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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner reinterpreted Ling, where Ling discloses wherein the diameter of the main body decreases from the first end towards the second end (see annotated Fig below in claims 1, 16, 19, paragraph 24 where the main body is elastic and where, towards the second end relative to the first end, the diameter decreases such that there is a smaller diameter adjacent the second end. The examiner notes that applicant is not claiming that the second end has a smaller diameter than the first end or that the diameter “decreases from the first end to the second end.” If applicant were to claim this, then it would overcome Ling. However, rejections can be made in view of Lin US 2017/0189222 (see rejections below where the first end has a bigger diameter than the second end) for Claims 1, 19 but not for Claim 16.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “valve securing element” in claim 1, 16, 19. The examiner notes that the specification discloses that the valve securing element can come in a variety of configurations, for example: “According to certain embodiments, each of the main body 104, the attachment rim 106, the valve 110, and the valve securing element 112, may be integral with one another, or may be separate components permanently or removably connected to one another” (paragraph 28), “The valve securing element 112 may be generally cylindrical or ring-shaped, and may extend around the second opening 122 at the second end 114 of the main body 104.” (paragraph 43).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-3, 5, 11-13, 15, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin US 2017/0189222.
Regarding Claim 1, Lin discloses a medical device (Fig 3) for use during a gynecological procedure (abstract), comprising:
a main body (see Fig below, extending from second end #5 to a first end adjacent rim #13);
an attachment rim (#13) disposed at a first end (adjacent to #13) of the main body (Fig 3);
a valve securing element (see Fig below, where it is cylindrical and integral with the main body and valve #41 and thus secures/connects the valve #41 with the main body, see Claim Interpretation above) disposed at a second end (#5) of the main body (Fig 3, see Fig below); and
a valve (#41) disposed between the main body and the valve securing element (Fig 3, see Fig below);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig 3); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 25 “prevent leakage”).
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Regarding Claim 2, Lin discloses the main body has a predetermined configuration that is substantially cup-shaped (Fig 3).
Regarding Claim 3, Lin discloses the main body may be deformed when a pressure is applied thereto and wherein the main body resumes the predetermined configuration when the pressure is not applied thereto (paragraph 26, at least the second end is able to be deformed/squeezed) .
Regarding Claim 5, Lin discloses an outer surface (Fig 2) of the main body includes a groove (see Fig below).
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Alternatively, see Fig below where the outer surface has a groove.
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Regarding Claim 11, Lin discloses the valve is one of integral with and permanently fastened to the valve securing element (as discussed above in claim 1).
Regarding Claim 12, Lin discloses the valve is a one-way valve (paragraph 26).
Regarding Claim 13, Lin discloses the valve is one of a flap valve (paragraph 26, made up of two flaps), a duckbill valve, and a gel-port.
Regarding Claim 15, Lin discloses the valve is one of:
configured to extend upwardly toward the attachment rim when the attachment rim is inserted into a patient first (as seen in Fig 3 where valve #41 is extending upwardly towards attachment rim #13);
configured to extend upwardly away from the main body and the attachment rim when the valve securing element is inserted into the patient first; and
configured to extend upwardly toward the attachment rim and upwardly away from the main body and the attachment rim, depending on an orientation of the medical device upon insertion into the patient.
Regarding Claim 19, Lin discloses a method of using a medical device during a gynecological procedure, comprising:
providing a medical device (Fig 3) for use during a gynecological procedure (abstract), comprising:
a main body (see Fig below, extending from second end #5 to a first end adjacent rim #13);
an attachment rim (#13) disposed at a first end (adjacent to #13) of the main body (Fig 3);
a valve securing element (see Fig below, where it is cylindrical and integral with the main body and valve #41 and thus secures/connects the valve #41 with the main body, see Claim Interpretation above) disposed at a second end (#5) of the main body (Fig 3, see Fig below); and
a valve (#41) disposed between the main body and the valve securing element (Fig 3, see Fig below);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig 3); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 25 “prevent leakage”); and
inserting the medical device into a patient (paragraph 24-25 placed in the body).
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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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lin US 2017/0189222 in view of Lalli US 2017/0181607.
Lin as modified discloses the claimed invention as discussed above but does not disclose the main body includes a translucent material.
Lalli discloses an elastic main body (#301, paragraph 55) that can be translucent which provides for desired visualization through the medical device and visualization of the surrounding anatomy (paragraph 55).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Lin to have the main body include a translucent material in view of Lalli above because this provides a known type of material that allows for provides for desired visualization through the medical device and visualization of the surrounding anatomy. The examiner notes this would be beneficial for when the medical device of Lin is first deployed where the medical personal can visualize proper placement as well as examination/ visualization through the medical device and the surrounding anatomy.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lin US 2017/0189222 in view of Ahn US 2015/0209073.
Regarding Claim 6, Lin discloses the main body includes at least one support ring (#13) disposed intermediate the first end and the second end (Fig 1-3) but does not disclose the support ring is flexible.
Ahn discloses a medical device (inner unit #300) that is made from an elastic material (paragraph 48, 57), where the elastic material allows it to deform to allow insertion and withdrawal of the medical device (paragraph 57) and when returned to its original shape, prevented from removal (paragraph 50).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the medical device of Lin, including the support ring, to be elastic/flexible in view of Ahn above because this allows the medical device to deform for insertion and removal such that when in its original shape, unwanted removal is prevented.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lin US 2017/0189222 in view of Ahn US 2015/0209073.
Regarding Claim 20, Lin discloses the claimed invention as discussed above where the medical device is flexible (paragraph 7) and the steps of
inserting the medical device into a patient (paragraph 24-25 placed in the body));
performing a gynecological procedure (paragraph 26 where fluid is collected and then the medical device is activated to open the valve to discharge the liquid)(examiner notes that the specific procedure is not being claimed), where the one of ordinary skill in the art recognizes that the medical device would need to be removed for cleaning and/or replacement but does not disclose deforming the medical device prior to inserting the medical device into a patient; releasing the medical device in the patient; deforming the medical device; and removing the medical device from the patient.
Ahn discloses a medical device (inner unit #300) that is made from an elastic material (paragraph 48, 57), deforming the medical device prior to inserting the medical device into a patient (paragraph 48); releasing the medical device in the patient (paragraph 48, 50, 57 “original shape”); deforming the medical device; and removing the medical device from the patient (paragraph 57) where the elastic material allows it to deform to allow insertion and withdrawal of the medical device (paragraph 57) and when returned to its original shape, prevented from removal (paragraph 50).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the medical device of Lin to be elastic in view of Ahn such that the medical device is deformed prior to inserting the medical device into a patient; to release the medical device in the patient; deforming the medical device; removing the medical device from the patient for cleaning and/or replacement because the elastic material allows the medical device to be inserted easily and prevented from escaping when returned to its original shape and prevent unwanted removal.
Claims 1-3, 5, 8, 10, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 in view of Steigerwald US 4,895,346.
Regarding Claim 1, Ling discloses a medical device (Fig 1) for use during a gynecological procedure (Fig 2 abstract), comprising:
a main body (#2, Fig 1);
an attachment rim (#1, Fig 1) disposed at a first end of the main body (Fig 1, disposed at a first/front end);
and a valve (“valve” paragraph 29);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig below, paragraph 24 where the main body is elastic and where, towards the second end relative to the first end, the diameter decreases such that there is a smaller diameter adjacent the second end)(examiner notes that applicant is not claiming that the second end has a smaller diameter than the first end or that the diameter “decreases from the first end to the second end”); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 23 in Ling “tightly adhere to a wall of the vagina”).
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Ling discloses the main body has hole (#5 or #6) that houses the valve (paragraph 29, Fig 1-2) but does not disclose a valve securing element disposed at a second end of the main body, the valve is disposed between the main body and the valve securing element.
Steigerwald, in the same field of endeavor of providing seals and/or pertinent to the particular problem of providing a valve/seal for instruments, discloses a medical device (Fig 1) comprising a main body (see Fig below) with a first end (see Fig below), a hole with a valve housing (#22, see Fig below) defining a second end of the main body (see Fig), a valve securing element (see Fig below where the valve securing element is in the form of a cylindrical flange that helps attach a valve assembly to the body Fig 10, Col 7 lines 12-45) coupled at the second end (see Fig below, Col 2 lines 42-52 via threading), a valve (in the form of valves #76, #82) disposed between the main body and the valve securing element (see Fig below where the valve assembly is between the valve securing element and the first end of the main body), where the valve provides a known type of valve that allows passage of an instrument (“catheter”, Col 4 lines 20-25) therethrough to provide a seal which prevents passage of air and fluids (Col 4 lines 20-25), the valve housing (#22) and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument (Col 3 lines 30-48).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling to include a valve housing, valve securing element and valve in view of Steigerwald above because the valve provides a known type of valve that allows passage of an instrument therethrough and still provide a seal to prevent passage of air and fluids, where the valve housing and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument. The examiner notes that with the modification, the valve housing (#22 of Steigerwald) would be placed into a hole (#5 or #6 in Ling) to house the valve, with an externa threaded portion of the valve housing exposed to allow the valve securing element to couple thereto.
Regarding Claim 2, Ling as modified discloses the main body (#2 in Ling) has a predetermined configuration that is substantially cup-shaped (as seen in Fig 1 in Ling).
Regarding Claim 3, Ling as modified discloses the main body may be deformed when a pressure is applied thereto and wherein the main body resumes the predetermined configuration when the pressure is not applied thereto (paragraph 23 in Ling where the made body #2 is elastic and thus capable of deforming under pressure and resuming its predetermined configured when not under pressure).
Regarding Claim 5, Ling as modified discloses an outer surface of the main body includes a groove (see Fig 1 in Ling below, paragraph 23 in Ling where the main body is flexible and is able to produce a groove, likewise, see Fig 2 below where during use, the outer surface forms a groove).
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Regarding Claim 8, Ling as modified discloses the attachment rim (#1 in Ling) includes an expandable material and wherein the attachment rim is hollow (paragraph 23 in Ling, the rim #1 is flexible and hollow and able to be “inflated”).
Regarding Claim 10, Ling as modified discloses the valve securing element is rigid (Col 4 lines 49-51 in Steigerwald), and wherein the valve securing element has a ring-shaped configuration (see Fig above, Fig 1 in Steigerwald where the valve securing element is in the form of a cylindrical/ring flange #40 that helps attach a valve assembly to the body Fig 10, Col 7 lines 12-45).
Regarding Claim 14, Ling as modified discloses the valve is adapted to receive examination tools having variable diameters and form a seal with the examination tools having variable diameters (with the modification, Col 5 lines 1-15 in Steigerwald, the valve has slits that allow it seal around tools of various diameters).
Claims 12, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 in view of Steigerwald US 4,895,346, as applied to claim 1 and in further view of additional teachings of Steigerwald.
Ling as modified discloses the claimed invention as discussed above where the valve includes upper and lower valves (#76, #82 respectively in Steigerwald) but does not disclose the valve is a one-way valve (in Claim 12), the valve is a duckbill valve (in Claim 13), the valve is configured to extend upwardly toward the attachment rim when the attachment rim is inserted into a patient first (in Claim 15).
Steigerwald discloses an another embodiment of a valve (Fig 10) that includes an upper valve (#142) and a lower valve (#136) in the form of a duckbill valve (#136, Fig 10) which provides an alternate type of valve that is a one-way type valve, which seals against the outer surface of an instrument (Col 7 lines 13-30).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling as modified to have the lower valve be a duckbill valve in view of another embodiment of Steigerwald above because this provides an alternate type of valve that is a one-way type valve, which seals against the outer surface of an instrument.
Regarding Claim 15, Ling as modified discloses wherein the valve is one of:
the valve is configured to extend upwardly toward the attachment rim when the attachment rim is inserted into a patient first (Fig 2 in Ling and Fig 10 in Steigerwald, where with the modification include a duckbill valve, the duckbill valve would extend towards the attachment rim)
configured to extend upwardly away from the main body and the attachment rim when the valve securing element is inserted into the patient first; and
configured to extend upwardly toward the attachment rim and upwardly away from the main body and the attachment rim, depending on an orientation of the medical device upon insertion into the patient.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 and Steigerwald US 4,895,346, as applied to claim 1 above, and in further view of Lalli US 2017/0181607.
Ling as modified discloses the claimed invention as discussed above but does not disclose the main body includes a translucent material.
Lalli discloses an elastic main body (#301, paragraph 55) that can be translucent which provides for desired visualization/examination of the vagina (paragraph 55).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling as modified to have the main body include a translucent material in view of Lalli above because this provides a known type of material that allows for provides for desired visualization/examination of the vagina.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 and Steigerwald US 4,895,346, as applied to claim 1 above, and in further view of Lalli US 2022/0000345 (‘345).
Ling as modified discloses the claimed invention as discussed above but does not disclose wherein the main body includes at least one flexible support ring disposed intermediate the first end and the second end.
Lalli ‘345 discloses a main body (#1001, Fig 8a-8b) having first and second opposing ends (distal and proximal ends of #1001, Fig 8a-8b), the main body includes at least one flexible support ring (#1010, paragraph 78, 97, 107, where the main body including the support ring are flexible) disposed intermediate the first end and the second end (Fig 8a-8b, paragraph 102), the support ring helps limit the movement of the main body when inserted into the vagina of a patient (paragraph 3, 102).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling as modified and include at least one support ring disposed intermediate the first and second ends in view of Lalli ‘345 above because the support ring helps limit movement of the main body when inserted into the vagina of a patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 and Steigerwald US 4,895,346, as applied to claim 1 above, and in further view of Harmon US 8,343,036.
Ling as modified discloses the claimed invention as discussed above but does not disclose the attachment rim is in fluid communication with a tube, and wherein the tube is adapted to introduce a fluid into and remove air from the attachment rim.
Harmon, pertinent to the problem of inflating/deflating an attachment rim, discloses a medical device (Fig 1-1a) comprising a main body (#10,) with an attachment rim (#20) at a first end (Fig 1-1a), the attachment rim (#20) includes an expandable material and wherein the attachment rim is hollow (Fig 1-1a, where the attachment rim is in the form of a hollow inflatable balloon Col 4 lines 50-67), the attachment rim is in fluid communication with a tube (#18), and wherein the tube is adapted to introduce a fluid into and remove air from the attachment rim (Col 4 lines 50-67).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling as modified to include a tube in view of Harmon above because this provides a known means of inflating and deflating the attachment rim.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 in view of Steigerwald US 4,895,346.
Regarding Claim 1, Ling discloses a medical device (Fig 1) for use during a gynecological procedure (Fig 2 abstract), comprising:
a main body (#2, Fig 1);
an attachment rim (#1, Fig 1) disposed at a first end of the main body (Fig 1, disposed at a first/front end);
and a first valve (“valve” paragraph 29);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig below, paragraph 24 where the main body is elastic and where, towards the second end relative to the first end, the diameter decreases such that there is a smaller diameter adjacent the second end)(examiner notes that applicant is not claiming that the second end has a smaller diameter than the first end or that the diameter “decreases from the first end to the second end”); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 23 in Ling “tightly adhere to a wall of the vagina”).
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Ling discloses the main body has hole (#5 or #6) that houses the valve (paragraph 29, Fig 1-2) but does not disclose a valve securing element disposed at a second end of the main body, a second valve disposed between the main body and the valve securing element.,
Steigerwald, in the same field of endeavor of providing seals and/or pertinent to the particular problem of providing a valve/seal for instruments, discloses a medical device (Fig 1) comprising a main body (#22);
an attachment rim (see Fig below) disposed at a first end of the main body (lower end of the main body #22, see Fig below);
a valve securing element (#20, see Fig below, the securing element #20 including a cylindrical flange #40 that helps attach valves to the main body, Col 4 lines 30-40) disposed at a second end of the main body (upper end of the main body #22, see Fig below);
a first valve (#76) disposed between the main body and the valve securing element (Fig 1, Fig below, the first valve #76 is located between #40 of valve securing element and the first end of the main body); and
a second valve (#82) disposed between the main body and the valve securing element (Fig 1, Fig below, the second valve #82 is located between #40 of valve securing element and the first end of the main body).
where the valve provides a known type of valve that allows passage of an instrument (“catheter”, Col 4 lines 20-25) therethrough to provide a seal which prevents passage of air and fluids (Col 4 lines 20-25), the valve housing (#22) and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument (Col 3 lines 30-48).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling to include a valve housing, valve securing element and first and second valves in view of Steigerwald above because th provides a known type of valve configuration that allows passage of an instrument therethrough and still provide a seal to prevent passage of air and fluids, where the valve housing and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument. The examiner notes that with the modification, the valve housing (#22 of Steigerwald) would be placed into a hole (#5 or #6 in Ling) to house the valve, with an externa threaded portion of the valve housing exposed to allow the valve securing element to couple thereto.
Regarding Claim 17, Ling as modified discloses at least one of the first valve and the second valve is a flap valve (Steigerwald: Fig 3, first valve #76 has three slits #88a-c that define three flaps/leaves).
Regarding Claim 18, Ling as modified discloses the first valve is a tri-leaflet valve (Steigerwald: fig 3, first valve #76 has three slits #88a-c that define three flaps/leaves) but does not disclose the second valve is a bi-leaflet valve.
Steigerwald discloses another embodiment (Fig 10) where the second valve (#136) is a bi-leaflet valve (Col 7 lines 13-20 “duckbill valve”) which is a known type of valve to close off the cavity of the main body and prevent passage or air and liquid therethrough (Col 7 lines 40-45).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the second valve of Steigerwald to be a bi-leaflet valve in view of another embodiment of Steigerwald because this provides a known alternative type of valve that prevents passage or air and liquid therethrough.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 in view of Steigerwald US 4,895,346.
Regarding Claim 19, Ling discloses a method of using a medical device (Fig 1) during a gynecological procedure (Fig 2 abstract), comprising:
providing the medical device (Fig 1) for use during the gynecological procedure (abstract, Fig 1-2), the medical device including a main body,
an attachment rim (#1, Fig 1) disposed at a first end of the main body (Fig 1, disposed at second/rear end);
and a valve (“valve” paragraph 29);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig below, paragraph 24 where the main body is elastic and where, towards the second end relative to the first end, the diameter decreases such that there is a smaller diameter adjacent the second end)(examiner notes that applicant is not claiming that the second end has a smaller diameter than the first end or that the diameter “decreases from the first end to the second end”); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 23 in Ling “tightly adhere to a wall of the vagina”).
inserting the medical device into a patient (Fig 2, paragraph 29).
Ling discloses the main body has hole (#5 or #6) that houses the valve (paragraph 29, Fig 1-2) but does not disclose a valve securing element disposed at a second end of the main body, and the valve disposed between the main body and the valve securing element.
Steigerwald, in the same field of endeavor of providing seals and/or pertinent to the particular problem of providing a valve/seal for instruments, discloses a medical device (Fig 1) comprising a main body (see Fig below) with a first end (see Fig below), a hole with a valve housing (#22, see Fig below) defining a second end of the main body (see Fig), a valve securing element (see Fig below where the valve securing element is in the form of a cylindrical flange that helps attach a valve assembly to the body Fig 10, Col 7 lines 12-45) coupled at the second end (see Fig below, Col 2 lines 42-52 via threading), a valve (in the form of valves #76, #82) disposed between the main body and the valve securing element (see Fig below where the valve assembly is between the valve securing element and the first end of the main body), where the valve provides a known type of valve that allows passage of an instrument (“catheter”, Col 4 lines 20-25) therethrough to provide a seal which prevents passage of air and fluids (Col 4 lines 20-25), the valve housing (#22) and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument (Col 3 lines 30-48).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling to include a valve housing, valve securing element and valve in view of Steigerwald above because the valve provides a known type of valve that allows passage of an instrument therethrough and still provide a seal to prevent passage of air and fluids, where the valve housing and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument. The examiner notes that with the modification, the valve housing (#22 of Steigerwald) would be placed into a hole (#5 or #6 in Ling) to house the valve, with an externa threaded portion of the valve housing exposed to allow the valve securing element to couple thereto.
Regarding Claim 20, Ling as modified discloses the claimed invention as discussed above, where Ling further discloses
deforming the medical device prior to inserting the medical device into a patient (paragraph 23-24, 29 where the main body of the medical device is elastic and during use it would “tightly adhere to a wall of the vagina” and although not explicitly disclosed, in order to be inserted, the main body would be deformed in an uninflated state prior to insertion into the vagina);
releasing the medical device in the patient (Fig 2, paragraph 29, see also paragraph 27-28 where the medical device is also inflated so that the medical device is “tightly pressed” against the vaginal wall);
performing a gynecological procedure ( Fig 2, performed using tong #11, paragraph 29, see also paragraph 3, 7);
deforming the medical device (while not explicitly disclosed, the medical device would be deformed back to a deflated state prior to removal, so that it is no longer “tightly pressed” against the vaginal wall, as discussed above, see also paragraph 27-28); and
removing the medical device from the patient (not explicitly disclosed, the medical device would be removed from the patient after completion of the procedure).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ling US 2016/0199094 in view of Johnson US 4,946,133.
Regarding Claim 1, Ling discloses a medical device (Fig 1) for use during a gynecological procedure (Fig 2 abstract), comprising:
a main body (#2, Fig 1);
an attachment rim (#1, Fig 1) disposed at a first end of the main body (Fig 1, disposed at a first/front end);
and a valve (“valve” paragraph 29);
wherein the diameter of the main body decreases from the first end towards the second end (see Fig below, paragraph 24 where the main body is elastic and where, towards the second end relative to the first end, the diameter decreases such that there is a smaller diameter adjacent the second end)(examiner notes that applicant is not claiming that the second end has a smaller diameter than the first end or that the diameter “decreases from the first end to the second end”); and
wherein the attachment rim is configured to form a fluid tight seal with a vaginal wall of a patient (paragraph 23 in Ling “tightly adhere to a wall of the vagina”).
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Ling discloses the main body has hole (#5 or #6) that houses the valve (paragraph 29, Fig 1-2) but does not disclose a valve securing element disposed at a second end of the main body, the valve is disposed between the main body and the valve securing element, where the valve is one of integral with and permanently fastened to the valve securing element to secure the valve onto the main body.
Johnson discloses a medical device (Figs 6-7) comprising:
a main body (#30);
an attachment rim disposed at a first end of the main body (see Fig below);
a valve securing element (#32, in the form of a disc, Fig 7) disposed at a second end of the main body (Fig 6-7); and
a valve (#10, Col 2 lines 50-59) disposed between the main body and the valve securing element (see Fig below, Fig 6 where the valve protrudes into the main body such that the valve is located between the valve securing element and the first end of the main body), where the valve is one of integral with and permanently fastened to the valve securing element to secure the valve onto the main body (Col 3 lines 44-46 permanently fastened via “ultrasonically welded”).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Ling to include a valve housing, valve securing element and valve in view of Steigerwald above because the valve provides a known type of valve that allows passage of an instrument therethrough and still provide a seal to prevent passage of air and fluids, where the valve housing and valve securing element provides a known configuration to secure the valve to the main body and maintain the seal even after removal of the instrument. The examiner notes that with the modification, the valve housing (#22 of Steigerwald) would be placed into a hole (#5 or #6 in Ling) to house the valve, with an externa threaded portion of the valve housing exposed to allow the valve securing element to couple thereto.
Conclusion
See PTO-892 for art of cited interest for other medical devices where a first end is greater than a second end.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773