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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 3-14, drawn to an implant nail for correcting a bunion, classified in A61B17/7233.
II. Claims 15-22, drawn to a method for correcting a bunion, classified in A61B 17/56.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process of Group II can be performed using an implant that has first and second holes formed in a head of the implant, where the first and second holes extend through the head along first and second axes that are parallel to each other, where a first screw is inserted through the first hole into a second metatarsal portion and a second screw is inserted through the second hole into a first metatarsal portion, and such an implant is materially different than the implant recited in Group I, which requires that a first hole extends through a head of the implant nail and is oriented along a first axis and a second hole extends through a neck of the implant nail and extends along a second axis that is off-axis from the first axis, and further requires that the first hole is open to the second hole at the outer surface of the implant nail.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Group I would require a search in at least A61B 17/7233, along with a unique text search. Group II would not be searched as above and would require a search in at least A61B 17/56, along with a unique text search.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Louis DelJuidice on June 19, 2026, a provisional election was made with traverse to prosecute the invention of Group I, Claims 3-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-22 of Group II are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 7-10 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.
Claim 7 recites the limitation "the implant axis" in line 2. There is insufficient antecedent basis for this limitation in the claim. Further, claim 7 currently recites “wherein the bone-facing surface at the neck and the first hole axis and the implant axis define a first angle that is within a range of 30 degrees to 60 degrees” and it is unclear if the “first angle” is defined between (a) the bone-facing surface at the neck and the first hole axis, (b) the bone-facing surface at the neck and an implant axis, or (c) the first hole axis and the implant axis. Claims 8-10 are rejected due to dependency on claim 1.
Claim Rejections - 35 USC § 102
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.
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 3-5 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson (US 2011/0009866 A1).
Regarding claim 1, Johnson teaches an implant nail (210; Figs. 1 and 16-22; para. 0045-0048) for correcting a bunion formed at a joint between a metatarsal and a great toe (para. 0007 teaches that the implant can be used for hallus valgus corrections and bunionectomies, i.e. for correcting a bunion formed at a joint between a metatarsal and great toe), the implant nail comprising:
a monolithic body (shown in Figs. 16-21) defining a bone-facing surface and an outer surface opposite the bone facing surface (see Examiner’s Annotated Fig. 17 below, the lower surface defines the bone-facing surface and the upper surface defines the outer surface), the body including:
a head at a first end of the monolithic body (see Examiner’s Annotated Fig. 16 of Johnson below, the head defined by the enlarged portion of implant 210 at the first end; Figs. 16-22), the head comprising a shoulder (see Examiner’s Annotated Fig. 16 of Johnson below), and a first bone fixation hole (see “1st Hole” in see Examiner’s Annotated Fig. 16 of Johnson below, analogous to first hole 122 in the embodiment of Figs. 13-15) that is oriented along a first hole axis and extends through the monolithic body from the outer surface to the bone-facing surface (see first hole axis identified in Examiner’s Annotated Figs. 16-17 below);
an anchor at a second end of the body opposite the first end (see Examiner’s Annotated Figs. 16-17 below); and
a neck disposed between the head and the anchor along a length direction of the implant nail (see Examiner’s Annotated Figs. 16-17 below, neck defined by the intermediate enlarged portion of implant 210),
wherein a second bone fixation hole (220; Figs. 16-17) extends through the monolithic body along a second hole axis that extends through the neck and is off-axis from the first hole axis (see Examiner’s Annotated Figs. 16-17 below),
wherein the first bone fixation hole is open to the second bone fixation hole at the outer surface (as shown throughout Figs. 16, 18-20 and 22, the second hole 220 is oriented toward and open to the first hole at the outer surface of implant 210, i.e. at the opening of hole shroud 222; para. 0048), and the first and second bone fixation holes are adjacent each other along the length direction of the implant nail (as shown in Figs. 16-17).
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Examiner’s Annotated Fig. 16 of Johnson
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Examiner’s Annotated Fig. 17 of Johnson
Regarding claim 4, Johnson teaches the implant nail of claim 3, wherein the second hole axis diverges from the first hole axis as it extends along an inward direction that is defined from the outer surface to the bone-facing surface (see Examiner’s Annotated Fig. 17 above, where second hole axis diverges from first hole axis as it extends along inward direction, i.e. towards the second end, from outer surface to bone-facing surface).
Regarding claim 5, Johnson teaches the implant nail of claim 3, wherein a second opening to the second bone fixation hole at the bone-facing surface is partially defined by the head (see Examiner’s Annotated Fig. 16 above, as well as Figs. 18-20 and 22, where the opening of shroud 222 at the bone-facing surface is partially located on the enlarged portion at the first end of implant 210 defining the head).
Regarding claim 12, Johnson teaches the implant nail of claim 3, wherein the first and second bone fixation holes are aligned with each other along the length direction of the implant nail (as shown, see Examiner’s Annotated Fig. 16 above).
Regarding claim 13, Johnson teaches the implant nail of claim 3, wherein the first and second bone fixation holes are the only bone fixation holes of the implant nail (see Figs. 16-22).
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2011/0009866 A1), as applied to claim 5 above, further in view of Lundquist (US 2017/0196602 A1).
Regarding claim 6, Johnson discloses the implant nail of claim 5.
Johnson also discloses, in para. 0007, that the implant nail can be used for hallus valgus corrections and bunionectomies, i.e. for correcting a bunion formed at a joint between a metatarsal and great toe.
However, Johnson does not disclose wherein the bone-facing surface at the head is angularly offset from the bone-facing surface at the neck.
Lundquist is analogous to the claimed invention because it is directed towards a spinal implant (300; Figs. 14-16) for correcting a hallus valgus deformity, i.e. bunion (para. 0004-0011, 0020), and discloses wherein the bone-facing surface at the head of the implant is angularly offset from the bone-facing surface at the neck (as shown in Fig. 16, the lower/bone-facing surface of implant 300 at the extramedullary head portion 302 is angularly offset by angle 310 from the bone-facing surface at the neck of intramedullary portion 301 adjacent the head; para. 0097-0099).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Johnson’s implant so as to have the claimed angular relationship on the bone-facing surface between the head and neck, as taught by Lundquist, because where Johnson and Lundquist are each directed towards an implant that can be used for correcting a bunion formed at the joint between a metatarsal and a great toe, Lundquist recognizes that such a configuration is a suitable structure for fitting a patient’s foot bones in such an application (see para. 0006 of Lundquist), and further because a change in the general shape of an object, particularly where such a change is intended to accommodate various anatomical differences as required for a given operation, are considered to require only routine experimentation in the art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2011/0009866 A1), as applied to claim 3 above, further in view of Fixel (US 5,087,260 A).
Regarding claim 14, Johnson discloses the implant nail of claim 3.
Johnson does not disclose further comprising a transverse hole disposed between the first and second bone fixation holes, the transverse hole configured to receive a suture.
Fixel is considered analogous to the claimed invention because it is directed to a plate-like implant for effecting compression of bone segments (see Figs. 1-8), and teaches the plate comprising various transverse holes (holes 47, for allowing a length of wire to be wrapped around the bone to secure the plate; Fig. 1; col. 6, ll. 3-17), with at least one transverse hole disposed between first and second bone screw fixation holes (12/13/16, as shown; Fig. 1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated one of Fixel’s transverse holes with Johnson’s implant nail, e.g. between the first and second bone fixation holes as claimed, because Fixel teaches that such a feature can be used for receiving a wire or suture for securing the plate/implant to the bone in the initial stages of operation and/or to secure bone segments together as needed (see Fixel, Figs. 1-8, col. 6, ll. 3-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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