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 63/225109 filed on 7/23/2021.
Status of Claims
Claims 1-20 are pending.
Claims 1-7 and 16-20 have been withdrawn from consideration.
Election/Restrictions
Applicant's election with traverse of Invention III (Rotating Hinge Subassembly), Species 1 (Figures 1-4), and Sub-Species A (Figures 8A-C) in the reply filed on 10/21/2025 is acknowledged.
The applicant argues that Groups III and IV should be examined because claims 15 and 8 have all the same limitations and there would be no burden. In order to advance prosecution Groups III and IV have been joined into a single group
With respect to the Species election the applicant appears to be using this election to rejoin non-elected group II. This is not how species elections work. The examined claims must be directed at both the elected group and elected species. Group II only includes claims 8-14, so the species election would either include all of these claims or limit them to less claims. Therefore claims 2 and 6-7 remain withdrawn from consideration. With respect to the Species election, the applicant further argues the same points about the burden and field of search that were previously addressed with respect to the Group election. The search done for examination is not limited to just a single selection of a simplified class of subject matter. The search includes a plethora of searches that are substantially more complex. Initially the main classes based on subject matter are searched, but each claimed subcomponent then receives its own separate search including: subclasses based on refined subject matter, searches based on functionality, searches based on shapes/geometry, and searches based on material properties. Therefore, requiring the search for each of these varied combinations of varied components creates an undue burden and unfairly delays prosecution. With respect to the phone call, the examiner recalls getting an error message that the number had some sort of issue. So, to prevent delays the requirement was mailed in writing. The requirement is still deemed proper and is therefore made FINAL.
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, Hinge bore extending through two lateral sides of the head and both the arms disposed one different lateral sides of the heard (Claims 8 and 15, it’s unclear how there are two lateral sides and not one lateral and one medial side), the arms flushly disposed against the sides of the head (Claim 10, the drawings always show the bearings in between the arms and the head) and the hinge pin that doesn’t extend beyond the arms of a femur box in combination with a main body portion (Claim 11 see 112 rejection below for more details), 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.
Information Disclosure Statement
The Information Disclosure Statements filed on 04/22/22, 11/23/22, 01/27/23, 11/14/23, and 09/17/25 have been considered by the examiner.
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 11 and 13 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 11 is rendered indefinite because the drawings clearly show the hinge pin extending beyond the arms into the head. The hinge pin does not extend outwardly beyond the arms, but because the arms are spaced apart the hinge pin extends beyond the inner edges of each arm. The applicant is advised to better define the extending beyond with respect to the outer surfaces of the arms.
Claim 13 is rendered indefinite by the requirement for “other biocompatible clinically proven articulating materials” because a person of ordinary skill in the art would not be able to determine the scope of this recitation. What does clinically proven mean? Clinically meaning only with patients, not a lab? Proven to do what? Proven to be beneficial? Proven to last a specific amount of time? Proven to work with what type of patient? What is an articulating material? Does it have to articulate? Can it just be used with something that articulates? The applicant is advised to delete this phrase and end the claim with “and combinations thereof.”
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) 8-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeder et al (Reeder) US 2019/0336297 A1.
8. Reeder discloses a rotating hinge subassembly (Figure 1) comprising:
a tibial yoke (22 Figure 5) comprising:
a head 142 defining a transverse hinge bore 162 extending through a first lateral side and a second lateral side of the head (Figure 5),
a tibial axial post 146 extending away from the head, and
a body member 148 disposed between the head and the tibial axial post, the body member separating the head from the tibial axial post by an offset distance (Offset to the left and up in Figure 5);
a femur box (102 Figures 5-6) comprising:
a first arm and a second arm (left and right flanges 182/184) extending posteriorly from a main body portion 180,
the main body portion having a femoral fastening mechanism 190 configured to engage a transverse surface of a femur box cavity of a femoral component of a knee joint endoprosthesis (Figures 12-13),
wherein the first arm and the second arm respectively define axially aligned first and second arm bores (188 Figure 6),
wherein the first arm is adjacently disposed to the first lateral side and the second arm is adjacently disposed to the second lateral side such that the first arm bore and the second arm bore axially align with the transverse hinge bore (aligned along axis 176 in Figure 5 and shown assembled in Figures 12-13);
a transverse hinge pin 164 extending through the transverse hinge bore and into the first arm bore and the second arm bore (aligned along axis 176 in Figure 5 and shown assembled in Figures 12-13).
9. Reeder discloses the rotating hinge subassembly is preassembled (this amounts to the applicant’s intended use or method of making their invention, It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed or assembled does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the assembly of Reeder is fully capable of being assembled during use or prior to implantation. Furthermore the claim fails to identify what it is preassembled relative to. For example is it preassembled prior to implantation, to the surgery, or to closing up the patient? Therefore the assembly is inherently preassembled at least before the surgery concludes).
10. Reeder discloses the first arm and the second arm are flushly disposed against the lateral sides of the head (Figures 5-7 disclose the arms disclosed relative to the head and bearings in the same manner as the applicant’s invention, therefore Reeder reads upon this limitation as much as the applicant’s own invention).
11. Reeder discloses the transverse hinge pin 164 does not extend beyond the first and second arms of the femur box (this is best shown in Figure 18).
12. Reeder discloses a bearing 170 disposed between a first lateral side of the head and the first arm (Figure 5).
13. Reeder discloses the femur box is made from a material from a group of materials consisting essentially of: a cobalt chrome molybdenum alloy, a titanium allow, a zirconia toughened alumina ceramic, a ceramic material, an ultrahigh molecular weight polyethylene, a polyether ether ketone, combinations thereof, and other biocompatible clinically proven articulating materials (every implanted knee system component inherently includes clinically proven articulating materials, additionally Reeder discloses forming the implant from cobalt chromium and UHMWPE [0037], [0039], [0052], [0053], [0064]).
14. Reeder discloses the femoral fastening mechanism is selected from the group consisting essentially of: a femur box securing bore configured to receive a femur fastener (190 Figure 6).
15. Reeder discloses a rotating hinge subassembly (Figure 1) comprising:
a tibial yoke (22 Figure 5) comprising:
a body member 148 having a head 142 disposed at a first end (left side Figure 5), and
a tibial axial post 146 extending from a second end of the body member (right side Figure 5), the second end being distally disposed from the first end (Figure 5),
the head defining a transverse hinge bore 162 extending through a first lateral side and a second lateral side of the head (Figure 5),
the transverse hinge bore defining a transverse axis 176 extending transversely through the transverse hinge bore,
the tibial axial post defining a midline axis 140 extending longitudinally through the tibial axial post,
wherein a reference axis extends orthogonally through the transverse axis and parallelly to the midline axis (Figure 5), and
wherein an offset distance separates the midline axis from the reference axis (Figure 5);
a femur box (132 Figure 6) comprising:
a first arm and a second arm (flanges 182/184) extending posteriorly from a main body portion 102 (Figure 6),
the second arm opposing the first arm (Figure 6),
the main body portion defining a femoral fastening mechanism 190 configured to engage a transverse surface of a femur box cavity of a femoral component of a knee joint endoprosthesis (Figures 12-13),
wherein the first arm defines a first bore 188,
wherein the second arm defines a second bore 188,
wherein the first bore axially aligns with the second bore (Figure 6),
wherein the first arm is adjacently disposed to the first lateral side and the second arm is adjacently disposed to the second lateral side such that the first bore and the second bore axially align with the transverse hinge bore (aligned along axis 176 in Figure 5 and shown assembled in Figures 12-13); and
a transverse hinge pin 164 extending through the transverse hinge bore and into the first bore and the second bore to thereby hingedly engage the femur box to the head of the yoke (aligned along axis 176 in Figure 5 and shown assembled in Figures 12-13).
Conclusion
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
/Christopher D. Prone/Primary Examiner, Art Unit 3774