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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because Figs. 4A-10 have handwritten element numbers. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term Olympus, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 1 of the claim should read “A suction valve for an endoscope, the suction valve comprising:” and Line 10 should read “wherein the actuator button is collapsible…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 3 recites that the upper distal head of the plunger element is wider than the annular seat of the diaphragm. However, Figs. 4A-8A show the opposite configuration with the annular seat of the diaphragm wider than the plunger element. The specification provides no other suggestion that the upper distal head of the plunger element is wider than the annular seat of the diaphragm. The claim will be interpreted as having the configuration seen in Figs. 4A-8 with the annular seat being wider than the plunger’s upper distal head.
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 3-5, 8-9, and 10-12 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.
Claims 3-5 and 10-11 are rejected under 35 U.S.C. 112(b) for containing a limitation that lacks sufficient antecedent basis. The following is a list of these limitations:
Claim 3 – “the upper distal head of the plunger assembly” and “the annular seat of the diaphragm”
Claim 4 – “the annular diaphragm”
Claim 5 – “the annular diaphragm”
Claim 10 – “the suction tube”
Claim 11 – “the radius of curvature R1 of the intermediate curved section”
In regards to claims 8, 9, and 12, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8, 9, and 12 recite the broad recitation “having a radius of curvature R1 of at least 50% of the length L1 of the suction arm” (claims 8 and 9) and “a distal straight section disposed at an angle theta of 20 degrees to 40 degrees to the proximal section” (Claim 12), and the claims also recite “the intermediate curved section has a radius of curvature R1 that is at least 60% of the length of L1 of the suction arm” (Claim 8), “the intermediate curved section has a radius of curvature R1 that is 80% to 120% of the length of L1 of the suction arm” (Claim 9), and “the distal straight section of the suction arm is disposed at an angle theta of 25 degrees to 35 degrees to the proximal straight section” (Claim 12) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In regards to claims 10 and 11, the term “about” in claims 10 and 11 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 recites that the endoscope is a bronchoscope; however, the endoscope of claim 1 is only in the preamble and not positively recited in the body of the claim. Moreover, claim 1 recites the structural limitations of a suction valve to be used with an endoscope. Therefore, the intended use of the suction valve is for use with an endoscope. For these reasons, claim 6 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent Application Publication 2012/0071844 to Yamone et al (hereinafter “Yamone”).
In regard to claim 1, Yamone discloses a suction valve for an endoscope ([0059] [0062]), the suction valve comprising: a valve housing (Fig. 4A, element 30) having a first lumen (Elements 40 to 41 to 42 [0069]), a lower part (Element 34) configured for mounting in a suction cylinder of an endoscope ([0067]), and an upper part (see annotated Fig. 4A below); a suction arm (Element 44) extending laterally of the upper part of the valve housing and having a second lumen (Element 21) is fluidic communication with the first lumen (see Fig. 4A); and an actuator (Fig. 3, 18) comprising a valve to open and close the first lumen (Element 58, [0076]) and an actuator button (Fig. 3, Element 26) operatively coupled to the valve, in which the actuator button is collapsible to actuate the valve to open the first lumen ([0063] [0064] [0072]), characterised in that the actuator button is collapsible from an at-rest configuration in which a top surface of the actuator button comprises a first step and a collapsed configuration in which the top surface of the actuator button comprises a first step and a second step (Elements 62 and 63, [0083] [0085] [0088]).
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In regards to claim 2, Yamone discloses that the actuator button (Element 26) comprises an annular diaphragm (Element 71) with a through lumen (Element 65) and an annular seat (Element 37), and the valve comprises a plunger element (Element 25) that extends into the first lumen of the valve housing (Fig. 3) with a lower lumen closure (Element 53) and an upper distal head (Element 52) that is seated on the annular seat of the annual diaphragm to provide the first step ([0072]).
In regards to claim 3, Yamone discloses that the upper distal head of the plunger element is wider than the annular seat of the diaphragm (Figs. 2 and 3 show element 52 and 57 in the same configuration as Applicant’s Figs. 4A-8A, alternatively Yamone teaches this configuration in [0106] and [0110])
In regards to claim 4, Yamone discloses that the annular diaphragm comprises an upper section that is axially collapsible upon actuation and a lower section comprising the second step that is axially non- collapsible upon actuation, whereby when the diaphragm is collapsed, the upper section of the diaphragm collapses bringing the first step and second step into proximity at a top surface of the collapsed button (Figs. 2-3 show Element 71 with a collapsible upper portion above Element 38 and a non-collapsible area adjacent to Element 39)
In regards to claim 5, Yamone discloses that the annular diaphragm comprises an upper section that is axially collapsible upon actuation and a lower section comprising the second step that is axially non- collapsible upon actuation, whereby when the diaphragm is collapsed, the upper section of the diaphragm collapses bringing the first step and second step into proximity at a top surface of the collapsed button (Figs. 2-3 show Element 71 with a collapsible upper portion above Element 38 and a non-collapsible area adjacent to Element 39), in which an upper part of the lower section of the diaphragm projects radially inwardly to meet a lower part of the upper section to provide the second step (Figs. 2 and 3 show Element 71 with an inward projection adjacent to Element 39)
In regards to claim 6, Yamone discloses that the endoscope is a bronchoscope ([0121])
In regards to claims 16 and 17, Yamone discloses all of the limitations of claim 1 and that the device is an endoscope or bronchoscope ([0121])
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.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamone in view of US Patent Application Publication 2021/0016075 to Nakajima (hereinafter “Nakajima”). In regards to claims 7-9, Yamone discloses that the suction arm (44) comprises a proximal straight section and a distal straight section disposed at an angle (see annotated Fig. 4B below).
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However, Yamone does not teach:
The angle is 20 to 40 degrees to the proximal straight section and an intermediate curved section having a radius of curvature R1 that is at least 50% the length L1 of the suction arm
The intermediate curved section has a radius of curvature R1 that is at least 60% of the length L1 of the suction arm
The intermediate curved section has a radius of curvature R1 that is 80 to 120% of the length L1 of the suction arm
In regards to claims 7-9, Nakajima teaches a suction valve for an endoscope comprising a proximal straight section, a distal straight section disposed at an angle to the proximal straight section and an intermediate curved section having a radius of curvature in relation to the length of the suction arm (Fig. 2B, Element 21). It would have been obvious before the effective filing date of the claimed invention to modify Yamone with the intermediate curved section such as that taught by Nakajima in order to provide the use with the ability to move the endoscope without disconnection from the suction source.
In regards to claims 7-9, Yamone and Nakajima fail to explicitly disclose that the angle between the proximal straight section and the proximal distal section is 20-40 degrees.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the angle between the proximal and distal sections of Yamone in view of Nakajima to be 20 to 40 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction arm would not operate differently with the claimed offset angle. Further, Applicant places no criticality on the range claimed, indicating on page 5 of the applicant’s specification that the suction arm having an angle is critical, but the specific angle is not recited as critical.
In regards to claims 7-9, Yamone and Nakajima fail to explicitly disclose wherein the radius of curvature is at least 50%, at least 60%, or between 80% to 120% of the length of the suction arm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the radius of curvature of the suction arm of Yamone in view of Nakajima to be at least 50%, at least 60%, or between 80% to 120% of the length of the suction arm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction arm would not operate differently with the claimed radius of curvature. Further, Applicant places no criticality on the range claimed, indicating on page 4 of the applicant’s specification that the ability to have the suction arm curve is critical, but the specific radius of curvature is not recited as critical.
Claim(s) 10 are rejected under 35 U.S.C. 103 as being unpatentable over Yamone. Yamone discloses a suction tube (Element 44 or Element 21), but does not disclose that the length of the tube is 6-10cm. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the length of the suction tube of Yamone 6-10 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction arm would not operate differently with the claimed offset angle. Further, Applicant places no criticality on the range claimed, indicating on page 4 of the applicant’s specification that the suction arm has a length, but the specific length is not recited as critical.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yamone in view of Nakajima. In regards to claim 11, Yamone does not disclose a radius of curvature for the suction arm. However, Nakajima discloses a suction valve for an endoscope comprising a suction arm having an intermediate section with a radius of curvature (Fig. 2B, Element 21). It would have been obvious before the effective filing date of the claimed invention to modify Yamone with the intermediate curved section such as that taught by Nakajima in order to provide the use with the ability to move the endoscope without disconnection from the suction source.
In regards to claim 11, Yamone and Nakajima fail to explicitly disclose wherein the radius of curvature is about 6 to 10 cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the radius of curvature of the suction arm of Yamone in view of Nakajima to be 6-10 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction arm would not operate differently with the claimed radius of curvature. Further, Applicant places no criticality on the range claimed, indicating on page 4 of the applicant’s specification that the ability to have the suction arm curve is critical, but the specific radius of curvature is not recited as critical.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamone in view of Nakajima. In regards to claim12, Yamone discloses that the suction arm (44) comprises a proximal straight section and a distal straight section disposed at an angle (see annotated Fig. 4B below).
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However, Yamone does not teach that and an intermediate curved section having a radius of curvature R1 that is at least 50% the length L1 of the suction arm and that the angle is 20 to 40 degrees to the proximal straight section and and/or 25-35 degrees to the proximal section.
In regards to claim 12, Nakajima teaches a suction valve for an endoscope comprising a proximal straight section, a distal straight section disposed at an angle to the proximal straight section and an intermediate curved section having a radius of curvature in relation to the length of the suction arm (Fig. 2B, Element 21). It would have been obvious before the effective filing date of the claimed invention to modify Yamone with the intermediate curved section such as that taught by Nakajima in order to provide the use with the ability to move the endoscope without disconnection from the suction source.
In regards to claims 12, Yamone and Nakajima fail to explicitly disclose that the angle between the proximal straight section and the proximal distal section is 20-40 degrees and/or 25-35 degrees.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make/set the angle between the proximal and distal sections of Yamone in view of Nakajima to be 20 to 40 degrees and/or 25-35 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the suction arm would not operate differently with the claimed offset angle. Further, Applicant places no criticality on the range claimed, indicating on page 5 of the applicant’s specification that the suction arm having an angle is critical, but the specific angle is not recited as critical.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamone as applied to claim 1 above, and further in view of U.S. Patent 4610220 to Goldberg et al (hereinafter “Goldberg”). In regards to claims 13-15, Yamone teaches that the suction arm (44) comprises a proximal end section joined to the valve housing (see Figs. 2 and 3) and comprising opposed sides (see Fig. 4a). However, Yamone does not teach:
wherein first and second rigid strengthening ribs (30) are provided connecting each opposed side of the proximal end of the suction arm with the valve housing.
Wherein each strengthening rib (30)has a planar shape with a curved end dimensioned to conform to a sidewall of the valve housing and a sidewall dimensioned to conform to a side of the proximal end of the suction tube.
Wherein the strengthening ribs (30) are disposed such that a plane of each rib is generally orthogonal to a longitudinal axis of the valve housing (5)
In regards to claims 13-15, Goldberg discloses a suction valve:
wherein first and second rigid strengthening ribs are provided connecting each opposed side of the proximal end of the suction arm with the valve housing (Fig. 2, Element 40, Col 3 Ln 35-42)
Wherein each strengthening rib has a planar shape with a curved end dimensioned to conform to a sidewall of the valve housing and a sidewall dimensioned to conform to a side of the proximal end of the suction tube (Fig. 2, Element 40, Col 3 Ln 35-42)
Wherein the strengthening ribs are disposed such that a plane of each rib is generally orthogonal to a longitudinal axis of the valve housing (Plane of Fig. 2 is orthogonal to the longitudinal axis of element 12 in Fig. 1)
It would have been obvious before the effective filing date of the claimed invention to modify Yamone to include the strengthening ribs such as that taught by Goldberg in order to avoid a total collapse of the valve under suction (Goldberg Col 3 Ln 35-42).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795