DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application has claims filed with subject matter only disclosed on or after March 16, 2013 and therefore is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
Applicant’s amendments to the specification, abstract and claims in the preliminary amendment filed on 6/12/2023 is acknowledged.
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. 16921954 does not disclose a device with a hollow rod, deployment element and drawing device as required in independent claim 22.These limitations are only disclosed in the new drawing figures 26-28 filed in the current application. Accordingly, the effective filing date of claims 22-32 is 06/12/2023.
Double Patenting
Claims 22-32 of this application are patentably indistinct from claims 1-11 of Application No. 18/208,417. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 22-32 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-11 of copending Application No. 18/208,417 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 deployment element (part of device as described in claim 22) which encloses a filler material (claims 23-30) 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.
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 the subject matter found in claims 26-32 (in combination with independent claim 22 limitations).
It appears that the claims conflate mutually exclusive species disclosed in the specification which are not disclosed as being used together (balloon-type components and filler materials are not described as being used with the embodiments shown in Fig. 26-28).
Claim Objections
Claims 22-32 are objected to because of the following informalities:
Claim 22, line 1, “Device for…” should be “A device for…”
Claims 23-32, line 1, “Device for…” should be “The device for…”
Claim 23, remove the comma after “drawing device” in line 1.
Appropriate correction is required.
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 23, 24, 25, 30, and 32 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.
Regarding claims 23, 24, 25, 30, and 32, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the limitations following “preferably” in claims 23, 24, 25, 30, and 32 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) 22-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nijenbanning (US Publication No. 2008/0262497 A1).
Regarding Claim 22, Nijenbanning discloses a device (7+6, Fig. 1) for repairing a femoral fracture [0029, Fig. 1], including
- a hollow rod (element 50 of pin 7 which is shown in detail in Fig. 4) insertable into a bore of the greater trochanter (shown inserted in Fig. 1), which greater trochanter bore extends from a flair of a greater trochanter into femoral head, the hollow rod featuring a first end placeable at a flair of the greater trochanter, and at least one opening (52, 53, Fig. 4, [0042]) at a second end, the second end being an end opposite to the first end of the hollow rod, the second end placeable within the femoral head (see figure below),
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- a deployment element (55) insertable in the hollow rod (50) (fig. 4-9) [0043], and
- a drawing device (57) for pushing the deployment element towards the second end and pulling the hollow rod towards the drawing device at the same time (due to threaded connection acting on the inner surface of the outer tube 50 while pushing towards the second end the inner tube element 55) [0044], whereby the deployment element is adapted to expand into the cancellous region of the femoral head through the at least one opening of the hollow rod, when pressed toward the second end of the hollow rod (fig. 9, shown in Fig. 1).
Regarding Claim 23, the drawing device (57) having a drawing thread and the hollow rod (50) having a threaded part (51) at its first end, so that the drawing thread and the threaded part are adapted to interact with each other, the drawing device is a screw (Fig. 4-9) [0042-0044].
Regarding Claim 24, including a bone plate (6), adapted to be fixed to the flair of the greater trochanter (fig. 1), the bone plate placeable at the flair of the greater trochanter for stabilizing the device when fixed to the greater trochanter (Fig. 1).
Regarding Claim 25, the bone plate (6) is fixable to the greater trochanter by at least one fastening element (5), the fastening element being a bone screw (Fig. 1) [0037].
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) 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nijenbanning (US Publication No. 2008/0262497 A1) in view of Bramlet et al. (US Publication No. 2004/0193162 A1).
Nijenbanning discloses the deployment element (55) as described in the rejection of claim 22 above. The deployment element (55) is a hollow tube with openings on the end when the strips 52’, 53’ are expanded [0016, 0046]. However, Nijenbanning is silent to the element 55 enclosing a filler material.
Bramlet discloses a femoral fracture device in the same field of endeavor which injects ortho-biologic material [0031] through the fixation device in order to aid in recovery [0011]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to inject through the cannulated device of Nijenbanning an ortho-biologic material as taught by Bramlet in order to aid in recovery. The material contained within the inner cannula of the deployment element would be considered to be enclosed in the deployment element.
Regarding Claim 27, Bramlet discloses the filler material is bone cement [0031, Bramlet].
Regarding Claim 28, Bramlet discloses the filler material comprises a gelatinous material [0031, Bramlet].
Regarding Claim 29, Bramlet discloses the filler material comprises a material selected from one of the group consisting of glue; adhesive; foam [0031, Bramlet].
Regarding Claim 30, Bramlet discloses the filler material comprises a bone growth chemical regulator [0031, Bramlet].
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nijenbanning (US Publication No. 2008/0262497 A1) in view of Babic et al. (US Publication No. 2018/0280065 A1).
Nijenbanning discloses the deployment element (55) as described in the rejection of claim 22 above. The deployment element (55) is a hollow tube with openings on the end when the strips 52’, 53’ are expanded [0016, 0046]. However, Nijenbanning is silent to the element 55 being at least partially formed from a material that increases its rigidity upon the application of a certain wavelength of light or heat.
Babic discloses a device in the analogous art of orthopedic/hip devices [0002-0003] which injects biocompatible cement through the fixation device and into the surrounding tissue in order to improve the fixation of the implant [0107]. Babic discloses the cement is a UV curable resin [0107] or cured with heat [0107]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to inject through the cannulated device of Nijenbanning a curable cement material (either UV curable or heat curable) as taught by Babic in order to aid in fixation of the implant. The cement material contained within the inner cannula of the deployment element would be considered to be enclosed in the deployment element.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773