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 .
Amendment Entered
In response to the amendment filed on July 8th, 2026, amended claims 1-2, 4-6, 9-12, and 16-18, and new claim 19 are entered. Claims 1-19 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the majority of the rejections under 35 U.S.C. 112(b) have been fully considered. The majority of the rejections are withdrawn in view of the amendment, except for the rejection of Claim 12. Although the Applicant has amended the claim to remove the first two recitations of “about” in line 2, Claim 12 still recites the term “about” in line 3. Therefore, the rejection of Claim 12 has been maintained.
Applicant's arguments, filed on July 8th, 2026, with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claim 12 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 6-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shabaz et al (U.S. Publication No. 2019/0021705; cited by Applicant; previously cited) in view of Lavi et al (U.S. Publication No. 2017/0112520).
Regarding Claim 1, Shabaz discloses a biopsy needle for penetrating soft tissue (Biopsy device with aperture orientation and improved tip; Abstract), comprising:
an elongate body (tubular section or cannula 15; [0045]) extending between a proximal end and a distal end (Figure 1), the elongate body having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); and
a tissue piercing tip (tissue penetrating tip 16) at the distal end of the elongate body (a tubular section or cannula 15 with a tissue penetrating tip 16 on the distal end thereof; [0045]), the tissue piercing tip comprising:
a first set of facets defined by three first faces (proximal portions of first concave surface 72, second concave surface 73, and third concave surface 74; [0054]; See Annotated Figure 1 below for example of proximal portion of first surface 72) and three first cutting edges (proximal portions of first curved cutting edge 75, second curved cutting edge 76, and third curved cutting edge 77; See Annotated Figure 2 below for examples of proximal portions of first curved cutting edge 75 and third curved cutting edge 77), wherein each first cutting edge is formed by adjacent faces of the three first faces ([0055]; Figures 10-11), and wherein each first cutting edge forms a first angle relative to the central longitudinal axis (Figure 10 shows wherein the proximal portion of the cutting edge forms a first angle relative to the central longitudinal axis; See Annotated Figure 3 below), and
a second set of facets positioned distal to the first set of facets, the second set of facets being defined by three second faces (distal portions of first concave surface 72, second concave surface 73, and third concave surface 74; [0054]; See Annotated Figure 1 below for example of distal portion of first surface 72) and three second cutting edges (distal portions of first curved cutting edge 75, second curved cutting edge 76, and third curved cutting edge 77; See Annotated Figure 2 below for examples of distal portions of first curved cutting edge 75 and third curved cutting edge 77), wherein each second cutting edge is formed by adjacent faces of the three second faces ([0055]); Figures 10-11, and wherein each second cutting edge forms a second angle relative to the central longitudinal axis (Figure 10 shows wherein the distal portion of the cutting edge forms a second angle relative to the central longitudinal axis; See Annotated Figure 3 below), the second angle being smaller than the first angle (Figure 10 shows wherein the second angle is smaller than the first angle; See Annotated Figure 3 below), the three second cutting edges converging to form a distal end point of the biopsy needle (sharp distal point 71; Figures 10-11).
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Shabaz fails to disclose wherein each of the three first cutting edges and the three second cutting edges is a straight cutting edge.
In a similar technical field, Lavi teaches a medical device for tissue removal (Abstract), wherein each of the three first cutting edges (the proximal end portion PP includes an elongated prism-like portion/member 106 having at least three surfaces/sides (planar or curved) 106S, with at least one of prism edges 106E between the sides being configured as a tissue cutting blade; [0031]) and the three second cutting edges (the piercing tip 102) is a straight cutting edge (It should be noted that for the purposes of the present disclosure, the pyramid-shaped piercing tip may have straight or rounded edges between the surfaces of the pyramid, as well as may have planar or curved surfaces; [0008]; Figures 1-2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the straight cutting edge teachings of Lavi into those of Shabaz in order to ensure that all the edges are configured to be blades that can be configured as tissue cutting blades (Lavi [0008]).
Regarding Claim 6, Shabaz discloses wherein a diameter of the elongate body is greater than a diameter of the tissue piercing tip (Examiner’s Note: Figures 10-11 show wherein the diameter of elongate body 15 is greater than the diameter of the tissue piercing tip 16 at sharp distal point 71).
Regarding Claim 7, Shabaz discloses wherein the elongate body includes a sidewall defining a lumen (a tubular section or cannula 15 with a…an open, tissue receiving aperture 17; [0045]).
Regarding Claim 8, Shabaz discloses wherein the elongate body includes a tissue receiving aperture in the sidewall (a tubular section or cannula 15 with a…an open, tissue receiving aperture 17; [0045]), the tissue receiving aperture being positioned adjacent to the tissue piercing tip in the distal end of the elongate body (Examiner’s Note: Figure 1 shows the tissue receiving aperture 17 being positioned adjacent to the tissue piercing tip 16).
Regarding Claim 9, although Shabaz discloses wherein a distance between the distal end point and the tissue receiving aperture defines a dead space (a tubular section or cannula 15 with a tissue penetrating tip 16 on the distal end thereof and an open, tissue receiving aperture 17; [0045]; Examiner’s Note: Figure 1 shows the tissue receiving aperture 17 being positioned adjacent to the tissue piercing tip, with space in between, equivalent to the “dead space”), Shabaz fails to explicitly disclose the dead space ranging from 8 mm to 11 mm.
However, there is no evidence of record that establishes that changing the length of the dead space would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that “an acceptable minimum dead space D may be about 8 mm to about 9 mm”…“an acceptable minimum dead space D may be about 9.5 mm to about 11 mm” (Applicant’s Specification [0052]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a dead space ranging from 8 mm to 11 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 10, although Shabaz discloses an elongate body (tubular section or cannula 15; [0045]) having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); wherein each first cutting edge forms a first angle relative to the central longitudinal axis (Figure 10 shows wherein the proximal portion of the cutting edge forms a first angle relative to the central longitudinal axis; See Annotated Figure 3 above); wherein each second cutting edge forms a second angle relative to the central longitudinal axis (Figure 10 shows wherein the distal portion of the cutting edge forms a second angle relative to the central longitudinal axis; See Annotated Figure 3 below); and wherein a distance between the distal end point and the tissue receiving aperture defines a dead space (a tubular section or cannula 15 with a tissue penetrating tip 16 on the distal end thereof and an open, tissue receiving aperture 17; [0045]; Examiner’s Note: Figure 1 shows the tissue receiving aperture 17 being positioned adjacent to the tissue piercing tip, with space in between, equivalent to the “dead space”), Shabaz fails to explicitly disclose wherein the first angle is 20 degrees, the second angle is 9 degrees, and the dead space is 8.4 mm.
However, there is no evidence of record that establishes that changing the first angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the first angle “ranges between about 17 degrees and about 23 degrees”, and offering other acceptable ranges (“the first angle of the biopsy needle ranges between about 17 degrees and about 23 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a first angle of 20 degrees as an obvious matter of design choice within the skill of the art.
Furthermore, there is no evidence of record that establishes that changing the second angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the second angle is “9 degrees”, and offering other acceptable ranges (“the second angle ranges between about 9 degrees and about 15 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a second angle of 9 degrees as an obvious matter of design choice within the skill of the art.
Finally, there is no evidence of record that establishes that changing the length of the dead space would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, Applicant has not disclosed that the claimed length solves any stated problems, merely indicating that “the dead space is about 8.4 mm” (Applicant’s Specification [0012]), and offering other acceptable ranges (“an acceptable minimum dead space D may be about 8 mm to about 9 mm”…“an acceptable minimum dead space D may be about 9.5 mm to about 11 mm” Applicant’s Specification [0052]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a dead space of 8.4 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 11, although Shabaz discloses an elongate body (tubular section or cannula 15; [0045]) having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); wherein each first cutting edge forms a first angle relative to the central longitudinal axis (Figure 10 shows wherein the proximal portion of the cutting edge forms a first angle relative to the central longitudinal axis; See Annotated Figure 3 above); wherein each second cutting edge forms a second angle relative to the central longitudinal axis (Figure 10 shows wherein the distal portion of the cutting edge forms a second angle relative to the central longitudinal axis; See Annotated Figure 3 below); and wherein a distance between the distal end point and the tissue receiving aperture defines a dead space (a tubular section or cannula 15 with a tissue penetrating tip 16 on the distal end thereof and an open, tissue receiving aperture 17; [0045]; Examiner’s Note: Figure 1 shows the tissue receiving aperture 17 being positioned adjacent to the tissue piercing tip, with space in between, equivalent to the “dead space”), Shabaz fails to explicitly disclose wherein the first angle is 20 degrees, the second angle is 12 degrees, and the dead space is 8.4 mm.
However, there is no evidence of record that establishes that changing the first angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the first angle has acceptable ranges (“the first angle of the biopsy needle ranges between about 17 degrees and about 23 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a first angle of 20 degrees as an obvious matter of design choice within the skill of the art.
Furthermore, there is no evidence of record that establishes that changing the second angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the second angle has acceptable ranges (“the second angle ranges between about 9 degrees and about 15 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a second angle of 12 degrees as an obvious matter of design choice within the skill of the art.
Finally, there is no evidence of record that establishes that changing the length of the dead space would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, Applicant has not disclosed that the claimed length solves any stated problems, merely indicating that the dead space has acceptable ranges (“an acceptable minimum dead space D may be about 8 mm to about 9 mm”…“an acceptable minimum dead space D may be about 9.5 mm to about 11 mm” Applicant’s Specification [0052]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have the dead space of 8.4 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 12, although Shabaz discloses an elongate body (tubular section or cannula 15; [0045]) having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); wherein each first cutting edge forms a first angle relative to the central longitudinal axis (Figure 10 shows wherein the proximal portion of the cutting edge forms a first angle relative to the central longitudinal axis; See Annotated Figure 3 above); wherein each second cutting edge forms a second angle relative to the central longitudinal axis (Figure 10 shows wherein the distal portion of the cutting edge forms a second angle relative to the central longitudinal axis; See Annotated Figure 3 below); and wherein a distance between the distal end point and the tissue receiving aperture defines a dead space (a tubular section or cannula 15 with a tissue penetrating tip 16 on the distal end thereof and an open, tissue receiving aperture 17; [0045]; Examiner’s Note: Figure 1 shows the tissue receiving aperture 17 being positioned adjacent to the tissue piercing tip, with space in between, equivalent to the “dead space”), Shabaz fails to explicitly disclose wherein the first angle is 20 degrees, the second angle is 15 degrees, and the dead space is about 8.4 mm.
However, there is no evidence of record that establishes that changing the first angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the first angle has acceptable ranges (“the first angle of the biopsy needle ranges between about 17 degrees and about 23 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a first angle of 20 degrees as an obvious matter of design choice within the skill of the art.
Furthermore, there is no evidence of record that establishes that changing the second angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the second angle has acceptable ranges (“the second angle ranges between about 9 degrees and about 15 degrees” Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a second angle of 15 degrees as an obvious matter of design choice within the skill of the art.
Finally, there is no evidence of record that establishes that changing the length of the dead space would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed lengths. Lastly, Applicant has not disclosed that the claimed length solves any stated problems, merely indicating that “the dead space is about 8.4 mm” (Applicant’s Specification [0012]), and offering other acceptable ranges (“an acceptable minimum dead space D may be about 8 mm to about 9 mm”…“an acceptable minimum dead space D may be about 9.5 mm to about 11 mm” Applicant’s Specification [0052]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have the dead space of about 8.4 mm as an obvious matter of design choice within the skill of the art.
Regarding Claim 13, Shabaz discloses wherein the three first faces are all symmetrical to each other and the three first cutting edges are all symmetrical to each other (Examiner’s Note: Figure 10 shows surface 72 while Figure 11 shows surfaces 73 and 74, which are all symmetrical to each other).
Regarding Claim 14, Shabaz discloses wherein the three second faces are all symmetrical to each other and the three second cutting edges are all symmetrical to each other (Examiner’s Note: Figure 10 shows cutting edges 75 and 77 while Figure 11 shows a different view of cutting edges 75, 76, and 77, which are all symmetrical to each other).
Regarding Claim 19, Shabaz fails to disclose wherein each of the three first faces and the three second faces is a planar surface.
In a similar technical field, Lavi teaches a medical device for tissue removal (Abstract), wherein each of the three first faces (the proximal end portion PP includes an elongated prism-like portion/member 106 having at least three surfaces/sides (planar or curved) 106S, with at least one of prism edges 106E between the sides being configured as a tissue cutting blade; [0031]) and the three second faces (the piercing tip 102) is a planar surface (It should be noted that for the purposes of the present disclosure, the pyramid-shaped piercing tip may have straight or rounded edges between the surfaces of the pyramid, as well as may have planar or curved surfaces; [0008]; Figures 1-2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the planar surface teachings of Lavi into those of Shabaz in order to ensure that all the edges are configured to be blades that can be configured as tissue cutting blades (Lavi [0008]).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Shabaz et al and Lavi et al as applied to claim 1 above, and further in view of Smith (U.S. Publication No. 2013/0030323; previously cited).
Regarding Claim 2, Shabaz and Lavi fail to specifically disclose wherein the biopsy needle is a nine-gauge (9-G) needle.
In a similar technical field, Smith teaches a needle biopsy device and related method (Abstract), wherein the biopsy needle is a nine-gauge (9-G) needle (the needle 32 is a 9 gauge needle; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the nine-gauge needle teachings of Smith into those of Shabaz and Lavi in order to ensure that the needle can be of any known gauge size suitable for performing any particular biopsy procedure (Smith [0036]).
Regarding Claim 3, Shabaz and Lavi fail to specifically disclose wherein the biopsy needle is a seven-gauge (7-G) needle.
In a similar technical field, Smith teaches a needle biopsy device and related method (Abstract), wherein the biopsy needle is a seven-gauge (7-G) needle (The needle 32 may be provided in any desired size. For example, needle 32 may be sized within the range of 6-18 gauge…it should be noted that the needle 32 can be of any known gauge size suitable for performing any particular biopsy procedure; [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the seven-gauge needle teachings of Smith into those of Shabaz and Lavi in order to ensure that the needle can be of any known gauge size suitable for performing any particular biopsy procedure (Smith [0036]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shabaz et al and Lavi et al as applied to claim 1 above, and further in view of Baldridge (U.S. Patent No. 5,357,974; previously cited).
Regarding Claim 15, Shabaz and Lavi fail to specifically disclose wherein the tissue piercing tip comprises one or more reliefs.
In a similar technical field, Baldridge teaches a biopsy instrument (Abstract), wherein the tissue piercing tip comprises one or more reliefs (A pair of diametrically opposed relief slots 80 allow for compression of the distal extreme of the shaft 70 as it is drawn into the shaft 45 of the aspirate needle 25 (FIGS. 9-12); Column 6 Lines 20-23; The relief slots 80 are approximately 0.5 mm wide and 7 mm long extending from the distal end 72 toward the proximal end 92 of the shaft 70; Column 6 Lines 47-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the relief teachings of Baldridge into those of Shabaz and Lavi in order to allow for compression of the distal end of the needle shaft (Baldridge Column 6 Lines 20-23).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shabaz et al, Lavi et al, and Smith as applied to claim 3 above, and further in view of Shabazet al.
Regarding Claim 4, although Shabaz discloses an elongate body (tubular section or cannula 15; [0045]) having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); and wherein each first cutting edge forms a first angle relative to the central longitudinal axis (Figure 10 shows wherein the proximal portion of the cutting edge forms a first angle relative to the central longitudinal axis; See Annotated Figure 3 above), Shabaz, Lavi, and Smith fail to explicitly disclose wherein the first angle ranges between 17 degrees and 23 degrees relative to the central longitudinal axis.
However, there is no evidence of record that establishes that changing the first angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the first angle ranges between “about 17 degrees and about 23 degrees” (Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a first angle ranging between 17 degrees and 23 degrees relative to the central longitudinal axis as an obvious matter of design choice within the skill of the art.
Regarding Claim 5, although Shabaz discloses an elongate body (tubular section or cannula 15; [0045]) having a central longitudinal axis (longitudinal axis 28; [0047]; Figures 4A-4B, 8); and wherein each second cutting edge forms a second angle relative to the central longitudinal axis (Figure 10 shows wherein the distal portion of the cutting edge forms a second angle relative to the central longitudinal axis; See Annotated Figure 3 below), Shabaz, Lavi, and Smith fail to explicitly disclose wherein the second angle ranges between 9 degrees and 15 degrees relative to the central longitudinal axis.
However, there is no evidence of record that establishes that changing the second angle would result in a difference in the function of the needle of Shabaz. Further, a person having ordinary skill in the art, being faced with modifying the needle of Shabaz, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, Applicant has not disclosed that the claimed range solves any stated problems, merely indicating that the second angle ranges between “about 9 degrees and about 15 degrees” (Applicant’s Specification [0010]). Thus, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Shabaz to have a second angle ranging between 9 degrees and 15 degrees relative to the central longitudinal axis as an obvious matter of design choice within the skill of the art.
Allowable Subject Matter
Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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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/CHANEL J YOON/Examiner, Art Unit 3791
Prosecution Insights