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 63/323234, filed 03/24/2022.
Status of Claims
Claims 10-19 are pending.
Claims 14, 15, 18, and 19 have been withdrawn from consideration.
Claims 1-9 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of Invention II (Apparatus) and Species 1 (Figures 1-4) in the reply filed on 07/15/2026 is acknowledged.
Upon further review claims 14, 15, 18, and 19 have been withdrawn as being directed at non-elected species. The elected embodiment is not shown (Figures 1-4) or described in the specification as having a set screw within a bore in the body. The specification [0053]-[0054] specifically describes non-elected figure 12 as comprising the set screw components, which are not part of the elected embodiment. Therefore these claims have been withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/23/2024 has been considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
Claim Objections
Claim 12 is objected to because it is inconsistent with claim 10. Claim 10 introduces a single proximal aperture and claim 12 defines at least one aperture. Claim 12 does not positively refer back to the same apertures and defines a different amount. The applicant is advised to amend claim 12 to recite wherein the proximal aperture in line 1.
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.
Claims 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because it is directed at or encompassing a human organism.
In line 8 claim 16 requires fixture being disposed in a bore extending through a calcaneus bone
This recitation is considered to be positively reciting part of the human body. The applicant is advised to amend this limitation to recite that the … is “capable of” or “configured to” mate with …
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 16-17 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 16 is rendered indefinite for antecedent basis issues. Claim 16 recites “the terminal end” line 10 but this component has not been identified. The applicant is advised to amend the claim to say a terminal end.
Claim 16 is rendered indefinite because it is unclear how the fixture can engage the proximal end of the nail when it is fully engaged with the distal end as shown in Figure 2. The applicant is advised to amend claim 16 to change proximal end to distal end.
Claim 17 is rendered indefinite because a person of ordinary skill in the art would not be able to determine the scope of the affecting limitation. What is meant by the bore not affecting more than 5% of a surface area? Is this referring to the original surface area of the joint? What would and would not constitute an affect? Does it have to change the surface area to affect it? Does the boring itself affect it? Or does it affect it after by things like weakening or allowing flow to? Does this mean the area of the bore is less than 5% of the surface area? The applicant is advised to amend the claim to define the surface area of the bore in comparison to the remaining surface area of a surface. The applicant is reminded to keep all recitations within that which is supported by the original disclosure.
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) 10-13 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janna et al (Janna) US 2006/0200141 A1.
It is noted that the specific implant location and non-positively claimed components are considered intended use and components related to the intended use. The claims are directed at the nail itself and a system including it. Therefore the placement steps and specific location are considered intended use limitations and given limited weight.
10. Janna discloses an intramedullary nail 112 for tibiotalar arthrodesis (Figures 2 and 3A), comprising:
a proximal end portion (tapered tip at top of Figure 3) of the intramedullary nail adapted for insertion into an intramedullary space of a tibia bone of a patient (Figure 2);
a distal end portion (flat tubular tip at bottom of Figure 3) of the intramedullary nail adapted to extend across a tibiotalar joint such that a terminal end of the distal end portion is disposed in a talus bone proximal to a subtalar joint for isolated positioning of the intramedullary nail across the tibiotalar joint (Figure 2 shows it within the Calcaneus but it is fully capable of being inserted higher within the claimed implant site);
a body extending between the proximal end portion and the distal end portion (shaft between the ends in Figure 3);
a proximal aperture (elongated opening 137 at top of Figure 3) extending through the body for receipt of a tibia locking fastener (it is capable of receiving any appropriately sized fastener or locking fastener); and
a distal aperture (any of the three openings 122/130/132 at bottom of Figure 3) extending through the body for receipt of a talus locking fastener (it is capable of receiving any appropriately sized fastener or locking fastener).
11. Janna discloses the distal end portion comprises a fixture interface (open and slotted end at the bottom of Figure 3) adapted to engage a fixture that extends through a bore defined through a calcaneus bone and the subtalar joint for placement of the intramedullary nail through the talus bone, and the tibiotalar joint (it is capable of engaging any appropriately sized fixture or device).
12. Janna discloses the at least one proximal aperture is adapted to receive the tibia locking fastener laterally with respect to the tibia bone to extend through the proximal aperture of the intramedullary nail for bicortical fixation at the proximal end portion of the intramedullary nail (the nail of Janna can be rotated or angled to any orientation allowing the opening 137 to receive a fastener in any orientation including laterally).
13. Janna discloses the distal aperture is adapted to receive one talus locking fastener anteriorly with respect to the talus bone to extend through the distal aperture of the intramedullary nail for unicortical fixation at a distal portion of the intramedullary nail (the nail of Janna can be rotated or angled to any orientation allowing the openings 122/130/132 to receive a fastener in any orientation including anteriorly).
16. Janna discloses a system for tibiotalar arthrodesis (Figure 3A), comprising:
an intramedullary nail 112 comprising a body (middle section of 112 Figure 3) extending between a proximal end portion (top section of 112 Figure 3) adapted for insertion in an intramedullary space of a tibia bone of a patient (Figure 3A) and a distal end portion (bottom section of 112 Figure 3) adapted to extend across a tibiotalar joint such that a terminal end of the distal end portion is disposed in a talus bone proximal to a subtalar joint for isolated positioning of the intramedullary nail across the tibiotalar joint (Figure 2 shows it within the Calcaneus but it is fully capable of being inserted higher within the claimed implant site);
a fixture (119 and complementary instruments [0029]) adapted for engagement with the proximal end portion of the intramedullary nail (as explained above in the 112 rejection the applicant’s own fixture is a tool that engages the distal end not the proximal end, therefore Janna’s instruments reads upon the limitation as much as the applicant’s own invention), the fixture being disposed in a bore extending through a calcaneus bone through which the intramedullary nail is inserted to dispose the fixture across the subtalar joint when the intramedullary nail is positioned across the tibiotalar joint to dispose the terminal end in the talus bone proximal to the subtalar joint;
a tibia locking fastener [0054] advanceable laterally with respect to the tibia bone to dispose the tibia locking fastener through a proximal aperture 137 extending through the body (since the nail is capable of twisting and being angled the fastener can be advanced in any direction including laterally); and
a talus locking fastener (any of the three fasteners 150) advanceable anteriorly with respect to the talus bone to dispose the talus locking fastener through a distal aperture 122/130/132 extending through the body (since the nail is capable of twisting and being angled the fastener can be advanced in any direction including anteriorly).
17. Janna discloses the bore affects not more than about 5% of a surface area of the articular surface of the subtalar joint (as explained in the 112 rejection above, the scope of this recitation is indefinite, furthermore the bore is theoretical and not part of the kit. The theoretical bore would have to account for how much of the actual articular surface remains. Was it deteriorated prior to being bored? Did the patient have an undersized or diseased subtalar joint? Where does the area of the articular surface start and stop? Does it include the entire articular surface? How does a bore affect a surrounding surface? If the bore is properly drilled and no surrounding cracks or chips were applied to the surrounding surface, isn’t it not having any affect on the surface regardless of the shapes and sizes? With all this in mind a person of ordinary skill in the art could inherently find a bore that affects less than 5% of a surface area of the subtalar joints articular surface).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights