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 .
This Office action is in response to the amendment filed 08/26/2026. Claims 1, 3, and 7 have been amended, claims 15 and 16 have been canceled, and claims 17-20 have been added. Claims 1-14 and 17-20 are pending.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 2, insert --;-- after "a first fixation end"
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 1-14 and 17-20 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 1 recites the limitation "the first elongate member" in line 10. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously introduces "a first elongate rod" and "a first fixation member," and it is unclear which of these structures "the first elongate member" refers to. The ambiguity is material because the claim language points to the rod, while the specification describes mirror image halves only for octarod 340, which serves as a fixation member (see pars. 0042 and 0044). For purposes of examination, "the first elongate member" is interpreted as reading on either the first elongate rod or the first fixation member.
Claim 20 recites the limitations "the first elongate member" in lines 1-2 and "the second elongate member" in line 3. There is insufficient antecedent basis for these limitations in the claim, and it is unclear whether they refer to the first and second elongate rods or to the first and second fixation members of claim 1. For purposes of examination, they are interpreted as reading on either the first and second elongate rods or the first and second fixation members, respectively.
Claims 2-14 are rejected under 35 U.S.C. 112(b) by virtue of their dependency from claim 1.
Claim 17 recites “a first fixation member comprising a plurality of first segments extending from an adjacent of the plurality of first segments.” It is unclear what structure Applicant is attempting to claim. The recitation appears to recite that a plurality of first segments extend from a location adjacent the plurality of first segments. The recited structure can’t be identified from the Specification or Drawings.
Claim 18 recites “each of the plurality of first segments extends from the adjacent of the plurality of first segments at an obtuse angle.” The recited structure is not clear and is not identified in the drawings or specification.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, as amended, recites "wherein the first elongate member comprises mirror image halves coupled together, forming passages sized to allow screws to be installed therethrough." As explained in the rejection under 35 U.S.C. 112(b) above, "the first elongate member" can reasonably be read as the first elongate rod, so the claim encompasses a first elongate rod comprising mirror image halves. The original disclosure does not describe the first elongate rod (110) as comprising mirror image halves. The only mirror image halves disclosed are halves 342, 344 of octarod 340 (see par. 0044 and Fig. 8). The octarods are disclosed as alternatives to fixation members 140, 160, not to elongate rods 110, 120 (see par. 0042, i.e., octarods 240, 260 "can be used as the fixation members"). Elongate rods 110, 120 are disclosed only as having ratchet ends 112, 122 with tooth racks 116, 126 engaged by pinion 134 of ratchet assembly 130 (see pars. 0029-0032 and Figs. 1-3). Nothing in the original disclosure describes forming the ratcheting rods from mirror image halves or providing those rods with passages for screws. Claims 2-14 depend from claim 1 and include the same unsupported subject matter.
Claim 20 recites that "the first elongate member comprises five first member segments" and "the second elongate member comprises five second member segments such that the first and second elongate members can be attached to each other to form an octagon." Read as the first and second elongate rods (see the rejection under 35 U.S.C. 112(b) above), this subject matter lacks support. The original disclosure describes five segments (242, 244, 246, 248, 250) and an octagonal shape only for octarods 240, 260, which take the place of fixation members 140, 160 (see pars. 0042-0043 and Fig. 7). In the frame of Fig. 9, the systems 100 that include elongate rods 110, 120 extend between the octagons 280; they do not form the octagons (see par. 0045). The disclosure therefore does not describe first and second elongate rods that each have five segments and attach to each other to form an octagon.
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.
Claim(s) 17-19, as best understood is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomke et al. (U.S. 7,618,417 B2).
Concerning claim 17, as best understood, Thomke et al. disclose an external fixation system comprising: a first fixation member (see Fig. 26, element 71 upper) comprising a plurality of first segments extending from an adjacent of the plurality of first segments, wherein the first fixation member comprises mirror image halves (see Fig. 26, element 71 lower) coupled together, forming passages sized to allow screws (see Fig. 26, element 16) to be installed therethrough.
Concerning claim 18, as best understood, wherein each of the plurality of first segments extends from the adjacent of the plurality of first segments at an obtuse angle.
Concerning claim 19, further comprising a second fixation member (see Fig. 26, element 71 lower) comprising a plurality of second segments, wherein the second fixation member is configured to be attached to the first fixation member (see Fig. 26, element 71 upper).
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(s) 1, 2 and 5-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. 2020/0297390 A1) in view of Vikinsky et al. (U.S. 2017/0071632 A1), and further in view of Hoffman et al. (U.S. 2002/0077629 A1).
Concerning claim 1, as best understood, Zhang et al. disclose an external fixation system comprising: a first elongate rod (see Fig. 7C below) having a first end (see below) and a first fixation end (see below); a second elongate rod (see below) having a second end (see below) and a second fixation end (see below); a first fixation member (see below) attached to the first fixation end; and a second fixation member (see below) attached to the second fixation end.
[AltContent: connector][AltContent: textbox (First Fixation Member)][AltContent: connector][AltContent: textbox (Second Fixation Member)][AltContent: textbox (Second End)][AltContent: textbox (Second Fixation End)][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: connector][AltContent: arrow][AltContent: textbox (First Fixation End)][AltContent: arrow][AltContent: textbox (First End)][AltContent: textbox (Second Elongate Rod)][AltContent: textbox (First Elongate Rod)]
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However, Zhang et al. do not disclose that the first end and second end include a ratchet, or a ratchet assembly attached to the first ratchet end and the second ratchet end, the ratchet assembly configured to compress the first and second elongate rods to each other.
Vikinsky et al. disclose an external fixation system comprising an adjustable strut (see Fig. 1B) having a first ratchet end, a second ratchet end and a ratchet assembly (see Fig. 1B, element 132 and par. 0104) configured to compress the first and second elongate rods to each other (see par. 0105) in the same field of endeavor for the purpose of providing adjustable support.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute Vikinsky's ratchet assembly for Zhang's adjustable connector in order to permit incremental one-directional movement while preventing backsliding. The concept of an orthopedic support having an adjustable component – such as a threaded rod, telescoping sleeves, and cams – is well known in the art. A ratchet is simply another known mechanism that yields predictable results. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007); MPEP 2143(I)(B). It is further noted that Applicant has not demonstrated that incorporating a ratchet mechanism produces any result that would have been unexpected or surprising.
Zhang et al. in view of Vikinsky et al. do not disclose wherein the first elongate member (read on the first fixation member, see the rejection under 35 U.S.C. 112(b) above) comprises mirror image halves coupled together, forming passages sized to allow screws to be installed therethrough.
Hoffman et al. teach an external fixation system comprising a fixation member (bone pin locking assembly including pin vise portion 1, see Figs. 1A, 3 and 6) comprising mirror image halves (first and second opposing plates 2, 2') coupled together (by vise bolts 12, 12', see par. 0026), forming passages (spaced parallel grooves 8, 8' in confronting relation on engaging faces 4, 4') sized to allow screws (bone pins 28) to be installed therethrough (see par. 0025) in the same field of endeavor for the purpose of locking multiple bone pins installed at multiple angles on either side of a fracture (see par. 0008). Plates 2, 2' are mirror image halves in that each has an engaging face with corresponding grooves arranged in confronting relation, and each outside face carries a threaded bore and a serrated bearing face for a rod attachment portion (bore 26 and serrations 24 on plate 2; bore 20 and serrations 23 on plate 2'; see pars. 0029 and 0031-0032). That one plate receives the vise bolts in plain bores 14, 14' and the other in threaded bores 16, 16' does not distinguish the claimed halves, since Applicant's own halves 342, 344 are likewise joined by screws 345 that pass through one half and thread into the other (see Fig. 8). Hoffman et al. also treat bone pins and screws interchangeably as the transcutaneous bone anchors of a fixator (see par. 0003).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further provide the first fixation member of Zhang et al. in view of Vikinsky et al. with a bone pin locking assembly mounted on its fixation rod, as taught by Hoffman et al. (rod attachment portion 50 snaps onto a bone fixation rod, see par. 0009), in order to lock multiple bone pins installed at multiple angles (see par. 0008) using a pin vise that can be slipped onto pins already installed in the bone and then fixed with only minor additional tightening (see par. 0027). The first fixation member as modified comprises mirror image halves (plates 2, 2') coupled together, forming passages sized to allow screws to be installed therethrough.
Concerning claim 2, Vikinsky et al. also disclose that the ratchet assembly is configured to alternatively distract the first and second elongate rods from each other (see par. 0104).
Concerning claim 5, wherein Vikinsky's ratchet assembly is motor operated (see par. 0072).
Concerning claim 6, wherein Vikinsky's ratchet assembly further comprises an electronic receiver configured to electronically receive a signal to operate the motor (see par. 0096).
Concerning claim 7, wherein Vikinsky et al. further disclose a transmitter configured to remotely transmit a signal to the receiver to operate the motor (see par. 0096).
Concerning claim 8, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the external fixation system of Zhang et al. in view of Vikinsky et al. and Hoffman et al. such that the head is rotatably attached to the rod support in order to accommodate the complex, non-uniform geometry of fractured or deformed limbs. Rigid, non-rotatable connections between fixation components create stress concentrations at the bone interface when components cannot be precisely aligned. Incorporation of a rotatable connection to accommodate angular misalignment is a well-known and obvious solution.
Concerning claim 9, wherein the first fixation member further comprises a fixation rod (see Fig. 7C below) extending through the rod support (see below).
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Concerning claim 10, wherein the fixation rod (see above) is longitudinally translatable along the rod support (see above).
Concerning claim 11, further comprising a first screw (see Fig. 7C above) attached to the rod on a first side of the rod support.
Concerning claim 12, further comprising a second screw (see above) attached to the rod on a second side of the rod support.
Concerning claim 13, wherein the first screw (see above) is longitudinally translatable along the fixation rod.
Concerning claim 14, wherein the first fixation member comprises a straight rod (see Fig. 7C – Fixation Rod above).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. 2020/0297390 A1) in view of Vikinsky et al. (U.S. 2017/0071632 A1) and Hoffman et al. (U.S. 2002/0077629 A1) as applied to claim 1 above, further in view of Penn (U.S. 2022/0387086 A1).
Zhang et al. in view of Vikinsky et al. and Hoffman et al. disclose the invention substantially as described above. However, Zhang et al. in view of Vikinsky et al. and Hoffman et al. do not explicitly disclose that the first ratchet end comprises a first tooth rack, the second ratchet end comprises a second tooth rack, and the ratchet assembly comprises a pinion engaged with the first rack and the second rack.
Penn teaches a manually operating ratchet assembly (see Figs. 24 and 25) comprising a first ratchet end comprising a first tooth rack (2431C), a second ratchet end comprising a second tooth rack (2420C), and wherein the ratchet assembly comprises a pinion (2333) engaged with the first rack and the second rack in the same field of endeavor for the purpose of causing retraction or distraction of an orthopedic implant.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to simply substitute a ratchet assembly operating as disclosed by Penn for the ratchet assembly of Zhang et al. in view of Vikinsky et al. and Hoffman et al. in order to drive the first and second racks in opposite directions from a single pinion, providing controlled retraction or distraction. A rack-and-pinion drive is a known adjustment mechanism that yields predictable results. See KSR, 550 U.S. at 416; MPEP 2143(I)(B).
Concerning claim 4, Penn teaches that the ratchet assembly is manually operated (see Figs. 24 and 25).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (U.S. 2020/0297390 A1) in view of Vikinsky et al. (U.S. 2017/0071632 A1) and Hoffman et al. (U.S. 2002/0077629 A1) as applied to claim 1 above.
Concerning claim 20, as best understood in view of the rejections under 35 U.S.C. 112(a) and (b) above, Zhang et al. in view of Vikinsky et al. and Hoffman et al. disclose the claimed invention except for the first and second elongate members each comprising five segments such that they can be attached to each other to form an octagon. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to form each of the first and second elongate members with five segments such that they can be attached to each other to form an octagon, since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art absent persuasive evidence that the particular configuration of the claimed invention is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B). Applicant's own disclosure indicates that the octagonal configuration is not significant, stating that the external fixation system can instead be hexagonal or have any other appropriate shape (see par. 0046).
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (U.S. 2002/0077629 A1) in view of Pennig (U.S. 5,320,623).
Concerning claim 17, as best understood, Hoffman et al. disclose an external fixation system comprising: a first fixation member (bone pin locking assembly including pin vise portion 1, see Figs. 1A, 3 and 6), wherein the first fixation member comprises mirror image halves (first and second opposing plates 2, 2') coupled together (by vise bolts 12, 12', see par. 0026), forming passages (grooves 8, 8' in confronting relation) sized to allow screws (bone pins 28) to be installed therethrough (see par. 0025). Plates 2, 2' are mirror image halves for the reasons given in the rejection of claim 1 above.
However, Hoffman et al. do not disclose that the first fixation member comprises a plurality of first segments, each extending from an adjacent one of the plurality of first segments.
Pennig teaches a fixation member (clamping coupling, see Fig. 1) comprising a plurality of segments, i.e., a first clamping component (elongate body of half shells 2, 3) and a second clamping component (10, half shells 11, 12) extending from the adjacent end of the first clamping component via a rotary connection (stud 8 received in bore 9), each segment having half shells with confronting arcuate recesses (5) that receive bone screws, in the same field of endeavor for the purpose of achieving substantially enhanced anchorage to the condyle region of a fractured limb, particularly when the fracture extends into the joint.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the first fixation member of Hoffman et al. with a plurality of segments, each extending from an adjacent segment, by adding a second pin vise segment extending from the first, as taught by Pennig, in order to clamp a second array of bone screws along a second orientation axis and thereby enhance anchorage near a joint.
Concerning claim 19, Hoffman et al. further disclose a second fixation member (the second bone pin locking assembly, installed on the bone pins on the second side of the fracture, see par. 0014 and Fig. 6) that is configured to be attached to the first fixation member (both assemblies are snapped onto and locked along the same bone fixation rod 100, see par. 0014). Forming the second fixation member with a plurality of second segments would have been obvious for the same reason given for claim 17, i.e., to enhance anchorage of the bone screws on the second side of the fracture.
Response to Arguments
Applicant’s arguments filed 08/26/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
