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
This office action is responsive to the amendment filed on 01/02/2026. As directed by the amendment: claim 1 has been amended and claim 9 has been cancelled. Thus, claims 1-8 and 10-20 are presently pending in this application.
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:
“limiter that limits” in claim 13; for examination purposes this limitation will be interpreted based on [0063] as a tab or protrusion mating with a slot, a notch, stop, spring-loaded mechanism and structural equivalents thereof;
“release mechanism for releasing” in claim 14; for examination purposes this limitation will be interpreted based on [0063] as a pushable protrusion and structural equivalents thereof.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 depends from claim 9 which is cancelled rendering the scope of the claim unclear. For examination purposes, the claim will be interpreted as dependent from claim 1.
Claim 10 recites the limitation "the set of blade mounts" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites “the expandable cutting tool includes a set of blade mounts” however independent claim 1 recites “two blade mounts” rendering it unclear if the set of blade mounts in claim 11 is the same as the two blade mounts in claim 1. For examination purposes, the limitation will be interpreted as “the two blade mounts”
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.
Claims 1, 3, 4, 6, 8, 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Huddleston (US 20130190793 A1) in view of Burroughs et al. (US 20230099684 A1).
Regarding claim 1 Huddleston discloses (fig. 1-2) a scalpel device 10 comprising:
a body 40 sized to translate within a guide tube for delivery to a patient (see note below);
an expandable cutting tool (20+30) coupled with a distal end of the body 40 (see [0074]),
an actuator including a control feature 52 coupled with a proximal end of the body 40 (see fig. 1), wherein the actuator enables adjustment of the expandable cutting tool (20+30) according to an incision width selected from a set of incision widths defined by the control feature (see [0076]).
The language “the sized to translate within a guide tube for delivery to a patient” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Huddleston meets the structural limitations of the claim, and the body is capable of translating within a guide tube for delivery to a patient as there are many sizes of guide tubes that 40 could fit into.
Huddleston is silent regarding the expandable cutting tool comprising a one-piece cartridge configured to be removably coupled with a distal end of the body, wherein the one-piece cartridge comprises a main body and two blade mounts each connected to a blade.
However Burroughs, in the same filed of endeavor, teaches (fig. 2A-2C, 3D and 5) a scalpel device comprising: a body 204, a cutting tool 202 (see fig. 2A and [0044]), wherein the cutting tool 202 comprising a one-piece cartridge 202 (see [0044]) configured to be removably coupled with a distal end of the body 204 (see [0048]), wherein the one-piece cartridge 202 comprises a main body 210 and two blade mounts (412, 414) each connected to a blade (206, 208; see fig. 4A and [0047]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Huddleston to have the expandable cutting tool comprising a one-piece cartridge configured to be removably coupled with a distal end of the body, wherein the one-piece cartridge comprises a main body and two blade mounts each connected to a blade as taught by Burroughs, for the purpose of being able to use different size blades as needed for different procedures (see Burroughs [0046]).
Regarding claim 3, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston further discloses (fig. 1-2) the cutting assembly includes a scalpel blade (20, 30), and wherein adjustment of the scalpel blade includes at least one of changing an angle of the scalpel blade relative to an axis of the body (see fig. 1-2 and [0076]).
Regarding claim 4, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston further discloses (fig. 1-2) the scalpel blade includes a plurality of scalpel blades (20, 30) pivotably coupled to one another (see fig. 1-2 and [0076]).
Regarding claim 6, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston further discloses (fig. 1-2) the body 40 includes an outer shaft 40 and an inner shaft 60 within the outer shaft (see [0076]).
Regarding claim 8, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston further discloses (fig. 1-2) the actuator 50 is coupled with a proximal end of the body (see fig. 1-2).
Regarding claim 10, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston as modified further teaches each blade (Huddleston 20, 30) has a cutting edge (see Huddleston [0076]) and a coupler (opening in 206, 206, see Burroughs fig. 4A-4B) for connecting with the set of blade mounts (see Burroughs fig. 4A-4B and [0047]).
Regarding claim 11, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 8. Burroughs further teaches the expandable cutting tool 202 includes a set of blade mounts (412, 414, see fig. 4A-4B and [0047]) coupled with a distal end of the body 204 (see fig. 5, the blade mounts are indirectly coupled with the body), wherein the set of blade mounts (412, 414) enable detachable coupling of at least one blade to the body (the entire portion 202 is detachably coupled with the body; furthermore blade mounts 412 and 414 are protrusions received by openings in the blade. With enough force applied one could remove the blades from the protrusions).
Regarding claim 12, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Huddleston further discloses (fig. 1-2) the actuator 50 includes at least one of a push-to-actuate feature (see [0076]).
Regarding claim 13, Huddleston as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Huddleston further discloses (fig. 1-2) the control feature 52 includes a limiter (edges that engage one another) that limits the push-to-actuate feature 50 (see annotated fig. 2 below).
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Claims 1-4, 6-8, 12, 13, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sivadas et al. (US 20230143304 A1) in view of Huddleston and Burroughs.
Regarding claim 1 Sivadas discloses (fig. 1-8) a scalpel device comprising:
a body 110 sized to translate within a guide tube 30 for delivery to a patient (see fig. 1, [0029] and [0035]);
an expandable cutting tool 10 coupled with a distal end of the body 110 (indirectly via pin 150, see [0044] and via contact with the distal end, see fig. 8), the expandable cutting tool 160 including a cutting assembly (scalpel blade; see [0030] and fig. 7-8); and
an actuator 180 including a control feature 120 (see [0049]) coupled with a proximal end of the body 110 (indirectly via pin 150, see [0044] and via contact with the proximal end, see fig. 5 and 8), wherein the actuator 180 enables adjustment of the cutting assembly according to an incision width selected from a set of incision widths defined by the control feature (see fig. 7-8 and [0049]).
Sivadas is silent regarding the expandable cutting tool includes two blades.
Huddleston, in the same filed of endeavor, teaches (fig. 1-2) a scalpel device 10 comprising: a body 40; an expandable cutting tool (20+30) coupled with a distal end of the body 40 (see [0074]), an actuator including a control feature 52 coupled with a proximal end of the body 40 (see fig. 1), wherein the actuator enables adjustment of the expandable cutting tool (20+30) according to an incision width selected from a set of incision widths defined by the control feature (see [0076]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas to have the expandable cutting tool includes two blades as taught by Huddleston, for the purpose of being able to create a wider opening by cutting both sides of the incision (see Huddleston [0016], [0041]-[0048]).
Sivadas as modified is silent regarding the expandable cutting tool comprising a one-piece cartridge configured to be removably coupled with a distal end of the body, wherein the one-piece cartridge comprises a main body and two blade mounts each connected to one of the blades blade.
However Burroughs, in the same filed of endeavor, teaches (fig. 2A-2C, 3D and 5) a scalpel device comprising: a body 204, a cutting tool 202 (see fig. 2A and [0044]), wherein the cutting tool 202 comprising a one-piece cartridge 202 (see [0044]) configured to be removably coupled with a distal end of the body 204 (see [0048]), wherein the one-piece cartridge 202 comprises a main body 210 and two blade mounts (412, 414) each connected to a blade (206, 208; see fig. 4A and [0047]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have the expandable cutting tool comprising a one-piece cartridge configured to be removably coupled with a distal end of the body, wherein the one-piece cartridge comprises a main body and two blade mounts each connected to one of the blades as taught by Burroughs, for the purpose of being able to use different size blades as needed for different procedures (see Burroughs [0046]).
Regarding claim 2, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the control feature includes a lock 120 for fixing a position of the cutting assembly (see [0049]).
Regarding claim 3, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the cutting assembly includes a scalpel blade 10 (see fig. 7-8 and [0030]), and wherein adjustment of the scalpel blade includes at least one of: changing an angle of the scalpel blade relative to an axis of the body (see fig. 8 [0044] and [0052]).
Regarding claim 4, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the scalpel blade includes a plurality of scalpel blades pivotably coupled to one another (the device can include scissory which care 2 blades pivotably coupled to one another, see [0031]).
Regarding claim 6, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the body 110 includes an outer shaft 110 and an inner shaft 160 (160 is coupled to 110 thus it can be considered part of the body; see [0044]) within the outer shaft (see fig. 7-8).
Regarding claim 7, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 6. Sivadas further discloses (fig. 1-8) the outer shaft includes a set of external grooves 114 for aligning the scalpel device with the guide tube 30 (see fig. 2 and [0036]), wherein the set of external grooves aids in orienting the cutting assembly relative to the patient (see [0036]).
Regarding claim 8, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the actuator 180 is coupled with a proximal end of the body (via 160, see fig. 7).
Regarding claim 12, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the actuator includes at least one of a push-to-actuate (the actuator is pushed by the user to move the device; see fig. 8 and [0048]).
Regarding claim 13, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 12. Sivadas further discloses (fig. 1-8) the control feature 120 includes a limiter 122 (a tab meeting the interpretation under 112f) that limits the push-to-actuate (see [0049]).
Regarding claim 18, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) the expandable cutting tool is sized to fit within the guide body when retracted (the expandable cutting tool is capable of fitting within the guide body when retracted) and expand radially beyond the guide body when extended (see fig. 7-8). The language “the expandable cutting tool is sized to fit within the guide body when retracted” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sivadas meets the structural limitations of the claim, and the expandable cutting tool is capable of fitting within the guide body when retracted. The cutting tool is slidable in the body and smaller than the body thus it is capable of fitting in the body if retracted.
Regarding claim 19, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas further discloses (fig. 1-8) a surgical robot system comprising the scalpel device of claim 1 (see [0029]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sivadas in view of in view of Huddleston and Burroughs, as applied to claim 13 above, and further in view of Marczyk et al. (US 20160256188 A1).
Regarding claims 14 and 15, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 13. Sivadas as modified is silent regarding the limiter includes a release mechanism for releasing the actuator; the release mechanism causes the actuator to revert to a default position.
However Marczyk, in the same field of endeavor, teaches (fig. 1) a limiter 970 includes a release mechanism 974 (pushable projection meeting the interpretation under 112f) for releasing an actuator (see [0035]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have the limiter includes a release mechanism for releasing the actuator as taught by Marczyk, for the purpose of being able to quickly and easily release the lock on the actuator (see Marczyk [0035]).
Sivadas as modified teaches the release mechanism causes the actuator to revert to a default position. Sivadas is modified to have the release mechanism on the limiter and release the lock of the actuator. This release would allow the actuator to be freely moveable and thus return to whatever is its natural default position.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sivadas in view of in view of Huddleston and Burroughs, as applied to claim 13 above, and further in view of Prywes (US 5,224,950) and Marczyk.
Regarding claims 16 and 17, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas as modified is silent regarding the actuator includes a visual indicator of the incision width; adjustment of the actuator causes a change in the visual indicator of the set of incision widths.
However Prywes, in the same field of endeavor, teaches (fig. 1-3) a visual indicator of the incision width (col. 4 ln. 30-42).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have a visual indicator of the incision width as taught by Prywes, for the purpose of the use being able to tell how far and deep they have gone (see Prywes col. 4 ln. 30-42).
Sivadas as modified is silent regarding the actuator includes the visual indicator, adjustment of the actuator causes a change in the visual indicator of the set of incision widths.
However Marczyk, in the same field of endeavor, teaches (fig. 1 and 3) an actuator (940+950) includes a visual indicator 958 (see [0034]); adjustment of the actuator causes a change in the visual indicator (see [0034]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have the actuator includes the visual indicator, adjustment of the actuator causes a change in the visual indicator as taught by Marczyk, for the purpose of being able to see the visual indication at the rear of the device making it easier for a user to determine (see Marczyk [0034]).
Sivadas as modified teaches adjustment of the actuator causes a change in the visual indicator of the set of incision widths. Sivadas is modified to have a visual indicator that indicated insertion width and is further modified to have that indication change upon adjustment.
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sivadas in view of in view of Huddleston and Burroughs, as applied to claim 13 above, and further in view of Hussain et al. (US 20180064497 A1).
Regarding claim 5, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Sivadas as modified is silent regarding the guide tube includes a dilator.
However Hussain, in the same filed of endeavor, teaches (fig. 7B) a guide tube 606, wherein the distal end of the guide tube includes a taper that can function as a dilator (see fig. 7B). The Office notes that applicant’s guide tube has a similar taper which is the only part capable of being a dilator.
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have the distal end of the guide tube includes a taper that can function as a dilator, as taught by Hussain since it has been held that a change in shape is an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed shape was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 20, Sivadas as modified discloses the claimed invention substantially as claimed, as set forth above for claim 19. Sivadas further discloses (fig. 1-8) a robot having a robot arm 20 (see [0029]); the guide tube for receiving the body 110 of the scalpel device (see fig. 1).
Sivadas as modified fails to expressly disclose a robot base, the robotic arm coupled to the robot base an end-effector coupled to the robot arm, the end effector including the guide tube.
However Hussain, in the same filed of endeavor, teaches (fig. 6-8) a robot having a robot base 610, a robot arm 604 coupled to the robot base 610 (see fig. 6 and [0069]), and an end-effector 602 coupled to the robot arm 604 (see fig. 6 and [0069]), the end effector including a guide tube 606 (see [0069] and fig. 6-8).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sivadas as modified to have a robot base, the robotic arm coupled to the robot base an end-effector coupled to the robot arm, the end effector including the guide tube, as taught by Hussain for the purpose of assisting the user with operating on the patient (see [0069]).
Response to Arguments
Applicant’s arguments, see pg. 4-6, filed 01/02/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Huddleston and Burroughs.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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