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 .
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.
the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention positively claims the human body:
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 1-15 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).
In regards to claim 3, the claim limitation(s) “…wherein each of said first and said second guide components is designed to uniquely mate an anatomical site of prosthesis implantation… ensuring a proper orientation of the seat having the triangular cross-section inside the bone…” positively recites the human body and is considered non-statutory subject matter. It is suggested to use language such as “adapted for,” “configured to,” etc.
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 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 the limitation "the prosthetic element." There is insufficient antecedent basis for this limitation in the claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-13 & 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Poggie et al. (US 2014/0012390).
Poggie et al. discloses:
1.
A kit for installing prosthetic components and/or biomedical implants, said kit comprising: a prosthetic component comprising, made as one piece, an intraosseous taproot fixation of said prosthetic component to a bone of a patient, said prosthetic component and said intraosseous taproot being made of a biocompatible metal material,
E.G. via the disclosed support structure for a shell component having pilings/pins 22-22b made of solid metal, which provide greater retention in the bone {[0033]-[0034] & (Figs 2-4)}.
Note: The examiner is interpreting the disclosed pilings/pins as being the prosthetic component comprising an intraosseous taproot fixation.
wherein said intraosseous taproot of said prosthetic component comprises a solid central body comprising an axial through-hole and, externally to said central body, a trabecular portion solidly connected to, or made of a one piece with, said central body,
E.G. via the disclosed pin 22 having cylindrical shape with a ‘diameter’ with a solid metal core 25 and a porous tissue ingrowth surface 27 formed around the outer surface of the pin 22 {[0033] & (Fig 3)}.
Note: The examiner is interpreting the disclosed tissue ingrowth surface 27 that fits around the external surface of the pin as being the claimed trabecular portion.
and wherein the kit has, viewed in a horizontal cross-section, at least one seat having a triangular cross-section;
E.G. via the disclosed cross-sectional view of the leading end 54 of the pin 22c as illustrated in Figure 8, which is described as having a ‘cone-shaped’ part-spherical leading end shown as being triangular {[0044] & (Fig 10)}.
and a first guide component for guide wire to guide an insertion of a guide wire (K) into the bone, and a second guide component for an impactor having a triangular cross-section.
E.G. via the disclosed drill guide 32 having a tubular guide member 36 which utilized with the windowed trial 30 via being ‘aligned’ with the locations marked in the template for receiving the pilings/pins 22-22n {[0037] & (Figs 5 & 6)}.
Note: The examiner is interpreting the disclosed windowed trial 30 having the triangular-shaped windows 31 as being the impactor having a triangular cross-section.
2.
The kit as claimed in claim 1, wherein each of said first and said second guide components is made in a patient-tailored manner, by processing images from a Computed Tomography scan of an anatomy of the patient.
E.G. via the ‘design’ being made during a computer-aided tomography (CAT) scan [0037].
3.
The kit as claimed in claim 1, wherein each of said first and said second guide components is designed to uniquely mate an anatomical site of prosthesis implantation, thereby ensuring a proper positioning of guide elements, and hence of the guide wire and the triangular cross-section impactor having the triangular cross-section, thereby ensuring a proper orientation of the seat having the triangular cross-section inside the bone and a proper positioning of the intraosseous taproot.
E.G. {[0037]-[0039] & (Figs 5-7)}.
4.
The kit in that as claimed in claim 1, wherein said prosthetic component and said intraosseous taproot are made as one piece.
E.G. [0034]
5.
The kit as claimed in claim 4, wherein said prosthetic component and said intraosseous taproot are made as one piece using electron beam melting (EBM) technologies.
E.G. via the disclosed piling/pins being made from a ‘delective’ laser melting process [0034].
7.
The kit as claimed in claim 1, wherein said intraosseous taproot has the central body of triangular cross-section along at least a portion or over an entire length thereof, as viewed in a horizontal plane.
E.G. Figs 9C & 10.
8.
The kit as claimed in claim 1, wherein said intraosseous taproot of said prosthetic element component comprises end sections having a triangular cross-section as viewed in a horizontal plane.
E.G. via the disclosed cross-sectional view of the leading end 54 of the pin 22c as illustrated in Figure 8, which is described as having a ‘cone-shaped’ part-spherical leading end shown as being triangular {[0044] & (Fig 10)}.
9.
The kit as claimed in claim 1, wherein said intraosseous taproot comprises, at a front end thereof, an end element having a frustoconical profile as viewed in a vertical plane.
E.G. via the disclosed piling designs, which is includes a conical surface 205 {[0045] & (Figs 11-11c)}.
10.
The kit as claimed in claim 1, wherein said intraosseous taproot has an end element with a width (D), in a vertical longitudinal plane, that is equal to an overall footprint of the intraosseous taproot in the same plane.
{[0045] & (Figs 11-11c)}.
11.
The kit as claimed in claim 1, wherein said intraosseous taproot comprises, at a rear end (lib) of said intraosseous taproot designed for connection to the prosthetic component to be associated with the bone, a base element having a width (D) in a vertical longitudinal plane that is equal to an overall footprint of the intraosseous taproot in the same plane.
{[0045] & (Figs 11-11c)}.
12.
The kit as claimed in claim 1, wherein said intraosseous taproot is made in one piece with the prosthetic element.
E.G. ([0033]-[0034]).
13.
The kit as claimed in claim 7, wherein said intraosseous taproot extends around said central body having the triangular cross section but remains within a shape defined by end elements of the intraosseous taproot.
{[0033]-[0034], [0045] & (Figs 11-11c)}.
15.
The kit as claimed in claim 1, wherein said trabecular portion of said intraosseous taproot is formed by EBM in one piece with the central body.
E.G. ([0033]-[0034]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poggie et al. (US 2014/0012390) in view of one having ordinary skill in the art.
Poggie et al. discloses the claimed invention having a piling/pin having multiple, triangular designs, such as shape of a cone [0043] except wherein said shape has the triangular cross-section along its entire length, as viewed in a horizontal plane. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize a pins/pilings with a shape having a triangular cross section along its entire length since it has been held to be within the general skill of a worker in the art to select a known shape on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Poggie et al. (US 2014/0012390) in view of one having ordinary skill in the art.
Poggie et al. discloses the claimed invention having pins/pilings 22 defined by trabecular portion having a diameter D and a length L except wherein said diameter is specifically defined as the range from 400 to 800 microns. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the diameters as having a range from 400 to 800 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796