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 .
DETAILED ACTION
Applicant’s arguments, filed 6/17/2026, have been fully considered but they are not deemed to be (fully) persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claims 1-8 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 recitation “is known” in claims 6-7 further renders the claims indefinite as it is unclear who or what is doing the knowing and how they determined that the parameter “is known,” and the claim therefor fails to provide an objective, precise boundary for “is known.” Further regarding claims 6-7, the claims are unclear because they do not recite in what way the concentration is determined “based on the ratio” (claim 6) and “based on the density” (claim 7). Claim 1 recites “the tissue.” As there is no tissue previously enumerated in the claim, there is insufficient antecedent basis for this “the tissue.”
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that “is known” is commonly used in patent claims to indicate that parameter has been predetermined or established prior to use, applicant has provided no evidence for this statement, nor the assertion that “is known” means that the ratio or density has been determined by or measured beforehand and is available for use in the concentration calculation. Applicant has shown no evidence of above, nor has applicant addressed the rejection, which states that “is known” further renders the claims indefinite as it is unclear who or what is doing the knowing and how they determined that the parameter “is known,” and the claim therefor fails to provide an objective, precise boundary for “is known.” As the application is unclear as to who or what is doing the knowing, and what is known, and how what is known is used in the claim, the artisan would not know the scope of the claim and what systems fall under the scope of applicant’s invention and which systems do not. Regarding applicant’s argument that the claim is clear as to how the concentration is determined as it recites “by converting a concentration of marking additive to the concentration of the chemical substance based on the ratio,” applicant has not addressed the rejection as the basis of the rejection is that the claim nor does the application clarify what property of aspect of the density is used in the determining and how that property or aspect is used to determine the concentration. Applicant’s tatement that it means “the density is used in an in put to derive the concentration,” this is not in the application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20170301082 to Allmenoinger (IDS filed 10/12/2023). Allmenoinger teaches a system comprising a source comprising a therapeutic chemical substance, such as water (paragraphs 4-5 and 114), and a marking additive, such as iodine (a therapeutic agent; iodine is spectrally visible) (paragraphs 5-6, 60-62, 91, 99, 119-126), wherein the iodine is incorporated into the water (the marking additive is incorporated into the chemical substance) (paragraphs 4-5), a computed tomography (CT) device (an imaging device), and a computer (a computing device) (paragraphs 15-16) configured to analyze an image captured by the imaging device of a tissue after the chemical substance and the marking additive have been delivered to the tissue and determine a concentration of the chemical substance in the tissue (paragraphs 4, 6, 9-10, 13, 58, 60-21, 83-85, 99, 102, 114-115, and 121-123, 190, 211, 230-231). The chemical substance is therapeutic and configured to deliver iodine (a therapeutic chemical) to a target region in the tissue (paragraphs 5-6, 60-62, 91, 99, 119-126). The chemical substance and the marking additive deposit homogeneously in vasculature of tissue (5, 10-11, and 101). The amount of water and iodine are measured, which is deemed to read on “is known,” and Allmenoinger teaches that the concentration of the iodine in water can be determined by converting a concentration of iodine to the concentration of the water based on the ratio, and further teaches that the density of water and iodine can be used to determine the concentration (paragraph 96, 111, 114-115, and 134). This reads on wherein a ratio of the chemical substance to the marking additive is known and the concentration of the chemical substance is determined by converting a concentration of marking additive to the concentration of the chemical substance based on the ratio (claim 6), and wherein a density of a mixture of the chemical substance and the marking additive is known and the concentration of the chemical substance is determined based on the density (claim 7).
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that there is no “therapeutic chemical substance” in Allmeninger, the examiner’s response is that water is a therapeutic chemical substance in medical contexts because it is actively used to treat, prevent, or support recovery from health conditions, and its administration is regulated and monitored by healthcare professionals. Water is not the same as iodine. Regarding applicant’s argument that the reference does not teach determining, the examiner’s response is that the amount of water and iodine are measured, which is deemed to read on “is known,” and Allmenoinger teaches that the concentration of the iodine in water can be determined by converting a concentration of iodine to the concentration of the water based on the ratio, and further teaches that the density of water and iodine can be used to determine the concentration (paragraph 96, 111, 114-115, and 134). This reads on wherein a ratio of the chemical substance to the marking additive is known and the concentration of the chemical substance is determined by converting a concentration of marking additive to the concentration of the chemical substance based on the ratio (claim 6), and wherein a density of a mixture of the chemical substance and the marking additive is known and the concentration of the chemical substance is determined based on the density (claim 7).
Conclusion
Applicants amendment necessitated the new grounds of rejection. Therefore, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
August 25, 2026
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