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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 03/24/2026 has been entered.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0364906 A1 to Palese et al. (hereinafter “Palese”) in view of US 2022/0061833 A1 to Peter et al. (hereinafter “Peter”) and further in view of US 2006/0100640 A1 to Bolduc (hereinafter “Bolduc”) (all references previously of record).
Regarding claim 1, Palese discloses (see abstract; Figs. 1-4 and 11-13; and [0028]-[0062]) a surgical instrument (10/10", see [0029]/[0055]) configured to secure an anchor in bone (see at least [0028]), the anchor comprising a fixation member (40/40") and an insertion member (416), the surgical instrument comprising:(i) a handle (50); (ii) a cannulated (154) drive shaft (30) extending from the handle, the cannulated drive shaft configured to drive the fixation member of the anchor (see Figs. 1-4 and [0034]-[0037]); (iii) an insertion shaft (20/20") extending from the handle and through the cannulation of the drive shaft (see Figs. 1-4 and [0034]-[0037]), the insertion shaft configured for the insertion member to be mounted thereon (see Figs. 11-13 and [0055]); and (iv) a button/collar (186) proximate a distal end of the handle and extending about the handle (see Figs. 1/4), the collar movable between a locked configuration and an unlocked configuration, wherein, when the collar is in the locked configuration, the collar prevents the insertion shaft from translating relative to the drive shaft, and wherein, when the collar is in the unlocked configuration, the collar does not prevent the insertion shaft from translating relative to the drive shaft (see Figs. 1/4 and [0037]-[0040]).
Palese further discloses (claim 2) further comprising a detent (198), wherein, when the collar is in the locked configuration, the detent fixedly engages the insertion shaft, and wherein, when the collar is in the unlocked configuration, the detent resiliently engages the insertion shaft (see Fig. 4 and [0038]-[0040]); (claim 3) further comprising a resilient member (202), wherein, when the collar is in the unlocked configuration, the resilient member biases the detent to engage the insertion shaft (see Fig. 4 and [0040]); (claim 4) wherein, when the collar is in the locked configuration, the collar prevents the detent from moving relative to the insertion shaft (see Fig. 4 and [0038]-[0040]); (claim 5) wherein, when the collar is in the locked configuration, the resilient member is spaced from the detent (see Fig. 4 and [0038]-[0040]); (claim 10) wherein the collar is a slidable collar, wherein translating the collar along a portion of the handle moves the collar between the locked and unlocked configurations (see Fig. 4 and [0038]-[0040], translates radially inwardly); (claim 11) wherein the collar is biased away from a body of the handle, and wherein translating the collar towards the body of the handle moves the collar from the locked configuration to the unlocked configuration (see Fig. 4 and [0038]-[0040]); (claim 12) wherein translating the collar towards the body of the handle lifts a lock member (198) to an unlocked position (see Fig. 4 and [0038]-[0040]); (claim 13) wherein translating the collar towards the body of the handle brings a resilient member into contact with a detent (see Fig. 4 and [0038]-[0040]); (claim 14) wherein the collar is biased toward a body of the handle, and wherein translating the collar away from the body of the handle moves the collar from the locked configuration to the unlocked configuration (see Fig. 4 and [0038]-[0040]); and (claim 16) wherein the instrument does not include a resilient member configured to bias the collar in the locked configuration (see [0038], biasing member 202 is optional).
Palese discloses the invention substantially as claimed, however, with respect to claim 1, Palese fails to specifically disclose wherein the collar extends entirely around a portion of the handle, the collar rotatable about the handle, and with respect to claim 6, Palese fails to specifically disclose wherein the collar is a rotatable collar, wherein rotating the collar partially about the handle moves the collar between the locked and unlocked configurations. Rather, Palese discloses wherein the collar comprises a push-button collar (see [0039]). Peter discloses, in the same field of endeavor of suturing surgical instruments (see abstract), the known interchangeable use of push buttons or rotatable knobs/wheels etc. (that would extend entirely around a portion of the handle) as suitable actuators to move an inner shaft relative to an outer shaft (see [0040]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007)), to obtain the predictable result of an actuator mechanism, by substituting the push button of Palese with the rotatable knob taught by Peter, since these are known interchangeable actuation mechanisms, and therefore rotation of the knob/collar would move the collar between the locked and unlocked configuration, analogous to pushing or not pushing the button would move that actuator between locked and unlocked configurations.
Bolduc discloses (see abstract; Fig. 1; and [0031]-[0077]), in the same field of endeavor, a guide tool (10) including an actuator (26), wherein the actuator comprises a rotatable knob (26, as shown in Fig. 1) that extends entirely around a portion of handle (see Fig. 1 and [0065]-[0066]) at the distal end of the handle for the purpose of positioning the knob so that it can be rotated by the thumb of the clinician’s hand that holds the handle in his/her palm (see [0065]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Peter’ modification of Palese by arranging the rotatable knob at the distal end and extending entirely around a portion of the handle in order to position the knob so that it can be rotated by the thumb of the clinician’s hand that holds the handle in his/her palm.
Regarding claim 7, the combination of Palese, Peter (and Bolduc), as discussed above for the reasons set forth above, would disclose the limitations of the claim because Palese discloses a resilient member (202) and a detent (distal tip of 198), the detent configured to engage the insertion shaft (via 238), and where the unlocked configuration brings the resilient member into contact with the detent (see Fig. 4 and [0037]-[0040], and the modification with Peter (and Bolduc) above would make the push button into a rotatable collar such that rotating the collar would move to the unlocked configuration.
Regarding claim 8, the combination of Palese, Peter (and Bolduc), as discussed above for the reasons set forth above, would disclose the limitations of the claim because Palese discloses a stop (226, receiving 198 therein) moveable with the collar, wherein, when the collar is in the locked configuration, the stop limits translation of the insertion shaft relative to the drive shaft; and wherein, when the collar is in the unlocked configuration, the stop does not limit translation of the insertion shaft relative to the drive shaft (see Fig. 4 and [0039]), and the modification with Peter (and Bolduc) above would make the stop rotatable with the collar instead of moveable with the push button.
Regarding claim 9, the combination of Palese, Peter (and Bolduc), as discussed above for the reasons set forth above, would disclose the limitations of the claim because Palese discloses wherein, when the collar is in the locked configuration, the stop is positioned to block a proximal end of the insertion shaft (see Fig. 4 and [0039]).
Response to Arguments
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that there isn’t sufficient detail for one of ordinary skill in the art to incorporate the rotatable actuator into Palese in place of the slideable actuator, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). "It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements." In re Mouttet, 686 F.3d 1322, 1332, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012) (citing In re Etter, 756 F.2d 852, 859, 225 USPQ 1, 6 (Fed. Cir. 1985) (en banc)) ("Etter's assertions that Azure cannot be incorporated in Ambrosio are basically irrelevant, the criterion being not whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole."). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) ("[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review."); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) ("Combining the teachings of references does not involve an ability to combine their specific structures.").
A person of ordinary skill in the art would possess the technical capability and understanding to convert an actuator that slides to an actuator that rotates as a collar about a handle while still providing the same feature/function of actuating. Further, there is no evidence that making such a proposed combination would render the device defective for its intended purpose. The basic principle and functioning of Palese’s device would not change – merely the form of the actuator and how the user actuates the devices. The surgical arts are replete with examples of teachings that push buttons are interchangeable with rotating knobs that are used for actuating a device without detailed explanations explaining how the rotating knob would replace the push button because this substitution is within the skill of those ordinary artisans and requires no further explanation. See, e.g., US 2002/0029060 A1 to Hogendijk at [0055], US 2002/0183839 A1 to Garrison at [0084], US 2005/0004582 A1 to Edoga at [0212], US 2013/0317528 A1 to Anderson at [0055], US 2013/0331839 A1 to Hester at [0054], US 2017/0119526 A1 to Luong at [0100], US 2017/0189040 A1 to Anand at [0061], US 2018/0221009 A1 to Mitelberg at [0041], US 2021/0059726 A1 to Artaki at [0050], etc. Accordingly, Applicant’s arguments are not persuasive, as it would be obvious to and within the skill of an ordinary artisan to modify Palese’s actuator to make it a rotatable collar as a known alternative actuation mechanism that would still function in the same way in manipulating the device of Palese and would not render the device defective for its intended purpose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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