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 Claims
Claims 1-18 are pending and examined on the merits.
Information Disclosure Statement
The five information disclosure statements (IDS’s) submitted on 10/24/2024, 04/03/2025, 07/23/2025, 11/05/2025, and 05/28/2026 were filed before the mailing date of the First Office Action on the Merits. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-18 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.
Claim 1 recites the limitation "a portion of the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this examination, and in the interest in compact prosecution, Examiner will treat this claim to read “a portion of a catheter”. Appropriate correction required.
Claim 10 recites the limitation "the rigid support" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of this examination, and in the interest in compact prosecution, Examiner will treat this claim to read “a second portion of the support body”. Appropriate correction required.
Claim 14 recites the limitation "the channel" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-2, 9, 11-12, 14, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richardson (U.S. Pre Grant Pub. No. 2004/0044307 A1).
Regarding claim 1, Richardson teaches: A catheter occlusion device (see Abstract, Figs. 1-2, and Claim 1), comprising:
a support body (see outer tube 1 in Fig. 1 and para. [0089]) configured to enclose a portion of the catheter (as shown in Fig. 1, outer tube 1 encloses inner tube 2; see also para. [0089]); and
an inflatable member (see portion 5 of reduced thickness in Figs. 1-2 and para. [0089-0090]) coupled to the support body (see Fig. 1), the inflatable member in fluid communication with an inflation line (see connecting tube 7 in Fig. 1), the inflatable member configured to transition between a deflated state (see Fig. 1) and an inflated state (see Fig. 2) to collapse the portion of the catheter enclosed in the support body (see Fig. 2 and para. [0092]).
Regarding claim 2, Richardson teaches the invention as discussed above in claim 1. Additionally, Richardson teaches wherein the inflatable member includes an expandable balloon or a piston with a slidable piston head (see at least para. [0092]).
Regarding claim 9, Richardson teaches the invention as discussed above in claim 1. Additionally, Richardson teaches wherein the support body encircles the catheter through an arc of 360o and defines a toroidal cross-sectional shape (as seen in Figs. 1, 2, and 5, outer tube 1 encircles the inner tube 2).
Regarding claim 11, Richardson teaches the invention as discussed above in claim 1. Additionally, Richardson teaches wherein the inflation line is coupled to a drainage tube in fluid communication with the catheter (as shown in Fig. 7 and discussed in para. [0097], tube for catheter 25 comprises an inner tube for carrying urine to the discharge point 10, therefore, as broadly recited, the discharge point 10 is the drainage tube is or connected to a drainage tube for draining urine; additionally, as broadly recited, the inflation line is considered to be coupled to the drainage tube at least because each of connection tube 7 and discharge point 10 branch from catheter tube 25, and are therefore considered to be coupled to each other).
Regarding claim 12, Richardson teaches the invention as discussed above in claim 11. Additionally, Richardson teaches wherein the inflation line simultaneously provides an inflation fluid to the inflatable member and the drainage tube (as broadly recited, and as shown in Fig. 7, since connection tube 7 is in fluid communication with main catheter tube 25, it provides inflation fluid to the inflatable member 5 through main catheter tube 25, which is considered to be a drainage tube).
Regarding claim 14, Richardson teaches the invention as discussed above in claim 1. Additionally, Richardson teaches wherein the support body is formed of a flexible material (see at least para. [0089]) and encircles the catheter through an arc of more than 360o to define a channel (as seen in Figs. 1, 2, and 5, outer tube 1 encircles the inner tube 2).
Regarding claim 16, Richardson teaches the invention as discussed above in claim 14. Additionally, Richardson teaches wherein the inflatable member includes an elongate balloon extending through a wall of the support body (see at least para. [0092] and Fig. 2).
Regarding claim 17, Richardson teaches the invention as discussed above in claim 14. Additionally, Richardson teaches wherein the catheter is a Foley catheter (see at least para. [0019]).
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 (i.e., changing from AIA to pre-AIA ) 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, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Richardson (U.S. Pre Grant Pub. No. 2004/004307 A1) in view of White (U.S. Pre Grant Pub. No. 2019/0030282).
Regarding claim 3, Richardson teaches the invention as discussed above in claim 1. However, Richardson fails to explicitly teach wherein a surface of the inflatable member includes an adhesive configured to adhere to an outer surface of the catheter.
White teaches an analogous urinary catheter system (see Abstract) and a method for assembling the catheter system (see Fig. 16 and para. [0174]), comprising the steps of coupling an inflation balloon to a shaft 120 (see Fig. 16 and para. [0175]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Richardson to incorporate the teachings of White by including an adhesive on a surface of the inflatable member that is configured to adhere to an outer surface of the catheter at least because Richardson teaches that the inner and outer tubes are bonded together (see para. [0023]) but does not explicitly teach how the tubes are bonded. Therefore, one of ordinary skill in the art would have reasonably looked to White for teachings of how the inflation balloon and the shaft 120 are bonded together (as taught in Fig. 16 and para. [0175] of White).
Claims 1, 5-7, 9, 13-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (U.S. Pre Grant Pub. No. 2013/0197621 A1) in view of Richardson (U.S. Pre Grant Pub. No. 2004/004307 A1).
Regarding claim 1, Ryan teaches: A catheter occlusion device (see Abstract and Figs. 2A-2D and 18-22D), comprising:
a support body (see flow control assembly 125 in para. [0135] and Fig. 1) configured to enclose a portion of the catheter (see Figs. 2A-D); and
an occlusion member (see plates 1405 in Figs. 20A-D) coupled to the support body (since plates 1405 are within flow control assembly 125, they are coupled to the flow control assembly 125; see Figs. 2A, 18, and 20A-D; see also para. [0048-0049]), the inflatable member configured to transition between a first state (see Figs. 20A, C) and a second state (see Figs. 20B, D) to collapse the portion of the catheter enclosed in the support body (see Fig. 20B, D and para. [0225]).
However, Ryan fails to teach that the occlusion member is an inflatable member coupled to the support body, the inflatable member in fluid communication with an inflation line, the inflatable member configured to transition between a deflated state and an inflated state to collapse the portion of the catheter enclosed in the support body, as required by the claim.
Richardson teaches an analogous catheter occlusion device (see Abstract, Figs. 1-2, and Claim 1), comprising an inflatable member (see portion 5 of reduced thickness in Figs. 1-2 and para. [0089-0090]), the inflatable member in fluid communication with an inflation line (see connecting tube 7 in Fig. 1), the inflatable member configured to transition between a deflated state (see Fig. 1) and an inflated state (see Fig. 2) to collapse the portion of the catheter enclosed in the support body (see Fig. 2 and para. [0092]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan to incorporate the teachings of Richardson by substituting the two plates of Ryan for the inflatable balloons of Richardson since it is the substitution of one known element for another to yield predictable results to one of ordinary skill in the art (see MPEP 2143). In the instant case, one of ordinary skill in the art would have reasonably substituted the occlusion device of Ryan (plates 1405) for the occlusion device of Richardson (balloon 5), as well as necessary components such as an inflation line, to yield a predictable result of having inflating balloons occlude the catheter 120 of Ryan.
Regarding claim 5, Ryan in view of Richardson teaches the invention as discussed above in claim 1. Additionally, Ryan in view of Richardson teaches wherein the inflatable member comprises opposing first and second chambers configured to inflate toward one another to collapse the portion of the catheter enclosed in the support body (as shown in Figs. 20A-D of Ryan, plates 1405, which are substituted with the inflatable balloons of Richardson, are opposing first and second chambers which inflate toward another to collapse the portion of catheter 120 enclosed within flow control assembly 125; see also Fig. 18).
Regarding claim 6, Ryan in view of Richardson teaches the invention as discussed above in claim 5. Additionally, Ryan in view of Richardson teaches wherein the opposing first and second chambers transition between the deflated state and the inflated state along an inflation axis perpendicular to a longitudinal axis of the catheter (see Figs. 20A-D).
Regarding claim 7, Ryan in view of Richardson teaches the invention as discussed above in claim 6. Additionally, Ryan in view of Richardson teaches wherein the inflation axis of aligns with a radial mid-point of the catheter (see Figs. 20A-D).
Regarding claim 9, Ryan in view of Richardson teaches the invention as discussed above in claim 1. Additionally, Ryan in view of Richardson teaches wherein the support body encircles the catheter through an arc of 360o and defines a toroidal cross-sectional shape (as seen in Figs. 2A-D, flow control assembly 125 encircles catheter 120).
Regarding claim 13, Ryan in view of Richardson teaches the invention as discussed above in claim 1. Additionally, Ryan teaches wherein the support body is formed of a rigid material (para. [0194] teaches that flow control assembly 125 is a housing).
Regarding claim 14, Ryan in view of Richardson teaches the invention as discussed above in claim 1. Additionally, Ryan teaches wherein the support body is formed of a flexible material (as broadly recited, virtually any material has a certain degree of flexibility) and encircles the catheter through an arc of more than 360o to define a channel (see at least Figs. 2A-D and 18).
Regarding claim 18, Ryan in view of Richardson teaches the invention as discussed above in claim 1. Additionally, Ryan teaches further comprising a catheter stabilization device configured to releasably secure the catheter to the support body (para. [0182] teaches that the flow control assembly 125 can be removably attached to shunt 120; therefore, as broadly recited, a catheter stabilization device is considered to be the mechanism that allows flow control assembly 125 to be removably attached to shunt 120).
Claims 4, 8, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan (U.S. Pre Grant Pub. No. 2013/0197621 A1) in view of Richardson (U.S. Pre Grant Pub. No. 2004/004307 A1), as applied to claim 1 above, and further in view of Hoyte (U.S. Pre Grant Pub. No. 2010/0063465 A1).
Regarding claim 4, Ryan in view of Richardson teaches the invention as discussed above in claim 1. However, neither Ryan nor Richardson explicitly teach wherein the support body has a cross-sectional shape of a “horse-shoe” or “C”, as required by the claim.
Hoyte teaches an analogous catheter occlusion device (see Abstract and Claim 1) comprising upper arm 53 and lower arm 52 which have a generally “horse-shoe” or “C” cross-sectional shape (see at least Figs. 7-8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan in view of Richardson to incorporate the teachings of Hoyte by changing the shape of the plates 1405 of Ryan to have a generally “horse-shoe” or “C” cross-sectional shape such as in Hoyte at least because it has been held that changes in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant (see In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); see also MPEP 2144.04).
Regarding claim 8, Ryan in view of Richardson teaches the invention as discussed above in claim 6. However, neither Ryan nor Richardson explicitly teach wherein the inflation axis is offset from a radial mid-point of the catheter.
Hoyte shows that the that the upper arm 53 exerts more force to collapse catheter tube 6 (see Figs. 7-8) which is offset from a radial mid-point of the catheter 6.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan in view of Richardson to incorporate the teachings of Hoyte by making the inflation axis offset from a radial mid-point of the catheter at least because Hoyte teaches that such a configuration is possible while still occluding the catheter. In the instant case, one of ordinary skill in the art could have reasonably adjusted the upper and lower plates 1405 of Ryan such that one of the plates 1405 inflates more than the other thereby exerting force on the catheter 120 and allowing the catheter 120 to have one side of its wall collapse towards an opposite side, as taught in Hoyte (see at least Fig. 8).
Regarding claim 10, Ryan in view of Richardson teaches the invention as discussed above in claim 9. However, neither Ryan nor Richardson explicitly teach wherein a first portion of the support body is releasably engaged with a second portion of the support body via a latch, clasp, hinge, or living hinge, as required by the claim.
Hoyte teaches wherein a first portion of the support body (see upper arm 53 in Fig. 7 and para. [0030]) is releasably engaged with a second portion of the support body (see lower arm 52 in Fig. 7 and para. [0030]) via a latch, clasp, hinge, or living hinge (see wheel 56).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan in view of Richardson to incorporate the teachings of Hoyte by making the flow control assembly 125 of Ryan comprise the mechanism shown in Figs. 7-8 of Hoyte at least in order to occlude catheter 120 of Ryan via crimping, as taught by Hoyte (see para. [0032]).
Regarding claim 15, Ryan in view of Richardson teaches the invention as discussed above in claim 14. However, neither Ryan nor Richardson explicitly teach wherein a first portion of the support body is coupled to a second portion of the support body by one of a buckle, clasp, hook and loop attachment, or adhesive, as required by the claim.
Hoyte teaches wherein a first portion of the support body (see upper arm 53 in Fig. 7 and para. [0030]) is coupled to a second portion of the support body (see lower arm 52 in Fig. 7 and para. [0030]) by one of a buckle, clasp, hook and loop attachment, or adhesive (para. [0031] teaches that tension spring 54 is attached at each end to upper arm 53 and lower arm 52; as broadly recited, the attachment region of the tension spring 54 is considered to be a clasp).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ryan in view of Richardson to incorporate the teachings of Hoyte by connecting a first portion and second portion of the support body by one of a buckle, clasp, hook and loop attachment, or adhesive at least in order to pull the plates 1405 of Ryan together thereby enabling crimping of the catheter 120, as taught by Hoyte (see para. [0031-0032]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leonard (U.S. Pre Grant Pub. No. 2018/0360606 A1) – Flow Control Valves.
Zhang (U.S. Patent No. 9,314,590 B2) – Method and Apparatus for Retroperfusion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781
