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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a bone fusion assembly, classified in A61B17/8014.
II. Claims 16-22, drawn to a bone screw, classified in A61B17/8605.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of group I does not require the head portion having superior and inferior ends with a shaped opening disposed within the superior end and configured to engagedly receive a tool for driving the bone screw, a shank extending from the inferior end, the shank comprising distal threads and a proximal smooth portion, and a distal end configured to be advanced within the hole. The subcombination has separate utility such as fusing bone portions without the use of a bone plate.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a different status in the art in view of their different classificaitons;
The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
The inventions require a different field of search (for example, searching different groups/subgroups or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Hani Z. Sayed on 17 November 2025 a provisional election was made without traverse to prosecute the invention of group II, claims 16-22. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19, line 2: “ends” (between “inferior” and “so”) should be changed to --end--.
Appropriate correction is required.
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.
Claims 18 and 19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the surface" in line 3. 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)(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) 16-21 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sanders et al., U.S. PG-Pub 2003/0158555.
Regarding claim 16, Sanders et al. discloses a bone screw for compressing adjacent bones across a bone fusion site, comprising: a head portion (6) comprising a superior end and an inferior end; a shaped opening (3) disposed within the superior end and configured to engagedly receive a tool for driving the bone screw into a hole drilled across the fusion site; a shank (2) extending from the inferior end, the shank comprising distal threads (5) and a proximal smooth portion; and a distal end configured to be advanced within the hole (examiner annotated Fig. 1a below).
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Regarding claim 17, Sanders et al. discloses wherein the shaped opening (3) is substantially concentric with a longitudinal axis of the shank and comprises a multi-lobe shape suitable to receive the tool (examiner annotated Figs. 1a and 1d below).
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Regarding claims 18 and 19, Sanders et al. discloses wherein the inferior end is configured to be received within a slanted aperture of a bone plate, such that the head portion countersinks within the slanted aperture and presses the bone plate against a surface of the adjacent bones; and wherein a maximal circumference of the head portion (6) is disposed between the superior end and the inferior end so as to minimize protrusion of the head portion above an upper surface of the bone plate (examiner annotated fig. 1a below).
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Regarding claim 20, Sanders et al. discloses wherein the distal threads (5) are configured to rotatably engage within the hole, and wherein the proximal smooth portion is configured to pass through the bone with relatively little resistance, the smooth portion being configured to allow the bone fusion site to close as the adjacent bones are compressed together (examiner annotated Fig. 1a under the rejection of claim 16 above).
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.
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) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al., U.S. PG-Pub 2003/0158555 in view of Mobasser, U.S. PG-Pub 2012/0136398.
Regarding claims 21 and 22, Sanders et al. discloses the invention essentially as claimed except for wherein the distal end includes one or more shapes/flutes that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom.
Mobasser discloses a bone screw having threads (200) with one or more flutes (180) that spiral along a portion of the threads (Fig. 3) for conveying bone material away from the tip of the screw during insertion of the screw into bone and for removing bone material (paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end to includes one or more shapes/fluts that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom in view of Mobasser to permit conveying bone material away from the distal end of the screw during insertion of the screw into the bones and to permit removal of bone material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (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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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775