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 .
Claim Objections
Claims 13/14 are objected to because of the following informalities: the use of the word “tightly” when describing a structural relationship between two elements of the claimed invention does not impart structural weight to this claim. Two rigid elements in a mated configuration are as close as can be, and “tightly” does not change this relationship further and so does not need to be recited within these claims. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fukushima et al (U.S. Patent Application Publication 2015/0148606, hereinafter “Fukushima”) in view of Stanton et al (U.S. Patent Application Publication 2020/0386330, hereinafter “Stanton”). Regarding claim 1, Fukushima teaches a suction valve assembly (figure 3 element 29) for a medical device, comprising:
a valve body having a top (figure 3 below pointed at with the upper arrow), a bottom (figure 3 below pointed at with the lower arrow), and a side surface (figure 3 below pointed at with the middle arrow), the valve body having a central channel (figure 3 space within valve cylinder 50) extending vertically between a plurality of vent openings (figure 3 elements 95, paragraph 76 details “cap vents”) in the top and a working opening in the bottom (figure 3 element 56), the valve body also having a suction source opening (figure 3 element 57 “suction port hole”) in the side surface open to the central channel
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a sliding shaft having a central bore (figure 3 “flow path surface” 72), a side surface (figure 3 inside wall of valve cylinder 50), and a plurality of vent channels, each vent channel corresponding to a different one of the plurality of vent openings in the valve body (paragraph 76 details the vent channels fluidly connected to the valve body vent openings), the side surface having a side channel (figure 3 “upper hole opening” 71) open to the central bore, the sliding shaft moving within the central channel of the valve body between:
an upper position (shown in figure 9) where each of the plurality of vent channels is adjacent to and in fluid communication with its corresponding vent opening (paragraph 72 details the venting state of the vent channels when in the unpressed button configuration), where the side opening is above and not in fluid communication with the suction source opening (figure 9 below see suction channel port opening 57 is blocked as opposed to figure 10 where it is in fluid communication with the side opening)
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a lower position where the side opening is adjacent and in fluid communication with the suction source opening (figure 10 above see circled region),
Fukushima fails to teach a suction valve assembly for a medical device, comprising:
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel
the sliding shaft moving within the central channel of the valve body between:
an upper position where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel
a lower position where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
Stanton teaches a suction valve assembly (figure 1A element 100) for a medical device, comprising:
a flap seal (figure 1A element 122) positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel (paragraph 21 Channel seal 122 may prevent passage of fluid or other substance into channel 124 when in a closed position”)
the sliding shaft moving within the central channel of the valve body between:
an upper position where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel (figure 1A see flap seal 122 is closed)
a lower position where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel (figure 1B see sliding shaft extends below working opening 108, and flap seal 122 is opened by element 121)
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It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the valve assembly of Fukushima with the flap seal of Stanton in order to create a fluid communication channel between the working opening and central sliding shaft channel that can be variably turned on and off by user manipulation of the button cap, offering the user control of the rate of flow within the central channel depending on the depth the button cap is pressed. This rate of flow control aids the operator in applying the correct level of suction to the target area within the patient, protecting the patient from damage caused by an excess of suction power.
Regarding claim 2, Fukushima and Stanton combined teach the elements of claim 1, and Fukushima further teaches a suction valve assembly wherein the valve body further comprises a flange thickening a region of the valve body surrounding the suction source opening (paragraph 58 details flange 60a surrounding the suction source opening).
Regarding claim 3, Fukushima further teaches a suction valve assembly wherein the flange is an annular flange surrounding an outer surface of the valve body (paragraph 86 “annular flange”).
Regarding claim 4, Fukushima further teaches a suction valve assembly further comprising a button cap moving between the upper and lower positions with the sliding shaft (see figure 9 in comparison with figure 10, where figure 9 depicts the unpressed button configuration, and figure 10 depicts a pressed button configuration).
Regarding claim 5, Fukushima fails to teach a suction valve assembly further comprising a cap seal attached to the cap moving between the upper and lower positions with the cap, the cap seal seated against the plurality of vent openings of the valve body when in the lower position to obstruct fluid flow through the vent openings into the central channel.
Stanton teaches a suction valve assembly further comprising a cap seal attached to the cap moving between the upper and lower positions with the cap, the cap seal seated against the plurality of vent openings of the valve body when in the lower position to obstruct fluid flow through the vent openings into the central channel (figures 1A and 1B element 130 shown below, paragraph 27 “Seal 130 may prevent fluid from exiting from valve cylinder 102 through lumen 189.”)
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It would have been obvious before the effective filing date of the claimed invention to modify the valve assembly of Fukushima with the cap seals of Stanton to prevent fluid entrance/escape from the inner channel through the vents in the cap. This ensures that the suction delivered to the patient is exact, and unaffected by fluid communication with the room via the cap. Exact suction allows the operator to perform operations with precision, and reduces variables that may cause harm to the patient.
Regarding claim 6, Fukushima and Staunton combined teach the elements of claims 1-5, and Fukushima further teaches a suction valve assembly further comprising a valve stem (figure 2 element 51, paragraph 52 “valve stem”) extending between the cap and the sliding shaft and moving between the upper and lower positions with the cap and the sliding shaft.
Regarding claim 7, Fukushima further teaches a suction valve assembly further comprising a spring member (figure 3 spring 78) biasing the valve into the upper position.
Regarding claim 8, Fukushima fails to teach a suction valve assembly wherein the flap seal is made of a flexible material having a lower durometer than the sliding shaft. Stanton teaches a suction valve assembly wherein the flap seal is made of a flexible material (paragraph 21 details flap seal 122 being made of an elastomeric material) having a lower durometer than the sliding shaft (paragraph 23 “channel stem 120 may be rigid, metal, plastic, or other suitable material”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the valve assembly of Fukushima with the flap seal of Stanton in order to create a fluid communication channel between the working opening and central sliding shaft channel that can be variably turned on and off by user manipulation of the button cap, offering the user control of the rate of flow within the central channel depending on the depth the button cap is pressed. This rate of flow control aids the operator in applying the correct level of suction to the target area within the patient, protecting the patient from damage caused by an excess of suction power. It would be obvious to construct the flap seal of a lower durometer material than the sliding shaft in order to retain the property of the flap seal being able to be pushed open upon pressing of the button, a rigid material like that of the sliding shaft would not have the give required to function as a flap seal as presented in Stanton.
Regarding claim 9, Fukushima fails to teach a suction valve assembly wherein the central bore of the sliding shaft extends from a bottom opening in the bottom surface of the sliding shaft. Stanton teaches a suction valve assembly wherein the central bore of the sliding shaft extends from a bottom opening (figure 1A opening covered by flap seal 122) in the bottom surface of the sliding shaft. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the valve assembly of Fukushima with the bottom opening in the sliding shaft of Stanton in order to incorporate a flap seal and create a fluid communication channel between the working opening and central sliding shaft channel that can be variably turned on and off by user manipulation of the button cap, offering the user control of the rate of flow within the central channel depending on the depth the button cap is pressed. This rate of flow control aids the operator in applying the correct level of suction to the target area within the patient, protecting the patient from damage caused by an excess of suction power.
Regarding claim 10, Fukushima and Stanton combined teach the elements of claims 1 and 9, and Fukushima further teaches a suction valve assembly wherein the bottom surface of the sliding shaft is a beveled surface (figure 10 beveled surface circled below).
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Regarding claim 11, Fukushima further teaches a suction valve assembly of claim 10, wherein the bottom surface of the sliding shaft is beveled such that, when the sliding shaft is in the upper position, a portion of the side surface of the sliding shaft radially opposite the suction source opening is at the elevation of the suction source opening, but the portion of the side surface of the sliding shaft radially aligned with the suction source opening ends above the elevation of the suction source opening (see left and right arrows in figure 10 above showing side surface radially opposite the suction opening (left) and side surface ending above the suction opening (right)).
Regarding claim 12, Fukushima teaches a suction valve assembly (figure 3 element 29) for a medical device, comprising:
a valve body having a top (figure 3 below pointed at with the upper arrow), a bottom (figure 3 below pointed at with the lower arrow), and a side surface (figure 3 below pointed at with the middle arrow), the valve body having a central channel (figure 3 space within valve cylinder 50) extending vertically between a plurality of vent openings (figure 3 elements 95, paragraph 76 details “cap vents”) in the top and a working opening in the bottom (figure 3 element 56), the valve body also having a suction source opening (figure 3 element 57 “suction port hole”) in the side surface open to the central channel
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a sliding shaft having a central bore (figure 3 “flow path surface” 72), a side surface (figure 3 inside wall of valve cylinder 50), and a plurality of vent channels, each vent channel corresponding to a different one of the plurality of vent openings in the valve body (paragraph 76 details the vent channels fluidly connected to the valve body vent openings), the side surface having a side channel (figure 3 “upper hole opening” 71) open to the central bore, the sliding shaft moving within the central channel of the valve body between:
an upper position (shown in figure 9) where each of the plurality of vent channels is adjacent to and in fluid communication with its corresponding vent opening (paragraph 72 details the venting state of the vent channels when in the unpressed button configuration), where the side opening is above and not in fluid communication with the suction source opening (figure 9 below see suction channel port opening 57 is blocked as opposed to figure 10 where it is in fluid communication with the side opening)
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a lower position where the side opening is adjacent and in fluid communication with the suction source opening (figure 10 above see circled region),
a source of suction in fluid communication with the suction source opening of the suction valve assembly, such that, when the sliding shaft of the valve is in the lower position, it provides suction to the working channel of the endoscopic probe from the suction source opening, through the valve body, and into the working channel opening (paragraph 67 “the piston rod 51 comes to the halfway position upon the halfway depression of the button cap 47. The flow space of the flow path surface 72 cooperates with the upper passage hole 74 as a second passage, for connecting the exhaust port hole 58 with the suction port hole 57 for suction”).
Fukushima fails to teach a suction valve assembly for a medical device, comprising:
a flap seal positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel
the sliding shaft moving within the central channel of the valve body between:
an upper position where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel
a lower position where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel.
Stanton teaches a suction valve assembly (figure 1A element 100) for a medical device, comprising:
a flap seal (figure 1A element 122) positioned at the bottom of the valve body, the flap seal resiliently biased to seat against the valve body to obstruct fluid flow through the working opening into the central channel (paragraph 21 Channel seal 122 may prevent passage of fluid or other substance into channel 124 when in a closed position”)
the sliding shaft moving within the central channel of the valve body between:
an upper position where the flap seal is seated against the valve body to obstruct fluid flow through the working opening into the central channel (figure 1A see flap seal 122 is closed)
a lower position where a second part of the sliding shaft extends below the working opening in the bottom of the valve body, the sliding shaft unseating the flap seal to allow fluid flow through the working opening into the central channel (figure 1B see sliding shaft extends below working opening 108, and flap seal 122 is opened by element 121)
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It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the valve assembly of Fukushima with the flap seal of Stanton in order to create a fluid communication channel between the working opening and central sliding shaft channel that can be variably turned on and off by user manipulation of the button cap, offering the user control of the rate of flow within the central channel depending on the depth the button cap is pressed. This rate of flow control aids the operator in applying the correct level of suction to the target area within the patient, protecting the patient from damage caused by an excess of suction power.
Regarding claim 13, Fukushima and Stanton combined teach the elements of claim 12, and Fukushima further teaches an endoscopic surgical device further comprising an endoscopic handle having a suction valve location (figure 2 pointed at below) with an inner wall, the side surface of the valve body of the suction valve assembly pressing tightly against the inner wall of the suction valve location of the endoscopic handle (suction valve fits into suction valve location).
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Regarding claim 14, Fukushima further teaches an endoscopic surgical device wherein the valve body of the suction valve assembly comprises a flange thickening a region of the valve body surrounding the suction source opening (paragraph 58 details flange 60a surrounding the suction source opening), the flange pressing tightly against the inner wall.
Regarding claim 15, Fukushima further teaches an endoscopic surgical device wherein when the sliding shaft of the valve is in the upper position, the source of suction is in fluid communication with the vent opening of the valve assembly such that the source of suction is open to room air (paragraph 93 details the fluid communication between the suction source opening and room air when in the upper button position).
Regarding claim 16, Fukushima further teaches an endoscopic surgical device, the suction valve assembly further comprising a button cap moving between the upper and lower positions with the sliding shaft (see figure 9 in comparison with figure 10, where figure 9 depicts the unpressed button configuration, and figure 10 depicts a pressed button configuration).
Regarding claim 17, Fukushima fails to teach an endoscopic surgical device, the suction valve assembly further comprising a cap seal attached to the cap moving between the upper and lower positions with the cap, the cap seal seated against the plurality of vent openings of the valve body when in the lower position to obstruct fluid flow through the vent openings into the central channel. Stanton teaches an endoscopic surgical device, the suction valve assembly further comprising a cap seal attached to the cap moving between the upper and lower positions with the cap, the cap seal seated against the plurality of vent openings of the valve body when in the lower position to obstruct fluid flow through the vent openings into the central channel (figures 1A and 1B element 130 shown below, paragraph 27 “Seal 130 may prevent fluid from exiting from valve cylinder 102 through lumen 189.”).
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It would have been obvious before the effective filing date of the claimed invention to modify the valve assembly of Fukushima with the cap seals of Stanton to prevent fluid entrance/escape from the inner channel through the vents in the cap. This ensures that the suction delivered to the patient is exact, and unaffected by fluid communication with the room via the cap. Exact suction allows the operator to perform operations with precision, and reduces variables that may cause harm to the patient.
Regarding claim 18, Fukushima further teaches an endoscopic surgical device, the suction valve assembly further comprising a valve stem (figure 2 element 51, paragraph 52 “valve stem”) extending between the cap and the sliding shaft and moving between the upper and lower positions with the cap and the sliding shaft.
Regarding claim 19, Fukushima fails to teach an endoscopic surgical device wherein the central bore of the sliding shaft extends from a bottom opening in the bottom surface of the sliding shaft. Stanton teaches an endoscopic surgical device wherein the central bore of the sliding shaft extends from a bottom opening in the bottom surface of the sliding shaft (figure 1A opening covered by flap seal 122). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the valve assembly of Fukushima with the bottom opening in the sliding shaft of Stanton in order to incorporate a flap seal and create a fluid communication channel between the working opening and central sliding shaft channel that can be variably turned on and off by user manipulation of the button cap, offering the user control of the rate of flow within the central channel depending on the depth the button cap is pressed. This rate of flow control aids the operator in applying the correct level of suction to the target area within the patient, protecting the patient from damage caused by an excess of suction power.
Regarding claim 20, Fukushima and Stanton combined teach the elements of claims 12 and 19, and Fukushima further teaches an endoscopic surgical device wherein the bottom surface of the sliding shaft is a beveled surface (figure 10 beveled surface circled below).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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