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 .
Response to Amendment
In response to amendment filed May 8, 2026, claim 1 is amended. No claims are cancelled and no new claims are added. Claims 1-19 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed May 8, 2026, with respect to the rejection(s) of claim(s) 1-19 under 35 U.S.C 103 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burnside (US 20140163356 A2).
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 8-9 and of co-pending Application No. 17/421045 (reference application) and Harris. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application includes the same limitations as the co-pending application and those not included in the co-pending application are taught by Harris.
Claims 4-10, 12-15 and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 8-10 of copending Application No. 17/421045 in view of Maguire (US 20150065916 A1; cited by applicant). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application includes the same limitations as the co-pending application and those not included in the co-pending application are taught by Maguire.
Claims 11 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 8-9 of copending Application No. 17/421045 in view of Browka (US 20180161519 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application includes the same limitations as the co-pending application and those not included in the co-pending application are taught by Browka.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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.
Claims 1-10, 12-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire (US 20150065916 A1; previously cited by applicant) in view of Burnside (US 20140163356 A2).
Von Allmen (EP 3145409 B1; previously cited) and Harris (US 9364171 B2).
With respect to claim 1, Maguire discloses
A cannula insertion system (see Figs 3A-3C), for inserting a cannula into a human or animal body (see paragraph 0103, injection of needle #13 into target vessel), comprising:
a cannula (see Fig. 3B and paragraph 0103, needle #13);
a cannula insertion device to hold and insert the cannula into the human or animal body in an insertion direction (see Fig. 3B and paragraph 0105, carrier #12 that is capable of being held to insert needle #13 in insertion direction), wherein the cannula insertion device comprises a cannula holder to hold the cannula (see Fig. 3B and paragraph 0106, needle device carrier housing #14); and
a cannula holder sensor (see paragraph 0103 and Fig. 3B, position sensor #21 within #14) configured to determine […].
Although Maguire teaches a cannula holder sensor in the form of a position sensor, Maguire does not specifically teach that the cannula holder sensor is configured to determine whether the cannula is held by the cannula holder.
Burnside teaches a sensor that is configured to determine whether a cannula is held by a cannula holder (see paragraph 0145-0146: needle #1200 has cannula #1202 where holder #1270 holds needle and advances it longitudinally with trigger #1272; and see paragraph 0119, 0144-0146: sensors #1192 track position, orientation and motion of needle used with holder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire with the teachings of Burnside because it would have resulted in the predictable result of detecting the position, orientation and movement of a needle during an ultrasound imaging procedure (Burnside: [0119]).
With respect to claim 2, all limitations of claim 1 apply in which Maguire further discloses the cannula holder sensor is configured to determine a position of the cannula in at least one degree of freedom (see paragraph 0093, system has six degrees of freedom movement and it is interpreted that sensor #21 is capable of measuring those six degrees).
With respect to claim 3, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine alignment of the cannula with the insertion direction of the cannula insertion device (see paragraph 0103, position sensor #21 is provided to provide position of #12 that holds #13; and see paragraph 0100, guidance for insertion of needle direction).
With respect to claim 4, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula insertion system comprises a control device connected to the cannula holder sensor (see paragraph 0108, computer component that controls motion of automated robotic end-effector unit seen in Fig. 3B), wherein the control device is configured to check that the cannula is properly held by the cannula insertion device before a procedure of automatic insertion of the cannula into a body part is started (see paragraph 0108, position profiles are generated and utilized to adjust position and force).
With respect to claim 5, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine a position of the cannula with respect to at least one of:
the cannula insertion device
the human or animal body,
one or more sensors configured to determine one or more features or characteristics of the human or animal body (see paragraph 0103, position sensor #21 determines position of needle using information from position sensor #18).
With respect to claim 6, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula holder is configured to releasably hold the cannula (see paragraph 0121, needle is released manually).
With respect to claim 7, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula holder sensor is arranged on a cannula insertion device positioning system (see paragraph 0092-0093, automated robotic end effector unit as seen in Fig. 3B is where sensor #21 is part of; it is interpreted that the automated robotic end effector is a positioning system as it can move with six degrees of freedom), a second sensor, or a positioning system for the second sensor.
With respect to claim 8, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula insertion system comprises a contact sensor (see paragraph 0103, position sensor #18), wherein the cannula holder sensor is arranged at a location where it can determine a relative position of the cannula with respect to the contact sensor by measuring from the location both the position of the cannula and the position of the contact sensor (see Figs 3A-3C).
With respect to claim 9, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula insertion system comprises a contact sensor (see paragraph 0103, position sensor #18), wherein the cannula holder sensor is arranged on the contact sensor or a positioning system for the contact sensor to determine a relative position of the cannula with respect to the contact sensor (see Figs 3A-3C).
With respect to claim 10, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine a relative position change between a distal end of the cannula and a target area of the human or animal body for introduction of the cannula (see paragraph 0103, spatial positions between needle and target area are measured).
With respect to claim 12, all limitations of claim 3 apply in which Maguire further discloses
wherein the cannula holder is configured to adapt a position of the cannula to align the cannula with the insertion direction in response to a determination that the cannula is not properly aligned with the insertion direction (see paragraph 0103, position sensor #21 is provided to provide position of #12 that holds #13; and see paragraph 0100, guidance for insertion of needle direction; and see paragraph 0112).
With respect to claim 13, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula insertion system further comprises:
a positioning system supporting the cannula insertion device (see paragraph 0108, automated robotic end-effector unit seen in Fig. 3B); and
a control device configured to control the positioning system to position, on the basis of a determined location for insertion of the cannula into the human or animal body, the cannula insertion device in a suitable position to insert the cannula into the human or animal body (see paragraph 0108, computer component that controls motion of automated robotic end-effector unit seen in Fig. 3B)
With respect to claim 14, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula is a needle (see Fig. 3B and paragraph 0103, needle #13).
With respect to claim 15, all limitations of claim 1 apply in which Maguire further discloses wherein the cannula insertion system is an autonomous cannula insertion system constructed to autonomously insert the cannula into a blood vessel (see paragraph 0059, autonomously adjust needle to insert into selected vessel target) or autonomously draw blood from a blood vessel, or both (see paragraph 0132, blood can be withdrawn from a target vessel from the automated vessel puncture device).
With respect to claim 17, all limitations of claim 2 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine the position of the cannula in at least three degrees of freedom (see paragraph 0093, system has six degrees of freedom movement and it is interpreted that sensor #21 is capable of measuring those six degrees).
With respect to claim 18, all limitations of claim 17 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine the position of the cannula in at least six degrees of freedom (see paragraph 0093, system has six degrees of freedom movement and it is interpreted that sensor #21 is capable of measuring those six degrees).
With respect to claim 19, all limitations of claim 5 apply in which Maguire further discloses wherein the cannula holder sensor is configured to determine the position of the cannula with respect to a contact sensor of the cannula insertion system (see paragraph 0103, position sensor #21 determines position of needle using information from position sensor #18).
Claims 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire in view of Burnside as applied to claim 1 above, and further in view of Browka (US 20180161519 A1; previously cited).
With respect to claim 11, all limitations of claim 1 apply in which Maguire further discloses safety guidelines for operation (see paragraph 0112).
However, Maguire and Burnside do not teach wherein the cannula insertion system comprises a safety device configured to retract the cannula or to release the cannula from the cannula insertion device in response to a determination that a safety requirement is not met.
Browka teaches a safety device (see Fig.1 and paragraph 0055, safety device #10) configured to retract the cannula or to release the cannula from the cannula insertion device in response to a determination that a safety requirement is not met (see paragraph 0020 and 0056, proximally directed force applied to lock clip #30 compresses spring #34 distally causing housing #28 to retract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to have modified Maguire and Burnside with the teachings of Browka to add a safety device because it would have resulted in the predictable result of safe shielding a used needle automatically to help healthcare workers operate efficiently (Browka: see [0004]).
With respect to claim 16, all limitations of claim 11 apply in which the combination of Maguire, Burnside and Browka further teaches wherein the cannula insertion system is configured to activate the safety device to retract the cannula or to release the cannula from the cannula insertion device in response to a determination of an unexpected movement between the distal end of the cannula and a target area of the human or animal body for introduction of the cannula (Browka: see paragraph 0020 and 0056, proximally directed force applied to lock clip #30 compresses spring #34 distally causing housing #28 to retract which can happen with unexpected movement).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
