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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/11/26 has been entered.
Claim Rejections - 35 USC § 103
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.
(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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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) 1, 11, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman et al. (US 2017/0049993 cited in IDS 11/21/2019 - referred to as Cosman) in view of Quearry, (US 2014/0265024 cited in instant PGPUB ¶ 0004 and IDS 11/21/2019) Crisman et al. (US 2017/0112464 - referred to as Crisman), and Ryan (US 2010/0168684 cited in instant PGPUB ¶ 0005 and IDS 11/21/2019).
Regarding claim(s) 1, Cosman teaches a medical needle (Figs. 2 and 8A: ¶ 0029, "probe can be a needle,...a radiofrequency needle, an epidural needle, a biopsy needle, or a spinal needle"; ¶ 0081) comprising
a longitudinal body (straight shaft, ¶ 0064, Fig. 2, #200, ¶ 0076, Fig. 8A, #800) extending between a distal end and a proximal end along a longitudinal axis A (shaft #200 #800 extends between a distal end [left end of Fig. 2] and a proximal end [right end of Fig. 2] along a longitudinal axis, as shown in Fig. 2: ¶ 0025, "probe can have a distal and proximal end"; ¶ 0027, "needle can have a distal and proximal end"; ¶ 0064 ¶ 0048, "needle has a sharpened distal end, and is terminated...at its proximal end"),
an outer surface of the needle includes (¶ 0028, "first echogenic feature is an indentation in the surface of the probe"; ¶ 0064 ¶ 0051-0052, "echogenic markers...can be indentations in the surface of the shaft") a plurality of concave echogenic ultrasonic reflector depressions (echogenic markers, ¶ 0028 ¶ 0051-0052 ¶ 0064 ¶ 0074-0075, Fig. 2, #205, ¶ 0076, Fig. 8A, #801 #802) formed along at least a portion of a length of the needle (as shown in Figs. 2 and 8A) to enhance the visibility of the needle under ultrasound guidance (¶ 0051-0052 ¶ 0064 ¶ 0075 ¶ 0076 ¶ 0002, "means of enhancing the ultrasound image of probes"; ¶ 0023, "medical needles can be more easily visualized and directed in the human body by means of ultrasound guidance") by scattering and reflecting back toward (curved surface of Figs. 7D-F scatters and reflects sound waves back toward ultrasound probe/transceiver #805: ¶ 0076 ¶ 0064 ¶ 0051-0052, "macroscopic dents can reflect ultrasound waves when the shaft...is positioned at a steep angle relative to the ultrasound transceiver"; ¶ 0074-0075, "probe is more likely to reflect ultrasound waves back toward the ultrasound transceiver") a transducer (ultrasound probe/transceiver, ¶ 0076, Fig. 8A, #805) sound waves (sound waves, ¶ 0076, including beams, ¶ 0076, Fig. 8A, #810 #811 #812; and ¶ 0076, "An array of ultrasound beams are present between beams #810 and #811, and between #811 and #812, as is understood by one skilled in the art") incident thereon (¶ 0052 ¶ 0076, "Beam #810 is incident on the probe #800 ... Beam #811 is incident on the probe #800 ... Beam #812 is incident on the probe #800," Fig. 8A),
a row of said depressions are evenly distributed around the entire circumference (as shown in Fig. 2) of a circular cylindrical section of the needle (¶ 0064 ¶ 0048, "The shaft...be substantially cylindrical"),
said circular cylindrical section having depressions around the entire circumference is a depression section (as shown in Fig. 2), wherein
each of said plurality of depressions (¶ 0074-0076 ¶ 0064 ¶ 0051-0052, "echogenic markers...can include...macroscopic echogenic dents [examples of one of which include the markers shown in FIG. 5, FIGS. 6A-C, and FIGS. 7A-F] in the surface of shaft") comprises two non-planar reflector surfaces (¶ 0074-0075, "echogenic marker shown by shaft wall #739 #749 #759 and curved surface with distal part #730 #740 #750 and proximal part #735 #745 #755 is a curved depression in the surface of the shaft," Figs. 7D-F), a first reflector surface (distal part, ¶ 0074, Figs. 7D-F, #750 #740 #730) and a second reflector surface (proximal part, ¶ 0074, Fig. 7F, #755 #745 #735),
wherein the second reflector surface having a longitudinal symmetry axis S that is inclined in the direction of the proximal end of the needle in relation to the longitudinal axis A of the needle by an inclination angle a (proximal part #755 #745 #735 of the curved surface has a longitudinal symmetry axis S that is inclined in the direction of the proximal end in relation to the longitudinal axis by an inclination angle, as shown in Figs. 7D-F).
While Cosman teaches two non-planar reflector surfaces that are curved as described in ¶ 0074-0075 and shown in cross-sectional views of Figs. 7D-F, Cosman appears to be silent on a shape of these surfaces beyond the cross-sectional view and may not explicitly teach that the first reflector surface is a semi-spherical surface, and the second reflector surface is a part of a cylindrical or a conical surface. Cosman fails to show wherein an angle formed between the second reflector surface and the longitudinal axis A is from 20 to 35 degrees, and a longitudinal symmetry axis of a cone defining the part of the conical surface extends in the direction of the longitudinal axis A.
Cosman fails to show that the second reflector surface opens up to the first reflector surface in the proximal direction of each depression, thereby improving the visibility of the needle for ultrasound waves along a direction having an angle in relation to the longitudinal axis A that is between 0 and 40 degrees, wherein the depression of the second reflector has the shape of a right circular cone having an apex angle of 10-17.5 degrees, and wherein the radius of the part of the cone making up the second reflector surface is the same or larger than the radius of the sphere making up the first reflector surface.
In an analogous echogenic medical device field of endeavor, Quearry teaches a plurality of concave echogenic ultrasonic reflector depressions (features, ¶ 0054-0055, Figs. 4-5, #30), a row of said depressions are evenly distributed around the entire circumference of a circular cylindrical section (as shown in Figs. 4-5), said circular cylindrical section having depressions around the entire circumference is a depression section (as shown in Figs. 4-5), wherein each of said plurality of depressions comprises two non-planar reflector surfaces, a first reflector surface and a second reflector surface (distal portion and proximal portion of curved depression surface, ¶ 0054, Figs. 4-5), wherein
the first reflector surface is a semi-spherical surface, and the second reflector surface is a part of a cylindrical or a conical surface (first reflector surface is a semi-spherical surface and second reflector surface is a part of at least a conical surface, as shown in Figs. 4-5: ¶ 0053-0055 ¶ 0027; also figure 9 is similar to applicant’s Figure 11).
Quearry shows that the second reflector surface opens up to the first reflector surface in the proximal direction of each depression, thereby improving the visibility of the needle for ultrasound waves along a direction having an angle in relation to the longitudinal axis A that is between 0 and 40 degrees, wherein the depression of the second reflector has the shape of a right circular cone having an apex angle of 10-17.5 degrees, and wherein the radius of the part of the cone making up the second reflector surface is the same or larger than the radius of the sphere making up the first reflector surface (Figure 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first reflector surface and the second reflector surface of each of the depressions of the medical needle as taught by Cosman to be a semi-spherical surface and be a part of a cylindrical or a conical surface, respectively, since such a first reflector surface being a semi-spherical surface and such a second reflector surface being part of a conical surface was known in the art as taught by Quearry. The motivation would have been to provide enhanced ultrasound visualization throughout a wide range of ultrasound frequencies and relative angles between a medical device and ultrasound transducer (Quearry, ¶ 0052-0054), and there was reasonable expectation of success. It would further be obvious to modify the shape of the depressions, such that the second reflector surface opens up to the first reflector surface in the proximal direction of each depression, thereby improving the visibility of the needle for ultrasound waves along a direction having an angle in relation to the longitudinal axis A that is between 0 and 40 degrees, wherein the depression of the second reflector has the shape of a right circular cone, and wherein the radius of the part of the cone making up the second reflector surface is the same or larger than the radius of the sphere making up the first reflector surface. Different shapes of reflector surfaces will allow for ultrasound beams of any incident angle to impinge on the surface, increasing the echogenicity of the device.
Further regarding claim(s) 1, Cosman does not explicitly teach an inclination angle a being in the interval of 20-35 degrees.
In an analogous echogenic needle field of endeavor, Crisman teaches a medical needle (needle, ¶ 0021, Figs. 1-2 and 6, #2) comprising a longitudinal body (shaft, ¶ 0021, Figs. 1-2 and 5, #4) extending between a distal end (distal or patient end, ¶ 0021-0022, Figs. 1-2, #6) and a proximal end (proximal end, ¶ 0021, Fig. 1, #10) along a longitudinal axis A (longitudinal axis, ¶ 0021, Figs. 1 and 3, #6), an outer surface of the needle (¶ 0024, “outer surface of the circumferential wall of shaft #4”: outside walls, ¶ 0025, Figs. 3-4 and 7, #4a, of shaft #4) includes a plurality of concave echogenic ultrasonic reflector depressions (grooves, ¶ 0022, Figs. 2-3, #16 #16a #16b) formed along at least a portion of a length of the needle (grooved sections, ¶ 0023, Figs. 1-2, #12a #12b) to enhance the visibility of the needle under ultrasound guidance by scattering and reflecting back toward (¶ 0027, “ultrasound wave #28a′ in a substantially reverse direction [approximately at 180°] back to transducer #26, presumably to its receiver. Thus, an improved reflection view of the exemplar inventive needle may be gleaned under ultrasound or radiographic imaging,” Fig. 7) a transducer (ultrasound transducer probe, ¶ 0027, Fig. 7, #26) sound waves incident thereon (ultrasound wave, ¶ 0027, Fig. 7, #28), each of said plurality of depressions comprises two non-planar reflector surfaces (¶ 0030, “It should be appreciated that instead of a V-shaped groove, each of the grooves may be U-shaped”), a first reflector surface (wall, ¶ 0025, Figs. 4 and 6-7, #16w2’) and a second reflector surface (wall, ¶ 0025, Figs. 4 and 6-7, #16w1’), wherein
the second reflector surface having a longitudinal symmetry axis S that is inclined in the direction of the proximal end of the needle in relation to the longitudinal axis A of the needle (¶ 0003 ¶ 0005 ¶ 0025, “the groove ‘tilted’…toward the proximal end of the needle”) by an inclination angle a (angle, ¶ 0025, Figs. 4 and 6-7, β: an inclination angle a is interpreted in light of the instant specification [instant Fig. 9 and instant PGPUB ¶ 0036] to be equivalent to the β angle in Crisman) being in the interval of 20-40 degrees or being 35 degrees (¶ 0025, “it was found that the α angle may range from approximately 5° to 25°, and preferably at 10°” which gives a β angle and hence an inclination angle in the interval of 40° to 20°, or preferably 35°, at according to ¶ 0025 and Figs. 6-7 [it is noted that α appears to be labelled incorrectly in Fig. 4; see corrected Drawing filed 08/05/2019 in US App. No. 15/297,731 of Crisman]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inclination angle of the second reflector surface of the medical needle as made obvious by Cosman in view of Quearry to be in the interval of 20-35 degrees, since such an inclination angle being in the interval of 20-40 degrees and being 35 degrees was known in the art as taught by Crisman; since a prima facie case of obviousness exists in the case where the claimed range overlaps or lies inside the range disclosed by the prior art (MPEP § 2144.05, subsection I); since a specific example in the prior art which is within a claimed range anticipates the range (MPEP § 2131.03, subsection I); and since no criticality is given for the claimed range. The motivation would have been to glean an improved reflection view of a needle under ultrasound or radiographic imaging (Crisman, ¶ 0027), and there was reasonable expectation of success.
Cosman further teaches that the first surface of the depression (distal part #750 #740 #730 discussed above) ranges from a steep portion extending from a first end portion of the depression facing the distal end of the needle and abutting a space between adjacent depressions nearly perpendicular to the longitudinal axis A of the needle (as shown in Figs. 7D-F), and wherein the first reflector surface continues to the bottom of the depression and further in the proximal direction (as shown in Figs. 7D-F) where the first surface transitions to the second reflector surface being a shallow portion extending to a second end portion of the depression at an angle less steep than that of the steep portion (as shown in Figs. 7D-F).
It is noted that Cosman does not explicitly teach the semi-spherical shape of the first reflector surface. In an analogous echogenic medical device field of endeavor, Quearry teaches the semi-spherical shape of the first reflector surface (discussed above in claim 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first reflector surface of each of the depressions of the medical needle as taught by Cosman to be a semi-spherical surface because of reason(s) and motivation(s) discussed above.
Regarding claim(s) 1 and 4, Cosman in view of Quearry and Crisman and Ryan makes obvious all limitations of the claim(s), as discussed above.
While Cosman appears to further teach that the surface of the steep portion at said first end portion is close to a plane perpendicular to the longitudinal axis A of the needle sloping slightly toward a plane parallel to the longitudinal axis A (as shown in Figs. 7D-F and best shown in Fig. 7F), Cosman may not explicitly teach:
the surface of the steep portion at said first end portion is close to a plane perpendicular to the longitudinal axis A of the needle sloping slightly toward a plane parallel to the longitudinal axis A, such that at least a portion of ultrasound waves from said transducer positioned anywhere in the range of slightly more than 0° to close to 90°, relative to the longitudinal axis A of the needle will impact a portion of the depression which is substantially perpendicular to a front of the wave sending the wave directly back to the transducer.
said steep portion is positioned to reflect waves back to a transducer aimed nearly parallel (close to 0°) to the needle 100 while the shallow portion, i.e. the second transducer surface, is oriented to reflect waves back to a transducer positioned substantially perpendicular to the longitudinal axis A (close to 90°) of the needle.
In an analogous echogenic needle field of endeavor, Ryan teaches a medical needle (needle, ¶ 0011, Figs. 1-2, #100, Figs. 3-4, #200, Fig. 5, #300) comprising a longitudinal body (longitudinal body, ¶ 0011, #118) extending (¶ 0011, "longitudinal body #118 extending between a distal end #120 and a proximal end #122") between a distal end (distal end, ¶ 0011, #120; distal tip, Fig. 1, #110) and a proximal end (proximal end, ¶ 0011, #122; left end of Fig. 1 opposite of distal tip #110) along a longitudinal axis A (longitudinal axis, ¶ 0011, "longitudinal axis of the longitudinal body #118"), an outer surface of the needle (outer surface, ¶ 0011, Fig. 1, #104) includes a plurality of concave echogenic ultrasonic reflector depressions (plurality of depressions, ¶ 0011, Figs. 1-2, #106, Figs. 3-4, #206, Fig. 5, #306: ¶ 0014, "it will be understood by those skilled in the art that the depression #106 may extend around only a portion of the circumference of the needle #100 or may be configured as a slot on the outer surface #104 of the needle #100"; ¶ 0019, "patterns formed by the depressions #106, #206, #306 may be applied to the needles #100, #200, #300, respectively, in the form of...other similar elements applied around at least a portion of the outer surfaces of the needles #100, #200 and #300") formed along at least a portion of a length of the needle to enhance the visibility of the needle under ultrasound guidance by scattering and reflecting back toward a transducer sound waves incident thereon (¶ 0011, "plurality of depressions #106 formed along at least a portion of a length of the needle #100 to enhance the visibility of the needle #100 under ultrasound guidance by scattering and reflecting back toward a transducer sound waves incident thereon"),
the first surface of the depression ranges from a steep portion extending from a first end portion of the depression facing the distal end of the needle and abutting a space between adjacent depressions nearly perpendicular to the longitudinal axis A of the needle (¶ 0013, "a surface of the depression #106 ranges from a steep portion #112 extending from a first end portion abutting a space #108 between adjacent depressions #106 nearly perpendicular to a longitudinal axis of the needle #100," Fig. 2), and wherein first reflector surface continues to the bottom of the depression and further in the proximal direction (¶ 0013, "a surface of the depression #106 ranges from a steep portion #112...to a trough #114 at which the depression 106 transitions to a shallow portion #116 extending to a second end portion of the depression #106"; claim 8, "the second end of each of the second depressions is at a proximal end thereof") where the first surface transitions to the second reflector surface being a shallow portion extending to a second end portion of the depression at an angle less steep than that of the steep portion (¶ 0013, "a surface of the depression #106 ranges from a steep portion #112...to a trough #114 at which the depression #106 transitions to a shallow portion #116 extending to a second end portion of the depression #106 at an angle less steep than that of the steep portion #112 ... steep portion #112 may face proximally," Fig. 2).
the surface of the steep portion at said first end portion is close to a plane perpendicular to the longitudinal axis A of the needle sloping slightly toward a plane parallel to the longitudinal axis A (¶ 0013, "At the first end, the surface of the steep portion #112 is, therefore, close to a plane perpendicular to a longitudinal axis of the needle #100 sloping slightly toward a plane parallel to the longitudinal axis," Fig. 2), such that at least a portion of ultrasound waves from said transducer positioned anywhere in the range of slightly more than 0° to close to 90°, relative to the longitudinal axis A of the needle will impact a portion of the depression which is substantially perpendicular to a front of the wave sending the wave directly back to the transducer (¶ 0013, "Thus, at least a portion of sound waves from a transducer positioned anywhere in the range of slightly more than 0° to close to 90°, relative to a longitudinal axis of the needle 100 will impact a portion of the depression 106 which is substantially perpendicular to a front of the wave sending the wave directly back to the transducer," Fig. 2).
said steep portion is positioned to reflect waves back to a transducer aimed nearly parallel (close to 0°) to the needle 100 while the shallow portion, i.e. the second transducer surface, is oriented to reflect waves back to a transducer positioned substantially perpendicular to the longitudinal axis A (close to 90°) of the needle (¶ 0013, "The steep portion #112 is positioned to reflect waves back to a transducer aimed nearly parallel (close to)0° to the needle 100 while the shallow portion is oriented to reflect waves back to a transducer positioned substantially perpendicular to the longitudinal axis (close to 90°) of the needle 100," Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device as made obvious by Cosman in view of Quearry and Crisman such that the surface of the steep portion at said first end portion is close to a plane perpendicular to the longitudinal axis A of the needle sloping slightly toward a plane parallel to the longitudinal axis A, such that at least a portion of ultrasound waves from said transducer positioned anywhere in the range of slightly more than 0° to close to 90°, relative to the longitudinal axis A of the needle will impact a portion of the depression which is substantially perpendicular to a front of the wave sending the wave directly back to the transducer; or [4] said steep portion is positioned to reflect waves back to a transducer aimed nearly parallel (close to 0°) to the needle 100 while the shallow portion, i.e. the second transducer surface, is oriented to reflect waves back to a transducer positioned substantially perpendicular to the longitudinal axis A (close to 90°) of the needle, since such a steep portion and such a shallow portion were known in the art as taught by Ryan. The motivation would have been to enhance the visibility of the needle under ultrasound guidance by scattering and reflecting back toward a transducer sound waves incident thereon (Ryan, ¶ 0011), and there was reasonable expectation of success.
Furthermore, it would have been an obvious design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the size/shape of the depressions, so that an angle formed between the second reflector surface and the longitudinal axis A is from 20 to 35 degrees, and a longitudinal symmetry axis of a cone defining the part of the conical surface extends in the direction of the longitudinal axis A. Different shapes of reflector surfaces will allow for ultrasound beams of any incident angle to impinge on the surface, increasing the echogenicity of the device. A specific size/shape of a depression may be selected by one of ordinary skill in the art without undue experimentation.
As noted in the patent board decision on 12/11/25, Cosman disclosing advantages of the “curved” shapes of the echogenic depression in its Figure 9B is that the ultrasound image is improved for steep angles of needle placement (Figs. 7A-7F, [0074], [0080]). Quearry and Ryan teach similar advantages. Quearry teaches that the device having features with dimensions and angular orientations is capable of providing enhanced ultrasound visualization throughout a wide range of ultrasound frequences and relative angles between device and the transducer (Figs. 4-5, [0057]). Ryan discussing enhanced visibility of needle based on scattering and reflecting of sound waves back toward a transducer ([0011]).
Furthermore, it has been held that a change in size (In re Rose, 200 F.2d 459, 105 USPQ 237 (CCPA 1955) or a change in shape (In re Dailey, 357 F.2d 669, 149 UPSQ 47 (CCPA 1966) requires only ordinary skill in the art and are considered routine expedients.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman et al. (US 2017/0049993 cited in IDS 11/21/2019 - referred to as Cosman) in view of Quearry (US 2014/0265024 cited in instant PGPUB ¶ 0004 and IDS 11/21/2019) and Crisman et al. (US 2017/0112464 - referred to as Crisman), and Ryan (US 2010/0168684 cited in instant PGPUB ¶ 0005 and IDS 11/21/2019) as applied to claim(s) 1 above, and further in view of Ward et al. (US 2003/0135117 cited in IDS 11/21/2019).
Regarding claim(s) 5, Cosman in view of Quearry and Crisman and Ryan makes obvious all limitations of claim(s) 1, as discussed above.
Cosman does not explicitly teach that the number of depressions of one depression section is five, six, seven or eight.
In an analogous echogenic medical device field of endeavor, Ward teaches a medical needle (medical device, ¶ 0022-0031, Figs. 4-7, #110: ¶ 0022, "medical device #110 may be any device intended for use within a human body such as a needle") comprising a longitudinal body (medical device #110 comprises a longitudinal body extending between a distal end and a proximal end along axis #155, as best shown in Figs. 4A and 4C and 5-6) extending between a distal end (¶ 0023, "distal end or tip of the needle") and a proximal end (end opposite of the distal end) along a longitudinal axis A (axis, ¶ 0025, Fig. 4C, #155), an outer surface of the needle (surface, ¶ 0022-0023, Figs. 4-7, #120, of medical device #110) includes a plurality of concave echogenic ultrasonic reflector depressions (concave slots, ¶ 0022-0023, Figs. 4-7, #115) formed along at least a portion of a length of the needle (¶ 0022-0023, "medical device #110 with concave slots #115 formed on the surface 120 of the medical device #110," as best shown in Figs. 4A and 4C and 5-6) to enhance the visibility of the needle under ultrasound guidance (¶ 0002 ¶ 0010, "echogenic surface that reflects more of the ultrasound waves back to the transducer. Such an echogenic surface would provide improved ultrasonic visibility of medical instruments, such as needles. This would make it easier for physicians to guide the medical instruments inside the body using ultrasonography"), a row of said depressions are evenly distributed around the entire circumference of a circular cylindrical section of the needle (as best shown in Fig. 7), said circular cylindrical section having depressions around the entire circumference is a depression section (as best shown in Figs. 4A and 4C and 5-6), wherein
the number of depressions of one depression section is five, six, seven or eight (five, Fig. 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of depressions of one depression section of the medical needle as made obvious by Cosman in view of Quearry and Crisman and Ryan to be five, six, seven or eight, since such a depression section with the number of depressions being five was known in the art as taught by Ward; and since it would have been well within the skill of one of ordinary skill in the art to customize how many depressions are distributed around the circumference of a circular cylindrical section of the needle according to factors such as size of the depressions, diameter/circumference of the needle, desired level of ultrasonic visibility, and specific medical procedure. The motivation would have been to provide improved ultrasonic visibility of medical instruments in order to make it easier for physicians to guide the medical instruments inside the body using ultrasonography (Ward, ¶ 0010), and there was reasonable expectation of success.
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman et al. (US 2017/0049993 cited in IDS 11/21/2019 - referred to as Cosman) in view of Quearry (US 2014/0265024 cited in instant PGPUB ¶ 0004 and IDS 11/21/2019) and Crisman et al. (US 2017/0112464 - referred to as Crisman), and Ryan (US 2010/0168684 cited in instant PGPUB ¶ 0005 and IDS 11/21/2019) as applied to claim(s) 1 above, and further in view of Hoyns (US 5,759,154).
Regarding claim(s) 6-10, Cosman in view of Quearry and Crisman and Ryan makes obvious all limitations of claim(s) 1, as discussed above.
Cosman further teaches that adjacent depression sections are off-set in relation to each other by an off-set angle (as shown in Figs. 2 and 8A).
Cosman does not explicitly teach:
the maximal width of a depression in a plane perpendicular to the longitudinal axis A, is essentially equal to the minimum space between two depressions.
straight radial lines through bottoms of adjacent depressions in a cross-sectional plane are separated by a separation angle 13.
adjacent depression sections are off-set in relation to each other by an off-set angle being half the separation angle 13.
adjacent depression sections are off-set in relation to each other by an off-set angle, and
wherein the most distal parts of depressions in a first depression section being interleaved in relation to the most proximal parts of depressions in an adjacent second depression section located distally said first depression section.
the most distal parts of the depressions in a first depression section are located distally the most proximal parts of depressions in a second depression section by a predetermined distance d along the longitudinal axis A, and
wherein said second depression section is adjacent and located distally said first depression section.
In an analogous echogenic medical device field of endeavor, Hoyns teaches a medical needle (needle, col. 4, lines 13-24, Fig. 1A, #10) comprising a longitudinal body (shaft, col. 4, lines 20-24, Fig. 1A, #11) extending between a distal end (left end of Fig. 1A: col. 4, line 20, “forward end of the shaft #11 is formed into a sharpened cutting surface #12”) and a proximal end (right end of Fig. 1A) along a longitudinal axis A (longitudinal axis, col. 4, lines 32-33, Fig. 1A, col. 5, line 39, Fig. 4, #30), an outer surface of the needle includes a plurality of concave echogenic ultrasonic reflector depressions (depressions, col. 4, lines 25-44, Fig. 1A, #14 #14a #14b) formed along at least a portion of a length of the needle to enhance the visibility of the needle under ultrasound guidance (col. 1, lines 7-21, “medical device…which is echogenically enhanced to improve its visibility under ultrasound … medical devices which are advantageously guided under ultrasound visualization”) by scattering and reflecting back toward a transducer sound waves incident thereon (col. 4, lines 45-54, “depression #14 are arranged to reflect an incident ultrasound beam back along the same line as the incident beam … ultrasound is a longitudinal wave and may be considered as an infinite number of vectors perpendicular to the wave front”), a row of said depressions are evenly distributed around the entire circumference of a circular cylindrical section of the needle, said circular cylindrical section having depressions around the entire circumference is a depression section (col. 4, lines 25-26, “forward end of the shaft has a matrix #13 of depressions #14 formed around its circumference”; Figs. 1A and 8), wherein
the maximal width of a depression in a plane perpendicular to the longitudinal axis A, is essentially equal to the minimum space between two depressions (maximal width of a depression in a plane perpendicular to the longitudinal axis is essentially equal to minimum space between two depressions, as shown in Figs. 1A and 8).
straight radial lines through bottoms of adjacent depressions in a cross-sectional plane are separated by a separation angle 13 (straight radial lines through bottoms of adjacent depressions in a cross-sectional plane are separated by a separation angle, as shown in Fig. 1A, wherein a separation angle is interpreted in light of the instant specification [instant Fig. 8 and instant PGPUB ¶ 0043]; see annotations in first annotated Fig. 8 below).
adjacent depression sections are off-set in relation to each other by an off-set angle being half the separation angle 13 (circular cylindrical section having diamond depressions and circular cylindrical section having square depressions are off-set in relation to each other by an off-set angle being half the separation angle, as shown in Fig. 1A, wherein an off-set angle and the separation angle are interpreted in light of the instant specification [instant Fig. 8 and instant PGPUB ¶ 0043]; see annotations in second annotated Fig. 8 below).
adjacent depression sections (circular cylindrical section having diamond depressions and circular cylindrical section having square depressions, Figs. 1A and 8) are off-set in relation to each other by an off-set angle (discussed above in claim 8; see off-set angle in second annotated Fig. 8 below), and
wherein the most distal parts of depressions in a first depression section being interleaved in relation to the most proximal parts of depressions in an adjacent second depression section located distally said first depression section (the most distal parts of diamond depressions in a circular cylindrical section having diamond depressions are interleaved in relation to the most proximal parts of square depressions in an adjacent circular cylindrical section having square depressions located distally of said circular cylindrical section having diamond depressions, as shown in Figs. 1A and 8).
the most distal parts of the depressions in a first depression section are located distally the most proximal parts of depressions in a second depression section by a predetermined distance d along the longitudinal axis A (the most distal parts of diamond depressions in a circular cylindrical section having diamond depressions are located distally of the most proximal parts of square depressions in an adjacent circular cylindrical section having square depressions by a predetermined distance along the longitudinal axis, as shown in Figs. 1A and 8), and
wherein said second depression section is adjacent and located distally said first depression section (said circular cylindrical section having square depressions is adjacent and located distally of said circular cylindrical section having diamond depressions, as shown in Figs. 1A and 8).
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First and Second Annotated Fig. 8 of Hoyns
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical needle as made obvious by Cosman in view of Quearry and Crisman and Ryan such that [6] the maximal width of a depression in a plane perpendicular to the longitudinal axis A, is essentially equal to the minimum space between two depressions; or [7] straight radial lines through bottoms of adjacent depressions in a cross-sectional plane are separated by a separation angle 13; and/or [8] adjacent depression sections are off-set in relation to each other by an off-set angle being half the separation angle 13; or [9] adjacent depression sections are off-set in relation to each other by an off-set angle, and wherein the most distal parts of depressions in a first depression section being interleaved in relation to the most proximal parts of depressions in an adjacent second depression section located distally said first depression section; or [10] the most distal parts of the depressions in a first depression section are located distally the most proximal parts of depressions in a second depression section by a predetermined distance d along the longitudinal axis A, and wherein said second depression section is adjacent and located distally said first depression section., since a pattern of depressions separated, off-set, interleaved, and spaced apart as such was known in the art as taught by Hoyns; and since it would have been well within the skill of one of ordinary skill in the art to customize how depressions are separated, off-set, interleaved, and spaced apart according to factors such as size of the depressions, diameter/circumference of the needle, desired level of ultrasonic visibility, and specific medical procedure. The motivation would have been to improve a medical device’s visibility under ultrasound in order to advantageously guide the medical device under ultrasound visualization (Hoyns, col. 1, lines 7-21), and there was reasonable expectation of success.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman et al. (US 2017/0049993 cited in IDS 11/21/2019 - referred to as Cosman) in view of Quearry (US 2014/0265024 cited in instant PGPUB ¶ 0004 and IDS 11/21/2019) and Crisman et al. (US 2017/0112464 - referred to as Crisman), and Ryan (US 2010/0168684 cited in instant PGPUB ¶ 0005 and IDS 11/21/2019) as applied to claim(s) 11 above, and further in view of Ducharme (US 2011/0046619).
Regarding claim(s) 12-13, Cosman in view of Quearry and Crisman and Ryan makes obvious all limitations of claim(s) 1, as discussed above.
Cosman fails to explicitly teach that the medical device is a sheath or a stylet.
Ducharme discloses an echogenic medical device. Ducharme teaches that the medical device is a sheath or a stylet ([0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Cosman, Quearry, Crisman, and Ryan to utilize echogenic markings on different types of medical devices such as a sheath or stylet as taught by Ryan, as one of ordinary skill in the art would recognize that it would be desirable to provide echogenic visibility to a wide variety of different known medical devices, such that they may be appropriately visualized during their use within the patient’s body, so that that the device may be accurately oriented as described by Ducharme ([0018]).
Response to Arguments
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive.
Applicant’s arguments regarding the combination of the references is not persuasive, the rationale set forth in the patent board decision on 12/11/25 has been maintained.
As noted in the patent board decision on 12/11/25, Cosman discloses advantages of the “curved” shapes of the echogenic depression in its Figure 9B is that the ultrasound image is improved for steep angles of needle placement (Figs. 7A-7F, [0074], [0080]). Quearry and Ryan teach similar advantages. Quearry teaches that the device having features with dimensions and angular orientations is capable of providing enhanced ultrasound visualization throughout a wide range of ultrasound frequences and relative angles between device and the transducer (Figs. 4-5, [0057]). Ryan discussing enhanced visibility of needle based on scattering and reflecting of sound waves back toward a transducer ([0011]).
Furthermore, it has been held that a change in size (In re Rose, 200 F.2d 459, 105 USPQ 237 (CCPA 1955) or a change in shape (In re Dailey, 357 F.2d 669, 149 UPSQ 47 (CCPA 1966) requires only ordinary skill in the art and are considered routine expedients.
Conclusion
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/JONATHAN CWERN/ Primary Examiner, Art Unit 3797