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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 15, 2025 has been entered.
Response to Amendment
In response to amendment filed December 15, 2025, 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 December 15, 2025, 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 Therefore, the rejection has been withdrawn.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 Harris (US 9364171 B2).
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 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 position sensor is configured to determine whether the cannula is properly held by the cannula holder.
Von Allmen teaches a cannula (see Fig. 5, syringe #76) and a cannula holder (see Fig. 5, syringe holder #80) and further teaches a cannula holder sensor that is configured to determine whether the cannula is held by the cannula holder (see Fig. 5 and see paragraph 0034, position sensor #110 such as an encoder may be coupled to linear motor #104 to determine the position of syringe holder #80 and thereby needle assembly #30 relative to z-bar holder #82 and further determine the relative position of housing #106 along rod #108 where it is interpreted to teach that the position sensor can determine whether the syringe #76 is held by the cannula holder #80; and see paragraph 0082, when needle is outside of body the position is informed by the motor encoders which is interpreted that the encoder determines the position of sensor when held outside body).
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 Von Allem to have a sensor that determines whether a cannula is being held because it would have resulted in the predictable result of providing location of cannula with respect for relative positioning to plan trajectory of a needle to inject target vasculature (Von Allmen: see [0013]; [0034]).
Although Maguire and Von Allem teaches a cannula holder sensor that is configured to determine whether the cannula is held by the cannula holder, they do not teach that the cannula holder sensor is configured to determine whether the cannula is properly held by the cannula holder.
Harris teaches a sensor that provides positioning information (see Col 7 lines 4-15, one or more of the primary sensors #91 may be mounted on robot arm #1), where the sensor is configured to determine whether the cannula is properly held by the cannula holder (see Col 7 lines 4-15, it is interpreted that the robot arm #1 is the cannula holder and the needle #41 is the cannula where the sensors #91 are positioned at a stationary vantage point thus implying that the sensor has to identify both the insertion site and the needle to know whether the needle is in correct position which is interpreted to teach that the sensor determines whether the needle is properly held by the cannula).
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 Von Allem with the teachings of Harris to have included a sensor that determines whether a structure is properly held because it would have resulted in the predictable result of providing positioning information to a system to recognize potential insertion sites and their locations and orientations in a coordinate system (Harris: see col 7 lines 4-15).
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 Von Allmen and Harris 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 does not disclose 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 Von Allmen 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, Von Allmen 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
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/N.N.P./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791