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 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.
Claim(s) 1-17, 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2013/0085381 to Comerota et al. (Comerota hereinafter) in view of US Pre-Grant Publication 2010/0130963 to Ebert et al. (Ebert) and U.S. Patent 4,610,671 to Luther (Luther).
Regarding claim 1, Comerota teaches an infusion catheter including a shaft (12) with a delivery portion (18) having a plurality of apertures (42) in fluid communication with a lumen, a radiopaque marker (54, 56), and a body (16) within the distal end of the shaft. Comerota is silent to the shape of the body beyond general linearity. Luther teaches a catheter system generally and particularly teaches that a stylet (60) is provided in a catheter shaft (56) for piercing a user’s vein (col. 1, ln. 66 through col. 2, ln. 12). As such, Luther teaches a body (60) with a pointed tip (59) for use within a catheter and providing a piercing ability. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a stylet as taught by Luther to the catheter of Comerota in order to provide a piercing ability thereto. Alternatively, it would have been obvious to add markers and a plurality of apertures as taught by Comerota to the catheter of Luther in order to provide a distributed and precise infusion capability thereto. Neither Comerota nor Luther teach echogenic markers, though as noted above, Comerota does teach radiopaque markers. Ebert teaches another medical device generally, and particularly teaches that visibility materials may include both radiopaque and echogenic materials to allow visibility with both fluoroscopic and ultrasonic imaging techniques (paragraph 4). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a material which is both radiopaque and echogenic as taught by Ebert in the markers of Comerota in order to allow them to be visible when viewed with ultrasonic imaging technologies.
Regarding claim 2, Luther teaches a pointed distal tip (59), a wider midpoint (55a) and a proximal insertion portion (55).
Regarding claim 3, Luther teaches that a diameter of the tip (at 55a) is greater than that of its shaft (55).
Regarding claim 4, Comerota teaches at least two apertures (42). The examiner notes that the claim is open-ended, and therefore does not exclude numbers of apertures above 100.
Regarding claim 5, Comerota teaches that the apertures extend radially from a central axis.
Regarding claim 6, Comerota teaches that the proximal apertures (42) are smaller than the distal apertures (42).
Regarding claim 7, Comerota teaches apertures of increasing width approaching the distal end (see Fig. 5).
Regarding claims 8, 12 and 16, it has been held that when the difference between the cited prior art and the claimed invention is a recitation of relative dimensions and the dimensions do not change the function of the device then the claimed device is not patentably distinct from the prior art (MPEP 2144.04 IV. A.). In this case, the limitations of claim 1 are discussed above, and there do not appear to be functional distinctions conferred by the claimed dimensions. Accordingly, the examiner holds that these claims are rendered obvious by the combined references.
Regarding claim 10, Comerota teaches a marker at a proximal end (56) and a distal end (54).
Regarding claim 11, Comerota teaches a ring (56) at the proximal end, and a ring (54) at the distal end. Providing a second ring at each end constitutes no more than the duplication of existing parts (MPEP 2144.04 VI. B).
Regarding claim 13, Comerota teaches an infusion catheter including a shaft (12) with a delivery portion (18) having a plurality of apertures (42) in fluid communication with a lumen, a set of radiopaque markers (distally at 54, proximally at 56), and a body (16) within the distal end of the shaft. Comerota is silent to the shape of the body beyond general linearity. Luther teaches a catheter system generally and particularly teaches that a stylet (60) is provided in a catheter shaft (56) for piercing a user’s vein (col. 1, ln. 66 through col. 2, ln. 12). As such, Luther teaches a body (60) with a pointed tip (59) for use within a catheter and providing a piercing ability. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a stylet as taught by Luther to the catheter of Comerota in order to provide a piercing ability thereto. Alternatively, it would have been obvious to add markers and a plurality of apertures as taught by Comerota to the catheter of Luther in order to provide a distributed and precise infusion capability thereto. Neither Comerota nor Luther teach echogenic markers, though as noted above, Comerota does teach radiopaque markers. Ebert teaches another medical device generally, and particularly teaches that visibility materials may include both radiopaque and echogenic materials to allow visibility with both fluoroscopic and ultrasonic imaging techniques (paragraph 4). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a material which is both radiopaque and echogenic as taught by Ebert in the markers of Comerota in order to allow them to be visible when viewed with ultrasonic imaging technologies.
Regarding claim 14, Comerota teaches a ring (56) at the proximal end, and a ring (54) at the distal end. Providing a second ring at the each end constitutes no more than the duplication of existing parts (MPEP 2144.04 VI. B).
Regarding claim 15, Luther teaches a gradually pointed distal tip (59), a wider midportion (55a) and a proximal insertion portion (55).
Regarding claim 17, Comerota teaches inserting the cannula with the claimed structure (see e.g. Fig. 3A), positioning the delivery portion within a target tissue (“thrombus”) with the assistance of the marker, and delivering the fluid through the lumen to the target tissue. Ebert teaches detecting the echogenic marker with ultrasound (paragraph 4) in particular.
Regarding claim 19, Comerota teaches arranging the effective length of the delivery portion to match a delivery site (Fig. 3D), which is tantamount to placing the markers delimiting the delivery portion at the borders of the site.
Regarding claim 21, as illustrated in Fig. 1, Comerota teaches at least 6 apertures. The examiner notes that the recitation is open-ended and therefore the recitation of 100 apertures does not disclaim a higher number.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comerota in view of Ebert and Luther as applied to claim 17 above, and further in view of US Pre-Grant Publication 2017/0007310 to Rajagopalan (Rajagopalan).
Regarding claim 18, the previously applied references teach the limitations of claim 17 from which claim 18 depends, as discussed above, but do not teach a fluid with a viscosity increasing near body temperature. Rajagopalan teaches another medical device generally, and particularly teaches that fluids are known for injection which have a viscosity increasing as their temperature approaches body temperature (paragraph 208). These various fluids have known medical applications which render their use with the cannula of Comerota obvious as of the effective filing date of the instant application.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comerota in view of Ebert and Luther as applied to claim 17 above, and further in view of US Pre-Grant Publication 2013/0158517 to Bouchard et al. (Bouchard).
Regarding claim 20, the previously applied references teach the limitations of claim 17 from which claim 20 depends, as discussed above, but do not teach treatment periods in excess of 24 hours. Bouchard teaches that there are known applications, such as venous infusion, in which a catheter or cannula must be at a treatment site for at least 24 hours (paragraphs 2, 4). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a catheter such as that of Comerota to perform known long-term treatments as taught by Bouchard in order to provide the known benefits of those treatments to patients.
Response to Arguments
Applicant’s arguments, see page 1, filed 6/22/2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Comerota in view of Luther and Ebert as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 6,306,125, Fig. 7; U.S. Patent 3,030,953, Fig. 8.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 28 September 2026
