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 .
Response to Arguments
Claims 1, 8, and 16 were amended and claim 7 was canceled.
Claims 1-6 and 8-20 are pending.
Applicant’s arguments with respect to claim(s) 1-6 and 8-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Although Applicant’s amendment defines over the prior art reference to Forsell(US 8287444) as applied in the previous examiner’s action dated January 8, 2026, the amendment appears to introduce new matter as set forth below. In view of the amendments and giving the claims their broadest reasonable interpretation, a new rejection is set forth in view of the reference cited by applicants to Helms et al.( US 4256093). The claims are considered to be broad with respect to the structural relationships between the housing, the cavity, the sealing member, the base and the adjustment member.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 16 were amended to include the language “an adjustment member configured to engage the base member, at least a portion of the adjustment member being disposed outside of the cavity defined by the housing.” . The specification sets forth in paragraphs [0043], [0046] and [0047] , [0043]: “..an adjustment member 268 ..”, [0046]: “..The adjustment member 268 is configured to engage the base member 266 to move the base member 266 within the cavity 232 of the housing 230. In some embodiments, the adjustment member 268 is a screw member such as a set screw. In other embodiments, the adjustment member 268 is a different type of adjustment mechanism. For example, in some embodiments, the adjustment member may be a movable rod or a piston mechanism..”, and [0047]: “.. the adjustment member 268 may be set (and thereby move the base member 266) as desired from the outside of the housing 230. In the illustrated embodiment, the adjustment member 268 includes an indicator 272. The housing 230 includes markings 274 that indicate a pressure. The adjustment member 268 may be rotated, for example, by physician, to set the location of the base member 266 and thereby set the pressure of the inflatable member 220 at which the sealing member 234 will be moved. .”. Also Figure 5, shows the indicator.
PNG
media_image1.png
556
522
media_image1.png
Greyscale
However there is nothing that seems to show the structural relationship between element 268 and element 272. It is unclear if element 268 actually extends to the outside of the housing and thus includes a portion external the cavity created by the housing or if element 272 extends into the housing to engage the element 268. There does not seem to be actual language or a figure that supports the language “at least a portion of the adjustment member being disposed outside of the cavity defined by the housing”.
It is certainly clear from paragraphs [0046] and [0047], That the adjustment member may be set as desired from outside of the housing and that the adjustment member includes an indicator 272.
To overcome this rejection, the examiner suggests, amending the independent claims to more clearly represent what is set forth in paragraph [0047] of the specification where “the adjustment member 268 may be set (and thereby move the base member 266) as desired from the outside of the housing 230… the adjustment member 268 includes an indicator 272.”.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1,2,5,6,9-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helms et al.(4256093) hereinafter Helms et al.
Helms et al. teaches pump/valve unit for controlling the inflation and deflation of a urethral collar in a prosthetic urinary sphincter device is disclosed including a compressible bulb pump defining a reservoir made integral with a valve unit for implant wherein the valve unit includes a movable valve member operable by depression of a flexible portion of the valve unit housing for controlling fluid flow between the reservoir and collar and a pressure sensing means which operates the valve member to relieve an excess pressure in the collar should too much pressure be applied by the patient.
PNG
media_image2.png
726
527
media_image2.png
Greyscale
Regarding claims 1 and 16, 18 Helms et al. teaches an inflatable member; a pump configured to transfer fluid to the inflatable member; and a housing operatively coupled to the inflatable member and to the pump, the housing defining a cavity, the housing including a base member disposed within the cavity defined by the housing and a sealing member disposed within the cavity defined by the housing, the sealing member being configured to move with respect to the base member; and an adjustment member configured to engage the base member, at least a portion of the adjustment member being disposed outside of the cavity defined by the housing. Note the annotated figure above and the corresponding description in Helms et al. Paragraph 2, a device for pressurizing and relieving the collar B, of a urinary prosthetic sphincter device. The device includes a compressible bulbous pump means C, having a press bulb 10 made from a soft synthetic material such as a silicon elastomer which provides a reservoir for a suitable fluid solution which is used as a pressurizing fluid, such as a saline solution and an integral valve unit D, having a housing 12 which encloses the components thereof. The housing 12 is illustrated as being cylindrical in shape consisting of a cap portion 13 and a base portion 14 received within a flange portion 13a of the cap which may be bonded or welded. The reservoir bulb material 10 is made integral with the housing 12. Paragraph 6, A flexible diaphragm 34 is attached at one end between the retainer body 33 and main body 20 and is partially carried by valve member 25 by attachment at a diaphragm seat member 35 integral with member 25. Paragraph (7), The diaphragm 34 divides the interior of housing 12 into a first compartmented section 12a in fluid communication with collar B and a second compartmented section 12b in fluid communication with reservoir 10. Paragraph (8), A spring 37 biases the valve body 27 in its normal position wherein flange 32 abutts the retaining member 33 away from the base 20. The amount of bias of spring 37 may be adjusted by adding or removing annular shims 38 received over stem 23. It is the examiner’s interpretation that the device includes the housing 12, which is divided into two cavity portions 12a and 12b, a base member 35, a sealing member or flexible diaphragm 34 which will move as base 25 is moved and an adjustment member which includes element 37 and shims 38 which engages and is able to move the base member 35 and at least a portion of the elements 37 and 38 are disposed outside of cavity portion 12a defined by the housing.
Regarding claim 2, Helms et al. teaches wherein the sealing member is configured to form a fluidic seal with an inner surface of the housing. Paragraph (7), The diaphragm 34 divides the interior of housing 12 into a first compartmented section 12a in fluid communication with collar B and a second compartmented section 12b in fluid communication with reservoir 10.
Regarding claim 5, Helms et al. teaches wherein the housing includes a projection extending from an inner surface of the housing. Note paragraph 3, The body 20 includes two upstanding leg portions 21 and 22 and a central upstanding stem portion 23 which serves as a valve stem.
Regarding claim 6, Helms et al. teaches wherein the housing includes a projection extending from an inner surface of the housing and into the cavity defined by the housing, the projection being configured to engage the sealing member. The claim does not require it to be directed engaging the sealing member. Note paragraph 3, The body 20 includes two upstanding leg portions 21 and 22 and a central upstanding stem portion 23 which serves as a valve stem.
Regarding claim 9, Helms et al. teaches wherein the housing is operatively coupled to the pump via a tubular member. Note annotated figure above and corresponding description.
Regarding claim 10, Helms et al. teaches wherein the housing is operatively coupled to the inflatable member via a tubular member. Note annotated figure above and corresponding description.
Regarding claim 11, Helms et al. teaches wherein the inflatable member is configured to be placed near a urethra of a patient. Note annotated figure above and corresponding description.
Regarding claim 12 and 20, Helms et al. teaches wherein the inflatable member is an inflatable cuff member. Note annotated figure above and corresponding description.
Regarding claims 13 and14, Helms et al. teaches further comprising:
a reservoir, the reservoir being operatively coupled to the housing and being configured to receive fluid. Note annotated figure above and corresponding description.
Regarding claim 15, Helms et al. teaches a reservoir, the reservoir being operatively coupled to the housing and being configured to receive fluid, the housing including a projection extending from an inner surface of the housing. Note annotated figure above and corresponding description. Note paragraph 3, The body 20 includes two upstanding leg portions 21 and 22 and a central upstanding stem portion 23 which serves as a valve stem.
Regarding claim 17, Helms et al. teaches wherein the housing includes a projection member extending from an inner surface of the housing, the projection member configured to engage the sealing member when the sealing member is in the first position. Note annotated figure above and corresponding description. The claim does not require it to be directed engaging the sealing member. Note paragraph 3, The body 20 includes two upstanding leg portions 21 and 22 and a central upstanding stem portion 23 which serves as a valve stem.
Allowable Subject Matter
Claims 3, 4, 8, and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Although the claims would have to overcome the rejection over 112(a) first paragraph, the prior art of record does not set forth the subject matter of the independent claims and where the biasing member is disposed between the base and the sealing member or where the adjustment member includes a screw member configured to engage the base member.
To put the application in better form for allowance, the examiner suggests amending the independent claims as set forth above regarding the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph: The examiner suggests, amending the independent claims to more clearly represent what is set forth in paragraph [0047] of the specification where “the adjustment member 268 may be set (and thereby move the base member 266) as desired from the outside of the housing 230… the adjustment member 268 includes an indicator 272.”.
The examiner also suggests amending the pre-amble of the claims to include “implantable apparatus” which is more consistent with the technical field of the invention as set forth in the specification and to better define the intended scope of the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Henkel et al.( US 8276591) teaches method of preventing inadvertent inflation of an implantable prosthetic includes biasing a valve assembly such that an outlet is substantially closed and using inadvertent pressure increases from the inlet to supplement the biasing of the valve assembly. It may further include the step of preventing fluid flow through the outlet by selectively varying fluid pressure within a bypass passageway having a first end which is in fluid communication with an inlet and a second end which is in fluid communication with a chamber. And, may also additionally include the step of displacing a flexible abutting wall disposed between the chamber and the valve assembly so that the abutting wall is caused to contact the valve assembly and urge the valve assembly into a closed position when the fluid pressure within the chamber exceeds a predetermined amount.
Cooke (US 5778925) teaches a pressure regulation valve is disclosed which comprises a housing including first and second ports, a support for slidably supporting a tubular member defining a valve seat against which a valve element is engageable. The tubular member and valve element are spring biased into engagement with one another. It is noted applicant’s claims are not specifically limited to implantable devices.
Hakim et al. ( US 4551128) teaches a surgically-implantable shunt valve for venting cerebrospinal fluid in the treatment of hydrocephalus and for shunting other body fluids, the valve having a flexible diaphragm mounted within a non-metallic housing, a plate mounted on the flexible diaphragm, the plate having a circular aperture and the diaphragm having an opening aligned with the aperture, the diaphragm being generally coplanar with the plate, the diaphragm and plate dividing the housing into inlet and outlet chambers that communicate through the aperture, the inlet and outlet chambers being generally free of blind cavities so as to inhibit collection of debris, the valve having a valve element (such as a spherical ball) residing on the inlet side of the aperture, the valve element being biased against the circular periphery of the aperture to keep it closed until the cerebrospinal fluid pressure in the inlet chamber exceeds a preselected popping pressure, and the valve having a screw for making external adjustments to the popping pressure.
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).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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, Charles Marmor can be reached at (571)272-4730. 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.
/BRIAN L CASLER/Primary Examiner, Art Unit 3791
Prosecution Insights