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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-34 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rajagopalan et al. (US 2021/0196341 A1).
Regarding claim 1, Rajagopalan et al. (‘341) teach an assembly for facilitating ultrasonic visualization of positioning of a needle inserted into tissue (see [0092]), the needle having a needle length, the assembly comprising: a sheath having a sheath length and configured for concentrically receiving the needle, the sheath having a sheath head disposed at a proximal end configured for introducing fluid into a transport channel defined between an outer surface of the needle and an inner surface of the sheath, wherein the transport channel comprises features configured for inducing formation of ultrasonically visible features at a distal end of the sheath (see [0092], [0569]; and Figs. 1, 6); and a fluid source in fluid communication with the sheath head for introducing fluid under pressure (see [0581]).
Regarding claim 2, Rajagopalan et al. (‘341) teach the assembly of claim 1, wherein the transport channel comprises at least one longitudinal channel formed in the inner surface of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 3, Rajagopalan et al. (‘341) teach the assembly of claim 2, wherein the at least one longitudinal channel comprises a plurality of longitudinal channels extending along the sheath length (see [0569], [0581]; and Fig. 6).
Regarding claim 4, Rajagopalan et al. (‘341) teach the assembly of claim 3, wherein the plurality of longitudinal channels are defined by ribs extending radially inward from the inner surface of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 5, Rajagopalan et al. (‘341) teach the assembly of claim 2, wherein the at least one longitudinal channel comprises a plurality of longitudinal channels shorter than the sheath length disposed near the distal end of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 6, Rajagopalan et al. (‘341) teach the assembly of claim 2, wherein the sheath has a plurality of radial openings disposed therein near a distal end of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 7, Rajagopalan et al. (‘341) teach the assembly of claim 1, wherein the transport channel comprises at least one longitudinal channel formed in an outer surface of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 8, Rajagopalan et al. (‘341) teach the assembly of claim 7, wherein the at least one longitudinal channel extends a partial length of the needle to intersect with an annular channel configured to direct the fluid radially outward from the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 9, Rajagopalan et al. (‘341) teach the assembly of claim 8, wherein the annular channel is disposed at a position along the needle length corresponding to the distal end of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 10, Rajagopalan et al. (‘341) teach the assembly of claim 8, wherein the annular channel is disposed at a position along the needle length that is less than the full sheath length, and wherein the sheath has a plurality of radial openings disposed to align with the annular channel (see [0569], [0581]; and Fig. 6).
Regarding claim 11, Rajagopalan et al. (‘341) teach the assembly of claim 8, wherein the annular channel is disposed at a position along the needle length that is less than the full sheath length, and wherein the sheath has a plurality of tapered grooves formed on the inner surface, each groove having a first end that aligns with the annular channel and a second end that extends to the distal end of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 12, Rajagopalan et al. (‘341) teach the assembly of claim 8, further comprising a plurality of tapered grooves disposed near a distal end of the needle, wherein the plurality of tapered grooves extend distally from the annular channel (see [0569], [0581]; and Fig. 6).
Regarding claim 13, Rajagopalan et al. (‘341) teach the assembly of claim 7, wherein the at least one longitudinal channel is formed by flattening a side of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 14, Rajagopalan et al. (‘341) teach the assembly of claim 7, wherein the at least one longitudinal channel comprises at least one groove formed in the outer surface of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 15, Rajagopalan et al. (‘341) teach the assembly of claim 1, wherein the needle length is greater than the sheath length (see [0569], [0581]; and Fig. 6).
Regarding claim 16, Rajagopalan et al. (‘341) teach the assembly of claim 1, wherein the fluid is air or a contrast media suspension (see [0429]).
Regarding claim 17, Rajagopalan et al. (‘341) teach a method for visualizing positioning of a needle inserted into tissue, comprising: inserting into a target tissue the assembly of claim 1; introducing an echogenic media into the assembly; and using an ultrasonic imaging instrument to generate an image of ultrasonically visible features at the distal end of the sheath (see [0092], [0429], [0581]).
Regarding claim 18, Rajagopalan et al. (‘341) teach an assembly for facilitating ultrasonic visualization of positioning of a needle inserted into tissue, the assembly comprising: a sheath comprising a hollow tubing having a sheath length and a sheath end, the sheath having a sheath head disposed at a proximal end configured for introducing fluid into the sheath, the needle concentrically disposed within the sheath to define a transport channel between an outer (see [0092], [0569]; and Fig. 6) surface of the needle and an inner surface of the sheath, wherein the transport channel comprises features configured for inducing formation of ultrasonically visible features at the sheath end (see [0569]); and a fluid source in fluid communication with the sheath head for introducing fluid under pressure (see [0581]).
Regarding claim 19, Rajagopalan et al. (‘341) teach the assembly of claim 18, wherein the transport channel comprises at least one longitudinal channel formed in the inner surface of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 20, Rajagopalan et al. (‘341) teach the assembly of claim 19, wherein the at least one longitudinal channel comprises a plurality of longitudinal channels extending along the sheath length (see [0569], [0581]; and Fig. 6).
Regarding claim 21, Rajagopalan et al. (‘341) teach the assembly of claim 20, wherein the plurality of longitudinal channels are defined by ribs extending radially inward from the inner surface of the sheath (see [0569], [0581]; and Fig. 6).
Regarding claim 22, Rajagopalan et al. (‘341) teach the assembly of claim 19, wherein the at least one longitudinal channel comprises a plurality of longitudinal channels shorter than the sheath length disposed near the sheath end (see [0569], [0581]; and Fig. 6).
Regarding claim 23, Rajagopalan et al. (‘341) teach the assembly of claim 19, wherein the sheath has a plurality of radial openings disposed therein near the sheath end (see [0569], [0581]; and Fig. 6).
Regarding claim 24, Rajagopalan et al. (‘341) teach the assembly of claim 18, wherein the transport channel comprises at least one longitudinal channel formed in an outer surface of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 25, Rajagopalan et al. (‘341) teach the assembly of claim 24, wherein the at least one longitudinal channel extends a partial length of the needle to intersect with an annular channel configured to direct the fluid radially outward from the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 26, Rajagopalan et al. (‘341) teach the assembly of claim 25, wherein the annular channel is disposed at a position along the needle length corresponding to the sheath end (see [0569], [0581]; and Fig. 6).
Regarding claim 27, Rajagopalan et al. (‘341) teach the assembly of claim 25, wherein the annular channel is disposed at a position along the needle length that is less than the full sheath length, and wherein the sheath has a plurality of radial openings disposed to align with the annular channel (see [0569], [0581]; and Fig. 6).
Regarding claim 28, Rajagopalan et al. (‘341) teach the assembly of claim 25, wherein the annular channel is disposed at a position along the needle length that is less than the full sheath length, and wherein the sheath has a plurality of tapered grooves formed on the inner surface, each groove having a first end that aligns with the annular channel and a second end that extends to the sheath end (see [0569], [0581]; and Fig. 6).
Regarding claim 29, Rajagopalan et al. (‘341) teach the assembly of claim 25, further comprising a plurality of tapered grooves disposed near a distal end of the needle, wherein the plurality of tapered grooves extend distally from the annular channel (see [0569], [0581]; and Fig. 6).
Regarding claim 30, Rajagopalan et al. (‘341) teach the assembly of claim 24, wherein the at least one longitudinal channel is formed by flattening a side of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 31, Rajagopalan et al. (‘341) teach the assembly of claim 24, wherein the at least one longitudinal channel comprises at least one groove formed in the outer surface of the needle (see [0569], [0581]; and Fig. 6).
Regarding claim 32, Rajagopalan et al. (‘341) teach the assembly of claim 18, wherein the needle length is greater than the sheath length (see [0569], [0581]; and Fig. 6).
Regarding claim 33, Rajagopalan et al. (‘341) teach the assembly of claim 18, wherein the fluid is air or a contrast media suspension (see [0429]).
Regarding claim 34, Rajagopalan et al. (‘341) teach a method for visualizing positioning of a needle inserted into tissue, comprising: inserting into a target tissue the assembly of claim 18; introducing an echogenic media into the assembly; and using an ultrasonic imaging instrument to generate an image of ultrasonically visible features at the sheath end (see [0092], [0429], [0581]).
Conclusion
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/MARK D REMALY/Primary Examiner, Art Unit 3797