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 .
Claim Objections
Claim 12 and 13 are objected to because of the following informalities:
Claim 13 recites “a third circumferentially recessed portion at which the second seal is located” should recite – a third circumferentially recessed portion at which the third seal is located--. Appropriate correction is required.
Claim 14 recites “the second, seal”. The comma needs to be removed for grammatical reasons.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-10, 15-16, 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondo (US 2003/0181787 A1).
With regard to claim 1, Kondo discloses A suction valve assembly (Fig. 1 and 2) for a medical device, comprising: a valve well (102) having a proximal opening (at 115a), a distal opening (at 108), and an intermediate opening (106) positioned between the proximal opening and the distal opening; a valve stem (104) configured to translate within the valve well (see between Fig. 1 and 2), the valve stem comprising: a first opening (110); a second opening (opening where 112c is located); and a lumen extending from the first opening to the second opening (see annotated Fig below); a first seal (112a) extending circumferentially around the valve stem at a location proximal of the first opening (110); a second seal (112b) extending circumferentially around the valve stem at a location distal of the first opening; and a third seal (112c) extending circumferentially around the valve stem at a location distal of the second seal; and wherein the valve stem has a first configuration (shown in Fig.1) in the valve well in which the second seal (112b) is a barrier between the proximal opening and the intermediate opening, the third seal (112c) is a barrier between the intermediate opening and the distal opening, and the lumen is fluidly isolated from the intermediate opening (shown in Fig. 1, the second seals the fluid from going into the intermediate opening at 106); wherein the valve stem has a second configuration (shown in Fig. 2) in the valve well in which the first seal (112a) is proximal the intermediate opening and the lumen is fluidly isolated from the proximal opening (via 112a, which seals the fluid from entering from the proximal opening 115a) and the first seal is a barrier between the proximal opening and the intermediate opening (shown In Fig. 2).
PNG
media_image1.png
702
526
media_image1.png
Greyscale
With regard to claim 2, Kondo discloses wherein when the valve stem (104) is in the first configuration (fig. 1), the proximal opening (115a) and the distal opening (108) are in fluid communication through the lumen of the valve stem ([0046] air can flow from air grooves 122 through proximal opening 115a and through the lumen and out the distal opening 108).
With regard to claim 3, Kondo discloses wherein when the valve stem (104) is in the second configuration (Fig. 2), the intermediate opening (106) and the distal opening (108) are in fluid communication through the lumen of the valve stem (in Fig. 2, fluid can flow from the suction source connected at 108 and through the lumen and through the intermediate opening 106 and is sealed away from the proximal opening of 115a by the first seal 112a).
With regard to claim 4, Kondo discloses wherein when the valve stem is in the first configuration (Fig. 1), the third seal (112c) is distal of the intermediate opening and the distal opening (108) is fluidly isolated from the intermediate opening (via seal of 112b and 112c).
With regard to claim 5, Kondo discloses wherein the second seal (112b) and the third seal (112c) are configured to contact an inner wall of the valve well when the valve stem is in the first configuration (see Fig. 1, where 112b and 112c contact the walls of the valve well 102).
With regard to claim 6, Kondo discloses wherein the first opening (110) is a radial opening in the valve stem (see Fig. 1) and the second opening (see annotated Fig above) is an axial opening in the valve stem (see annotated Fig above).
With regard to claim 7, Kondo discloses wherein the valve well further comprises: a main body (102 forms the main body) defining the intermediate opening and the distal opening; and a collar (see the annotated Fig above) couplable to the main body, the collar defining the proximal opening (defined and formed by the collar parts 115 and the portion annotated above).
With regard to claim 8, Kondo discloses wherein the first seal (112a) is configured to engage the collar when the valve stem is in the first configuration (Fig. 1, first seal 112a engages the collar by being embedded in element 104 which is contacting collar element 115. The first seal is not required to be directly contacting the collar).
With regard to claim 9, Kondo discloses further comprising: a cap (120) coupled to the valve stem; a bias mechanism (114) extending between the cap and the valve well; and wherein the bias mechanism is configured to bias the valve stem to the first configuration (shown in Fig. 1, [0045], [0060]).
With regard to claim 10, Kondo discloses wherein the cap (120), the bias mechanism, the valve stem (104), and the valve well (102) are configured such that actuation of the cap in a direction opposite a direction of a bias force of the bias mechanism is configured to adjust the valve stem from the first configuration to the second configuration (as shown moving from fig. 1 to Fig. 2).
With regard to claim 15, Kondo discloses A suction valve assembly (Fig. 1 and 2) for use in an endoscope (shown In Fig. 7 which shows the entire system using a different embodiment of the suction valve (element 216) but is the same overall system for the valve of Fig. 1 and 2) having a lumen (204) configured to extend into a patient's body cavity, the suction valve assembly comprising: a valve well (fig. 1 and 2, element 102) defining a port (106) configured to be in fluid communication with the lumen; and a valve stem (104) configured to adjust within the valve well (shown between Fig. 1 and 2), the valve stem comprising a first circumferential seal (112a), a second circumferential seal (112b), a third circumferential seal (112c), a first connection component (see annotated Fig below, the term component is broad and can be considered any part of the valve stem) extending between the first circumferential seal and the second circumferential seal, and a second connection component (see annotated drawing below, the term component is broad and be considered any part of the valve stem) extending between the second circumferential seal and the third circumferential seal; and wherein the valve stem is configured to fluidly isolate the port from a negative pressure when in a first configuration (shown in fig. 1, seal 112b and 112c blocks the port in Fig. 1) within the valve well; and wherein the valve stem is configured to fluidly couple the port with the negative pressure and fluidly isolate the port from atmosphere when in a second configuration within the valve well (shown in Fig. 2, seal 112a block the fluid from contacting with the atmosphere at 115a and 122).
PNG
media_image2.png
676
635
media_image2.png
Greyscale
With regard to claim 16, Kondo discloses wherein the valve stem further comprises: a first opening (110), a second opening (see first annotated Fig above), and a lumen (see first annotated Fig above) extending between the first opening and the second opening; wherein the first circumferential seal (112a) is proximal of the of the first opening (see Fig. 1); and wherein the second circumferential seal (112b) and the third circumferential seal (112c) are distal of the first opening (see Fig. 1).
With regard to claim 18, Kondo discloses A medical device (Fig. 7, Fig. 1 and 2, Fig. 7 shows the entirety of the endoscope device used with suction valve 216. The suction valve of Fig. 1 and 2, element 100 is also used in a similar endoscope device but no drawing is provided showing the entirety of the device with the suction valve of Fig. 1 and 2. Thus citations for the medical device will be taken from Fig. 7 for reference but the suction valve of Fig. 1 and 2 will be used as the suction valve used in the medical device endoscope) comprising: a proximal endoscope handle (Fig. 7, element 202); a distal tip unit ( that would be located at the distal end of 204) adapted to be inserted into a patient's body cavity; an elongate tube (204) extending between the proximal endoscope handle and the distal tip unit; and a suction valve (100, or equivalent shown in Fig. 7 as 216) in communication with a lumen of the elongate tube to adjustably fluidly couple the lumen to a negative pressure (via 206), the suction valve comprises: a valve well (102); and a valve stem (104) configured to adjust within the valve well (shown between Figs 1 and 2), the valve stem comprising a first circumferential seal (112a), a second circumferential seal (112b), and a third circumferential seal (112c); and wherein the valve stem is configured to fluidly isolate the lumen from the negative pressure when in a first configuration (Fig. 1) within the valve well; and wherein the valve stem is configured to fluidly couple the lumen with the negative pressure and fluidly isolate the lumen from atmosphere when in a second configuration within the valve well (Fig. 2, atmosphere is vented at 115a and 122, in Fig. 2, this is sealed off because of first seal 112a).
With regard to claim 19, Kondo discloses wherein the valve stem comprises: a radial opening (110); an axial opening (see the first annotated drawing above with regard to Fig. 1 where it is labeled second opening); a valve stem lumen (see first annotated drawing with regard to claim 1) fluidly coupling the radial opening and the axial opening; and wherein the first circumferential seal (112a) is located proximal of the radial opening (see Fig. 1) and the second circumferential seal (112b) and the third circumferential seal (112c) are located between the radial opening and the axial opening (see Fig. 1).
With regard to claim 20, Kondo discloses wherein the valve stem comprises: a radial opening (110); an axial opening (see the first annotated drawing with regard to claim 1); a valve stem lumen (see first annotated drawing with regard to claim 1) fluidly coupling the radial opening and the axial opening (see Fig. 1); and wherein when the valve stem is in the first configuration (Fig. 1), the radial opening is in fluid communication with atmosphere and the negative pressure (shown in Fig. 1, valve is open to the atmosphere via gap 122, 115a and then flow through the lumen and out the distal opening 108); and wherein when the valve stem is in the second configuration (Fig. 2), the radial opening (110) is in fluid communication with the lumen and fluidly isolated from atmosphere (see Fig. 2).
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.
Claim(s) 11-14, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kondo (US 2003/0181787 A1) in view of Bellofatto et al. (US 2015/0144215 A1).
With regard to claim 11, Kondo discloses wherein the valve stem comprises: a first circumferentially recessed portion (Fig. 1 shows first seal 112a which is embedded into the valve stem 104 and thus form a first recessed portion) at which the first seal is located; a second circumferentially recessed portion (see where 112b where the seal is embedded into the valve stem which forms a second recess) at which the second seal is located.
However, Kondo does not disclose a longitudinal recessed portion.
Bellofatto teaches a similar handheld medication device (Fig. 1) with a suction valve (50, better shown in Fig. 5, 7a and 7b). The suction valve stem (Fig. 7a) has a radially opening (at 170) and a second opening (at 122) and seal elements (130, Fig. 8) with a first seal (133) and a second seal (134) and a third seal (135) where the first seal is proximal the radial opening and the second and third seal is distal to the radial opening. Bellofatto further teaches a first circumferentially recessed portion (127b) where the first seal would sit, a second recessed portion (127c) for holding the second seal and further teaches a longitudinal recessed portion (see annotated drawing below for the first longitudinal recessed portion).
PNG
media_image3.png
714
402
media_image3.png
Greyscale
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kondo to have the longitudinal recessed portion as taught by Bellofatto for the purpose of holding the sealing sections in place ([0052]).
With regard to claim 12, Kondo discloses wherein the valve stem comprises: a first circumferentially recessed portion (Fig. 1 shows first seal 112a which is embedded into the valve stem 104 and thus form a first recessed portion) at which the first seal is located; a second circumferentially recessed portion (see where 112b where the seal is embedded into the valve stem which forms a second recess) at which the second seal is located and a third circumferentially recessed portion (see where 112c is located which is embedded in the wall of 104 which forms the third recessed portion) at which the second seal is located.
However, Kondo does not disclose a first and second longitudinal recess.
Bellofatto teaches a valve stem (Fig. 7a) having a first longitudinal recess (see annotated Fig above with regard to claim 11) extending between the first circumferentially recessed portion (127b) and the second circumferentially recessed portion (127c); and a second longitudinal recess (see annotated drawing above with regard to claim 11) extending between the second circumferentially recessed portion (127c) and the third circumferentially recessed portion (127d).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kondo to have the longitudinal recessed portion as taught by Bellofatto for the purpose of holding the sealing sections in place ([0052]).
With regard to claim 13, Kondo discloses the claimed invention except for the material forming the seal extending within one or both of the first and second longitudinal recess.
Bellofatto teaches wherein a material forming one or more of the first seal, the second, seal, and the third seal extends within one or both of the first longitudinal recess and the second longitudinal recess (see Fig. 8 showing the seal element 130 which is a single piece made up of the first (133), second (134) and third (135) seal as well as the portions that extend within one or both of the first longitudinal recess (at 138) and second longitudinal recess (at 137)).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kondo to have the material extend into the longitudinal recessed portions as taught by Bellofatto for the purpose of holding the sealing sections in place ([0052]).
With regard to claim 14, Kondo discloses the claimed invention except for the first, second and third seal extending along the first and second longitudinal recess.
Bellofatto teaches wherein a material forming the first seal (Fig. 8, seal 130, with first seal 133), the second seal (134) and the third seal (135) (a) extends along the first longitudinal recess (element 138) and links the first seal to the second seal and (b) extends along the second longitudinal recess (at 137) and links the second seal to the third seal.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kondo to have the material extend into the longitudinal recessed portions as taught by Bellofatto for the purpose of holding the sealing sections in place ([0052]).
With regard to claim 17, Kondo discloses wherein the valve stem comprises: a first circumferentially recessed portion (Fig. 1 shows first seal 112a which is embedded into the valve stem 104 and thus form a first recessed portion) at which the first seal is located; a second circumferentially recessed portion (see where 112b where the seal is embedded into the valve stem which forms a second recess) at which the second seal is located and a third circumferentially recessed portion (see where 112c is located which is embedded in the wall of 104 which forms the third recessed portion) at which the second seal is located.
However, Kondo does not disclose a first and second longitudinal recess.
Bellofatto teaches a valve stem (Fig. 7a) having a first longitudinal recess (see annotated Fig above with regard to claim 11) extending between the first circumferentially recessed portion (127b) and the second circumferentially recessed portion (127c); and a second longitudinal recess (see annotated drawing above with regard to claim 11) extending between the second circumferentially recessed portion (127c) and the third circumferentially recessed portion (127d); and wherein the first circumferential seal, the second circumferential seal, the third circumferential seal, the first connection component, and the second connection component are a single piece of material (Fig. 8, shows the seal elements and the first connection components and second connection component as a single piece).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kondo to have the longitudinal recessed portion as taught by Bellofatto for the purpose of holding the sealing sections in place ([0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lauren P Farrar/Primary Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783