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/Restrictions
Applicant’s election of Group I in the reply filed on June 25th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 25th, 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first member being formed by a plurality of separate and distinct components (claim 18) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Double Patenting
Claims 1-14, 16, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,232,715. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-14, 16, and 17 of the current application and the invention of claims 1-24 of the patent lies in the fact that the invention of claims 1-24 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-24 of the patent is in effect a "species" of the "generic" invention of claims 1-14, 16, and 17 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-14, 16, and 17 are anticipated by claims 1-24, claims 1-14, 16, and 17 are not patentably distinct from claims 1-24.
Current Application
U.S. Patent 12,232,715
1, 4, 5, 6
1
2
2
3
3
5
10
6
23
7
24
8
6
9
7,8
10
18
11,12
22 (the teeth extend about the periphery and therefore define at least a portion of the periphery)
13
18
14
19
16
13
17
16
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,232,715 in view of Blacklidge (U.S. Publication 2018/0055623.
The U.S. Patent discloses the invention as claimed, see above, except for the inner side of the first and second head portions being concave. Blacklidge teaches a device comprising a first head portion (22) and a second head portion (14), wherein the first and second head portions includes an inner side having a concave shape (for example see Figure 17 showing a concave shapes on both inner surfaces). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of U.S. Patent 12,232,715 wherein the inner surfaces of the first head portion and the second head portion have concave shapes in view of Blacklidge, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an inner surface of a head portion. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,232,715 in view of Kollmer (U.S. Publication 2011/0137356.
The U.S. Patent discloses the invention as claimed, see above, except for the first member being formed of a plurality of separate and distinct elements. Kollmer teaches a device comprising a first member (16) and a second member (26), wherein the first member is formed from a plurality of separate and distinct elements (18, 26, 36, etc.; see Figure 3). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of the U.S. Patent wherein the first member is formed from a plurality of separate and distinct parts in view of Kollmer, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
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 3 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 3 recites the limitation "the second drive opening" in line 3. There is insufficient antecedent basis for this limitation in the claim. The examiner will interpret the claim as the second head portion including a first drive opening and the cannulated opening of the second member for examination purposes.
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.
Claims 1-9 and 16-18 are rejected as best understood under 35 U.S.C. 103 as being unpatentable over Sevrain (U.S. Patent 5,707,373) in view of Kollmer (U.S. Publication 2016/0135861) and in view of Lerch (U.S. Patent 5,800,436).
Sevrain (U.S. Patent 5,707,373) discloses a device (for example see Figures 2-6) comprising:
(claim 1) a first member (38) including
(claim 1) a first head portion (40)
(claim 1) wherein the first head portion includes a row of teeth (52)
(claim 4) wherein the row of teeth extend from an inner side of the first head portion
(claim 5) wherein the row of teeth includes only a single row of teeth
(claim 6) wherein the row of teeth extend about the first shaft portion
(claim 8) wherein the teeth define axis that are aligned with an axis of the cannulated opening of the first member (for example the center axis of each tooth is aligned, i.e. substantially parallel to the center axis of the cannulated opening)
(claim 9) wherein an outer surface of the teeth are angled toward an axis of the cannulated opening as they extend to a tip of the teeth (see Figure 6; the outer side of the teeth extend towards the cannulated opening)
(claim 9) wherein an inner surface of the teeth are angled away from the axis of the cannulated opening as they extend to a tip of the teeth (see Figure 6; the inner side of the teeth extend away from the cannulated opening)
(claim 1) a first shaft portion (46) at an inner side of the first head portion
(claim 1) a cannulated opening (48) extending through the first shaft portion
(claim 17) wherein the first member is of a one-piece configuration (for example see Figures 2 and 6)
(claim 1) a second member (60) including
(claim 1) a second head portion (62)
(claim 1) a second shaft portion (68) at an inner side of the second head portion
(claim 1) a cannulated opening (64) extending through the second head portion and into the second shaft portion
(claim 3) wherein the outer side of the head portion includes a drive opening (the opening of element 64)
(claim 3) wherein the cannulated opening is aligned with and extends from the drive opening
(claim 1) wherein the first and second shaft portions are configured to threadably engage with each other
Sevrain fails to disclose the cannulated opening extends through the first head portion and the first shaft portion and the cannulated opening extends through the second head portion and the second shaft portion (claims 1-3), the first head portion including a plurality of through holes between the first shaft portion and the row of teeth (claim 1), and the first head portion including a first drive opening aligned with the cannulated opening (claim 2), the row of teeth extending about the periphery of the first head portion (claim 7), the second head portion comprising a row of teeth (claims 10-14), and the first member being formed from a plurality of separate and distinct components (claim 18).
Regarding the cannulated opening extending through the first head portion and the first shaft portion and the cannulated opening extending through the second head potion and the second shaft portion and the first head portion including a first drive opening, Kollmer teaches a device (for example see Figures 2A and 2C) comprising a first member (for example see Figure 5A) including a first head portion (30 and 36), a first shaft portion (26), a non-circular first drive opening (42; for example see Figure 5B), and a cannulated opening (28) aligned with and extending from the first drive opening and a second member (16; for example see Figure 4A) including a second head portion (20), a second shaft portion (18), a non-circular second drive opening (40), and a cannulated opening (24) aligned with and extending from the first drive opening, wherein the cannulated opening extends through the first head portion and the first shaft portion and the cannulated opening extends through the second head portion and the second shaft portion in order to allow the device to be used with a guidewire. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Sevrain wherein the first member includes a first drive opening and a cannulated opening extending through the first head portion and the first shaft portion and the second member includes a second drive opening and a cannulated opening extending through the second head portion in view of Kollmer in order to allow the device to be used with a guidewire.
Regarding the first head portion including a plurality of through holes positioned between the row of teeth and the first shaft, Lerch teaches a device (for example see Figures 1-4) comprising a first member including a first head portion (21), a first shaft portion (112) extending from an inner side of the first head portion, and a row of teeth (213), wherein the first head portion further includes a plurality of through holes (see Figure 4) between the row of teeth and spaced about the first shaft portion in order to provide a device with less weight. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Sevrain as modified by Kollmer wherein the first head portion further includes a plurality of through holes between the teeth and the first shaft portion in view of Lerch in order to provide a device with less weight.
Regarding the row of teeth extending about a periphery of the first head portion, Lerch teaches a device (for example see Figures 1-4) comprising a first member including a first head portion (21), a shaft portion (112) extending from an inner side of the first head portion, and a row of teeth (213), wherein the row of teeth extend about a periphery of the head portion. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Sevrain as modified by Kollmer as further modified by Lerch wherein the row of teeth extend about the periphery of the first head portion, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 16, the device of Sevrain as modified by Kollmer as modified by Lerch disclose the device wherein the plurality of through holes are spaced about an axis of the cannulated opening of the first member.
Regarding the first member being formed from a plurality of separate and distinct components, Kollmer teaches a device comprising a first member (for example see Figures 3, 5A, and 6A) and a second member (see Figure 4A), wherein the first member is formed from a plurality of separate and distinct elements (26, 36, etc.; see Figures 5A-6A). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Sevrain wherein the first member is formed from a plurality of separate and distinct parts in view of Kollmer, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Claims 10-13 are rejected as best understood under 35 U.S.C. 103 as being unpatentable over Sevrain (U.S. Patent 5,707,373) in view of Kollmer (U.S. Publication 2016/0135861) further in view of Lerch (U.S. Patent 5,800,436) further in view of Lerch (U.S. Patent 5,800,436).
The device of Sevrain as modified by Kollmer as further modified by Lerch discloses the invention as claimed except for the second head portion having a row of teeth extending about the second shaft portion. As discussed above the device of Sevrain as modified by Kollmer as modified by Lerch disclose a first member including a first head portion, a first shaft portion, a row of teeth extending about and define a portion of the periphery of the first head portion, and a plurality of through holes extending between the row of teeth and the first shaft portion and spaced about the first shaft portion, wherein the row of teeth includes an outer surface of the teeth angled toward an axis of the cannulated opening as they extend to a tip of the teeth (see Figure 6; the outer side of the teeth extend towards the cannulated opening) and an inner surface of the teeth are angled away from the axis of the cannulated opening as they extend to a tip of the teeth (see Figure 6; the inner side of the teeth extend away from the cannulated opening). Lerch teaches a device comprising a first member including a first head portion, a second member including a first head portion, and a shaft portion, wherein the both the first head portion and the second head portion include a row of teeth extending about the periphery of the head portions. It would have been obvious to one having ordinary skill in the art at the time the invention was to provide the device of Sevrain as modified by Kollmer as further modified by Lerch wherein the second head portion further includes a row of teeth extending about the periphery of the second head portion similar to the row of teeth extending about the periphery of the first head portion in view of Lerch, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 15 is rejected as best understood under 35 U.S.C. 103 as being unpatentable over Sevrain (U.S. Patent 5,707,373) in view of Kollmer (U.S. Publication 2016/0135861) further in view of Lerch (U.S. Patent 5,800,436) further in view of Blacklidge (U.S. Publication 2018/0055623).
The device of Sevrain as modified by Kollmer as further modified by Lerch discloses the invention as claimed except for the inner side of the first head portion and the inner side of the second head portion being concave. Blacklidge teaches a device (for example see Figure 17) comprising a first member (14) including a first head portion having an inner surface and a second member including a second head portion (22) having an inner surface, wherein the inner surfaces of the head portions are concave. It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to provide the device of Sevrain as modified by Kollmer as further modified by Lerch wherein the inner surfaces of the first head portion and the second head portion have concave shapes in view of Blacklidge, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing an inner surface of a head portion. In re Dailey and Eilers, 149 USPQ 47 (1966).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. However, claim 14 is rejected under non-statutory double patenting as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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