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 .
1. The Election filed August 27, 2026 in response to the Office Action of May 28, 2026 is acknowledged and has been entered. Applicant's election with traverse of Group I, claims 1-14 and 19 and the species of anti-gp34 antibody and the anti-gp34 antibody wt11 is acknowledged.
2. Regarding the group restriction, Applicant argues that in the outstanding Office Action, the Examiner asserts that the inventions of Groups I - III do not relate to a single general inventive concept because the shared technical feature - which the Examiner identifies as "an antibody or antigen binding fragment thereof which binds to the extracellular domain of an Fc-gamma-binding glycoprotein of human cytomegalovirus, wherein the glycoprotein is gp34 or gp68 - does not distinguish over the prior art, as evidenced by a 2019 publication from Hartmut Hengel entitled "Project P08". The Examiner characterizes the Hengel reference as teaching the "making [of] antibodies to the extracellular / ectodomains of gp34 or gp68" and thus demonstrates that the shared technical feature defined by claim 1 "does not define a contribution over the prior art."
Applicant argues against this characterization and, to that end, directs the Examiner's attention to the International Preliminary Report on Patentability issued in connection with the underlying PCT application on December 14, 2023 (copy enclosed). See in particular Sections 3.1.1-3.1.2, wherein the examining authority expressly characterizes the Hengel publication (designated as "D1") as merely disclosing the concept of such antibodies without actually making such available as of publication. Given the admitted absence of a truly enabling public disclosure, Applicant submits that the Hengel reference may not be fairly characterized as undermining the "special" character of the presently claimed antibody compositions and associated methods and thus the instant challenge to unity of invention is necessarily flawed. Thus, in view of the limitations of the Hengel reference, Applicant submits that the technical features denoted as shared by the instant claims, namely the recitations of independent claim 1 from which claims 2-19 directly or indirectly depend, must necessarily be found to distinguish over the prior art and unite the claims under the umbrella of a single general inventive concept.
Applicant argues that furthermore, under 37 C.F.R. § 1.475, unity of invention exists when there is a technical relationship among the inventions involving one or more of the same or corresponding "special technical features", i.e., those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. As discussed above, the special technical feature outlined in independent claim 1 and shared by dependent claims 2-19, namely an antibody or antigen binding fragment thereof which binds to the extracellular domain of gp34 or gp68 of human cytomegalovirus, defines a novel and non-obvious contribution over the cited art. Critically, this special technical feature is also shared by newly added claim 20, support for which is found in the accompanying specification; see, for example, page 92, lines 22-24, of the Substitute Specification filed July 18, 2024. As discussed therein, the combination of anti-gp34 and anti-gp68 antibodies coordinate to prevent gp34/gp68-mediated and FcRn-dependent transcytosis of HCMV virions. This synergy forms the basis for the unity of the present invention, effectively linking the inventions of Groups I, II, and III and rendering moot the objection to unity. As such, Applicant respectfully petitions for reconsideration and withdrawal thereof.
Applicant argues that as a final matter, Applicant respectfully submits that the search required for the antibodies of claims 1-14, 19, and 20 necessarily overlaps with the search required for the methods of use associated therewith set forth in claims 15-18. Thus, Applicant respectfully submits that it would not be an undue burden for the Examiner to search and consider the inventions of Group I, II, and III in combination. For this additional reason, Applicant respectfully petitions for reconsideration and withdrawal of the above requirement.
Applicant’s arguments have been considered, but have not been found persuasive. Regarding the argument that the disclosure of Hengel is not enabling, the prior is presumed to be enabled when it anticipates or makes obvious all of the elements of the claimed invention. The burden is on applicant to provide facts rebutting the presumption of enablement. See MPEP 2121 (I)(II). Given Hengel teaches making antibodies to the extracellular/ectodomains of gp34 or gp68, the methods of antibody generation were well known in the art, and Applicant has not provided facts demonstrating that the that the disclosure of Hengel is not enabling, Applicant’s arguments are not found persuasive.
Regarding the International Preliminary Report on Patentability, the findings of the International Searching Authority are not binding on US patentability decisions. Nevertheless, the International Searching Authority also found the Hengel reference to be an X type reference with respect to claims 1-19 and 13-18 in the International Search Report. Thus, the claims were found not to be novel with respect to the Hengel reference. This indicates that the International Searching Authority found the disclosure was sufficiently enabling. Thus, Applicant’s arguments are not found persuasive.
Regarding the argument that the combination of anti-gp34 and anti-gp68 antibodies is the special technical feature, the method claims are not drawn to a combination of anti-gp34 and anti-gp68 antibodies. Thus, the combination of anti-gp34 and anti-gp68 antibodies cannot be the special technical feature that forms the single general invention concept that joins the groups of inventions. Thus, Applicant’s arguments are not found persuasive.
Regarding the arguments that it would not be an undue burden for the Examiner to search and consider the inventions of Group I, II, and III, the instant application is a National Stage application filed under 35 U.S.C. §371 and the restriction of the various groups is determined with respect to unity of invention as covered in chapter 1800 of the MPEP. See MPEP 801. Burden of search is not the criteria for proper restriction under 37 C.F.R. 1.475, PCT article 17(3) (a), and 37 C.F.R 1.476 (c). Thus, Applicant’s arguments are not found persuasive. Nevertheless, in arguendo, the claims of the different groups are drawn to various methods with distinct method steps with distinct criteria for success and distinct products. Thus, the different groups would require different fields of search and likely raise different non-prior art issues and would be a serious search and examination burden. Thus, Applicant’s arguments are not found persuasive.
For these reasons the restriction requirement is deemed to be proper and is therefore made FINAL.
Applicant additionally traversed the Election of Species in the Remarks of August 27, 2026. Without acquiescing to or agreeing with Applicant’s arguments, but in view of compact prosecution, the species of antibodies are rejoined for examination.
3. Claims 1-20 are pending.
4. Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
5. Claims 1-14, 19 and 20 are currently under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
6. Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located on pages 3-4 and Figs. 52 and 55.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
7. The disclosure is objected to because of the following informalities: the specification should contain as a separate section: BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
Appropriate correction is required.
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.
8. Claims 1-14, 19 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 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.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 759 F.3d 1285, 111 USPQ2d 1780 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. “Functional” terminology may be used “when the art has established a correlation between structure and function” but “merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing one has invented a genus and not just a species.” Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 598 F3d 1336, 94 USPQ2d 1161, 1171 (Fed Cir. 2010).
On 22 February 2018, the USPTO provided a Memorandum clarifying the Written Description Guidelines for claims drawn to antibodies, which can be found at www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. That Memorandum indicates that, in compliance with recent legal decisions, the disclosure of a fully characterized antigen no longer is sufficient written description of an antibody to that antigen. Accordingly, the instant claims have been evaluated in view of that guidance.
Scope of the claimed genus
The claims are drawn broadly drawn to an antibody or antigen binding fragment thereof which binds to the extracellular domain of an Fc-gamma-binding glycoprotein of human cytomegalovirus, whereby the glycoprotein is gp34 or gp68. The claimed antibodies are required to have several activities in addition to binding to the target antigen. The activities include blocking binding of glycoprotein gp34 to an Fc part of immunoglobulin gamma, blocking binding to an IgG B cell receptor, blocking binding of glycoprotein gp34 to C-reactive protein, blocking binding of glycoprotein gp34 to a neonatal Fc receptor to restore the natural function of the neonatal Fc receptor or blocking binding of glycoprotein gp68 to an Fc part of immunoglobulin gamma. Thus, claims are drawn to two large genera of gp34 or gp68 antibodies with specific functional activities in addition to binding to gp34 or gp68
State of the Relevant Art
As was well-known in the antibody art, antibodies as a class share an overall structure generally comprising two heavy chain polypeptides that each comprises a heavy chain variable region (VH) and a heavy chain constant region made up of several domain (CH1, hinge, CH2, CH3, and for some antibodies, a CH4). Each of the heavy chains pairs with a light chain polypeptide that comprises a light chain variable region (VL) and a constant region. But while this overall structure is shared amongst antibodies from a wide variety of sources (human, rat, mouse, rabbit), the structure each antibody uses to bind its particular epitope on an antigen is structurally distinct and is formed by a recombination event that results in high variability at the amino acid sequence level. By the time the invention was made, it is well established in the art that the formation of an intact antigen-binding site in an antibody usually required the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three “complementarity determining regions” (“CDRs”) which provide the majority of the contact residues for the binding of the antibody to its target epitope. See Almagro & Fransson, Frontiers in Bioscience 2008; 13:1619-33 (see Section 3) “Antibody Structure and the Antigen Binding Site” and Figure 1). Humanized antibodies comprise only the CDRs, or in some cases an abbreviated subset of residues within the CDRs, of a parental rodent antibody in the context of human framework sequences. Id. at Section 4. All of the CDRs of the heavy and light chain, in their proper order of CDR1, then 2, then 3, and in the context of framework sequences which maintain their required conformation are generally required to produce a humanized antibody in which the heavy and light chains associate to form an antigen-binding region that binds the same antigen as the parental rodent antibody. Id. at Section 4.
Overall, at the time the invention was made, the level of skill for preparing antibodies and then selecting those antibodies with desired functional properties was high. However, even if a selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structure provided by all six CDRs of a parental antibody in the context of appropriate VH and VL framework sequences, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what an antibody with a particular set of functional properties would look like structurally.
Summary of Species disclosed in the original specification
The specification teaches fifteen anti-gp34 antibodies. Subsets of the claimed antibodies have some of the claimed activities like blocking binding of glycoprotein gp34 to an Fc part of immunoglobulin gamma, blocking binding to an IgG B cell receptor, blocking binding of glycoprotein gp34 to C-reactive protein, or blocking binding of glycoprotein gp34 to a neonatal Fc receptor. See Table 8-p.48 and Table 9-p. 51.
The specification teaches eight anti-gp68 antibodies. All eight anti-gp68 antibodies interfere with the ability of gp68 to bind IgG. See Table 6- p. 44.
Are the disclosed species representative of the claimed genus?
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The specification discloses the reduction to practice of fifteen anti-gp34 antibodies with some of the claimed activities and eight anti-gp68 antibodies that interfere with the ability of gp68 to bind IgG. Antibodies produced by different methods, such as in different species or in phage or to different epitopes, would have been generally expected to be highly structurally diverse, particularly in the CDR sequences, and in function. Thus, while applicant has described fifteen species of anti-gp34 antibodies and eight species of anti-gp68 antibodies within each of the two genera recited, each genus is very large and encompass an almost unlimited number of . anti-gp34 antibodies and anti-gp68 antibodies. The species described therefore cannot be considered representative of either of the two recited genera of antibodies. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
Identifying characteristics and structure/function correlation
In the absence of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics; i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe structural features that convey the claimed binding activity, a prerequisite for utility in the recited methods of treating.
As noted above, the art generally accepted that the combination of the CDRs within the VH and VL pair of an antibody were essential for binding specificity. But the specification does not describe what residues within the CDRs confer the binding activity and blocking activities claimed. Accordingly, the skilled artisan would not be able to discern a structure/function correlation for antibodies other than those comprising either all six CDRs (in the context of VH and VL regions) of one parental antibody, or the VH and VL of one parental antibody.
For all of the reasons presented above, one of skill in the art would not know which of the countless other antibodies encompassed by the independent claims that meet the highly general structural requirements of the claims would also be able bind to the extracellular domain of gp34 or gp68 with the additional claimed functional activities. Neither the specification nor the dependent claims provide sufficient additional structure or a structure/function correlation to provide an adequate written description of the genera claimed. Therefore, the skilled artisan would not reasonably conclude that the inventors, at the time the application was filed, had full possession of antibodies as broadly claimed. Given the lack of shared structural properties that provide the claimed binding activity, the limited number of species described, and the fact that the species that were described cannot be considered representative of the broadly claimed genera Applicant was not in possession of the invention as claimed.
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.
9. Claim(s) 1-3, 10 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartmut Hengel, Project P08, Julians-Maximilians-Universitaet-Wuerzburg Institute for Human Virology, IDS, (2019), “Hengel”.
Hengel teaches making antibodies to the extracellular/ectodomains of gp34 or gp68.
Regarding claim 3, the extracellular domain of gp34 would have SEQ ID NO: 1 as claimed and thus the anti-gp34 antibodies of Hengel would bind to it.
Regarding claim 11, the extracellular domain of gp36 would have SEQ ID NO: 3 as claimed and thus the anti-gp38 antibodies of Hengel would bind to it.
10. Claim(s) 1-4, 10, 11, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0327482 A1 (Weeks et al. Nov. 15, 2018), “Weeks”.
Weeks teaches antibodies for the treatment of HCMV infection. See abstract and ¶¶ 0007-0013 and claims 1-29.
Weeks teaches the antibodies bind to an extracellular epitope n extracellular epitope of a protein expressed on the plasma membrane of HCMV infected cells (e.g., an epitope listed in Table 5). See ¶¶ 0009-0012 and 0064 and claims 9 and 10.
The HCMV extracellular epitopes include gp34/RL11 and gp68/UL119 epitopes. See Table 5-p. 8-9.
The gp34/RL11 epitopes include epitopes found in SEQ ID NOs: 1 and 2, like KPLKLANYRA (SEQ ID NO: 51) and TRTLVTR (SEQ ID NO: 52. See Table 5-p. 9.
The gp68/UL119 epitopes include epitopes found in SEQ ID NO: 3, like ASTSVIA (SEQ ID NO: 20) and PDILSVTCYAR (SEQ ID NO: 22). See Table 5-p. 8-9.
Weeks teaches making humanized forms of the antibodies of the invention that has at least one CDR derived from a mammal other than a human, and a FR region and the constant region of a human antibody. See ¶¶ 0009, 0012, 0054 and 0064 and claim 6.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claim(s) 1-4, 10, 11, 13, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0327482 A1 (Weeks et al. Nov. 15, 2018), “Weeks” in view of Hartmut Hengel, Project P08, Julians-Maximilians-Universitaet-Wuerzburg Institute for Human Virology, IDS, (2019), “Hengel”.
Weeks teaches as set forth above, but does not teach an example of a combination of an anti-gp34 antibody and an anti-gp38 antibody.
Weeks additionally teaches pharmaceutical compositions comprising combination of the antibody agents of the invention for the treatment of HCMV. See ¶¶ 0092, 0093 and 99-101.
Hengel teaches as set forth above. Hengel additionally teaches that gp34/RL11 and gp68/UL119 are co-expressed during HCMV infection and block IgG mediated activation of host FcgRs like ADCC.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Weeks and Hengel and make a combination of an anti-gp34 antibody and an anti-gp38 antibody because Weeks teaches pharmaceutical compositions comprising combination of the antibody agents of the invention for the treatment of HCMV and Hengel teaches that gp34/RL11 and gp68/UL119 are co-expressed during HCMV and block IgG mediated activation of host FcgRs like ADCC. Thus, one of skill in the art would have been motivated to combine an anti-gp34 antibody and an anti-gp38 antibody as taught by Weeks and Hengel to target gp34/RL11 and gp68/UL119 which are co-expressed during HCMV infection to optimize treatment of HCMV infection.
Conclusion
12. No claims allowed. It is noted that the elected species wt.11 antibody comprising the heavy chain variable region of SEQ ID NO: 34 and comprising the light chain variable region of SEQ ID NO: 35 is free of prior art.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached M-F 8:30-5:30 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER J REDDIG/Primary Examiner, Art Unit 1646
