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 .
Disposition of Claims
Claims 31-50 were pending. Claims 1-30 remain canceled. Claims 41-44 and 47-50 were withdrawn. Amendments to claims 31-41 and 43-50 are acknowledged and entered. New claims 51-61 are acknowledged and entered.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230034906A1, Published 02/02/2023.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
The examiner of your application in the Patent and Trademark Office has been reassigned. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Rachel Gill, Art Unit 1671.
Response to Arguments
Applicants’ arguments filed 01/12/2026 regarding the previous Office action dated 09/10/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Optional Authorization to Initiate Electronic Communications
The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Election/Restrictions
Applicant's election with traverse of Group I (claims 31-40 and 45-46) as well as the species of anti-gB antibody of TNR1019 with six CDRs comprising SEQ ID Nos. 3, 7, 11, 23, 27, and 31, a VH of SEQ ID NO. 15, a VL of SEQ ID NO. 35, a heavy chain of SEQ ID NO. 41, and a full light chain of SEQ ID NO. 42, in the reply filed on 07/07/2025 is acknowledged and was made final in the previous Office action dated 09/10/2025.
Claims 41-44 and 47-50 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/07/2025.
Newly submitted claims 56-61 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the newly presented claims are drawn to non-elected method inventions, or are drawn to non-elected host cells.
Since applicants have received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 56-61 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicants traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Accordingly, claims 31-40, 45-46, and 51-55 will be examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Receipt is acknowledged of a certified English translation of the foreign priority application on 01/12/2026.
Drawings
(Objection withdrawn.) The objection to the drawings is withdrawn in light of the amendments submitted to the drawings.
Nucleotide and/or Amino Acid Sequence Disclosures
(Objection withdrawn.) The objection to the sequences is withdrawn in light of the amendments submitted to the specification.
Specification
(Objection withdrawn.) The objection to the specification is withdrawn in light of the amendments submitted to the specification.
Claim Objections
(Objection withdrawn.) The objection to Claim 40 is withdrawn in light of the amendments to the claim.
(New objection.) Claim 39 is objected to because of the following informalities: to place the claim in better form, the “or” after “single chain antibody” should be replaced with a comma, so that it is clear that the alternative list of embodiments of the Markush group of claim 39 does not have a separate sub-group due to the use of “or” twice in the Markush group. Appropriate correction is required.
(New objection.) Claims 53 and 54 are objected to because of the following informalities: to place the claim in better grammatical form, an article should appear before the second recitation of “amino acid” in line 2 of each claim, and preferably the second recitation of “amino acid” should be removed (e.g. “…wherein the amino acid substitution is a conservative substitution.” and “…wherein the amino acid change is a substitution.”). Appropriate correction is required.
Claim Interpretation
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 examiner notes that all uses of the VL sequence of/shown in, the VH sequence of/shown in, the heavy chain sequence of/shown in, and the light chain sequence of/shown in are interpreted to require the full-length of the sequence identifier(s) that follow these phrases.
The examiner notes that in the “Remarks” dated 01/12/2026, the CDRs were determined as per the specification using IMGT numbering.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 31-40 and 45-46 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 32-33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 39 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 40 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection maintained and extended – necessitated by amendment.) Claim 46 remains 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.
The claim recites “one or more pharmaceutically acceptable auxiliary materials” but subsequently recites “the pharmaceutically acceptable auxiliary material is a pharmaceutically acceptable carrier or a pharmaceutically acceptable excipient, including a buffer or diluent.” It is unclear whether the latter limitation (e.g. “including a buffer or diluent”) applies to the excipient, the carrier, or both. Further, the antecedent basis of “the pharmaceutically acceptable auxiliary material” is unclear, as the claim previously recites “one or more pharmaceutically acceptable auxiliary materials”, so it is unclear if the latter recitation modifies only one of the materials or all of the “one or more pharmaceutically acceptable auxiliary materials” previously recited.
Further, as there are two separate antibody items to be selected from in the composition (e.g. the monoclonal antibody or an immunoconjugate comprising the monoclonal antibody and a label), it is suggested that “according to claim 31” be repeated after “monoclonal antibody” in line 3 to make the antecedent basis of said antibody clear.
For at least these reasons, the metes and bounds of the claim remain unclear.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive.
Applicant argues that the claim, as amended, has clarified the metes and bounds of “acceptable auxiliary materials”, but the Office disagrees. One suggestion is to amend the claim along the lines of the following: “A pharmaceutical composition comprising:
the monoclonal antibody or antigen-binding fragment thereof according to claim 31; or an immunoconjugate comprising the monoclonal antibody or antigen-binding fragment thereof according to claim 31 and a label; and
one or more pharmaceutically acceptable carriers, excipients, buffers, or diluents.”
This is only one suggestion, as applicants are free to amend the claims however they deem necessary to overcome the rejection.
(New rejection – necessitated by amendment.) Claim 31 and dependent claims 32-40, 45-46, and 51-55 thereof 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.
The term “specifically binds” in claim 31 is a relative term which renders the claim indefinite. The term “specifically binds” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As neither the claim nor the specification has provided a degree as to what is, and what is not, an antibody that “specifically” binds to human cytomegalovirus (hCMV) glycoprotein B (gB), and only the CDRs are claimed for the antibody, the binding affinity/avidity of the resulting antibody depending on the framework region used can vary. Therefore, it is suggested that either this limitation be removed from the claim (e.g. claim the antibody without the functional limitations) or if the functional limitations are desired, then they should be clearly delineated (e.g. providing a dissociation constant (Kd) value that is indicative of “specifically binds”).
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant claim 32 is rejected on the grounds of being indefinite. Claim(s) 32-40, 45-46, and 51-55 are also rejected since they depend from claim 31, but do not remedy these deficiencies of claim 31.
(New rejection – necessitated by amendment.) Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 recites the limitation "the amino acid changes" in parts (a)(i) and (b)(i) of the claim. There is insufficient antecedent basis for this limitation in the claim, as in these parts, there are no specific “amino acid changes” recited previously in either part (a)(i) or (b)(i).
Claim 33 recites the limitation "the amino acid changes" in parts (a)(iii) and (b)(iii) of the claim. There is insufficient antecedent basis for this limitation in the claim, as in parts (a)(iii) and (b)(iii) there can be one change or more than one change, and the use of “changes” does not agree with a single change.
For at least these reasons, the metes and bounds of the claim are unclear.
(New rejection – necessitated by amendment.) Claims 51-54 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.
Claims 51-53 recite the limitation "the amino acid changes". There is insufficient antecedent basis for this limitation in the claim. First, it should be noted that there can be as little as one amino acid change, so these claims are reciting a plurality of changes when only one change may happen, making the antecedent basis unclear. Second, these claims depend upon claim 33, which recite “amino acid changes” in different areas throughout the claim, as there are “amino acid changes” recited in parts (a) (i) and (iii) and parts (b)(i) and (iii). Third, in claims 51 and 52, it is unclear from the wording of the claims what “no more than 20 or 10 on heavy chain or light chain” or “no more than 5, 4, 3, 2, or 1 on heavy chain or light chain” are referencing, as this could refer to a single amino acid mutation, or regions/domains of amino acids being mutated, or types of amino acids (e.g. cysteines, serines, etc.) being mutated.
For at least these reasons, claims 51-54 are rejected on the grounds of being indefinite.
Claim Rejections - 35 USC § 112(a); First Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 31-40, and 45-46 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as for being non-enabled, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claims 31-40 and 45-46 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, is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claim 46 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in light of the amendments to the claim.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection maintained and extended – necessitated by amendment.) Claims 31-40 and 46 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product/judicial exception without significantly more. This rejection is extended to include new claims 51-54.
The claim(s) recite(s) an anti-human CMB gB glycoprotein antibody defined by partial CDR set. Its functional embodiments are found on page 28 in the table. However, all these antibodies were isolated from human patients (Pg. 25, Examples 2-3). Thus, they are all natural products. While the elected species TRN1019 appeared to have been engineered in Example 4, the CDRs and VH/VL all still appear to be from the naturally isolated antibody and there is no data showing any functional difference between the antibody of Example 4 and the naturally isolated antibody. Further, the constant regions (heavy chain and light chain) of the engineered antibody of Example 4 are not presently claimed until instant claim 33, and even there, there is sufficient breadth for mutations to SEQ ID NOs: 41 and 42 in instant claim 33 and dependent claims 51-54 that allow it to read upon the natural VH/VL residing in the natural heavy/light chain regions. Further limitations, such as being present in a pharmaceutical composition with a buffer, excipient, or carrier, do not impart any meaningful structural or functional limitation that changes the antibody from its naturally occurring counterpart.
This judicial exception is not integrated into a practical application because the claims are all product claims, and no application steps are thus required by the claims. Furthermore, there is no element that changes the structure of the antibody away from that of the natural product or a fragment of said natural product (e.g. instant claims 39, instant claim 55). Therefore, no claim above prevents a monopoly over the natural product. Even claim 46 fails to require anything structurally new to the antibody but can include addition of an excipient such as water, which is in the blood of the human patients from which the antibody was isolated. Indeed, blood itself is a pharmaceutical composition in several contexts. Thus, the claims above do not integrate the natural product into a practical application.
Similarly, the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements required by the claims other than the natural structures or fragments thereof, which themselves are natural. The antibody or blood of patients that produce the same meet all requirements of the claims above and so no additional elements are present to render the claims significantly more. Even if additional ingredients were required in claim 46, as currently recited, these additional recited ingredients are nothing more than well-understood, routine, and conventional in the art of therapeutic antibody compositions, used to provide a stable aqueous solution of injectable antibody.
Taken together, the claims are patent ineligible and rejected here.
Response to Arguments
Applicant's arguments filed 01/12/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are drawn to patent-eligible subject matter, and points to Examples 3 and 4 to show how these antibodies were engineered. However, the issue is the antibody that was generated in Example 4 differs from the instantly claimed 31 antibody as the antibody of the instant claim does not require the particular engineered constant regions used in Example 4. Instead, the antibody of claim 31 still reads on the naturally occurring patient antibody containing those same CDRs or VH/VL regions. Furthermore, Examples 3 and 4 do not teach anything regarding an increase in structural stability, do not show a comparison of the natural anti-gB antibody to the antibody made in Example 4 in terms of antigen binding ability, do not show anything with regards to the selected constant region increasing the half life of TRN1019 relative to the patient’s naturally occurring antibody, nor do Examples 3 or 4 show any markedly different effector activity different from its natural counterpart merely because the variable and constant genes were joined by PCR.
Under the broadest reasonable interpretation, instant claim 31 is drawn to an antibody with the same function and the same CDRs as the naturally occurring antibody from which the TRN1019 variable region/CDR sequences were obtained. Because the claim requires no characteristic that markedly distinguishes the claimed antibody from that naturally occurring counterpart, it recites a product of nature. Narrowing from the six CDR sequences to the complete VH or VL sequences does not introduce any structural difference from the antibody which existed naturally in the patient’s B cell. The distinction is not in how specifically the antibody is defined, but whether that claimed antibody had a markedly different characteristic from its naturally occurring counterpart. In the specification, the inventors specifically sorted gB-antigen-specific memory B lymphocytes from human peripheral blood. There is no evidence that the framework regions in the VH or VL regions differ from those of the naturally occurring antibody. The complete variable region genes were amplified from the individua naturally occurring B cells. The application even reports substantial somatic mutation in those recovered VH sequences, which is consistent with the sequences representing the mature antibody repertoire of the patient’s memory B cells. So, while the framework regions introduced are additional structural limitations, they still appear to be natural limitations. The constant regions are present in claim 33, but it is still not clear that SEQ ID NO: 41 or 42 are different from the naturally occurring wild-type antibody, and, even if they are, claim 33 allows for mutations specifically to the constant region, which can make the antibody more like the wild type antibody and less like the antibody generated in Example 4. This is why it is important to claim specific engineered mutations at specific regions, so it is clear that the claimed product, under broadest reasonable interpretation, possesses markedly different characteristics from its naturally occurring counterpart. There is no data showing that the antibody generated in Examples 3-4 is markedly distinct structurally or functionally from its naturally occurring counterpart.
One suggestion is to claim specific framework regions for the CDRs that are not naturally occurring. For instance, if the CDRs are claimed, then a non-natural framework region can be claimed (e.g. wherein the CDRs are within a framework regions from a murine, goat, or rabbit antibody). Specific framework sequences or specific framework substitutions are preferable, as then the structural distinction is provided for directly in the claim. Another suggestion is to claim that the CDRs are within chimeric antibodies (e.g. TRN1019 human VH/VL associated with a murine constant region). An antibody with a specific engineered framework mutation or engineered Fc mutation (e.g. increase/decrease glycosylation, increase/decrease cysteine bonding, etc.) would also be patent eligible. Incorporation of limitations from claims not included in this rejection into the independent claim would also aid in establishing patent eligibility.
For at least these reasons, the claims remain ineligible, and the arguments were not persuasive.
Claim Rejections - Improper Markush Grouping
(Rejection withdrawn.) The rejection of Claims 31-40 and 45-46 on the judicially-created basis that they contain an improper Markush grouping of alternatives is withdrawn in light of the amendments to the claims.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and is listed below.
Wu C, et. al. Cell Rep. 2025 May 27;44(5):115646. Epub 2025 May 17. Applicant-related post-filing art related to the instant claims.
US20090004198. Teaches Human monoclonal antibody binding to HCMV gB AD1 region. Not utilized as antibody is not the same, but conceptually teaches a similar antibody.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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, MICHAEL ALLEN can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671
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