DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment and Election/Restrictions
The Amendment filed 03/30/26 has been entered. Applicant’s election without traverse of Group II, claims 9-20, in the reply filed on 03/30/26 is acknowledged. Claims 1-8 have been cancelled. Claims 9-20 are addressed in the following office action
Claim Objections
Claim 16 objected to because of the following informalities:
In line 12, “locked position” should read “locked configuration”.
In line 13, “unlocked position” should read “the unlocked configuration”.
In line 13, “locked position” should read “locked configuration”.
In line 16, “unlocked position” should read “unlocked configuration”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 9 and 12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Way et al. (US 2007/0299459) in view of Justis et al. (US 2007/0260184).
Regarding claim 9, an invention relating to surgical cannulas, Way discloses (Figs. 1-2) a probe system (100) comprising: a handle assembly including a handle (20); a stylus (30) removably connected to the handle assembly (Par. 0044); a cannula (70), wherein the stylus is disposable within the cannula (Par. 0037); a quick connect system removably attaching the cannula to the handle assembly, the quick connect system being adjustable between a first position (Fig. 2) and a second position (Fig. 13) and including a collar (50), the collar including: a portion movable between the first position and the second position along a portion of the handle assembly in a direction parallel to a longitudinal axis (95) of the cannula (Par. 0039, 0043, 0061-0062); a compression element (60) compressible between the handle assembly and the collar (Par. 0051); and a locking element (76) held between the collar and the cannula (Par. 0053-0054); wherein the compression element compresses the collar against the locking element when the collar is in the first position to cause the locking element to be compressed against the cannula such that the position of the cannula relative to the handle assembly is fixed, and the locking element is in a state when the collar is in the second position such that the handle assembly and the cannula are slidable relative to each other (Par. 0060-0063). Also, Way discloses the stylus may be fixed to the handle within a bore by any suitable means including without limitation mating threads, an adhesive, a locking mechanism, interference fit, shrink fit, or combinations thereof (Par. 0044).
However, Way fails to disclose a cap rotatable relative to the handle between a locked position and an unlocked position; and the cannula disposed within the handle assembly.
In the same field of endeavor, which is surgical cannulas, Justis teaches (Figs. 1-2) a cap (514) rotatable relative to a handle (400) between a locked position (Fig. 6A) and an unlocked position (Fig. 5; Par. 0041-0042); a stylus (300) removably connected to the handle assembly; and a cannula (100 or 200) disposed within a handle assembly (400 & 514; Par. 0036 & 0040).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Way to have a cap rotatable relative to the handle between a locked position and an unlocked position; and the cannula disposed within the handle assembly. Doing so would permit a surgeon to easily determine whether the associated component is locked or unlocked to handle without having to visually observe the instrument (Par. 0043), as taught by Justis. Also, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the cannula disposed within the handle assembly because Applicant has not disclosed that the particular structure provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Way’s device, and applicant’s invention, to perform equally well with either the cannula disposed outside the handle as taught by Way or the claimed cannula disposed within the handle assembly since it has been held that rearranging parts or aesthetic design changes of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 12, Way, as modified by Justis, discloses further wherein both the handle assembly and the stylus are removable from the cannula when the quick connect system is in the second position (Par. 0061-0063) and the cap is in the unlocked position (Par. 0044) [Note, the cap, as taught by Justis, is a suitable means for fixing the stylus to the handle of Way’s device].
Claims 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Groenke et al. (US 2004/0077973) in view of Whitmore, III et al. (US 2010/0081920).
Regarding claim 16, an invention relating to biopsy, Groenke discloses (Figs. 1 & 8) a probe system (1, 50, 60) comprising: a handle assembly (1) including: a lower portion (3); an upper portion (2) configured to be removably connected with the lower portion (Par. 0038); a locking mechanism (80 & 81) configured to lock and unlock the lower portion and upper portion relative to one another, the locking mechanism having a locked configuration and an unlocked configuration (Par. 0039-0040); a stylus (50) removably connected to the handle assembly (Par. 0038); and wherein the upper portion of the handle assembly is configured to rotate relative to the lower portion to transition the locking mechanism between the locked position and unlocked position, and when the upper portion is rotated to the locked position, the locking mechanism is moved into engagement with the stylus to prevent axial movement of the stylus relative to the handle assembly, and when the upper portion is rotated to the unlocked position, the locking mechanism is disengaged with the stylus allowing axial movement (Par. 0037-0040). However, Groenke fails to disclose a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus.
In the same field of endeavor, which is biopsy, Whitmore teaches a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus (Par. 0052-0054).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Groenke to have a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus. Doing so would allow the position to be tracked (Par. 0018 & 0054), as taught by Whitmore.
Regarding claim 17, Groenke, as modified by Whitmore, discloses (Figs. 1 & 9) the probe system of claim 16. Groenke discloses further comprising a cannula (60) disposed within the handle assembly, wherein the stylus is disposable within the cannula, and a quick connect system (70) removably attaching the cannula to the handle assembly, the quick connect system being adjustable between a first position and a second position, wherein the cannula is fixed in position relative to the handle assembly when the quick connect system is in the first position, and wherein the cannula is movable relative to the handle assembly when the quick connect system is in the second position (Par. 0036 0038 0041 0043).
Claims 10-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Way et al. (US 2007/0299459) in view of Justis et al. (US 2007/0260184) as applied to claim 9 above, and further in view of Scholl et al. (US 7,942,826).
Regarding claims 10-11, Way, as modified by Justis, discloses the probe system of claim 9. However, Way fails to disclose wherein the probe system further comprises a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus [Claim 10]; and wherein the tracking module is in a fixed position relative to the stylus [Claim 11].
In the analogous art of cannulas and access devices, Scholl teaches wherein the probe system further comprises a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus; and wherein the tracking module is in a fixed position relative to the stylus (Col. 14, lines 10-35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Way, in view of Justis, to have wherein the probe system further comprises a tracking module connected to the handle assembly, the tracking module configured to detect at least one of position and orientation of the stylus [Claim 10]; and wherein the tracking module is in a fixed position relative to the stylus [Claim 11]. Doing so would allow the position to be tracked (Col. 14, lines 10-35), as taught by Scholl.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 10-11 of U.S. Patent No. 10,751,137. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant applications are fully contained within the clam of the patent application.
Claims
18/417,776
9
10
11
12
13
14
15
16
17
18
19
20
Claims
US Patent No.
10,751,137
1
2
2
5
10
11
11
1 & 2
1 & 2
3
11
11
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9 of U.S. Patent No. 9,877,786. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant applications are fully contained within the clam of the patent application.
Claims
18/417,776
9
Claims
US Patent No.
10,751,137
1, 5, 9
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 April 18, 2026