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 .
Detailed Action
This is in response to the non-provisional application filed 08/23/2025
Allowable Subject Matter
Claims 2, 3, 5-10, 16, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: claim 2 recites wherein each of said first assembly and said second assembly comprise an elongate shaft having an inner central lumen extending along the shaft long axis and configured for passing of at least a segment of said at least two elongate surgical tools through.
The office agrees the art of record fail to teach or suggest these features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 11, 17, 19-21, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 6,726,675 (Beyar)
Regarding claims 1, 11, Beyar discloses as shown in Figures 2, 3 a compact robotic device capable of driving and manipulating movement of at least two elongate surgical tools, comprising: a device housing (housing of device 28, see col. 6, lines 12-20) defining an inner volume including: a first assembly (wheels 62, 66 and wheels of rollers 63, 67 of mechanism 52) comprising a first assembly housing (indicated in Figure 2), a second assembly (wheels 62, 66 and wheels of rollers 63, 67 of mechanism 54, see col. 6, lines 12-20) comprising a second assembly housing (indicated in Figure 2), wherein the first and second assemblies are located within the inner volume, where each of the first assembly and the second assembly is capable of linearly moving and/or rolling one of the two elongate surgical tools placed in direct contact with the at least two assemblies; one or more motors (motors 60, motor 61 of mechanism 50 and mechanism 54 , see col. 6, lines 59-67), wherein said at least two assemblies are aligned side by side (shown in Figure 2) within the device housing, wherein said device housing comprises walls defining entry apertures and exit apertures for the at least two elongate surgical tools. See Figure 3.
Regarding claim 4, Beyar discloses a guiding catheter unit (mechanism 50, see col. 6, lines 12-20) coupled to an external wall of said device housing (see Figure 2 showing mechanism 50 disposed within external housing of propelling device and thus necessarily coupled to in order to function as described, see col. 6, lines 12-20) and configured to hold and manipulate a third elongated surgical tool of said at least two elongate surgical tools, wherein said at least two elongate surgical tools are configured to be received within a lumen of said third elongated surgical tool.
Regarding claim 17, Beyar et al. discloses wherein an elongate surgical tool from the at least two elongate surgical tools comprises a guidewire or a microcatheter. See col. 6, lines 12-20.
Regarding claim 19, 21, Beyar discloses as shown in Figures 2, 3 a method of preparing a compact robotic device for driving and manipulating movement of at least two elongate surgical tools, comprising: a. providing a robotic device (propelling device 28, see col. 6, lines 12-20) according to claim 1, shaped and sized to be placed adjacent or on a surgical bed; b. loading at least a proximal segment of a first elongate surgical tool (guide wire 46, see col. 6, lines 12-20) into an inner volume of the device such that said proximal segment is directly contacted by a first movement driving assembly (propelling mechanism 54, see col. 6, lines 12-20) located within said inner volume; loading at least a proximal segment of a second elongate surgical tool (catheter 26, see col. 6, lines 12-20) into said inner volume of the device such that said proximal segment of said second elongate surgical tool is directly contacted by a second movement driving assembly (propelling mechanism 50, see col. 6, lines 12-20) located within said inner volume; introducing a distal segment of said first and said second elongate surgical tool into a body of a patient lying on said surgical bed; and actuating at least one motor (motors 60, motor 61 of mechanism 50 and mechanism 54 , see col. 6, lines 59-67) configured inside said inner volume of the device to drive said first and said second movement driving assemblies and thereby move said first and said second elongate surgical tools axially and/or roll said first and said second elongate surgical tools; wherein said proximal segments of said first and second elongate surgical tools contacted by said first and second assemblies lies within said same inner volume as said at least one motor; wherein said first and second assemblies are aligned parallel to one another within said device housing, not covering the device nor any portions of the device with a sterile drape.
Regarding claim 20, Beyar et al. discloses wherein bodily fluids flowing along said elongate surgical tool and which reached inside said device inner volume are allowed to flow into contact with components of the device residing in said inner volume, because Beyar et al. does not disclose any structure which would prevent this.
Beyar’s device 28 places the guidewire/catheter path through rollers/motors in an open inner volume (col. 6, lines 46-58; Fig. 2–3). Absent seals or barriers around the feed path, bodily fluids wicking along the tool necessarily enter the inner volume and can contact components; this is inherent in the disclosed configuration. See MPEP 2112.
Note: claim 20 does not actually recite the step of bodily fluids flowing along said elongate surgical tool which reach inside the device. Only a structure which allows fluids to do so.
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Regrading claim 23, Beyar et al. discloses wherein said actuating is controlled remotely using a remote control device (console 34, see col. 5, lines 12-22, 37-46.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 6,726,675 (Beyar)
Regarding claim 12, Beyar fails to disclose wherein a maximal dimension of said device housing is sized according to a distance between said entry apertures and exit apertures, as measured across said inner volume.
It would have been obvious to a person of ordinary skill in the art (POSITA) before the effective filing date of the claimed invention to size the housing’s maximal dimension to the separation between entry and exit apertures to minimize footprint while maintaining feed path alignment, a predictable packaging optimization in instrument design (KSR; MPEP 2143).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 6,726,675 (Beyar) in view of U.S. Patent Number 6,171,234 (White et al.)
Regarding claim 13, Beyar fails to disclose wherein said device housing comprises an anchoring location for holding a proximal end of said elongate surgical tool, said anchoring location located outside said inner volume.
White et al., from the same field of endeavor teaches a similar device as shown in Figure 1, where the device includes a housing comprises an anchoring location (portion of alignment device 20 outside of first mount 60) for holding a proximal end of said elongate surgical tool, said anchoring location located outside said inner volume, for the purpose of helping align the surgical tool. See col. 4, lines 63-67. This is analogous to Beyar’s field (surgical tool manipulation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device disclosed by Beyar to include the anchoring location taught by White et al. such that wherein said device housing comprises an anchoring location for holding a proximal end of said elongate surgical tool, said anchoring location located outside said inner volume in order to stabilize/align the proximal segment before entering the rollers, predictably improving tool feed reliability (KSR; MPEP 2141.01(a), 2143).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 6,726,675 (Beyar)
Regarding claim 14, Beyar fails to disclose wherein said inner volume is smaller than 2800 cm{circumflex over ( )}3 and wherein said device has a weight of less than 850 grams.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention such that wherein said inner volume is smaller than 2800 cm{circumflex over ( )}3 and wherein said device has a weight of less than 850 grams as a matter of optimizing Beyar’s packaging to meet <2800 cm³ and <850 g as routine miniaturization absent criticality, with a reasonable expectation of success. See MPEP 2144.05 (ranges/optimization).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 6,726,675 (Beyar) in view of U.S. Patent Publication Number 2005/0197566 (Strommer et al.), U.S. Patent Publication Number 2016/0030709 (Losordo et al.), U.S. Patent Number 3,789,841 (Antoshkiw) Regarding claim 22, Beyar et al. fails to disclose disposing said device including said elongate surgical tool following a surgical procedure.
Strommer, from the same field of endeavor teaches an analogous method as shown in Figure 1, where the method includes the step of disposing a similar robotic device, for the purpose of maintaining sterility. See paragraph [0025].
Losordo, from the same field of endeavor teaches an analogous method as shown in Figure 2 where the method includes the step of disposing an elongate surgical tool following the procedure so as to maintain sterility in the operating room. See paragraph [0045].
Antoshkiw from the same field of endeavor teaches an analogous method as shown in Figure 1 where the method includes the step of disposing an elongate surgical tool following the procedure so as to maintain sterility in the operating room. See col. 1, lines 6-10.
Since disposal of single-use instruments and accessories is standard sterilization practice across minimally invasive procedures (Strommer ¶[0025]; Losordo ¶[0045]; Antoshkiw col. 1, ll. 6–10), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Beyar to include the disposal step for the device and tool segments in Beyar’s method to maintain operating room sterility and meet infection-control protocols (KSR; MPEP 2141.01(a), 2143).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771