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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 4th, 2026 has been entered.
Response to Amendment
The claims filed on September 4th, 2026 have been entered. Claims 1-14 and 16- 21 are pending in the application. Claims 6-8, 10, and 12- 20 remain withdrawn from further consideration for being drawn to an unelected invention. The amendment to claim 21 overcome the previous claim objection.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “flexible transmission member” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“Flexible transmission member” is being interpreted as “a cable” (Paragraph 0088) or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-4, 9, 11, and 21 under 35 U.S.C. 103 over West et al. (US 2012/0271327) in view of Brock et al. (US 2007/0088340) has been withdrawn in light of applicant’s amendments; specifically West does not teach an actuator extending through the elongate flexible robotic instrument.
The rejection of claim 5 under 35 U.S.C. 103 over West et al. (US 2012/0271327) in view of Brock et al. (US 2007/0088340), as applied to claim 1 above, in view of Seibold et al. (CA 2837372) has been withdrawn in light of applicant’s amendments; specifically West does not teach an actuator extending through the elongate flexible robotic instrument.
Claim(s) 1-4, 9, 11, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitelberg et al. (US 2019/0321037) in view of Brock et al. (US 2007/0088340).
Regarding claim 1, West (West et al.) teaches a surgical system (710)(Figs. 70- 75B) for use on a patient (abstract, Paragraph 0002), comprising: a flexible elongate instrument (endoscope 712, transmission assembly 732)(abstract and Paragraph 0264) having a proximal end and a distal end (see annotated Fig. 70 below), the distal end configured for insertion through a natural orifice of the patient to access a gastrointestinal tract of the patient (Paragraph 0002 teaches that the endoscope is small enough to be inserted into the body, therefore it can be inserted through a natural orifice of the patient.); and a fastening tool (endoscopic suturing device 720) at the distal end (Paragraph 0264), the fastening tool having a first fastener holder arm (Needle holder arm 740) adapted to move a releasable tissue fastener (needle assembly 741, suture 748)(Paragraph 0264) through a path (see annotated Figs. 73A and 72B below); wherein the instrument includes an actuator (elongated transmission member 744, push member joint 752, mounting bracket 754, push member gear link 755, needle holder arm gear link 760)(Paragraphs 0264- 0265) extending through the elongate flexible instrument (As the transmission assembly is considered a part of the elongate flexible instrument, and West teaches in Paragraph 0264 that the elongated transmission member 744 extends through the transmission assembly, then the actuator extends through the elongate flexible instrument.) operably coupled to the fastener holder arm to move the first fastener holder arm (Paragraph 0265), and the instrument is adapted to drive the actuator to move the releasable tissue fastener from a first position at a first end of the path to a second position at a second end of the path (Paragraphs 0264- 0265)(see Figs. 72B- 73A).
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West does not teach wherein the surgical system is robotic, wherein the robotic surgical system comprises a robotic system, wherein the robotic system further includes a mechanized system to control movement of the robotic instrument and to operate the tissue fastening tool.
Brock (Brock et al.) teaches a robotic surgical system (10)(Figs. 1- 6)(abstract) comprising: a robotic system (drive unit 8, insert 16, 18) including a flexible robotic instrument (insert 16) having a proximal end and a distal end (see annotated Fig. 1 below), the distal end configured for insertion into a patient (Paragraphs 0049, 0141, 0142, and 0144), wherein the robotic system further includes a mechanized system (drive unit 8) to control movement of the robotic instrument and to operate a tool (18)(Paragraphs 0139- 0140).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical system as taught by West to be robotic and include a robotic system with a mechanized system as taught by Brock, since Brock teaches that this system increases “portability of the instrument assembly for ease of positioning with respect to the patient and ease of access to the patient during the procedure, e.g., avoiding bulky and unnecessary electromechanical equipment” and “increase ease of access to the patient, enabling detachment, sterilization and reusability of certain components” (Paragraph 0018 and 0019). Furthermore, Brock teaches that this system is capable of being used with any type of surgical instrument (Paragraphs 0143 and 0144).
Regarding claim 2, West and Brock make obvious the robotic surgical system as discussed above.
West further teaches wherein the releasable tissue fastener (needle assembly 741, suture 748) is a suture needle (needle assembly 741) coupled with a length of suture (suture 748)(Paragraphs 0264 and 0266).
Regarding claim 3, West and Brock make obvious the robotic surgical system as discussed above.
West further teaches wherein the actuator (elongated transmission member 744, push member joint 752, mounting bracket 754, push member gear link 755, needle holder arm gear link 760) rotates the first tissue fastener holder arm (needle holder arm 740) about an axis (see annotated Figs. 73A and 72B below)(Paragraphs 0264- 0266).
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Regarding claim 4, West and Brock make obvious the robotic surgical system as discussed above.
The combination does not teach the system further comprising human interface controls which convert human manual input to movement of a component of the robotic system via the mechanized system.
Brock (Brock et al.) teaches a robotic surgical system (10)(Figs. 1- 6)(abstract) comprising: a robotic system (drive unit 8, insert 16, 18) including a flexible robotic instrument (insert 16) having a proximal end and a distal end (see annotated Fig. 1 below), the distal end configured for insertion into a patient (Paragraphs 0049, 0141, 0142, and 0144), wherein the robotic system further includes a mechanized system (drive unit 8) to control movement of the robotic instrument and to operate a tool (18)(Paragraphs 0139- 0140). Brock further teaches the system further comprising human interface controls (input devices 3) which convert human manual input to movement of a component of the robotic system via the mechanized system (Paragraph 0066 and 0137).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical system as taught by West to further comprise human interface controls as taught by Brock, since Brock teaches that the controls enables a surgeon to remotely operate the system (Paragraph 0137), reduces the amount of space occupied by the device and reduces the complexity of the device (Paragraphs 0397, 0406, and 0410).
Regarding claim 9, West and Brock make obvious the robotic surgical system as discussed above.
West further teaches wherein the tissue fastening tool (endoscopic suturing device 720) has a longitudinal axis, and the first tissue fastener holder arm (needle holder arm 740) is rotated in a plane about an axis oriented transverse to the longitudinal axis (see annotated Figs. 73A and 72B below).
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Regarding claim 11, West and Brock make obvious the robotic surgical system as discussed above.
West further teaches wherein the first tissue fastener holder arm (needle holder arm 740) is rotated in a plane (see annotated Figs. 73A and 72B below).
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Regarding claim 21, West and Brock make obvious the robotic surgical system as discussed above.
The combination does not teach a processor comprising robotic system software configured to facilitate operation of the surgical system to perform a surgical procedure.
Brock (Brock et al.) teaches a robotic surgical system (10)(Figs. 1- 6)(abstract) comprising: a robotic system (drive unit 8, insert 16, 18) including a flexible robotic instrument (insert 16) having a proximal end and a distal end (see annotated Fig. 1 below), the distal end configured for insertion into a patient (Paragraphs 0049, 0141, 0142, and 0144), wherein the robotic system further includes a mechanized system (drive unit 8) to control movement of the robotic instrument and to operate a tool (18)(Paragraphs 0139- 0140). Brock further teaches the system further comprising a processor comprising robotic system software configured to facilitate operation of the surgical system to perform a surgical procedure (Paragraphs 0079- 0080, and 0163).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the surgical system as taught by West to further comprise a processor as taught by Brock, since Brock teaches that the processor connects the movement of a user to the drive unit for operating the system and determines the location of the distal end of a tool when the instrument is inserted into the body therefore allowing the physician to know where the tool is located (Paragraphs 0079- 0080, 0163).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitelberg et al. (US 2019/0321037) in view of Brock et al. (US 2007/0088340), as applied to claim 1 above, in further view of Seibold et al. (CA 2837372).
Regarding claim 5, West and Brock make obvious the robotic surgical system as discussed above.
West further teaches wherein the actuator (elongated transmission member 744, push member joint 752, mounting bracket 754, push member gear link 755, needle holder arm gear link 760) includes a flexible transmission member (elongated transmission member 744)(Paragraph 0264) which is driven by being pulled into tension (In Paragraphs 0264 and 0265, West teaches that the elongate transmission member of the transmission assembly is moved through axial movement and shows in Fig. 72B that it is lower when the arm is closed and higher when the arm is open in Fig. 73A, therefore the elongate transmission member is being pulled into tension when driven.).
West does not teach wherein the system further comprises a spring adapted to provide a counter force to the flexible transmission member.
Seibold (Seibold et al.) teaches a similar robotic surgical system (1)(Figs. 1- 4) for use on a patient (abstract, Page 1, Lines 8-16), comprising: an instrument (first robot element 10, second robot element 14, force transmitting device 20, pull/push rod 24/34), and a tool (grasping or cutting element 16, support element 22), the tool having a first arm (grasping or cutting element 16); wherein the instrument includes an actuator (force transmitting device 20, pull/push rod 24/34) operably coupled to the first arm to move the first arm (Page 8, Lines 18- 20), wherein the actuator includes a flexible transmission member (pull/push rod 24/34) which is driven by being pulled into tension (Page 11, Lines 6- 8, as the transmission member is taught to be a pull cable, to drive the transmission member, the cable is pulled into tension.), and a spring adapted to provide a counter force to the flexible transmission member (As Seibold teaches on Page 7, Lines 1- 10 and Page 11, Lines 6- 8 that the pull/push rod can be a spring-biased pull cable, there is a spring that provides the bias to the pull/push rod and therefore act as a counter force to the flexible transmission member.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by West to have a spring adapted to provide a counter force as taught by Seibold, since Seibold teaches that the spring allows for the grasping and/or cutting elements of the instrument to return to the open position under the spring bias during use (Page 7, Lines 3- 10) therefore allowing for the device to return to a neutral position after use.
Response to Arguments
Regarding applicant’s arguments filed March 16th, 2026 with respect to the 103 rejection of claims 1-4, 9, 11, and 21 over West et al. (US 2012/0271327) in view of Brock et al. (US 2007/0088340) and the 103 rejection of claim 5 over West et al. (US 2012/0271327) in view of Brock et al. (US 2007/0088340) in view of Seibold et al. (CA 2837372) have been fully considered but are moot since, as discussed above, the previous prior art rejections have been withdrawn in view of applicant’s amendments. However, it is noted that Brock and Seibold is still relied upon for limitations not argued.
Applicant’s arguments, see Pages 6-7, regarding the 35 U.S.C. 112(f) interpretation of “flexible transmission member” has been fully considered but is not persuasive. This limitation is being considered under 112(f) due to the language of “transmission member”, which invokes functional language of transmitting as an actuator. As “member” is a generic placeholder, 112(f) is invoked.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
