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 .
Claim Objections
Claims 16 and 9 are objected to because of the following informalities:
Claim 16, line 3, “the” should be inserted before “at least one of the CT scan and the MRI scan”.
Applicant is advised that should claim 8 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
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.
Claim(s) 1-3, 6, 11-15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0290547 (Levine).
1. A method or use for managing one or more acute ischemic events, the method or use comprising:
delivering a guidewire (guidewire 150) through a microcatheter (catheter 170) to a site of a clot in the vasculature (FIG. 11A-11B; P0125), the guidewire comprising one or more sensors (density sensor 156 and/or pH sensor) connected to or adjacent a distal portion of the guidewire, the one or more sensors configured to measure properties of the clot in the vasculature (FIG. 11B; P0126 and P0142);
sensing properties of the clot using the one or more sensors at a first location of the site of the clot in the vasculature (FIG. 11B; P0126 and P0142); and
generating an output from the sensed properties, whereby the output relates to at least one of a chemical composition and physical properties of the clot (FIG. 11B; P0126 and P0142).
2. The method includes selecting one or more devices and/or procedural steps to treat the clot based on the output (P0127).
3. The distal portion of the guidewire is an atraumatic clot-circumventing configured distal end, and wherein the one or more sensors are circumferentially disposed or wrapped about an outer surface of the guidewire (FIG. 11B; P0126 and P0142).
6. The method incudes classifying the clot based on the sensed properties and generating a classification (P0115).
11. The one or more sensors are one or more fiberoptic strands or bundles disposed on an outer surface of the guidewire and operable to transmit and collect certain ranges of the electromagnetic spectrum (FIG. 11B; P0126-P0127 and P0071).
12. The method includes ascertaining one or more physical properties of the clot by measuring different spectral features of the clot based on the output (FIG. 11B; P0126-P0127 and P0142).
13. The method includes interpreting information contained in the output to determine in real-time at least one of levels of red blood cell content, white blood cell content, platelet content, levels of fibrin, a clot size, a clot shape, a clot density, and a clot location in the vasculature (FIG. 11B; P0126-P0127 and P0142).
14. The method includes sensing properties of the clot using the one or more sensors at a second location distal or proximal of the clot and the first location (P0119, P0133, P0142); and generating an output from the second location, whereby the output of the second location relates to at least one of a chemical composition and physical properties of the clot (P0119, P0133, P0142).
15. The method includes classifying the clot based on the output and one or more of a clinical exam, a blood test, a computerized tomography (CT) scan, a magnetic resonance imaging (MRI) scan, an ultrasound scan, a cerebral angiogram, and an echocardiogram (P0114 and P0119).
17. The method includes determining criteria of the clot by determining one or more quantitative indications selected from one or more of white blood cell levels, red blood cell levels, serum levels, fibrin levels, clot size, clot location, clot strength, clot elasticity, rate of clot formation or rate of clot lysis (e.g., at least clot location at P0096 and P0119).
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.
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.
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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0290547 (Levine), as applied above, and further in view of US 10,667,833 (Vale).
Levine discloses the invention substantially as claimed as discussed above but does not disclose the guidewire distal portion being flattened. Vale teaches a method in the same field of endeavor having a guidewire distal portion which is a flattened distal portion having a planar geometric shape and thickness less than an outer diameter of a remaining non-flattened portion (FIG. 2A and 10A; col. 7-8, lns. 65-32) for the purpose of providing an atraumatic tip (FIG. 2A and 10A; col. 7-8, lns. 65-32). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire distal portion of Levine to be flattened as taught by Vale in order to provide an atraumatic tip.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0290547 (Levine), as applied above, and further in view of US 2008/0300493 (Gatto).
Govari discloses the invention substantially as claimed as discussed above but does not disclose the instrumentation being for near infrared spectroscopy. Gatto teaches a method in the same field of endeavor where a reading of a clot is taken by instrumentation for near infrared spectroscopy (P0007) for the purpose of non- invasively and rapidly detecting a blood clot as well as its component parts (P0007). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of Levine to be for near infrared spectroscopy as taught by Gatto in order to non-invasively and rapidly detects a blood clot as well as its component parts.
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0290547 (Levine), as applied above, and further in view of US 2019/0380351 (Carreel).
Levine discloses the invention substantially as claimed as discussed above and further discloses the sensor being disposed on an outer surface of the guidewire (FIG. 11B; P0126-P0127) but does not disclose the sensor being an impedance sensor. Carreel teaches a method in the same field of endeavor having an impedance sensor (P0072) for the purpose of classifying the clot/lesion based on impedance spectra (P0072). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of Levine to be an impedance sensor as taught by Carreel in order to classify the clot/lesion based on impedance spectra.
Claim(s) 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0290547 (Levine), as applied above, and further in view of US 2020/0046267 (Govari).
Levine discloses the invention substantially as claimed as discussed above and further discloses the sensor being disposed on an outer surface of the guidewire and operable to transmit and collect certain ranges of the electromagnetic spectrum (FIG. 11B; P0126-P0127) but does not disclose the sensor being a Raman spectroscopy sensor. Govari teaches a method in the same field of endeavor having a Raman spectroscopy sensor (P0004) for the purpose of classifying the clot/lesion based on scattered radiation (P0004). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of Levine to be a Raman spectroscopy sensor as taught by Govari in order to classify the clot/lesion based on scattered radiation.
Levine discloses the invention substantially as claimed as discussed above and further discloses analyzing information to determine physical and/or chemical composition of the clot, including levels of red blood cell content, white blood cell content, levels of fibrin, a clot size, a clot shape, and/or a clot location in the vasculature (e.g., at least clot location at P0096 and P0119) but does not disclose determining criteria of the clot by performing at least one of a CT scan. Govari teaches a method in the same field of endeavor having a clot criteria determined by performing a CT scan (P0021) for the purpose of determining clot criteria other than composition through CT imaging (P0021). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Levine to determine clot criteria (e.g., clot location) via CT scan imaging as taught by Govari in order to determine clot criteria other than composition through CT imaging.
Allowable Subject Matter
Claim 5 is 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights