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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following:
Reference character “1” has been used to designate different embodiments.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1, 2, 4, 6, 7 and 8 is/are objected to because of the following informalities:
In claim 1, line 6, the term “working” should be inserted before the term “fluid” to match the language used earlier in the claim.
In claim 1, line 14, the phrase “a second part” should be “the second part” since line 12 introduces this part.
In claim 1, line 23, “a fluid communication” should be corrected to “the fluid communication” since this term was previously introduced in line 13.
In claim 2, lines 1, “the restraining mechanism” should be corrected to “the restraining element” for claim language consistency.
In claim 2, line 8, the term “be” should be placed at the beginning of the line.
In claim 4, lines 5-6, “a pressure” should be “the pressure” in view of dependence on claim 3.
In claim 6, line 10, “the restraining mechanism” should be corrected to “the restraining element” for claim language consistency.
In claim 7, line 1-2, “the restraining mechanism” should be corrected to “the restraining element” for claim language consistency.
In claim 8, line 1-2, “the restraining mechanism” should be corrected to “the restraining element” for claim language consistency.
Appropriate correction is required.
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.
Claim(s) 1, 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al. (US20190275295A1, herein Jamous), and further in view of Pedersen et al. (US7744620B2, herein Pedersen).
Regarding claim 1, Jamous discloses a catheter (20 in Fig. 1) comprising:
a primary balloon (balloon 36 in Fig. 1) adapted to be inflated or deflated to retain the primary balloon inside a human body part (balloon catheter is inserted into the narrowed or blocked area, and the balloon is inflated to expand the constricted area [0003]) or to apply a medication inside the human body part, or to install a device inside the human body part,
a inflation/deflation port (hub assembly 38 in Fig.1) adapted to be connected to a pumping means to pump in a working fluid (via an inflation medium supplied [0043]) to inflate the primary balloon (balloon 36 can be inflated [0043]), and to pump out the fluid to deflate the primary balloon (and deflated as desired [0043]),
Jamous fails to explicitly disclose a restraining element configured to transition between a closed state and an open state and is adapted:
to be in the closed state to keep a first part of the primary balloon or an opening of the primary balloon in a restrained position until a pressure inside a second part of the primary balloon or the primary balloon is within a first predefined threshold, so as to close a fluid communication:
between a second part of the primary balloon and the first part of the primary balloon, or
between the opening of the primary balloon and an environment outside of the primary balloon, and
to be in the open state to keep the first part of the primary balloon or the opening of the primary balloon in an expanded position when the pressure inside the second part of the primary balloon or the primary balloon surpasses the first predefined threshold and until the pressure inside the second part of the primary balloon or the primary balloon gets below the first predefined threshold, so as to open a fluid communication:
between the second part of the primary balloon and the first part of the primary balloon, or
between the opening of the primary balloon and the environment outside of the primary balloon.
However, Pedersen teaches that a catheter (200 in Fig. 5D) with a restraining element configured to transition between a closed state and an open state and is (taper zone 602 in Fig. 5E; the proximal aortic portion 202a includes a yarn reinforced sleeve configuration that forecloses expansion of the proximal aortic portion 202a until pressure within the balloon 202 reaches a predetermined pressure P2 [Col 9, lines 50-55]; it can be interpreted that the yarn reinforced sleeve works in conjunction with the taper zone to restrain expansion of 202a and consequently 202b; thus establishing a closed state as seen in Fig. 5E and open state in Fig. 5F) adapted:
to be in the closed state (the proximal aortic portion 202a includes a yarn reinforced sleeve configuration that forecloses expansion of the proximal aortic portion 202a until pressure within the balloon 202 reaches a predetermined pressure P2 [Col 9, lines 50-55]; it can be interpreted that the yarn reinforced sleeve works in conjunction with the taper zone to restrain expansion of 202a and consequently 202b; thus establishing a closed state as seen in Fig. 5E) to keep a first part (202A in Fig. 5E) of the primary balloon or an opening of the primary balloon in a restrained position (see 202A in deflated state in Fig. 5E) until a pressure inside the second part of the primary balloon or the primary balloon is within a first predefined threshold (see 202B in first expanded state in Fig. 5E), so as to close a fluid communication:
between a second part of the primary balloon and the first part of the primary balloon (catheter balloon 200 allows for progressive inflation [0061], meaning 202A cannot expand until 202B is fully expanded, therefore no fluid communication between them before full expansion of 202B), or
between the opening of the primary balloon and an environment outside of the primary balloon, and
to be in the open state to keep (the proximal aortic portion 202a includes a yarn reinforced sleeve configuration that forecloses expansion of the proximal aortic portion 202a until pressure within the balloon 202 reaches a predetermined pressure P2 [Col 9, lines 50-55]; it can be interpreted that the yarn reinforced sleeve works in conjunction with the taper zone to restrain expansion of 202a and consequently 202b; thus establishing an open state as seen in Fig. 5F) the first part of the primary balloon or the opening of the primary balloon in an expanded position (see expansion of 202A in Fig. 5F) when the pressure inside the second part of the primary balloon or the primary balloon surpasses the first predefined threshold (pressure within the catheter balloon begins to increase further [0061], see also second expanded state of 202B in Fig. 5F) and until the pressure inside the second part of the primary balloon or the primary balloon gets below the first predefined threshold, so as to open a fluid communication:
between the second part of the primary balloon and the first part of the primary balloon (progressive inflation of 202A once 202B is fully expanded [0061], thus showing fluid communication between both balloons) or
between the opening of the primary balloon and the environment outside of the primary balloon.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Jamous with Pedersen to include a restraining mechanism adapted: to keep a first part of the primary balloon or an opening of the primary balloon in a restrained position until a pressure inside the second part of the primary balloon or the primary balloon is within a first predefined threshold, so as to close a fluid communication: between a second part of the primary balloon and the first part of the primary balloon, or between the opening of the primary balloon and an environment outside of the primary balloon, and to keep the first part of the primary balloon or the opening of the primary balloon in an expanded position when the pressure inside the second part of the primary balloon or the primary balloon surpasses the first predefined threshold and until the pressure inside the second part of the primary balloon or the primary balloon gets below the first predefined threshold, so as to open a fluid communication: between the second part of the primary balloon and the first part of the primary balloon, or between the opening of the primary balloon and the environment outside of the primary balloon to allow a user to precisely control the expansion sequence and maximal achieved diameter for each catheter balloon section [0062].
Regarding claim 2, Jamous, as modified by Pedersen, disclosed all limitations of claim 1. Pedersen further teaches, wherein the restraining mechanism is a stretchable band (see taper 602 expand in Fig. F) which is adapted to:
- cover a part of the primary balloon dividing the primary balloon (taper 602 placed between segments 202A and 202B [0065]) the first part (202A in Fig. 5E) and the second part (202B in Fig. 5E), wherein the second part is adapted to be inflated or deflated using the pumping means (as inflation media enters the catheter balloon 202, the more compliant section 202B [0062]) for retaining the second part of the primary balloon inside the human body part (distal anchoring section 202b [0062], it is noted in [0042] sets forth that distal anchoring balloon more closely conforms to the anatomical structure of the LVOT, preventing abrupt back and forth movement) or to apply the medication inside the human body part, or to install the device inside the human body part, or
placed at the opening of the primary balloon which connects the primary balloon to the environment outside of the primary balloon.
It is also further taught by Pedersen that 202A includes a yarn reinforced sleeve configuration [0064] and a fabric covering the entire balloon 200, the makeup of the fabric would control and govern the shape ultimately achieved by the balloon membrane [0071], which can be further considered as resilient band.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Jamous with Pedersen to include wherein the restraining mechanism is a stretchable band which is adapted to: cover a part of the primary balloon dividing the primary balloon the first part and the second part, wherein the second part is adapted to be inflated or deflated using the pumping means for retaining the second part of the primary balloon inside a human body part or to apply a medication inside the human body part, or to install a device inside the human body part, or placed at the opening of the primary balloon which connects the primary balloon to the environment outside of the primary balloon, to create a section of the primary balloon to engage within the body and preventing abrupt back and forth movement of the catheter [0062].
Regarding claim 9, Jamous as modified disclosed all limitations of claim 1. Jamous further discloses wherein the inflation/deflation port is placed at a proximal end (hub assembly 38 is connected to a proximal end 46 [0025]) of the catheter and the primary balloon is placed in proximity to a distal end of the catheter (catheter shaft 30 carries the balloon 36 adjacent a distal end 40 [0025]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al. (US20190275295A1, herein Jamous) as modified by Pedersen et al. (US7744620B2, herein Pedersen) and in further in view of Jenkins et al (WO2010033629 A1, herein Jenkins).
Regarding claim 3, Jamous as modified by Pedersen disclosed all limitations of claim 2. However, Jamous and Pedersen failed to explicitly disclose wherein the first part of the primary balloon comprises a weak area which is adapted to burst when a pressure inside the first part of the primary balloon surpasses a second predefined threshold.
Jenkins taught that a porous balloon 918 (in Fig. 15B) is mounted at the distal end of the hypotube 916. When fluid is injected, the porous balloon 918 expands to open pores 919 and then fluid flows out of the pores [00137]. It can be recognized by those skilled in the art the problem of excessive internal balloon pressure and employ mechanisms to relief such pressure, albeit through a different structural means.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Jamous as modified by Pedersen, with Jenkins, which discloses a balloon configured to release internal pressure upon excessive expansion through a pore-opening mechanism. The rationale to support this conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. (See MPEP 2143.I.B)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al. (US20190275295A1, herein Jamous) as modified by Pedersen et al. (US7744620B2, herein Pedersen) and Jenkins et al (WO2010033629 A1, herein Jenkins), and in further in view of Hakky et al (US20190224455 A1, herein Hakky).
Regarding claim 4 Jamous as modified by Pedersen and Jenkins disclosed all limitations of claim 3. However, Jamous as modified by Pedersen and Jenkins failed to explicitly disclose wherein the first part of the primary balloon and the environment outside of the primary balloon are fluidly connected to each other through a fluid communication channel, the catheter comprises a flow controller which is adapted to open the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon when a pressure inside the first part of the primary balloon surpasses the second predefined threshold, and to close the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon when the pressure inside the first part of the primary balloon gets below the second predefined threshold.
However, Hakky teaches wherein the first part of the primary balloon and the environment outside of the primary balloon are fluidly connected to each other through a fluid communication channel (channel 26 in Fig. 1B), the catheter comprises a flow controller (two-way valve 20 in Fig. 1B) which is adapted to open the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon (two way valve 20 located outside of the catheter and connected to channel 26, see Fig. 1B) when a pressure inside the first part of the primary balloon surpasses the second predefined threshold, and to close the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon when the pressure inside the first part of the primary balloon gets below the second predefined threshold.
It can be recognized by those skilled in the art the problem of excessive internal balloon pressure and use the two way valve 20 from Hakky to relief pressure from the balloon via the channel 26. Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Jamous as modified by Pedersen and Jenkins, with Hakky to include wherein the first part of the primary balloon and the environment outside of the primary balloon are fluidly connected to each other through a fluid communication channel, the catheter comprises a flow controller which is adapted to open the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon when a pressure inside the first part of the primary balloon surpasses the second predefined threshold, and to close the fluid communication channel between the first part of the primary balloon and the environment outside of the primary balloon when the pressure inside the first part of the primary balloon gets below the second predefined threshold to relief internal pressure from the balloon. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamous et al. (US20190275295A1, herein Jamous) as modified by Pedersen et al. (US7744620B2, herein Pedersen) and in further in view of Hakky et al (US20190224455 A1, herein Hakky).
Regarding claim 6, Jamous as modified by Pedersen disclosed all limitations of claim 2. However, Jamous and Pedersen fails to explicitly disclose wherein the environment outside the primary balloon is:
a working fluid channel through which the primary balloon is inflated using the working fluid, or
a body fluid drainage channel through which a body fluid is drained out of the human body, or
a cavity/lumen of the body part in which the primary balloon of the catheter is placed, or
a secondary balloon connected to the primary balloon through a fluid flow channel (8) via the restraining mechanism, wherein the secondary balloon is placed in proximity to the primary balloon.
Hakky teaches that wherein the environment outside the primary balloon (channel 26 leading from balloon to outside, see Fig. 1B) is:
a working fluid channel (channel 26 in Fig. 1B) through which the primary balloon is inflated using the working fluid (sterile fluid 25 flows through channel 26 to the balloon and inflates balloon [0018]), or
a body fluid drainage channel through which a body fluid is drained out of the human body, or
a cavity/lumen of the body part in which the primary balloon of the catheter is placed, or
a secondary balloon connected to the primary balloon through a fluid flow channel via the restraining mechanism, wherein the secondary balloon is placed in proximity to the primary balloon.
Regarding claim 8, Jamous as modified by Pedersen disclosed all limitations of claim 1. However Jamous and Pedersen failed to explicitly disclose wherein the restraining mechanism is a restraining valve which is adapted to be in a closed position to keep the first part of the primary balloon or the opening of the primary balloon in the restrained position until the pressure inside the second part of the primary balloon or the primary balloon is within a first predefined threshold, and to be in an open position to keep the first part of the primary balloon or the opening of the primary balloon in the extended position when the pressure inside the second part of the primary balloon or the primary balloon surpasses the first predefined threshold, and until the pressure inside the second part of the primary balloon or primary balloon gets below the first predefined threshold.
However, Hakky teaches a restraining mechanism is a restraining valve (two way valve 20 in Fig. 1B) which is adapted to be in a closed position keep the first part of the primary balloon or the opening of the primary balloon (channel 26 in Fig. 1B) in the restrained position (two way valve 20 prevents the fluid from escaping from the inflated balloon [0019]).
It can be recognized by those skilled in the art the problem of excessive internal balloon pressure and use the two-way valve 20 from Hakky to relief pressure from the balloon via the channel 26. Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter of Jamous as modified by Pedersen, with Hakky to include wherein the restraining mechanism is a restraining valve which is adapted to be in a closed position to keep the first part of the primary balloon or the opening of the primary balloon in the restrained position until the pressure inside the second part of the primary balloon or the primary balloon is within a first predefined threshold, and to be in an open position to keep the first part of the primary balloon or the opening of the primary balloon in the extended position when the pressure inside the second part of the primary balloon or the primary balloon surpasses the first predefined threshold, and until the pressure inside the second part of the primary balloon or primary balloon gets below the first predefined threshold. Such reasoning is consistent with known engineering principles and represents a predictable design choice (See MPEP 2144.03).
Allowable Subject Matter
Claim(s) 5, 7 and 10 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject
matter:
The subject matter of dependent claims 5, 7 and 10 could not be found nor was
suggested in the prior art of record.
Claim 5 requires the flow controller to be an automated valve and work on at least one of the mechanical, electrical or magnetic principles, or combination thereof. Hakky disclosed a two-way valve which is functionally not equivalent.
Claim 7 requires the restraining mechanism to be a restraining balloon smaller than the primary balloon and placed onto a part of the primary balloon, so as to enclose a part of the primary balloon, such that the enclosed part of the primary balloon makes the first part of the primary balloon, the restraining balloon has a stretchable opening which keeps the first part of the primary balloon incommunicado to the second part. Pedersen disclosed a restraining mechanism which are a taper zone, a yarn enforced sleeve and elastic fabric, which are not equivalent to a restricting balloon.
Claim 10 requires the flow controller to be an retractable plug and work on at least one of the mechanical, electrical or magnetic principles, or combination thereof. Hakky disclosed a two-way valve which is functionally not equivalent.
Response to Amendment
The Applicant has amended Figs. 2 and 3 to include missing reference character for catheter. Applicant has amended these figures to identify the features “restraining balloon” of claim 7 and “restraining valve” of claim 8, which overcomes the objections set forth in the Non-Final Office Action. Therefore, Examiner accordingly withdraws these drawing objections.
However, Applicant failed to amend the objection of using reference character “1” to designate different embodiments. Therefore, this drawing objection is maintained.
The Applicant has amended claims 1, 4 and 8 which were previously objected to. Examiner accordingly withdraws the objection of claims 4 and 8. The objection of claim 1 is maintained since amendments were not appropriately made by Applicant (objection of line 6 in claim 1 set forth above).
The Applicant has amended claims 4, 5 and 6 which were previously rejected under the U.S.C § 112(b) rejection. Examiner accordingly withdraws the 112(b) rejection of claims 4, 5 and 6. Applicant has amended claim 5 to remove the “retractable plug” limitation and include it in new claim 10.
Response to Arguments
Applicant’s argument filed on 03/23/2026 have been fully considered but they are not found persuasive.
Applicant made argument that the restraining element of amended claim 1 regulates fluid communication based on pressure conditions within the balloon, and Jamous and Pedersen either separately or in combination fail to disclose this. The Examiner respectfully disagrees. Pedersen teaches in Col. 9, lines 50-55 that a yarn reinforced sleeve configuration restrains expansion of the segment 202a until a predetermined pressure P2 is reached. It is also set forth in Col. 9, lines 50-55 that the fibers in the yarn reinforced sleeve are configured to mechanically limit the enlargement of the portion 202a. Upon reaching the predetermined pressure P2, the portion 202a is expanded, and it can be interpreted from Fig. 5F that the taper zone is also expanded which can be further interpreted to allow expansion of 202b beyond the volumetric dimension shown in Fig. 5D and 5E. This configuration of the yarn reinforced sleeve in combination with the taper zone can be interpreted as a closed state before P2 is reached and open state after P2 is reached.
The Applicant made argument Jamous, Pedersen and Jenkins either separately or in combination fail to disclose or suggest “a weak area adapted to burst”. Applicant argued that Jenkins teaches a porous balloon which is structurally different from a burstable weak region in a balloon as required by claim 3. Applicant argued that the burstable weak region of the balloon in claim 3 is configured to burst when a second predefined pressure is exceeded.
However, it is set forth by Applicant in page 8, line 22 of Specification that the weak area bursts to control the excess built up pressure, which could be interpreted as a form of pressure relief.
Jenkins also specified in Para [0137] that the pores 919 opens upon expansion of the balloon 918, which can be interpreted as the pores opening when the pressure inside balloon 918 reaches a second predefined pressure.
Furthermore, it is set forth in MPEP 2144.06 that if two materials /component/ processes are known in the art as interchangeable for the same purposes (relieving pressure), then combining or substituting them is ordinarily obvious. The Applicant has further made argument that Jamous, Pedersen and Hakky either separately or in combination fail to disclose or suggest an internal pressure-responsive mechanism within the catheter system to selectively control fluid communication between the balloon parts or between the balloon and its environment. However claims 4, 6 and 8 can be interpreted such that a flow controller (such as the two-way valve of Hakky) can be adapted to open or close a fluid communication channel between the balloon and its environment, as taught by Hakky.
Conclusion
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).
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday to Friday 8am - 5pm EST. 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, Kevin Sirmons can be reached at (571)272-4965. 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.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights