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 .
Specification
The disclosure is objected to because of the following informalities:
“…The present invention generally relates to an apparatus for treating incontinence and more specifically relates an apparatus for providing an inflatable artificial sphincter…” in para.[0002] needs to be corrected. A suggested correction is --The present invention generally relates to an apparatus for treating incontinence and more specifically relates to an apparatus for providing an inflatable artificial sphincter--.
“…The isotonic fluid loaded in the artificial sphincter may become contaminated in either during the surgical implantation or later on in time during use of the same…” in para.[0007] needs to be corrected. A suggested correction is -- The isotonic fluid loaded in the artificial sphincter may become contaminated [[in]] either during the surgical implantation or later on in time during use of the same--.
“The artificial sphincter (1) further comprises a balloon holder (11) having a lumen (28) which establishes fluid communication in between said fluid reservoir” in para. [0028] needs to be corrected. A suggested correction is --The artificial sphincter (1) further comprises a balloon holder (11) having a lumen (28) which establishes fluid communication [[in]] between said fluid reservoir--.
“In this position, semi-rigid check valve (431) the blocks flow of the pressurizing fluid towards the pump bulb (6)” in para. [0058] needs to be corrected. A suggested correction is -- In this position, semi-rigid check valve (431) [[the]] blocks flow of the pressurizing fluid towards the pump bulb (6)--.
“Normally, all the fluid contained in the pump bulb (6) can be transferred to the stretchable fluid reservoir (23) after the patient squeeze and release the bulb a plurality of times” in [0059] needs to be corrected. A suggested correction is --Normally, all the fluid contained in the pump bulb (6) can be transferred to the stretchable fluid reservoir (23) after the patient squeezes and releases the bulb a plurality of times--.
Appropriate correction is required.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 “a pump means having a first port in fluid communication with the inflatable occlusion means via a first tube and a second port in fluid communication with the stretchable fluid reservoir via a second tube for selectively transferring pressurizing fluid from the inflatable occlusion means to the reservoir to deflate the inflatable occlusion means …. body passage is allowed to be opened” and “wherein the pressure sensitive check valve always allows fluid flow from the pressure compensation balloon towards the lumen so that the fluid contained in the pressure compensation balloon is freely flowable towards the inflatable occlusion means” needs to be corrected. A suggested correction is --a pump means having a first port in fluid communication with the inflatable occlusion means via a first tube and a second port in fluid communication with the stretchable fluid reservoir via a second tube for selectively transferring pressurizing fluid from the inflatable occlusion means to the reservoir to deflate the inflatable occlusion means [[so]] in a manner that …body passage is allowed to be opened-- and --wherein the pressure sensitive check valve always allows fluid flow from the pressure compensation balloon towards the lumen [[so]] in a manner that the fluid contained in the pressure compensation balloon is freely flowable towards the inflatable occlusion means—respectively to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Each of claim 2-3 and 7 recite “so that” encompassing intended result/functional limitations which need to be corrected to --wherein the semipermeable check valve has a recessed seating having one or more recesses [[so]] in a manner that a restricted fluid flow—in claim 2; --wherein the semipermeable check valve has an annular seating and a cratered ball having a plurality of craters [[so]] in a manner that a restricted fluid flow from the stretchable fluid reservoir—in claim 3; and --wherein a density of the ball is substantially equal to a density of the pressurizing fluid [[so]] in a manner that the ball [[freely]] floats freely in the nest—in claim 7 respectively to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Each of claims 6, 8-9 recite “such that” encompassing intended result/functional limitations which need to be corrected to -- wherein a pervious seat is provided in between the ball and the lumen [[such]] in a manner that free flow of the pressurizing fluid around the ball towards the lumen is ensured—in claim 6; -- wherein the check valve in the pump is arranged [[such]] in a manner that pressurizing fluid in the pressure compensation balloon is freely flowable towards the inflatable occlusion means at all times—in claim 8; -- wherein the resilient material is allowed to expand by way of stretching [[such]] in a manner that, in a stretched state—in claim 9 respectively to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “such that” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required.
Claim 1 “when in use” limitations i.e. “An artificial sphincter containing, when in use, a pressurizing fluid, the artificial sphincter comprising:”, “wherein the pressure compensation balloon is in fluid communication with the lumen of the balloon holder and, when in use, is to be implanted in an abdomen of a patient”, “the fluid contained in the pressure compensation balloon is freely flowable towards the inflatable occlusion means and, when in use, a sudden pressure increase which occurs in the abdomen of the patient is instantly conveyed to the inflatable occlusion means” need to be corrected. A suggested correction is – An artificial sphincter configured to contain a pressurizing fluid, the artificial sphincter comprising:--, -- wherein the pressure compensation balloon is in fluid communication with the lumen of the balloon holder which is configured to be implanted in an abdomen of a patient --, -- the fluid contained in the pressure compensation balloon is freely flowable towards the inflatable occlusion means in a manner that a sudden pressure increase which occurs in the abdomen of the patient is instantly conveyed to the inflatable occlusion means —respectively, to avoid conditional limitation recitation which would raise question as to what occurs when the “when” encompassing condition is not met.
Claim 10 recites “wherein the pump means has a bulb, wherein the bulb contains pressurizing fluid and transfers the pressurizing fluid to the stretchable fluid reservoir when compressed” which needs to be corrected. A suggested correction is -- wherein the pump means has a bulb, wherein the bulb contains pressurizing fluid and transfers the pressurizing fluid to the stretchable fluid reservoir [[when]] while compressed-- to avoid conditional limitation recitation which would raise question as to what occurs when “when” encompassing condition is not met.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 1-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Each of claims 5-6 recite the limitation "the ball". There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “a pervious seat” which renders this claim unclear. More specifically, it is unclear as to whether claim 6 “a pervious seat” is the same as, different than or in addition to “a pervious seat” recited in claim 5 line 2.
Claim 1 in line 10 “a blocked body passage” in the limitation “a blocked body passage is allowed to be opened” which renders this claim unclear. More specifically, it is unclear as to whether claim 1 line 10 “a … body passage” is the same as, different than or in addition to “a body passage” recited in claim 1 line 3. If same Examiner suggests amending claim 1 line 10 “a blocked body passage is allowed to be opened” to -- the body passage that is occluded is allowed to be opened—or -- the body passage that is blocked is allowed to be opened—.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the pressure sensitive check valve blocks fluid flow towards the pressure compensation balloon only while the fluid pressure in pressure compensation balloon is substantially less than the fluid pressure in the lumen of the balloon holder as also evidenced in instant application specification as-filed at least para. [0043]. More specifically, it is unclear as to how claim 1 “a sudden pressure increase which occurs in the abdomen of the patient is instantly conveyed to the inflatable occlusion means” is even structurally, functionally and fluidically possible in light of claim 1 in lines 19-23 “wherein the semipermeable check valve always allows fluid flow coming from the second tube to pass towards the stretchable fluid reservoir and wherein the semipermeable check valve only allows a restricted fluid flow from the stretchable fluid reservoir towards the second tube” and claim 1 lines 25-27 recitation “wherein the pressure sensitive check valve always allows fluid flow from the pressure compensation balloon towards the lumen” i.e. as recited the semipermeable check valve always allows fluid flow coming from second tube to pass towards fluid reservoir but it only allows restricted fluid flow from the reservoir to second tube and thus, during a pressure spike fluid is flowing from pressure compensation balloon
into lumen, a substantial part of it will flow directly into the reservoir and not into the occlusion means. Further, the pressure sensitive check valve is recited as the only access from lumen into pressure compensation balloon and it is blocked in the flow direction into the balloon. Thus, as recited it is unclear as to how claim 1 “a sudden pressure increase which occurs in the abdomen of the patient is instantly conveyed to the inflatable occlusion means” is even structurally, functionally and fluidically possible in light of recitations in claim 1 in lines 19-23 and claim 1 lines 25-27. Examiner suggests further including the limitation – and wherein the pressure sensitive check valve blocks fluid flow towards the pressure compensation balloon only while the fluid pressure in pressure compensation balloon is substantially less than the fluid pressure in the lumen of the balloon holder--.
Dependent claims 2-12 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-12 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation – 35 U.S.C 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. More specifically, the following terms are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
Claims that invoke 35 U.S.C 112 (f)
Means term
Specification Support in instant application specification as-filed dated 01/08/2024
1, 4, 8, 10, 12
“inflatable occlusion means”
At least fig. 1 “20”
1, 10
“pump means”
At least fig. 1 “7”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed para. 0039], [0043], [0059].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Contingently Allowable Subject-Matter
As per independent claim 1, independent claims 1 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-12, dependent claims 2-12 would be contingently allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and by further including all of the limitations of the base claims and any intervening claims in addition to overcoming any other rejections/objections enumerated above.
As per dependent claims 2-12, dependent claims 2-12 each is being 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 in addition to overcoming any other rejections/objections enumerated above.
The following is a statement of reasons for the indication of allowable subject matter:
As per independent Claim 1, the prior art of record fails to disclose or render obvious an artificial sphincter containing… a pressurizing fluid… comprising … a pump means having a first port in fluid communication with the inflatable occlusion means via a first tube and a second port in fluid communication with the stretchable fluid reservoir via a second tube for selectively transferring pressurizing fluid from the inflatable occlusion means to the reservoir to deflate the inflatable occlusion means … a balloon holder having a lumen, wherein the lumen establishes fluid communication in between the stretchable fluid reservoir and the second tube, a pressure compensation balloon, wherein the pressure compensation balloon is in fluid communication with the lumen of the balloon holder and, when in use, is to be implanted in an abdomen of a patient, a semipermeable check valve, wherein the semipermeable check valve is located in the lumen of the balloon holder, wherein the semipermeable check valve always allows fluid flow coming from the second tube to pass towards the stretchable fluid reservoir and wherein the semipermeable check valve only allows a restricted fluid flow from the stretchable fluid reservoir towards the second tube, and a pressure sensitive check valve in between the pressure compensation balloon and the lumen of the balloon holder, wherein the pressure sensitive check valve always allows fluid flow from the pressure compensation balloon towards the lumen so that the fluid contained in the pressure compensation balloon is freely flowable towards the inflatable occlusion means and, when in use, a sudden pressure increase which occurs in the abdomen of the patient is instantly conveyed to the inflatable occlusion means including all the other features, structures, specific arrangement and combination of features and structures in independent Claim 1.
Prior art US 20190374324 A1 to Luleci et al. discloses artificial sphincter including an inflatable occlusion means for occluding a body passage, a stretchable fluid reservoir and a pump means. The pump means has a first port in fluid communication with the occlusion means and a second port in fluid communication with the fluid reservoir for selectively transferring an isotonic fluid from the occlusion means to said reservoir to deflate said occlusion means. The artificial sphincter further includes a pressure compensation balloon which is attached to the fluid reservoir and which, in use, is to be implanted in the abdomen of a patient
Prior art US 20130274546 A1 to Anderson et al. discloses implantable method for occluding the urethra or bladder neck utilizing an occlusive cuff connected to a control mechanism via a conduit tube. The occlusive cuff is reversibly changed from an activated/occlusive condition to a de-activated/non-occlusive condition by depressing a deactivation button contained within a resilient, elastomeric sheath surrounding the control mechanism. The occlusive condition is once again obtained by depressing an activation button also situated within the resilient sheath. In the occlusive condition, a preset tension is applied to a flexible diaphragm through a tensioning suture by a constant force spring contained within the control mechanism. This tension is translated into an occlusive pressure applied to the urethra or bladder neck sufficient to prevent urinary leakage.
Prior art US 20130303841 A1 to Fogarty discloses a fluid control system for implantable artificial inflatable urinary and anal sphincter prostheses. More specifically, fluid transfer system for an inflatable sphincter prosthesis. The implantable inflatable sphincter prosthesis may include a fluid transfer system and at least one inflatable cuff for occluding a body channel. The fluid transfer system may include an inflate pump, a deflate pump, and three one-way valves.
Prior art US 4222377 A to Burton discloses pressure-regulated artificial sphincter apparatus for controlling vesicular incontinence. The apparatus comprises a generally toroidal cuff member for constricting a vessel to be opened and closed in response to fluid pressure, a squeezable fluid supply pump bulb in communication with the cuff, and a fluid pressure regulator for maintaining substantially constant fluid pressure within the cuff. The pressure regulator preferably comprises a variable volume, distensible balloon which is in fluid flow communication with the cuff. Check valve means are provided to maintain correct fluid flow throughout the apparatus. One form of this invention includes a low pressure fluid reservoir interconnected with the fluid supply bulb. Another form of this invention includes pump means for deflating the cuff by manually transferring fluid therefrom into the balloon and a restricted flow passageway extending between the balloon and the cuff to reinflate the cuff after a predetermined time to automatically occlude the affected vessel. A fluid transfer bulb described and claimed herein for use with artificial sphincter systems includes an interiorly-located, restricted flow passageway for automatic actuation of a fluid pressure responsive element.
Prior art US 4386601 A to Trick discloses artificial sphincter for reversibly closing a body passage. More specifically, artificial sphincter comprises an inflatable occlusion means which is normally inflated with hydraulic fluid under pressure to cut off flow through a body passage, an improved accumulator balloon having a relatively inelastic shell which serves as a reservoir for hydraulic fluid for the inflatable occlusion means and a gas filled bladder which controls fluid pressure in the closed system, a pump to suck fluid from the occlusion means to deflate it and open the body passage to fluid flow and tubing connecting the inflatable occlusion means, the accumulator balloon and the pump to form a closed system. The sphincter also includes a first check valve at the inflatable occlusion means which allows fluid to freely flow out of the inflatable occlusion means, a second check valve at the accumulator balloon which allows fluid to freely flow into the accumulator balloon and resistance means which restricts fluid flow into the inflatable occlusion means and out of the accumulator balloon to a low rate of flow.
However, patentable subject-matter as now explicitly, positively and specifically recited by the Applicants in independent device claim 1 has neither been disclosed nor is rendered obvious by the prior art of record.
Additionally, as per dependent claims 2-12 would be contingently allowable based on their direct/indirect dependency on contingently allowable respective base claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 4682583 A to Burton et al. discloses a means for occluding the fluid flow between the fluid reservoir and the inflatable cuff in an refilling inflatable artificial sphincter similar to that disclosed. More specifically, artificial sphincter including a means for occluding a body passage, a fluid reservoir, and a mechanism for transferring fluid between the occluding mechanism and the fluid reservoir, wherein the sphincter also includes a lock-out mechanism for occluding fluid flow between the fluid reservoir and the inflatable cuff and the occluding mechanism. The occluding mechanism is preferably a valve which is positioned in the fluid path between the reservoir and the occluding mechanism. The valve may be either manually or hydraulically actuated to control one or more aspects of fluid flow through the valve.
Prior art US 6095969 A to Karram et al. discloses apparatus to constrict the user's urethra in response to an increase in abdominal pressure similar to that disclosed. More specifically, apparatus for controlling stress incontinence in patients employs a flexible diaphragm element positioned in the patient's abdominal space to compress in response to increases in intraabdominal pressure. Upon such compression of the diaphragm, pressurized fluid flows therefrom via a flexible tubing, optionally via a flow control element, to an inflatable urethra-constricting element in fluid communication therewith and positioned over the patient's urethra close to her bladder neck. Thus, when the patient experiences an increase in intraabdominal pressure, e.g., when she coughs, fluid from the diaphragm flows rapidly to the urethra-constricting element which presses against and forcibly constricts the urethra adjacent thereto. Upon abatement of the intraabdominal pressure, the flow control element releases fluid from the urethra-constricting element which then ceases to press on the urethra.
Prior art US 20030024571 A1 to Simmons et al. discloses a ball-type check valve that incorporates annular valve seats similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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