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 with traverse of Species A (Figs. 1a-5b) in the reply filed on September 27, 2025 is acknowledged. The traversal is on the ground(s) that the claimed inventions share the fundamental technical feature of an osteosynthesis device with novel features. This is not found persuasive because (a) the alleged novel features are the reason for a lack of unity of invention as noted on pg. 4 of the Restriction Requirement, (b) claim 1 is not generic as seemingly alleged by Applicant, and (c) Applicant has not addressed the technical features as identified on pg. 4 of the aforementioned Restriction Requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species (only nonelected Species C includes a fixing element 30 with a fixing pin 431 or 432), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 27, 2025.
Claims 16-21 have been examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 16-21 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. Claim 16 recites “an osteosynthesis device for the treatment of the spine, consisting of or having…” (lines 1-2). “Consisting of” excludes any element not specified in the claim (see MPEP § 2111.03(II)) whereas “having” is to be interpreted in light of the specification (see MPEP § 2111.03(IV)). It is noted that the specification does not provide clear guidance as to the meaning of the word “having.” However, it is also noted that dependent claims 20 and 21 recite an additional element in the form of a thrust piece. Such is in contradiction to the use of “consisting of” in claim 16. Thus, the Examiner is interpreting claim 16 as reciting “an osteosynthesis device for the treatment of the spine,
Claims 16-21 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. Claim 16 recites the limitation "the head region of the bone anchor" (line 13). There is insufficient antecedent basis for this limitation in the claim as the bone anchor has not been previously recited as including a head region. Claims 17-21 are rejected because they depend from claim 16.
Claim 18 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 18 recites the limitation "the radially inwardly directed contact region of the fixing element" (lines 2-3). There is insufficient antecedent basis for this limitation in the claim as the fixing element has not been previously recited as including a radially inwardly directed contact region.
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 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders (US 2007/0270810 A1).
Claim 16. Sanders discloses an osteosynthesis device, for the treatment of the spine, consisting of or having a fork head (body 10) which is U-shaped in a side view (see Fig. 1) and has a through opening (see Fig. 3A inset), and the fork head has two fork legs (bridge 28 is one leg; brackets 30 in combination is another leg) in the proximal direction with an inner-lying thread (thread of bore 40 – see para. 0015), and a connecting rod (rod 32) can be received therein, and a ball head receiving region (region of body 10 that receives head 22 of screw 18) is provided in the fork head in the distal direction in the through opening, and a bone anchor (screw 18) is pivotably mounted therein, wherein the centre of the inner-lying thread (see Fig. 3A inset) and the centre of the ball head receiving region (see Fig. 3A inset) define a central axis (see Fig. 3A inset; note that the claim does not require that the central axis extend through the aforementioned centres; the central axis extends centrally, or midway, between the centres) and at least one leg provides an axial opening (bore 40), arranged parallel to the central axis, for a positioning element (setscrew 42), wherein a transverse opening (see Fig. 3A inset) is provided in the fork head, which communicates with the axial opening and with the through opening of the fork head, and a fixing element (wedge 48) is movably guided in this transverse opening along an axis (see Fig. 3A inset), and the fixing element clamps the head region of the bone anchor in an angularly stable manner in the fork head with introduction of a compression force along the transverse opening axis (see para. 0017) (Figs. 1-3A; paras. 0012-0018).
Claim 17. Sanders discloses wherein the transverse opening in the fork head is provided transversely to the axial opening and the central axis (see Fig. 3A), and wherein the compression force introduced along the transverse opening axis is generated by the positioning element (see para. 0017) (Figs. 1-3A; paras. 0012-0018).
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Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammill et al. (US 2011/0040336 A1).
Claim 16. Hammill discloses an osteosynthesis device, for the treatment of the spine, consisting of or having a fork head (upper connector member 31 and lower connector member 33 in combination) which is U-shaped in a side view (see Fig. 6) and has a through opening (see Fig. 6 inset), and the fork head has two fork legs (see Fig. 6 inset) in the proximal direction with an inner-lying thread (thread 54), and a connecting rod (see Fig. 1) can be received therein, and a ball head receiving region (region in upper connector member 31 and lower connector member 33 that receives connector 18 of bone screw 12 as shown in Fig. 5) is provided in the fork head in the distal direction in the through opening, and a bone anchor (bone screw 12) is pivotably mounted therein, wherein the centre of the inner-lying thread (see Fig. 5 inset) and the centre of the ball head receiving region (see Fig. 5 inset) define a central axis (see Figs. 5 and 6 inset) and at least one leg provides an axial opening (see Fig. 6 inset; note that the opening extends parallel to the central axis and can thus be considered an axial opening), arranged parallel to the central axis, for a positioning element (see Fig. 6 inset), wherein a transverse opening (see Fig. 6 inset; note that the opening extends in a direction transverse to the central axis, in addition to parallel to the central axis, and can thus be considered a transverse opening) is provided in the fork head, which communicates with the axial opening and with the through opening of the fork head, and a fixing element (see Fig. 6 inset) is movably guided in this transverse opening along an axis (axis parallel to the central axis), and the fixing element clamps the head region of the bone anchor in an angularly stable manner in the fork head with introduction of a compression force along the transverse opening axis (Figs. 1-13; paras. 0075-0084).
Claim 20. Hammill discloses wherein the fork head has a thrust piece (retaining ring 42) and the thrust piece has a through opening (see Fig. 6 inset), a distally directed contact region (surface 56) towards the bone anchor head region, a proximally directed stave bearing (surface 53), and, in the region of the bone anchor head region, a lateral opening or partial cutout (see Fig. 6 inset; see also Fig. 8A), in which the fixing element is arranged such that it can move freely (Figs. 4-13; paras. 0075-0084).
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Claims 16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (US 2008/0147129 A1).
Claim 16. Biedermann discloses an osteosynthesis device, for the treatment of the spine, consisting of or having a fork head (receiving part 1) which is U-shaped in a side view (see Fig. 3) and has a through opening (see Fig. 3 inset), and the fork head has two fork legs (see Fig. 3 inset) in the proximal direction with an inner-lying thread (internal thread 11), and a connecting rod (rod 12) can be received therein, and a ball head receiving region (region of receiving part 1 that receives head 15 as shown in Fig. 3) is provided in the fork head in the distal direction in the through opening, and a bone anchor (bone anchoring element 13) is pivotably mounted therein, wherein the centre of the inner-lying thread (see Fig. 3 inset) and the centre of the ball head receiving region (see Fig. 3 inset) define a central axis (see Fig. 3 inset, extending into the page; note that the claim does not require that the central axis extend through the aforementioned centres; the central axis extends centrally, or midway, between the centres) and at least one leg provides an axial opening (see Fig. 8 inset), arranged parallel to the central axis, for a positioning element (see Fig. 8 inset), wherein a transverse opening (see Fig. 8 inset; note that the opening extends in a direction transverse to the central axis, in addition to parallel to the central axis, and can thus be considered a transverse opening) is provided in the fork head, which communicates with the axial opening and with the through opening of the fork head, and a fixing element (see Fig. 8 inset) is movably guided in this transverse opening along an axis (see arrow in Fig. 8), and the fixing element clamps the head region of the bone anchor in an angularly stable manner in the fork head with introduction of a compression force along the transverse opening axis (Figs. 1-6 and 8; paras. 0025-0036).
Claim 21. Biedermann discloses wherein the fork head provides a thrust piece (pressure element 20) and, when the bone anchor head region is clamped solely by the fixing element, the thrust piece is unloaded (see Fig. 3) (Figs. 1-6 and 8; paras. 0025-0036).
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Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heuer et al. (DE 10 2018 102 173 B3).
Claim 16. Heuer discloses an osteosynthesis device, for the treatment of the spine, consisting of or having a fork head (head 10) which is U-shaped in a side view (see Fig. 1e) and has a through opening (see Fig. 1e inset), and the fork head has two fork legs (legs 12) in the proximal direction with an inner-lying thread (thread 60), and a connecting rod (see para. 0024) can be received therein, and a ball head receiving region (see region that receives head 8 as shown in Fig. 1e) is provided in the fork head in the distal direction in the through opening, and a bone anchor (anchor 4) is pivotably mounted therein, wherein the centre of the inner-lying thread (see Fig. 1e inset) and the centre of the ball head receiving region (see Fig. 1e inset) define a central axis (see Fig. 1e inset) and at least one leg provides an axial opening (opening 51), arranged parallel to the central axis, for a positioning element (adjusting means 50), wherein a transverse opening (recess 30) is provided in the fork head, which communicates with the axial opening and with the through opening of the fork head, and a fixing element (pressure piece 18) is movably guided in this transverse opening along an axis (axis extending parallel to the central axis), and the fixing element clamps the head region of the bone anchor in an angularly stable manner in the fork head with introduction of a compression force along the transverse opening axis (Figs. 1a-2e; paras. 0024-0031).
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Claim Rejections - 35 USC § 103
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 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Heuer et al. (DE 10 2018 102 173 B3) in view of Chao (US 2008/0015580 A1).
Claim 18. Heuer discloses wherein the fixing element includes a radially inwardly directed contact region (surface of pressure piece 18 that contacts head 8 as shown in Fig. 1e) (Figs. 1a-2e; paras. 0024-0031).
Heuer fails to disclose wherein the radially inwardly directed contact region has an increased roughness, notches or teeth (claim 18).
Chao teaches an osteosynthesis device comprising a fixing element (insert 20), wherein the fixing element includes a radially inwardly directed contact region (inner surface 26) for contacting a head (head 42) of a bone anchor (shank 40), wherein the radially inwardly directed contact region has an increased roughness, notches or teeth (para. 0029 states that inner surface 26 includes knurling, blasting, or ridges to provide texture) for better gripping of the head of the bone anchor (see para. 0029) (Figs. 1A-2D; para. 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the osteosynthesis device of Heuer such that the radially inwardly directed contact region has an increased roughness, notches or teeth (claim 18), as suggested by Chao, to enable better gripping of the head of the bone anchor by the fixing element.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2008/0147129 A1) in view of Heuer et al. (DE 10 2018 102 173 B3).
Biedermann fails to disclose wherein the transverse opening for the fixing element has an inner thread at least in sections (claim 19).
Heuer teaches a fixing element (adjusting means 50) received in an opening (recess 48 and opening 74 in combination), wherein the opening has threaded sections (thread 53 and thread 76), and wherein the fixing element has corresponding threaded sections (threads 52 and 78) separated by an unthreaded section (Figs. 3a-3e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the osteosynthesis device of Biedermann such that the transverse opening for the fixing element has an inner thread at least in sections (claim 19) and the fixing element has corresponding threaded sections separated by an unthreaded section, as suggested by Heuer, as such a configuration would ensure that the fixing element does not separate from the fork head after completion of the surgical procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773