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
The Amendment filed on 6/4/2026 has been entered. Claims 1-19 and 22-29 remain pending in the application. Claims 23-29 have been withdrawn from further consideration as detailed in the Non-final Office action mailed 2/6/2026.
Applicants amendments to the specification have overcome the specification objections previously set forth in the Non-final Office Action mailed 2/6/2026.
Applicants amendments to the claims have overcome the claim objections previously set forth in the Non-final Office Action mailed 2/6/2026.
Applicants amendments to the claims have failed to overcome all of the rejections under 35 USC 112 previously set forth in the Non-final Office Action mailed 2/6/2026. See rejections under 35 U.S.C. 112 below.
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.
Claims 9-18 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.
In regard to claim 9,
Line 1-2 recites “wherein one or more of the first distal port, the second distal port, or the second proximal port, includes a plurality of openings”. Claim 9 depends on claim 1. Claim 1 requires a first distal port defining one or more openings, a second distal port defining one or more openings, and a second proximal port defining one or more openings. It is unclear if the plurality of openings of the first distal port, the second distal port, or the second proximal port in claim 9 are in addition to the one or more openings of the first distal port, the second distal port, or the second proximal port or are the same. For examination purposes Examiner construes the one or more openings to include a plurality of openings. Examiner suggests replacing “wherein one or more of the first distal port, the second distal port, or the second proximal port, includes a plurality of openings” in line 1-2 of claim 9 with “wherein one or more of the one or more openings of the first distal port, the one or more openings of the second distal port, or the one or more openings of the second proximal port, includes a plurality of openings”.
In regard to claim 10,
Line 1-3 recites “wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port”. Claim 10 depends on claim 9. Claim 9 recites “wherein one or more of the first distal port, the second distal port, or the second proximal port, includes a plurality of openings”. The plurality of openings of the second distal port and the plurality of openings of the first distal port are not necessarily required by claim 9 because of the “or” phrase. It is unclear if claim 10 is intending to require the plurality of openings of the second distal port and the plurality of openings of the first distal port. For examination purposes Examiner construes the plurality of openings of the second distal port and the plurality of openings of the first distal port to be required in claim 10. Examiner suggests replacing “wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port” in line 1-3 of claim 10 with “wherein the one or more openings of the second distal port include the plurality of openings and the one or more openings of the first distal port include the plurality of openings, wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port”.
In regard to claim 11,
Line 2-3 recites “a proximal-most opening of the plurality of openings of the first distal port”. Claim 11 depends on claim 10. Claim 10 recites a proximal-most opening of the plurality of openings of the first distal port. It is unclear if the proximal-most opening of the plurality of openings of the first distal port of claim 11 is the same as claim 10 or is an additional proximal-most opening. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “a proximal-most opening of the plurality of openings of the first distal port” in line 2-3 of claim 11 with “the proximal-most opening of the plurality of openings of the first distal port”.
In regard to claim 12,
Line 1-2 recites “the second distal port of the second structure includes a plurality of openings”. Claim 12 depends on claim 9 and claim 1. Claim 1 recites a second distal port defining one or more openings and claim 9 recites the second distal port can include a plurality of openings. It is unclear if the plurality of openings of claim 12 are the same as the plurality of openings of claim 9 or if the plurality of openings of claim 12 are of the one or more openings of claim 1. For examination purposes Examiner construes the plurality of openings of claim 12 to be the same as claim 9. Examiner suggests replacing “the second distal port of the second structure includes a plurality of openings spaced apart” with “the second distal port of the second structure includes the plurality of openings which are spaced apart”.
In regard to claim 13,
Line 1-2 recites “the second distal port of the second structure includes an opening on a distal end face of the second structure”. Claim 13 depends on claim 9 and claim 1. Claim 1 recites a second distal port defining one or more openings and claim 9 recites the second distal port can include a plurality of openings. Claim 13 does not necessarily require the second distal port to include a plurality of openings because of the “or” phrase in claim 9. It is unclear if the opening on a distal end face of the second structure is in addition to the one or more openings of claim 1 or if the one or more openings of claim 1 includes the opening of claim 13. For examination purposes Examiner construes the one or more openings of the second distal port to include the opening of claim 13. Examiner suggests replacing “the second distal port of the second structure includes an opening on a distal end face of the second structure” in line 1-2 of claim 13 with “the one or more openings of the second distal port of the second structure includes an opening on a distal end face of the second structure”.
In regard to claim 14,
Line 1-2 recites “the second proximal port of the second structure includes one or more openings”. Claim 14 depends on claim 9 and claim 1. Claim 1 recites a second proximal port defining one or more openings and claim 9 recites the second proximal port can include a plurality of openings. It is unclear if the one or more openings are in addition to the one or more openings of claim 1 or if the one or more openings of claim 14 are of the one or more openings of claim 1. For examination purposes Examiner construes them to be of the one or more openings of claim 1. Examiner suggests replacing “the second proximal port of the second structure includes one or more openings distal” with “one or more openings of the one or more openings of the second proximal port of the second structure are distal”
Line 2-3 recites “all of the openings of the first proximal port of the first structure”. Claim 14 depends on claim 1. Claim 1 recites a first proximal port defining one or more openings. It is unclear which openings “all of the openings of the first proximal port of the first structure” refers to. For examination purposes Examiner construes “all of the openings of the first proximal port of the first structure” to be “the one or more openings of the first proximal port of the first structure”. Examiner suggests replacing “all of the openings of the first proximal port of the first structure” in line 2-3 of claim 14 with “all of the one or more openings of the first proximal port of the first structure”.
In regard to claim 15,
Line 1-2 recites “the second proximal port of the second structure includes a plurality of openings”. Claim 15 depends on claim 14, claim 9 and claim 1. Claim 1 recites a second proximal port defining one or more openings and claim 9 recites the second proximal port can include a plurality of openings. It is unclear if the plurality of openings of claim 15 are the same as the plurality of openings of claim 9 or if the plurality of openings of claim 12 are of the one or more openings of claim 1. For examination purposes Examiner construes the plurality of openings of claim 15 to be the same as claim 9. Examiner suggests replacing “the second proximal port of the second structure includes a plurality of openings spaced apart” with “the second proximal port of the second structure includes the plurality of openings which are spaced apart”.
In regard to claim 16,
Line 1-2 recites “the second proximal port of the second structure includes an opening”. Claim 16 depends on claim 14, 9, and 1. Claim 14 recites “the second proximal port includes one or more openings”, claim 9 recites that the second proximal port of the second structure can include a plurality of openings, and claim 1 recites that the second proximal port of the second structure defines one or more openings. It is unclear if the opening of claim 16 is of the one or more openings. For examination purposes Examiner construes the opening to be of the one or more openings. Examiner suggests replacing “the second proximal port of the second structure includes an opening” in line 1-2 of claim 16 with “the one or more openings of the second proximal port of the second structure includes an opening”.
In regard to claim 17,
Line 1-2 recites “the first distal port of the first structure includes one or more openings on a distal end face of the first structure”. Claim 17 depends on claim 9 and 1. Claim 9 recites that the first distal port of the first structure can include a plurality of openings and claim 1 recites that the first distal port of the first structure defines one or more openings. It is unclear if the one or more openings of claim 17 is of the one or more openings. For examination purposes Examiner construes the one or more openings to be of the one or more openings. Examiner suggests replacing “the first distal port of the first structure includes one or more openings on a distal end face of the first structure” in line 1-2 of claim 17 with “the one or more openings of the first distal port of the first structure includes one or more openings on a distal end face of the first structure”.
In regard to claim 18,
Line 1-2 recites “the first distal port of the first structure includes an opening on a distal end face of the first structure”. Claim 18 depends on claim 9 and 1. Claim 9 recites that the first distal port of the first structure can include a plurality of openings and claim 1 recites that the first distal port of the first structure defines one or more openings. It is unclear if the opening of claim 18 is of the one or more openings. For examination purposes Examiner construes the opening to be of the one or more openings. Examiner suggests replacing “the first distal port of the first structure includes an opening on a distal end face of the first structure” in line 1-2 of claim 18 with “the one or more openings of the first distal port of the first structure includes an opening on a distal end face of the first structure”.
In regard to claim 22,
Line 11 recites “the cavity”. There is insufficient antecedent basis for the limitation in this claim. Examiner suggests replacing “the cavity” in line 11 of claim 22 with “a cavity”.
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 1-9, 17, 19, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a first interpretation of Malkowski (U.S. PG publication 20190328983).
In regard to claim 1,
Malkowski discloses an instrument (figure 6 and 7, item 200), comprising:
a first structure (portion of elongate body 120 that defines lumen 122) defining a first lumen (figure 6, item 122), the first structure including:
[AltContent: textbox (First distal end portion)][AltContent: connector][AltContent: rect][AltContent: connector][AltContent: rect][AltContent: textbox (First proximal end portion)]
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a first proximal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first proximal port (see opening at proximal end of the first proximal end portion) defining one or more openings in communication with the first lumen (see figure 6 above; paragraph [0052] and [0048]), wherein the first proximal port is configured to be coupled to a suction source (figure 6, item 142; paragraph [0052]; Examiner notes “configured to be coupled to a suction source” is a functional limitation. The suction source is not positively required by the claim. The first proximal port is fully capable of the recited function due to its structure as supported by paragraph [0052]);
a first distal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first distal port (figure 6, item 123) defining one or more openings in communication with the first lumen (see figure 6; paragraph [0052] and [0048]), wherein the first distal end portion including the first distal port are configured to be located at a site within a cavity of a subject (see figure 7; Examiner notes “configured to be located at a site within a cavity of a subject” is a functional limitation. The first distal end portion including the first distal port is fully capable of the recited function due to its structure as supported by figure 7 and paragraph [0052]); and
wherein the first structure is configured to cause tissue and/or gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source (Examiner notes “configured to cause tissue and/or gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source” is a functional limitation. The first structure is fully capable of causing gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source as supported by paragraph [0052]); and
a second structure (portion of elongate body 120 that defines lumen 124) defining a second lumen (figure 6, item 124), the second structure including:
[AltContent: rect][AltContent: textbox (Second proximal end portion)][AltContent: connector][AltContent: textbox (Second distal end portion)][AltContent: connector][AltContent: rect]
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a second proximal end portion (see figure 6 above) comprising a second proximal port (see opening at proximal end of the second proximal end portion) defining one or more openings in communication with the second lumen (see figure 6; paragraph [0048] and [0053]), wherein the second proximal end portion including the second proximal port are configured to be located outside the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject (see figure 7; Examiner notes “configured to be located outside the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject” is a functional limitation. The second proximal end portion including the second proximal port are fully capable of the recited function due to their structure as supported by figure 7 and paragraph [0051]), and wherein the second proximal port of the second structure is configured to be exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject (Examiner notes “configured to be exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject” is a functional limitation. The second proximal port of the second structure is fully capable of being exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject as supported by paragraph [0053]); and
a second distal end portion (see figure 6 above) comprising a second distal port (figure 6, item 125) defining one or more openings in communication with the second lumen (see figure 6; paragraph [0048] and [0053]), wherein the second distal end portion including the second distal port are configured to be located within the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject (see figure 6; Examiner notes “configured to be located within the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject” is a functional limitation. The second distal end portion including the second distal port are fully capable of the recited function due to their structure as supported by paragraph [0051]); and
wherein the second structure is configured to allow make-up gas to flow from an ambient environment into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject to reduce negative pressure in the cavity, when the tissue and/or the gas is drawn into the first distal port of the first lumen of the first structure (Examiner notes “configured to allow make-up gas to flow from an ambient environment into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject to reduce negative pressure in the cavity, when the tissue and/or the gas is drawn into the first distal port of the first lumen of the first structure” is a functional limitation. The second structure is fully capable of the recited function as supported by paragraph [0053]).
In regard to claim 2,
Malkowski discloses the instrument of claim 1, wherein:
the first structure defines a first length between the first proximal end portion and the first distal end portion (see figure 6); and
the second structure defines a second length between the second proximal end portion and the second distal end portion (see figure 6).
In regard to claim 3,
Malkowski discloses the instrument of claim 2, wherein the first and second structures are coupled to one another along the first and second lengths (see figure 6).
In regard to claim 4,
Malkowski discloses the instrument of claim 3, further comprising a handle (figure 6, item 210) on the first proximal end portion of the first structure (see figure 6).
In regard to claim 5,
Malkowski discloses the instrument of claim 4, wherein the first length is greater than the second length (see figure 6).
In regard to claim 6,
Malkowski discloses the instrument of claim 5, wherein the handle is located on the first structure proximal of the second proximal end portion of the second structure (see figure 6 wherein the handle is located on the first structure and a portion of the handle is proximal of the second proximal end portion of the second structure).
In regard to claim 7,
Malkowski discloses the instrument of claim 4, wherein the first proximal port is located adjacent to or proximal to a distal end of the handle (see figure 6).
In regard to claim 8,
Malkowski discloses the instrument of claim 2, wherein the first length is greater than the second length (see figure 6).
In regard to claim 9,
Malkowski discloses the instrument of claim 1, wherein one or more of the first distal port, the second distal port, or the second proximal port, includes a plurality of openings (see figure 6 wherein the first distal port comprises a plurality of openings 123).
In regard to claim 17,
Malkowski discloses the instrument of claim 9, wherein first distal port of the first structure includes one or more openings through a side of the first structure (see figure 6, item 123).
In regard to claim 19,
Malkowski discloses the instrument of claim 1, wherein the second structure is configured to allow the make-up gas to be drawn into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject, in response to the tissue and/or the gas being drawn into the first distal port of the first lumen of the first structure (Examiner notes “configured to allow the make-up gas to be drawn into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject, in response to the tissue and/or the gas being drawn into the first distal port of the first lumen of the first structure” is a functional limitation. The second structure is fully capable of the recited function due to its structure as supported by paragraph [0053]).
In regard to claim 22,
Malkowski discloses an instrument (figure 6 and 7, item 200), comprising:
a first structure (portion of elongate body 120 that defines lumen 122) defining a first lumen (figure 6, item 122), including:
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a first proximal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first proximal port (see opening at proximal end of the first proximal end portion) defining one or more openings (see figure 6) in communication with the first lumen (see figure 6 above; paragraph [0052] and [0048]); and
a first distal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first distal port (figure 6, item 123) defining one or more openings (see figure 6) in communication with the first lumen (see figure 6; paragraph [0052] and [0048]); and
a second structure (portion of elongate body 120 that defines lumen 124) defining a second lumen (figure 6, item 124), including:
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a second proximal end portion (see figure 6 above) comprising a second proximal port (see opening at proximal end of the second proximal end portion) defining one or more openings (see figure 6) in communication with the second lumen (see figure 6; paragraph [0048] and [0053]), wherein the second proximal port is configured to be exposed to atmospheric pressure outside the cavity of the subject (Examiner notes “configured to be exposed to atmospheric pressure outside the cavity of the subject” is a functional limitation. The second proximal port is fully capable of being exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject as supported by paragraph [0053] and figure 7); and
a second distal end portion (see figure 6 above) comprising a second distal port (figure 6, item 125) defining one or more openings (see figure 6) in communication with the second lumen (see figure 6; paragraph [0048] and [0053]), wherein the second distal end portion is configured to be inserted into and located within the cavity of the subject (see figure 6; Examiner notes “configured to be inserted into and located within the cavity of the subject” is a functional limitation. The second distal end portion is fully capable of the recited function due to its structure as supported by paragraph [0051]); and
wherein the instrument is configured to be inserted into the subject with the first and second distal end portions located in the cavity of the subject to facilitate suction of tissue and/or gas from the cavity through the first lumen (Examiner notes “configured to be inserted into the subject with the first and second distal end portions located in the cavity of the subject to facilitate suction of tissue and/or gas from the cavity through the first lumen” is a functional limitation. The instrument is fully capable of the recited function as supported by figure 7 and paragraph [0052]) and to facilitate entry of make-up gas from an ambient environment into the cavity through the second lumen via the second proximal port and the second distal port to reduce negative pressure in the cavity caused by the suction of the tissue and/or the gas from the cavity (Examiner notes “configured… to facilitate entry of make-up gas from an ambient environment into the cavity through the second lumen via the second proximal port and the second distal port to reduce negative pressure in the cavity caused by the suction of the tissue and/or the gas from the cavity” is a functional limitation. The instrument is fully capable of the recited function as supported by figure 7 and paragraph [0053]).
Claims 1-4, 7, 9, 17, 19, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a second interpretation of Malkowski (U.S. PG publication 20190328983). Examiner notes the second interpretation differs from the first interpretation in regard to the instrument and second structure.
In regard to claim 1,
Malkowski discloses an instrument (figure 6 and 7, item 200 and 20), comprising:
a first structure (portion of elongate body 120 that defines lumen 122) defining a first lumen (figure 6, item 122), the first structure including:
[AltContent: textbox (First distal end portion)][AltContent: connector][AltContent: rect][AltContent: connector][AltContent: rect][AltContent: textbox (First proximal end portion)]
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a first proximal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first proximal port (see opening at proximal end of the first proximal end portion) defining one or more openings in communication with the first lumen (see figure 6 above; paragraph [0052] and [0048]), wherein the first proximal port is configured to be coupled to a suction source (figure 6, item 142; paragraph [0052]; Examiner notes “configured to be coupled to a suction source” is a functional limitation. The suction source is not positively required by the claim. The first proximal port is fully capable of the recited function due to its structure as supported by paragraph [0052]);
a first distal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first distal port (figure 6, item 123) defining one or more openings in communication with the first lumen (see figure 6; paragraph [0052] and [0048]), wherein the first distal end portion including the first distal port are configured to be located at a site within a cavity of a subject (see figure 7; Examiner notes “configured to be located at a site within a cavity of a subject” is a functional limitation. The first distal end portion including the first distal port is fully capable of the recited function due to its structure as supported by figure 7 and paragraph [0052]); and
wherein the first structure is configured to cause tissue and/or gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source (Examiner notes “configured to cause tissue and/or gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source” is a functional limitation. The first structure is fully capable of causing gas to be drawn into the first distal port and through the first lumen when the first proximal end portion is coupled to the suction source as supported by paragraph [0053]); and
a second structure (figure 6, item 210 and portion of elongate body 120 that defines lumen 124) defining a second lumen (figure 6, item 124 and 250), the second structure including:
[AltContent: textbox (Portion of the second proximal end portion)][AltContent: connector][AltContent: rect]
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a second proximal end portion (figure 6, item 210 and portion of item 120 labeled in figure 6 above) comprising a second proximal port (figure 6, item 242a and proximal opening of item 120 which forms lumen 124) defining one or more openings in communication with the second lumen (see figure 6 and paragraph [0053]), wherein the second proximal end portion including the second proximal port are configured to be located outside the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject (Examiner notes “configured to be located outside the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject” is a functional limitation. The second proximal end portion including the second proximal port are fully capable of the recited function due to their structure as supported by figure 7 and paragraph [0051]), and wherein the second proximal port of the second structure is configured to be exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject (Examiner notes “configured to be exposed to atmospheric pressure outside the cavity of the subject when the first distal end portion is located within the cavity of the subject” is functional limitation. The second proximal port is fully capable of the recited function due to its structure as supported by figure 7 and paragraph [0051]); and
[AltContent: rect][AltContent: textbox (Second distal end portion)][AltContent: connector]
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a second distal end portion (see figure 6 above) comprising a second distal port (figure 6, item 125) defining one or more openings in communication with the second lumen (see figure 6 and paragraph [0053]), wherein the second distal end portion including the second distal port are configured to be located within the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject (Examiner notes “configured to be located within the cavity of the subject when the first distal end portion including the first distal port of the first structure are located within the cavity of the subject” is a functional limitation. The second distal end portion including the second distal port is fully capable of the recited function due to its structure as supported by paragraph [0051] and figure 7); and
wherein the second structure is configured to allow make-up gas to flow from an ambient environment into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject to reduce negative pressure in the cavity, when the tissue and/or the gas is drawn into the first distal port of the first lumen of the first structure (Examiner notes “configured to allow make-up gas to flow from an ambient environment into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject to reduce negative pressure in the cavity, when the tissue and/or the gas is drawn into the first distal port of the first lumen of the first structure” is a functional limitation. The second structure is fully capable of the recited function as supported by paragraph [0053]).
In regard to claim 2,
Malkowski discloses the instrument of claim 1, wherein:
the first structure defines a first length between the first proximal end portion and the first distal end portion (see figure 6); and
the second structure defines a second length between the second proximal end portion and the second distal end portion (see figure 6).
In regard to claim 3,
Malkowski discloses the instrument of claim 2, wherein the first and second structures are coupled to one another along the first and second lengths (see figure 6).
In regard to claim 4,
Malkowski discloses the instrument of claim 3, further comprising a handle (figure 7, item 20) on the first proximal end portion of the first structure (see figure 7).
In regard to claim 7,
Malkowski discloses the instrument of claim 4, wherein the first proximal port is located adjacent to or proximal to a distal end of the handle (see figure 7 and figure 6).
In regard to claim 9,
Malkowski discloses the instrument of claim 1, wherein one or more of the first distal port, the second distal port, or the second proximal port, includes a plurality of openings (see figure 6 wherein the first distal port and the second proximal port include a plurality of openings)
In regard to claim 17,
Malkowski discloses the instrument of claim 9, wherein first distal port of the first structure includes one or more openings through a side of the first structure (see figure 6, item 123).
In regard to claim 19,
Malkowski discloses the instrument of claim 1, wherein the second structure is configured to allow the make-up gas to be drawn into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject, in response to the tissue and/or the gas being drawn into the first distal port of the first lumen of the first structure (Examiner notes “configured to allow the make-up gas to be drawn into the second proximal port, through the second lumen and out the second distal port, and into the cavity of the subject, in response to the tissue and/or the gas being drawn into the first distal port of the first lumen of the first structure” is a functional limitation. The second structure is fully capable of the recited function due to its structure as supported by paragraph [0053]).
In regard to claim 22,
Malkowski discloses an instrument (figure 6 and 7, item 200 and 20), comprising:
a first structure (portion of elongate body 120 that defines lumen 122) defining a first lumen (figure 6, item 122), including:
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a first proximal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first proximal port (see opening at proximal end of the first proximal end portion) defining one or more openings in communication with the first lumen (see figure 6 above; paragraph [0052] and [0048]); and
a first distal end portion (see portion labeled above of the portion of elongate body 120 that defines lumen 122) comprising a first distal port (figure 6, item 123) defining one or more openings in communication with the first lumen (see figure 6; paragraph [0052] and [0048]); and
a second structure (figure 6, item 210 and portion of elongate body 120 that defines lumen 124) defining a second lumen (figure 6, item 124 and 250), including:
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a second proximal end portion (figure 6, item 210 and portion of item 120 labeled in figure 6 above) comprising a second proximal port (figure 6, item 242a and proximal opening of item 120 which forms lumen 124) defining one or more openings in communication with the second lumen (see figure 6 and paragraph [0053]), wherein the second proximal port is configured to be exposed to atmospheric pressure outside the cavity of the subject (Examiner notes “configured to be exposed to atmospheric pressure outside the cavity of the subject” is functional limitation. The second proximal port is fully capable of the recited function due to its structure as supported by figure 7 and paragraph [0051]); and
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a second distal end portion (see figure 6 above) comprising a second distal port (figure 6, item 125) defining one or more openings in communication with the second lumen (see figure 6 and paragraph [0053]), wherein the second distal end portion is configured to be inserted into and located within the cavity of the subject (Examiner notes “configured to be inserted into and located within the cavity of the subject” is a functional limitation. The second distal end portion is fully capable of the recited function due to its structure as supported by figure 7 and paragraph [0051]); and
wherein the instrument is configured to be inserted into the subject with the first and second distal end portions located in the cavity of the subject to facilitate suction of tissue and/or gas from the cavity through the first lumen (Examiner notes “configured to be inserted into the subject with the first and second distal end portions located in the cavity of the subject to facilitate suction of tissue and/or gas from the cavity through the first lumen” is a functional limitation. The instrument is fully capable of the recited function as supported by figure 7 and paragraph [0052]) and to facilitate entry of make-up gas from an ambient environment into the cavity through the second lumen via the second proximal port and the second distal port to reduce negative pressure in the cavity caused by the suction of the tissue and/or the gas from the cavity (Examiner notes “configured… to facilitate entry of make-up gas from an ambient environment into the cavity through the second lumen via the second proximal port and the second distal port to reduce negative pressure in the cavity caused by the suction of the tissue and/or the gas from the cavity” is a functional limitation. The instrument is fully capable of the recited function as supported by figure 7 and paragraph [0053]).
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.
Claims 10-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the first interpretation of Malkowski (U.S. PG publication 20190328983).
In regard to claim 10,
Malkowski discloses the instrument of claim 9, wherein the second distal port (figure 6, item 125) is located proximal to a proximal-most opening of the plurality of openings of the first distal port (figure 6, item 123).
The first embodiment of Malkowski is silent as to wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port.
A second embodiment of Malkowski teaches a plurality of openings of the second distal port (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for a plurality of openings, as taught by the second embodiment of Malkowski, therefore resulting in wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the number of openings of the second distal port (paragraph [0064]).
In regard to claim 11,
Malkowski teaches the instrument of claim 10, wherein each of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port (see figure 6 and analysis of claim 10 above).
In regard to claim 12,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure.
The second embodiment of Malkowski teaches wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for a plurality of openings including one or more openings through a side of the second structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the second distal port (paragraph [0064]).
In regard to claim 13,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the second distal port of the second structure includes an opening on a distal end face of the second structure.
The second embodiment of Malkowski teaches wherein the second distal port of the second structure includes an opening on a distal end face of the second structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for an opening on a distal end face of the second structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the second distal port of the second structure includes an opening on a distal end face of the second structure, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the second distal port (paragraph [0064]).
In regard to claim 14,
Malkowski discloses the instrument of claim 9.
Malkowski fails to disclose wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Malkowski to include wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Additionally, it would have been an obvious matter of design choice to modify Malkowski to include wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure since applicant has not disclosed that having wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 15,
Malkowski teaches the instrument of claim 14.
Malkowski fails to disclose wherein the second proximal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure.
it would have been an obvious matter of design choice to modify Malkowski to include wherein the second proximal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure since applicant has not disclosed that having wherein the second proximal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the second proximal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 16,
Malkowski teaches the instrument of claim 14, wherein the second proximal port of the second structure includes an opening on a proximal end face of the second structure (see figure 6).
In regard to claim 18,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the first distal port of the first structure includes an opening on a distal end face of the first structure.
The second embodiment of Malkowski teaches wherein the first distal port of the first structure includes an opening on a distal end face of the first structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the first distal port for a first distal port including an opening on a distal end face of the first structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the first distal port of the first structure includes an opening on a distal end face of the first structure, because the substitution is a simple substitution that would yield the same predictable result of enabling removal (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the openings of the first distal port (paragraph [0064]).
Claims 5-6, 8, 10-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the second interpretation of Malkowski (U.S. PG publication 20190328983).
In regard to claim 5,
Malkowski discloses the instrument of claim 4.
Malkowski is silent as to wherein the first length is greater than the second length.
It would have been an obvious matter of design choice to modify Malkowski to include wherein the first length is greater than the second length since applicant has not disclosed that having wherein the first length is greater than the second length solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the first length is greater than the second length, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 6,
Malkowski teaches the instrument of claim 5, wherein the handle is located on the first structure proximal of the second proximal end portion of the second structure (see figure 6 and 7 and analysis of claim 1 above wherein the handle is located on the first structure proximal of a portion of the second proximal end portion of the second structure).
In regard to claim 8,
Malkowski discloses the instrument of claim 2.
Malkowski is silent as to wherein the first length is greater than the second length.
It would have been an obvious matter of design choice to modify Malkowski to include wherein the first length is greater than the second length since applicant has not disclosed that having wherein the first length is greater than the second length solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the first length is greater than the second length, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 10,
Malkowski discloses the instrument of claim 9, wherein the second distal port (figure 6, item 125) is located proximal to a proximal-most opening of the plurality of openings of the first distal port (figure 6, item 123).
The first embodiment of Malkowski is silent as to wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port.
A second embodiment of Malkowski teaches a plurality of openings of the second distal port (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for a plurality of openings, as taught by the second embodiment of Malkowski, therefore resulting in wherein at least one of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the number of openings of the second distal port (paragraph [0064]).
In regard to claim 11,
Malkowski teaches the instrument of claim 10, wherein each of the plurality of openings of the second distal port is located proximal to a proximal-most opening of the plurality of openings of the first distal port (see figure 6 and analysis of claim 10 above).
In regard to claim 12,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure.
The second embodiment of Malkowski teaches wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for a plurality of openings including one or more openings through a side of the second structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the second distal port of the second structure includes a plurality of openings spaced apart from one another along a length of the second structure, including one or more openings through a side of the second structure, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the second distal port (paragraph [0064]).
In regard to claim 13,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the second distal port of the second structure includes an opening on a distal end face of the second structure.
The second embodiment of Malkowski teaches wherein the second distal port of the second structure includes an opening on a distal end face of the second structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the second distal port for an opening on a distal end face of the second structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the second distal port of the second structure includes an opening on a distal end face of the second structure, because the substitution is a simple substitution that would yield the same predictable result of enabling delivery (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the second distal port (paragraph [0064]).
In regard to claim 14,
Malkowski discloses the instrument of claim 9, wherein the second proximal port (figure 6, item 242a and proximal opening of item 120 which forms lumen 124) of the second structure includes one or more openings (proximal opening of item 120 which forms lumen 124).
Malkowski fails to disclose one or more openings distal to all of the openings of the first proximal port of the first structure.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal opening of item 120 which forms lumen 124 of Malkowski to be distal to all of the openings of the first proximal port of the first structure since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Additionally, it would have been an obvious matter of design choice to modify the proximal opening of item 120 which forms lumen 124 of Malkowski to be distal to all of the openings of the first proximal port of the first structure since applicant has not disclosed that having wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of wherein the second proximal port of the second structure includes one or more openings distal to all of the openings of the first proximal port of the first structure, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 15,
Malkowski teaches the instrument of claim 14, wherein the second proximal port (figure 6, item 242a and proximal opening of item 120 which forms lumen 124) of the second structure includes a plurality of openings (figure 6, item 242a and proximal opening of item 120 which forms lumen 124) spaced apart from one another along a length of the second structure (see figure 6), including one or more openings (figure 6, item 242a) through a side of the second structure (see figure 6).
In regard to claim 16,
Malkowski teaches the instrument of claim 14, wherein the second proximal port of the second structure includes an opening (proximal opening of item 120 which forms lumen 124) on a proximal end face of the second structure (see figure 6).
In regard to claim 18,
Malkowski discloses the instrument of claim 9.
The first embodiment of Malkowski is silent as to wherein the first distal port of the first structure includes an opening on a distal end face of the first structure.
The second embodiment of Malkowski teaches wherein the first distal port of the first structure includes an opening on a distal end face of the first structure (paragraph [0064]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Malkowski to substitute the first distal port for a first distal port including an opening on a distal end face of the first structure, as taught by the second embodiment of Malkowski, therefore resulting in wherein the first distal port of the first structure includes an opening on a distal end face of the first structure, because the substitution is a simple substitution that would yield the same predictable result of enabling removal (paragraph [0052]). Furthermore, Malkowski supports modifications can be made to the openings of the first distal port (paragraph [0064]).
Response to Arguments
Applicant’s arguments with respect to claims 1-19 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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