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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: This is believed to be an extensive listing of all the reference characters that are present in the drawings and absent in the specification but my not be a complete listing. Applicant is requested to double check that there are no other additional reference characters present in the drawings but absent from the specification.
111, figure 6
131, 132, 136, figure 8
174, figure 12A
175, figure 12B
208, figure 13
222, 224, 226, 228, 232, figure 14
216, figure 19
212 (x2), 216, figure 20
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
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 17-19, 28-30 and 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). Regarding claim 17, Applicant recites “a wire coupling the chip to a mid-line bore in one of the metatarsal bone or a phalanx bone.”
The act of coupling the chip to a mid-line bore in one of the metatarsal bone or phalanx bone requires the metatarsal bone or phalanx bone for the chip to couple to it. The Examiner suggests amending the claim to recite: ““a wire configured to couple the chip to a mid-line bore in one of the metatarsal bone or a phalanx bone.
Regarding claim 28, Applicant recites “a wire coupling the chip to a mid-line bore in the proximal phalanx bone.”
The act of coupling the chip to a mid-line bore in the phalanx bone requires the phalanx bone for the chip to couple to it.
The Examiner suggests amending the claim to recite: ““a wire configured to couple the chip to a mid-line bore in the phalanx bone.
Regarding claim 33, Applicant recites “a wire coupling the chip to a mid-line bore in a proximal.”
The act of coupling the chip to a mid-line bore in the proximal requires the bone for the chip to couple to it.
The Examiner suggests amending the claim to recite: ““a wire configured to couple the chip to a mid-line bore in one of the proximal.
Claims 18-19 and 29-30 are rejected under 35 U.S.C. 101 as they depend from a rejected base claim and do not rectify the issue(s) at hand.
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 16-19, 28-30 and 33-35 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. With respect to claim 16, Applicant recites “A targeting guide comprising: a chip having proximal and distal…. and at least two openings passing through the medial or lateral surfaces and a thickness of the chip, each of the at least two openings having different angular opening axes and planes.” Applicant’s specification fails to provide support for a chip having at least two openings. The embodiment of the chip is element 152 show in figure 11A. The chip is absent any openings in any surface of the chip. The chip is a solid body having no openings through the thickness of the chip.
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 33 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.
Regarding claim 33, Applicant recites “the chip to a mid-line bore in a proximal”. It is unclear what the “a proximal” is referring to as it is open-ended.
For the purpose of examination, the limitation has been interpreted to read “the chip to a mid-line bore in a proximal bone.” The Examiner notes that this interpretation may be inconsistent with Applicant’s specification and is advised to make an amendment consistent with their disclosure.
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.
(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.
Claims 16-19, 28-30 and 33-35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Branthover, III et al. (US 2022/0079602).
Regarding claim 16, Branthover, III et al. disclose a targeting guide, comprising a chip (100) having a proximal (see figure below) and distal (see figure below) aspects thereof, the chip having a medial or lateral surfaces (106 or 108) thereof (figure 5) configured to approximate a medial or lateral skin surface over a joint or bone (figures 8-14); and at least two openings (102, 104, 110, 112) passing through the medial or lateral surfaces and a thickness of the chip (figures 1, 5), each of the at least two openings having different angular openings axes and planes (figures 1, 5).
Regarding claim 17, Branthover, III et al. disclose the joint or bone is a metatarsal bone of a first metatarsal-phalangeal joint; and the chip further comprises an opening (110) on the distal aspect thereof and a wire (¶38) coupling the chip to a mid-line bore in one of the metatarsal or a phalanx bone (¶38).
Regarding claim 18, Branthover, III et al. discloses the chip includes a channel (126, figures 1, 3, 5) on a plantar surface of the chip (106/108) configured to engage and isolate an extensor hallucis longus ligament therein (capable if placed over the ligament as it would cover/surround/isolate it within the opening).
Regarding claim 19, Branthover, III et al. disclose the angular opening axes and planes of the at least two openings are configured to create drilling and affixation screw bores that pass through the metatarsal bone and into a proximal phalanx bone without intersecting or interfering with each other (figure 5 as both paths, 111 & 114 diverge from one another).
Regarding claim 28, Branthover, III et al. disclose the joint or bone is a metatarsal bone of a first metatarsal-phalangeal joint; and the chip further comprises an opening (110) on the distal aspect thereof and a wire (¶38) coupling the chip to a mid-line bore in the proximal phalanx bone (¶38).
Regarding claim 29, Branthover, III et al. disclose the chip includes a channel (126, figures 1, 3, 5) on a plantar surface of the chip (106/108) configured to engage and isolate an extensor hallucis longus ligament therein (capable if placed over the ligament as it would cover/surround/isolate it within the opening). Regarding claim 30, Branthover, III et al. disclose the angular opening axes and planes of the at least two openings are configured to create drilling and affixation screw bores that pass through the proximal phalanx bone and into a metatarsal bone without intersecting or interfering with each other (figure 5 as both paths, 111 & 114 diverge from one another).
Regarding claim 33, Branthover, III et al. disclose the chip further comprises an opening (110) on the distal aspect thereof and a wire (¶38) coupling the chip to a mid-line bore in a proximal (¶38).
Regarding claim 34, Branthover, III et al. disclose the guide further comprises a channel (126, figures 1, 3, 5) in a surface of the chip (106) configured to engage and isolate an at least one of a muscle, tendon, or ligament therein (capable if placed over the muscle, tendon or ligament as it would cover/surround/isolate it within the opening).
Regarding claim 35, Branthover, III et al. disclose the angular opening axes and planes of the at least two openings are configured to create drilling and affixation screw bores that pass through a first bone and into a second bone without intersecting or interfering with each other (figure 5 as both paths, 111 & 114 diverge from one another).
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Claims 44-49 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fallin et al. (US 2016/0199076).
Regarding claim 44, Fallin et al. disclose an interphalangeal joint targeting guide comprising a main body member (200, figure 14) having a longitudinal axis (234) and a targeting pin (302/304) projecting distally from the main body member along a mid-line of the main body member and co-axial with the longitudinal axis of the main body member (figures 15, 18).
Regarding claim 45, Fallin et al. disclose the main body member has a generally cruciform shape (figure 14). Regarding claim 46, Fallin et al. disclose the main body member has a concave plantar surface (230, figure 16) configured to nest against skin covering a proximal phalanx (¶52). Regarding claim 47, Fallin et al. disclose the main body member has a concave plantar surface (230, figure 16) configured to nest against skin covering a proximal phalanx (¶52). Regarding claim 48, Fallin et al. disclose a targeting guide comprising a main body (200, figure 14) having a longitudinal axis (234), a first (see figure below) and second (see figure below) longitudinal extensions, and a first (see figure below) and second (see figure below) lateral extensions, and the main body further defines a plurality of elongate openings (215, 220) extending through the first and second longitudinal extensions from a dorsal surface to a plantar surface thereof (figures 15, 17). Regarding claim 49, Fallin et al. disclose the main body has a generally cruciform shape (figures 14-15).
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Claims 48 and 50-53 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Campbell et al. (US 2022/0370211).
Regarding claim 48, Campbell et al. disclose a targeting guide comprising a main body (100) having a longitudinal axis (considered the central longitudinal axis), a first (110) and second (115) longitudinal extensions, and a first (see figure below) and second (see figure below) lateral extensions, and the main body further defines a plurality of elongate openings (125, 130 and 109’s) extending through the first and second longitudinal extensions from a dorsal surface to a plantar surface thereof (figures 2B, 2D). Regarding claim 50, Campbell et al. disclose the plurality of elongate openings include a first set of elongate openings (109’s) and a second set of elongate openings (125, 130), the first set being parallel to the longitudinal axis (figure 2C), and the second set being perpendicular to the longitudinal axis (figure 2C). Regarding claim 51, Campbell et al. disclose the first set of the plurality of elongate openings are configured to (i.e. capable of) allow a fixation wire to be placed through an opening of the first set to secure the main body to both a distal aspect of a first metatarsal bone and a proximal aspect of a phalangeal bone while allowing longitudinal adjustment of the main body relative to the longitudinal axis (figures 8-14). Regarding claim 52, Campbell et al. disclose the second set of the plurality of elongate openings are configured to (i.e. capable of) allow different size burrs to pass into and through an opening of the second set to allow surgical access to articular surfaces and ends of each of the first metatarsal bone and the phalangeal bone (figures 8-14). Regarding claim 53, Campbell et al. disclose a first set of the plurality of elongate openings have graduated opening widths (@127’s) or graduated angular positions relative to the longitudinal axis to permit cutting of different curvatures in each of a metatarsal bone and a phalangeal bone (if one so chooses).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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