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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16921954, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 16921954 does not disclose a device with a hollow rod and deployment element disclosed within the hollow rod and comprising at least one elongate prong movable from a constrained configuration to a radially outwardly expanded configuration upon engagement of an internal deflection surface as required by claim 22. Accordingly, the effective filing date of claims 22-33 is 6/12/23.
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 [0057] in the published version of the application (US PUB 2023/0380979 A1) references Fig. “20h”. There is no such figure. Correction is required.
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 22-33 are 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 22, lines 4 and 5 recite “the hollow rod including a first end positioned at a flair of the greater trochanter, and a second end positioned within the femoral head” thereby positively requiring human anatomy. Examiner suggests amending with “configured to be positioned” to overcome this rejection.
Claims 23-33 are rejected under 101 as being dependent from claim 22 and containing all the limitations of claim 22.
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 26-33 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 22 requires a hollow rod configured for insertion into a greater trochanter into a femoral head and deployment element disposed therein with at least one elongate prong movable from a constrained configuration to a radially outward expanded configuration. This configuration of deployment element is shown in the drawings at Figures 26A, 26B, and 28A-B and described in the originally filed specification [clean copy page 16, lines 15+] as hollow rod (262), deployment element (110’) with prong (234). The deployment element 110’ shown in Fig. 26A-B and 28A-B is depicted as a solid structure (see below). The deployment element with prongs shown in 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. Therefore, the subject matter of claim 26-33 in combination with independent claim 22 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 23 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 23, line 2 and 4 recites “the drawing device” there is no antecedent basis for this limitation in the claims. For examination purposes, the drawing device will be interpreted as “a drawing device”.
Claim 23, line 4, recites “preferably being a screw”. It is unclear from the use of “preferably” whether or not a screw is required. For examination purposes, a screw will not be required by the claim.
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) 22-29 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 22, Bramlet discloses a device for repairing a femoral fracture (shown in Fig. 3), comprising.
a hollow rod (19+13), Fig. 6) configured for insertion into a bore extending from a greater trochanter into a femoral head (Fig. 3), the hollow rod (19+13) including
a first end positioned at a flair of the greater trochanter (shown below and in Fig. 3), and
a second end (shown below)) positioned within the femoral head (in Fig. 3) and including at least one lateral opening (29) [0028] (fig. 5) and at least one internal deflection surface (shown below);
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a deployment element (14+6) disposed within the hollow rod and comprising at least one elongate prong (9) (Fig. 6) movable from a constrained configuration (“non-deployed position”) within the hollow rod to a radially outwardly expanded configuration (“deployed position”) [0028]; and
an actuation member (inherently present as element which translates tang 14 [0028] or actuation member can be considered element 7 shown in Fig. 8) operatively coupled to the deployment element (14) (in Fig. 11), wherein advancement of the deployment element (14) toward the second end causes the at least one prong to engage the internal deflection surface and thereby be redirected outward through the lateral opening into cancellous bone of the femoral head to form a mechanical anchoring interface with the cancellous bone [0028].
Regarding Claim 23 (as best understood), comprising a drawing device (4) having a drawing thread and the hollow rod (19+13) having a threaded part (16) at its first end (bottom end in fig 6), so that the drawing thread and the threaded part are adapted to interact with each other [0029].
Regarding Claim 24, Bramlet discloses a bone plate (3) adapted to be fixed to the flair of the greater trochanter (shown in Fig. 3), the bone plate placeable at the flair of the greater trochanter for stabilizing the device when fixed to the greater trochanter (Fig. 3).
Regarding Claim 24, Bramlet discloses the bone plate (3) is fixable to the greater trochanter by at least one fastening element (5) , the fastening element being a bone screw, a nail or an anchor (5 is a cortical screw, [0029] Fig. 3).
Regarding Claim 26, the deployment element (14+6) encloses a filler material (element 6 of deployment element encloses ortho-biological material, [0031]).
Regarding Claim 27, the filler material is bone cement ( ‘bone cements, such as PMMA, [0031]).
Regarding Claim 28, the filler material comprises a gelatinous material (“BMP, bone morphogenic proteins, DBM, demineralized bone matrix, BOTOX and other viral vectors, any bone marrow aspirate, platelet rich plasma”, [0031]).
Regarding Claim 29, the filler material comprises a material selected from one of the group consisting of glue; adhesive; foam (“other adhesives”, [0031]).
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) 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bramlet et al. (US Publication No. 2004/0193162 A1) in view of Brumfield et al. (US Publication No. 2010/0249852 A1)..
Regarding Claim 30, Bramlet discloses the filler material comprises a treating agent may include hormonal, antibiotic, anti-cancer, or growth factor substances, among others [0031] but is silent to specifically a bone growth chemical regulator selected from one of the group of hyaluronic acid and glycosaminoglycan.
Brumfield discloses a femoral fracture fixation device in the same field of endeavor which uses a bone cement (deployable material 82) to provide rigid fixation [0064]. Brumfield discloses that the suitable materials for the deployable material include hyaluronic acid [0065], photopolymerizable materials [0065] and polymers that harden in situ [0065], specifically describing that the deployable material's solidification may be catalyzed by increased temperature or humidity within the bone cavity [0067].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the filler material of Bramlet to include hyaluronic acid or photopolymerizable or polymer that harden in situ (with the body temperature being the catalyst) as taught by Brumfield since these material is shown as suitable for use in a femoral cement material.
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
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