DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 3/24/26 has been entered in full. Claims 1-3 are amended. Claims 6-8 are canceled. Claims 1-5 and 9-15 are pending.
Applicants’ election of Group I, currently claims 1-5, was previously acknowledged and treated as an election without traverse. Claims 9-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The elections of (1) “PD1 and IFNg” as the species of “first measured surface marker”, and (2) bexmarilimab as the species of “Clever-1 binding agent” were also previously acknowledged. These elections read on each claim in the elected group.
Claims 1-5 are under consideration, as they read upon the elected species.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (2/4/26).
The specification objection at page 2 is withdrawn in view of the amended title.
All objections and/or rejections of canceled claims 6-8 are moot.
The objections to claims 1-5 at page 3 are withdrawn in view of the amendments to the claims, except for those indicated as maintained below.
The rejection of claims 1-5 at pages 3-5 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims, except for those indicated as maintained below.
The rejection of claims 1-5 at pages 6-10 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims.
Maintained Objections and/or Rejections
Claim Objections
Claims 1-5 are objected to because of the following informalities:
In claim 1, line 11, “IFNg level” should be “IFNg”; compare with lines 10, 13 and 15.
This objection was set forth at page 3 of the 2/4/26 Office action.
In the reply at page 6, Applicants indicate that the claims have been amended as suggested for each of the objections set forth in the previous Office Action. However, the above change to line 11 of claim 15 was not made. Instead, the word “level” was removed on line 15. As such, the objection set forth previously is maintained.
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.
Claims 1-5 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 pre-AIA the applicant regards as the invention. This rejection was set forth at pages 3-6 of the 2/4/26 Office action.
Several grounds of rejection set forth previously are maintained.
---At page 4, the following ground of rejection was set forth:
“In claim 1, lines 14-16, the antecedent basis of “said cell surface markers” is unclear with respect to the alternative portion of the measuring step that is directed only to measuring the expression level of IFNg. More specifically, the measuring step of claim 1 is directed to measuring the expression levels of “two or more cell surface markers … and/or interferon gamma (IFNg)”, and the conjunction “and/or” encompasses “or”, and as such the step encompasses, in the alternative, measuring only the expression level of IFNg. In this case, the concluding wherein clause is directed only to “wherein… an increase in the IFNg level is an indication for initiation of concomitant administration of an agent that affects said surface markers”, but in this alternative it is unclear which cell surface markers are being referenced, because only IFNg (which is not a cell surface marker) has been measured.”
In the reply at page 7, Applicants respond:
“The Office contends that "the measuring step of claim 1 is directed to measuring the expression levels of 'two or more cell surface markers... and/or interferon gamma (IFNg)'," but in the alternative where only IFNg is measured "it is unclear which cell surface markers are being referenced, because only IFNg (which is not a cell surface marker) has been measured." Without conceding that claim 1 was unclear as previously phrased, the replacement of "said cell surface markers" with "the two or more cell surface markers" and the addition of the second "wherein" to the final clause of claim 1 resolves any alleged unclarity on these points”.
These arguments, and the amendments to the claims, have been fully considered but are not found persuasive. It remains that in alternative, claim 1 encompasses measuring only IFNg (lines 8-10), comparing only the level of IFNg (lines 1111), and then observing an increase in the IFNg level as “an indication for initiation of the concomitant administration of an agent that affects said cell surface markers”. However, in this embodiment no cell surface markers were measured, and thus it is indefinite which cell surface markers are being referenced with respect to the agent to be administered. In order to clarify this embodiment, the claim must clearly indicate what cell surface markers are being targeted when only IFNg is measured and found to be increased.
---At page 4, the following ground of rejection was set forth:
“In claim 1, lines 15-16, it is unclear whether “an agent that affects said cell surface markers” is a single agent that affects both of the two or more cell surface markers, or multiple agents; i.e., one agent per marker.”
In the reply at page 7, Applicants respond:
“The Office contends that "it is unclear whether 'an agent that affects said cell surface markers' is a single agent that affects both of the two or more cell surface markers, or multiple agents; i.e., one agent per marker." Applicant respectfully disputes that there is a need to make this distinction, or that there is any corresponding unclarity about the distinction. The Federal Circuit has repeatedly emphasized the general rule that "the indefinite article 'a' means 'one or more' in open-ended claims containing the transitional phrase 'comprising."' Salazar v. AT&T Mobility, 64 F.4th 1311, 1315 (Fed. Cir. 2023). The application of the general rule to this claim results in the conclusion that "an agent" means "one or more agents," such that both "a single agent that affects both of the two or more cell surface markers" and "multiple agents, one per marker" are included in the recitation "an agent." There is nothing unclear from this result. The ordinary reader applying the ordinary canons of claim construction can easily understand the meaning of the recitation "an agent" in this context.”
These arguments have been fully considered but are not found persuasive. While it is found persuasive that, in accord with Salazar, “an agent” may broadly encompass “one or more agents”, each of the “one or more agents” must be capable of performing the recited function, i.e., each of the “one or more agents” must affect said cell surface markers (multiple markers). See Salazar at pages 10-11, which discusses “claim language that introduces a claim element using an indefinite article and further defines the element with subsequently recited functionality” (page 10). Salazar quotes an earlier decision which provided an example of such: “For a dog owner to have “a dog that rolls over and fetches sticks,” it does not suffice that he have two dogs, each able to perform just one of the tasks” (page 10). Thus, in the instance case, it does not suffice to have two agents each of which affects one cell surface marker; instead, each of the “one or more agents” must affect all of “said cell surface markers” (which refers to “two or more cell surface markers” from the selected group for antecedent basis). Applicants’ reply at page 7, however, states on the record that the term is intended to encompass “multiple agents, one per marker”. Furthermore, dependent claim 5 encompasses administration of multiple agents that only affect a single marker rather than the minimum of “two or more cell surface markers”. Thus, it is maintained that the claimed method is indefinite as it is not clear whether “an agent that affects said cell surface markers” is a single agent that affects multiple markers, or multiple agents that each affect one marker.
---At page 5, the following ground of rejection was set forth:
“In claim 4, line 2, the antecedent basis of “the sample” (singular) is unclear because parent claim 1 refers to two samples obtained at different time points, and thus it is unclear whether the limitation in claim 4 applies to only one or both”
In the reply at page 8, Applicants respond:
“The Office contends that in claim 4, line 2, the antecedent basis of “the sample” (singular) is unclear because parent claim 1 refers to two samples. Claim 2 is herein amended to recite “the samples.””
The amendment has been fully considered, but is not sufficient to overcome this ground of rejection, because it has been made to claim 2 instead of claim 4. Amended claim 2 to recite “the samples” has also introduced a new ground of objection and a new ground of rejection under 35 U.S.C. 112(b) (see below).
---At page 5, the following ground of rejection was set forth:
“Claim 5 is further indefinite because parent claim 1 is directed to administration of “an agent” but claim 5 indicates administration of “PD1 and/or PD-L1 inhibitor” which, in the alternative, encompasses two agents.”
In the reply at page 8, Applicants respond:
“…the Office contends that claim 5 is further indefinite because claim 1 is directed to administration of "an agent" but claim 5 indicates administration of "PD1 and/or PD-L1 inhibitor," which encompasses two agents. As noted above, the ordinary, canonical construction of "an agent" is "one or more agents." There is, therefore, nothing unclear about the possibility of two agents, when the skilled reader approaches the language of claims 1 and 5 within the context of the ordinary canons of claim construction.”
This argument has been fully considered but is not found persuasive. As set forth above, while it is acknowledged that “an agent” may encompass “one or more agents”, each of the agents in the recitation of “one or more agents” must have the required functionality; i.e., affecting the “said cell surface markers” (which relies on “two or more cell surface markers” for antecedent basis) that are measured as part of the method. However, each of the agents recited in dependent claim 5 only affects a single cell surface marker, PD-1 or PD-L1), and thus is not encompassed by either “an agent” or “one or more agents”, each of which affects two or more cell surface markers.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
New objections and/or rejections necessitated by Applicants’ amendment
Claim Objections
Claims 1-6 are objected to because of the following informalities:
In claim 1, line 2 as amended includes a marking indicating that a space has been deleted between “Clever-1” and “has”, i.e., “…Clever-1-has…”, which results in the claim now reading “…Clever-1has…” This space should be re-introduced to the claim.
In claim 1, line 5, the comma at the end of the line is now missing. This should be added back, i.e., “agent capable of binding to Clever-1 to a patient,”
In claim 1, line 14, “absence of desired change” should be “absence of a desired change”.
In claim 1, line 18, “bexmarilmab variant” should be “a bexmarilimab variant”.
In claim 2, line 1 as amended recites “the samples”, which is plural, but the verb has not been correspondingly updated; i.e., changing “is obtained” to “are obtained”. However, prior to correcting the verb, Applicants are requested to check that the change from “the sample” to “the samples” was intended to be made in claim 4, not claim 2.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
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.
Claim 2 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 pre-AIA the applicant regards as the invention.
Claim 2, as amended, recites in lines 1-2, “…characterized in that the samples at the first point of time is obtained prior to the beginning of the anti-Clever-1 therapy…” While there are two samples recited in parent claim 1, only one is from the first point of time; the other sample is taken “at a later point of time after the administration of an agent capable of binding to Clever-1”. Thus, the antecedent basis for “the samples” in claim 2 is unclear, rendering the claim indefinite. As indicated above, it appears that this change was intended to be made in claim 4 rather than claim 2.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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