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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 3, 2026 has been entered.
Status of the Claims
This Office Action is responsive to the amendment filed April 3, 2026. As directed by the amendment: Claims 1 and 15 have been amended. Claims 2 and 5 were cancelled. Claims 1, 3, 4, and 6-26 are presently pending in this application.
Claim Rejections - 35 USC § 112(b)
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.
Claims 15-26 are 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 “smooth” in claim 15 is a relative term which renders the claim indefinite. The term “smooth” 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.
Claims 16-26 are rejected on being dependent to a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 6-8, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sutika (US 2019/0262048).
Regarding claim 1, Sutika discloses a bone auger (30) (figure 1A) for use in minimally invasive spine surgery (considered functional) comprising a handle (e.g. driver 56, ¶51) at a proximal end (¶51 and figure 15) and a lumen (e.g. cannulated, ¶50) extending from the handle (e.g. driver 56, ¶51) to a distal end (e.g. figures 1A, 1B, 3, 4), wherein the distal end (e.g. figures 1A, 1B, 3, 4) comprises a plurality of threads (42) on an exterior circumferential surface (figures 1A, 1B, 3, 4) of at least a portion of the distal end (e.g. figures 1A, 1B, 3, 4) and a plurality of teeth (elements 44) at a distal most tip of the distal end (e.g. figures 1A, 1B, 3, 4), wherein the bone auger (30) is configured to (i.e. capable of) create an access path through hard tissue to a spinal region and be subsequently withdrawn after use (considered as intended use), wherein the plurality of teeth (elements 44) are separate and distinct from the plurality of threads (42) (figures 1A, 1B) and configured to (i.e. capable of) transition to a flat configuration as the bone auger is advanced through hard tissue (the Examiner note this is dependent on the material of the teeth and the amount of force applied between two surfaces) to prevent over-penetration, and increase safety profile, of the distal most tip of the bone auger (30).
Regarding claim 6, Sutika discloses where one or more of the plurality of teeth (44) comprises a material (¶46) configured to (i.e. capable of) be filed down to the flat configuration as the distal tip travels through hard tissue (the Examiner note this is dependent on the material of the teeth and the amount of force applied between two surfaces).
Regarding claim 7, Sutika discloses wherein the plurality of teeth (elements 44) are configured to (i.e. capable of) aid with grinding and penetration of hard tissue (considered functional).
Regarding claim 8, Sutika discloses wherein the bone auger (30) is configured to (i.e. capable of) provide access to a target treatment area to perform a procedure of surgery (considered functional).
Regarding claim 11, Sutika discloses wherein the lumen (e.g. cannulated, ¶50) is configured to (i.e. capable of) receive working instruments and guide the working instruments to a target treatment area (considered functional).
Claim(s) 15, 18, 19, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez (US 2016/0143671).
Regarding claim 15, Jimenez discloses a bone auger (902) (figures 9A-9E) for use in minimally invasive spine surgery (considered functional) comprising a handle (e.g. driver, not shown, received in element 920) at a proximal end (figures 9A-9E), and a lumen (figures 9A-9E) extending from the handle (e.g. driver, not shown, received in element 920) to a distal end (figures 9A-9E), wherein a distal most tip of the distal end is tapered (914) (figures 9A-9E), wherein the distal end comprises a plurality of flutes (elements 922) along a circumference of the distal end (figures 9A-9E), wherein the plurality of flutes (elements 922) are helical (figures 9A-9E), and a continuous circumferential edge (914) that is smooth (figure 9C) and devoid of flutes at the distal most tip of the distal end (figures 9A-9E), and wherein the bone auger (902) is configured to (i.e. capable of) create an access path through hard tissue to a spinal region and be subsequently withdrawn after use (considered as intended use).
Regarding claim 18, Jimenez discloses wherein the distal most tip (figures 9A-9E) is configured to (i.e. capable of) aid with grinding and penetration of hard tissue (considered functional).
Regarding claim 19, Jimenez discloses wherein the bone auger (902) is configured to (i.e. capable of) provide access to a target treatment area to perform a procedure of surgery (considered functional).
Regarding claim 22, Jimenez discloses wherein the lumen (figures 9A-9E) is configured to (i.e. capable of) receive working instruments and guide the working instruments to a target treatment area (Abstract).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutika (US 2019/0262048).
Regarding claims 3, 4, Sutika’s bone auger discloses all the features/elements as claimed but lacks a detailed description on wherein the plurality of threads comprise a rake angle relative a helical axis between about -30 degrees to about 30 degrees and wherein the plurality of threads comprise a depth from about 0.10 mm to about 2.0 mm.
However, the prior art discovering the optimum or workable ranges involves only routine skill in the art.
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 Sutika’s plurality of threads with a rake angle relative a helical axis between about -30 degrees to about 30 degrees and a depth from about 0.10 mm to about 2.0 mm, since discovering the optimum or workable ranges involves only routine skill in the art.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutika (US 2019/0262048) in view of Frankel et al. (US 2005/0107800), herein referred to as Frankel.
Regarding claims 9, 10, Sutika’s bone auger discloses all the features/elements as claimed but lacks wherein the handle comprises a T, L, or C shape, or wherein the handle comprises a spherical, oval, triangular, rectangular, or square shape.
However, Frankel teaches a handle (124) comprises a T (figure 7), L, or C shape, or wherein the handle (124) comprises a spherical, oval (figure 7), triangular, rectangular, or square shape.
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 Sutika’s handle with wherein the handle comprises a T shape, or wherein the handle comprises oval shape as taught by Frankel, since such a modification would provide an alternative handle shape, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutika (US 2019/0262048) in view of Linderman et al. (US 2012/0239050), herein referred to as Linderman.
Regarding claims 12, 13, 14, Sutika’s bone auger discloses all the features/elements as claimed but lacks wherein the handle comprises a housing and an insert removably coupled with the housing, wherein the insert is coupled with the housing via at least one of a snap-fit connection, an interference fit connection, a magnetic connection, and a mechanical connector, wherein the insert comprises a plurality of posts configured to couple with corresponding recesses in the housing.
However, Linderman teaches a handle (40) (figures 1, 2A) comprises a housing (46) and an insert (44) removably coupled with the housing (46), wherein the insert (44) is coupled with the housing (46) via at least one of a snap-fit connection (¶49), an interference fit connection, a magnetic connection, and a mechanical connector, wherein the insert (44) comprises a plurality of posts (elements 48) configured to (i.e. capable of) couple with corresponding recesses (50) in the housing (¶49 and figure 2A).
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 Sutika’s handle with wherein the handle comprises a housing and an insert removably coupled with the housing, wherein the insert is coupled with the housing via a snap-fit connection, wherein the insert comprises a plurality of posts configured to couple with corresponding recesses in the housing as taught by Linderman, since such a modification would provide an alternative handle that allows the user to remove parts via snap-fit connection.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez (US 2016/0143671).
Regarding claims 16, 17, Jimenez’s bone auger discloses all the features/elements as claimed but lacks a detailed description on wherein the plurality of flutes comprise a rake angle relative a helical axis between about -30 degrees to about 30 degrees and wherein the plurality of flutes comprise a depth from about 0.10 mm to about 2.0 mm.
However, the prior art discovering the optimum or workable ranges involves only routine skill in the art.
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 Jimenez’s plurality of flutes with a rake angle relative a helical axis between about -30 degrees to about 30 degrees and a depth from about 0.10 mm to about 2.0 mm, since discovering the optimum or workable ranges involves only routine skill in the art.
Claim(s) 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez (US 2016/0143671) in view of Frankel (US 2005/0107800).
Regarding claims 20, 21, Jimenez’s bone auger discloses all the features/elements as claimed but lacks a detailed description on wherein the handle comprises a T, L, or C shape, or wherein the handle comprises a spherical, oval, triangular, rectangular, or square shape.
However, Frankel teaches a handle (124) comprises a T (figure 7), L, or C shape, or wherein the handle (124) comprises a spherical, oval (figure 7), triangular, rectangular, or square shape.
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 Jimenez’s handle with wherein the handle comprises a T shape, or wherein the handle comprises oval shape as taught by Frankel, since such a modification would provide an alternative handle shape, wherein a change in shape is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez (US 2016/0143671) in view of Linderman (US 2012/0239050).
Regarding claims 23, 24, 25, Jimenez’s bone auger discloses all the features/elements as claimed but lacks wherein the handle comprises a housing and an insert removably coupled with the housing, wherein the insert is coupled with the housing via at least one of a snap-fit connection, an interference fit connection, a magnetic connection, and a mechanical connector, wherein the insert comprises a plurality of posts configured to couple with corresponding recesses in the housing.
However, Linderman teaches a handle (40) (figures 1, 2A) comprises a housing (46) and an insert (44) removably coupled with the housing (46), wherein the insert (44) is coupled with the housing (46) via at least one of a snap-fit connection (¶49), an interference fit connection, a magnetic connection, and a mechanical connector, wherein the insert (44) comprises a plurality of posts (elements 48) configured to (i.e. capable of) couple with corresponding recesses (50) in the housing (¶49 and figure 2A).
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 Jimenez’s handle with wherein the handle comprises a housing and an insert removably coupled with the housing, wherein the insert is coupled with the housing via a snap-fit connection, wherein the insert comprises a plurality of posts configured to couple with corresponding recesses in the housing as taught by Linderman, since such a modification would provide an alternative handle that allows the user to remove parts via snap-fit connection.
Regarding claim 26, the modified Jimenez’s bone auger discloses all the features/elements as claimed but lacks wherein a post of the plurality of posts has a cruciform cross-sectional profile and wherein a corresponding recess of the recesses in the housing has a corresponding cruciform-shaped slot to receive the post therethrough.
However, a change in shape is generally recognized as being within the level of ordinary skill in the art.
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 modified Jimenez’s bone auger with wherein a post of the plurality of posts has a cruciform cross-sectional profile and wherein a corresponding recess of the recesses in the housing has a corresponding cruciform-shaped slot to receive the post therethrough, since such a modification is considered a change in shape is generally recognized as being within the level of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed April 3, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 7-13, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to the amended claims 1 and 15 and the references Sutika and Jimenez. Applicant argues on pages 8-9 of the Remarks that “Sutika discloses a "bone fusion screw" designed for permanent placement to hold bones stationary until fusion occurs. See Sutika, Title; paragraph [0002]. In contrast, the present invention is a removable bone auger - a tool designed to bore an access path through hard tissue bone structure to a spinal region and be subsequently withdrawn to allow for the introduction of other instruments”. In response to applicant's argument that Sutika is for permanent placement and the present invention is a removable bone auger - a tool designed to bore an access path through hard tissue bone structure to a spinal region and be subsequently withdrawn to allow for the introduction of other instruments, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner notes that an user is capable of performing the function of withdrawal and furthermore, notes that the claims are drawn to the device rather than the method.
Next, applicant argues that “Sutika thus fails to disclose, and it would be contrary to the purpose of its permanent implant teeth to include, teeth that transition to a flat configuration”. However, the Examiner respectfully disagrees because as generally claimed, Sutika discloses the plurality of teeth (elements 44) are configured to (i.e. capable of) transition to a flat configuration as the bone auger is advanced through hard tissue (the Examiner note this is dependent on the material of the teeth and the amount of force applied between two surfaces) to prevent over-penetration, and increase safety profile, of the distal most tip of the bone auger (30). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner further notes that the claims are drawn to the device rather than the method.
Applicant’s arguments on pages 10-12 of the Remarks are directed to the amended claim 15 and the reference Jimenez. Applicant argues that “Similar to Sutika, Jimenez describes permanent insert screws for sacroiliac joint fusion (see Title, Abstract, Figs. 9A-9E). It is not a bone auger instrument configured to be withdrawn after creating an access path in hard tissue. Jimenez's screw (102) is designed to stay in the patient to promote fusion”. In response to applicant's argument that Jimenez is not a bone auger instrument configured to be withdrawn after creating an access path in hard tissue, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Examiner notes that an user is capable of performing the function of withdrawal and furthermore, notes that the claims are drawn to the device rather than the method.
Applicant argues under (i) that “Jimenez contains no disclosure of "flutes”. However, the Examiner respectfully disagrees because inasmuch as applicant’s invention, the disclosure states in paragraph 96 that “the bone auger may include threads (flutes), as described above, at its distal end”. Thus, inasmuch as applicant’s, elements 922 are considered flutes. A flute is defined as “any groove or furrow” by Dictionary.com.
Applicant argues under (ii) that “Jimenez requires a separate, non-integral tool for drilling”. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues under (iii) that “In direct contrast, claim 15 recites a continuous circumferential edge at the distal most tip that is smooth and devoid of cutting teeth or flutes. Jimenez's "tip" is actually an opening for a separate tool, not a smooth, continuous structural element of the auger itself”. However, as generally claimed, Jimenez discloses a continuous circumferential edge (914) that is smooth (figure 9C) and devoid of flutes at the distal most tip of the distal end (figures 9A-9E).
Lastly, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775
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