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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation of “the bulb” should read “the compression bulb” to keep with consistent terminology throughout the claim. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: the recitations of “the reservoir” should read “the stretchable fluid reservoir” to keep with consistent terminology through the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 states “implanted in an abdomen of a patient”. The way the claim is structured it appears that the patient an abdomen are positively recited. It is suggested that the claims used configured to be implanted” to avoid the 101 issue.
Claim Interpretation
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.
In claim 1, the “inflatable occlusion means” is being interpreted under 112(f) as it invokes 112(f). However, there is no structure in the specification. See 112(b) below.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “pump means” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-12 are 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.
Regarding the claims with the claim limitation “inflatable occlusion means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Here, there is no hardware in the specification associated with the means for limitation. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claims 4 and 6-7, the claims use the terminology “semi-permeable” when referring to a valve. However, “semi-permeable” is not a term of the art when referring to valves. It is unclear if this term is referring to the ball being permeable or the valve allows for fluid through it in a particular direction. For examination purposes, the examiner takes this valve to be a valve that perform the same actions as claimed. Dependents 5 and 8-11 are similarly rejected due to their dependency.
Regarding claim 7, the claim states that the ball is cratered and that the craters allow for fluid flow through the crater. However, a crater is not seen as a hole or porous. The specification supports that there can be gaps between the craters and other elements of the ball. Therefore, the claim is seen as indefinite. It is suggested to amend claim 7 to use the terminology and explanation in the specification.
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)(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.
Claim(s) 1-6, 8-9, and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luleci, US 20190374324, herein referred to as “Luleci”.
Regarding claim 1, Luleci teaches: An artificial sphincter containing, when in use, a pressurizing fluid (Fig. 1), the artificial sphincter (Fig. 1, element 1) comprising: an inflatable occlusion means for occluding a body passage (Fig. 1, element 20; occlusion means), a stretchable fluid reservoir (Fig. 1; reservoir, element 23), a pump means (Fig. 1; element 7, the pump) having a first port (Fig. 1, element 13) in fluid communication with the inflatable occlusion means via a first tube (Fig. 1, elements 13, 9 which are a port and tube that connects to element 20) and a second port in fluid communication with the stretchable fluid reservoir via a second tube (Fig. 1; element 14 (second port) which is connected via tube 8 to elements 24 and 23) for selectively transferring the pressurizing fluid from the inflatable occlusion means to the reservoir to deflate the inflatable occlusion means so that a blocked body passage may be opened ([0051]); a compressible bulb which is attached to the pump means and which, when in use, contains part of the pressurizing fluid (Fig. 1; element 6, the pump bulb), a balloon holder having a lumen which establishes fluid communication in between the stretchable fluid reservoir and the second tube (Fig. 1; element 11), a pressure compensation balloon which is in fluid communication with the lumen of the balloon holder and which, when in use, is to be implanted in an abdomen of a patient (Fig. 1; element 11 which connects element 24 (the balloon) with element 23 the reservoir), wherein the pump means comprises; a lumen, whose first end has a ball seating and a ball accommodated on the seating and whose second end is open to the bulb, a blockage seat which is located in the entry of the first port and which is sized and shaped to block fluid flow towards the first port when the ball is forced to lean on the blockage seat by the pressurized fluid coming from the bulb, a chamber in which the ball is movable, the chamber being located in between blockage seat and the ball seating, one or more resilient lips located circumferentially above the ball in the chamber, wherein the annular cavity formed by the distal ends of the one or more resilient lips has a diameter which is less than the diameter of the ball so that the ball can be guided towards the blockage seat by the one or more resilient lips when the bulb is squeezed (Fig. 2A-2B and element 10 which shows the lips for guiding the ball).
Regarding claim 2, Luleci teaches: wherein a primary axis of the annular cavity formed by the distal ends of the one or more the resilient lips and the primary axis of the blockage seat coincide with each other so that the ball can be guided by the resilient annular lips for tightly blocking the blockage seat (Fig. 2A-B).
Regarding claim 3, Luleci teaches: wherein the ball seating has a spring supporting the ball towards the one or more resilient lips (Fig. 2A-B; spring 4).
Regarding claim 4, Luleci teaches: wherein the artificial sphincter further comprises a semipermeable check valve which 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 ([0066] and Fig. 3 and Fig. 6A-B).
Regarding claim 5, Luleci teaches: wherein the artificial sphincter further comprises 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 a patient is instantly conveyed to the inflatable occlusion means ([0066]-[0067] and Fig. 3 and Fig. 4A-B).
Regarding claim 6, Luleci teaches: wherein the semipermeable check valve has a recessed seating having one or more recesses so that a restricted fluid flow from the stretchable fluid reservoir towards the second tube is established through the recesses (Fig. 6B and element 10 where the recessed seat for the ball in the check valve.)
Regarding claim 8, Luleci teaches: wherein the pressure sensitive check valve has a ball located inside a nest, the ball allowing fluid flow from the lumen towards the pressure compensation balloon only during inflation of the occlusion means (Fig. 6A-B specifically the two valves with balls).
Regarding claim 9, Luleci teaches: wherein the pressure sensitive check valve has a pervious seat which is located in between the ball and the lumen and which ensures that the ball always allows, due to its spherical geometry, passage of fluid flow from the pressure compensation balloon towards the lumen (Fig. 6A-B).
Regarding claim 11, Luleci teaches: wherein the reservoir is made of a resilient material which may expand by way of stretching such that, in the stretched state, the pressurizing fluid contained in the reservoir has a pressure more than the abdominal pressure of the patient due to stretching of the resilient material ([0061]; specifically the elasticity of the reservoir and [0066]).
Regarding claim 12, Luleci teaches: wherein the occlusion means is sized and shaped to occlude an anal or urethral canal of a human being (claim 12).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luleci in view of McCLOSKEY et al., US 20130233397, herein referred to as “McCloskey”.
Regarding claim 7, Luleci discloses: wherein the semipermeable check valve has an annular seating (Fig. 2 which shows element 10 which is seen as annular seating where all the ball valves are show having element 10). Luleci does disclose that the ball allows for fluid flow between the stretchable fluid reservoir and the second tube as seen in Figs. 6A-B. Luleci does not explicitly disclose that the ball which allows this is a cratered ball a plurality of craters so that a restricted fluid flow from the stretchable fluid reservoir towards the second tube is established through the craters.
However, McCloskey does disclose: a cratered ball having a plurality of craters so that a restricted fluid flow is established through the craters ([0041]; specifically the weeping or porous ball in the ball valve which allows fluid to flow).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the valve of Luleci with the porous ball in the ball valve of McCloskey. The motivation being to allow for control of pressure gradients as seen in McCloskey ([0041]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luleci in view of Fogarty, US 8801594, herein referred to as “Fogarty”.
Regarding claim 10, Luleci does not explicitly disclose: wherein the ball has a density which is substantially equal to the density of the pressurizing fluid so that the ball freely floats freely in a nest. However, Fogarty does disclose: wherein the ball has a density which is substantially equal to the density of the pressurizing fluid so that the ball freely floats freely in a nest (column 8, lines 1-38; specifically the ball or poppet having the same density of the fluid.)
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the valve of Luleci with the density equality of Fogarty. The motivation being to allow for an unbiased valve (Fogarty, Column 8, lines 10-38).
Double Patenting
The present application is co-pending with application 18577445. However, the claims at the moment are seen as distinguishable over the double patenting 101. However, this could change in the future.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOANNE M RODDEN whose telephone number is (303)297-4276. The examiner can normally be reached Monday - Friday 9:00 AM-5:00 PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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