Did 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.
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.
Claim 5 is 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). The claim as written says the fixture member is passing through the hole and into bone tissue. The plain meaning of that phrase at least suggests that the bone tissue is required by the claim. It is suggested to add that “the fixture member is configured to pass through the bore and into bone tissue” to overcome the 101 rejection.
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) 1-3 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dacosta et al. U.S. Publication 2014/0257509 A1.
Regarding Claim 1, Dacosta et al. discloses for mid-foot arthrodesis (paragraphs [0049], [0058]), comprising a dowel 80 having a longitudinal taper from a proximal surface to a distal surface thereof (as seen in Figure 7E, paragraphs [0007], [0009], [0055-0056]), wherein the dowel has a non-circular transverse cross-sectional profile (as seen in Figure 7E and paragraph [0055]).
Regarding Claim 2, Dacosta et al. discloses wherein the dowel is comprised of an osteophilic material (paragraphs [0056] and [0061], wherein applicant discloses PEEK, titanium as suitable osteophilic and porous material, see paragraph [00155] in applicant’s specification).
Regarding Claim 3, Dacosta et al. discloses wherein the dowel is comprised of a porous material (paragraphs [0056] and [0061], wherein applicant discloses PEEK, titanium as suitable osteophilic and porous material, see paragraph [00155] in applicant’s specification).
Regarding Claim 12, Dacosta et al. discloses wherein the osteophilic material further is a biocompatible material selected from the group of titanium or polyether ether ketone (paragraphs [0056] and [0061]).
Claim(s) 1, 6-7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vistosky et al. U.S. Publication 2002/0038123 A1.
Regarding Claim 1, Vistosky et al. discloses for mid-foot arthrodesis (abstract and paragraph [0007] as seen in Figure 1, 2A, 4A), comprising a dowel 10 having a longitudinal taper from a proximal surface to a distal surface thereof (as seen in Figures 1-4E, paragraphs [0007], [0009]), wherein the dowel has a non-circular transverse cross-sectional profile (as seen in Figures 1, 2A, 4A).
Regarding Claim 6, Vistosky et al. discloses wherein the dowel further comprises an opening 32 passing through the proximal surface 30 thereof, the opening 32 configured to removably receive an insertion instrument (as seen in Figure 1, paragraphs [0024], [0026], [0029]).
Regarding Claim 7, Vistosky et al. discloses wherein the dowel further comprises a recess 31 in the proximal surface that extends diametrically across the proximal surface 30 of the dowel 10 (paragraphs [0026] and [0028]).
Regarding Claim 11, Vistosky et al. discloses wherein the non-circular transverse cross-sectional profile of dowel is elliptical along an entire or partial longitudinal axis of the dowel (see claim 1).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vistosky et al. U.S. Publication 2002/0038123 A1 in view of Gotfried U.S. Publication 2017/0189188 A1.
Regarding Claim 2, 3, 12, Vistosky et al. does not expressly disclose wherein the dowel is comprised of an osteophilic material, wherein the osteophilic material further is a biocompatible material selected from the group of titanium or polyether ether ketone. Gotfried teaches a device for a bone replacement in the same field of endeavor, the device having a longitudinal taper from the proximal surface to the distal surface (as seen in Figures 1-3B), the device is formed from an osteophilic material such as titanium or PEEK (paragraph [0099], wherein applicant discloses PEEK, titanium as suitable osteophilic and porous material, see paragraph [00155] in applicant’s specification). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vistosky’s device to further include titanium or PEEK as taught by Gotfried for the purpose of bone implant that exhibits strength and is biocompatible for implantation.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vistosky et al. U.S. Publication 2002/0038123 A1 in view of Boyce et al. U.S. Publication 2001/0020186 A1
Regarding Claim 4, 5, Vistosky et al. does not expressly disclose wherein the dowel further comprises a transverse bore passing through lateral wall surfaces of the dowel and further comprising a fixation member passing into and through the transverse bore and into bone tissue adjacent the dowel. Boyce et al. teaches a device for a bone replacement in the same field of endeavor, the device having a proximal surface and a distal surface (as seen in Figures 49-52), the device 270 comprising an opening 286 passing through the proximal surface and a transverse bore 274 passing through the lateral wall surface (see Figures 49 and 50 and paragraph [0110]) for the purpose of having an opening for receipt of an insertion tool (paragraph [0016], [0091] and [0097]) and a bore for receiving a plug or fixation member 276 that extends outward from the dowel to engage the tissue around the bone (paragraph [0110]) and facilitate bone growth (paragraph [0016] and [0110]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vistosky’s device to further include a device having an opening through the proximal surface and a transverse bore passing through the lateral surface of the device for receiving a fixation member as taught by Boyce et al. for the purpose of having multiple connection interfaces to engage an insertion tool and facilitate bone ingrowth and fixate the device around the tissue around the bone.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vistosky et al. U.S. Publication 2002/0038123 A1 in view of Hartdegen et al. U.S. Publication 2018/0353172 A1.
Regarding Claims 8, 9, 10, Vistosky et al. does not expressly disclose a compression plate engageable within the recess and configured to be affixed to a surface of bone tissue adjacent the dowel, wherein the compression plate further comprises a staple and wherein the compression plate further comprises tissue anchor openings at opposing ends of the compression plate configured to receive a tissue anchor in each of the tissue anchor openings. Hartdegen et al. teaches a device for a bone replacement, the device 1900 comprises dowel/spacer 1950 and a compression plate 4000 engageable within a recess on the spacer (as seen in Figures 9A-9B, 12 and further seen in Figures 51-54), the compression plate comprises a staple 200 and tissue anchors 2280 at opposing ends of the compression plate for the purpose of having one or more fasteners to relieve stress from the main body of the compression plate and allow the implant to be secured to the bone (paragraphs [0212-0214]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Vistosky’s device to further include a compression plate engageable with the recess of the dowel and having a staple and tissue anchors at opposite sides of the compression plate for the purpose of having one or more fasteners to relieve stress from the main body of the compression plate and allow the implant to be secured to the bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEEMA MATHEW/
Primary Examiner, Art Unit 3774