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 .
Claim Objections
Claims 13 and 18 are objected to because of the following informalities:
Claim 13 line 2 “the surgical navigation system” is suggested to read “the navigation system” for better claim language consistency.
Claim 18 lines 5-6 “the surgical navigation system” is suggested to read “the navigation system” for better claim language consistency.
Appropriate correction is required.
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 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.
Claims 8, 11, 16-17, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al. (US PGPub 2005/0267501) in view of Edwards et al. (US PGPub 2014/0155889) in view of Malinouskas et al. (US PGPub 2011/0125138) hereinafter known as “Johnston,” “Edwards,” and “Malinouskas,” respectively.
With regards to claims 8 and 21-22, Johnston discloses (Figures 1-38) a method of operating a tool assembly (Abstract), comprising:
engaging and locking a cartridge member 112/62 to a handpiece 2 (paragraphs 127-128), wherein the cartridge member 112 includes a first line 126, a second line 128, and an electrical contact 62 configured to electrically communicate with a corresponding electrical contact of the handpiece 2 (paragraph 130; figures 5 and 10-12 – functional limitation – electrical contact 62 is capable of electrically communicating to the handpiece 2 it is engaged and locked to);
connecting a first instrument assembly 8 to the handpiece 2 and making a first connection 134 to the first line 126 and a second connection 136 to the second line 128 (figures 5 and 13-15; paragraphs 141-145 – gap 134 communicates with irrigation fluid channel 58 which communicates with irrigation fluid projection 126; distal suction channel 136 communicates with suction channel 56 which communicates with suction projection 128);
delivering electrical energy to the handpiece 2 from the first line 126 through at least one electrical contact 62 (paragraph 101– controller 6 sends signals to motor assembly 38 via electric connector 62, the signals indicated in paragraph 236 via irrigation pump prime button 280 to the first line 126), wherein engaging and locking the cartridge member to the handpiece orients the first line 126 and the second line 12 and orients the electrical contact 62 of the cartridge member 112/62 in registration with the corresponding electrical contact (see figure 5 where electrical contact 62 is connected to) of the handpiece 2;
maintaining the cartridge member 112 lockingly engaged to the handpiece 2 while removing the first instrument assembly 8 (paragraph 132- this structure provides an advantage of enabling the cutting blade assembly 8 or a part thereof to be changed without requiring that the irrigation fluid supply tube 24 and/or the suction supply tube 30 be disconnected from the handle 2, which enhances operation of the apparatus 1. This feature is especially advantageous in surgical procedures that require the cutting blade assembly 8 or a part thereof to be changed during the surgical procedure or operation, such as in sinus surgery which may require the use of more than one blade during a single operation or procedure);
after removing the first instrument assembly 8, connecting a second instrument assembly to the handpiece 2 while maintaining the cartridge member 112 lockingly engaged to the handpiece 2 (paragraph 132 – “sinus surgery which may require the use of more than one blade during a single operation”; therefore, the subsequent blade being used is the second instrument assembly and would have similar characteristics as the first instrument assembly); and
making a third connection 134 to the first line 126 and a fourth connection 136 to the second line 128 (second instrument assembly is a blade similar to the blade of the first instrument assembly 8 therefore having similar elements).
Johnston is silent wherein the cartridge is slideably engaged and locked to the handpiece (as claimed in claim 8); wherein a distal end of the handpiece includes a rail defined therein which is configured to slidingly receive a corresponding groove defined in a proximal end of the cartridge member (as claimed in claim 21); and wherein a proximal end of the rail includes a detent extending therefrom which is configured to engage a corresponding indent defined in a proximal end of the groove, the detent and indent configured to lockingly engage one another when the cartridge member is fully slidably received within the handpiece (as claimed in claim 22).
However, in a similar field of endeavor of operating a tool assembly, Edwards teaches (Figures 1-10) wherein the cartridge 70 is slideably engaged and locked to the handpiece 40 (figures 1-2; paragraph 73);
wherein a distal end of the handpiece 40 includes a rail (track 44) defined therein which is configured to slidingly receive a corresponding groove 72 defined in a proximal end of the cartridge member 70 (paragraphs 73 and 80); and
wherein a proximal end of the rail 44 includes a detent (adjacent surface of the bumps 120 and surfaces 122; paragraph 79) extending therefrom which is configured to engage a corresponding indent (bumps 120/surfaces 122) defined in a proximal end of the groove 72, the detent (adjacent surface of the bumps 120 and surfaces 122) and indent 120/122 configured to lockingly engage one another when the cartridge member 70 is fully slidably received within the handpiece 40 (paragraph 79).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the connection of the cartridge member to the handpiece of Johnston for the slideable connection of the cartridge member to the handpiece as taught by Edwards. The difference between the prior art and the claimed invention is that Johnston does not teach a slideable connection. Edwards teaches (see Figures 1-9) a similar tool comprising a slideable connection of the cartridge member to the handpiece. Accordingly, the prior art references teach that it is known that the connection of Johnston and the slideable connection of Edwards are elements that are functional equivalents for providing securement of the cartridge member to the handpiece. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the slideable connection taught by Edwards for the connection of Johnston because both elements were known equivalents for providing and would have resulted in the predictable results of providing a secure attachment of the cartridge member to the handpiece (MPEP 2143). Furthermore, Johnston discloses in paragraphs 127-128 that “any other method can be used to secure the tube connector 112 to the barrel”, therefore allowing for a simple substitution of the slideable connection of Edwards.
Johnston/Edwards are silent wherein the cartridge member includes a plurality of electrical contacts configured to electrically communicate with at least a corresponding plurality of electrical contacts of the handpiece; and wherein slidingly engaging and locking the cartridge member to the handpiece orients the plurality of electrical contacts of the cartridge member in registration with the corresponding plurality of electrical contacts of the handpiece.
However, in a similar field of endeavor of operating a tool assembly, Malinouskas teaches (Figures 6-10) wherein the cartridge member 500 includes a plurality of electrical contacts 593a/593b (paragraph 141); wherein the handpiece 600 includes a corresponding plurality of electrical contacts 693a/693b; where electrical energy is delivered through one of the plurality of electrical contacts 593a/593b (paragraph 141); and
wherein slidingly engaging and locking the cartridge member 500 to the handpiece 600 orients the plurality of electrical contacts 593a/593b of the cartridge member 500 in registration with the corresponding plurality of electrical contacts 693a/693b of the handpiece 600 (paragraph 141; figures 9-10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of operating a tool assembly of Johnston/Edwards to include a plurality of electrical contacts in the cartridge member and a corresponding plurality of electrical contacts in the handpiece as taught by Malinouskas for the purpose of identifying surgical attachment data corresponding to, e.g., a surgical attachment type and/or serial number, a cartridge or insert identifier, sensor data, and/or any other appropriate communication (paragraph 141 of Malinouskas).
With regards to claim 11, Johnston further discloses wherein making the first connection 134 and making the third connection 134 include making an irrigation supply connection (paragraphs 144-145 and 157).
With regards to claim 16, Johnston further discloses further comprising:
performing a procedure with both the first instrument assembly 8 and then the second instrument assembly 8 (paragraph 132) while irrigating a worksite through both the first instrument assembly 8 and then the second instrument assembly 8 through only the cartridge member 112 (paragraphs 130 and 144).
With regards to claim 17, Johnston further discloses wherein connecting the cartridge member 112 to the handpiece 2 includes connecting at least a power source 16, an irrigation source 22, or a vacuum source 28 (figure 2; paragraphs 81, 84-86, 141-142, 144, 225; power source 16 is indirectly coupled to the cartridge member 112 via the console 6).
With regards to claim 19, Johnston further discloses wherein the cartridge member 112/62 is the only connection to the console 6 from the handpiece 2 (see figures 1-2).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston in view of Edwards in view of Malinouskas, and further in view of Ding et al. (US PGPub 2017/0333052), hereinafter known as “Ding.”
With regards to claim 9, Johnston/Edwards/Malinouskas disclose the method as claimed in claim 8. The combination is silent to further comprising: wirelessly transferring power to at least one of the handpiece, the first assembly connected to the handpiece, or the second instrument assembly connected to the handpiece.
However, in a similar field of endeavor of operating a tool assembly, Ding teaches (Figures 1-2) wirelessly transferring power to the motor 16/18 of the medical device 10 (paragraph 63 discloses “Components of the computer system, including components of the processor and memory, may be located, for example, in components of a robotic device and system coupled to the medical device 10”; paragraph 60 discloses “the computer system may be used to control the motion of the control wires 30 and/or the rotation of the cutting tool 50, and may further be used to implement any of the various functions described herein. Motion of the medical device 10 and any other components of the robotic device may be controlled in concert with movements of those devices by an operator”; paragraph 65 discloses “The computer system may further include one or more communication interfaces. The communication interfaces can be or include wired or wireless interfaces (e.g., jacks, antennas, transmitters, receivers, transceivers, wire terminals, etc.) for conducting data communications with external sources via a direct connection or a network connection” – therefore a wireless transmission of power is provided from the computer system to the medical device 10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Johnston/Edwards/Malinouskas to include the wirelessly transferring power as taught by Ding for the purpose of removing the restrictions of a wire in a working environment.
With regards to claim 10, as rejected above, it would have been obvious to modify Johnston/Edwards to include the plurality of electrical contacts and the corresponding plurality of electrical contacts as taught by Malinouskas. Malinouskas further discloses wherein at least one electrical contact 593a/593b of the plurality of electrical contacts of the cartridge member 500 is configured to exchange information between at least one corresponding electrical contact 693a/693b of the plurality of electrical contacts disposed in the handpiece 600 upon axial alignment therewith (paragraph 141). Thus, when incorporating the plurality of electrical contacts in the cartridge member and the corresponding plurality of electrical contacts in the handpiece as taught by Malinouskas, the claimed limitation is considered obvious.
Claims 12-15, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston in view of Edwards in view of Malinouskas, and further in view of Hartmann et al. (US PGPub 2012/0296203), hereinafter known as “Hartmann.”
With regards to claims 12 and 14-15, Johnston/Edwards/Malinouskas disclose the method as claimed in claim 8. The combination is silent wherein making the second connection and making the fourth connection includes connecting a tracking device with a navigation system (as claimed in claim 12);
further comprising:
powering a tracking device with the second connection or the fourth connection;
receiving a tracking signal from the tracking device at a tracking signal receiver within the cartridge member (as claimed in claim 14); and
receiving a signal at the second connection or the fourth connection within the cartridge member from an identification member operably associated with at least one of the first instrument assembly or the second instrument assembly (as claimed in claim 15).
However, in a similar field of endeavor of operating a tool assembly, Hartmann teaches (Figure 1) wherein making the second connection 25 and making the fourth connection 25 (paragraph 20 – multiple instruments may be used and therefore the connections remain the same) includes connecting a tracking device 50 with a navigation system 20 (paragraphs 29 and 70);
further comprising:
powering a tracking device 50 with the second connection 25 or the fourth connection 25 (paragraphs 70 and 88 – communication and transmission line);
receiving a tracking signal from the tracking device 50 at a tracking signal receiver 94 within the cartridge member (paragraph 38 – tracking device 94 can be in a handle of instrument 24); and
receiving a signal at the second connection 25 or the fourth connection 25 within the cartridge member from an identification member 214 operably associated with at least one of the first instrument assembly 24 or the second instrument assembly (paragraphs 85-87).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of operating a tool assembly disclosed by Johnston/Edwards/Malinouskas to include the tracking device with a navigation system, a tracking signal at a tracking signal receiver, and an identification member as taught by Hartmann for the purpose of viewing a relative position of an instrument to a coordinate system that will ensure accurate navigation (paragraphs 19 and 46 of Hartmann).
With regards to claim 13, the combination discloses further comprising tracking a signal from the tracking device (Hartmann: 50) with the surgical navigation system (Hartmann: 20) (Hartmann: paragraph 38) via the first line (Johnston: 14), wherein the first line (Johnston: 14) is further configured to deliver power (Johnston: paragraphs 101-102) to the tracking device (Hartmann: 50) through the at least one electrical contact (Malinouskas: 593a/593b) of the cartridge member (Johnston: 112/62) and the at least one corresponding electrical contact (Malinouskas: 693a/693b) of the handpiece (Johnston: 2).
With regards to claim 18, the combination discloses the method as claimed in claim 12. Johnston/Hartmann disclose further comprising:
removing the first instrument assembly (Johnston: 8) from the handpiece (Johnston: 2; paragraph 132- this structure provides an advantage of enabling the cutting blade assembly 8 or a part thereof to be changed without requiring that the irrigation fluid supply tube 24 and/or the suction supply tube 30 be disconnected from the handle 2, which enhances operation of the apparatus 1. This feature is especially advantageous in surgical procedures that require the cutting blade assembly 8 or a part thereof to be changed during the surgical procedure or operation, such as in sinus surgery which may require the use of more than one blade during a single operation or procedure);
connecting a second instrument assembly (Johnston: 8) to the handpiece (Johnston: 2) to be powered by the motor (Johnston: 38; paragraph 132 – “sinus surgery which may require the use of more than one blade during a single operation”; therefore, the subsequent blade being used is the second instrument assembly and would have similar characteristics as the first instrument assembly).
The combination is silent wherein, upon connection of the second instrument assembly, the cartridge member:
connects a second tracking device associated with the second instrument assembly to the surgical navigation system via the first line.
However, Hartmann further teaches connecting a second tracking device (Hartmann: 50) associated with the second instrument assembly (Hartmann: 24, akin to Johnston’s: 8) to the surgical navigation system (Hartmann: 20; paragraph 20 – “the illustrated instrument 24 is only exemplary of any appropriate instrument and may also represent many instruments, such as a series or group of instruments. Identity and other information relating to the instrument 24 can also be provided to the navigation system 20”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of operating a tool assembly disclosed by Johnston/Edwards/Malinouskas/Hartmann to include a second tracking device with a surgical navigation system as taught by Hartmann for the purpose of viewing a relative position of a second instrument to a coordinate system that will ensure accurate navigation (paragraphs 19 and 46 of Hartmann).
The combination results in wherein, upon connection of the second instrument assembly (Johnston: 8), the cartridge member (Johnston: 112/62):
connects a second tracking device (Hartmann: 50) associated with the second instrument assembly (Hartmann: 24, akin to Johnston’s: 8) to the surgical navigation system (Hartmann: 20; paragraph 20 – “the illustrated instrument 24 is only exemplary of any appropriate instrument and may also represent many instruments, such as a series or group of instruments. Identity and other information relating to the instrument 24 can also be provided to the navigation system 20”) via the first line (Johnston: 14).
With regards to claim 20, as rejected above, it would have been obvious to modify the method of Johnston/Edwards to include the plurality of electrical contacts in the cartridge member and the corresponding plurality of electrical contacts in the handpiece of Malinouskas. Malinouskas further discloses wherein the information exchanged between at least one electrical contact 593a/593b of the plurality of electrical contacts of the cartridge member 500 and at least one corresponding electrical contact 693a/693b of the plurality of corresponding electrical contacts of the handpiece 600 includes at least one of: identification information relating to an instrument assembly (paragraph 141 – “a cartridge or insert identifier”). Thus, when incorporating the plurality of electrical contacts in the cartridge member and the corresponding plurality of electrical contacts in the handpiece as taught by Malinouskas, the claimed limitation is considered obvious.
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 8-12, 14-17, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-10 of U.S. Patent No. 12,114,883 (Schwamb). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are anticipated by the claims of the Schwamb patent (see table below).
Application 18/912,640 Claims
US Patent 12,114,883 (Schwamb) Claims
8
1
9
1
10
1
11
2
12
3
14
4
15
5
16
6
17
7
21
9
22
10
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 01/28/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771