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 .
Election/Restrictions
Applicant’s election of species A, Figs. 1-9b in the reply filed on 28 November 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species B, Figs. 10-13b, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 November 2025.
Claim Objections
Claim 23 and 29 are objected to because of the following informalities:
Claim 23, line 3: “which is suitable to this end” should be changed to --configured--.
Claim 29, line 2: “drilling” (between “entire” and “instrument”) should be changed to --surgical--.
Appropriate correction is required.
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.
Claims 1-20 and 22-35 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.
Claims 1-20 and 22-35 are replete with 35 U.S.C. 112 errors. Such errors include:
Claim 1 recites the limitation "the longitudinal axis" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the longitudinal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the circumferential direction" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites “wherein the first shaft element has at least one opening that is completely enclosed partially along the longitudinal direction but in the circumferential direction.” It is unclear what is meant by “but in the circumferential direction” as the claim appears to be incomplete. A further clarifying amendment is required.
Claim 3 recites the limitation "the opening" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "proximal direction" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the cam discs" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the outer diameter" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the cam discs" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the central axis" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the radial direction" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “this recess extends” in line 4. It is unclear which recess is being referred to since each cam disc has a recess previously recited in the claim. A further clarifying amendment is required.
Claim 9 recites the limitation "the circumferential direction" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “along the lateral surface” in line 5. It is unclear which lateral surface is being referred to since each cam disc has a lateral surface previously recited in the claim. A further clarifying amendment is required.
Claim 10 recites the limitation "the translation path" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites “the shaft element” in line 3. It is unclear which shaft element is being referred to since there are two shaft elements previously recited in claim 1. A further clarifying amendment is required.
Claim 10 recites the limitation "the maxima" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the sine wave" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the rotor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the translation path" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the translation path" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the translation path" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the sine wave" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “the lateral surface” in line 3. It is unclear which lateral surface is being referred two since each cam disc has a lateral surface previously recited in claim 9. A further clarifying amendment is required.
Claim 14 recites the limitation "the sinusoidal curved line" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “wherein the sinusoidal curved line of the first shaft element is in a phase shift with respect to the sinusoidal curved line of the first shaft element.” It is unclear how the sinusoidal curved line of the first shaft element can be in a phase shift with respect to itself. A further clarifying amendment is required.
Claim 15 recites the limitation "the oscillation period" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the sine wave" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the cam discs" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the rotor" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the recess" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the first cam disc" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the recess" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the second cam disc" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the pins" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “as well as the pins.” It is unclear if these pins are the same as or different than the pins previously recited in the claim. A further clarifying amendment is required.
Claim 19 recites the limitation "the circumferential direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the pins" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the rotor" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the pins" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the radial direction" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the rotor" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the rotor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the orientation" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the drill bit" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the same angle" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the circumferential direction" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the drilling elements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the drilling elements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the bone" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the drilling elements" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the bone" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the central axis" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the depth" in line 33. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the drilling elements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the drilling elements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the bone" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites “the opening” in line 3. It is unclear which opening is being referred to since the claim previously recites “generate openings.” A further clarifying amendment is required.
Claim 35 recites the limitation "the orientations" in line 4. There is insufficient antecedent basis for this limitation in the claim.
The examiner believes to have pointed out each 35 U.S.C. 112 error. However, applicant is advised to go back and check each claim to make sure none were overlooked.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 32, 33 and 35 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 32 recites “wherein the drilling elements in combination generate openings in the bone that have a non-round cross section.”
Claim 33 recites “wherein the drilling elements in combination generate openings in the bone that deviate from the central axis along the depth.”
Claim 35 recites “wherein the drilling elements in combination generate openings in the bone, and the opening has a first cross section and a second cross section at two different depths, and the orientations of the both cross sections are different.”
It is clear that claims 32, 33 and 35 are positively reciting the bone as a limitation of the claims. It is suggested that applicant amend the claims to make the bone functionally recited, i.e. “configured to generate openings in the bone,” “adapted to generate openings in the bone,” etc.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 19, 20, 22-25 and 27-35 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bourque et al., U.S. PG-Pub 2014/0276844.
Regarding claim 1, Bourque et al. discloses a surgical instrument for drilling into bones or bone fragments, comprising: a drill section (1102, 1108), a gear section (1140, 1142) and a longitudinal shaft section (1103, 1104) located therebetween, having a first (1104) and a second (1103) shaft element, wherein the second shaft element is supported at least partially in the first shaft element, and each shaft element performs cyclic translational movement along a longitudinal axis for drilling (Figs. 10a-11b).
Regarding claims 2-5, Bourque et al. discloses wherein the first shaft element (1104) has at least one opening (distal most end) that is completely enclosed partially along a longitudinal direction but in the circumferential direction; wherein the second shaft element (1103) has a concentric outer wall at least partially (1103 is tubular), and the concentric outer wall of the second shaft element is inserted into the opening of the first shaft element; wherein the first shaft element is at least partially tubular; and wherein the second shaft element is designed at least partially tubular or as a fully round rod (Fig. 10b and paragraph [0038]).
Regarding claims 19, 20 and 22, Bourque et al. discloses wherein pins (1164) and pins (1162) are placed at an angle to one another in a circumferential direction; wherein pins (1162 and 1164) are releasable from a rotor (1106); and wherein once pins (1162 and 1164) are released or displaced in a radial direction, the shaft elements (1103 and 1104) can be removed from a rotor (Figs. 12a and 15-16).
Regarding claims 23 and 24, Bourque et al. discloses wherein a rotor (1106) has a proximally extending shaft area (1166) which provided a coupling connection configured for transmitting a torque to the rotor; and wherein the shaft elements (1103 and 1104) are in contact to one another directly or indirectly along the longitudinal axis on at least one section and a twist of the shaft elements against each other is thus excluded (Figs. 10b and 16).
Regarding claims 25, 27 and 28, Bourque et al. further comprises a stator (1156) configured to serve as a reference for orienting the drill section (1102 and 1108); wherein the stator has at least one handle (1156 can be gripped); and wherein a surface or projection (1162), which is in contact with the stator, is provided on at least one of the shaft elements (1104), such that the shaft element with the stator are always at a same angle to one another in a circumferential direction (Fig. 16).
Regarding claims 29-31, Bourque et al. discloses wherein the entire surgical instrument, including the drill section, is continuously cannulated and a guide wire (1114) can be accommodated therein (Fig. 6a); wherein the drill section (1102 and 1108) consists of two drilling elements which are separate from one another but are in direct contact, and a first drilling element (1108) is connected to the first shaft element (1104) and a second drilling element (1102) is connected to the second shaft element (1103); and wherein the drilling elements (1102, 1108) are releasably connected to the shaft elements (Figs. 7 and 11a-11b).
Regarding claims 32-35, Bourque et al. discloses wherein the drilling elements (1102 and 1108) in combination are configured to generate openings in bone that have a non-round cross section, that deviate from a central axis along a depth, form a blade shape (1108 is a blade shape), and an opening has a first cross section (via 1102) and a second cross section (via 1108) at two different depths, and orientations of both cross sections are different (one sits more proximal than the other) (Fig. 11b).
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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourque et al., U.S. PG-Pub 2014/0276844.
Regarding claims 11 and 12, Bourque et al. discloses wherein with respect to a rotor (1106), a translation path of the first and/or second shaft element (1104 and 1103) is a distance and corresponds to a distance with respect to each other (Figs. 10a-11b)
Bourque et al. does not disclose the translation path being between 0.1 mm and 5 mm or the translation path of the first shaft element being twice the translation path of the second shaft element.
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 translation path to be between 0.1 mm and 5 mm or the translation path of the first shaft element being twice the translation path of the second shaft element, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bourque et al., U.S. PG-Pub 2014/0276844 in view of Aho et al., U.S. PG-Pub 2010/0268234.
Bourque et al. discloses the invention essentially as claimed except for wherein the stator has an indicator which indicates an orientation of the drill section.
Aho et al. discloses a surgical instrument having a stator with an indicator (975) to indicate movement back to an initial position or any required location along a length of a drilled hole (Fig. 8C and paragraph [0172]).
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 stator of Bourque et al. to have an indicator which indicates an orientation of the drill section in view of Aho et al. to permit indicating movement of the drilling section back to an initial position or any required location along a length of a drill hole.
Allowable Subject Matter
Claim 6 is 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.
Claims 7-10 and 13-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775