DETAILED ACTION
This office action is responsive to the Response to Restriction Requirement of November 10, 2025. By that response, claims 43-62 are pending.
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 of Invention I, claims 43-54, in the reply filed on November 10, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 55-62 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 10, 2025.
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 45, 51 and 52 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 45 recites “a first and a second sleeve portions”. However, claim 43, from which this claim depends, already recited a first sleeve portion and a second sleeve portion. It is unclear if this is claiming an additional sleeve portion, or re-statement of the already recited sleeve portions. Correction is required. For examination purposes, this is treated as having been intended as further clarification of the already recited first and second sleeve portions.
Claim 51 requires the plurality of apertures of claim 50. However, claim 50 provides for those apertures in only a single option, which is not required by the claim if one of the other options is met. Therefore, there are situations in which claim 51 lacks antecedent basis.
Claim 52 requires the locking mechanism of claim 50. However, claim 50 provides for that locking mechanism in only a single option, which is not required by the claim if one of the other options is met. Therefore, there are situations in which claim 52 lacks antecedent basis.
Claim Rejections - 35 USC § 102
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) 43-52 and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schlatterer (US 12,089,884 B2).
Regarding claim 43, Schlatterer teaches a bone fracture fixation device as at fig. 19 for setting a fractured bone (see e.g. fig. 16 to demonstrate usage; see e.g. fig. 19 to demonstrate full ‘sleeve’ configuration; see figs. 8-14 to demonstrate differently sized segments and disclosure to discuss building of differently sized arcs to up to 360 degrees), the device comprising:
a sleeve (assembly of structures 10, as at fig. 19) having measures to fully or essentially fully surround at least a segment of the fractured bone including the fracture, the sleeve comprising:
at least two sleeve portions (the first, choosing two elements 10, together, as a first portion; and the second, choosing the third element 10), wherein a first sleeve portion (two of 10) having measures to surround above 180 degrees about the fractured bone (240 degrees), and a second sleeve portion (the third portion 10, 120 degrees) to thereby fully or essentially fully surround the fractured bone when the device is in use.
The optional limitation is not considered.
Regarding claim 44, the first sleeve portion surrounds more than 210 degrees (240 degrees demonstrated) of the fractured bone when the device is in use. Once a first of the options is met, the other optional limitations are not considered.
Regarding claim 45, as best understood, the first and second sleeve portions surround 360 degrees about the fractured bone when the device is in use as at fig. 19.
Regarding claim 46, the sleeve further comprises a plurality of protrusions see e.g. fig. 9; each portion 10 includes protrusions 20) attached to an inner wall of the sleeve as arranged in fig. 19 to be capable of pressing on the fractured bone and fixing the bone in place when the device is in use. Once a first of the options is met, the other optional limitations are not considered.
Regarding claim 47, the protrusions 20 are characterized by having blunt tips. Once a first of the options is met, the other optional limitations are not considered.
Regarding claim 48, the sleeve of fig. 19 comprises two orifices (out of the page, and into the page, through the middle of the device) through which the fractured bone passes when the device is in use and the protrusions 20 are dispersed in proximity to each of the orifices.
Regarding claim 49, a central portion of the inner wall of the sleeve that is proximal to the fracture is free of protrusions (e.g. portions of the inner wall can be seen to not have protrusions thereon, between protrusions 20).
Regarding claim 50, the sleeve portions comprise an inter-sleeve portion locking mechanism 40 to allow closing the sleeve. Once a first of the options is met, the other optional limitations are not considered.
Regarding claim 51, the claim is considered to further limit a structure not required by any other claim. Therefore the claim is not further evaluated.
Regarding claim 52, locking mechanism is characterized by one or more straps, wires, cerclage or a combination thereof. Once a first of the options is met, the other optional limitations are not considered.
Regarding 54, the two sleeve portions have different lengths (the first encompassing two element 10, the other only a single element 10).
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.
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schlatterer in view of Fulmer et al. (US 2008/0262630 A1).
Regarding claim 53, Schlatterer teaches the invention of claim 43, as above.
However, Schlatterer does not teach the claimed film.
Fulmer teaches a bone implant device for repairing a bone fracture (e.g. bone plate 30). Fulmer teaches a film 12 [0029] disposed on faces of the implant. The film includes a drug impregnated into the material (claim 1), the drug including bone growth factors (claim 12). Once a first of the options is met, the other optional limitations are not considered. Fulmer teaches that a wide variety of implant types, shapes, and sizes can be used with the device. [0005]
It would have been obvious to one with ordinary skill in the art at the time of the invention to place the Schlatterer implants (sleeve portions – considered analogous to bone plates) into a film of the Fulmer design. Such would have resulted in the inner face (e.g. bone-facing surface) having had the film present thereon. One would have done so in order to provide for a drug-releasing means to be utilized with the Schlatterer implant. (Fulmer, [0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAVID W BATES/Primary Examiner, Art Unit 3799