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 .
Priority
Examiner notes that support for a fixator comprising a spanning structure for fractures and an applicator (as claimed in claim 1) is supported in parent application 16/693,214 (paragraph 52, 70) filed November 22, 2019. As such, Claim 1 has an effective filing date of November 22, 2019.
Examiner notes that the other previous parent applications only mention an applicator as it pertains to an acetabular cup and not a spanning structure. Furthermore, support for Claim 2 (robotic materials with the applicator as claimed in claim 1) and Claim 5 (spanning structure with sensing element, computational element, actuation element, internal structures with an applicator) was not found in any of the parent applications and thus Claim 2, 5 and their dependent claims have an effective filing date of the application, August 21, 2023.
The examiner notes that the applicator in 16/693,214 was used only with a spanning structure that is degradable/absorbable and not with a spanning structure with robotic materials (see paragraph 52, 70).
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on September 15, 2025 is acknowledged.
Claims 3-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 15, 2025.
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 “applicator” in claims 1, 5 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The limitations of Claim 2 (in view of Claim 1) and Claim 5 were not disclosed in the original specification. As discussed in the priority section above, an applicator was only ever disclosed with a spanning structure that was degradable, not with a spanning structure with robotic materials.
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 1-2, 5-7 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 2 and Claim 5 line 2 each recite “a spanning structure having a length spanning the set of fractures” which positively recites the body as part of the invention. It is recommended to recite “a length adapted to span” or other similar functional language to overcome the 101 rejection.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Behzadi US 2017/0340448 in view of Beger US 2013/0066387.
Regarding Claim 1, Behzadi discloses a fixator for a set of fractures in a bone (Fig 15), comprising:
a spanning structure (#1510) having a length spanning the set of fractures (Fig 15), said spanning structure including both an anisotropic component and a viscoelastic component (paragraph 127), said components providing a variable bone-structure-mimicking profile (due to the anisotropic and viscoelastic properties, paragraph 104, 127).
Behzadi discloses the spanning structure is a rod (Fig 15) that is able to be applied after a reduction of the set of fractures (Fig 14, paragraph 126-127) but does not disclose an applicator, coupled to said spanning structure, configured to position and apply said spanning structure to the bone after a reduction of said set of fractures.
Beger discloses an applicator (#26, Fig 1) coupled to an end of a spanning structure/rod (Fig 1) in order to handle/manipulate a rod (#25) to a desired location, position and/or orientation (paragraph 117, 122).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Behzadi to include an applicator in view of Beger above because this provides a known tool in the orthopedic art to handle/manipulate an elongated element such as a spanning structure/rod to a desired location, position and/or orientation. The examiner notes that with the modification, the applicator is able to be deployed at any time during a procedure and is able to couple to the spanning structure and position/apply said spanning structure to the bone after a reduction of said set of fractures.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Behzadi US 2020/0205988 in view of Beger US 2013/0066387.
Regarding Claim 1, Behzadi discloses a fixator for a set of fractures in a bone (Fig 15), comprising:
a spanning structure (#2400, Fig 24, which can be used similar to that of spanning structure #1510 in Fig 15, paragraph 51, 69, 243) having a length spanning the set of fractures (Fig 15), said spanning structure including both an anisotropic component and a viscoelastic component (paragraph 51, 69, 253-254), said components providing a variable bone-structure-mimicking profile (paragraph 51, 69, 253-254).
Regarding Claim 2, Behzadi discloses a set of robotic materials configured to adjust said bone-structure-mimicking profile in situ while said spanning structure includes said length spanning the set of fractures (paragraph 253-254).
Behzadi discloses the spanning structure is a rod (Fig 15) that is able to be applied after a reduction of the set of fractures (Fig 14, paragraph 126-127), where Behzadi teaches in another embodiment for the spanning structure that an applicator is applied to a spanning structure to position the spanning structure after reduction of the fracture (paragraph 70) but does not disclose an applicator, coupled to said spanning structure, configured to position and apply said spanning structure to the bone after a reduction of said set of fractures.
Beger discloses an applicator (#26, Fig 1) coupled to an end of a spanning structure/rod (Fig 1) in order to handle/manipulate a rod (#25) to a desired location, position and/or orientation (paragraph 117, 122).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Behzadi to include an applicator in view of Beger above because this provides a known tool in the orthopedic art to handle/manipulate an elongated element such as a spanning structure/rod to a desired location, position and/or orientation. The examiner notes that with the modification, the applicator is able to be deployed at any time during a procedure and is able to couple to the spanning structure and position/apply said spanning structure to the bone after a reduction of said set of fractures.
Claim 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Behzadi US 2020/0205988 in view of Beger US 2013/0066387.
Regarding Claim 5, Behzadi discloses a fixator (Fig 24) for a set of fractures in a bone, comprising:
a spanning structure (#2400, Fig 24, which can be used similar to that of spanning structure #1510 in Fig 15, paragraph 51, 69, 243) having a length spanning the set of fractures (Fig 15), wherein said spanning structure includes an amorphous composite material component having a variable material properties profile (paragraph 242), said amorphous composite material component having a set of internal structures including a sensing element, a computational element, and an actuation element (paragraph 245, 254, Fig 24), said set of internal structures configured for implementing said variable material properties (paragraph 242, 253-254).
Regarding Claim 6, Behzadi discloses said amorphous material is configured to adjust said variable material properties profile in situ while said spanning structure includes said length spanning the set of fractures (paragraph 51, 242, 253-254).
Regarding Claim 7, Behzadi discloses said spanning structure is configured to provide a load-sharing of at least one fracture of the set of fractures (paragraph 41-42) and wherein said amorphous material is configured for:
sensing an internal loading force component of said load-sharing in said amorphous composite material component responsive to said sensing element (“sensors” paragraph 41-42, 253, 245); and thereafter modifying said variable material properties using said actuation element producing a modified material property of said amorpous composite material component (paragraph 42-42, 253, 245); and
thereafter adjusting a loading force component of said load-sharing in said fractured bone responsive to said modified material property (paragraph 42-42, 253, 245).
Behzadi discloses the spanning structure is a rod (Fig 15) that is able to be applied after a reduction of the set of fractures (Fig 14, paragraph 126-127), where Behzadi teaches in another embodiment for the spanning structure that an applicator is applied to a spanning structure to position the spanning structure after reduction of the fracture (paragraph 70) but does not disclose an applicator, coupled to said spanning structure, configured to position and apply said spanning structure to the bone after a reduction of said set of fractures.
Beger discloses an applicator (#26, Fig 1) coupled to an end of a spanning structure/rod (Fig 1) in order to handle/manipulate a rod (#25) to a desired location, position and/or orientation (paragraph 117, 122).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Behzadi to include an applicator in view of Beger above because this provides a known tool in the orthopedic art to handle/manipulate an elongated element such as a spanning structure/rod to a desired location, position and/or orientation. The examiner notes that with the modification, the applicator is able to be deployed at any time during a procedure and is able to couple to the spanning structure and position/apply said spanning structure to the bone after a reduction of said set of fractures.
Conclusion
See PTO 892 for art of cited interest, in particular other publications of Behzadi that disclose robotic materials. Other refences cited are directed to applicators for handling spanning structures/rods. The examiner notes prior art of relevance cited in the application, Donofrio US 2007/0233065 which discloses a spanning structure with robotic materials (Fig 7-8).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm 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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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773