DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on April 9, 2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2, 6-8, 10-11, 15-16 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ackerman (USPN 6,450,963), in view of Miller et al., US 20080312636 A1 (“Miller” - of record) and in view of Hayakawa US 20100331766 A1.
Regarding claim 1, Ackerman discloses an imaging fluid creation and delivery device ([abstract], Fig. 1, apparatus “10” and col. 5, ll. 1-7 - by manipulating pumps 50, 51 simultaneously, the mixture of saline and air is delivered under pressure) comprising:(a) a first syringe for fluid, and a second syringe for air (col. 3, ll. 53-55, Fig. 1, pumps 50 and 51 respectively) each in fluid connection with an exit port comprising at least an attachment element (col. 3, ll. 32-34 and col. 4, ll. 16-18, distal end “62” read on an exit port that is in fluid communication with first and second syringe 50, 51 as illustrated in Fig. 1,exit port “62” is coupled to catheter assembly 11, attachment elements are necessarily present to allow distal end “62” to be coupled to proximal end “39” of the catheter assembly – Official Notice is taken in this regard in that it is well known in the art to use attachment elements such as luer fitting to facilitate connection of components in the same filed of endeavor, hence it would have been obvious to include an attachment element such as a luer fitting, to facilitate attachment of distal end “62” to proximal end “39), each syringe having a plunger slidably disposed therein, and configured to be moved simultaneously (col. 5, ll.1-5 “syringe plungers”, the plungers are configured to be moved simultaneously by virtue of being positioned close to each other to allow manipulating pumps 50, 51 simultaneously as discussed in col. 5, ll. 1-7I - examiner notes that this recitation is broad to read on the structure of Ackerman); wherein the device is configured to take a fluid into the device through the exit port comprising at least the attachment element and into the first syringe and air into the second syringe ( see illustration Fig. 1, with pinch clamp 71 in a position to allow flow to pump 50 – col. 4, ll. 2-5, rotary valve 74 in a first position to allow air to pump 51 – col. 4, ll. 24-27, and owing to the first one-way valves 72 and 77 – col. 4, ll. 8-10, 18-20, in the event the plungers are moved proximally, the device is configured to take a fluid in the first syringe and air into the second syringe because one way valves 72 and 77 will ensure that air is allowed in pump 51 via valve 74, and open pinch clamp 71 will allow fluid to flow to pump 50), and is configured to create and deliver an imaging fluid comprising a mixture of the fluid and air out of the device through the exit port comprising the at least an attachment element (col. 5, ll. 1-5, mixing and delivery occur simultaneously when both pumps 50 and 51 are operated simultaneously).
Ackerman does not explicitly disclose (b) a pressure relief valve in fluid connection between the exit port comprising the at least an attachment element and the syringes, wherein the pressure relief valve is configured to move from a closed state to an open state at a predetermined fluid pressure, and (c) a stopcock having an open configuration and a closed configuration, positioned between the pressure relief valve and the exit port comprising the attachment elements.
Miller discloses in Fig. 3 a syringe “360” and associated discussion in the specification e.g., [0117-0118] that the syringe comprise a pressure relief valve “370” in fluid connection between an exit port comprising an attachment element “354”, wherein the pressure relief valve is configured to move from a closed state to an open state at a predetermined fluid pressure - [0121],thus allowing releasing of material at a predetermined pressure, and a stopcock “356” having an open configuration - Fig. 3G - [0075], [0125] and a closed configuration - Fig. 3H - [0076], [0126] positioned between the pressure relief valve and the exit port comprising the attachment elements (see illustration Fig. 3C), the stopcock allow for either isolation or connection of an inlet and outlet.
In view of the teachings of Miller, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention to have modified the imaging fluid creation and delivery device of Ackerman to include a pressure valve and a stopcock as taught by Miller, to facilitate automatic release of the mixture of fluid and air when a predetermined pressure is achieved via the pressure valve and manual control downstream of the pressure valve via the stopcock to either connect the inlet with the outlet or isolate the inlet from the outlet in purview of a user.
Even with a narrow interpretation of the claim to require a physical structure or member that configures the first and second syringe to be moved simultaneously which is not recited or required by the claim, Hayakawa discloses such a structure as known in the prior art, see Fig. 1 and [0087] “… a flange connecting portion 72 which connects the flange 29 of the pusher 26 of the first syringe 2 with the flange 29 of the pusher 26 of the second syringe 3”, this structure allows for simultaneous movement of two syringes. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have further modified the first and second syringe 50, 51 of Ackerman to include a flange connection portion that connects the syringe plungers of the two syringes as taught by Hayakawa, to facilitate simultaneous movement of the first and second syringe, because Ackerman requires the two syringes to be moved simultaneously.
Regarding claim 2, see illustration Fig. 1, Ackerman discloses a catheter 14, attached to the exit port comprising the attachments.
Regarding claim 6, Ackerman in view of Miller and Hayakawa as discussed in claim 1 discloses an imaging fluid creation and delivery device used for administering an imaging fluid created and delivered with pressure control (i.e., via the pressure valve) to a subject having an altered physical structure of at least one fallopian tube or uterus, or both (see Ackerman col. 1 ll. 7-15 and col. 5, ll. 5-7, “The physician can then use the second hand 5 to operate the ultrasound scanner again to sonographically observe the patency of the fallopian tubes” examiner note: patency encompasses fallopian tubes with altered structure), the method comprising: a) contacting the exit port comprising the at least an attachment element to a fluid (see Ackerman illustration Fig. 1 and paragraph bridging col. 3-4, flow of saline from receptacle 68 to first pump), and proximally moving the two plungers to simultaneously (as modified by Hayakawa, the two plungers will be moved simultaneously) fill the first syringe with the fluid entering through the exit port comprising the at least an attachment element (Ackerman paragraph bridging col. 3-4), and the second syringe with air (Ackerman Col. 4: 24-26 “… In a first position, the second rotary valve 74 permits outside air to be drawn only through the air inlet 76 and air filter element 80 into the second pump 51”; b) attaching the exit port comprising the at least an attachment element to a proximal end of a catheter (Ackerman col. 3, ll. 32-34 and col. 4, ll. 16-18 and illustration Fig. 1 – inherent step) ;c) positioning the catheter's distal end at a target site of at least one fallopian tube or uterus (Ackerman col. 4, ll. 35-39); d) simultaneously moving the two plungers distally to move the fluid and air from the respective syringes and to mix the fluid and air to form the imaging fluid (Ackerman col. 5, ll. 1-5); and e) delivering the imaging fluid at or near the target site of the at least one fallopian tube or uterus, at or below the predetermined pressure (as modified by the teachings of Miller the imaging fluid will be delivered at or below the predetermined pressure, owing to the pressure valve).
Regarding claim 7, in modified Ackerman, when the imaging fluid reaches the predetermined pressure, the pressure relief valve opens, and the imaging fluid exits through the relief valve in view of the teachings of Miller in [0121].
Regarding claim 8 and 11, see Ackerman col. 5, ll. 5-7, “The physician can then use the second hand 5 to operate the ultrasound scanner again to sonographically observe the patency of the fallopian tubes”.
Regarding claim 10, see Ackerman col. 4, ll. 41-44 “The inflated balloon 23 locks the position of the apparatus 10 and seals the uterine cavity to prevent leakage of the saline therefrom so that imaging can then be performed on the subject uterus and/or fallopian tubes”.
Regarding claims 15-16, see Ackerman col. 5, ll. 1-2 “At this point, the mixture of saline and air is injected, via the catheter 14, into uterus and fallopian tubes”.
Regarding claim 19, see discussion in claim 1 above, regarding stopcock allows for isolating the pressure relief valve by closing the stop clock, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to close the stop clock when a predetermined fluid pressure is reached, so as to allow a user to stop administering of the imaging fluid at a pressure that is not safe.
Claims 3, 9, 13-14, 17, 20 and 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ackerman in view of Miller and Hayakawa as applied to claim 1 or 6 above, and further in view of in view of “A Practical Manual of Hysteroscopy and endometrial ablation techniques” hereinafter “the Manual” - of record.
Regarding claims 3 and 17, Ackerman in view of Miller and Hayakawa discloses the invention of claim 1 or 6 but for the pressure relief valve is configured to move from a closed state to an open state at 150 mmHg. However, the Manual, in the same field of endeavor of visualization of uterine cavity, teaches safety operation with intrauterine pressure that do not exceed a predetermined pressure (200 mmHg), to achieve adequate visualization, this process as described is manual, wherein an assistant instill the fluid - In Chapter 6, page 69, ll. 13-19. In view of teachings of the Manual that pressure should be maintained at a predetermined intrauterine pressure that is known to be safe, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the device and/or method of Ackerman in view of Miller and Hayakawa to ensure that intrauterine pressure will not exceed the predetermined pressure of 200 mmHg as taught by the Manual by setting the relied vale to move from a closed state to open state at 200 mmHg, as this is a known pressure that ensures imaging would be safe .
Regarding claims 9, 13-14 and 20-21, Ackerman in view of Miller and Hayakawa discloses the invention of claim 6 but for wherein the at least one fallopian tube and/or uterus of the subject have an altered physical structure and/or has undergone one or more of a surgical procedure, a medical procedure, or a trauma that has changed the physical structure of the at least one uterus or fallopian tube
Ackerman discloses in col. 5, ll. 5-7, “observe the patency of the fallopian tubes”, as evidenced by the Manual in introduction section of Chapter 10, in page 118, evaluation of tubal patency is performed in uterus or fallopian tube – uterotubial, with an altered physical structure which could be as a result of previous medical or surgical procedures or trauma that changed physical structure of the uterus and or tubal occlusion. Alternatively, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention to observe patency of a uterus of a patient with an altered physical structure as a result of a surgical or medical procedure and/or trauma or patency of a fallopian tube that has been occluded or blocked or severed, so as to evaluate tubal patency of the patient for diagnosis purposes.
Claims 4, 12 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ackerman in view of Miller and Hayakawa as applied to claim 1 or 6 above, and further in view of Adams et al., WO 2010036721 A2, hereinafter “Adams”.
Regarding claims 4, 12 and 18, Ackerman in view of Miller and Hayakawa discloses the invention of claim 1 or 6 but for the pressure relief valve is configured to move from a closed state to an open state at 150 mmHg [claim 4 or 18] or the imaging fluid further comprising a treatment fluid [claim 12].
Adams, in the same filed of endeavor of gynecologic and urologic procedures disclose system and devices that provide simplified use and reduced risk of adverse events [abstract] wherein a drug may be administered topically to the uterus by flushing the uterine cavity with a carrier fluid or distention fluid carrying the drug, Adams further teaches infusion of distention media into the uterine cavity so that the uterine pressure is between about 10 to 150 mmHg [0186]. Accordingly, Adams teaches that it was known in the prior art to include a drug with a distention media to facilitate both diagnosis and therapeutic procedures by the same distension media, and a pressure upper range of 150 mmHg.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the method and/or apparatus of Ackerman in view of Miller and Hayakawa, with an imaging fluid that includes a drug or treatment fluid, for additional benefit of performing both diagnosis and treatment in the uterus and/or fallopian tube, and set a pressure of 150 mmHg for the pressure relief valve to move from a closed state to an open state, because Adams teaches a pressure of 150 mmHg is a safe maximum pressure for uterine and or fallopian tube treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached on Mon. - Thurs. 5:30 am - 4:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached on (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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