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 11 is objected to because of the following informalities: In claim 11, third to last line reads “such that catheter” but should read “such that the catheter”. Additionally, the spacing of claim 11 should be corrected. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially” in claims 1,5, and 11 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, it is unclear to what degree the artificial semination device valve is “fluid tight”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 4-6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao (US 6610005) in view of Jeyendran (US 5536243), as cited in the applicant’s IDS.
Regarding claim 1, Tao teaches a medical device comprising:
an arm having a proximal end and a distal end configured to insert into an orifice (column 10, line 35 “ the insertable portion 29” The examiner notes in figure 1, the arm (element 29) is inserted into an orifice.),
wherein the medical device has a bore extending longitudinally through the arm such that the bore has an opening at the distal end of the arm (The examiner notes the hollow element 28 is a bore.) and
a valve disposed at the distal end of the arm, wherein the valve is operable between an open position and a closed position (figure 22, element 53B. Column 13, line 24 “such end opening means is a slit, normally closed but openable for permitting passage of a such inner catheter pushed along such central axis from within such cylindrical hollow into a such uterus.”), wherein the valve is operable to form a substantially fluid--tight seal over the opening at the distal end of the arm when the valve is in the closed position (column 10, line 21 “protects the interior of the outer sleeve 24 at the depositing end 31 from accumulating deposits of mucus 35 when the outer sleeve 24 is inserted through the cervix 26.”).
However, Tao fails to teach a shield configured to cover an orifice, wherein the shield and the arm are configured to secure the medical device in place during use, an opening on the side of the shield opposite the arm.
Jeyendran teaches an insemination device with a shield (figure 5; column 4, line 61 “The insemination device includes a dome-shaped cervical cap 11 constructed of a flexible material adapted to conform and adhere to the cervix C by surface adhesion” The examiner notes in figure 5, element 12 an arm and the shield located at one end of the arm, therefore the shield and arm are configured to secure the medical device in place during use.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught in Tao to have the shield as taught in Jeyendran. One of ordinary skill would have been able to recognize that the shield is necessary for maintaining the device in communication with the cervical canal which leads to the uterine cavity UC of the uterus U. Please see column 4, line 63 of Jeyendran.
Regarding claim 2, Tao in view of Jeyendran teach the medical device of claim 1, and Tao further teaches a valve comprises a plurality of flaps (Figure 22, element 53B. Column 13, line 32 “the cross-cut slit 53B”)
However, Tao does not teach that the flaps in figure 22 are elastomeric. In a different embodiment Tao further teaches that the distal end of the inserted medical device should be made of an elastomeric material. (column 18, line 48 “The distal end 72 of the outer sleeve is preferably softest and least stiff because the wire does not extend all the way to the distal end 72. Also, the preferred material is softer and more flexible and permits the hinge 84 to work properly when end cap 73 is cut as described (no more than about a cm at the distal end 72 is preferably made of DOW [TM] polyurethane 2363 [medical grade] 80A)”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the flaps taught by Tao to be elastomeric. One of ordinary skill in the art would have been able to recognize that polyurethane is a biocompatible flexible material that would allow for safe insertion of the medical device.
Regarding claim 4, Tao in view of Jeyendran teach the medical device of claim 1, and Tao further teaches wherein the bore is operable to receive a catheter. (column 10, line 8 “The outer sleeve 24 is substantially tubular, as shown, and has a longitudinal round-cylindrical hollow 28 (having interior surface 30) appropriately sized for loosely containing the inner catheter 25 .”)
Regarding claim 5, Tao in view of Jeyendran teach the medical device of claim 4, Tao further teaches wherein the valve is operable to form a substantially fluid-tight seal around the catheter at the distal end of the arm when the valve is in the open position. (column 10, line 21 “protects the interior of the outer sleeve 24 at the depositing end 31 from accumulating deposits of mucus 35 when the outer sleeve 24 is inserted through the cervix 26.” The examiner notes that since the catheter is protected from contamination by the flaps then it is providing a fluid tight seal.)
Regarding claim 6, Tao in view of Jeyendran teach the medical device of claim 1, and Jeyendran further teaches wherein the shield has a concave shape (Figure 4, element 11. Element 11 concave shape can be seen in figure 5 and 7. ), wherein the proximal end of the arm is secured to the concave side of the shield. (The examiner is modifying the arm taught by Tao (element 29) to connect to the shield taught by Jeyendran thus providing an opening on the side of the shield opposite the arm).
Regarding claim 9, Tao in view of Jeyendran teach the medical device of claim 1, and Jeyendran further teaches wherein the shield is flexible. (column 4, line 63 “dome-shaped cervical cap 11 constructed of a flexible material”).
Claim(s) 11 - 14, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran in view of Chung (US 5496272).
Regarding claim 11, Tao teaches a method for artificial insemination , said method comprising the steps of: providing a medical device comprising:
an arm having a proximal end and a distal end configured to insert into an orifice, (column 10, line 35 “ the insertable portion 29” The examiner notes in figure 1, the arm is inserted into an orifice.),
a bore extending longitudinally through the arm such that the bore has an opening at the distal end of the arm (column 2, line 61 “a longitudinal cylindrical hollow having a central longitudinal axis, such catheter sleeve means being structured and arranged for containing an inner catheter in such cylindrical hollow.”).”); and
a valve disposed at the distal end of the arm, wherein the valve is operable between an open position and a closed position (figure 22, element 53B. Column 13, line 24 “such end opening means is a slit, normally closed but openable for permitting passage of a such inner catheter pushed along such central axis from within such cylindrical hollow into a such uterus.”), wherein the valve is operable to form a substantially fluid--tight seal over the opening at the distal end of the arm when the valve is in the closed position (column 10, line 21 “protects the interior of the outer sleeve 24 at the depositing end 31 from accumulating deposits of mucus 35 when the outer sleeve 24 is inserted through the cervix 26.”).
providing a catheter wherein the bore of the medical device is operable to receive the catheter (column 9, line 64 “The catheter system 20 is comprised of catheter sleeve means embodied by catheter outer sleeve 24 and inner catheter means embodied by an inner catheter 25. The outer sleeve 24 contains and protects the inner catheter 25 (the two being concentrically disposed),“ Figure 2, element 25 is the catheter inserted into the bore element 24. The examiner notes the outer sleeve is hollow as taught by limitation above in column 2, line 61.), and wherein the valve is operable to form a substantially fluid- tight seal around the catheter at the distal end of the arm when the valve is in the open position (figure 22, element 53B. Column 13, line 24 “such end opening means is a slit, normally closed but openable for permitting passage of a such inner catheter pushed along such central axis from within such cylindrical hollow into a such uterus.” And column 10, line 21 “protects the interior of the outer sleeve 24 at the depositing end 31 from accumulating deposits of mucus 35 when the outer sleeve 24 is inserted through the cervix 26.”);
inserting the medical device and the catheter into the patient such that the arm of the medical device extends into the patient’s cervical canal (column 1, line 3 “the catheter system 20 is inserted into the vagina, through the cervix 26, and into the uterus 21.”);
pushing the catheter through the opening at the distal end of the arm, such that catheter forces the valve into the open position (column 13, line 31 “The single slit 53A and the cross-cut slit 53B in, respectively, the first and second alternate embodiments of the end opening means are normally closed to maintain a closed depositing end 31 along the axis or centerline CL but are openable when and if catheter distal end 39 is pushed through said sleeve distal end 31”).
However, Tao fails to teach a shield configured to cover an orifice, wherein the shield and the arm are configured to secure the medical device in place during use, a bore extending longitudinally through the shield and having an opening on the side of the shield opposite the arm, the shield of the medical device substantially covers the external os of the patient’s cervix, and introducing a semen sample into the patient’s cervical canal or uterine cavity via the catheter.
Jeyendran teaches an insemination device with:
a shield configured to cover an orifice, wherein the shield and the arm are configured to secure the medical device in place during use (figure 5; column 4, line 61 “The insemination device includes a dome-shaped cervical cap 11 constructed of a flexible material adapted to conform and adhere to the cervix C by surface adhesion” The examiner notes in figure 5, element 12 an arm and the shield located at one end of the arm, therefore the shield and arm are configured to secure the medical device in place during use.),
a bore extending longitudinally through the shield and having an opening on the side of the shield opposite the arm (column 5, line 31 “nipple's proximal end 12a includes a hub 13 for connection to a time-release mechanism, generally designated at 14, which discharges semen through the passageway of the nipple and into the cervical canal or uterine cavity. The time-release mechanism includes an elongated hollow tubular member 15”)
the shield of the medical device substantially covers the external os of the patient’s cervix (The examiner notes in figure 1 the shield covers the external os of the cervix, which is the outer opening that connects the cervix to the vaginal canal, noted as VC in figure 1.), and
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught in Tao to have the shield, bore, and step of introducing a semen sample as taught in Jeyendran. One of ordinary skill would have been able to recognize that the shield is necessary for maintaining the device in communication with the cervical canal which leads to the uterine cavity UC of the uterus U (see column 4, line 63 of Jeyendran) and the bore is necessary to introduce material through the passageway of the nipple and into the cervical canal or uterine cavity (see column 5, line 33).
However, both Tao and Jeyendran are silent on whether a device used for embryo transfer can introduce a semen sample into the patient’s cervical canal.
Chung teaches an invention capable of doing artificial insemination and embryo transfer, and introducing a semen sample into the patient’s cervical canal or uterine cavity via the catheter. (column 1, line 7 “a device for transferring a reproductive organism of a mammal such as semen or embryo into a genital organ of a female to provide artificial insemination or embryo transplantation.” Column 1, line 18 “ Usually, in order to enhance the rate of pregnancy by artificial insemination, sperms should be introduced to a rear zone of the cervical canal 2 or at a front zone 4a of the uterine cavity 4.” The examiner notes that Tao teaches a catheter and bore to receive the catheter), the examiner is modifying the system used by Tao for also introducing a semen sample)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Tao and Jeyendran in view of Chung. One of ordinary skill in the art would have been able to recognize that having a device capable of doing two different procedures would be more efficient in both a surgical or non-surgical setting.
Regarding claims 12 and 13, Tao, Jeyendran, and Chung teach the device of claim 11, and Tao further teaches the method further comprises a step of removing the medical device from the patient after a period of time (of claim 12) and further comprising the step of removing the catheter (of claim 13). (column 12, line 5 “After the embryos 22 are deposited within the uterus 21, the catheter system 20 is withdrawn from the cervix 26, uterus 21 and the vagina.”).)
Regarding claim 14, Tao in view of Jeyendran and Chung teach the medical device of claim 1, and Tao further teaches a valve comprises a plurality of flaps. (Figure 22, element 53B. Column 13, line 32 “the cross-cut slit 53B”)
However, Tao does not teach that the flaps in figure 22 are elastomeric. Tao further teaches in a different embodiment that the distal end of the inserted medical device should be made of an elastomeric material. (column 18, line 48 “The distal end 72 of the outer sleeve is preferably softest and least stiff because the wire does not extend all the way to the distal end 72. Also, the preferred material is softer and more flexible and permits the hinge 84 to work properly when end cap 73 is cut as described (no more than about a cm at the distal end 72 is preferably made of DOW [TM] polyurethane 2363 [medical grade] 80A)”)
It would be prima facie obvious to one of ordinary skill before the effective filing date to modify the flaps taught by Tao to be elastomeric. One of ordinary skill in the art would have been able to recognize that polyurethane is a biocompatible flexible material that would allow for safe insertion of the medical device.
Regarding claim 16, Tao in view of Jeyendran and Chung teach the medical device of claim 1, and Jeyendran further teaches wherein the shield has a concave shape (Figure 4, element 11. Element 11 concave shape can be seen in figure 5 and 7. ), wherein the proximal end of the arm is secured to the concave side of the shield. (The examiner is modifying the arm taught by Tao (element 29) to connect to the shield taught by Jeyendran thus providing an opening on the side of the shield opposite the arm.).
Regarding claim 19, Tao in view of Jeyendran and Chung teach the medical device of claim 1, and Jeyendran further teaches wherein the shield is flexible. (column 4, line 63 “dome-shaped cervical cap 11 constructed of a flexible material”)
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran further in view of Thompson (US 6004260).
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran in view of Chung further in view of Thompson (US 6004260).
Regarding claim 3 and 15 Tao in view of Jeyendran teach the medical device of claim 1 and 11, but fail to teach wherein the arm comprises a circumferential bulge positioned along a length of the arm, wherein the bulge is operable to secure the arm in place during use.
Thompson teaches an in semination device with a circumferential bulge. (Column 6, line 17 “The step or annual ring 42 limits the proximal motion of the annular ring or seal 42 on the proximal end 38”)
It would be prima facie obvious to modify the system taught by Tao in view of Jeyendran to have a circumferential bulge on the arm. One of ordinary skill in the art would have been able to recognize that having a larger distance on the arm would limit the motion of the seal on the farther end of the arm. See Column 6, line 17 of Thompson.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran further in view of Tracy (US 6526980).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran in view of Chung further in view of Tracy (US 6526980).
Regarding claim 7 and 17, Tao and Jeyendran teach the medical device of claim 1 and 11, but fail to teach further comprising an insert member secured to the shield, wherein the insert member is secured to the opposite side of the shield as the proximal end of the arm.
Tracy teaches cervical delivery system with an insert member secured to a shield (column 4, line 38 “a cylindrical structure 102” Figure 1, element 102.)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Tao andJeyendran to have an insertion member behind the shield as taught in Tracy. One of ordinary skill in the art would have been able to recognize that a mechanism is needed to insert and remove the insemination device easily into the cervix. See column 5, line 10 of Tracy.
Regarding claim 8 and 18, Tao, Jeyendran, and Tracy teach the device of claim 7 and 17, and further teaches wherein the insert member has an annular cavity and wherein the insert member has an external opening that provides external access to the annular cavity. (The examiner notes that an annular cavity is a ring-shaped cavity. Tracy teaches a cylindrical structure that is a ring-shaped cavity with a string attached (figure 1, element 106).)
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the system taught by Tao, Jeyendran, and Tracy to have a cavity for attaching a string. One of ordinary skill in the art would have been able to recognize that a cervical insertion device would require a string used for removal of the apparatus securely attached. See column 4, line 39 of Tracy.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran further in view of Cline (US 2016/0199630).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tao in view of Jeyendran and Chung further in view of Cline (US 2016/0199630).
Regarding claims 10 and 20, Tao and Jeyendran teach the medical device of claim 1 and 11 but fail to teach, wherein the shield is translucent.
Cline teaches a device for delivering treatments to the cervix with a translucent shield. (paragraph [0231] “The containing element 3702 may also have shields 3709… In some embodiments, a delivery system for delivery of an occlusive element and/or a coating material may contain at least one component that is translucent or transparent.)
It would be prima facie obvious to one of ordinary skill in the art to make the shield taught by Tao and Saadat to be translucent as taught by Cline. One of ordinary skill in the art would have been able to recognize that there needs to be a way to monitor the inside of the cervix while the device is inserted.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Simmet (US 2002/0193658) teaches an artificial insemination device for a sow.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA JOY LACAY DECASTRO whose telephone number is (571)272-8316. The examiner can normally be reached Monday - Friday 9:00 AM - 5:30.
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, Jacqueline Cheng can be reached at 571-272-5596. 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.
/A.L.D./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights