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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
Claim Objections
Claim 21 is objected to because of the following informalities: the phrase “the elongated scope exerts radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel,” should read, “radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel,”. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 04/08/2025 have been fully considered but they are not persuasive. Applicant argues that the previously cited references do not teach the amended limitations of the outer edge the outer edge including an elongated channel defined therein configured to transversely receive the elongated shaft of the endoscope therein, wherein, in operation of the sheath, radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel, and wherein the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath. However, the combination of Saadat/Crafton/Holbrooks reads on amended claims 21, 29, and 37 as set forth in the rejection below.
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 21, 23-24, 29-30, 35, 37 and 39-43 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (EP 0890342 A1) in view of Crafton (US 20210177645 A1) further in view of Holbrooks (US 11278322 B2).
Regarding Claim 21, Saadat discloses a fluid collecting sheath (Fig 2, cervical dam 10) comprising: a proximal end having a first diameter (Fig 2, proximal end at apex 28 has a first diameter);
a distal end having a second diameter (Fig 2 distal end at base 26 has a second diameter), wherein the second diameter is greater than the first diameter (Fig 2 Col 7 ln 23-31, body 24 of cervical dam 10 is dome shaped and thus the diameter of base 26 is greater than the diameter at apex 28);
a proximal orifice defined in the proximal end (Fig 2-3, aperture 30) wherein the proximal orifice is configured to selectively expand in width to operably engage an elongated shaft of an endoscope (Fig 2-3, Col 8 ln 1-60, aperture 30 is configured for insertion of a scope instrument 16 and may comprise a elastomeric disc valve, duck bill valve, universal seal, or preformed slit each of which selectively expands to engage the shaft of a scope);
an outer edge configured to collapse for insertion into a patient's vagina and flex to conform to and create a seal against walls of the patient's vagina (Fig 2, Col 6 ln 28-38, Col 7 ln 23-31 cervical dam 10 may be an elastomeric material comprising outer edge of base 26 which fully capable of collapsing for insertion into the patient’s vagina as shown in Fig 2, thereby forming a seal and damming the cervical canal to capture liquid), the outer edge including an elongated channel defined therein configured to transversely receive the elongated shaft of the endoscope therein (Fig 3, cylindrical tube 33 creating aperture 30 receives a scope instrument 16 therein), wherein, in operation of the sheath, the elongated scope exerts radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel (Fig 3 elastomeric discs 54 55 necessarily exert at least some inward radial pressure toward scope 16 in order to provide a seal, providing at least some resistance); and
a fluid line extending into and integrally formed with the collecting sheath, the fluid line forming a fluid drain at the distal end (Fig 2, combination of drainage port 36, tubular extension 38, and drainage tube 40 forms a fluid drain wherein fluid is initially captured at the distal end at base 26. The drainage port portion 36 and tubular extension 38 of the fluid line are integrally formed with and extend into cervical dam 10).
Saadat is silent whether the distal end includes at least one aperture defined in a lower portion of the sheath, the at least one aperture configured to collect fluid from the patient’s vagina, and whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Crafton teaches a cervical cup, thus from the same field of endeavor, wherein the distal end includes at least one aperture defined in a lower portion of the sheath, the at least one aperture configured to collect fluid from the patient’s vagina (Fig 16 ¶[0034][0060-0061], cervical cup 250 includes vents 252 disposed around the entirety of the distal end, which would include a lower portion of the sheath. Applicator 20 may include tube 22 connected to a vacuum generating device 24 connected to port 16 of 250, thus collecting fluid from the patient’s vagina) to help with cervical mucous drainage and to allow medication administration (¶[0060-0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Saadat so that the distal end includes at least one aperture defined in a lower portion of the sheath, the at least one aperture configured to collect fluid from the patient’s vagina, as taught by Crafton to help with cervical mucous drainage and to allow medication administration (as motivated by Crafton ¶[0060-0061]).
Saadat/Crafton is silent whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Holbrooks teaches a uterine manipulator, thus from the same field of endeavor, wherein the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath
(Fig 1, 2A-B, 4 Col 4 ln 52-67, Col 5 ln 19-55 manipulator tube 13 which passes through hole 37 comprises retention mechanism 27 configured to prevent detachment of cervical cup 23, allowing 13 and 23 to move in concert with one another) to significantly increase the retention force of the cervical cup on the manipulator tube and prevent detachment of the cervical cup from the manipulator tube (Col 5 ln 46-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat/Crafton of claim so that the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath, as taught by Holbrooks to significantly increase the retention force of the cervical dam on the endoscope tube and prevent detachment of the cervical dam from the endoscope tube (as motivated by Holbrooks Col 5 ln 46-55).
Regarding Claim 23, Saadat/Crafton/Holbrooks discloses that the fluid line is configured to couple to a vacuum source (Col 10 ln 55-Col 11 ln 2) fluid may be drained via drainage tube 40 by application of a vacuum).
Regarding Claim 24, Saadat/Crafton/Holbrooks discloses a collection vessel in fluid communication with the fluid line, wherein the collection vessel is configured to receive fluid captured by the fluid drain (Col 10 ln 55-Col 11 ln 2 fluid collection via drainage tube 40 is envisioned, thus implying the presence of a collection vessel).
Regarding Claim 29, Saadat discloses a system (Fig 2), comprising an endoscope defining a proximal end, a distal end, and an elongated shaft extending between the proximal end and the distal end of the endoscope (Fig 2 Col 6, ln 28-52, hysteroscope 16 is shown with its distal end disposed through the patients cervical canal 12, a proximal end manipulated by a user (not shown) and an elongated shaft); a fluid collecting sheath configured for insertion into a vaginal opening (Fig 2, cervical dam 10), wherein the fluid collecting sheath includes:
a proximal end having a first diameter (Fig 2, proximal end at apex 28 has a first diameter);
a distal end having a second diameter (Fig 2 distal end at base 26 has a second diameter), wherein the second diameter is greater than the first diameter (Fig 2 Col 7 ln 23-31, body 24 of cervical dam 10 is dome shaped and thus the diameter of base 26 is greater than the diameter at apex 28);
a proximal orifice defined in the proximal end of the fluid collecting sheath (Fig 2-3, aperture 30) wherein the proximal orifice is configured to selectively expand in width to operably engage the elongated shaft of an endoscope (Fig 2-3, Col 8 ln 1-60, aperture 30 is configured for insertion of a scope instrument 16 and may comprise a elastomeric disc valve, duck bill valve, universal seal, or preformed slit each of which selectively expands to engage the shaft of a scope);
an outer edge configured to collapse for insertion into a patient's vagina and flex to conform to and create a seal against walls of the patient's vagina (Fig 2, Col 6 ln 28-38, Col 7 ln 23-31 cervical dam 10 may be an elastomeric material comprising outer edge of base 26 which fully capable of collapsing for insertion into the patient’s vagina as shown in Fig 2, thereby forming a seal and damming the cervical canal to capture liquid), the outer edge including an elongated channel defined therein configured to transversely receive the elongated shaft of the endoscope therein (Fig 3, cylindrical tube 33 creating aperture 30 receives a scope instrument 16 therein), wherein, in operation of the sheath, the elongated scope exerts radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel (Fig 3 elastomeric discs 54 55 necessarily exert at least some inward radial pressure toward scope 16 in order to provide a seal, providing at least some resistance); and
a fluid line extending into and integrally formed with the collecting sheath, the fluid line forming a fluid drain at the distal end of the fluid collecting sheath (Fig 2, combination of drainage port 36, tubular extension 38, and drainage tube 40 forms a fluid drain wherein fluid is initially captured at the distal end at base 26. The drainage port portion 36 of the fluid line is integrally formed with and extends into cervical dam 10).
Saadat is silent regarding the distal end including a plurality of apertures defined therein and configured to drain vaginal fluid therethrough; and whether a fluid line is operably coupled to the plurality of apertures defined in the distal end, the plurality of apertures and the fluid line cooperating to form a fluid drain at the distal end of the fluid collecting sheath, and whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Crafton teaches a cervical cup, thus from the same field of endeavor, wherein the distal end including a plurality of apertures defined therein and configured to drain vaginal fluid therethrough; a fluid line is operably coupled to the plurality of apertures defined in the distal end; the plurality of apertures and the fluid line cooperating to form a fluid drain at the distal end of the fluid collecting sheath (Fig 16 ¶[0034][0060-0061], cervical cup 250 includes a plurality of vents 252 disposed at the distal end. Applicator 20 may include tube 22 connected to a vacuum generating device 24 connected to port 16 of 250, thus collecting fluid from the patient’s vagina); to help with cervical mucous drainage and to allow medication administration (¶[0060-0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Saadat so that the distal end including a plurality of apertures defined therein and configured to drain vaginal fluid therethrough; a fluid line is operably coupled to the plurality of apertures defined in the distal end; the plurality of apertures and the fluid line cooperating to form a fluid drain at the distal end of the fluid collecting sheath as taught by Crafton to help with cervical mucous drainage and to allow medication administration (as motivated by Crafton ¶[0060-0061]).
Saadat/Crafton is silent whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Holbrooks teaches a uterine manipulator, thus from the same field of endeavor, wherein the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath
(Fig 1, 2A-B, 4 Col 4 ln 52-67, Col 5 ln 19-55 manipulator tube 13 which passes through hole 37 comprises retention mechanism 27 configured to prevent detachment of cervical cup 23, allowing 13 and 23 to move in concert with one another) to significantly increase the retention force of the cervical cup on the manipulator tube and prevent detachment of the cervical cup from the manipulator tube (Col 5 ln 46-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat/Crafton of claim so that the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath, as taught by Holbrooks to significantly increase the retention force of the cervical dam on the endoscope tube and prevent detachment of the cervical dam from the endoscope tube (as motivated by Holbrooks Col 5 ln 46-55).
Regarding Claim 30, Saadat/Crafton/Holbrooks discloses a vacuum source in fluid communication with the fluid line, wherein the vacuum source is configured to apply negative pressure to the fluid drain to draw fluid through the fluid line(Col 10 ln 55-Col 11 ln 2) fluid may be drained via drainage tube 40 by application of a vacuum).
Regarding Claim 35, Saadat/Crafton/Holbrooks discloses that the fluid collecting sheath and the fluid line are a single integrally formed structure in which the fluid line extends within the fluid collecting sheath between the proximal end and the distal end of the fluid collecting sheath (Figs 2-3 tubular extension 38 is shown as an integrally formed part of cervical dam 10 which is disposed between the apex 28 and base 26).
Regarding Claim 37, Saadat discloses a system (Fig 2), comprising an endoscope defining a proximal end, a distal end, and an elongated shaft extending between the proximal end and the distal end of the endoscope (Fig 2 Col 6, ln 28-52, hysteroscope 16 is shown with its distal end disposed through the patients cervical canal 12, a proximal end manipulated by a user (not shown) and an elongated shaft); a fluid collecting sheath (Fig 2, cervical dam 10) defining a proximal end and a distal end (Fig 2, proximal end at apex 28, distal end at base 26), wherein the fluid collection sheath is configured for insertion into a vaginal opening (Fig 2, cervical dam 10 shown inserted into a vaginal opening), wherein the fluid collecting sheath includes:
a fluid line extending into and integrally formed with the collecting sheath forming a fluid drain at the distal end (Fig 2, combination of drainage port 36, tubular extension 38, and drainage tube 40 forms a fluid drain wherein fluid is initially captured at the distal end at base 26. The drainage port portion 36 of the fluid line is integrally formed with and extends into cervical dam 10); and
a channel configured to selectively expand in width to operably engage the elongated shaft of an endoscope (Fig 2-3, Col 8 ln 1-60, aperture 30 is configured for insertion of a scope instrument 16 and may comprise a elastomeric disc valve, duck bill valve, universal seal, or preformed slit each of which selectively expands to engage the shaft of a scope); and
an outer edge including an elongated channel defined therein configured to transversely receive the elongated shaft of the endoscope therein (Fig 3, cylindrical tube 33 creating aperture 30 receives a scope instrument 16 therein), radial pressure exerted by the elongated channel on the elongated shaft is configured to fix the elongated shaft of the endoscope within the elongated channel (Fig 3 elastomeric discs 54 55 necessarily exert at least some inward radial pressure toward scope 16 in order to provide a seal, providing at least some resistance)
Saadat is silent regarding a plurality of distal-facing fluid collecting apertures defined at the distal end of the fluid collecting sheath; a fluid line in fluid communication with the plurality of distal-facing fluid collecting apertures, and whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Crafton teaches a cervical cup, thus from the same field of endeavor, with a plurality of distal-facing fluid collecting apertures defined at the distal end of the fluid collecting sheath (Fig 16 ¶[0060], cervical cup 250 includes vents 252); a fluid line in fluid communication with the plurality of distal-facing fluid collecting apertures (Figs 1 ¶[0034][0061], applicator 20 may include tube 22 connected to a vacuum generating device 24 connected to port 16 of 250) to help with cervical mucous drainage and to allow medication administration (¶[0060-0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Saadat to include a plurality of distal-facing fluid collecting apertures defined at the distal end of the fluid collecting sheath; a fluid line in fluid communication with the plurality of distal-facing fluid collecting apertures, as taught by Crafton to help with cervical mucous drainage and to allow medication administration (as motivated by Crafton ¶[0060-0061]).
Saadat/Crafton is silent whether the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath.
However, Holbrooks teaches a uterine manipulator, thus from the same field of endeavor, wherein the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath
(Fig 1, 2A-B, 4 Col 4 ln 52-67, Col 5 ln 19-55 manipulator tube 13 which passes through hole 37 comprises retention mechanism 27 configured to prevent detachment of cervical cup 23, allowing 13 and 23 to move in concert with one another) to significantly increase the retention force of the cervical cup on the manipulator tube and prevent detachment of the cervical cup from the manipulator tube (Col 5 ln 46-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat/Crafton of claim so that the elongated shaft of the endoscope and the fluid collecting sheath are configured to move in concert with one another upon distal advancement of the fluid collecting sheath, as taught by Holbrooks to significantly increase the retention force of the cervical dam on the endoscope tube and prevent detachment of the cervical dam from the endoscope tube (as motivated by Holbrooks Col 5 ln 46-55).
Regarding Claim 39, Saadat/Crafton/Holbrooks discloses at least one drip flange formed at the distal end of the fluid collecting sheath (Fig 2, area adjacent base 26 acts as a drip flange), wherein the at least one drip flange is configured to direct fluid away from the channel of the fluid collecting sheath (Fig 1, the shape of the area adjacent base 26 works along with drainage port 36, extension 38, and drainage tube 40 to direct fluid away from the aperture 30).
Regarding Claim 40, Saadat/Crafton/Holbrooks discloses the fluid line in communication with the plurality of distal-facing fluid collection apertures as set forth above for claim 37.
Saadat further discloses a collection vessel in communication with the fluid line (Col 10 ln 55-Col 11 ln 2 fluid collection via drainage tube 40 is envisioned, thus implying the presence of a collection vessel). In combination, the collection vessel of Saadat would be configured to receive fluid captured by the plurality of distal-facing fluid collecting apertures taught by Crafton.
Regarding Claim 41-43, Saadat/Crafton/Holbrooks discloses the at least one aperture positioned in a lower portion of the sheath as set forth above for Claim 21.
Saadat is silent whether the at least one aperture is operably coupled to a vacuum source, the at least one aperture is positioned in a lower portion of the sheath to collect fluid via gravity; and wherein the at least one aperture is operably associated with a negative pressure source to draw fluid through the at least one aperture.
However, Crafton teaches a cervical cup, thus from the same field of endeavor, wherein the at least one aperture is operably coupled to a vacuum source (Figs 1 ¶[0034][0061], applicator 20 may include tube 22 connected to a vacuum generating device 24 connected to port 16 of 250, thus operably connecting the vents 252 to the vacuum source 24), the at least one aperture is positioned in a lower portion of the sheath to collect fluid via gravity (Fig 16 ¶[0034][0060-0061], cervical cup 250 includes vents 252 disposed around the entirety of the distal end, which would include a lower portion of the sheath. At least one of the vents 252 would collect fluid via gravity when worn); and wherein the at least one aperture is operably associated with a negative pressure source to draw fluid through the at least one aperture (Figs 1 ¶[0034][0061], applicator 20 may include tube 22 connected to a vacuum generating device 24 connected to port 16 of 250, thus operably connecting the vents 252 to the negative pressure source 24) to help with cervical mucous drainage and to allow medication administration (¶[0060-0061]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat/Crafton/Holbrooks so that at least one aperture is operably coupled to a vacuum source, the at least one aperture is positioned in a lower portion of the sheath to collect fluid via gravity; and wherein the at least one aperture is operably associated with a negative pressure source to draw fluid through the at least one aperture, as taught by Crafton to help with cervical mucous drainage and to allow medication administration (as motivated by Crafton ¶[0060-0061]).
Claims 25 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (EP 0890342 A1) in view of Crafton (US 20210177645 A1), further in view of Holbrooks (US 11278322 B2), further in view of Tilson (US 20180271354 A1).
Regarding Claim 25 and 33, dependent from claims 21 and 29, respectively, as set forth above, Saadat/Crafton is silent regarding a partially elastic collar extending from the fluid line, wherein the collar is configured to be secured to an endoscope.
However, Tilson teaches attachments for endoscopes, thus from the same field of endeavor, including a partially elastic collar extending from the fluid line, wherein the collar is configured to be secured to an endoscope (Fig 23 ¶[0176], stretchable material 2372 extends around vacuum tube 105 and endoscope 101) to prevent lateral movement of the vacuum tube and to be easy to install (¶[0176]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat/Crafton of claim 21 and the system of Saadat/Crafton of claim 29 to include a collar extending from the fluid line, wherein the collar is configured to be secured to an endoscope, as taught by Tilson to prevent lateral movement of the vacuum tube and to be easy to install (as motivated by Tilson ¶[0176]).
Claims 28 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat (EP 0890342 A1) in view of Crafton (US 20210177645 A1), further in view of Holbrooks (US 11278322 B2), further in view of Begg (US 20180132702 A1).
Regarding Claims 28 and 36, dependent from claims 21 and 29, respectively, as set forth above, Saadat is silent whether the fluid collecting sheath tapers along its length forming a conical shape.
However, Begg teaches and endoscope drip flange attachment, thus from the same field of endeavor, wherein the fluid collecting sheath tapers along its length forming a conical shape (Fig 5 ¶[0027][0044] drip flange 502 comprises a conical shape) to prevent fluid from reaching endoscope tubing or attached equipment toward the proximal end of the endoscope device (¶[0046]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saadat of claim 21 and the system of Saadat of claim 29 so that the fluid collecting sheath tapers along its length forming a conical shape, as taught by Begg to prevent fluid from reaching endoscope tubing or attached equipment toward the proximal end of the endoscope device (as motivated by Begg ¶[0046]).
Conclusion
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights