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 .
Drawings
The drawings were received on 5/14/26. These drawings are unacceptable for containing new matter. The addition of a structural feature (filler material) in Fig. 26B and 27 which was not shown, disclosed or suggested in the original disclosure as being present in the implant of Fig. 26B and 27 is new matter. The replacement drawings filed 5/14/26 will not be entered.
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 specification does not disclose a deployment element disposed within the hollow rod and comprising at least one elongate prong and enclosing a filler material (subject matter of claims 26-32).
Specification paragraph [0028] references Fig. “20h”. There is no such figure. Correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 requires a hollow rod configured for insertion into a greater trochanter into a femoral head and deployment element insertable therein, the deployment element simultaneously pushed and expending through opening(s) in the hollow rod into the bone which the hollow rod is pulled towards the greater trochanter. This configuration of deployment element is shown in the drawings at Figures 26A through 28B and described in the originally filed specification [page 19, lines 4+] as hollow rod (262), deployment element (110’) with drawing device (268). The deployment element 110’ shown in Fig. 26 and 28 is depicted as a solid structure (see below). The deployment element having this configuration is not disclosed as being used with or encasing a bone filler. Further, there is no disclosure to suggest that filler material could be incorporated in the embodiment shown in Fig. 26A-B and 28A-B. With regards to the embodiment shown in Fig. 27, there is no description of a cannulated drawing device usable with the deployment element of Fig. 27 nor is there any description of the use of filler material in this embodiment. Therefore, the subject matter of claim 5-11 in combination with independent claim 1 was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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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.
Claim 12 is 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 12 recites that the hollow rod has “at least one opening at a second end” (line 4) and then recites that the hollow rod has “ at least one discrete opening at its second end” (line 8-9). It is unclear if this is referring to the same opening or different openings a new terms with antecedent basis are used. Based on the disclosure, it appears that the claim should be referring to the same opening and therefore will be interpreted as referring to the same opening in the second end of the hollow rod.
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) 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bramlet et al. (US Publication No. 2004/0193162 A1).
Regarding Claim 12, Bramlet discloses a device for repairing a femoral fracture (shown in Fig. 3), comprising.
a hollow rod (19+13), Fig. 6) insertable into a bore of the greater trochanter, the bore extending from a flair of the greater trochanter into a femoral head, (Fig. 3), the hollow rod (19+13) having a first end positioned at a flair of the greater trochanter (shown below, see placement in Fig. 3), and at least one opening (29) [0028] (fig. 5) at an opposite second end (shown below)) placeable within the femoral head (in Fig. 3);
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a deployment element (14) insertable within the hollow rod; and
a drawing device (inherently present as element which translates tang 14 [0028] or drawing device can be considered element 7 shown in Fig. 8) operatively coupled to the hollow rod (19+13) and the deployment element (14) (in Fig. 11), wherein the hollow rod (19+13) comprises a threaded hollow rod (threads 11) having at least one discrete opening (29) at its second end;
wherein the deployment element (14) comprises at least one elongate prong (9) (Fig. 6) configured to expand radially through the at least one discrete opening (29) into cancellous bone of the femoral head when the deployment element is pushed toward the second end [0028]; and
wherein the prong (9) is shaped and dimensioned to engage cancellous bone by deflecting against cam or deflection surfaces (shown above) located at the second end of the threaded hollow rod [0028].
Regarding Claim 13, Bramlet discloses a device for repairing a femoral fracture (shown in Fig. 3), comprising.
a hollow rod (19+13), Fig. 6) insertable into a bore of the greater trochanter,
the bore extending from a flair of the greater trochanter into a femoral head (fig. 3), the hollow rod having a first end placeable at the flair of the greater trochanter and at least one opening at a second end opposite the first end and placeable within the femoral head (shown in figure above);
a deployment element (14) insertable within the hollow rod;
a drawing device (inherently present as element which translates tang 14 [0028] or drawing device can be considered element 7 shown in Fig. 8) operatively coupled to the hollow rod and the deployment element; and a bone plate (3, Fig. 7) configured to be positioned at the flair of the greater trochanter (Fig. 3), the bone plate comprising one or more openings (22) for receiving at least one fixation element (5) fully capable of securing the bone plate to the greater trochanter and stabilizing the hollow rod during deployment and post-operative fixation.
Allowable Subject Matter
Claims 1-4 are allowed.
The following is an examiner’s statement of reasons for allowance: Prior art could not be found which teach or suggest a drawing device as recited in claim 1, in particular a drawing device which is operatively coupled to the hollow rod and the deployment element and being configured to simultaneously:
push the deployment element toward the second end of the hollow rod such that the deployment element expands through the at least one opening into cancellous bone of the femoral head, and
pull the hollow rod proximally toward the greater trochanter as the deployment element is pushed, thereby generating axial compression between the femoral head and the greater trochanter.
Prior art such as Nijenbanning (US Publication No. 2008/0262497 A1) teach a drawing element 57 which can push the deployment element 55 toward the distal end of the hollow rod but there are no counter-forces that the deployment element 55 imposes that would be able to pull the hollow rod proximally toward the greater trochanter as the deployment element is pushed, thereby generating axial compression between the femoral head and the greater trochanter.
Singh et al. (US Publication No. 2020/0323571 A1) indicates in [0085] that the screw 511 (drawing element) in fig 9b both expands the fingers and pulls back the end to compress fracture but these actions happen subsequently, not simultaneously as required by the claim.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s amendment has obviated the provisional double patenting rejection. The examiner has withdrawn this rejection.
Applicant’s arguments with respect to the introduction of new matter is not persuasive. Applicant argues that the specification as originally filed already describes delivery of material into bone cavities and use of filler materials and therefore one of ordinary skill in the art would understand that filler materials may be used with a variety of structures and that delivery of filler material through the implant is a conventional design feature. The examiner disagrees. The test of whether or not one of ordinary skill in the art would understand that features can be combined is not sufficient to prove that at the time of filing the inventor had possession of the claimed invention. The deployment elements shown in the figures 26 and 28 are what is described in the independent claim. This structure is solid, not cannulated. There is no written specification to link this deployment element structure with a structure that can also enclose filler material. There is no statement in the specification that filler material can be used with the embodiment shown in Fig. 26-28, nor is there any statement in the specification that would suggest structure shown in Fig. 26 and 28 can be modified to receive filler material. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention and the specification fails to satisfy this requirement. Applicant has not provided any specific examples of language or showings of sufficient detail and has argued that a person of ordinary skill would understand these features exist. That is not sufficient to show the specific combination of features was envisioned by the inventor.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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, 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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
