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
As of the reply filed 10/9/2025, claims 208-209, 211-214, 216-218, 220, and 228-245 are pending. Claims 1-207, 210, 215, 219, and 221-227 remain canceled. Claims 208, 218, 220, 232, 239, and 244 have been amended. Claim 245 is new.
Response to Arguments
Applicant’s amendments have overcome each of the previously set forth claim objections, therefore these objections are withdrawn.
Applicant’s arguments with respect to amended claim 208 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, in view of Applicant’s amendments to the claims.
In response to applicant's arguments that the first coupling member of the previous art “[have] no function whatsoever as a coupling element adapted to couple any part of the surgical portal… to a face mask” (see Remarks page 18) and that the features “are neither identical nor substantially identical in structure or composition, or would they be produced by identical nor substantially identical processes” (see page 19 of Remarks), the Examiner clarifies that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention (emphasis added, see MPEP 2173.05(q): “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims”) and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. This counterargument also replies to Applicant’s argument that “there is no disclosure nor is there any suggestion… of a provision of a second coupling element being provided in the surgical portal… for coupling a second end or any other end of the clamping member 100 to an instrument” (see page 21 of Remarks). Any structure which meets the claimed structural limitations is considered to be configured to perform the recited functionality (see MPEP 2112.01).
Claim Rejections - 35 USC § 102
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.
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.
Claims 208-209, 211-214, 216-217, 228-244, and 245 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray et al. (US PGPub 2010/0081881 A1).
With respect to claim 208, Murray et al. discloses an instrument shielding device (400 in Figs. 15A-C) for shielding an instrument (see Figs. 15B-C, an instrument can be inserted through the internal lumen to be shielded), the instrument shielding device (400) comprising:
an elongated shielding sleeve (408) extending between a first end and a second end and defining an elongated instrument accommodating lumen (see lumen of 408) extending therethrough from the first end to the second end for accommodating the instrument therein (an instrument can be accommodated within 408),
a sleeve storing housing (410) defining a hollow interior region (annular region within 410) and comprising:
a tubular element (406) located in and extending through the hollow interior region of the sleeve storing housing (see Fig. 15B, 406 extends through the inner region of 410),
the tubular element (406) defining with the sleeve storing housing (410), an annular storage chamber (chamber around 406 and 410) extending around the tubular element (406) in the hollow interior region (annular region within 410) for storing the shielding sleeve (408) therein in a stored state thereof (PP [0108]: “The retractor can be formed of any suitable material known in the art, for example silicone, urethane, thermoplastic elastomer, and rubber”, 408 is made of a flexible material and can be stored in the chamber/lip region around 406 and 410) with the tubular element (406) extending into the instrument accommodating lumen of the shielding sleeve (406 extends through the lumen of 408),
one of the first and second ends of the shielding sleeve (408) being sealably secured to the sleeve housing (410) in the storage chamber (see 414 in the chamber around 406 and 410), and
the tubular element (406) defining an instrument accommodating bore (406 can accommodate an instrument through its lumen) extending through the sleeve storing housing (410) for accommodating an instrument through the storage chamber (chamber around 406 and 410, an instrument inserted through the lumen through 406 would also traverse the storage chamber),
a first coupling element (unmarked bottom rim of 408) adapted to couple the first end of the shielding sleeve (408) to a face mask or a trocar (see MPEP 2112.01, the bottom rim of 408 is able to couple to a face mask or trocar), and
a second coupling element (404 in Fig. 15A) adapted to couple the second end of the shielding sleeve (400) to the instrument (see MPEP 2112.01, 402 is able to couple to an instrument).
Regarding claim 209, Murray et al. further discloses wherein the first coupling element (unmarked bottom rim of 408 in Figs. 15A-C) is adapted to sealably couple the first end of the shielding sleeve (400) to the face mask or the trocar (see MPEP 2112.01, the bottom rim of 408 can be considered adapted to sealably couple depending on the structures of the face mask or trocar).
Regarding claim 211, Murray et al. further discloses wherein the sleeve storing housing (410 in Figs. 15A-C) comprises a closure member (402 in Fig. 15A) for closing the storage chamber (see Fig. 15A, 402 can cover the central annular space defined by 410 therefore it is configured to close the chamber around 406 and 410), the closure member (402) having an access opening (see plurality of openings in Fig. 15A) therethrough for accommodating the shielding sleeve (408) therethrough from the storage chamber (see MPEP 2112.01, the sleeve 408 can be accommodated through the openings).
Regarding claim 212, Murray et al. further discloses wherein the one of the first and second ends of the shielding sleeve (408 in Figs. 15A-C), which is sealably secured to the sleeve storing housing (410) is sealably secured to the sleeve storing housing (410) in the storage chamber (chamber around 406 and 410) thereof (see 408 being sealably secured to flange 412 via 414).
Regarding claim 213, Murray et al. further discloses wherein the second end of the shielding sleeve (408 in Figs. 15A-C) is sealably secured to the sleeve storing housing (the second end is attached to the upper end of 408 and therefore is also sealably secured via 414), and the second coupling element (404 in Fig. 15A) is adapted for coupling the sleeve storing housing (410) to the instrument (see MPEP 2112.01, 404 is adapted to couple to an instrument).
Regarding claim 214, Murray et al. further discloses wherein the first coupling element (unmarked bottom lip of 408 in Figs. 15B-C) is adapted to couple the first end of the shielding sleeve (408) directly onto the face mask or the trocar adjacent an instrument port thereof, or onto a port connector, the port connector being adapted for engaging the instrument port of the face mask or the trocar (see MPEP 2112.01, the unmarked bottom lip of 408 is adapted to couple onto one of these components depending on the receiving geometry).
Regarding claim 216, Murray et al. further discloses wherein the sleeve storing housing (410 in Figs. 15A-C) is adapted to releasably engage the face mask or the trocar (see MPEP 2112.01, the entire device is adapted to releasably engage a face mask or trocar because it isn’t fixedly attached to either).
Regarding claim 217, Murray et al. further discloses wherein the first end of the shielding sleeve (408 in Figs. 15A-C) is secured to the sleeve storing housing (410), and the first coupling element (unmarked bottom rim of 408) is adapted to couple the sleeve storing housing (410) to the face mask or the trocar (see MPEP 2112.01, the bottom rim of 408 is adapted to couple the device to a face mask or trocar depending on the receiving geometry).
Regarding claims 228, Murray et al. further discloses where in the first coupling element (unmarked bottom rim of 408 in Figs. 15B-C) is adapted to releasably couple the first end of the shielding sleeve (408) to one of the face mask and the trocar (see MPEP 2112.01, the bottom rim of 408 is adapted to couple the device to a face mask or trocar depending on the receiving geometry).
Regarding claim 229, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) is adapted to sealably couple the second end of the shielding sleeve (408) to the instrument (see MPEP 2112.01, PP [0150]: “a surgical access device 400 is provided having a seal base 402 with a plurality of sealing ports 404 extending therethrough”, 404 is adapted to sealably couple the entirety of 408, including the second end, to an instrument).
Regarding claim 230, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) is adapted to releasably couple the second end of the shielding sleeve (408) to the instrument (see MPEP 2112.01, PP [0150]: “a surgical access device 400 is provided having a seal base 402 with a plurality of sealing ports 404 extending therethrough”, 404 is adapted to releasably couple the entirety of 408, including the second end, to an instrument).
Regarding claim 231, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15B-C) is stored in the stored state in the storage chamber in a collapsed state (see MPEP 2112.01, 408 can be collapsed since it is a flexible material and it is able to be stored in the chamber/overhang around 406 and 410) and is urgeable from the collapsed stored state to an extended state for shielding the instrument (408 can be collapsed and extended since it is a flexible material).
Regarding claim 232, Murray et al. further discloses wherein the access opening in the closure member (openings through 402 in Fig. 15A) is centrally aligned with the instrument accommodating bore (lumen through 406, see Figs. 15B-C, the openings through 402 are centrally aligned with this bore) extending through the tubular element (406) for accommodating an instrument through the access opening of the closure member (402), and the tubular element (406) defines, with a rim of the closure member (402) defining the access opening (openings through 402) therein, an annular access opening (see Fig. 15A, 402 and 406 define an annular space through which 408 can extend since it comprises a flexible material, see MPEP 2112.01) for accommodating the shielding sleeve (408) from the storage chamber (chamber/overhang around 406 and 410).
Regarding claim 233, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) is located in the sleeve storing housing (410, see Fig. 15A, 404 is located radially within the bounds of 410).
Regarding claim 234, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) is located in the instrument accommodating bore extending through the sleeve storing housing (see Fig. 15A, 404 is located radially within the bounds of the instrument accommodating bore of 410).
Regarding claim 235, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) is adapted to slideably engage the instrument (see MPEP 2112.01, instruments are able to slide within 404).
Regarding claim 236, Murray et al. further discloses wherein the first coupling element (see unmarked bottom lip of 408 in Figs. 15A-C) comprises a coupling ring (the unmarked lip of 408 can be considered to be a ring) adapted to engage the face mask or the trocar adjacent the instrument port thereof or the port connector for securing the first end of the shielding sleeve (408) thereto (see MPEP 2112.01, the lip of 408 can engage a face mask or trocar to secure 408 to the face mask or trocar).
Regarding claim 237, Murray et al. further discloses wherein the closure member (402 in Fig. 15A) of the sleeve storing housing (410, 402 is part of 410 when they are connected) is adapted to releasably engage the one of the face mask and the trocar (see MPEP 2112.01, 402 is configured to releasably engage a face mask or trocar).
Regarding claim 238, Murray et al. further discloses wherein the first coupling element (unmarked bottom rim of 408 in Figs. 15A-C) is configured as an engagement port for engaging an instrument port in the face mask or the trocar, or a port connector, the port connector being adapted for engaging the instrument port of the face mask or the trocar (see MPEP 2112.01,).
Regarding claim 239, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15A-C) is stored in the storage chamber (chamber/overhang around 406 and 410) with the second end thereof extending outwardly from the storage chamber (chamber/overhang around 406 and 410) through the access opening of the closure member (openings through 402) to the second coupling element (404, 408 is a flexible sleeve and is configured to be stored in this way, see MPEP 2112.01).
Regarding claim 240, Murray et al. further discloses wherein the second coupling element (404 in Fig. 15A) comprises a band (404 includes an annular seal which can be considered to be a band) adapted to extend around the instrument to releasably and sealably couple the second end of the shielding sleeve (408) to the instrument (see MPEP 2112.01, 404 is configured to extend around and releasably and sealably couple to an instrument).
Regarding claim 241, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15A-C) comprises a flexible material (PP [0108]: “The retractor can be formed of any suitable material known in the art, for example silicone, urethane, thermoplastic elastomer, and rubber”, these are flexible materials).
Regarding claim 242, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15A-C) comprises a material impermeable to air and insufflating gases (PP [0108]: “The retractor can be formed of any suitable material known in the art, for example silicone, urethane, thermoplastic elastomer, and rubber”, these materials are impermeable to gases).
Regarding claim 243, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15A-C) comprises a film material (PP [0108]: “The retractor can be formed of any suitable material known in the art, for example silicone, urethane, thermoplastic elastomer, and rubber”, these materials are thin and flexible therefore 408 can be considered to be a film).
Regarding claim 244, Murray et al. further discloses wherein the shielding sleeve (408 in Figs. 15A-C) comprises a plastic material (PP [0108]: “The retractor can be formed of any suitable material known in the art, for example silicone, urethane, thermoplastic elastomer, and rubber”, urethane is a plastic material).
Regarding claim 245, Murray et al. further discloses wherein the closure member (402 in Fig. 15A) is releasably coupled to the sleeve storing housing (410, see 422 in Fig. 15C which allows attachment/release of 402).
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.
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.
Claim 218 is rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US PGPub 2010/0081881 A1), as applied to claim 208 above, and further in view of Lehman (US Patent No. 11,020,557 B1).
Regarding claim 218, Murray et al. discloses a system comprising the instrument shielding device as claimed in claim 208 (see rejection above), but fails to disclose a face mask comprising an instrument shielding device as claimed in claim 208.
In the related field of instrument insertion devices (abstract), Lehman teaches a face mask (see Fig. 9) for the insertion of a surgical instrument (col. 4, lines 65-end and col. 5, lines 1-4: “The oral aperture 112 may facilitate insertion of an oral scope, probe or tube 168 (FIG. 9) or other equipment, instrument or device from outside the mask body 102 into the mouth 148 of the patient 142 in typical application of the medical face mask 100”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the device of Murray et al. to incorporate the teachings of Lehman and include that it is part of a system including a face mask because one of ordinary skill in the art would have recognized that a face mask “may facilitate insertion of an oral scope, probe or tube 168 (FIG. 9) or other equipment, instrument or device from outside the mask body 102 into the mouth 148 of the patient 142” (Lehman col. 4, lines 65-end and col. 5, lines 1-4), which is relevant to the Murray et al. disclosure which also focuses on the insertion of instruments. Furthermore, since Murray et al. contemplates that “The retractor can be placed in any opening within a patient's body, whether a natural orifice or an opening made by an incision” (PP [0108]), the combination as proposed would yield predictable results, providing a sealed instrument shield capable of interfacing with a face mask for preventing the escape of any gases during the procedure (Murray et al. PP [0109]: “prevent air and/or gas from escaping”).
Claim 220 is rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. (US PGPub 2010/0081881 A1) as applied to claim 208 above, and further in view of Okoniewski (Canadian Patent CA 2 751 996).
Regarding claim 220, Murray et al. discloses a system comprising the instrument shielding device as claimed in claim 208 (see rejection above), but fails to disclose a trocar.
In the same field of access devices (abstract), Okoniewski teaches an instrument shielding device (22 in Fig. 3) and a trocar (82).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Murray et al. disclosure to incorporate the teachings of Okoniewski and include a trocar with the instrument shielding device as claimed in claim 208. One of ordinary skill in the art would have been motivated to perform this modification because it involves applying a known technique (the insertion of a trocar through an instrument shielding device during a surgical procedure) with a known device (the instrument shielding device as disclosed by Murray et al.) to yield predictable results, particularly since the Okoniewski reference contemplates this combination’s use in incision-less surgery such as through the mouth (see PP [0010] of Okoniewski), which is a surgical method that is also contemplated by Murray et al. (PP [0108]: “The retractor can be placed in any opening within a patient's body, whether a natural orifice or an opening made by an incision”).
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 Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771