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 .
Response to Amendment
The Amendment filed 12/10/2025 has been entered.
Claim 3 was previously cancelled.
Claims 1, 2, and 4-21 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 09/11/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites “a portion of the other one of the inner surface and the outer surface of the main body intersecting” in lines 9-10. This is not in the specification and is considered new matter.
Claims 9-16 are similarly rejected by virtue of their dependency upon claim 8.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Biyani et al. (U.S. Publication No. 20110034885), hereinafter Biyani, in further view of Silverman et al. (U.S. Patent No. 5478328), hereinafter Silverman.
Regarding claim 1, Biyani discloses a medical puncture needle (needle 20; see FIGS. 1-4 the Examiner notes that all reference characters cited below refer to FIGS. 1-4 unless otherwise stated), the medical puncture needle comprising:
a main body (cannula 21) possessing a central axis and a cylindrical shape (see FIG. 4), the main body including a through hole (bore 23a and first aperture 25) extending in an axial direction throughout the main body from a proximal end of the main body to a distal end of the main body (see FIG. 4), the main body having an inner surface surrounding the through hole (inner surface of cannula 21), the main body also having an outer surface (outer surface of cannula 21);
a portion of the inner surface or the outer surface of the main body being a tapered blade surface (surface 24a) that has an annular shape and that is tapered so that a thickness of the main body decreases toward the distal end of the main body (“end wall 24 has an outer surface 24a that is tapered toward a point”, [0017]; see FIG. 4);
a blade edge (edge of first aperture 25) that has an annular shape, the blade edge being at a tip of the blade surface and being configured so that the blade edge extends along a plane orthogonal to the central axis of the main body (see FIG. 4).
a liquid medicine passage groove (recessed area 27) formed on the inner surface of the main body, extending in the axial direction (see FIG. 4) and configured to guide the liquid medicine to a needle tip of the medical puncture needle when the through hole is closed by coring of the tissue resulting from insertion of the medical puncture needle into the tissue in the living body (see paths 51 and 52 in FIGS. 6 and 7), the liquid medicine passage groove having a width and a depth configured to inhibit entry of the tissue into the liquid medicine passage groove during the coring (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue);
the liquid medicine passage groove having a distal end and a proximal end that are spaced apart in the axial direction (see FIG. 7), the proximal end of the liquid medicine passage groove being at a position where the tissue cannot enter the liquid medicine passage groove during the coring (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue): and
the liquid medicine passage groove having a distal portion (portion of area 27 and aperture 25) that extends from the distal end of the liquid medicine passage groove toward the proximal end of the liquid medicine passage groove, the distal portion of the liquid medicine passage groove and the tapered blade surface (surface 24a) overlapping one another in the axial direction (see FIG. 7).
However, Biyani does not expressly state wherein the needle is configured to administer liquid medicine to tissue in a living body.
Silverman teaches needle modifications, and combinations thereof for increasing user safety (Col 5 Lines 4-5) wherein the needle is configured to administer liquid medicine to tissue in a living body (“injection and withdrawal of fluid.”, Col 1 Line 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle Biyani to be configured to administer liquid medicine to tissue in a living body. Doing so establishes fluidic communication via attachable tubing or syringes, as taught by Silverman (Col 1 Lines 15-20).
Regarding claim 2, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 1, and Biyani further discloses wherein the passage groove (area 27) terminates adjacent the blade edge (edge of aperture 25; see FIG. 4), the liquid medicine passage groove having an uneven structure (see spacers 44 that create uneven structure in area 27 seen in FIGS. 6 and 7).
Regarding claim 4, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 3, and Biyani further discloses wherein the inner surface of the main body (inner surface of cannula 21) includes a plurality of the liquid medicine passage groves (recessed area 27, area between end walls 43 and 24, first aperture 25, second aperture 26).
Regarding claim 5, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 1, and Biyani further discloses wherein the blade surface (surface 24a) is provided on an outer peripheral side of the main body (outer side of cannula 21; see FIG. 4).
Regarding claim 6, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Biyani does not expressly state wherein the blade surface is provided on both an inner peripheral side and an outer peripheral side of the main body.
Silverman teaches needle modifications, and combinations thereof for increasing user safety (Col 5 Lines 4-5) wherein the blade surface (taper 2) is provided on both an inner peripheral side and an outer peripheral side of the main body (see FIG. 3n).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the blade surface of Biyani to be provided on both an inner peripheral side and an outer peripheral side of the main body. Doing so provides a channel from inside the needle that in which simply merges to the sides of the tapered main body to create an opening(s), as taught by Silverman (Col 8 Lines 4-25).
Regarding claim 8, Biyani discloses a medical puncture needle (needle 20; see FIGS. 1-4 the Examiner notes that all reference characters cited below refer to FIGS. 1-4 unless otherwise stated) for puncturing tissue of a living body, the medical puncture needle comprising:
a cylindrically-shaped main body (cannula 21) possessing a central axis, the main body including a through hole (bore 23a and first aperture 25) that extends in an axial direction throughout the main body from a proximal end of the cylindrically-shaped main body to an opposite axial end of the cylindrically- shaped main body (see FIG. 4), the main body including an inner surface (inner surface of bore 23a) that surrounds the through hole and an outer surface;
the main body including a distal end portion (“second opposite end of the shaft portion 23”, [0017]) that terminates at the distal end of the main body (see FIG. 4), a portion of one of the inner surface and the outer surface of the main body being an annular-shaped inclined surface (surface 24a) at the distal end portion of the main body, the inclined surface being inclined relative to the central axis so that the distal end portion of the main body is tapered and a thickness of the main body decreases toward the distal end of the main body (“end wall 24 has an outer surface 24a that is tapered toward a point”, [0017]; see FIG. 4);
the inclined surface terminating at a blade edge (edge of first aperture 25 and surface 24a) that is first brought into contact with the tissue of the living body during the puncture of the tissue of the living body to administer the liquid medicine (“vertebral needle 20 can be inserted into the intermediate vertebra 11”, [0015]); and
a liquid medicine groove (recessed area 27) in the inner surface of the main body defining a flow path for guiding the liquid medicine to the distal end portion of the main body (“recessed area 27 provides communication between the bore 42a provided within the shaft portion 42 of the inner cannula 40 and the external region that is located axially adjacent to the second end of the outer cannula 21”, [0023]; see FIG. 4 and 7) when the through hole is closed as a result of coring during the puncture of the tissue (the Examiner notes FIG. 2 shows recessed area 27 acting as a flow path when the through hole is closed due to obturator 30).
the liquid medicine passage groove having a width and a depth configured to inhibit entry of the tissue into the liquid medicine passage groove during the coring (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue);
the liquid medicine passage groove having a distal end and a proximal end that are spaced apart in the axial direction (see FIG. 7), the proximal end of the liquid medicine passage groove being at a position where the tissue cannot enter the liquid medicine passage groove during the coring (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue): and
the liquid medicine passage groove having a distal portion (portion of area 27 and aperture 25) that extends from the distal end of the liquid medicine passage groove toward the proximal end of the liquid medicine passage groove, the distal portion of the liquid medicine passage groove and the tapered blade surface (surface 24a) overlapping one another in the axial direction (see FIG. 7).
However, Biyani does not expressly state wherein the needle is configured to administer liquid medicine to tissue in a living body.
Silverman teaches needle modifications, and combinations thereof for increasing user safety (Col 5 Lines 4-5) wherein the needle is configured to administer liquid medicine to tissue in a living body (“injection and withdrawal of fluid.”, Col 1 Line 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle Biyani to be configured to administer liquid medicine to tissue in a living body. Doing so establishes fluidic communication via attachable tubing or syringes, as taught by Silverman (Col 1 Lines 15-20).
Regarding claim 9, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, and Biyani further discloses wherein the blade edge (edge of first aperture 25 and surface 24a) is a circular-shaped blade edge (see FIG. 4), the circular-shaped blade edge lying in a plane that is perpendicular to the central axis (see Examiner annotated FIG. 4 below).
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Regarding claim 10, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, and Biyani further discloses wherein the liquid medicine passage groove (recessed area 27) possesses a distal-most end that is spaced proximally from the circular-shaped blade edge (see Examiner annotated FIG. 4 below).
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Regarding claim 11, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, and Biyani further discloses wherein the liquid medicine passage groove (recessed area 27) possesses a proximal-most end that is spaced distally from the proximal end of the main body (see Examiner annotated FIG. 4 above).
Regarding claim 12, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, and Biyani further discloses wherein the liquid passage groove is a first liquid passage groove (recessed area 27), and further including at least one other liquid medicine passage groove (area between end walls 43 and 24, first aperture 25, second aperture 26) in the inner peripheral surface of the main body (inner surface of cannula 21).
Regarding claim 13, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, and Biyani further discloses wherein the inclined surface (surface 24a) is the portion of the outer peripheral surface of the main body (cannula 21; see FIG. 4).
Regarding claim 14, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, however, Biyani does not expressly state wherein the inclined surface is the portion of the inner peripheral surface of the main body.
Silverman teaches needle modifications, and combinations thereof for increasing user safety (Col 5 Lines 4-5) wherein the inclined surface (taper 2) is the portion of the inner peripheral surface of the main body (see FIG. 3n).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inclined surface of Biyani to be an inner peripheral surface of the main body. Doing so provides a channel from inside the needle that in which simply merges to the sides of the tapered main body to create an opening(s), as taught by Silverman (Col 8 Lines 4-25).
Regarding claim 15, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, however, Biyani does not expressly state wherein the inclined surface is a first inclined surface and is the portion of the outer peripheral surface of the main body, a distal portion of the inner peripheral surface of the main body also being an inclined surface that is inclined relative to the central axis.
Silverman teaches needle modifications, and combinations thereof for increasing user safety (Col 5 Lines 4-5) wherein the inclined surface (taper 2) is an outer peripheral surface of the main body (see FIG. 3n), the portion of the inner surface of the main body being a second inclined surface that is inclined relative to the central axis (see FIG. 3n).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inclined surface of Biyani to be a first inclined surface and is the portion of the outer peripheral surface of the main body, a distal portion of the inner peripheral surface of the main body also being an inclined surface that is inclined relative to the central axis. Doing so provides a channel from inside the needle that in which simply merges to the sides of the tapered main body to create an opening(s), as taught by Silverman (Col 8 Lines 4-25).
Regarding claim 17, Biyani discloses a method of administering liquid medicine to tissue of a living body (“method of operation of the vertebral needle 20”, [0025]), the method comprising:
moving a medical puncture needle (needle 20) toward the tissue of the living body, the medical puncture needle comprising (see [0026]):
a cylindrically-shaped main body (cannula 21) possessing a central axis and a cylindrical shape (see FIG. 4), the main body including a through hole (bore 23a and first aperture 25) extending throughout the main body in an axial direction from a proximal end of the main body to a distal end of the main body (See FIG. 4), the main body having an inner surface surrounding the through hole, the main body also having an outer surface (inner and outer surface of cannula 21);
a portion of the inner surface or the outer surface of the main body being an annular-shaped blade surface (surface 24a) that is tapered so a thickness of the main body decreases toward the distal end of the main body (“end wall 24 has an outer surface 24a that is tapered toward a point”, [0017]; see FIG. 4); and
a circular-shaped blade edge (edge of first aperture 25 and surface 24a) at a distal-most end of the blade surface, the circular-shaped blade edge lying in a plane orthogonal to the central axis of the main body (see Examiner annotated FIG. 4 below); and
a liquid medicine passage groove (recessed area 27) formed on the inner surface of the main body and extending in the axial direction (see FIG. 6), the liquid medicine passage groove having a distal end and a proximal end that are spaced apart in the axial direction (see FIG. 7), the liquid medicine passage groove having a distal portion that extends from the distal end of the liquid medicine passage groove toward the proximal end of the liquid medicine passage groove, the distal portion of the liquid medicine passage groove and the annular-shaped blade surface (surface 24a) that is tapered overlapping one another in the axial direction (see FIG. 7).
puncturing the tissue of the living body with the circular-shaped blade edge and then inserting the medical puncture needle into the tissue (“The assembly of the outer cannula 21 and the obturator 30 is continued to be inserted until the tip portion 33 of the obturator 30 is disposed within the compression fracture 11a within the intermediate vertebra 11”, 0026]); and
delivering the liquid medicine to the tissue, after the puncturing of the tissue, by way of the through hole in the main body (“needle 20 is adapted to facilitate the injection of a convention bone cement or other material into the region of the compression fracture 11a during an interventional procedure”, [0015]; see FIGS. 6-7), the liquid medicine passage groove having a width and a depth configured to inhibit entry of the tissue into the liquid medicine passage groove during the coring (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue), the proximal end of the liquid medicine passage groove being at a position where the tissue cannot enter the liquid medicine passage groove during the coring the liquid medicine passage groove having a distal end and a proximal end that are spaced apart in the axial direction (see FIG. 6), the proximal end of the liquid medicine passage groove being at a position where the tissue cannot enter the liquid medicine passage groove during the coring.
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Regarding claim 18, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 17, and Biyani further discloses the through hole (bore 23a) being closed by coring of the tissue after the puncturing of the tissue, and guiding the liquid medicine in the through hole toward the distal end of the main body by flowing the liquid medicine through the liquid medicine passage groove (“recessed area 27 provides communication between the bore 42a provided within the shaft portion 42 of the inner cannula 40 and the external region that is located axially adjacent to the second end of the outer cannula 21”, [0023]; see FIG. 4 and 7) while the through hole is closed by the coring of the tissue (the Examiner notes the groove will accommodate the bone cement or other material injected into needle, not the tissue).
Regarding claim 19, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 18, and Biyani further discloses wherein the liquid medicine passage groove (recessed area 27) possesses a distal-most end that is spaced proximally from the circular-shaped blade edge (see Examiner annotated FIG. 4 below).
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Regarding claim 20, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 18, and Biyani further discloses wherein the liquid medicine passage groove (recessed area 27) possesses a proximal-most end that is spaced distally from the proximal end of the main body (see Examiner annotated FIG. 4 above).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Biyani et al. (U.S. Publication No. 20110034885), hereinafter Biyani, in further view of Silverman et al. (U.S. Patent No. 5478328), hereinafter Silverman, in further view of Tamura et al. (U.S. Publication No. 20070256289), hereinafter Tamura.
Regarding claim 7, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Biyani in view of Silverman does not expressly state wherein the blade surface that is tapered is provided only on an inner peripheral side of the main body.
Tamura teaches a method of manufacturing an injection needle used when a liquid such as a medicine is injected into a living body (see [0003]) wherein the blade surface that is tapered is provided only on an inner peripheral side of the main body (see FIG. 3 and 4A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the tapered blade surface of Biyani in view of Silverman to be provided only on an inner peripheral side of the main body. Doing so provides needle insertion and device utilization repeatability, as taught by Tamura (see [0042]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Biyani et al. (U.S. Publication No. 20110034885), hereinafter Biyani, in further view of Silverman et al. (U.S. Patent No. 5478328), hereinafter Silverman, in further view of Koyama et al. (U.S. Patent No. 20110125101), hereinafter Koyama.
Regarding claim 16, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, however, Biyani in view of Silverman does not expressly state wherein the liquid medicine passage groove is one of plural liquid medicine passage grooves that intersect one another to form a matrix.
Koyama teaches an otologic syringe needle for accurately injecting and dispersing a medical agent into an extremely small region (Abstract) wherein the liquid medicine passage groove is one of plural liquid medicine passage grooves (slits 18-1 and 18-2) that intersect one another to form a matrix (see FIG. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the passage groove of Biyani to be one of plural liquid medicine passage grooves that intersect one another to form a matrix. Doing so provides two directions in the needle tip resulting in the increase of the injection area and the enhancement of the dispersion of the medical agent, as taught by Koyama (see [0046]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Biyani et al. (U.S. Publication No. 20110034885), hereinafter Biyani, in further view of Silverman et al. (U.S. Patent No. 5478328), hereinafter Silverman, in further view Weber et al. (U.S. Publication No. 20040054374), hereinafter Weber.
Regarding claim 21, Biyani in view of Silverman teaches the claimed invention as discussed above concerning the rejection of claim 8, however, Biyani in view of Silverman does not expressly state the puncturing of the tissue of the living body with the circular-shaped blade edge includes puncturing an intestinal mucosa of the living body, a posterior eye segment of the living body or an olfactory mucosa of the living body.
Weber teaches an apparatus and methods for delivering ocular implants or microimplants (Abstract) wherein the puncturing of the tissue of the living body with the circular-shaped blade edge includes puncturing an intestinal mucosa of the living body, a posterior eye segment of the living body or an olfactory mucosa of the living body (see [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device Biyani in view of Silverman to include the puncturing of the tissue of the living body with the circular-shaped blade edge includes puncturing an intestinal mucosa of the living body, a posterior eye segment of the living body or an olfactory mucosa of the living body. Doing so provides a method of microimplant delivery using insertion of a needle cannula, as taught by Weber (see [0081-82]).
Response to Arguments
Applicant’s arguments, see Remarks pages 12-17, filed 12/10/2025, with respect to the rejection(s) of claim(s) 1-6, 8-14, and 16-20 under 35 U.S.C. 102 and 103 to Biyani have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Biyani (U.S. Patent Pub. 20110034885) in view of Silverman (U.S. Patent No. 5478328)
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744 The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
03/20/2025
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783