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 .
Disposition of Claims
Claims 1-22 are pending and rejected.
Claim Objections
Claim 1 is objected to because of the following informality:
Regarding Claim 1, Claim 1 recites the limitation “the elongated boy” on Line 6. This appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 13-22 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.
Regarding Claim 13, Claim 13 recites the limitations “more than one surgical instrument” and “surgical instruments” on Lines 5-6. It is unclear whether this “more than one surgical instrument” and “surgical instruments” are the same as the “surgical instruments” previously recited on Lines 3-4 of Claim 13 or separate, different surgical instruments. For the purpose of examination, “more than one surgical instrument” and “surgical instruments” are being interpreted as “more than one surgical instrument of the surgical instruments [emphasis added]” and “the surgical instruments [emphasis added]”, respectively.
Regarding Claim 14, Claim 14 recites the limitation “at least three side channels” on Line 1. It is unclear whether these “at least three side channels” are the same as the “plurality of side channels” previously recited on Line 7 of Claim 13, or separate, different channels. For the purpose of examination, “at least three side channels” is being interpreted as “at least three side channels of the plurality of side channels”.
Regarding Claim 15, Claim 15 recites the limitation “the irrigation channel” on Line 1. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, “the irrigation channel” is being interpreted as “an irrigation channel of the plurality of side channels”.
Regarding Claims 17-19, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, “about” is being interpreted as ± 10%.
Regarding Claim 22, Claim 22 recites the limitation “at least three side channels” on Line 3. It is unclear whether these “at least three side channels” are the same as the “plurality of side channels” previously recited on Line 7 of Claim 13, or separate, different channels. For the purpose of examination, “at least three side channels” is being interpreted as “at least three side channels of the plurality of side channels”.
Regarding Claim 22, Claim 22 recites the limitations “inserting a plurality of instruments” and “more than one instrument insertable” on Lines 6-7. It is unclear whether this “plurality of instruments” and “more than one instrument” are the same as the “surgical instruments” previously recited on Lines 3-4 of Claim 13 or separate, different instruments. For the purpose of examination, “inserting a plurality of instruments” and “more than one instrument insertable” are being interpreted as “inserting the surgical instruments” and “more than one surgical instrument of the surgical instruments insertable”.
Regarding Claim 22, Claim 22 recites the limitations “a first side channel”, “a second side channel” and “a third side channel” on Lines 8-10. It is unclear whether these “first side channel”, “second side channel” and “third side channel” are the same as the “plurality of side channels” previously recited on Line 7 of Claim 13, the “at least three side channels” previously recited on Line 3 of Claim 22, or separate, different channels. For the purpose of examination, “a first side channel”, “a second side channel” and “a third side channel” are being interpreted as “a first side channel of the at least three side channels of the plurality of side channels”, “a second side channel of the at least three side channels of the plurality of side channels” and “a third side channel of the at least three side channels of the plurality of side channels”, respectively.
Regarding Claims 16 & 20-21, Claims 16 & 20-21 are rejected as being dependent upon claims previously rejected under 35 U.S.C. § 112(b).
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 1-7, 9-11, 13, 15 & 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohajer-Shojaee (hereinafter "Mohajer") (US 2014/0163323).
Regarding Claim 1, Mohajer discloses a surgical access port (Fig. 1, 10; [0022]), comprising:
a support flange (Fig. 1, 32; [0025]) configured to be positioned exterior to a patient (see Fig. 1);
an elongated body (Fig. 1, a body comprising 20, 22, 26 and 30; [0023] – [0025]) configured to extend through an incision in the patient towards a surgical site (see Fig. 1);
a multi-instrument hollow working channel (Fig. 6, 36; [0025]) extending from the support flange through the elongated boy (see Fig. 6), the working channel comprising an open proximal end in the support flange (see Fig. 6) and an open distal end at a distal end of the elongated body (see Fig. 6);
a plurality of side channels (Fig. 6, 48 and 50; [0026]) extending through the elongated body at least partially along the working channel (see Fig. 6), wherein the plurality of side channels are at least partially separated from the working channel (see Fig. 6).
Regarding Claim 2, Mohajer discloses the surgical access port of Claim 1. Mohajer further discloses wherein the side channels merge with the working channel proximate to the open distal end ([0026]).
Regarding Claim 3, Mohajer discloses the surgical access port of Claim 2. Mohajer further discloses wherein the working channel is wider distal to where the side channels merge with the working channel (see Fig. 6).
Regarding Claim 4, Mohajer discloses the surgical access port of Claim 2. Mohajer further discloses wherein at least one of the plurality of side channels comprises an open proximal end in the support flange (see Fig. 6).
Regarding Claim 5, Mohajer discloses the surgical access port of Claim 4. Mohajer further discloses wherein at least one of the plurality of side channels (Fig. 6, 50; [0026]) comprises a proximal port (Fig. 6, 106; [0033]) extending through a side wall of the elongated body (Fig. 6, 106 extends through a side wall of 26 of the body; [0033]).
Regarding Claim 6, Mohajer discloses the surgical access port of Claim 5. Mohajer further discloses wherein the proximal port comprises an irrigation port configured to connect to a water source (Fig. 6, 106 is a fluid port and thus is capable of being connected to a water source; [0033]).
Regarding Claim 7, Mohajer discloses the surgical access port of Claim 1. Mohajer further discloses wherein the working channel has a diameter that is at least twice a diameter of each of the side channels (see Fig. 6).
Regarding Claim 9, Mohajer discloses the surgical access port of Claim 7. Mohajer further discloses wherein a diameter of a first side channel of the plurality of side channels is the same as a diameter of a second side channel of the plurality of side channels (see Fig. 6).
Regarding Claim 10, Mohajer discloses the surgical access port of Claim 1. Mohajer further discloses wherein the working channel is configured to allow visualization of the surgical site from the open proximal end (Fig. 6, an endoscope is inserted proximally through 36; [0031]).
Regarding Claim 11, Mohajer discloses the surgical access port of Claim 1. Mohajer further discloses a sealing cap (Fig. 6, 38; [0025]) configured to seal at least the open proximal end of the working channel from an ambient environment external to the patient ([0025]).
Regarding Claim 13, Mohajer discloses a surgical access port (Fig. 1, 10; [0022]), comprising:
an elongated working channel (Fig. 1, a body comprising 20, 22, 26 and 30; [0023] – [0025]) with a lower distal end opening (see Fig. 6) positionable near an internal surgical site (Fig. 1, 14; [0022]) and an upper proximal opening (see Fig. 6) that receives surgical instruments in use ([0031]), the working channel defining an internal hollow cavity (Fig. 6, 36; [0025]) with a diameter configured to receive more than one surgical instrument at a time (Fig. 7, 36 receives at least a pair of 16; [0026]) and that allows surgical instruments to be inserted at varying angles (see Fig. 6); and
a plurality of side channels (Fig. 6, 48 and 50; [0026]) extending along an outer perimeter of the working channel (see Fig. 6), each side channel defined by an inner-facing wall (Fig. 6, a wall defining 36; [0025]) and an outer wall (Fig. 6, 26; [0026]).
Regarding Claim 15, Mohajer discloses the surgical access port of Claim 13. Mohajer further discloses wherein the irrigation channel (Fig. 6, 50; [0026]) further comprises an irrigation port (Fig. 6, 106; [0033]).
Regarding Claim 20, Mohajer discloses the surgical access port of Claim 13. Mohajer further discloses wherein the inner-facing wall of each side channel terminates before the lower distal end opening (see Fig. 6).
Claims 1, 7-9, 12-15, 17-18 & 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ko (U.S. 5,354,302).
Regarding Claim 1, in an alternative, Ko discloses a surgical access port (Fig. 1, 10; Col. 5, Lines 31-33), comprising:
a support flange (Fig. 1, 42; Col. 6, Line 25) configured to be positioned exterior to a patient (see Figs. 7 & 8);
an elongated body (Fig. 1, 12; Col. 5, Lines 32-34) configured to extend through an incision (Fig. 7, 90; Col. 8, Lines 32-34) in the patient towards a surgical site (Fig. 7, 94; Col. 8, Lines 35-37);
a multi-instrument hollow working channel (Fig. 5, 70; Col. 7, Lines 41-43) extending from the support flange (Col. 7, Lines 37-46) through the elongated boy (Col. 7, Lines 37-46), the working channel comprising an open proximal end in the support flange (Col. 7, Lines 37-46) and an open distal end at a distal end of the elongated body (Col. 7, Lines 37-46);
a plurality of side channels (Fig. 4, 28, 32, 34 and 51; Col. 5, Line 67 – Col. 6 Line 10 & Lines 40-48) extending through the elongated body at least partially along the working channel (see Fig. 5), wherein the plurality of side channels are at least partially separated from the working channel (see Fig. 5).
Regarding Claim 7, in an alternative, Ko discloses the surgical access port of Claim 1. Ko further discloses wherein the working channel has a diameter that is at least twice a diameter of each of the side channels (see Fig. 5).
Regarding Claim 8, Ko discloses the surgical access port of Claim 7. Ko further discloses wherein a diameter of a first side channel (Fig. 5, 28; Col. 5, Lines 65-68) of the plurality of side channels is different from a diameter of a second side channel (Fig. 5, 32; Col. 6, Lines 3-5) of the plurality of side channels (see Fig. 5).
Regarding Claim 9, in an alternative, Ko discloses the surgical access port of Claim 7. Ko further discloses wherein a diameter of a first side channel (Fig. 5, 32; Col. 6, Lines 3-5) of the plurality of side channels is the same as a diameter of a second side channel (Fig. 5, 34; Col. 6, Lines 7-9) of the plurality of side channels (see Fig. 5).
Regarding Claim 12, Ko discloses the surgical access port of Claim 1. Ko further discloses a seal (Fig. 8, 20; Col. 5, Lines 35-38) configured to form a seal between at least one of the flange and the body with the patient (Col. 9, Lines 2-7).
Regarding Claim 13, in an alternative, Ko discloses a surgical access port (Fig. 1, 10; Col. 5, Lines 31-33), comprising:
an elongated working channel (Fig. 5, 70; Col. 7, Lines 41-43) with a lower distal end opening (Col. 7, Lines 37-46) positionable near an internal surgical site (Fig. 7, 94; Col. 8, Lines 35-37) and an upper proximal opening (Fig. 5, 70; Col. 7, Lines 41-43) that receives surgical instruments in use (Fig. 5, 54 and grasping forceps; Col. 6 Lines 51-55 & Lines 61-64), the working channel defining an internal hollow cavity (70 defines a hollow cavity) with a diameter configured to receive more than one surgical instrument at a time (Col. 7, Lines 37-46) and that allows surgical instruments to be inserted at varying angles (Col. 7, Lines 37-46); and
a plurality of side channels (Fig. 4, 28, 32, 34 and 51; Col. 5, Line 67 – Col. 6 Line 10 & Lines 40-48) extending along an outer perimeter of the working channel (see Fig. 5), each side channel defined by an inner-facing wall (see Fig. 5) and an outer wall (see Fig. 5).
Regarding Claim 14, Ko discloses the surgical access port of Claim 13. Ko further discloses at least three side channels (Fig. 5, 28, 32 and 51; Col. 5, Line 67 – Col. 6 Line 10 & Lines 40-48), comprising a suction channel (Fig. 5, 51; Col. 6, Lines 46-48), an irrigation channel (Fig. 5, 32; Col. 6, Lines 4-7), and a camera channel (Fig. 5, 28; Col. 5, Lines 64-68).
Regarding Claim 15, in an alternative, Ko discloses the surgical access port of Claim 13. Ko further discloses wherein the irrigation channel further comprises an irrigation port (Fig. 11, 50; Col. 6, Lines 34-36).
Regarding Claim 17, Ko discloses the surgical access port of Claim 13. Ko further discloses wherein the internal hollow cavity comprises a diameter of about 8-35 mm (Fig. 5, given the hollow cavity of 70 receives 54, which has a diameter of 5 mm, and 56, which has a diameter of 3 mm and that 12 has a total diameter of 14-16 mm, the hollow cavity of 70 has a diameter between 8 mm and 16 mm; Col. 6, Lines 52-64 & Col. 7, Lines 15-18).
Regarding Claim 18, Ko discloses the surgical access port of Claim 13. Ko further discloses wherein the internal hollow cavity comprises a diameter of up to about 60 mm (Fig. 5, given the hollow cavity of 70 receives 54, which has a diameter of 5 mm, and 56, which has a diameter of 3 mm and that 12 has a total diameter of 14-16 mm, the hollow cavity of 70 has a diameter between 8 mm and 16 mm; Col. 6, Lines 52-64 & Col. 7, Lines 15-18).
Regarding Claim 21, Ko discloses the surgical access port of Claim 13. Ko further discloses a rigid material that does not bend or flex in use (Fig. 1, 12 of 10 is made of metal; Col. 9, Lines 64-68).
Regarding Claim 22, Ko discloses a method for accessing an internal surgical site (Col. 4, Lines 38-39), comprising:
providing the surgical access port of Claim 13 (FOR THE SAKE OF BREVITY THE REJECTION OF CLAIM 13 IS NOT REPRODUCED HEREIN), wherein the surgical access port comprises at least three side channels (Fig. 5, 28, 32 and 51; Col. 5, Line 67 – Col. 6 Line 10 & Lines 40-48);
inserting the lower distal end opening through an incision to a position at or near the internal surgical site (Col. 4, Lines 39-41);
inserting a plurality of instruments through the elongated working channel (Col. 6, Lines 54-65), with more than one instrument insertable at a time (Col. 7, Lines 1-5);
delivering suction through a first side channel (Fig. 5, 51; Col. 6, Lines 46-48);
delivering irrigation through a second side channel (Fig. 5, 32; Col. 6, Lines 4-7); and
delivering an endoscope camera through a third side channel (Fig. 5, 28; Col. 5, Lines 64-68).
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 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ko (U.S. 5,354,302).
Regarding Claim 19, Ko discloses the surgical access port of Claim 13. Ko fails to explicitly disclose wherein the elongated working channel has a length of about 35-130 mm.
Ko, however, discloses wherein the length of the elongated working channel is 30 cm (Ko; Col. 5, Lines 39-41). As such, the change in length of the elongated working channel is disclosed to be a result effective variable in that the length is dependent on fully inserting the elongated working channel through an opening in a body (Ko; Col. 5, Lines 41-45).
Therefore it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to change the length to be about 35-130 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, Applicant places no criticality on the range claimed, indicating that “the length of the working channel may range from about 35mm to about 130mm [emphasis added]” (see Para. [0021] of Applicant’s specification). Additionally, Applicant acknowledges the length “depend[s] on the surgery to be completed” (Id.)
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mohajer-Shojaee (hereinafter "Mohajer") (US 2014/0163323) in view of del Nido et al. (hereinafter "Nido") (US 2017/0231477).
Regarding Claim 16, Mohajer discloses the surgical access port of Claim 13. Mohajer fails to explicitly disclose a built-in camera.
However, Nido teaches a surgical access port (Fig. 3, 300; [0058]), comprising:
an elongated body (Fig. 3, 301; [0058]);
a hollow working channel (Fig. 3, 302; [0058]);
a side channel (Fig. 3, 335; [0059]); and
a built-in camera (Fig. 3, 321; [0059]).
The advantage of the built-in camera is to not require a separate imaging channel thereby providing a more compact design (Nido; [0056]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the surgical access port as disclosed by Mohajer, to include the built-in camera taught by Nido, to not require a separate imaging channel thereby providing a more compact design (Nido; [0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pantalos et al. (US 2020/0121358) teaches a multi-lumen arthroscopy cannula.
Jackson (US 2015/0351737) teaches a multi-chambered cannula.
Bonadio et al. (US 2011/0071359) teaches an instrument access device.
Mailhe (US 2009/0198188) teaches an adaptor for an introducer valve.
Regadas (US 2009/0192352) teaches an operating anoscope for transanal endoscopic microsurgery.
Burgess (US 2009/0036918) teaches an apparatus for containment of a surgical site.
Wilson et al. (US 2005/0251144) teaches a multiple lumen sensor attachment.
Mesallum (US 2004/0097801) teaches an apparatus for performing transesophageal cardiovascular procedures.
Kogasaka et a. (U.S. 6,371,968) teaches a cavity retaining tool.
Yoon (U.S. 5,842,971) teaches an optical endoscopic portal for passage through cavity walls.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL CAREY can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795