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
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 6 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.
Applicant has not provided any details regarding what “special pliers” are. One does not know what the special pliers are or what their parameters are that make them able to make the brackets adapt when the lid is implanted. One cannot determine what the bounds of the claim are. Furthermore, it is indefinite what makes the brackets guarantee a seal in the case of trauma.
Claim Rejections - 35 USC § 102
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.
Claims 1, 5-9 are rejected under 35 U.S.C. 102a1 as being anticipated by Khanna US 20110028972.
Regarding claim 1, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy comprising a lid and a plurality of brackets, said device being designed for the treatment of pathologies causing herniation of the brain with a consequent increase in intracranial pressure, of the type which provides for the creation of an opening in the cranial case, by milling along a craniotomy edge, able to allow the expansion of the brain and the application of said lid to a certain vertical distance from said craniotomy edge with functions of protection and containment of the brain, characterized in that said lid is connected to the craniotomy edge by said plurality of brackets (see figure 45) which are fixed simultaneously to the lid and to the craniotomy edge, said brackets comprising: - a central body (7/8), having the function of spacer between the craniotomy edge and the lid; and - two shelves (1 and 2) which fix said brackets in the anchorage point on the skull and prevent the lid from sinking [0014-0015].
Regarding claim 5, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy according claim 1 characterized in that said lid is the same bone operculum taken by means of a craniotomy [0001] – as customary in this procedure.
Regarding claim 6, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy according to claim 1 characterized in that said brackets are strong enough to guarantee a seal even in the event of trauma to the head and sufficiently malleable with special pliers so that it can adapt when the lid is implanted. See 112 above, the device of Khanna prevents unwanted movement see [0014-0015] which reads on the claim.
Regarding claim 7, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy according claim 6 characterized in that said brackets are made of titanium [0141].
Regarding claim 8, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy according to claim 6, characterized in that said brackets are made of thermoplastic material [0141].
Regarding claim 9, Khanna teaches a Cranial fixation device for decompressive / augmentative craniectomy according to claim 8, characterized in that said thermoplastic material is polyether ether ketone (PEEK) or a composite comprising carbon fibres impregnated with PEEK [0041].
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.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Khanna US 20110028972 as applied to claim 1 above, and further in view of Kirkpatrick DE 102015107646.
Regarding claims 2 and 4, Khanna teaches if possible the original bone flap is preserved [0008], however if not possible a prosthetic plate is used. Khanna does not disclose the materials used for prosthetic plates.
Kirkpatrick teaches the use of skull prostheses made of “polyamide (PA) polyetheretherketone (PEEK), polyetherketone ketone (PEKK), thermoplastic polyurethane (TPU) processed thermoplastic polyurethanes (ETPU)” and teaches the use of a 3D printer.
It 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 to use a synthetic bone flap as taught by Kirkpatrick in the event the original bone flap is unusable to ensure the skull is protected.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Khanna US 20110028972 and Kirkpatrick DE 102015107646 as applied to claim 2 above, and further in view of Christopher US 20200197180.
Regarding claim 3, the combination of Khanna and Kirkpatrick teaches a Cranial fixation device for decompressive / augmentative craniectomy according to claim 2, however fails to teach the material is characterized in that said synthetic material is polymethylmethacrylate (PMMA).
Christopher teaches that PMMA is a known cranial implant material [0010].
It 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 to use PMMA as the synthetic material as Christopher teaches it is a known cranial implant material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY REGINA WEISBERG whose telephone number is (571)270-5500. The examiner can normally be reached M-F 8:15-4:15.
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/AMY R WEISBERG/Supervisory Patent Examiner, Art Unit 3612
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