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 U.S. Patent 4,968,306 to Huss et al. (Huss hereinafter) in view of US Pre-Grant Publication 2010/0130963 to Ebert et al. (Ebert) and U.S. Patent 5,226,891 to Bushatz et al. (Bushatz).
Regarding claims 1-2, Huss teaches a cannula (10) comprising a shaft (12, 15) with a proximal end (at 15), a distal end (at 25), and a delivery portion (12) with a lumen therein, a plurality of apertures (18) in fluid communication with the lumen, a radiopaque marker (24, 25, 26) disposed along the shaft adjacent to the delivery portion, and a body (tube forming lumen 20) within the distal end of the shaft. Huss does not teach an echogenic marker. 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 Huss in order to allow them to be visible when viewed with ultrasonic imaging technologies. Furthermore, Huss does not teacha pointed distal tip. Bushatz teaches a cannula having a body (36) with a pointed distal tip, mid portion, and smaller diameter insertion portion (see e.g. Fig. 6, elements disclosed in ascending order from the lower pointed tip of 36). Bushatz teaches that this apparatus allows the cannula to pierce tissue of the patient (col. 1 ln. 59-62). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pointed tip as taught by Bushatz to pierce bodily tissues to thereby allow placement of the cannula of Huss at a desired treatment site. The examiner notes that the pointed distal tip of the claim has no recited function or structure (e.g. the tip is neither distinct nor integral with the cannula shaft).
Regarding claim 3, Bushatz teaches that a diameter of the tip is at least equal to that of its shaft (33).
Regarding claim 4, Huss teaches at least two apertures. The examiner notes that the claim is open-ended, and therefore does not exclude numbers of apertures above 100.
Regarding claim 5, Huss teaches that the apertures extend radially from a central axis.
Regarding claim 6, Huss teaches that the apertures (18) are smaller than the distal aperture (20).
Regarding claim 7, along the periphery of each aperture, the width along the circumference of the shaft increases in the distal direction until it reaches the maximum diameter of the aperture. The examiner notes that the width of claim 7 is not tied to respective ones of the apertures.
Regarding claims 8-9, 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, Huss teaches a marker at a proximal end (24, 26) and a distal end (25).
Regarding claim 11, Huss teaches rings (24, 26) at the proximal end, and a ring (25) at the distal end. Providing a second ring at the distal end constitutes no more than the duplication of existing parts (MPEP 2144.04 VI. B).
Regarding claim 13, Huss teaches a cannula (10) comprising a shaft (12, 15) with a proximal end (at 15), a distal end (at 25), and a delivery portion (12) with a lumen therein, a plurality of apertures (18) in fluid communication with the lumen, a radiopaque marker (24, 25, 26) disposed along the shaft adjacent to the delivery portion, and a body (tube forming lumen 20) within the distal end of the shaft. Furthermore, Huss teaches a marker at a proximal end (24, 26) and a distal end (25). Huss does not teach an echogenic marker. 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 Huss in order to allow them to be visible when viewed with ultrasonic imaging technologies.
Regarding claim 14, Huss teaches rings (24, 26) at the proximal end, and a ring (25) at the distal end. Providing a second ring at the distal end constitutes no more than the duplication of existing parts (MPEP 2144.04 VI. B).Regarding claim 15, Bushatz teaches a cannula having a body (36) with a pointed distal tip, mid portion, and smaller diameter insertion portion (see e.g. Fig. 6, elements disclosed in ascending order from the lower pointed tip of 36). Bushatz teaches that this apparatus allows the cannula to pierce tissue of the patient (col. 1 ln. 59-62). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a pointed tip as taught by Bushatz to pierce bodily tissues to thereby allow placement of the cannula of Huss at a desired treatment site.
Regarding claim 17, Huss teaches inserting the cannula with the claimed structure (as discussed with respect to claim 1 above), positioning the delivery portion within a target tissue (“desired treatment site”, col 1, ln. 22-36) 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, Huss teaches arranging the effective length of the delivery portion to match a delivery site (col. 3, ln. 3-44), 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, Huss 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 Huss in view of Ebert and Bushatz 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 Huss 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 Huss in view of Ebert 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 Huss 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 filed 4 February 2026 have been fully considered but they are not persuasive.
With respect to the argument that Bushatz does not teach a sharp distal tip, the examiner notes that the distal tip of the claims is not structurally linked to any other element. As such, a separate tip as taught by Bushatz falls within the scope of the independent claims. Furthermore, the examiner does not concede that the teaching in Bushatz of sharp tips for penetration of tissue and the general understanding in the art of this widely applied feature is either non-analogous or otherwise not relevant. As such, the examiner holds that a pointed distal tip is insufficient to distinguish the claimed invention from the prior art.
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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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 18 February 2026