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
Drawings/Specification
The drawings (and corresponding portions of the specification) are objected to because pages 6, 11 and 19 of the drawings all have “blank” drawings (i.e., Figures 14, 26-28, and 38-39). Accordingly, the drawings must be amended to remove these blank figures, and the specification must be amended with regard to any discussion or mentioning of these and all figures once the drawings are amended and new figure numbers are provided.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 38 is objected to because of the following informalities:
Claim 38 is objected to because it is missing a period at the end of the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
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 34 is 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 34 is rejected because “the fixing” lacks antecedent basis. It is believed that this claim should depend from claim 33 and not claim 22.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22 and 38-39 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pennoyer et al. (US Patent Pub. No. 2020/0188050, with priority to provisional application 62/546201 filed Aug. 16, 2017).
Pennoyer discloses a dispenser unit for applying a sterile drape (see Figure 4A illustrating a drape 200 as it would be received by the clinician in a telescopically folded form, see paragraph 54) over a surgical robotic arm having a base end and an end effector end (see drape 200 over robotic arm in Figure 3C), comprising:
a sterile drape (see drape 200 in folded form in Figure 4A and unfolded form in Figure 4B) with longitudinal sleeve form closed at one end and open at the other end (see longitudinal form in Figure 4B with closed end 200a and open end 200d), folded so as to reduce its longitudinal length (see drape 200 in folded form in Figure 4A, see paragraph 54) while maintaining a passage through the folded sleeve to the closed end (see Figure 4A which denotes the center of the drape in the folded form as both cavity 208 (see paragraph 56) and proximal opening 218),
an applicator fixed… to the open end of the longitudinal sleeve (see “deployment handle 300 red to facilitate positioning and maneuvering of drape 200 for covering surgical assembly 100, surgical robotic arm 2, and/or robotic arm cart 10” – paragraph 64, see handle 300 located at the open end 200d in Figure 4B; note that “optionally detachably” in this line is optional and therefore not required by the claim)
wherein the passage is configured to receive the robot arm (see Figure 3C),
the closed end of the longitudinal sleeve is configured to abut with robot arm effector end (see Figure 3C, showing closed end 200a at the robotic arm end effector),
the dispenser unit (note that the dispenser unit comprises the sterile drape and the applicator as claimed) configured to unfold the longitudinal sleeve over the robotic arm by movement of the applicator or robotic arm to bring the applicator closer to the base end of the robotic arm (see paragraph 73-74 for a description of how Pennoyer teaches to apply the drape over the robot arm, which meets this claim limitation).
Regarding claim 38, Pennoyer teaches that “drape 200 may be made of low-density polyethylene (LDPE), high-density polyethylene (HDPE), polypropylene, polyurethane, and/or polyethylene materials or other similar non-toxic, biocompatible compounds.”
Regarding claim 39, Pennoyer teaches that “Drape 200 may be translucent so that the components of surgical assembly 100 that drape 200 covers remain visible to a clinician” (see paragraph 53).
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 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pennoyer in view of Dye et al. (WO 2012/078620).
Pennoyer is described above with respect to claim 22. However, Pennoyer does not disclose a plurality of drapes packaged together, as claimed.
Dye teaches “methods and materials related to portals that can be used to create a channel through a surgical drape without compromising the sterile operating field. For example, a portal provided herein can include an applicator frame and sheath (e.g., flexible sheath) that is capable of creating a channel into a sterile operating field so that a device, whether sterile or not, can be used at the time of surgery without compromising the sterility of the surgical field” (see Abstract). In Dye, the “portal” is the drape through which the surgical instrument extends through. Dye teaches that “Portal 30 including an applicator frame 32 and sheath 34 as described herein can be packaged as a medical kit. The medical kit can include at least one portal 30. The medical kit can include more than one, such as two, three, or a plurality of portals 30” (see page 17, lines 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to package multiple portals (i.e., drapes) together in a single package/dispenser, as taught by Dye, thereby reducing costs and unnecessary use of additional packaging via packaging each drape singularly. Additionally, whether or not each “applicator” of each drape is attached to one or more other “applicators” within the packaging by this combination would be a matter of obviousness to one ordinary skill in the art, since it has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPC 70), and there is no disclosed criticality presented as to why this configuration is necessary.
Regarding claim 24, Dye teaches that the portal can be attached to different structures or supports, such as drape 28 in Figure 8. In this example figure, the drape 28 holds the portal and the surgical instrument is fed through from a non-patient side of the operating room. As such, the portal is attached to the support (drape 28 and stands holding the drape) for the particular procedure, and it maintains the portal in a fixed position relative to the surgical device (which would be a robotic arm based on the combination of this with Pennoyer) while the surgical device/robotic arm is advanced into the passage, as claimed.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Pennoyer in view of Devengenzo et al. (US Patent Pub. No. 2017/0086934).
Pennoyer is described above with respect to claim 22. However, Pennoyer does not disclose the use of magnetic clasps.
Devengenzo teaches a surgical drape for a patient side cart of a teleoperated surgical system [that] may include a body and an attachment device feature (see Abstract). “According to an exemplary embodiment, surgical drape 400 may include one or more attachment devices 412 configured to attach surgical drape 400 to a portion of a patient side cart … Attachment devices 412 may be chosen from, for example, a variety of mechanical fasteners (e.g., snap fasteners), magnetic fasteners, or other types of fasteners familiar to one of ordinary skill in the art” (see paragraph 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize magnetic clasps/fasteners “to attach surgical drape 400 to a portion of a patient side cart”, as taught by Devengenzo, within the system and methods of Pennoyer because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claims 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Pennoyer in view of Mohan et al. (US Patent No. 6,123,080).
Pennoyer is described above with respect to claim 22. However, the applicator of Pennoyer is not a frame, as claimed.
Mohan teaches a drape (see Title), where “the drape comprises a sleeve and a ring-shaped former. The ring-shaped former is arranged coaxially inside the sleeve, the majority of the latter being multiply folded over and carried on the ring-shaped former” (see Abstract). Figure 1 illustrates the drape folded within the former ring 16, with Figure 3 illustrating the ring being passed over elongate surgical equipment. As shown, the ring passes over the distal-most end of the surgical equipment and then continues down the length of the surgical equipment to a proximal end of the equipment, with the surgical equipment passing through an aperture at the center of the frame 16, and the drape unfolding as it is moved along the length of the surgical equipment.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a frame, as taught by Mohan, with the system and methods of Pennoyer because telescopic and concertina style drapes “require materials capable of retaining intricate shapes, not to mention experienced application, without which the integrity of the sterile covering may be impaired” (see column 1, lines 36-39), and the frame of Mohan solves this dilemma which would be experienced by the use of the drape of Pennoyer.
Regarding claim 35, it is evident from Figures 1 and 3 that the frame is annular shaped (also see column 2, lines 53-55).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Pennoyer in view of Tovey et al. (WO 00/41614).
Pennoyer is described above with respect to claim 22. However, Pennoyer does not disclose that the open frame is detachable.
Tovey teaches “a sterile sheath and applicator apparatus for use with a surgical instrument” (see Abstract). Figure 2 illustrates a handle (or frame) 14 that is detached from a sterile sheath 12. Figure 4 illustrates the combined handle and sheath for placement over a surgical device, with Figure 5 illustrating the sheath placed over the surgical device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a handle and open frame that can be attached and removed from a sheath, as taught and illustrated by Tovey, with the system and methods of Pennoyer, because this would allow for re-use of the handle with different sterile sheaths, thereby not requiring repeated manufacture of the handle for each sheath, improving costs for such manufacturing.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Pennoyer in view Mohan as applied to claim 33 above, and further in view of Tovey.
Pennoyer in combination with Mohan is described above with respect to claim 33. However, neither Pennoyer nor Mohan disclose that the open frame has a handle.
Tovey teaches “a sterile sheath and applicator apparatus for use with a surgical instrument” (see Abstract). Figure 2 illustrates a handle (or frame) 14 that is detached from a sterile sheath 12. Figure 4 illustrates the combined handle and sheath for placement over a surgical device, with Figure 5 illustrating the sheath placed over the surgical device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a handle and open frame that can be attached and removed from a sheath, as taught and illustrated by Tovey, with the system and methods of Pennoyer, because this would allow for re-use of the handle with different sterile sheaths, thereby not requiring repeated manufacture of the handle for each sheath, improving costs for such manufacturing.
Regarding claim 37, Tovey teaches that “in a preferred embodiment, handle 32 is rigid. Alternatively, it is envisioned that handle 32 may be relatively flexible” (see page 5, lines 22-23).
Conclusion
The following prior art is herein made of record is considered pertinent to applicant's disclosure, but not relied upon in the rejections above:
US Patent 10799211 to Nordgren – see Figures 1-4
D877931 to DaCosta et al. – see all Figures
WO 2018/004531 to Hutchison et al. – see all Figures
WO 2014/160224 to Marinchak – see all Figures
GB 2483154 to Mohan – see Figure 1, illustrating rigid open frame holding folded drape.
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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