DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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(s) 22 is/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 22 recites “the second sealing element includes a first rigid ring seating the first sealing element therein” in line 5; which renders the claim indefinite, since it is unclear how the first sealing element can be seated in the first rigid ring of the first support and in a first rigid ring of the second sealing element. It appears that the claim should instead recite “the second support includes a second rigid ring seating the second sealing element therein”; and for the purpose of compact prosecution will be examined below under this assumption.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 20, 22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 12, 14 of U.S. Patent No. 11,849,934 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
20. A surgical method, comprising: moving a first sealing element within a first predefined region formed in a housing of a surgical device, the movement of the first sealing element being relative to the housing, the first sealing element being seated in a first support of the surgical device, and the first sealing element having a first surgical instrument inserted therethrough and forming a seal around the first surgical instrument; and moving a second sealing element within a second predefined region formed in the housing, the movement of the second sealing element being relative to the housing and the first support, the second sealing element being seated in a second support of the surgical device, and the second sealing element having a second surgical instrument inserted therethrough and forming a seal around the second surgical instrument.
12. A surgical method, comprising: moving a first sealing element within a first predefined elongate path formed in a housing of a surgical device, the movement of the first sealing element being relative to the housing and causing deformation of a deformable membrane of the surgical device, the first sealing element being seated in a first support of the surgical device, and the first sealing element having a first surgical instrument inserted therethrough and forming a seal around the first surgical instrument; and moving a second sealing element within a second predefined elongate path formed in the housing, the movement of the second sealing element being relative to the housing, the second sealing element being seated in a second support of the surgical device, and the second sealing element having a second surgical instrument inserted therethrough and forming a seal around the second surgical instrument; wherein the first predefined elongate path extends radially, includes a first terminal end at a position adjacent to an outer diameter of the housing, and includes a second terminal end radially inward of the first terminal end; and the second predefined elongate path extends radially, includes a third terminal end at a position adjacent to the outer diameter of the housing, and includes a fourth terminal end radially inward of the third terminal end.
22. The method of claim 20, wherein the first support includes a first rigid ring seating the first sealing element therein; the first predefined region includes a first elongate path having first and second terminal ends; the second sealing element includes a first rigid ring seating the first sealing element therein; and the second predefined region includes a second elongate path having third and fourth terminal ends.
14. The method of claim 12, wherein the first support connects the first sealing element to the housing; the first support includes a first rigid ring seating the first sealing element therein; the second support connects the second sealing element to the housing; and the second support includes a second rigid ring seating the second sealing element therein.
As is evident from the table above, Patent claim 12 discloses all of the features of application claim 20. While Patent claim 12 uses slightly different wording than application claim 20, e.g. “elongate path” instead of “region”; however it is clear that an elongate path forms a region. In addition it is clear that Patent claim 12 discloses that the movement of the second sealing element being relative to the first support, since Patent claim 12 discloses “movement of the first sealing element being relative to the housing” and “movement of the second sealing element being relative to the housing”, since movement of the first sealing element seated in the first support and the second sealing element seated in the second support are relative to the housing, they are also relative to each other, e.g. movement of the second sealing element being relative to the first support.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 8, 10-12, 15-20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Fischvogt et al. (U.S. Pub. No. 2009/0287163 A1, hereinafter “Fischvogt”).
Fischvogt discloses, regarding claim 8, a surgical access device (10, see Fig. 1), comprising: a base (12) configured to be positioned relative to tissue of a patient to allow access therethrough to a body cavity of the patient (via 14, see Fig. 1, see ABSTRACT); a first frame (20) coupled to the base (see Fig. 1); a first sealing element (25 of member 20) supported by the first frame (e.g. supported by opening 24 of member 20) such that the first sealing element is connected to the base via the first frame (see Figs. 1 and 3); a second frame (30) coupled to the base (see Fig. 1); and a second sealing element (25 of member 30), supported by the second frame (e.g. in opening 24 of member 30) such that the second sealing element is connected to the base via the second frame (see Fig. 1, see also Fig. 3 and para. [0030] “members 20,30 are substantially identical”); wherein the first sealing element is configured to receive a first surgical instrument therethrough (see Figs. 5-7, see para. [0031] note “l1”) such that the first sealing element forms a seal around a perimeter of a shaft of the first surgical instrument (see Figs. 6-7, see para. [0031]); the second sealing element is configured to receive a second surgical instrument therethrough (see Figs. 5-7, see para. [0031] note “l2”) such that the second sealing element forms a seal around a perimeter of a shaft of the second surgical instrument (see Figs. 6-7, see para. [0031]); the first sealing element is configured to move relative to the second sealing element (see Fig. 7, note arrow “B” and “C”, see para. [0033] “first and second seal members 20, 30 rotate relative to each other”) in a first predetermined area (26 of member 30) within a perimeter defined by the base (e.g. perimeter of cylindrical cavity 13 within base 12, see para. [0029]); and the second sealing element is configured to move relative to the first sealing element (see Fig. 7, note arrow “B” and “C”, see para. [0033] “first and second seal members 20, 30 rotate relative to each other”) in a second predetermined area (26 of member 20) within the perimeter defined by the base (e.g. perimeter of cylindrical cavity 13 within base 12, see para. [0029]).
Regarding claim 10, wherein the first sealing element includes a first flexible sealing membrane (25, see para. [0031]), and the second sealing element includes a second flexible sealing membrane (25, see para. [0031]).
Regarding claim 11, wherein the first frame extends radially inward a first partial distance across a diameter of the base (see annotated Fig. 1 below); and the second frame extends radially inward a second partial distance across the diameter of the base (see annotated Fig. 1 below).
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Regarding claim 12, wherein the first frame is located proximal to the second frame (see annotated Fig. 1 above); the first sealing element is configured to receive the first surgical instrument therethrough in a proximal to distal direction such that a distal end of the first surgical instrument is located within the body cavity of the patient (see Figs. 6-7, see paras. [0032]-[0033]); and the second sealing element is configured to receive the second surgical instrument therethrough in a proximal to distal direction such that a distal end of the second surgical instrument is located within the body cavity of the patient (see Figs. 6-7, see paras. [0032]-[0033]).
Regarding claim 15, wherein the first elongate shape extends linearly (e.g. shape 26 extends linearly e.g. the depth of the shape extends linearly along axis “X”, see Fig. 1) and radially a first partial distance across a diameter of the base (see annotated Fig. 2 below); and the second elongate shape extends linearly (e.g. shape 26 extends linearly e.g. the depth of the shape extends linearly along axis “X”, see Fig. 1) and radially inward a second partial distance across the diameter of the base (see annotated Fig. 2 below, para. [0030] “members 20,30 are substantially identical”).
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Regarding claim 16, wherein the first elongate shape is curved defines a first curved path located radially outward of a central longitudinal axis of the base (see annotated Fig. 3 below); and the second elongate shape is curved and defines a second curved path located radially outward of the central longitudinal axis of the base (see annotated Fig. 3 below, see para. [0030] “members 20,30 are substantially identical”).
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Regarding claim 17, wherein the first and second sealing elements arc each configured to rotate independent of one another about a central longitudinal axis defined by the base (see Fig. 7, note arrow “B” and “C”, see para. [0033] “first and second seal members 20, 30 rotate relative to each other”).
Regarding claim 18, wherein the first and second sealing elements are configured to rotate as a unit about a central longitudinal axis defined by the base (see Fig. 6, note arrow “A”, see para. [0033] “first and second seal members 20, 30 rotate as one”).
Regarding claim 19, a surgical method, comprising: positioning the base of the surgical access device of claim 8 relative to the tissue of the patient (see ABSTRACT); advancing the first surgical instrument through the first sealing element (see Figs. 5, “I1”) such that the first sealing element forms the seal around the perimeter of the shaft of the first surgical instrument (see Figs. 5-7, see para. [0031]); and advancing the second surgical instrument through the second sealing element (see Figs. 5, “I2”) such that the second sealing element forms the seal around the perimeter of the shaft of the second surgical instrument (see Figs. 5-7, see para. [0031]).
Fischvogt discloses, regarding claim 20, a surgical method, comprising: moving (see para. [0033] “rotated”) a first sealing element (25 of member 20) within a first predefined region (26 of member 30) formed in a housing (12) of a surgical device (10, see Figs. 1 and 6-7), the movement of the first sealing element being relative to the housing (see para. [0033]), the first sealing element being seated in a first support (e.g. opening 24 of member 20) of the surgical device (see Figs. 2-3), and the first sealing element having a first surgical instrument (“I1”) inserted therethrough and forming a seal around the first surgical instrument (see Figs. 5-7, see para. [0031]); and moving (see para. [0033] “rotated”) a second sealing element (25 of member 30) within a second predefined region (26 of member 20) formed in the housing (see Fig. 1), the movement of the second sealing element being relative to the housing and the first support (see Fig. 7, see para. [0033]), the second sealing element being seated in a second support (e.g. in opening 24 of 30) of the surgical device (see Figs. 2-3), and the second sealing element having a second surgical instrument (“I2”) inserted therethrough and forming a seal around the second surgical instrument (see Figs. 5-7, see para. [0031]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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) 9 and 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fischvogt, as applied to claims 8 and 20 above, and in view of Richard (U.S. Pub. No. 2009/0221966 A1, hereinafter “Richard”).
Fischvogt discloses all of the features of the claimed invention, as previously set forth above. Fischvogt further discloses, regarding claim 22, wherein the first predefined region includes a first elongate path (26 of member 30) having first and second terminal ends (see annotated Fig. 2 above); and the second predefined region includes a second elongate path (26 of member 20) having third and fourth terminal ends (see annotated Fig. 2 above, see para. [0030] “members 20,30 are substantially identical”). Fischvogt fails to explicitly disclose, regarding claim 9, wherein the first sealing element includes a first gimbal, and the second sealing element includes a second gimbal; and regarding claim 22, wherein the first support includes a first rigid ring seating the first sealing element therein; and the second sealing element includes a first rigid ring seating the first sealing element therein.
Richard discloses a surgical device (400, see Fig. 5), wherein the sealing elements (315, see Fig. 3) are formed in a gimbal seal / rigid ring (310a, 310b, 310c, see Fig. 2) that are located within a support opening (332a, 332b, 332c) within a frame (305) and are configured to rotate in all directions relative to the support and frame (see para. [0037]) in order to enable the user to rotate the surgical instrument and the seal in all directions (see para. [0037]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the first and second sealing elements in Fischvogt to be formed within a first and second gimbal / first and second rigid ring inside of the first and second support in view of Richard in order to enable the user to rotate the surgical instrument and the seal in all directions.
Allowable Subject Matter
Claim(s) 13-14, 21, 23-25 is/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: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
A surgical access device with a first sealing element supported by a first frame connected to the base; a second sealing element supported by a second frame connected to the base; wherein the first and second sealing elements are configured to move relative to each other in predetermined areas within a perimeter of the base; and as per claim 13, further comprising a lock configured to lock the first and second frames in position relative to the base; and as per claim 14, the first and second predetermined areas do not overlap with one another;
A surgical method comprising moving a first sealing element within a first predefined region; moving a second sealing element within a second predefined region; and as per claim 21, the movement of the first sealing element causes deformation of a deformable membrane of the surgical device; and the movement of the second sealing element causes deformation of the deformable membrane; as per claim 23, the first and second predefined regions do not overlap one another; and as per claim 25, wherein the surgical device includes a deformable membrane underlying the first and second predefined regions; and the movement of the first / second sealing element causes deformation of the deformable membrane.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose surgical access devices with movable parts:
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.C.G/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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