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
This application claims priority from provisional application 62/915,203, filed 10/15/2019
Status of Claims
Claims 1-13, 15, 16, and 18 are pending.
Claims 14 and 17 have been cancelled.
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 rod-shaped truss (claim 8, the truss shown in the figures are plate shaped not rods) 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 Rejections - 35 USC § 112
The 112 rejections have been withdrawn in view of the applicant’s amendments.
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) 1-5, 8-11, and 13, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medoff US 2008/0208261 A1.
1. Medoff discloses an implant truss (24 Figure 26) for spanning the hock joint of a dog (the intended use language is given limited weight in the apparatus claims, the plate of Medoff is fully capable of being used with the method of the applicant’s disclosure), comprising
a proximal end (102 Figure 26) adapted for affixing to the tibia and a distal end adapted for fixing to the calcaneus (106 Figure 26),
wherein the proximal end of the truss is angled with respect to an extension direction of the truss in a first direction (as seen in figure 26 end 102 is angled down and to the left) and the distal end of the truss is angled with respect to the extension direction of the truss in a second direction different than the first direction (as seen in figure 26 end 106 is angled up and to the right).
2. Medoff discloses at least one hole on each end for inserting a bone locking screw to affix the truss to the tibia and to the calcaneus (Figure 26).
It is noted that the screws are not positively claimed in claims 3, 4, 11, or 12.
3. Medoff discloses two holes 96/98 for inserting mono-cortical locking screws with conical self-locking tapered heads proximally in the tibia and one hole 108 for inserting a bi-cortical screw with a self-locking tapered head distally in the calcaneus. (These holes are capable of accepting any type of screws)
4. Medoff discloses two holes 96/98 for inserting mono-cortical locking screws with conical self-locking tapered heads proximally in the tibia and up to three holes 108 for inserting bi-cortical screws with a self-locking tapered head distally in the calcaneus. (These holes are capable of accepting any type of screws)
5. Medoff discloses the implant truss is made of titanium or titanium alloys [0046].
8. Medoff discloses the implant truss is substantially rod shaped (the shape of the truss of Medoff is the same as that of the applicant’s, both read upon the rod shaped limitation in the same manner).
9. Medoff discloses at least one of the proximal and distal ends of the truss is angled with respect to the extension direction of the truss in adaptation to the respective extension direction of the tibia and of the calcaneus (It is noted that angled includes 0 and 180 degrees, but Figure 26 of Medoff shows both ends curved to form an angle with respect to the extension direction or longitudinal axis of the plate).
10. Medoff discloses the truss is adapted to span the hock joint distant therefrom such that the proximal and distal ends of the truss and the hock joint represent apexes of a substantially triangular configuration (this claim is considered to be a recitation of intended use and given limited weight, since the plate of Medoff is substantially similar is shape and have available through holes it is fully capable of performing the applicant’s claimed intended use).
11. Medoff discloses holes 96/98 for inserting two locking screws proximally in the tibia and one hole 108 for inserting a screw distally in the calcaneus.
13. Medoff discloses an implant kit for immobilizing the hock joint of a dog in extension (intended use explained above) comprising a truss 26 and screws [0013] for affixing the truss to the tibia and to the calcaneus (intended use explained above), wherein the truss comprises:
a proximal end (102 Figure 26) adapted for affixing to the tibia and a distal end adapted for fixing to the calcaneus (106 Figure 26), the proximal end being angled with respect to an extension direction of the truss in a first direction (as seen in figure 26 end 102 is angled down and to the left) and the distal end of the truss is angled with respect to the extension direction of the truss in a second direction different than the first direction (as seen in figure 26 end 106 is angled up and to the right).
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) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff in view of Tepic et al (Tepic) US 2016/0128748 A1.
Medoff discloses the invention substantially as claimed being described above. However, Medoff does not disclose the use of coatings on the bone facing sides of the truss.
Tepic teaches the use of a plate for use in a canine comprising titanium with a plasma coating with porous titanium or with hydroxyapatite in the same field of endeavor for the purpose of promoting healing and ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the plasma coating with porous titanium or with hydroxyapatite with the plate of Medoff in order to promote healing and ingrowth.
It is old and extremely well known to only use coatings on the functional sides of devices. A person of ordinary skill in the art would recognize that the truss of Medoff is designed so that only one side contacts bone. Therefore it would have been obvious to provide the coatings of Tepic on only the bone facing surfaces in order to save time and cost as well as to prevent any unwanted attachment to the non-bone engaging side.
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoff in view of Pollock USPN 4,966,599.
Medoff discloses the invention substantially as claimed being described above. However, Medoff does not disclose the a plurality of screw holes at each end.
Pollock teaches the use of numerous bone trusses comprising numerous openings at both ends (Figure 1) that are packaged in a sterile packaging (3:62-68) in the same field of endeavor for the purpose of providing a variety of screw attachment points to meet the needs of each patient and to ensure no contamination prior to surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distal end of the plate of Medoff to include multiple openings and to prepackage the implant in a sterile package in order to provide customizable openings to fit the needs of each patient and to reduce the risk of infection.
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rassier D. E., Macintosh B. R., and Herzog W., Length dependence of active force production in skeletal muscle, J Appl Physiol (1985). 1999 May; 86(5):1445-57) (Herein referred to as Rassier)(the 13 page NPL cited in the applicant’s IDS filed on 05/17/2022) in view of Horan et al (Horan) US 2012/0197410 A1.
As admitted to by the applicant Rassier discloses a surgical intervention by fixing the hock joint in extension [0021].
However, Rassier does not disclose the specific use of a truss with screws for the stabilizing step.
Horan teaches the use of a variety of different plates for use in stabilizing two bones across a joint in a canine [0002] in the same field of endeavor for securely stabilizing joint during and after the healing process.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the plate of Horan to perform the step of stabilizing the hock joint in Rassier in order to stabilize the joint and promote healing.
16. Specifically Horan discloses truss (82 Figure 5) comprising a proximal end 84 adapted for affixing to the tibia and a distal end 86 adapted for fixing to the calcaneus (Rassier discloses the desired bones to be stabilized) wherein the proximal end being angled with respect to an extension direction of the truss in a first direction and the distal end being angled with respect to the extension direction in a second direction different than the first direction (as explained above with respect to Medoff, the proximal and distal ends extend at angles with respect to the extension direction up to the left and down to the right as see in Figure 5 of Horan).
18. Horan discloses an implant kit (Figure 5), wherein said implant kit comprises a truss 82 and screws [0028] for affixing the truss to the tibia and to the calcaneus (See Rassier as admitted by the applicant).
Response to Arguments
Applicant's arguments filed 10/22/2025 have been fully considered but they are not persuasive.
With respect to the drawing rejections the applicant argues that rods are well known conventional shapes and that their depiction is not necessary. This is not persuasive because a person of ordinary skill in the art would look to the figures and not be able to determine what would and would not qualify as a rod shape since the applicant’s own invention is not rod shaped. Furthermore it is unclear how the rod shape exists with the ends and through holes. Is the entire thing rod shaped? Are the portions around the holes still flattened? How wide is the rod? Is it uniform shaped? Therefore this objection to the drawings has been maintained.
With respect to the prior art rejection the applicant argues that Medoff does not teach or suggest his truss is used for spanning the hock joint of a dog. The applicant contends that the rejection is a conclusory assertion and that there is no indication that it would have the configuration to perform the intended function. This is not persuasive because the claims are directed at the apparatus not a method of using it. As previously explained this is the applicant’s intended use for the device and given limited weight. Furthermore, a quick comparison of the applicant’s truss and that of Medoff shows they are both angled plates with through holes. They both function in the same manner wherein they are secured to bones with fasteners in the through holes. The intended use is not a complicated or multi step process. The applicant’s invention and Medoff simply stabilize bones. The applicant has failed to provide any factual evidence to support their claim. Therefore, Medoff is fully capable of performing the applicant’s intended use for the device.
The applicant further argues that Medoff fails to disclose his truss has ends that extend in different directions. This is not persuasive because in their current form the claimed directions are extremely broad and anticipated by Medoff. The complex curves and tapered edges allow for the extension direction to be interpreted to be a variety of directions and allow for each end to extend in a variety of directions. Furthermore, the term angled is not limited to any particular angle range and would depend upon the orientation of the implant. As explained above the truss of Medoff can be rotated to be diagonal forming angles, and the ends point in opposite directions (up to the right and down to the left).
The applicant further argues that Rassier fails to disclose the structure of the truss and screws. This is not persuasive because that rejection has been modified to include an additional reference providing a specific truss to perform the method already disclosed by Rassier.
The applicant further argues that Tepic fails to disclose coating only the bone facing surface. This is not persuasive because it is not a novel concept to only apply surface coatings to functional surfaces. As explained above limiting the coatings reduces costs and prevents unwanted attachment to non-functional surfaces.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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