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/Restrictions
Applicant’s election without traverse of Species V (Figs. 30-31) and Species A (Figs. 7-14) in the reply filed on 07/22/2026 is acknowledged.
Claims 12 and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subgroup II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the wrench claimed in line 3 of claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-11 and 13-15 are objected to because of the following informalities:
Claim 1 recites the limitation, “and which coupling device” in line 9. This is unclear. For examination purposes, the office will interpret this to read, “wherein said coupling device”.
Claim 1 recites the limitation, “in a lateral direction can be altered” in line 17. This is unclear. For examination purposes, the office will interpret this to read, “in a lateral direction”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11 and 13-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1, line 10, and claim 4, lines 3-4 both recited “can be fixed in place at an end in a bone part”. Because the positive recitation of bone is not patentable subject matter, the claims will instead be interpreted to read “is configured to be fixed in bone”.
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 5, 6, and 9 are is 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 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: It is unclear whether the screw lock is configured to be a component of the adjusting device, the nail, or whether it is intended to be its own unique element. For examination purposes, the office will interpret this claim to read, “wherein the nail comprises a screw lock that increases a friction of the thread”.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: in lines 3-6 of claim 6, applicant recites “wherein this is constructively implemented with a wrench which, starting at a predefined position of the adjusting device, no longer produces any contact with a corresponding counterpiece in the adjusting device”. This statement is unclear. As outlined in the drawing objection above, no wrench is shown in the figures of the application. When turning to the specification, no clear introduction of the wrench is made here either. p. 22, ll. 20-28 of the specification recites “here, the adjusting screw 20 comprises hexagon socket 29 at a lateral end 13 and can be actuated using a hex key, not illustrated. In order to prevent an unintentionally far screwing-in of the adjusting screw 20, the hex wrench is embodied such that is can only be guided up to a predefined position relative to the bone screw 5 in the medial direction 7 along the adjusting screw 20. For this purpose, a stop can be provided on the hex wrench and/or the bone screw 20, or slides out of the hexagon socket 29, so that no further screwing-in is possible. In this manner, an unintentionally far screwing-in of the adjusting screw 20 is prevented in a constructively simple design.” This recitation is following no previous mention of the wrench or the corresponding configuration thereof. It seems that the intended use of the term “wrench” is synonymous with “hex key”, “key”, and “hex wrench” based on the writing of the claim. There is no elaboration as to how such a component would meet at a predefined position on the adjusting device which would then go on to fall out of contact with said adjusting device, as is required by claim 6. For examination purposes, the office will interpret this claim to read, “wherein the adjusting device further comprises a socket configured to mate with a corresponding key”.
Claim 9 recites the limitation "the second stop surface" in line 1. There is insufficient antecedent basis for this limitation in the claim. No second stop surface is introduced prior to this recitation in the claim. Claims 1 and 8, upon which claim 9 is dependent, likewise do not introduce this feature. For examination purposes, the office will interpret this recitation to read, “a second stop surface”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 11, and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rakes et al. (US 12453585 B2) (hereon referred to as Rakes).
Regarding claim 1, Rakes teaches an apparatus (100) for treating a fracture (see Col. 1, ll. 45-51),
comprising a nail (110) which can be introduced into an intramedullary canal of a bone (see Col. 1, ll. 45-51),
wherein the nail (110) comprises a bore (122) that is aligned roughly transversely to a longitudinal axis nail (see Col. 9, ll. 30-36),
wherein a coupling device (130) is provided which can be introduced into the bore (122) such that the coupling device (130) protrudes past the bore (122) on both sides (see Fig. 5) and can be moved within the bore (122) along a transverse axis in a lateral direction and a medial direction (see labelled diagram of Fig. 5 below) oriented in an opposing manner to the lateral direction (see labelled diagram of Fig. 5 below), and wherein said coupling device (130) is configured to be fixed in bone (see Col. 9, ll. 54-58),
wherein an adjusting device (150) is provided which can be fixed in place in different positions relative to the nail (110), and
wherein the adjusting device (150) comprises a first stop surface (see labelled diagram of Fig. 5 below) that limits a mobility of the coupling device in a lateral direction when the coupling device (130) and adjusting device are arranged on the nail (110), so that by changing the position of the adjusting device (150) relative to the nail (110), a lateral end position up to which the coupling device (130) can be moved relative to the nail (110) in a lateral direction (see Col. 10, ll. 41-67).
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Regarding claim 2, Rakes teaches the apparatus according to claim 1, wherein the first stop surface is at least partially formed by a shoulder (circled in the labelled diagram of Fig. 5 above) in a region of a lateral end of the adjusting device (150, see labelled diagram of Fig. 5 above).
Regarding claim 3, Rakes teaches the apparatus according to claim 1, wherein the first stop surface is at least partially formed by a part of a thread (circled in the labelled diagram of Fig. 5 above) of the adjusting device (150), with which thread the adjusting device can be fixed in place relative to the nail (150, see labelled diagram of Fig. 5 above).
Regarding claim 4, Rakes teaches the apparatus according to claim 1, wherein the first stop surface is at least partially formed by a part of a thread (150, see labelled diagram of Fig. 5 above) of the coupling device (150), with which thread the coupling device is configured to be fixed in bone (see Col. 9, ll. 54-58).
Regarding claim 5, Rakes teaches the apparatus according to claim 1, wherein the adjusting device (150) is connected to the nail (110) by a thread (160), wherein the nail (110) comprises a screw lock (125) that increases a friction of the thread (see Col. 10, ll. 58-65).
Regarding claim 6, Rakes teaches the apparatus according to claim 1, wherein the adjusting device (150) can only be screwed into the nail (110) up to a predefined position, wherein the adjusting device further comprises a socket (see labelled diagram of Fig. 5 below) configured to mate with a corresponding key (note that a key may be configured to mate with the socket shown in Fig. 5).
Regarding claim 7, Rakes teaches the apparatus according to claim 1, wherein the adjusting device (150) comprises a second stop surface (thread circled by 125 in Fig. 5) which, when the coupling device (130) and adjusting device (150) are arranged on the nail (110), limits a mobility of the coupling device (130) in a medial direction (see Col. 10, ll. 58-65).
Regarding claim 8, Rakes teaches the apparatus according to claim 1, wherein a position of the adjusting device (150) relative to the nail (110) can be altered along an adjusting direction (see labeled diagram of Fig. 5 below and Col. 10, ll. 41-49).
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Regarding claim 11, Rakes teaches the apparatus according to claim 1, wherein the adjusting device (150) is embodied to be longer than the bore (122), so that the adjusting device (150) can be connected to the nail (110) in a position protruding past the bore (122) on both sides (see Fig. 5), wherein the first stop surface is arranged medially from the nail (see labelled diagram of Fig. 5 above).
Regarding claim 13, Rakes teaches the apparatus according to claim 1, wherein the bore (122) is embodied to receive the coupling device (130) in a proximal region and to receive the adjusting device (150) in a distal region (see labelled diagram of Fig. 5 below).
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Regarding claim 14, Rakes teaches the apparatus according to claim 1, wherein the coupling device (130) comprises a through-bore (164) projecting from a lateral end to a medial end (see Fig. 5), into which through-bore a K-wire can be inserted (note that this is a functional recitation, satisfied by the fact that a K-wire may be inserted if both components are sized accordingly).
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rossney et al. (US 20220202464 A1) (hereon referred to as Rossney).
Regarding claim 1, Rossney teaches an apparatus (see Fig. 7A) for treating a fracture (see Para. [0076]),
comprising a nail (201) which can be introduced into an intramedullary canal of a bone (see Para. [0078]),
wherein the nail (201) comprises a bore (211) that is aligned roughly transversely to a longitudinal axis nail (see Para. [0079]),
wherein a coupling device (203) is provided which can be introduced into the bore (211) such that the coupling device (230) protrudes past the bore (211) on both sides (see Fig. 4A) and can be moved within the bore (211) along a transverse axis in a lateral direction and a medial direction (see labelled diagram of Figs. 6A-6B below) oriented in an opposing manner to the lateral direction (see labelled diagram of Figs. 6A-6B below), and wherein said coupling device (230) is configured to be fixed in bone (see Para. [0082]),
wherein an adjusting device (205) is provided which can be fixed in place in different positions relative to the nail (201), and
wherein the adjusting device (205) comprises a first stop surface (see labelled diagram of Figs. 6A-6B below) that limits a mobility of the coupling device in a lateral direction when the coupling device (203) and adjusting device are arranged on the nail (201), so that by changing the position of the adjusting device (205) relative to the nail (201), a lateral end position up to which the coupling device (203) can be moved relative to the nail (201) in a lateral direction (see Para. [0082]).
Regarding claim 8, Rossney teaches the apparatus according to claim 1, wherein a position of the adjusting device (205) relative to the nail (201) can be altered along an adjusting direction (see labeled diagram of Figs. 6A-6B below and Para. [0078]).
Regarding claim 9, Rossney teaches the apparatus according to claim 8, wherein the first stop surface (see labelled diagram of Figs. 6A-6B below) and a second stop surface (see labelled diagram of Figs. 6A-6B below) are aligned at different angles to the adjusting direction so that (see Para. [0078]; note that adjusting device 205 is on a different axis than the adjusting direction), when the position of the adjusting device (205) relative to the nail (201) is changed, the lateral end position can be changed by a greater magnitude than the medial end position (note that because the lateral end is further from the nail, change in the position of the adjusting device will affect the lateral end more than that of the medial end).
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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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rakes as applied to claim 1 above, and further in view of In re Aller, 105 USPQ 233.
Rakes the apparatus according to claim 1 as outline din the rejection thereof above, wherein a position of the adjusting device (150) relative to the nail (110) can be altered along an adjusting direction (along the longitudinal axis of the adjusting device), however fails to teach wherein the adjusting direction is aligned at an angle of 0.1 degrees to 15 degrees to the transverse direction.
With regard to claim 10, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the angle of the adjusting direction such that is 0.1-15 degrees to the transverse direction, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rakes as applied to claim 1 above, and further in view of Jordan et al. (US 8366717 B2) (hereon referred to as Jordan).
Rakes the apparatus according to claim 1 as outlined in the rejection thereof above, however fails to teach wherein a cannulated introduction device is provided which can be connected to the nail so that bone cement can be introduced up to a region of a femoral head through the cannulated introduction device when the bone nail is arranged in a femoral shaft and the introduction device is connected to the nail.
Jordan teaches a cannulated surgical screw (100), further comprising a syringe (200), wherein the syringe is cannulated and filled with cement (250; see Col. 4, 11. 53-67). The cement is configured to be introduced into the femoral head of the patient (see Col. 5, ll. 26-43).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nail of Rakes to include a cannulated introduction device configured to connect to the nail and insert bone cement therein when implanted in the femur, as this would improve stabilization of the implanted nail (see Col. 3, ll. 48-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20090248025 A1: This reference teaches an intramedullary nail with two screws configured to pass through adjacent openings in said nail.
US 20080202498 A1: This reference teaches an intramedullary nail with two screws configured to pass through the same opening in said nail.
US 20030004513 A1: This reference teaches an intramedullary nail with various screw configurations envisioned.
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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