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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group IV, originally including claims 22 and 23, and drawn to a method of disease diagnosis (new claims 32-43), in the reply filed on 03/19/2026, is acknowledged.
Applicant’s election without traverse of intraplaque hemorrhage (species of diagnosed condition); acute coronary syndrome caused by intraplaque hemorrhage and/or atherosclerosis (species of treatment); in vitro and/or ex vivo diagnosis of intraplaque hemorrhage (species of additional diagnosed condition); heme oxygenase-1, HO-1 (species of imaging condition), in the reply filed on 03/19/2026, is acknowledged.
Claims 44-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/19/2026.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 32-43 are rejected under 35 U.S.C. 103 as being unpatentable over Tearney et al (US 2017/0209049 A1), in view of Wang et al (Journal of Biological Chemistry, 279(41), 42593-42604, 2004) and further in view of Htun et al (Nature Communications, 8:75, 1-16, 2017).
Tearney taught a method comprising inserting a catheter into a blood vessel; providing, through the catheter, light radiation to the blood vessel and a wavelength (between 550 nm and 900 nm); detecting, through the catheter, a second light radiation and a second wavelength (between 640 nm and 900 nm), wherein the second light radiation was based on an autofluorescence of a portion of the blood vessel being impacted by the first light radiation; and determining (e.g., diagnosing) an intraplaque hemorrhage, wherein the intraplaque hemorrhage contains endogenous porphyrins (reads on contacting a biological matter with a porphyrin compound) [claims 55 and 67], and where porphyrins generally contribute to the near infrared autofluorescence (NIRAF) signal [0076].
The determining procedure of Tearney comprised detecting wavelengths; characterizing spectral shape or relative intensity data; and, comparing the autofluorescence data to a training set (e.g., reads on recording the fluorescent response; also taught were: recording data to process and store in real time [0082, 0086, 0088]; recording from a detector to a computer-accessible medium [0096]) [claims 71-75].
Tearney generally taught porphyrin (e.g., endogenous) compounds; however, was silent the compounds instantly recited in claim 32.
Wang taught 5-phenylheme [page 42595, Figure 2, top left compound]:
PNG
media_image1.png
190
165
media_image1.png
Greyscale
.
And, Htun taught that it is highly likely that heme degradation products accumulate in the areas of intraplaque hemorrhage, and then become a source of NIRAF [page 11, last paragraph bridging to page 12].
Since Tearney generally taught that porphyrins contribute to the NIRAF, whereby Tearney’s endogenous porphyrins detected intraplaque hemorrhage, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Tearney, Wang’s 5-phenylheme. Since Htun taught that it is highly likely that heme degradation products accumulate in the areas of intraplaque hemorrhage and, then become a source of NIRAF, the ordinarily skilled artisan would have been motivated to contact Tearney’s blood (e.g., blood vessel as taught by Tearney) with Wang’s 5-phenylpheme (e.g., porphyrin), motivated by the desire to detect the intraplaque hemorrhage.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select 5-phenylheme for incorporation into a procedure, based on its recognized suitability for its intended use as a porphyrin that detects intraplaque hemorrhage. See MPEP 2144.07.
Tearney, in view of Wang and Htun, reads on claims 32-43.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELESTE A RONEY whose telephone number is (571)272-5192. The examiner can normally be reached Monday-Friday; 8 AM-6 PM.
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, Sahana S Kaup can be reached at 571-272-6897. 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.
/CELESTE A RONEY/Primary Examiner, Art Unit 1612
Prosecution Insights