DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed January 16, 2026. Currently, claims 1-2, 8, 10, 12-16 are pending.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
Power of Attorney
It is noted there is no Power of Attorney in the file. A filing of a paper does not show authorization to conduct an interview (see MPEP 405). Thus, the examiner was unable to contact Applicant to interview or discuss the case. Applicant may wish to file a POA so the examiner may contact Applicant to discuss the merits of the case in the future.
Priority
This application is a 371 of PCT/EP2021/064009, filed May 26, 2021 and claims priority to EPO 20305551.2, filed May 27, 2020.
Drawings
The drawings are acceptable.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mengozzi et al. (Anatol J. Cardiol. Vol. 23, pages 254-259, April 4, 2020) in view of Font et al. (Stroke Res. Treat. Vol. 2011, Article ID 607852, March 2011).
Mengozzi teaches cardioembolic thrombi consists of less RBCs (page 256, col. 1). RBCs are about as high in cryptogenic stroke as in cardioembolic stroke but definitely lower than in non-cardioembolic stroke (page 256, col. 1). Mengozzi further teaches relevant amounts of extracellular DNA are observed particularly in platelet-rich areas and boundary zones between platelet-rich and RBC-rich regions, whereas no DNA is found within the RBC-rich regions. Mengozzi thus teaches cardioembolic stokes have lower RBC content. Lower RBC content would have higher DNA.
Mengozzi does not teach treating cardioembolic stroke patients with an anticoagulant.
However, Font is a review of recommendations for patients with cardioembolic stroke types. Treatments include paroxysmal, warfarin, aspirin, antiplatelet, etc. .
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have tested patients who had strokes for DNA content in thrombi and administered an anticoagulant to the patient when high DNA was found. The ordinary artisan would have been motivated to have administered the patient the well-known preventative therapies, as taught by Font.
Response to Arguments
The response traverses the rejection. The response asserts “it cannot be assumed that less RBCs automatically translates to a higher DNA content”. This argument has been considered but is not convincing. The response has not provided any evidence that “other thrombus components such as fibrin or leukocytes are increased in cardioembolic thrombi vs non-cardioembolic thrombi while the DNA content is relative the same. The evidence on record in Mengozzi teaches that cardioembolic thrombi have less RBCs than non-cardioembolic thrombi and that RBC-rich regions have no DNA. While the response argues that it cannot be assumed that less RBCs automatically translates to higher DNA content, the ordinary artisan would have good reason to pursue the known options within his or her technical grasp to determine DNA content is higher in thrombi with lower RBC. It would have been obvious to try detecting higher levels of DNA as indication a patient has cardioembolic stroke. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense (see MPEP 2143 (E)). The ordinary artisan would have performed the analysis suggested by Mengozzi to determine if less RBCs translates to higher DNA content.
Even more, the art does not support Applicants that “other thrombus components such as fibrin or leukocytes are increased in cardioembolic thrombi vs non-cardioembolic thrombi while the DNA content is relative the same. Staessens et al. (Haematologica, Vol. 105, No. 2, pages 498-507, May 12, 2019) teaches RBC-rich area have limited complexity as they consist of RBC that are entangled in a meshwork of thin fibrin. Where platelet-rich areas are characterized by dense fibrin structures aligned with abundant amounts of leukocytes and DNA that accumulate around and in the platelet rich areas. Staessens teaches regions with less RBC have abundant amounts of leukocytes and DNA. Thus, the art does not support the arguments made by Applicant. Thus, for the reasons above and those already of record, the rejection is maintained.
Claims 8, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mengozzi et al. (Anatol J. Cardiol. Vol. 23, pages 254-259, April 4, 2020) in view of view of McKinney et al. (Research and Practice in Thrombosis and Haemostasis, (July 2017) Vol. 1, Supp. Supplement 1, pp. 1222-1223. Abstract Number: PB 567) and in view of Font et al. (Stroke Res. Treat. Vol. 2011, Article ID 607852, March 2011).
Mengozzi teaches cardioembolic thrombi consists of less RBCs (page 256, col. 1). RBCs are about as high in cryptogenic stroke as in cardioembolic stroke but definitely lower than in non-cardioembolic stroke (page 256, col. 1). Mengozzi further teaches relevant amounts of extracellular DNA are observed particularly in platelet-rich areas and boundary zones between platelet-rich and RBC-rich regions, whereas no DNA is found within the RBC-rich regions. Mengozzi thus teaches cardioembolic stokes have lower RBC content. Lower RBC content has higher DNA found.
Mengozzi does not teach quantifying GPVI content, determining a DNA/GPVI ration and treating cardioembolic stroke patients with an anticoagulant.
McKinnney teaches the GPVI dimer level is increased in ischemic stroke patients. McKinney teaches GPVI-levels tended to be elevated in strokes classified as cardioembolic strokes (CES).
Further, Font is a review of recommendations for patients with cardioembolic stroke types. Treatments include paroxysmal, warfarin, aspirin, antiplatelet, etc. .
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have tested patients who had strokes for DNA content and GPVI-levels in thrombi to determine whether the stroke was cardioembolic or non-cardioembolic. The prior art teaches both DNA content and GPVI-levels are associated with cardioembolic strokes. The ordinary artisan would have been motivated to have analyzed both criteria to get a better picture of the association. Once the ordinary artisan identified the patient as having cardioembolic stroke, the ordinary artisan would have administered an anticoagulant to the patient when high DNA was found and high GPVI-levels. The ordinary artisan would have been motivated to have administered the patient the well-known preventative therapies, as taught by Font.
Response to Arguments
The response traverses the rejection. The response asserts McKinney is the opposite teaching as that of the claimed invention as GPVI levels are lower in cardioembolic stroke patients and that a higher DNA =/GPVI ratio is diagnostic for cardioembolic stroke. This argument has been considered but is not convincing because the claim does not require detection of a lower level of GPVI. The claims are solely directed to the ratio of DNA/GPVI. As noted above, the specification teaches GPVI alone is not significantly associated with cardioembolic stroke.
Further, the claims do not require any predetermined reference value, and a higher value of GPVI, as suggested by McKinney would still be higher than an undisclosed predetermined reference value. The claims are not limited to any particular threshold for the ratio or any particular GPVI trend. The claims are limited to a ratio.
Thus for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DiMeglio et al. (Stroke, Vol. 51, No. 9, August 19, 2020) is applicants post-filing date work describing DNA content in ischemic stroke thrombi and DNA/GPVI ratios.
Induruwa et al. (PLOS One, Vol. 17, No. 1, e0262695, January 2022) teaches all stroke subtypes (LAS, CES, SVO, bleed) demonstrated significantly higher total GPVI (Fig 4A, P <0.0001). Induruwa teaches ischemic strokes from AF are cardioembolic strokes. AF patients expression significantly more GPVI-dimer compared with patients without AF.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
March 13, 2026