Detailed Action
This is the first office action on the merits for US application number 18/951,349.
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 .
Election/Restrictions
Applicant's election without traverse of invention I, claims 1-18 in the reply filed on September 18, 2026 is acknowledged.
Applicant’s election without traverse of dilating device species A)1), broach species B)1), implant species C)1), osteotome/chisel species D)1), and rotary channel boring system species E)1) in the reply filed on September 18, 2026 is acknowledged, which indicated that claims 1-18 read on the elected species.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
As to claim 8, the limitation of the drill guide comprises a triangular aperture does not read on the elected species with a square aperture. Further, a triangular drill guide aperture is only shown in Figs. 92A-92C as disclosed in ¶381, i.e. non-elected rotary channel boring system species E)2). Therefore, claim 8 does not read on the elected species.
Claims 9-12 depend from claim 8 and subsequently do not read on the elected species.
As to claim 13, the limitation of the system comprising both a primary drill bit configured to remove bone from a first region and a secondary drill bit configured to removed bone from a second region does not read on the elected species with bone cutting bit 922 of Figs. 91A-91D. Further, both a primary drill bit configured to remove bone from a first region and a secondary drill bit configured to removed bone from a second region is only shown in Figs. 94A and 94B as disclosed in ¶386, i.e. non-elected rotary channel boring system species E)4). Therefore, claim 13 does not read on the elected species.
Claims 14-18 depend from claim 13 and subsequently do not read on the elected species.
Accordingly, claims 8-18 are withdrawn from further consideration along with claims 19 and 20.
Information Disclosure Statement
In regards to the information disclosure statements filed March 21, 2025, July 14, 2025, and July 10, 2026, due to the large volume of information submitted by applicant, applicant is required to identify any specific references within the large volume which they may be aware of that may be relevant to the claimed invention. This requirement is necessary since there appear to be a number of references in the large volume that are not at all relevant to the claimed invention, including the container cap of WO-2011/124874, the staple of CN-104968283, the protease inhibitor-containing compositions with pharmaceutical assays of JP-2015-510506, the screw of JP-2016-515857, the IM rod with screws of JP 11-318931, the screw of CN 102429716, the plate with screws of WO 2004/043277, the fixing screw of EP 2796104. As such, the 1354 US documents, 9 foreign documents, and 14 NPL documents currently cited have received only a cursory review as the relevance of such documents to the instant application has not been established.
The information disclosure statement filed July 14, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. That is, 2 NPL documents have been cited but no copies of NPL have been received.
The information disclosure statement filed March 1,2 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. That is, 2 NPL documents have been cited but no copies of NPL have been received.
The information disclosure statement filed July 10, 2026 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. That is, 5 NPL documents have been cited but no copies of NPL have been received.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because currently provided Figs. 91A-91D do not constitute black and white line drawings as required by CFR 1.84 and the provided figures do not provide a clear indication of where one element begins and another ends. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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(s) 4-7 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 4 is/are unclear with regards to “the prime mover comprises a flexible shaft connected to a fixed position motor” in lines 1-2 and how a flexible shaft connected to a fixed position motor is disclosed and shown that is in addition to the rotary input shaft of claim 1 line 2 and the flexible or articulating drive shaft of claim 1 line 7. Examiner is interpreting this as broadly supported and suggests amending to clarify.
Claim(s) 5 is/are unclear with regards to “the drill guide comprises a square aperture” in lines 1-2 that is in addition to the aperture of claim 1 line 3. Examiner is interpreting this as referring to, and suggests amending as, “the drill guide aperture comprises a square aperture.”.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Etudes NPL (https://en.etudes.ru/etudes/drilling-square-holes/, see 2 attached documents showing the content and the date provided at the end of the video, hereinafter “Etudes”).
As to claim 1, Etudes discloses a system (see Fig. A) capable of use in bone channel preparation (in as much as Applicant’s, shown in Figs. A and B capable of use in cutting a hole in material) comprising: a rotary input shaft (see Fig. A) capable of being rotatably coupled to a prime mover (“Handheld drill motor” in Fig. A, Fig. A); a drill guide (see Fig. A) having an aperture (see Fig. A);a roller cam (see Fig. A) sized and shaped to capable of sliding and received within the aperture of the drill guide (see Fig. A); a bone cutting bit (see Fig. A), i.e. a bit capable of cutting bone (in as much as Applicant’s, shown in Figs. A and B capable of use in cutting a hole in material), coupled to the roller cam (see Fig. A); a flexible or articulating drive shaft (see Fig. A) capable of rotationally coupling the roller cam and the bone cutting bit to the rotary input shaft while allowing lateral movement therebetween (see Fig. A), wherein the roller cam is capable of following an inner contour of the aperture (Figs. A and B) capable of allowing circular motion from the rotary input shaft to be converted into motion along a non-circular path (Figs. A and B), thereby allowing the bone cutting bit to cut a non-circular bore (Figs. A and B) into one or more bone segments capable of receiving a complementary shaped non-circular implant (in as much as Applicant’s, Figs. A and B).
As to claim 2, Etudes discloses a prime mover (“Handheld drill motor” in Fig. A, Fig. A) coupled to the rotary input shaft (Fig. A).
As to claim 3, Etudes discloses that the prime mover comprises a handheld drill motor (Fig. A).
As to claim 4, Etudes discloses that the prime mover comprises a flexible shaft (in as much as Applicant’s, Fig. A) connected to a fixed position motor (in as much as Applicant’s, Fig. A).
As to claim 5, Etudes discloses that the drill guide aperture comprises a square aperture (Fig. B).
As to claim 6, Etudes discloses that the roller cam comprises exactly three rounded apices (Figs. A and B), each of which is capable of slidingly following along sides of the square aperture to trace out a square path (Figs. A and B), thereby causing the bone cutting bit to cut a square bore in bone (Fig. B).
As to claim 7, Etudes discloses that cutting edges (Figs. A and B) are provided on the bone cutting bit in line with each of the three rounded apices of the roller cam (Figs. A and B).
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Fig. A: Annotated screenshot of video of Etudes
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Fig. B: Additional screenshot of video of Etudes
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892, Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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 or telephone the Examiner.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
