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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/21/25, 11/1124, 10/08/24, 09/23/24, 09/16/24, 06/24/24, 06/04/24, 05/28/24, 03/08/24, 02/13/24, 02/06/24, 01/18/24, 12/15/23, 12/14/23, 11/08/23, 11/01/22 and 05/24/22 has been considered by the examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on December 30, 2025 has been entered.
Amendment Entered
In response to the amendment filed on December 30, 2025, amended claims 1, 4 and 6 have been entered.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action regarding Gunther, were fully considered, but were not persuasive. Applicant argues Gunther teaches a method of adhering a coating where the coating binds to iron ions, and once the coating is bound to the iron ions on the surface of the material, the iron-ion-consuming ability of the coating is destroyed since the coating used its ion-binding capacity to attach to the surface. Applicant further adds that whereas in the instant application, the ion-consuming coating/materials are needed to bind free ions after they are disposed on the surface of a material. Examiner notes that the need for the second ion-consuming coating is not clear. Therefore, this argument is moot.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Shi reference), and updated obviousness rationale.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kosa (U.S. Patent Document 8694069 B2) and in further view of Shi (CN105527264A)
Kosa was submitted in Applicant’s IDS and the previous office action
Regarding claim 1, Kosa teaches a probe for real-time sensing of a target biomarker [col. 4: lines 29-42] comprising: a needle comprising a tip and having an opening [col. 10: lines 48-67]; a luminescent probe encased within the opening of the needle [fig. 10A, elements 1030, 104; col. 31: lines 20-44], wherein the luminescent probe comprises a biomarker luminescent material disposed within and covering the opening of the needle [fig. 10A, elements 1030, 104; col. 8: lines 31-67, col. 31: lines 20-44; Examiner notes there is luminescent material within and surrounding the probe. Additionally, the probe covers the opening of the needle]; a coating comprising a biomarker luminescent material adjacent to or inside the tip of the needle [col. 6: lines 5-22; col. 10: lines 48-67]; wherein the biomarker luminescent material is in contact with a biological tissue more than once [col. 5: lines 16-37]
However, Kosa does not teach a coating comprising the biomarker luminescent material, and a first ion-consuming material, wherein the coating is adjacent to or inside the tip of the needle.
Shi teaches a coating comprising the biomarker luminescent material, and a first ion-consuming material, wherein the coating is adjacent to or inside the tip of the probe [par. 39, “ferric ions can specifically bind to oligoT 20 sensitized europium ion fluorescent probes, causing fluorescence quenching”, Examiner interprets ions binding to the probes, as an ion-consuming material]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kosa, to incorporate the biomarker luminescent material, and a first ion-consuming material, wherein the coating is adjacent to or inside the tip of the probe, to detect iron, as evidence by Shi [par. 9].
Regarding claim 2, Kosa further teaches the biomarker luminescent material comprises a fluorescent molecule [col. 24: lines 63-67-col. 25: lines 1-26]
Regarding claim 4, Shi further teaches the first ion-consuming material reacts to iron ions within the presence of blood [par. 9].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kosa, to incorporate the first ion-consuming material reacts to iron ions within the presence of blood, for achieving real-time, in-situ, highly sensitive quantitative detection of ferric ions and applying it to the determination of ferric ions in biological blood, as evidence by Shi [par. 9].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kosa and Shi and in further view of Currie (U.S. Patent Application Publication 2014/0025000 A1)
Currie was applied in Applicant’s IDS and the previous office action
Regarding claim 3, Kosa and Shi teach a probe for real-time sensing of a target biomarker, as disclosed above.
However, Kosa and Shi do not teach the fluorescent molecule comprises fluorescein.
Currie teaches the fluorescent molecule comprises fluorescein [par. 88, 178].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kosa and Shi, to incorporate the fluorescent molecule comprises fluorescein, as is a preferred fluorescent molecule in the art, as evidence by Currie [par. 88]. Additionally, it would have been obvious to one skilled in the art at the filing date of the invention to modify Kosa by incorporating fluorescein as the fluorescent molecule as taught by Currie, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kosa and Shi and in further view of Wang (CN 108114347 A)
Wang was applied in Applicant’s IDS and the previous office action
Regarding claim 5, Kosa and Shi teach a probe for real-time sensing of a target biomarker, as disclosed above.
However, Kosa and Shi does not teach the probe can signal the presence or absence of blood in real-time
Wang teaches the probe can signal the presence or absence of blood in real-time [par. 5, 7].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kosa and Shi, to incorporate the probe can signal the presence or absence of blood in real-time, to detect when a blood vessel is pierced, as evidence by Wang [par. 5].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kosa and Shi and in further view of Gunther (U.S. Patent Document 6423296 B2)
Gunther was applied in the previous office action
Regarding claim 6, Kosa and Shi teach a probe for real-time sensing of a target biomarker, as disclosed above.
However, Kosa and Shi do not teach a second ion-consuming material disposed underneath the first ion-consuming material wherein the second ion- consuming material has a stronger affinity for iron than the first ion- consuming material.
Gunther teaches a second ion-consuming material disposed underneath the first ion-consuming material wherein the second ion- consuming material has a stronger affinity for iron than the first ion- consuming material [col. 10: lines 18-32, col. 11: lines 23-27].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kosa and Shi, to incorporate a second ion-consuming material disposed underneath the first ion-consuming material wherein the second ion- consuming material has a stronger affinity for iron than the first ion- consuming material, for eliminating excess iron, as evidence by Gunther [col. 9: lines 49-67].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791