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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a bone positioning device” introduced in claim 20 and “an intramedullary implant insertion and bone positioning instrument” introduced in claim 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 21-23, 30, 38, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strohkirch et al. (US 20230218322 A1) (hereon referred to as Strohkirch).
Regarding claim 21, Strohkirch teaches a method (see Fig. 12C) comprising:
cutting a metatarsal bone of a foot into a first metatarsal portion (410) and a second metatarsal portion (412);
inserting a stem portion (110) of an intramedullary implant (100) into the first metatarsal portion (410) and positioning a fixation aperture (134) extending through a plate portion (130) of the intramedullary implant (100) overlying the second metatarsal portion (412) (see Para. [0258]);
using a bone positioning device (200) releasably connected to the intramedullary implant (100) to move the second metatarsal portion (412) relative to the first metatarsal portion (410) in at least one plane (see Para. [0082] and [0086]; also see Paras. [0097-0098]; note that the dorsal-plantar direction, as shown in Fig. 12B and described in Para. [0082], is aligned with the frontal plane of the patient); and
inserting a fixation member (452) through the fixation aperture (134) extending through the plate portion (130) of the intramedullary implant (100) and into the second metatarsal portion (412) to fixate a moved position of the second metatarsal portion (412) relative to the first metatarsal portion (410; see Para. [0101] and Fig. 13).
Regarding claim 22, Strohkirch teaches the method of claim 21, wherein:
the bone positioning device (200) comprises an intramedullary implant insertion and bone positioning instrument (240);
inserting the stem portion (110) of an intramedullary implant (100) into the first metatarsal portion (410; see Para. [0094]) comprises, with the intramedullary implant (100) releasably connected to the intramedullary implant insertion and bone positioning instrument (240), moving the intramedullary implant insertion and bone positioning instrument (240) to insert the stem portion (110) of the intramedullary implant (100) into the first metatarsal portion (see Para. [0094]); and
positioning the fixation aperture (134) of the intramedullary implant (100) overlying the second metatarsal portion (412) comprises, with the intramedullary implant (100) releasably connected to the intramedullary implant insertion and bone positioning instrument (240), moving the intramedullary implant insertion and bone positioning instrument to position the fixation aperture of the intramedullary implant overlying the second metatarsal portion (see Para. [0094] and [0097]).
Regarding claim 23, Strohkirch teaches the method of claim 22, wherein:
moving the intramedullary implant insertion and bone positioning instrument (240) to insert the stem portion (110) of the intramedullary implant (100) into the first metatarsal portion (410) comprises inserting the stem portion (110) of the intramedullary implant (100) at an angle relative to a shaft of the first metatarsal portion (note that any position is at an angle relative to the first metatarsal portion; even a 0 degree angle would be included in this limitation); and
moving the intramedullary implant insertion and bone positioning instrument (240) to position the fixation aperture (134) of the intramedullary implant (100) overlying the second metatarsal portion (214) comprises pushing the plate portion (130) of the intramedullary implant (100) against a medial surface (see Para. [0090]) of the second metatarsal portion (412; see Para. [0097], noting that the method teaches the step of pushing the bone positioning device into the distal bone portion, which would require pushing the plate portion thereto, as the plate portion sits in between the bone positioning device and the distal bone portion 412) to
(i) move the second metatarsal portion (412) laterally relative to the first metatarsal portion (see Para. [0090]) and
(ii) reduce the angle of the stem portion (110) of the intramedullary implant (100) relative to the shaft of the first metatarsal portion (see Para. [0097], wherein the optimum angle is achieved).
Regarding claim 30, Strohkirch teaches the method of claim 21, wherein the first metatarsal portion (410) is a proximal metatarsal portion and the second metatarsal portion (412) is a distal metatarsal portion (see Para. [0078]).
Regarding claim 38, Strohkirch teaches the method of claim 21, wherein inserting the fixation member (452) through the fixation aperture (134) extending through the plate portion (130) of the intramedullary implant (100) and into the second metatarsal portion (412) comprises inserting at least two fixation members (452, see Para. [0102]) through at least two fixation apertures (second aperture 1534b, see Fig. 13) extending through the plate portion (130) of the intramedullary implant (100) and into the second metatarsal portion (see Para. [0102] and [0106-0107], noting that a second screw may be implanted in the same manner as that of the first; and Para. [0184], noting that embodiments of the device may be combined).
Regarding claim 41, Strohkirch teaches the method of claim 21, further comprising inserting a fixation member (450) through a fixation aperture (112) extending through the stem portion (110) of the intramedullary implant (100) and into the first metatarsal portion (410, see Para. [0102]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Strohkirch as applied to claim 21 above, and further in view of Hollis et al. (US 20220409248 A1) (hereon referred to as Hollis).
Strohkirch teaches the method as outlined int eh rejection of claim 20 above, however fails to teach wherein cutting the bone of the foot into the first metatarsal portion and the second metatarsal portion comprises: attaching a cut guide proximal of a target cut location on the metatarsal bone and distal of the target cut location; and guiding a cutting instrument with the cut guide to cut the metatarsal bone at the target cut location.
Hollis teaches the method of claim 20, wherein cutting the bone of the foot into the first metatarsal portion and the second metatarsal portion (see rejection of claim 20 above) comprises:
attaching a cut guide (200) proximal of a target cut location on the metatarsal bone and distal of the target cut location (see labelled diagram of Fig. 8 below); and
guiding a cutting instrument (220) with the cut guide (200) to cut the metatarsal bone at the target cut location (see Paras. [0076] and [0078]).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Strohkirch to utilize a cutting guide for the step of cutting the bone of the foot such that the method further comprises attaching a cut guide proximal of a target cut location on the metatarsal bone and distal of the target cut location; and guiding a cutting instrument with the cut guide to cut the metatarsal bone at the target cut location, as such a method step would be an effective method of completing the osteotomy envisioned by Strohkirch (see Para. [0078] of Hollis and Para. [0007] of Strohkirch).
Allowable Subject Matter
Claims 24-29, 31-32, 34-35, 39-40, and 42-43 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20240058041 A1: This reference teaches a bone stabilization system and method.
US 20220401139 A1: This reference teaches an osteotomy method.
US 20200253650 A1: This reference teaches an osteotomy method and implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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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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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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