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 .
Status of the Claims
Claims 1, 5-7, and 12-27 are pending in the application.
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 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)(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.
Claims 1, 5, 12-13, and 24-27 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Younkins (US 2310564 A).
PNG
media_image1.png
350
415
media_image1.png
Greyscale
As to claim 1, Younkins teaches a device for insertion into a vagina (pessary, receptacle to receive uterine discharge, at least Col.1,ll.1-18); Fig.1,2,5,6), the device comprising: a cervical ring 3/8 configured to surround the cervix 11 Fig.1 (cervical as end 3 and cross member 8 forming ring 3/8 Fig.2,5; Fig.2;p.1; Col.2,ll.41-54); a positioning portion 2 configured to abut against a securing position along an interior wall of the vagina (cross member 2; Fig.2; p.1; Col.2,ll.19-33); and an elastically resilient connecting portion 1 (side portions 1; Fig.2) connecting the cervical ring 3/8 and the positioning portion 2 (Fig.2), wherein the elastically resilient connecting portion 1 is configured such that, when the device is positioned inside the vagina, the positioning portion 1 is biased against the securing position (Fig.3,7; p.1; Col.2,ll.28-30; Col.1,ll.23-41).
As to claim 5, Younkins teaches wherein the device further comprises a bag 11 (Fig.2,3) or 12 (Fig.4) connected to the cervical ring 3/8 (diaphragm 11 or 12 forming impervious bag structure with fluid proof connection to ring 3/8 to collect secretions or discharges p.2, Col.3,ll.55 to p.2,Col.3,ll.5).
As to claim 12, Younkins teaches wherein the positioning portion 2 further comprises an indentation (Fig.2, middle of 2) configured to accommodate [[the]]a urethra when the device is positioned inside the vagina (Fig.2, where indentation in 2 can be used to accommodate urethra when device in vagina; “inward curve of cross member”/positioning portion 2 has a “ purpose to relieve pressure on the urethra 5 (see Fig.1)”; p.1,Col.2,ll.25-28).
As to claims 13, 25, and 26, Younkins teaches wherein the device further comprises at least one or two tabs 4 protruding from the device (two protrusions 4; Fig.2) (claim 25) extending downwards (Fig.1,2) such that, when the device is positioned inside the vagina (Fig.1; p.1,Col.1,ll.24-25), the at least one tabs 4 extends towards the opening of the vagina (Fig.1); (claim 26); the two tabs 4 located on each side of the positioning portion 2 (Fig.2) such that, when the device is positioned inside the vagina (Fig.1), the device will have one tab 4 located on each side of the pubic bone 6 (Fig.1,2; p.1,Col.2,ll.28-33).
As to claim 24, Younkins teaches wherein the connecting portion 1 (side portions 1; Fig.2) is curved (Fig.3) and the gradient of the curve of the connecting portion 1 increases as distance from the cervical ring 3/8 increases (Fig.6; where gradient of curve of 1 increases at distal end adjacent protrusions 4, as shown in Fig.6).
As to claim 27, Younkins teaches wherein the indentation (Fig.2, middle of 2) is located in the centre of the positioning portion 2 (as shown in Fig.2; p.1;Col.2,ll.25-28).
Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 6-7 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Younkins in view of Kamen (US 6168609 B1).
As to claims 6-7, Younkins does not teach wherein (claim 6) the bag further comprises a valve and (claim 7) is configured to be removable from the cervical ring.
PNG
media_image2.png
217
551
media_image2.png
Greyscale
However, as to claims 1 and 5 (from which claims 6-7 depend) Kamen teaches a device for insertion into a vagina (catamenial collector, Abstract); comprising:
a cervical ring 14 (flexible and inflatable ring 14 Fig.6-7; Col.3,ll.47-53; inflatable via at least pump 20, fluid channels 62,75;one way valve 24; to inflate ring 14; Col.4,ll.51-Col.5,ll.23) configured to surround the cervix (Fig.6-7; Col.3,ll.47-53);
PNG
media_image3.png
204
428
media_image3.png
Greyscale
a positioning portion 10 (handle 10 with collapsable application tube 70 Fig.6-7) configured to abut against a securing position along an interior wall of the vagina (Col.4,ll.67 to Col.5,ll.14); an elastically resilient connecting portion 66/13 (coupling 66 Col.4,ll.54, receptacle 13 walls Col.4,ll.51-55; Fig.6-7) connecting the cervical ring 14 and the positioning portion 10 (Fig.6; Col.4,ll.51-55), wherein the elastically resilient connecting portion 66/13 is configured such that, when the device is positioned inside the vagina, the positioning portion is biased against the securing position (Col.5,ll.1-14); (claim 5) wherein the device further comprises a bag 13/75/24 (receptacle 13 connected to the cervical ring 14 via channel 75 and one-way valve 24 (Fig.6-7; Col.3,ll.46-53; Col.4,ll.25-34;57-67); wherein (claim 6) the bag further comprises a valve 24 and (improve comfort during use Col.4,ll.28-30 and to allow a pump to inflate the ring/rim 14 to seal the device within the vagina Col.4,ll.24-28); and (claim 7) the valve 24 is configured to be removable from the cervical ring 14 (where fluid channel 75 connects valve 24 with receptacle 13; Fig.6-7; Col.4,ll.66-67; and where valve 24 is detachable from ring 14 via tear mark 26 Col.4,ll.33-34); in order to improve comfort during use and to allow a pump 20 to inflate the ring/rim 14 to seal the device within the vagina Col.4,ll.25-34.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rim and bag of Younkins with the valve and bag arrangement of Kamen, and one of skill would have been motivated to do so, in order to improve comfort during use and to allow a pump to inflate the ring/rim 14 to seal the device within the vagina.
As to claims 14-16, Younkins teaches the invention of claim 1, as presented above, from which claims 14-16 depend.
Younkins does not teach wherein (claim 14) the cervical ring further comprises an inflatable portion (claim 15) positioned on the circumference of the cervical ring; and (claim 16) comprises a first pilot line with a first end connected to the inflatable portion and a second end connected to a first valve, wherein the first pilot line is configured to provide air to inflate the inflatable portion.
However, Kamen teaches wherein (claim 14) the cervical ring 14 further comprises an inflatable portion (flexible and inflatable ring 14 via pump 20 through channel 75 and one way valve 24; Fig.7; Col.3,ll.20-53) (claim 15) positioned on the circumference of the cervical ring flexible and inflatable ring 14; (Fig.7; Col.3,ll.47-67; Col.4,ll.57-67); and (claim 16) comprises a first pilot line 75 (channel 75 Fig.6-7) with a first end connected to the inflatable portion (of 14 Fig.6-7) and a second end connected to a first valve 24, wherein the first pilot line 75 is configured to provide air to inflate the inflatable portion (of 14 Fig.7) (Fig.6-7; Col.4,ll.57-67).
in order to improve comfort during use and to allow a pump to inflate the ring/rim 14 to seal the device within the vagina Col.4,ll.25-34.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rim and bag of Younkins with the valve and pilot line arrangement of Kamen, and one of skill would have been motivated to do so, in order to improve comfort during use and to allow a pump to inflate the ring/rim 14 to seal the device within the vagina.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Younkins in view of Kamen, and further in view of Justice (GB 05103 A (1909)).
Younkins in view of Kamen teach the invention of claim 14, from which claims 17-19 depend, as presented above.
As to claims 17-19, Younkins and/or Kamen does not teach: (claims 17) the device further comprises a washing tube, wherein the washing tube comprises a first opening configured to deliver water to the walls of the vagina; (claims 18-19) the washing tube is located in: (claim 18) the inflatable portion of the device or (claim 19) in the cervical ring.
PNG
media_image4.png
187
296
media_image4.png
Greyscale
However, Justice teaches (claim 1) a device for insertion into a vagina (pessary/receiving cup Fig.4; p.1,ll.33-34), the device comprising:
a cervical ring (c) (pessary ring/rim (c) Fig.4; p.1,ll.33-35) configured to surround the cervix (pessary/receiving cup a with tubular rim (c) capable of surrounding cervix; Fig.4; p.1,ll.33-34); wherein: (claims 17) the device further comprises a washing tube (b) and/or tube in ring/rim (c) (washing hose (b) in ring/rim (c) and/or conduit in ring/rim (c); Fig.4; p.1,ll.33 to p.2,ll.5), wherein the washing tube (b) comprises a first opening (as at least one perforation on outside of ring/rim (c) Fig.4; p.2,ll.2-5) configured to deliver water to the walls of the vagina (Fig.4; p.1,ll.36-38; p.2,ll.2-5); and (claims 18-19) the washing tube (b) and/or (c) is located in: (claim 18) the inflatable portion of the device (where rim (c) tube and/or hose (b) is capable of being inflated with air or fluid Fig.4 p.1,ll.33 to p.2,ll.5) or (claim 19) in the cervical ring (where ring/rim (c) tube and/or hose (b) can be part of ring (p.1,ll.43 to p.2,ll.5) and ring/rim (c) and/or hose (b) is capable of being inflated with air or fluid Fig.4 p.1,ll.33 to p.2,ll.5); in order to :provide a pessary with a rinsing or injecting device to provide ample rinsing or subjection of the parts to medical liquids p.1,ll.13-15 run water or liquid through the washing tube/ hose (b) and rim/ring (c) to wash the device/pessary p.1,ll.36-42.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ring/rim of Younkins and/or Kamen with the washing tube and components thereof of Justice, and one of skill would have been motivated to do so, in order to provide a pessary with a rinsing or injecting device to provide ample rinsing or subjection of the parts to medical liquids run water or liquid through the washing tube/ hose and rim/ring to wash the device/pessary.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Younkins in view of Justice.
Younkins teaches the invention of claim 5, from which claims 20-23 depend, as presented above.
As to claims 20-23, Younkins does not teach: (claims 20) the device further comprises a washing tube, wherein the washing tube comprises a first opening configured to deliver water to the walls of the vagina; (claim 21) the washing tube comprises a second pilot line with a first end connected to the washing tube and a second end connected to a second valve, wherein the second pilot line is configured to deliver water to the washing tube; (claim 22) the washing tube comprises a second opening configured to deliver water to the inside of the bag; and (claim 23) the first pilot line and second pilot line are removable.
PNG
media_image4.png
187
296
media_image4.png
Greyscale
However, Justice teaches (claim 1) a device for insertion into a vagina (pessary/receiving cup Fig.4; p.1,ll.33-34), the device comprising:
a cervical ring (c) (pessary ring/rim (c) Fig.4; p.1,ll.33-35) configured to surround the cervix (pessary/receiving cup a with tubular rim (c) capable of surrounding cervix; Fig.4; p.1,ll.33-34); wherein: (claim 5, from which claims 20-23 depend) the device further comprises a bag (a) (cup (a) Fig.4) connected to the cervical ring (c) (Fig.4; p.1,ll.33-34); (claim 20) the device further comprises a washing tube (b) and/or tube within ring/rim (c) (washing hose (b) and tubular ring/rim (c) and/or conduit in ring/rim (c); Fig.4; p.1,ll.33 to p.2,ll.5), wherein the washing tube (b) comprises a first opening (as at least one perforation on outside of ring/rim (c) Fig.4; p.2,ll.2-5) configured to deliver water to the walls of the vagina (Fig.4; p.1,ll.36-38; p.2,ll.2-5); (claim 21) the washing tube (b) comprises a second pilot line (irrigator line) with a first end (canula) connected to the washing tube (b) (hose b able to be attached to irrigator via canula as second end to run water or other liquid therethrough p.1,ll.34-38); wherein the second pilot line is configured to deliver water to the washing tube (hose b able to be attached to irrigator via canula as second end to run water or other liquid therethrough p.1,ll.34-38); (claim 22) the washing tube comprises a second opening (as at least one perforation on inside of rim (c) Fig.4; p.2,ll.2-5) configured to deliver water to the inside of the bag (a) (via irrigator/canula to tube b to perforations in the rim c into bag/cup a Fig.4; p.1,ll.34-38; p.2,ll.2-5); and (claim 23) the first pilot line and second pilot line are removable (hose b able to be attached as removable, to run water or other liquid therethrough p.1,ll.34-38)); in order to :provide a pessary with a rinsing or injecting device to provide ample rinsing or subjection of the parts to medical liquids p.1,ll.13-15 run water or liquid through the washing tube/ hose (b) and rim/ring (c) to wash the device/pessary p.1,ll.36-42.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rim and bag of Younkins with the pilot line/ends/ openings and arrangement of Justice, and one of skill would have been motivated to do so, in order to provide a pessary with a rinsing or injecting device to provide ample rinsing or subjection of the parts to medical liquids run water or liquid through the washing tube/ hose and rim/ring to wash the device/pessary.
The combination of Younkins and/or Justice does not teach a second end connected to a second valve. However, it would have been obvious to one of skill in the art before the effective filing date to further provide a second end connected to a second one way valve of washing tube, in order to prevent contaminated water or fluid from backwashing through the washing tube and contaminating the water or fluid source provided for washing the bag from the irrigator/canula.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781