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 .
Status of Claims
Claims 10 and 12-20 are pending in the instant application.
Claims 1-9 and 11 have been canceled.
Election/Restrictions
Newly submitted claims 16-20 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: In the reply to the restriction requirement received December 1st, 2025, Applicant elected group II, drawn to a conjugate of formula FG0-1-L-Q2-8. Claims 16-20 are drawn to methods of using the elected invention. Per MPEP 806.05(h), “A product and a process of using the product can be shown to be distinct inventions if either or both of the following can be shown: (A) the process of using as claimed can be practiced with another materially different product; or (B) the product as claimed can be used in a materially different process.” In the instant case, the product as recited in Claims 10 and 12-15 could be used, for example, in in vitro experiments not directed toward a method of treatment and/or tumor visualization as required by Claims 16-20. Further, Claims 16-20 could be practiced with compounds materially different than those instantly claimed.
Since applicant has 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 Accordingly, claims 16-20 are withdrawn from consideration as being directed to a non-elected invention.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 applicant 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.
Withdrawn Objections/Rejections
The replacement drawings received with the response filed May 28th, 2026 are acknowledged and are sufficient to overcome the objection to the drawings raised in the non-final rejection mailed January 8th, 2026. This objection is hereby withdrawn.
Applicant’s abstract submitted May 28th, 2026 is sufficient to overcome the objections to the specification raised in the non-final rejection mailed January 8th, 2026. This objection is hereby withdrawn.
The objection to Claim 11 is rendered moot in view of the amendment and cancellation of Claim 11. This objection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection over Claims 16-18 under 35 U.S.C. 112(d). This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 10-11 and 15-17 under 35 U.S.C. 103. Applicant’s cancellation of Claim 11 renders the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 11 renders the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of Claims 10, 12-13, and 15 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 is maintained.
Applicant has traversed this rejection, stating in the remarks filed May 28th, 2026 that “the Examiner has not explained the basis for their reasoning that the compounds encompassed by claims 10-13 are too expansive to determine the meets and bounds of the claimed invention.” Further, Applicant states “it is clear from the claims, read in light of the specification, that the compounds contained the claimed Markush groupings are quite specific for their intended purpose and limited by the requirements listed above.” Additionally, Applicant points to the amendment to Claim 10, stating “The presently provided claims specify the essential features of the invention – multiple (2-8) head-groups Q that are capable of binding to carbonic anhydrase IX, wherein said Q are defined by specific formulas.”
The examiner does not find this persuasive.
While the amendment overcomes the indefiniteness with respect to the possible moieties that can be Q, the claims are still indefinite with respect to the metes and bounds of moieties suitable to define L and FG in the recited formula FG0-1-L-Q2-8-.
In light of the specification, Applicant states “The compounds claimed herein via Markush groupings are a specific subset of compounds which 1. Target CA IX with high affinity [0004], 2. Are linkable via optional linker chemistry to allow for multiple head-groups to increase binding affinity [0016] and 3. Contain one or more functional group, therapeutical agents or imaging agents [0009]-[0012]. As such, it is clear from the claims, read in light of the specification, that the compounds contained the claimed Markush groupings are quite specific for their intended purpose and limited by the requirements listed above.”
In view of this statement, while the intended purpose of the compounds may be clear, but the structure of these compounds is not. The specification does not contain a definition for the Linker L or functional group, FG, that would direct a person having ordinary skill in the art to ascertain which moieties are appropriate for installation as L or FG in the recited formula FG0-1-L-Q2-8, nor would a person having ordinary skill in the art readily be able to understand the motivation for selecting a specific L or FG moiety.. Examples in the specification are non-limiting, and do not establish the metes and bounds of the recited claim limitations.
In other words, the breadth of the compounds that read on the formula FG0-1-L-Q2-8- is such that a person having ordinary skill in the art can not readily envisage all of the compounds defined by this Markush grouping. To this end, FG, when further limited at Claim 13 may be defined as a “therapeutic agent.” The specification provides no definition of therapeutic agent such that a person having ordinary skill in the art would understand the structures that satisfy this limitation. A person having ordinary skill in the art would readily envisage a myriad of moieties that might satisfy the limitation of “therapeutic agent,” and this broad limitation encompasses moieties that are both known presently and those yet to be discovered that would satisfy the broadest reasonable interpretation of a “therapeutic agent.”
These claims are rendered indefinite, not merely for breadth, but because the breadth of these limitations is so expansive as to not establish readily ascertainable metes and bounds of the limitation. Per MPEP 2173.05(h), I., “In certain circumstances, however, a Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention. For example, if a claim defines a chemical compound using one or more Markush groups, and that calim encompasses a massive number of distinct alternative members, the claim may be indefinite under 35 U.S.C. 112(b) if one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group(s). In such a circumstance, a rejection of the claim for indefiniteness under 35 U.S.C. 112(b) is appropriate.”
The following rejections are necessitated by amendment:
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kleemann et. al. (CA 2 546 602, publicly available 1995; issued 2008; hereinafter referred to as Kleemann).
At Page 22, Kleemann teaches compounds of the general formula:
PNG
media_image1.png
171
378
media_image1.png
Greyscale
At Page 53, Kleemann teaches a compound of this formula as example 10, wherein these variables are defined as follows:
R(1) and R(10) are each H.
R(2) and R(9) are each H.
R(3) and R(8) are each
PNG
media_image2.png
41
65
media_image2.png
Greyscale
.
R(4) and R(7) are each H2NSO2-.
R(5) and R(6) are each H.
For clarity, the full structure of this compound is:
PNG
media_image3.png
430
544
media_image3.png
Greyscale
This compound reads on a compound of formula FG0-1-L-Q2-8 as recited at instant Claim 10 when the variables are defined as follows:
FG is absent.
L is a linker that is
PNG
media_image4.png
88
87
media_image4.png
Greyscale
.
The linker links two Q groups, wherein each Q is
PNG
media_image5.png
146
151
media_image5.png
Greyscale
, wherein R is phenyl.
Regarding Claim 15, Kleemann teaches that this compound is suitable for use in a pharmaceutical to be administered orally, parenterally, intravenously or rectally, or by inhalation, and may be administered with pharmaceutical auxiliary substances both in veterinary and human medicine.
Allowable Subject Matter
Claim 14 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 10, 12-13, and 15 are rejected.
Claim 14 is objected to.
Claims 16-20 stand withdrawn.
No claim is 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights