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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Election/Restrictions
Applicant’s election of Invention Group I (talar implant) and Species D (figures 9B-11) in the reply filed on April 2, 2026 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)).
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 2, 2026.
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 1-12 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.
Independent claim 1 does not include a conjunction (and, but, or, etc.) between “a base…” (line 1) and “a top…” (lines 2-3). Therefore, the intended conjunction is unknown. The claims are indefinite.
Claim 1 recites the limitation “the top is configured to be inserted into the base”. The term “into” is plainly defined as “expressing movement or action with the result that someone or something becomes enclosed or surrounded by something else.” However, in the elected embodiment (e.g., see figures 9B and 9D) the top 50 is designed to be inserted onto not into the base 10, 20 30. See at least upper surface of base 10, 20, 30, which contacts lower surface of top 50 as depicted in figures 9B and 9D. “Onto” is plainly defined as “moving to a location on the surface of”. Thus, when read in light of the original disclosure, it is unclear what is meant by or how to achieve the limitation of “the top being configured to be inserted into the base, as required by independent claim 1. For purposes of examination, the claim will be assumed to recite “onto” not “into” such that examination as it relates to the prior art will more closely correspond to the disclosed invention.
Claim 2 depends from claim 1. Claim 2 recites the limitation “the at least one hole” in line 1. It is unclear if this is the “at least one hole of the base” (claim 1, line 2) or the “at least one hole of the top” (claim 1, line 3). The claim is indefinite.
Claim 4 depends from claim 1. Claim 4 recites the limitation “said at least one pin” in line 2. It is unclear if this is the “at least one pin of the base” (claim 1, line 2) or the “at least one pin of the top” (claim 1, line 3). The claim is indefinite.
Claim 6 depends from claim 1. Claim 6 recites the limitation “and at least one pin” [of the top] in lines 1-2. It is unclear if this is the “at least one pin” already recited in claim 1, line 3, upon which claim 6 depends, or an additional element (otherwise, why mention it again?).
Claim 9 depends from claim 6. Claim 9 recites the limitation “the top has a pin” in line 1. It is unclear if this is the same, different or related to “the top comprising at least one pin” as required by claim 1, line 3, upon which claim 9 depends. Is claim 9 further defining the at least one pin as being frustoconically shaped or merely reciting an additional frustoconically shaped pin? Thus, the claim is indefinite.
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.
Claims 1-6 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laskowitz et al. U.S. patent no. 8,961,606 (“Laskowitz”).
As best understood, regarding claim 1, among other interpretations and teachings [as described herein and those not expressly pointed out herein], in at least the embodiment of figures 11, Laskowitz discloses an implant (10) fully capable of the intended use recitation found in the preamble of being used as a “talus” implant, the implant (10) comprising: a base (14, i.e., “corresponding mating surface of figure 11B” or the like) having at least one hole (53) (col. 6, line 56) and at least one pin (corresponding “fixation member” extending through 12 and 14 -e.g., col. 6, lines 56-59, etc.); and a top (12) comprising at least one hole (80, 82) (figure 11A, col. 6, lines 42-46, etc., as described throughout) and at least one pin (52) (col. 6, lines 62-67), wherein said top (12) is configured to be inserted onto the base (14 or the like) (see at least col. 6, line 67, through col. 7, line 3). Moreover, in at least one other interpretation, in at least the embodiment of figures 10, Laskowitz discloses an implant (10) fully capable of the intended use recitation found in the preamble of being used as a “talus” implant, the implant (10) comprising: a base (14) having at least one hole (blind hole as identified in annotated version of figure 10C hereinbelow) and at least one pin (see annotated version of figure 10C hereinbelow); and a top (12) comprising at least one hole (blind hole as identified in annotated version of figure 10C hereinbelow) and at least one pin (see annotated version of figure 10C hereinbelow), wherein said top (12) is configured to be inserted onto the base (14 or the like) (figures 10, etc.). See at least col. 5, lines 43-60 and col. 6, lines 47-59).
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Regarding claims 2 and 10, Laskowitz discloses the base (14) comprises a plurality of holes (53 or figure 10C) with at least one hole (53 or hole corresponding with 80, 82, but extending through base 14, as described throughout) extending through and being positioned in a ‘central region’ of the base (e.g., figure 10C, 11B, etc.), and at least one additional hole (e.g., ‘channel’ between waffled pins formed as a ‘hole’, as shown in at least figure 10B) extending substantially transverse to the at least one hole (e.g., see at least figure 10B).
Regarding claim 3, Laskowitz discloses the implant (10) further comprising at least one additional hole (80, 82, seq.) configured so as to be fully capable of receiving at least one pin or post (e.g., fastener) fully capable of securing the base (14) into a bone in a patient’s leg (e.g., figures).
Regarding claim 4, Laskowitz discloses the base (14) comprises a top surface (e.g., figures), and wherein said at least one pin (52 or fastener or see at least annotated version of figure 10C above, etc.) comprises a plurality of pins (figures 11B and 10C, etc.).
Regarding claims 5 and 6, Laskowitz discloses the top (12) comprises a plurality of holes and at least one pin (figures 10 and 11, etc.), and wherein the plurality of holes are configured to receive the plurality of pins (figures 10 and 11, etc.).
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon et al. U.S. publication no. 2019/0053909 A1 (“Dhillon”) in view of Laskowitz et al. U.S. patent no. 8,961,606 (“Laskowitz”).
Regarding claim 1, Dhillon discloses a talus implant (300, 400 or 500; seq.), comprising: a base (300) having at least one hole (350, seq.) and at least one pin (including at least one of 312, 320, 330, 340, 426; seq.); and a top (400 or 500) comprising at least one hole (including at least one of 420, 440, etc.), and wherein said top (400 or 500) is configured to be inserted onto the base (300) (e.g., figures 10-21).
Dhillon is silent regarding the top comprising at least one pin substantially as claimed.
In the same field of endeavor, namely bone implants, Laskowitz teaches including a combination of pins (a.k.a. inserts 52) and holes (a.k.a. apertures 53) (e.g., figures 11A-B) in order to help maintain and secure multiple layers of an implant together before and during implantation (e.g., see at least col. 6, lines 60-67) and aid in rotational alignment and providing rotational stability of multiple layers of implant before, during and after implantation (figures).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to modify the invention of Dhillon to further include a series of pins and holes 52, 53, as taught by Laskowitz, to the invention of Dhillon in order to help maintain and secure multiple layers of an implant together before and during implantation and aid in rotational alignment and providing rotational stability of multiple layers of implant before, during and after implantation with predictable results and a reasonable expectation of success.
Regarding claims 2 and 10, Dhillon discloses the base (300) comprises a plurality of holes (350) with at least one hole (352) extending through and being positioned in a central region of the base (paragraphs [0058], figure 16B), and at least one additional hole (314) extending substantially transverse to the at least one hole (352) (e.g., see at least figures 12 and 16-17).
Regarding claim 3, Dhillon discloses the implant (300, 400 or 500) further comprising at least one additional hole (350) configured to receive at least one pin or post (340) for securing the base into a bone in a patient’s leg (e.g., figures 15).
Regarding claim 4, Dhillon discloses the base (300) comprises a top surface (304), and wherein said at least one pin (including at least one of 312, 320, 330, 340, 426; seq.) comprises a plurality of pins (e.g., figures 10-15 and 20).
Regarding claims 4-6 and 9, Dhillon in view of Laskowitz teaches the top (400 or 500) comprises a plurality of holes (440, 420) and at least one pin (52 of Laskowitz, as applied to the invention of Dhillon). Moreover, with regard to claim 9, Dhillon discloses the bottom has a frustoconically (i.e., Morse Taper) shaped pin (112, 312, seq.) (e.g., see at least paragraph [0032]).
However, Dhillon in view of Laskowitz, as applied above, is silent regarding the plurality of holes of the top are configured to receive the plurality of pins formed on the top surface of the base substantially as claimed. Dhillon in view of Laskowitz, as applied above, is further silent regarding the top comprising at least one pin that is frustoconically shaped.
It would have been obvious to one of ordinary skill in the art at the time of the effective filling date of the claimed invention to form the plurality of holes 53 or the like taught by Laskowitz on the top member of Dhillon and the corresponding inserts or pins 52 on a top surface of the base of Dhillon because placement of the holes 53 and pins 52 of Laskowitz in the invention of Dhillon would work equally well in an orientation with the pins 52 on the top or base and the corresponding holes 53 on a corresponding connection surface of the opposite of the top or base used for the reasons described with modification of Dhillon in view of Laskowitz as described in rejection of claim 1 above. It has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. Also see MPEP 2144.04(VI)(A). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to try including a plurality of holes on the top configured to receive a plurality of pins formed on a top surface of the base in order to select an orientation of the pins and holes of Laskowitz for use in the invention Dhillon from a finite set of possible options (mere reversal of essential working parts) that obtains the desired results of helping maintain and secure multiple layers of an implant together before and during implantation and aid in rotational alignment and providing rotational stability of multiple layers of implant before, during and after implantation with predictable results and a reasonable expectation of success.
Moreover, with respect to dependent claims 6 and 9, the invention of Dhillon in view of Laskowitz would work equally well with the frustoconically shaped pin (112, 312, seq.) extending from the top or bottom into a corresponding hole in the other of the top or bottom. It has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to merely reverse the essential working parts such that the frustoconically shaped pin (312) of Dhillon extends from the top into a hole in a top surface of the bottom in order to merely reverse essential working parts of the device to obtain a same result with predictable results and a reasonable expectation of success. See MPEP 2144.04.
Regarding claims 7 and 8, Dhillon discloses the top (500) comprises at least two dome shaped segments (522a-b-figure 21D).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Laskowitz et al. U.S. patent no. 8,961,606 (“Laskowitz”), as applied above, in view of Kowalczyk et al. U.S. publication no. 2017/0360488 A1 (“Kowalczyk”) and further in view of De Wilde et al. U.S. patent no. 8,764,836 (“De Wilde”).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Dhillon et al. U.S. publication no. 2019/0053909 A1 (“Dhillon”) in view of Laskowitz et al. U.S. patent no. 8,961,606 (“Laskowitz”), as applied above, in view of Kowalczyk et al. U.S. publication no. 2017/0360488 A1 (“Kowalczyk”) and further in view of De Wilde et al. U.S. patent no. 8,764,836 (“De Wilde”).
Regarding claims 11 and 12, Laskowitz or Dhillon in view of Laskowitz, each as applied above, teaches the invention substantially as claimed.
Laskowitz or Dhillon in view of Laskowitz is silent regarding the base further comprises a mesh region, wherein the mesh region comprises varying porosity, and wherein the mesh region extends across a portion of an outer surface of the base and across the at least one pin on the base.
In the same field of endeavor, namely bone implants, Kowalczyk teaches a base including a mesh region, wherein the mesh region comprises varying porosity, and wherein the mesh region extends across a portion of an outer surface of the base (e.g., see at least paragraphs [0227], [0230],-[00231] and figure 15).
Moreover, in the same field of endeavor, De Wilde teaches porosity for bone ingrowth may optionally be included across a portion of an outer surface of a base and across at least one pin extending from the base for engagement with bone (e.g., see at least col. 4, lines 8-16).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to include a mesh region in the invention of Laskowitz or Dhillon in view of Laskowitz, as taught and/or suggested by Kowalczyk, in order to provide bone ingrowth into the implant device for stability of the bone attachment to the implant over time with predictable results and a reasonable expectation of success. Moreover, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to include the mesh region in the invention of Laskowitz or Dhillon in view of Laskowitz each in view of Kowalczyk at locations across a portion of an outer surface of the base and across at least one pin, as taught and/or suggested by De Wilde, in order to select the desired implant locations for bone ingrowth with predictable results and a reasonable expectation of success.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/216,382 [published as 2025/0288425]. The main difference between the copending application claims are present application claims is the copending Application claims are narrower than the present application claims and combine different features within different claim groupings. See especially claims 12, 16 and 19 of the copending Application. This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Perler U.S. patent no. 9,468,532 discloses pins 58a-d and corresponding holes 81a-d (e.g., figures 3-6 and 9.
Dhillon et al. U.S. patent no. 10,136,998; Sander U.S. patent no. 9,949,839; and Sander U.S. patent no. 9,622,871 each discloses multi-component talar implants (e.g., see at least figures).
Mathias et al. WIPO publication no. WO 2016/181168 A1 is exemplary of a modular total talar prosthesis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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