DETAILED ACTION
This Office Action is in response to the restriction response filed 22 June 2026.
Notice of 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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Group 1 drawn to an introducer assembly, an actuation unit and a shearing unit (claims 42-48, 58-59) in the reply filed on 22 June 2026 is acknowledged.
Please note that dependent claims 68 and 69 were erroneously listed with Group 1 in the 23 April 2026 Unity of Invention Requirement. Claim 68 depends from claims 49 and intervening claim 52 and therefore, should have been listed with Group 2, drawn to a system including a shearing unit and an actuation unit. Claim 69 depends from claim 49 and intervening claims 53, 54 and also should have been listed with Group 2. Because claims 68 and 69 are dependent from withdrawn claims, they are also withdrawn from examination.
Claims 49-57, 60-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 22 June 2026.
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: “shearing unit” in claim 42. Paragraph [0084] of the specification states “As used in the present application, shearing refers to any separation of parts of tissue by tools such as a scalpel, scissors, or any other instruments for sharp or blunt dissection.”
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.
Claim 46 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 pre-AIA the applicant regards as the invention.
Claims 43, 44 recites the limitation “the mounting section”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claim should refer to “the at least one mounting section”.
Claims 45, 47 recites the limitation "the actuation unit”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, the claim should refer to “the at least one actuation unit”.
Claim 46 recites the limitation "the at least one mounting section”. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation "the engagement member”. There is insufficient antecedent basis for this limitation in the claim.
Claim 59 recites “the system comprises one actuation unit” while independent claim 58 introduces “at least one actuation unit”. It is unclear if the actuation unit of claim 59 is the same actuation unit introduced in claim 58. For the purpose of examination, Examiner will assume this is referring to the same actuation unit.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 42, 46-48, 58 are rejected under 35 U.S.C. 103 as being unpatentable over Sandhu et al. (US Patent Publication 2013/0165946) in view of Call et al. (US Patent 10,065,025).
Claim 42, 58: Sandu’946 teaches a system (10) for controlling an instrument assembly in a patient’s body, including a sheath (408) and an inner guiding unit (406) such that the sheath and guiding unit are movable relative to each other (paragraph [0055]);
wherein the system comprises at least one actuation unit (402 or 404) which is configured to actuate at least one the sheath and the guiding unit in a longitudinal direction of the assembly (paragraph [0055]).
Sandu’946 does not teach the assembly is an introducer assembly including a dilator, sheath, inner guiding unit and a dilator with a tapered outer section, but teaches the system (10) can be used with more than two instruments (paragraph [0043])
Sandu’946 incorporates Kirschenman et al. (US Patent Publication 2009/0247993) at paragraph [0006]. Kirschenman’993 is directed towards a similar system (see Figures 1 and 2b, for example). Kirschenman’993 teaches the system can be used with various instruments, including cutting tools and needle/dilator tools (paragraph [0068]).
Call’025 teaches an introducer assembly including a dilator (58) having a tapered outer section (Figure 10c shows the dilator is tapered) and a distal opening (guiding unit 16 is passing through the dilator in Figure 10c) arranged concentrically around a guiding unit 16, a sheath (56) having a distal opening (58 passes through sheath 56) and arranged around the dilator (Figure 10c). The guiding unit (16), dilator (58) and sheath (56) are movable relative to each other in a longitudinal direction (see Figures 10a-c).
Further regarding claim Call’025 further teaches a shearing unit (4; column 11, lines 20-22) which is actuatable to perform a sheared aperture at the insertion site (column 20, lines 26-36).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Sandu’946 with the dilator, sheath, inner guiding unit taught by Call’025 by connecting the dilator, sheath, inner guiding unit to a cassette so that they can be remotely and precisely controlled using the remote control and guidance system taught by Sandu’946 (Sandu’946 at paragraph [0006]). Sandu’946 and Kirschenman’993 teach using the system with different instruments (citation above).
Further regarding claim 42, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the modified device of Sadnu’946 with an actuatable (i.e. advanceable) shearing unit to create a sheared aperture at the insertion site, as taught by Call’025, in order to create an initial puncture in tissue for the dilator, sheath and guiding unit to pass through into a vessel.
Claim 46: Sandu’946 teaches the system comprises at least one guiding element (316) so that the actuation unit (402 or 404) and mounting section (426) is movable along the guiding element (paragraph [0054]; note: 426 is part of the cartridge 402/404; cartridge 402/404 is mounted to a manipulation base 308/310 which moves along guiding element 316).
Claim 47: Sandu’946 teaches the system includes a processing unit (200) adapted for control of the actuation unit (paragraphs [0041], [0042]).
Claim 48: Sandu’946 teaches the system includes the biomedical device (Sandu’946 discloses various elements in Figure 1 that are biomedical devices).
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Sandhu’946 in view of Call’025, as applied to claim 42, further in view of Canale et al. (WO 2021/011554)
Note: For ease, please note Canale’554 is published as US Patent Publication 2022/0233263, however, the rejection relies solely on the WIPO document.
Claim 43: Sandu’946 teaches the system has at least one mounting section (426) adapted for mounting at least one part of the instrument assembly (paragraph [0062]). The mounting section (426) has a partially open shape in the radial direction corresponding to the mountable instrument.
Sandu’946 does not explicitly disclose the instruments are releasably detached from the mounting section.
Like Sandu’946, Canale’554 teaches a robotic surgical system including a plurality of actuation units (32a-32d) each carrying the proximal end of a respective surgical instrument (“EMD”/elongate medical device; paragraph [0172]) in order to move the instruments relative to each other.
Canale’554 teaches the actuation units include a mounting section (Figure 26 shows the actuation unit has a mounting section 252 for removably mounting a part (242, 244) of a respective surgical instrument (240, 242, 244) (paragraph [0185]. This allows for the user to exchange instruments, as needed during the surgery (paragraph [0185]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Sadnu’946 such that the mounting section releasably mounts an instrument, as taught by Canale’554, in order to the user to easily exchange or switch instruments, as needed during surgery.
Claim 44: Sandu’946 does not teach the system has an engagement member.
Like Sandu’946, Canale’554 teaches a robotic surgical system including a plurality of actuation units (32a-32d) each carrying the proximal end of a respective surgical instrument (“EMD”/elongate medical device; paragraph [0172]) to move the instruments relative to each other.
Canale’554 teaches the mountable part of the surgical instrument is fixedly held within the mounting section with an engagement member in an engagement configuration (“cassette cover” is used in paragraphs [0218], [0247], [0248]; it is shown in Figure 7 as a cover attached to the cassette 91 via a hinge; Figures 13 and 75 show the engagement configuration). Canale’554 teaches the engagement member has a disengagement configuration in which the mountable part of the instrument (EMD) can be removed from the system (paragraphs [0247], [0248]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Sadnu’946 with an engagement member, as taught by Canale’554, in order to maintain the position of the instrument so it does not disengage from the actuation unit.
Claims 42, 43, 45, 47, 48, 58, 59 are rejected under 35 U.S.C. 103 as being unpatentable over Meglan et al. (US Patent 6,096,004) in view of Call’025.
Claim 42, 58: Meglan’004 teaches a system (Figure 2) for controlling an instrument assembly in a patient’s body, including a sheath (80) and an inner guiding unit (76) such that the sheath and guiding unit are movable relative to each other (column 4, lines 50-57)
wherein the system comprises at least one actuation unit (70) which is configured to actuate at least one the sheath and the guiding unit in a longitudinal direction of the assembly (column 4, lines 50-57).
Meglan’004 does not teach the assembly is an introducer assembly including a dilator, sheath, inner guiding unit and a dilator with a tapered outer section, but does teach the device can be used with various instruments (“catheters or similar tools”, abstract).
Call’025 teaches an introducer assembly including a dilator (58) having a tapered outer section (Figure 10c shows the dilator is tapered) and a distal opening (guiding unit 16 is passing through the dilator in Figure 10c) arranged concentrically around a guiding unit 16, a sheath (56) having a distal opening (58 passes through sheath 56) and arranged around the dilator (Figure 10c). The guiding unit (16), dilator (58) and sheath (56) are movable relative to each other in a longitudinal direction (see Figures 10a-c).
Further regarding claim 42: Call’025 further teaches a shearing unit (4; column 11, lines 20-22) which is actuatable to perform a sheared aperture at the insertion site (column 20, lines 26-36).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Meglan’004 with the dilator, sheath, inner guiding unit taught by Call’025 by connecting the dilator, sheath, inner guiding unit to a cassette so that they can be remotely and precisely controlled using the remote control and guidance system taught by Meglan’004 (column 2, line 66 to column 3, line 8). Meglan’004 teaches using the system with different instruments (citation above).
Further regarding claim 42: It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the modified device of Meglan’004 with an actuatable (i.e. advanceable) shearing unit to create a sheared aperture at the insertion site, as taught by Call’025, in order to create an initial puncture in tissue for the dilator, sheath and guiding unit to pass through into a vessel.
Claim 43: Meglan’004 teaches the system has a mounting section (area within tubes 96, 96 and between rollers 122, 140 as shown in Figure 6) adapted for releasably mounting an instrument. The mounting section is open in a radial direction (see openings of tube 98) corresponding to the mountable part of the instrument.
Claim 45, 59: Meglan’004 teaches the actuation unit (70) comprises a clutch (124) comprising two rollers (122, 140) which have an adjustable interdistance (Figures 8, 9; column 7, lines 21-29, 50-65). The actuation of the actuation unit can be switched between configurations to actuate different instruments having a different width/thickness (Figures 8-9).
Claim 47: Meglan’004 teaches the system comprises a processing unit (column 4, line 61 to column 5, line 15).
Claim 48: Meglan’004 teaches the system comprises the biomedical device (Meglan’004 discloses various elements in Figure 2 that are biomedical devices).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 28 July 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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