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 .
Examiner’s Note
The present Office Action fully replaces the Final Action mailed on 01/27/2026. Further, please note that the Examiner in this application has changed. Please send future correspondence to Examiner Marlene V. Buckmaster, Art Unit 1672.
Response to Amendment
The Amendment filed 10/16/2025 in which claims 1-4, were amended, new claims 5-7 were added, has been entered.
Claims 1-7 are under examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 01/05/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
(New claim interpretation necessitated by the addition of new claim 7 in the Response filed on 10/16/2025) The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Because the claim limitations of “means for specifically binding to each of the following subtypes of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7, type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85; wherein the means comprises a monoclonal antibody or an antigen-binding fragment thereof” in claim 7 is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the Specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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.
(Previous rejections, withdrawn as to claims 1-4) Claims 1-4 were 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.
See claims 1-4 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claims 1-4.
(New rejection, necessitated by the addition of new claim 7 in the Response filed on 10/16/2025) Claim limitation “means for specifically binding to each of the following subtypes of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7, type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85; wherein the means comprises a monoclonal antibody or an antigen-binding fragment thereof” in claim 7 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the disclosure fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
In the instant case, the generic structure of a monoclonal antibody or an antigen-binding fragment thereof does not disclose the specific structure (i.e., CDRs) that performs the specific function of binding adenovirus subtypes as required by the claim. As no clear link to the structure is recited within the instant disclosure for the recited “means”, instant claim 7 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 112(d)
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.
(Previous rejections, withdrawn as to claims 2-4) Claims 2-4 were 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.
See claims 2-4 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claims 2-4.
Claim Rejections - 35 USC § 112(a) Written Description
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.
(Previous rejections, maintained as necessitated by amendment as to claims 1-4, expanded as to claims 5-7) Claims 1-7 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 art that the inventor or a joint inventor had possession of the claimed invention as of the effective filing date of the application.
See claims 1-7 as submitted on 10/16/2025.
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, reduction to drawings, 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 inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Claim 1 recites, inter alia, the limitation of a monoclonal antibody or an antigen-binding fragment thereof, which undergoes antigen-antibody reaction with various subtypes of adenoviruses. Claims 2-3 are drawn to an immunoassay and claims 4-6 are drawn to an immunoassay device comprising the antibody/ antigen-binding fragment from claim 1. It should be noted that the decision arrived at in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) supports expanded analysis of whether a claim drawn to an antibody being specific for an epitope, even a specific epitope, permits an applicant to pursue all possible antibodies that are capable of being produced against such an epitope. Presently, the claimed monoclonal antibody or antigen-binding fragment thereof is only defined by functional properties (i.e., binding to adenoviruses) but no specific structure is recited by the claims, such as the CDR sequences that are required for specific antibody binding.
Example 3 of the Specification indicates that the antibody recognizes adenovirus hexon trimer. However, the specific hexon trimer epitope is not defined and the CDRs required for this recognition are not claimed. Thus, the Specification in its entirety fails to sufficiently describe the structural features (i.e., CDRs) that must be retained by members of the claimed antibody genus as to establish a structure-function relationship with respect to antigen binding. The claims encompass a massive genus of antibodies and/or antigen-binding fragments with no clear indication as to which members of the genus actually bind to the claimed subtypes of adenovirus.
While the claims are drawn to a massive genus of antibodies and antigen-binding fragments, the Specification has only adequately described and successfully reduced to practice two antibodies capable of binding multiple subtypes of adenovirus (“antibody 1” and “antibody 2” [Example 1, page 10]). This is not representative of the extremely large genus of antibodies and antigen-binding fragments as claimed since the Specification has only demonstrated specific binding to some but not all adenovirus hexon trimers with the two indicated antibodies.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case the CDRs that are responsible for binding to the various subtypes of adenovirus. However, as discussed above, the Specification fails to describe any substantive structural limitations as to establish a structure-function relationship with antigen-antibody binding.
Thus, it is not evident that the applicant had possession of an antibody or an antigen-binding fragment thereof capable of binding various subtypes of adenovirus as of the effective filing date of the invention.
Claim 1 recites the following limitation: the monoclonal antibody or antigen-binding fragment thereof “undergoes antigen-antibody reaction with” (i.e., binds) each of the following subtypes of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7 type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85. The Specification indicates that there are more than 80 types of adenovirus (¶ [0002]). However, the Specification has only adequately described and successfully reduced to practice detection of adenovirus types 1-3, 5-8, 11, 19, 31, and 37 (Example 2 and Table 1); no data are provided indicating that the claimed antibody or antigen-binding fragment thereof binds to each subtype of adenovirus; no data are provided indicating that the claimed antibody or antigen-binding fragment thereof binds to adenovirus types 4, 53, 54, 56, 64, 79, 81, or 85. It is herein noted that additional data was submitted in Declaration under 37 CFR 1.132 filed on 10/16/2025. It is further noted that such data lack controls (Declaration, Table 4). The absence of controls (negative and positive) renders the data presented in the Declaration as to the binding of the claimed monoclonal antibody or antigen-binding fragment thereof to adenovirus types 53, 54, 56, 64, 79, 81, or 85 meaningless. Finally, it is noted that neither the Specification nor the Declaration provide any data indicating that the claimed antibody or antigen-binding fragment thereof binds to adenovirus type 4.
In the absence of a representative number of examples, the Specification must at least describe the structural features that are required for the claimed function, in this case the CDRs that are responsible for making contact with the various subtypes of adenoviruses. As discussed above, the CDRs of the claimed antibodies are not provided.
Thus, it is not evident that the applicant had possession of a genus of an antibody or an antigen-binding fragment thereof capable of binding each subtype of adenovirus as recited in claim 1 as of the effective filing date of the invention.
Claim Rejections - 35 USC § 112(a) Enablement
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.
(New rejection, necessitated by the addition of new claim 7 in the Response filed on 10/16/2025) Claim 7 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the Specification to provide the structure, material or acts to support the claimed function. This is an enablement rejection. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the Specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
Claim 7 recites “means for specifically binding to each of the following subtypes of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7, type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85; wherein the means comprises a monoclonal antibody or an antigen-binding fragment thereof”, and as such encompass a large genus of “means” for binding to each of the following subtypes of adenoviruses: type 1, type 2, type 3, type 4, type 5, type 6, type 7, type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. See MPEP 2163.
While the originally filed Specification does disclose exemplary “means” for performing the function, the Specification fails to disclose a common identifying characteristic/structure that is common to all species of the genus such that could recognize which species belong to the genus. The originally filed Specification provides “means for solving the problems” page 3 and refers to “a monoclonal antibody capable of detecting many subtypes of adenovirus” and “a monoclonal antibody or an antigen-binding fragment thereof.” However, the exemplary means provided in the Specification are also extremely large genus’ themselves. As such, although the Specification does disclose exemplary “means”, there is still large variability among these “means”.
For example, it is not readily apparent what species of a monoclonal antibodies or an antigen-binding fragments thereof would be encompassed by the claim in terms of the limitation "means"; one of ordinary skill in the art would not readily envision which monoclonal antibodies, of all the possible ones in the art could serve as a “means” to achieve the desired functional characteristic recited in the claims, i.e. would be capable of specifically binding to each of the following subtypes of adenovirus: type 1, type 2, type 3, type 4, type 5, type 6, type 7, type 8, type 11, type 19, type 31, type 37, type 53, type 54, type 56, type 64, type 79, type 81, and type 85 because the specific structures required for such binding i.e., the CDRs are not disclosed. Further, the generic structure of a monoclonal antibody or an antigen-binding fragment thereof does not provide the specific structure such that one of ordinary skill in the art would be readily able to extrapolate which monoclonal antibodies, of all the possible ones in the art could serve as a “means” to achieve the desired functional characteristic recited in the claims. There is no common structural component/relationship common to all species of the genus of “means” indicated by the claims or the originally filed Specification such that would correlate structure with function so that one could readily ascertain which species of the extremely large genus would perform the desired function.
As a result, there is insufficient written description with regard to supporting the instant claims, specifically because the specification does not describe what species of the genus of “means” would accomplish claimed function.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous rejection, withdrawn as to claim 1) Claim 1 was rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for patent subject matter eligibility analysis.
See claim 1 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claim 1.
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.
(Previous rejection, withdrawn as to claims 1, 2 and 4) Claims 1, 2, and 4 were rejected under 35 U.S.C. 103 as being unpatentable over Timoshicheva et al (Biologicals 2019- included on IDS) and Ebner et al (Journal of Virology 2005- included on IDS).
See claims 1, 2, 4 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claims 1, 2, 4.
(Previous rejection, withdrawn as to claim 3) Claim 3 was rejected under 35 U.S.C. 103 as being unpatentable over Timoshicheva et al and Ebner et al as applied to claims 1 and 2 above and further in view of Bio-Rad (ELISA formats webpage 2018- see attached form 892).
See claim 3 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claim 3.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Previous rejection, withdrawn as to claims 1, 2, 4) Claims 1, 2, and 4 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of copending Application No. 17919026 in view of Timoshicheva et al and Ebner et al.
See claims 1, 2, 4 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claims 1, 2, 4.
(Previous rejection, withdrawn as to claim 3) Claim 3 was provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of copending Application No. 17919026 in view of Timoshicheva et al, Ebner et al, and Bio-Rad.
See claim 3 as submitted on 10/16/2025.
Applicant’s amendments to the instant claims have overcome previous objections to claim 3.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
Applicant contends on page 5 of the Remarks submitted on 10/16/2025:
As explained below, the rejection misapplies the law. The Federal Circuit's 2017 decision in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) remains the controlling written-description precedent and confirms that functional language may evidence possession when the underlying structure-function correlation is generally known or readily verifiable. That is precisely the case here, where the specification discloses the immunogen (adenovirus hexon trimer), the method of antibody production, and experimental data demonstrating cross-reactivity across numerous subtypes, all of which rest on well-established and publicly verifiable scientific facts. The contemporaneously filed Declaration further substantiates this with testing details and positive reactivity results for later genotypes (see Decl. paragraph 7, 10-11, Table 4).
In response:
The Examiner acknowledges Applicant’s arguments and analysis of the relevant case law. First, it is noted that in the instant case, the underlying structure of the claimed monoclonal antibody and the correlation to its claimed function is neither known nor readily verifiable. The Specification does not provide sufficient structure of the claimed antibody. Instead, the Specification generally refers to the immunogen which the claimed antibody binds to. Said immunogen is described as an adenovirus hexon trimer (Example 3). It should be noted that the specific hexon trimer epitope is not defined and the CDRs required for this recognition are not claimed in instant disclosure. Thus, the Specification in its entirety fails to sufficiently describe the structural features (i.e., CDRs) that must be retained by members of the claimed antibody genus as to establish a structure-function relationship with respect to antigen binding. Neither the immunogen nor the method of antibody production, nor the experimental data on cross-reactivity provide any information about the structural features of the claimed antibody itself (i.e., CDRs) that must be retained by members of the claimed antibody genus as to establish a structure-function relationship with respect to antigen binding to a hexon trimer epitope in each of the adenovirus subtypes indicated in claim 1. Applicant’s argument that these “rest on well-established and publicly verifiable scientific facts” lacks evidence. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
The U.S. Court of Appeals for the Federal Circuit (Federal Circuit)’s decision in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies, explained that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone is not considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. Here, Applicant contends that the immunogen (adenovirus hexon trimer), the method of antibody production, and experimental data on cross-reactivity provide written-description precedent and evidence of possession. This argument is unpersuasive because, as indicated above, neither the immunogen (adenovirus hexon trimer), nor the method of antibody production, nor the experimental data on cross-reactivity provide adequate written description for the antibody itself.
Applicant contends on page 6 of the Remarks submitted on 10/16/2025:
Accordingly, functional language continues to demonstrate possession where the correlation between antigen structure and antibody binding is a matter of ordinary scientific knowledge-precisely the situation presented here, and corroborated by the Declaration's test results for the recited later genotypes (see enclosed Decl. paragraphs 10-11).
In response:
With respect to Applicant’s argument on functional language, it is noted that the functional language in instant claims recite undergoing antigen-antibody reaction (or binding) between the claimed antibody and an immunogen. Such functional language fails to provide adequate written description support at least because “[a]dequate written description requires a precise definition, such as by structure, formula, chemical name or physical properties of the antibody itself, not a mere wish or plan for obtaining the claimed chemical invention.” Id. at 1566, 43 USPQ2d at 1404 (quoting Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606). See also Enzo-Biochem v. Gen-Probe 01-1230 (CAFC 2002).
Recent court cases have emphasized the need for correlation between a well-defined structure and recited functional limitations. For example, the courts have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See for example AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) as well as Amgen v. Sanofi, (Fed Cir, 2017-1480. 10/5/2017). Indeed, in Amgen the court indicated that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e. the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it.
As such, knowledge of where an antibody binds provides no information as to what such an antibody necessarily looks like (i.e. its primary amino acid structure or CDRs). “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. As such, disclosure of an immunoassay and an immunoassay device to test for functional properties of an antibody (such as its ability to bind to an adenovirus hexon trimer) does not provide evidence of possession of the antibody itself.
It is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR1, 2 and 3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (Janeway et al. Immunobiology: The Immune System in Health and Disease. 5th edition. New York: Garland Science; 2001. The structure of a typical antibody molecule. Available from: https://www.ncbi.nlm.nih.gov/books/NBK27144/. See entire document). It is also known that single amino acid changes in a CDR can abrogate the antigen binding function of an antibody (Rudikoff et al. Single amino acid substitution altering antigen-binding specificity. Proc Natl Acad Sci U S A. 1982;79(6):1979-1983, see entire document, particularly the abstract and the middle of the left column of page 1982). Thus, based upon the prior art, skilled artisans would reasonably understand that it is the structure of the CDRs within an antibody which gives rise to the functional property of antigen binding, the epitope to which said CDRs bind is an inherent property which appears to necessarily be present due to conservation of critical structural elements, namely the CDR sequences themselves. In Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted. To show invention, a patentee must convey in its disclosure that he/she/they “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention, in this case of the antibody itself. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358).
Further, an adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361). Indeed, the courts have long ruled that “When a patent claims a genus using functional language to define a desired result, the Specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” See Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005). Also, “A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus.” See AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69.
Artisans are well aware that knowledge of a given antigen (for instance an adenovirus hexon trimer) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Edwards et al. (Edwards, Bryan M et al. “The remarkable flexibility of the human antibody repertoire; isolation of over one thousand different antibodies to a single protein, BLyS.” Journal of molecular biology vol. 334,1 (2003): 103-18.) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences spanning almost the entire heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well, see entire document). Similarly, Lloyd et al. (Lloyd, C et al. “Modelling the human immune response: performance of a 1011 human antibody repertoire against a broad panel of therapeutically relevant antigens.” Protein engineering, design & selection : PEDS vol. 22,3 (2009): 159-68.) teach that a large majority of VH/VL germline gene segments are used in the antibody response to an antigen, even when the antibodies were selected by antigen binding, as their sequencing studies revealed that out of 841 unselected and 5,044 selected antibodies, all but one of the 49 functional VH gene segments was observed (see entire document). Further, it should be noted that degenerate binding of the same structural motif by antibodies does not require the existence of sequence homology or identity at any of their CDRs or other chemical similarities at the antigen-binding sites; side chain mobility of epitope residues can confer steric and electrostatic complementarity to differently shaped combining sites, allowing functional mimicry to occur (Lescar et al., “Crystal structure of a cross-reaction complex between Fab F9.13.7 and guinea fowl lysozyme.” The Journal of biological chemistry vol. 270,30 (1995): 18067-76. see entire document, in particular Abstract and Discussion). As such, it does not seem possible to predict the sequence/structure of an antibody that binds a given antigen as there does not appear to be any common or core structure present within all antibodies that gives rise to the function of antigen binding. Further, given data such as that of Edwards et al. indicating the diversity of sequence bound in a population of antibodies that bind to a given antigen no number of species appears to reasonably representative of the breadth of the genus of antibodies that bind the given antigen.
As discussed above, applicant has claimed a vast genus of antibodies by indicating part of the epitope to which they bind. As discussed in above as well as in court decisions, defining an antibody based upon the structure to which it binds (i.e. the antigen/epitope whether in full or in part) rather than the actual structure of the antibody itself (e.g. its primary amino acid sequence, CDRs) is generally insufficient to provide adequate written description for the claimed antibody.
Therefore, it is herein maintained that the functional language in instant claims fails to demonstrate possession of the claimed antibody as required by the written description requirement.
Applicant contends on page 6 of the Remarks submitted on 10/16/2025:
In Ex pane Inano (Appeal 2020-006045, Feb. 12, 2021), the Board reversed a similar §112(a) rejection in an immunoassay context, holding that disclosure of antibodies binding a known viral matrix protein region satisfied written description because "purification of [the antigen] and generation of monoclonal antibodies were routine at the time of filing" and the claims "provide[d] a sufficiently precise definition ... to allow the ordinary artisan to identify antibodies ... that fall within the scope of the claims."
The same rationale applies here.
In response:
The claims in Ex parte Inano cited by Applicant and instant claims are readily distinguishable. Firstly, in Ex parte Inano the claims were directed to a method for detecting and an immunoassay device, whereas the instant claims are directed explicitly or inherently to a monoclonal antibody or antigen-binding fragment thereof or a means for specifically binding, wherein the means comprises a monoclonal antibody or antigen-binding fragment thereof. It is reiterated that in Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co., 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted. To show invention, a patentee must convey in its disclosure that he/she/they “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the claimed invention itself, in this case of the antibody itself. Secondly, in Ex parte Inano the Specification teaches "the present inventors discovered that, by a sandwich method using two kinds of monoclonal antibodies whose epitopes are particular regions of M1 protein of influenza B virus, influenza B virus can be specifically detected with a higher sensitivity than conventional methods" (Ex parte Inano, Spec., ¶ 14), which clearly indicated that the claimed invention pertains a method and a device to carry out such method. In contrast, instant Specification teaches that “the present inventors have discovered a monoclonal antibody capable of detecting many subtypes of adenovirus with higher sensitivity” (Spec, ¶ 0008), clearly indicating that instant claims are directed to a product i.e., a monoclonal antibody or antigen-binding fragment thereof or a means for specifically binding, wherein the means comprises a monoclonal antibody or antigen-binding fragment thereof. Third, in Ex parte Inano the Specification teaches "[a]mino acid sequences of B-M1 are known, and described in, for example, GenBank: AEN79424 (SEQ ID NO:1 )" (Ex parte Inano, Spec., ¶ 18) as an exemplary antibody which can be used with the claimed invention. In stark contrast, instant Specification does not teach any sequences, no Sequence Listing has been filed with instant application, and there is no teaching referring to any sequences available in any publicly available databases such as GenBank. The exemplary antibodies in instant disclosure (Antibody 1 and Antibody 2) are only described in functional terms for their ability to bind adenoviruses of different subtypes (Spec, ¶¶ 0032-0035). Fourth, in terms of the antigen to which the anti-M1 antibody binds to, in Ex parte Inano the claims and the Specification teach the exact residues the antibody must bind to (Ex parte Inano, Spec., ¶ 56). In contrast, neither instant claims nor instant Specification teach the specific antigen to which the claimed antibody or antigen fragment thereof must bind to. As indicated above, the specific hexon trimer epitope is not defined and the CDRs required for this recognition are not claimed. Fifth, in Ex parte Inano, the Rizk Declaration submitted on 07/05/2019 explains that a "skilled person would understand that additional clones could be easily obtained through the routine and conventional methods disclosed in the specification" (Rizk Decl.,¶ 17). The Rizk Declaration further states that unlike the antibodies in Abbvie, the "present invention does not require specific functional behavior, such as neutralizing activity or a high koff rate. The present invention just requires an antibody useful in the claimed immunoassay" (Rizk Decl., ¶¶ 22, 24). Conversely, instant claims require that the claimed antibody or antigen-binding fragment thereof or a means for specifically binding, wherein the means comprises a monoclonal antibody or antigen-binding fragment thereof require the specific functional behavior of binding to each adenovirus subtype as recited in the claims. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal concerning Ex parte Inano fails to demonstrate that the same rationale of Ex parte Inano can be applied to the instant case. Therefore, it is herein submitted that instant application is readily distinguishable from Ex parte Inano.
Response to Declaration under 37 C. F. R. § 1.132
Applicant’s Rule 132 Declaration filed on 10/16/2025 has been thoroughly reviewed and fully considered.
The Declaration under 37 CFR 1.132 filed on 10/16/2025 is insufficient to overcome the rejection of instant claims as set forth in this Office Action because of the reasons explained below.
It is noted that the Declaration under 37 CFR 1.132 filed on 10/16/2025 by Mr. Takashi Miyazawa has a potential bias in favor of instant Application given that Mr. Miyazawa is one of two inventors of instant Application.
It is also noted that the Declaration under 37 CFR 1.132 filed on 10/16/2025 by Mr. Miyazawa does not provide any evidence or data with reference to the structure of the claimed antibody genus.
Turning to Applicant’s Declaration, as indicated above, instant claims recite a monoclonal antibody or an antigen-binding fragment thereof, which undergoes antigen-antibody reaction with various subtypes of adenovirus. Mr. Miyazawa has provided in the Declaration the methods by which the claimed antibody was produced, namely hybridoma technology which is well known and widely practiced in the art (see Kohler et al. cited in Applicant’s Declaration). Mr. Miyazawa has also provided immunoassay method by which the claimed antibody was used for detection of adenoviruses. Finally, Mr. Miyazawa has provided results in reference to binding of the claimed antibody to the following adenovirus subtypes 53, 54, 56, 57, 64, 79, 81 and 85.
However, as indicated above, the Declaration does not provide any evidence or data with reference to the structure of the claimed antibody genus. Further, the results in reference to binding of the claimed antibody to the following adenovirus subtypes 53, 54, 56, 57, 64, 79, 81 and 85 (Declaration, Table 4) lack controls. The absence of controls (negative and positive) renders the data meaningless. Therefore, the Declaration is deemed insufficient to overcome the rejection of instant claims as set forth in this Office Action.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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, Thomas J Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672