DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 14 April 2025. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 14 April 2025 are accepted by the examiner.
Claim Objections
Claim 6 is objected to because of the following informality:
In line 1, it appears that the phrase “distal translation” should read “the distal translation” (see line 1 of claim 2 for antecedent basis).
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7-9 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5 of U.S. Patent No. 12,295,591 (see Claim Mapping Table below). Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a "species" of the "generic" invention of the application claims. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Mapping Table
Current Application – 19/177,931
U.S. Patent No. 12,295,591
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is magnetically coupled to the ejector block in the first position.
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is releasably coupled to the ejector block in the first position, and distal translation of the bone punch from the first position to a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position; and wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 2: wherein the head of the bone punch is magnetically coupled to the ejector block.
Claim 2: wherein distal translation of the bone punch from the first position toward a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position.
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is releasably coupled to the ejector block in the first position, and distal translation of the bone punch from the first position to a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position; and wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 2: wherein the head of the bone punch is magnetically coupled to the ejector block.
Claim 3: wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is releasably coupled to the ejector block in the first position, and distal translation of the bone punch from the first position to a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position; and wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 2: wherein the head of the bone punch is magnetically coupled to the ejector block.
Claim 7: wherein the head of the bone punch includes one or more magnets disposed therein and the ejector block includes a magnetic material disposed therein opposite the one or more magnets.
Claim 3: wherein the head of the bone punch includes one or more magnets disposed therein and the ejector block includes a magnetic material disposed therein opposite the one or more magnets.
Claim 8: wherein the ejector block includes one or more magnets disposed therein and the head of the bone punch includes a magnetic material disposed therein opposite the one or more magnets.
Claim 4: wherein the ejector block includes one or more magnets disposed therein and the head of the bone punch includes a magnetic material disposed therein opposite the one or more magnets.
Claim 9: wherein the head of the bone punch includes one or more magnets disposed therein and the ejector block includes one or more magnets disposed therein opposite the one or more magnets disposed in the head of the bone punch.
Claim 5: wherein the head of the bone punch includes one or more magnets disposed therein and the ejector block includes one or more magnets disposed therein opposite the one or more magnets disposed in the head of the bone punch.
Claim 20: wherein the head of the bone punch is releasably coupled to the ejector block in the first position.
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is releasably coupled to the ejector block in the first position, and distal translation of the bone punch from the first position to a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position; and wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 2: wherein the head of the bone punch is magnetically coupled to the ejector block.
Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,295,591 in view of Yoko et al. (U.S. Patent 8,906,025).
Claims 1 and 6 disclose the following:
Claim Mapping Table
Current Application – 19/177,931
U.S. Patent No. 12,295,591
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is magnetically coupled to the ejector block in the first position.
Claim 1: a medical device configured to form one or more holes within a bone of a patient, comprising: a handle assembly including a housing, a lever rotatably coupled to the housing between an initial position and an extended position, and a sheath extending distally from the housing; and a bone punch including an elongate shaft, a head at a proximal end of the elongate shaft, and a piercing tip at a distal end of the elongate shaft, wherein the piercing tip is configured to be driven into the bone; wherein the elongate shaft is slidably disposed within the sheath in a first position when the lever is in the initial position; wherein the handle assembly includes a linkage disposed within the housing, the linkage including an ejector block slidably disposed within the housing; wherein the head of the bone punch is releasably coupled to the ejector block in the first position, and distal translation of the bone punch from the first position to a second position causes the linkage to rotate a distal end of the lever away from the housing to the extended position; and wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
Claim 4: wherein distal translation of the head of the bone punch from the first position to the second position translates the ejector block distally within the housing.
Claim 6: wherein distal translation of the head of the bone punch from the first position to the second position translates the ejector block distally within the housing.
Claims 1 and 6 disclose the claimed invention except for wherein the head of the bone punch is magnetically coupled to the ejector block in the first position.
Yoko et al. teach the use of a first element (12) and a second element (86), wherein the first element is magnetically coupled to (i.e. via the interaction between 92 and a metallic material) the second element, wherein the first element includes a magnet (92) and the second element includes a magnetic material (i.e. metal) disposed therein opposite the magnet (see Figures 6 and 7, and column 8, lines 24-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of claims 1 and 6 with wherein the head of the bone punch is magnetically coupled to the ejector block in the first position in view of Yoko et al. in order to provide an alternative, well-known and obvious means for reversibly coupling the head and the ejector block to yield predictable results.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-5 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Westling et al. (U.S. Patent Application Publication 2016/0120538) in view of Yoko et al. (U.S. Patent 8,906,025).
Regarding claims 1-2, 4-5, 7-10, 12, 14 and 20, Westling et al. disclose (as to part of claim 1) a medical device (i.e. device defined by 200 and 270) capable of forming one or more holes within a bone of a patient (i.e. via 272), comprising a handle assembly (200) including a housing (207), a lever (205) rotatably coupled to (i.e. via 231) the housing between an initial position (i.e. position as best seen in Figure 17) and an extended position (i.e. position as best seen in Figure 14), and a sheath (203) extending distally from the housing (extension as best seen in Figure 10A); and a bone punch (270) including an elongate shaft (273), a head (271) at a proximal end (i.e. end defining 271) of the elongate shaft, and a piercing tip (272) at a distal end (275) of the elongate shaft, wherein the piercing tip is capable of being driven into the bone (see paragraph 0121); wherein the elongate shaft is slidably disposed within the sheath (see paragraph 0118) in a first position (i.e. position where 270 is located within 203 and 205 is in the position as best seen in Figure 17) when the lever is in the initial position; and wherein the handle assembly includes a linkage (213) disposed within the housing (disposition as best seen in Figure 12), the linkage including an ejector block (213A) slidably disposed within the housing (see paragraph 0099), wherein (as to claim 2) distal translation of (i.e. in a direction from 257 toward 247, see Figure 17) the bone punch from the first position to a second position (i.e. position where 270 is located within 203 and 205 is in the position as best seen in Figure 14) causes the linkage to rotate a distal end (i.e. end of 205 opposite that connected to 231, see Figure 14) of the lever away from the housing to the extended position (i.e. force applied from 211 onto 213C, while 271 is connected to 213A, causes the distal translation), wherein (as to claim 4) distal translation of the head of the bone punch from the first position to the second position translates the ejector block distally within (i.e. due to 231A being connected to 270, while force applied from 211 onto 213C causes the distal translation) the housing, wherein (as to claim 5) a rotational position (i.e. positions at 241, 243, and 253) of the lever relative to the housing are capable of indicating a depth of the piercing tip within the bone (see Figure 17, and paragraphs 104, 107), and wherein (as to claim 20) the head of the bone punch is releasably coupled to (i.e. via 277/279) the ejector block in the first position (see Figures 10-17, 19 and 23-27, and paragraphs 0094-0129).
Westling et al. disclose the claimed invention except for wherein (as to the remainder of claim 1) the head of the bone punch is magnetically coupled to the ejector block in the first position, wherein (as to claim 7) the head of the bone punch includes one or more magnets disposed therein and the ejector block includes a magnetic material disposed therein opposite the one or more magnets, wherein (as to claim 8) the ejector block includes one or more magnets disposed therein and the head of the bone punch includes a magnetic material disposed therein opposite the one or more magnets, wherein (as to claim 9) the head of the bone punch includes one or more magnets disposed therein and the ejector block includes one or more magnets disposed therein opposite the one or more magnets disposed in the head of the bone punch, wherein (as to claim 10) the head of the bone punch includes one or more magnets fixedly attached thereto and the ejector block includes a magnetic material disposed opposite the one or more magnets, wherein (as to claim 12) the ejector block includes one or more magnets fixedly attached thereto and the head of the bone punch includes a magnetic material disposed opposite the one or more magnets, and wherein (as to claim 14) the head of the bone punch includes one or more magnets fixedly attached thereto and the ejector block includes one or more magnets fixedly attached thereto opposite the one or more magnets disposed in the head of the bone punch.
Yoko et al. teach the use of a first element (12) and a second element (86), wherein the first element is magnetically coupled to (i.e. via the interaction between 92 and a metallic material) the second element, wherein the first element includes a magnet (92) disposed therein (i.e. and fixedly attached thereto) and the second element includes a magnetic material (i.e. metal) disposed therein opposite the magnet (see Figures 6 and 7, and column 8, lines 24-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Westling et al. with wherein (claim 1) the head of the bone punch is magnetically coupled to the ejector block in the first position, wherein (claim 7) the head of the bone punch includes one or more magnets disposed therein and the ejector block includes a magnetic material disposed therein opposite the one or more magnets, and wherein (claim 10) the head of the bone punch includes one or more magnets fixedly attached thereto and the ejector block includes a magnetic material disposed opposite the one or more magnets in view of Yoko et al. in order to provide an alternative, well-known and obvious means for reversibly coupling and providing indexing of the head and the ejector block.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Westling et al. with wherein (claim 8) the ejector block includes the one or more magnets disposed therein and the head of the bone punch includes the magnetic material disposed therein opposite the one or more magnets, and wherein (claim 12) the ejector block includes one or more magnets fixedly attached thereto and the head of the bone punch includes a magnetic material disposed opposite the one or more magnets in view of Yoko et al. in order to provide an alternative, well-known and obvious means for reversibly coupling and providing indexing of the head and the ejector block, since it has been held that a mere reversal of the essential working parts of a device (i.e. reversing the locations of the magnet and magnetic material) involves only routine skill in the art (see In re Einstein, 8 USPQ 167).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Westling et al. with wherein (claim 9) the head of the bone punch includes the one or more magnets disposed therein and the ejector block includes one or more magnets disposed therein opposite the one or more magnets disposed in the head of the bone punch, and wherein (claim 14) the head of the bone punch includes one or more magnets fixedly attached thereto and the ejector block includes one or more magnets fixedly attached thereto opposite the one or more magnets disposed in the head of the bone punch in view of Yoko et al. in order to provide an alternative, well-known and obvious means for reversibly coupling and providing indexing of the head and the ejector block, since it has been held that mere duplication of the essential working parts of a device (i.e. providing magnets on both elements) involves only routine skill in the art (see St. Regis Paper Co. v. Bemis Co., 193 USPQ 8).
Regarding claims 11, 13 and 15-19, Westling et al. disclose the claimed invention except for wherein (as to claim 11) the one or more magnets is exposed to an exterior of the head of the bone punch, wherein (as to claim 13) the one or more magnets is exposed to an exterior of the head of the bone punch, wherein (as to claim 15) the one or more magnets of the head of the bone punch is exposed to an exterior of the head of the bone punch, wherein (as to claim 16) the one or more magnets of the ejector block is exposed to an exterior of the ejector block, wherein (as to claim 17) the head of the bone punch includes a plurality of magnets equidistantly spaced from a central longitudinal axis of the bone punch, wherein (as to claim 18) the plurality of magnets is symmetrically arranged around the central longitudinal axis of the bone punch, and wherein (as to claim 19) the plurality of magnets is arranged in diametrically opposed pairs.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Westling et al. in view of Yoko et al. with wherein the one or more magnets is exposed to an exterior of the head of the bone punch, wherein the one or more magnets is exposed to an exterior of the head of the bone punch, wherein the one or more magnets of the head of the bone punch is exposed to an exterior of the head of the bone punch, wherein the one or more magnets of the ejector block is exposed to an exterior of the ejector block, wherein the head of the bone punch includes a plurality of magnets equidistantly spaced from a central longitudinal axis of the bone punch, wherein the plurality of magnets is symmetrically arranged around the central longitudinal axis of the bone punch, and wherein the plurality of magnets is arranged in diametrically opposed pairs in order to provide a desired magnet orientation/configuration for reversibly coupling and providing indexing of the head and the ejector block, since it has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70).
Examiner’s Note
Claim 3 in the instant application has only been rejected on the ground of nonstatutory double patenting and has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the limitations required by claims 1 and 2, wherein rotation of the lever from the extended position toward a longitudinal axis of the bone punch when the bone punch is in the second position generates proximal translation of the bone punch to extract the piercing tip from the bone.
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.
Claim 6 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the limitations required by claims 1 and 2, wherein distal translation of the bone punch from the first position toward the second position shortens an axial distance between a proximalmost pivot point of the linkage and a distalmost pivot point of the linkage.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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