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 .
Receipt is acknowledged of Applicant’s Amendment filed on 10/30/2025.
Claims 20, 30, 38 have been amended.
Claims 20-23, 27-35, 37-38 are pending in the instant application.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 20-23, 27-35, 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over STEWART et al (US 2011/0135736) in view of WRIHGT et al (A simple and robust method for pre-wetting poly (lactic-co-glycolic) acid microspheres. Journal of Biomaterials Applications 2015, Vol. 30(2) 147–159), SHARMA et al (Long-term biocompatibility, imaging appearance and tissue effects associated with delivery of a novel radiopaque embolization bead for image-guided therapy. Biomaterials 103 (2016) 293-304), CAROVAC et al (Application of Ultrasound in Medicine. AIM 2011; 19(3): 168-171), WILLIAMSON et al (Use of real-time B-mode ultrasound for pregnancy diagnosis and measurement of fetal growth rate in captive bottlenose dolphins (Tursiops truncatus). J. Reprod. Fert. (1990) 88, 543-548) and SCONFIENZA et al (Contrast-enhanced ultrasound (CEUS) assessment of superselective uterine fibroid embolization (SUFE): Preliminary experience. Journal of Ultrasound (2008) 11, 158-161).
STEWART teaches a method of monitoring by Doppler ultrasound, radiography, CT scan, etc. (see [0091]) comprising of: selectively targeted by delivering at or near a tumor site (see [0031]) and target vasculature (see [0032]; [0038]; [0056]), which reads on identifying a preferred vascular access route in a target tissue and introducing, an embolic solid-phase particle (see abstract), such as polyvinyl alcohol (PVA; see [0048]) and polylactic-co-glycolic acid (PLGA) microspheres (see [0048]; [0049]; especially at [0126]), which is the same embolic agent used by Applicant (see Applicant’s specification at [0039]) and would have the same chemical/physical properties as claimed by Applicant, such as biodegradable (see [0030]), sono-responsiveness and density, etc.; the embolic agent is used for embolization (see [0016]) and will degrade with time (see [0111]), with no residual debris (see [0113]), normal blood flow one year after treatment (see [0116]). Additional disclosures include: microspheres size of 300-500um (see [0126]; administering a biodegradable microsphere with a platelet binding agent (see [0030]) for cell attachment (see [0054]) and thrombus formation (see [0018], such as collagen (see [0036]), which is the same blood cell/platelet binding agent used by Applicant (see Applicant’s specification at [0039]); administered by catheter (see [0031]; [0057]), which reads on conduit; used to treat uterine fibroids (see [0019]), which is the same medical treatment as disclosed in Applicant’s experiment (see Applicant’s Figures) and reads on tissue requiring augmentation to treat a medical condition; treating tumors (see [0025]); blood stream induces platelet binding and localized activation (see [0021]); tumor cells or hyperplastic tissue diminish or die as a result of loss of localized blood flow (see [0021]).
STEWART does not teach modifying the PLGA embolic agent to be wettable through chemical treatment, such as using ethanol; or that the ultrasound is B-mode ultrasound.
WRIGHT teaches the prior art had known of hydrophilization/wetting PLGA microspheres by immersion in ethanol (see abstract), wherein wet/hydrophilize surface allow cell attachment (see pg. 147, under Introduction).
SHARMA teaches the prior art had desired increasing hydrophilicity for handling and microcatheter delivery (see pg. 294, 1st col) in embolization beads (see title), such as PVA microparticles (see pg. 293, under Introduction; and pg. 294, under section 2.1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate modifying the PLGA embolic agent to be wettable through chemical treatment, such as immersion in ethanol. The person of ordinary skill in the art would have been motivated to make those modifications, because this would increase cell attachment for embolization and would have the prior art’s desire of increasing hydrophilicity for handling and microcatheter delivery, and reasonably would have expected success because the references have the same field of endeavor, such as embolization and cell attachments/bindings.
CAROVAC teaches application of ultrasound in medicine (see title) include A-mode, B-mode, M-mode, and Doppler mode (see pg. 169, 1st col), wherein “B-mode of the sonography became the widely accepted method” (see pg. 168, 2nd col) and development of real-time system led to, even, to the possibility of the continued visualization or the ultrasound fluoroscopy (see pg. 168, 2nd col), which would allow determining the travel and location of the embolic agent. Additional disclosures include: Doppler mode measures and visualizes blood flow (see pg. 169, 1st col); in B-mode ultrasound a linear array of transducer simultaneously scans a plane through the body that can be viewed as a two-dimensional image on screen (see pg. 169, 1st col) and in M-mode a rapid sequence of B-mode scans whose images follow each other in sequence on screen enables doctors to see and measure range of motion, as the organ boundaries that produce reflections move relative to the probe (see pg. 169, 1st col); example of display of the fetus in uterus (see pg. 169, Figure 3); B-mode and Doppler effect can also be observed in M-mode examples (see Figure 1 and 2).
WILLIAMSON teaches the prior art had known of real-time B-mode ultrasound (see title).
SCONFIENZA teaches the prior art had known of using B-mode sonographic examination/ultrasound assessment (see title and pg. 159, 2nd col) in uterine fibroid embolization.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate monitoring by A-mode, B-mode, M-mode and/or Doppler mode, especially B-mode for real-time monitoring. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow two-dimensional image and rapid sequence of B-mode scans whose images follow each other in sequence to visualizing/monitoring what is happening to the embolic agent in the body from start to finish/degradation during uterine fibroid embolization, especially when real-time monitoring would be better than snap shots of monitoring, and reasonably would have expected success because using well-known visualization methods, such as ultrasound, CT scan, MRI, etc., and B-mode sonographic examination/ultrasound have been conducted in uterine fibroid embolization. Note, it would have been obvious to repeat the ultrasound monitoring if needed to visualize the area of treatment.
Conclusion
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618