, and 20 are rejected based on their dependence on rejected base claims and their failure to add any meaningful limitations that would overcome a 35 U.S.C. 112(a) rejection.
Claim Objections
Claims 3-8 are objected to as being dependent upon a rejected base claim. Claims 3-8 contain subject matter which could overcome a 35 U.S.C. 112(a) written description rejection. However, as discussed below, the subject matter is not allowable based on novelty.
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 18 and 20 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 particular, the use of the words “for use” within both of these claims is unclear as to what limitations are being added to the claim. As discussed above under the claim interpretation, the use of “for use” is being interpreted as a product use claim. A product use claim only contains meaningful limitations if the recited purpose or intended use results in a structural difference between the claimed invention and the prior art. It is unclear from the language of the claims what structural differences are being claimed within claim 18. It is suggested the applicant provide structural limitations which are supported by the present application to overcome this rejection.
Further, claim 20 recites, “An anti-HSV antibody or a composition thereof for use of claim 18,” which is indefinite. Since claim 18 is drawn to an antibody composition this recitation is being interpreted as, “an antibody thereof for the use of an antibody.” This makes the claim indefinite. It is suggested the applicant rewrite the preamble to clearly define the dependence on claim 18.
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.
Claims 4, 6, and 8 are 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. Claims 4, 6, and 8 all depend from claims 3, 5, and 7, respectively. Claims 3, 5, and 7 all follow a similar pattern of claiming (a) VH chain of CDR1, CDR2, and CDR3; AND (b) VL chain of CDR1, CDR2, and CDR3. Claims 4, 5, and 6 all follow a similar pattern of claiming the VH region; AND/OR the VL region of the dependent claim. This is an improper dependent claim because “and/or” is interpreted as “or” and the dependent claim recites that both the VH and VL regions are required for the claim. The dependent claims are required to import the limitations of the prior claim which requires that both VH and VL regions be a part of the claimed limitation. 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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1, 3-10, 12-15, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by “Lai” (US 2010/0172906 as cited in IDS filed on 04/01/2024).
In regards to claim 1, Lai discloses, “A method for treating drug-resistant and/or recurrent herpes simplex virus (HSV) 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]).
In regards to claim 3, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody comprising a VH region comprising a CDR1 of SEQ ID NO:2, a CDR2 of SEQ ID NO:4, and a CDR3 of SEQ ID NO:6. (See pg. 3, SEQ ID NO:1 underlined portions). Lai further discloses the anti-HSV antibody comprising a VL region comprising 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 NO:2 underlined portions).
In regards to claim 4, Lai discloses the limitations of claims 1 and 3 as discussed above. Lai further discloses the VH region of SEQ ID NO:15 and the VL region of SEQ ID NO:16. (See pg. 3 SEQ ID NO:1 and 2).
In regards to claim 5, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody comprising a VH region comprising a CDR1 of SEQ ID NO:18, a CDR2 of SEQ ID NO:20, and a CDR3 of SEQ ID NO:22. (See pg. 3 SEQ ID NO:3 underlined portions). Lai further discloses the anti-HSV antibody comprising a VL region comprising 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 NO:4 underlined portions).
In regards to claim 6, Lai discloses the limitations of claims 1 and 5 as discussed above. Lai further discloses the VH region of SEQ ID NO:30 and the VL region of SEQ ID NO:31. (See pg. 3 SEQ ID NOs: 3 and 4).
In regards to claim 7, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody comprising a VH region comprising a CDR1 of SEQ ID NO:2, a CDR2 of SEQ ID NO:33, and a CDR3 of SEQ ID NO:6. (See pg. 4 SEQ ID NO:41 underlined portions). Lai further discloses the anti-HSV antibody comprising a VL region comprising 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 NO:42 underlined portions).
In regards to claim 8, Lai discloses the limitations of claims 1 and 7 as discussed above. Lai further discloses the VH region of SEQ ID NO:40 and the VL region of SEQ ID NO:41. (See pg. 4 SEQ ID NOs:41 and 42).
In regard to claim 9, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the antibody is an antigen-binding fragment thereof. (See pg. 1 [0008] lines 3-4).
In regard to claim 10, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the antibody is humanized. (See pg. 3 [0022] lines 6-7).
In regard to claim 12, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the subject is a patient having a weakened immune system. (See pg. 1 [0002] lines 7-10).
In regard to claim 13, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody is administered to the subject in a single dose. (See pg. 9 [0075]).
In regard to claim 14, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody is administered to the subject at an early stage of the infection. (See pg. 10 [0077] lines 5-9).
In regard to claim 15, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses administering the antibody in an effective amount to reduce symptoms caused by HSV infection. (See pg. 10 [0077] lines 5-9).
In regard to claim 17, Lai discloses the limitations of claim 1 as discussed above. Lai further discloses the anti-HSV antibody is administered to the subject after symptoms occur. (See pgs. 9-10 [0076]-[0077]).
In regards to claims 18 and 20, Lai discloses the limitations of claim 1 as discussed above. As discussed under claim interpretation, claims 18 and 20 is an intended use claim and is evaluated to determine whether the intended use results in a structural limitation. The intended use listed in claims 18 and 20 do not provide any structural differences to the product of claims 1. Therefore, claim 18 and 20 are evaluated based on the product, the anti-HSV antibody of claim 1, which is anticipated by Lai.
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.
Claims 2, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over “Lai” (US 2010/0172906 as cited in IDS filed on 04/01/2024) in view of “Bauer” (Bauer et al., 2017 Virology 512:194-200).
In regards to claims 2 and 11, Lai discloses the limitations of claim 1 as discussed above. Lai does not disclose the anti-HSV antibody is effective in neutralizing drug-resistant HSV strains or inhibiting viral transmission or administration to 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).
A person having ordinary skill in the art would have been motivated to apply the teaching of Bauer to administer the antibody of Lai to treat drug-resistant and recurrent infections of the present invention. Lai teaches the antibody structure of the present invention. Acyclovir-resistant HSV infections is a target for the current invention (See pg.1 [0004]). The monoclonal antibody of Lai and the present invention targets glycoprotein D of HSV-1 and HSV-2, which is a different target for HSV infections than acyclovir agents. Therefore, a person of ordinary skill in the art would have been motivated at the time of the effective filing date to treat acyclovir-resistant HSV strains using the monoclonal antibody of Lai with a reasonable expectation of success.
In regard to claim 16, Lai discloses the limitations of claim 1 as discussed above. Lai does not disclose the antibody administered as effective to delay recurrent incidents or reducing recurrent frequency.
Bauer teaches the successful use of an anti-HSV antibody to prevent the reactivation of drug-resistant ocular HSV infection. (See Bauer et al., pg. 197 Section 3.5).
It would be obvious to try for a person of ordinary skill in the art to apply the teachings of Bauer to use the antibody of Lai for the prevention of recurrent HSV infections. Recurrent infections are a common problem with HSV (pg. 1 [0003]). In Bauer, the administration of an anti-HSV antibody was effective at preventing reactivation of recurrent infection with drug-resistant strains in treating ocular 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 anti-HSV antibody of Lai to treat recurrent drug-resistant HSV based on the success achieved by Bauer.
Conclusion
In summary, claims 1-18, and 20 are rejected.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642