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 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) 1-4 and 10 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Amley et al. (US 2007/0221275, hereinafter “Amley”).
As to claim 1, Amley discloses a suction valve stem for a medical device, the valve stem comprising:
an elongate body (body portion 60 of shuttle 48, Fig.2,3A);
a first opening in the elongate body (88, Fig.3A, [0030]);
a second opening in the elongate body (opening of passage 78 at 80, Fig.3A, [0030]);
a lumen (passages 78,84, Fig.3A, [0030]) extending from the first opening to the second opening (Fig.3A);
a first seal (seal 70, shown in annotated figure below) extending circumferentially around the elongate body (shown in Fig.2) at a location proximal of the first opening (see location right of opening 88 in annotated figure below); and
PNG
media_image1.png
168
286
media_image1.png
Greyscale
a second seal (seal 70, shown in annotated figure below) extending circumferentially around the elongate body (shown in Fig.2) at a location distal of the first opening (see location left of opening 88 in annotated figure below);
wherein the first opening is a radial opening (opens radially to surface 62, Fig.3A) and the second opening is an axial opening (opens along longitudinally extending passage 78 at 80, Fig.3A) in a distal end of the elongate body (80 constitutes a relative “distal” end opposite a relative “proximal end”), the second opening being in fluid communication with the first opening to allow a negative pressure through the first opening and the second opening (via passages 84,79, the openings/passages are capable of allowing fluid flow/pressure in either direction, Figs.3A,3B); and
wherein the elongate body, the first seal, and the second seal are formed from a single material (the body portion and seals can be integrally formed from an (same) elastomeric material as an alternative to being formed from separate material and bonded together, [0029]).
As to claim 2, wherein the elongate body, the first seal, and the second seal are monolithic (as set forth above with respect to claim 1, [0029]).
As to claim 3, further comprising: a third seal (seal 66, Fig.3A, [0029]) extending circumferentially around the elongate body (shown in Fig.2) at a location distal of the second seal (see location left of second seal 70 in annotated figure above), wherein the third seal is formed from the single material used to form the elongate body, the first seal, and the second seal ([0029]).
As to claim 4, further comprising: a first recess (see annotated figure below) extending circumferentially around the elongate body at a first axial location (see Fig.2); and a second recess (see annotated figure below) extending circumferentially around the elongate body at a second axial location spaced from the first axial location (see Fig.2), wherein the first seal extends from the first recess to the second recess (as shown in annotated figure below).
PNG
media_image2.png
168
286
media_image2.png
Greyscale
As to claim 10, wherein an engagement portion extends proximally from the elongate body (portion of body 60 extending proximally of the first seal 70 (to the right of first seal 70 in the figures), and including seal 68).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amley et al. (US 2007/0221275, hereinafter “Amley”) in view of Hernandez et al. (US 2021/0204797, hereinafter “Hernandez”).
As to claim 5, Amley only discloses that the elongate body and seals is formed from an elastomeric material and thus fails to disclose that the material is a thermoplastic elastomer. Hernandez teaches that the body and seals of a valve stem (i.e. components of the valve stem, [0090]-[0091]) can be formed of a thermoplastic elastomer (e.g. thermoplastics) ([0092]). Since Amley fails to specify any particular elastomeric material for the elongate body and seals, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed such components from a material known in the art to be suitable for such components, including thermoplastic elastomers, as taught by Hernandez.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amley et al. (US 2007/0221275, hereinafter “Amley”).
As to claim 6-7, Amley, as set forth above with respect to claim 1, fails to disclose any particular dimensions for the valve stem, and specifically that a wall thickness of the elongate body between the lumen and an outer surface of the elongate body at an axial location between the first seal and the second seal is in a range of 1.00 millimeters (mm) and 2.00 mm, or at least 1.50 mm. However, choice of wall thickness when designing the valve stem of Amley to provide adequate support for the intended purposes of functioning as a valve stem would qualify as an obvious choice in design (e.g. thickness capable of accommodating dynamic fluid pressures while providing enough rigidity to accommodate a stem movement force without deformation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wall thickness at any location between 1 mm or more since Applicant has not disclosed that a wall thickness of 1 mm or more provides an advantage, is used for a particular purpose, or solves a stated problem, and one of ordinary skill in the art would have expected, depending on the particular material used to construct the valve stem, a wall thickness of 1 mm or more to provide adequate support for the intended purposes of functioning as a valve stem.
Claim(s) 8 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amley et al. (US 2007/0221275, hereinafter “Amley”) in view of Moss (US 2014/0191452)
As to claim 8, Amley, as set forth with respect to claim 1 above, fails to disclose the durometer of the material used to form the elongate body and seals, and thus fails to disclose that the single material has a durometer in a range of 50 Shore A to 75 Shore A. However, Moss evidences that a suitable durometer for a valve seal material, in order to provide the desired characteristic of sealing, can be between 20 and 95 Shore A, depending on the material used ([0021]). Since Applicant presents no advantage, particular purpose, or solution to a stated problem for the claimed durometer range, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a material having a durometer in the range of 50 Shore A to 75 Shore A since such durometer values fall within the range known as suitable for a valve stem seal, as evidenced by Moss.
As to claim 19, Amley discloses a suction valve stem for use in an endoscope having a suction valve well, the suction valve stem comprising:
an elongate body (body portion 60 of shuttle 48, Fig.2,3A);
a first opening in the elongate body (88, Fig.3A, [0030]));
a second opening in the elongate body (opening of passage 78 at 80, Fig.3A, [0030]);
a lumen (passages78,84, Fig.3A, [0030]) extending from the first opening to the second opening (Fig.3A); and
a seal (seal 70) extending circumferentially around the elongate body (shown in Fig.2) at a location proximal of the first opening (either location of seal 70, Fig.3A),
wherein the elongate body and the seal are formed from a same polymer material (the body portion and seals can be integrally formed from an (same) elastomeric material as an alternative to being formed from separate material and bonded together, [0029]).
Amley fails to disclose that the material has a durometer in a range of 50 Shore A to 75 Shore A. However, Moss evidences that a suitable durometer for a valve seal material, in order to provide the desired characteristic of sealing, can be between 20 and 95 Shore A, depending on the material used ([0021]). Since Applicant presents no advantage, particular purpose, or solution to a stated problem for the claimed durometer range, and since Amley fails to mention any particular durometer values, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a material having a durometer in the range of 50 Shore A to 75 Shore A since such durometer values fall within the range known in the art as suitable for a valve stem seal, as evidenced by Moss
As to claim 20, Amley further discloses a first recess (see annotated figure above with respect to claim 4) extending circumferentially around the elongate body (see Fig.2); and a second recess (see annotated figure above with respect to claim 4) extending circumferentially around the elongate body (see Fig.2), wherein the seal extends from the first recess to the second recess (seal 70, as shown in annotated figure above with respect to claim 4).
As to claim 21, Amley, as set forth above with respect to claim 19, fails to disclose any particular dimensions for the valve stem, and specifically that a wall thickness of the elongate body between the lumen and an outer surface of the elongate body at an axial location between the first seal and the second seal is in a range of 1.00 millimeters (mm) and 2.00 mm, or at least 1.50 mm. However, choice of wall thickness when designing the valve stem of Amley to provide adequate support for the intended purposes of functioning as a valve stem would qualify as an obvious choice in design (e.g. thickness capable of accommodating dynamic fluid pressures while providing enough rigidity to accommodate a stem movement force without deformation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wall thickness at any location between 1 mm or more since Applicant has not disclosed that a wall thickness of 1 mm or more provides an advantage, is used for a particular purpose, or solves a stated problem, and one of ordinary skill in the art would have expected, depending on the particular material used to construct the valve stem, a wall thickness of 1 mm or more to provide adequate support for the intended purposes of functioning as a valve stem.
As to claim 22, wherein the first opening is a radial opening (opens radially to surface 62, Fig.3A) and the second opening is an axial opening in a distal end of the elongate body (opens along longitudinally extending passage 78 at 80, Fig.3A; 80 constitutes a relative “distal” end opposite a relative “proximal end”).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. (US 2021/0204797, hereinafter “Hernandez”) in view of Moss (US 2014/0191452).
As to claim 19, Hernandez discloses a suction valve stem for use in an endoscope having a suction valve well, the suction valve stem comprising:
an elongate body (main stem 22,Fig.1);
a first opening in the elongate body (hole 28, Fig.2);
a second opening in the elongate body (opening 38, Fig.4);
a lumen (channel 32, Fig.4) extending from the first opening to the second opening (Fig.4); and
a seal (gasket 48) extending circumferentially around the elongate body at a location proximal of the first opening (gasket 48 at top of Fig.3),
wherein the elongate body and the seal are formed from a same polymer material (same polymer material, [0090],[0091]).
Hernandez fails to disclose that the material has a durometer in a range of 50 Shore A to 75 Shore A. However, Moss evidences that a suitable durometer for a valve seal material, in order to provide the desired characteristic of sealing, can be between 20 and 95 Shore A, depending on the material used ([0021]). Since Applicant presents no advantage, particular purpose, or solution to a stated problem for the claimed durometer range, and since Hernandez fails to mention any particular durometer values, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a material having a durometer in the range of 50 Shore A to 75 Shore A since such durometer values fall within the range known in the art as suitable for a valve stem seal, as evidenced by Moss.
As to claim 20, Hernandez further discloses a first recess (recessed portion of main stem proximal of gasket 48) extending circumferentially around the elongate body; and a second recess (recessed portion of main stem distal of gasket 48) extending circumferentially around the elongate body, wherein the seal extends from the first recess to the second recess (largest diameter of gasket 48 extends between the recesses, Fig.3).
As to claim 21, Hernandez, as set forth above with respect to claims 19, fails to disclose the wall thickness between the lumen and the outer surface of the stem (either between the first and second seal, or at the second location). However, Hernandez does indicate that the holes (e.g. opening 30) can be from about 1 mm to about 4 mm in diameter ([0070]), suggesting from relative dimensions of the hole 30 and wall thickness in figure 4, that the wall thickness is anywhere between at least 0.5 mm and 2 mm. In addition, choice of wall thickness when designing the valve stem of Hernandez to provide adequate support for the intended purposes of functioning as a valve stem would qualify as an obvious choice in design (e.g. thickness capable of accommodating dynamic fluid pressures while providing enough rigidity to accommodate a stem movement force without deformation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the wall thickness at any location between 1 mm or more since Applicant has not disclosed that a wall thickness of 1 mm or more provides an advantage, is used for a particular purpose, or solves a stated problem, and one of ordinary skill in the art would have expected, depending on the particular material used to construct the valve stem, a wall thickness of 1 mm or more to provide adequate support for the intended purposes of functioning as a valve stem.
Allowable Subject Matter
Claims 11-14 and 23-24 are allowed.
Response to Arguments
Rejections and objections from the previous Office Action that have not been repeated in this Office Action should be considered as addressed or corrected, and thus hereby withdrawn.
Applicant's arguments filed February 5, 2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant’s amendments directed to the specific locations of the openings avoids the Hernandez reference and thus such rejection has been withdrawn. However, the Examiner would like to make a few comments. Firstly, recitation in the claims that the valve stem is for “suction” or “for an endoscope having suction” are merely intended use recitations that carry no weight in limiting the structure of the valve stem. Secondly, Hernandez does indeed expressly disclose both a single-material construction AND a monolithic construction. For instance, Hernandez, in paragraph [0090], specifically states that the MAIN STEM and SEALS, as two of the multiple components of the adapter, can be made from the SAME MATERIAL (as an alternative to a different material). Paragraph [0093] of specifies that the components of the adapter, which are defined as including the main stem and seals in paragraph [0090], can be MONOLITHICALLY FORMED. There is nothing in the Hernandez reference that indicates that the word “monolithic” is being defined any differently than Applicant’s definition of this word.
Claim 11 has been amended to include the allowable subject matter of claim 18 (including intervening claims) and thus is now allowable over the prior art of record.
Regarding claim 19, although Hernandez does not recognize durometer as a result-effective variable, the Moss reference was previously presented to evidence durometer values known in the art as suitable for a valve stem seal. Absence a teaching of any particular durometer in either Amley or Hernandez, one of ordinary skill in the art would turn to the prior art (e.g. Moss) to determine a suitable durometer valve for the material used as the seal material.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on PTO-892.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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, Anhtuan T Nguyen can be reached at 571-272-4963. 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.
/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795
Prosecution Insights