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 amendments received after a Non-Final Rejection on 12 August 2026. Claims 1 and 4-21 are currently pending.
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 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 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, 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, 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 21: 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.
Note: On 21 August 2026, the Office of Patent Legal Administration disapproved the Terminal Disclaimer submitted on 12 August 2026 for the following reason: “The applicant name is missing the TD form. The name(s) must be listed in it's entirety as it is on the ADS. To resolve disapproval please resubmit and type the applicant name above the line/space on the form or send attachment on a separate page. No additional fee is required with the resubmission.”
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.
Claim 21 is 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).
Westling et al. disclose (as to part of claim 21) 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) (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 21) 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) 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 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 and providing indexing of the head and the ejector block.
Examiner’s Note
Claim 1 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, the claimed invention (see “Examiner’s Note” section in the Non-Final Rejection mailed on 04 June 2026 regarding the subject matter of previous claim 3.
Allowable Subject Matter
Claims 4-5 and 7-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 6 is allowed (see “Allowable Subject Matter” section in the Non-Final Rejection mailed on 04 June 2026 regarding the subject matter of claim 6).
Response to Arguments
The applicant's arguments with respect to claim 21 have been fully considered but they are not persuasive.
The applicant argues that the rejection fails to provide a motivation for the modification of the medical device of Westling et al. in view of Yoko et al., the examiner relies upon impermissible hindsight, and Yoko et al. fail to teach particular claim limitations. The examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation used in paragraph 4 of the above rejection can be found in column 8, lines 24-67 of Yoko et al.
As a reminder, 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 (provided in paragraph 1 of the above rejection), 2. ascertaining the differences between the prior art and the claims at issue (provided in paragraph 2 of the above rejection), 3. resolving the level of ordinary skill in the pertinent art. (provided in paragraph 3 of the above rejection), and 4. considering objective evidence present in the application indicating obviousness or non-obviousness (provided in paragraph 4 of the above rejection).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper (see In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971)).
In response to applicant's arguments against the references individually (e.g. Yoko et al. failing to teach particular claim limitations), one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Yoko et al. was relied upon for an alternative means for reversibly coupling and providing indexing of the head and the ejector block. Yoko et al. was not relied upon for an ejector block, or any other limitation not mentioned in the above rejection.
For clarity of record, the examiner is providing an annotated Figure showing the effect of modifying Westling et al. with the teachings of Yoko et al. as recited in the above rejection. It is the examiner’s position that modifying Westling et al. to include a magnetic connection between the head of the bone punch and the ejector block would not interfere with other mechanics of the medical device as disclosed by Westling et al.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
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