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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The amendment filed 05/05/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/FR2021/052249 and of the foreign patent application FR2013004 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 12/09/2021, see MPEP 1893.03(b). Therefore, the specification amendment of 05/05/2023 to include the incorporation by reference is new matter, per MPEP 608.01(p). Applicant is advised to remove the phrase “, both of which are hereby incorporated by reference herein in their entireties”
Applicant is required to cancel the new matter in the reply to this Office Action.
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 13 and 14 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “a thickness between 0.01 mm and 0.3 mm”, and the claim also recites “preferably between 0.03 mm and 0.015 mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “a stiffness constant between 0.2 and 15 N/mm”, and the claim also recites “preferably between 1 and 4 N/mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Lamraoui (US 2017/0325926 A1; cited by applicant on IDS dated 10/18/2023) in view of Wirbisky et al. (US 2012/0157759 A1) (Wirbisky).
Referring to claim 1: Lamraoui teaches a system (see figure 1) that is implantable in a human or animal body (see abstract), comprising: a fluid circuit comprising: an inflatable element (see figure 1, #3) containing a variable volume of a fluid (see paragraphs [0081]-[0082]); a variable-volume fluid reservoir (see figure 2, #5; paragraphs [0081]-[0082]), said reservoir comprising a stationary first part (see figure 2, #1; paragraphs [0086] and [0094]) and a second part (see figure 2, #6/9) movable relative to the first part (paragraphs [0094], [0099] and [0105]); a fluidic connection (see figure 1, #2) between the reservoir and the inflatable element; and an actuator (see figure 2, #8; paragraph [0110]), mechanically coupled to the second part in order to selectively move the second part relative to the first part so as to vary a volume of the reservoir until a determined volume is attained (see abstract; paragraphs [0111] and [0131]). Lamraoui further teaches a stress-reducing member designed for absorbing a portion of the pressure in the fluidic circuit so as to reduce the stresses experienced by the actuation device, so as to reduce the stresses down to a level too low for a risk of damaging the actuation device (see paragraphs [0240]-[0242]), a component of the circuit being made of a flexible material having the property of deforming from a certain pressure threshold (see paragraph [0247]), the reservoir with variable volume being designed so as to be deformable beyond a certain pressure threshold or depending on the applied pressure (see paragraph [0249]). Lamraoui does not explicitly teach the second part (#9) being elastically deformable, such that, when the second part is stationary relative to the first part, the second part is adapted for being mechanically deformed at least in response to a variation in pressure in the fluid circuit, so as to adjust the volume of the reservoir relative to the determined volume in order to compensate, at least in part, said variation in pressure in the fluid circuit.
Wirbisky teaches a system (see figure 2) that is implantable in a human or animal body, comprising: a fluid circuit comprising: an inflatable element (see figure 2, #30) containing a variable volume of a fluid; and a movable inflation/deflation element (see figures 6A-6B, #41) that is elastically deformable, such that, the inflation/deflation element is adapted for being mechanically deformed at least in response to a variation in pressure in a fluid circuit of the system, so as to adjust the volume of fluid relative to the determined volume in order to compensate, at least in part, said variation in pressure in the fluid circuit (see figures 6A-6B; paragraphs [0028]-[0029]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the movable, bellow second part of Lamraoui to being flexible like taught by Wirbisky in order to absorb minor fluctuations of the pressure in the fluidic circuit so as to reduce the stresses experienced by the actuation device, thereby reducing the stresses down to a level too low for a risk of damaging the actuation device.
Referring to claim 2: Lamraoui, as modified by Wirbisky, teaches when the second part is stationary relative to the first part, the second part is in a rest configuration when the pressure in the fluid circuit is less than or equal to a limit pressure, the volume of the reservoir corresponding to the determined volume, and the second part is in a deformed configuration when the pressure in the fluid circuit is greater than the limit pressure, the deformation of the second part causing an increase in the volume of the reservoir adapted for re-establishing the limit pressure in the fluid circuit (see Lamraoui paragraphs [0240]-[0242], [0247] and [0249]; Wirbisky figures 6A-6B, paragraphs [0028]-[0029]).
Referring to claim 3: Lamraoui further teaches a means for measuring pressure in the fluid circuit (see paragraphs [0114] and [0135]) and a control unit, the control unit being adapted, when the pressure measured in the fluid circuit does not correspond to a setpoint pressure, to control an actuation of the actuator adapted for moving the second part so as to modify the volume of the reservoir in order to compensate the variation in pressure in the fluid circuit (see paragraphs [0078], [0110], and [0222]-[0227]; claim 2).
Referring to claim 4: Lamraoui further teaches the inflatable element is an inflatable occlusive cuff (see figure 1; paragraph [0075]).
Referring to claim 5: Lamraoui further teaches the inflatable occlusive cuff is adapted for being arranged around an anatomical conduit in order to selectively close said anatomical conduit (see paragraphs [0058] and [0075]).
Referring to claim 6: Lamraoui, as modified by Wirbisky, further teaches the second part comprises a movable wall (see Lamraoui figure 2, #6) and an elastically deformable bellows (see Lamraoui figure 2, #9) extending between the movable wall and the first part (see Lamraoui figure 2).
Referring to claim 7: Lamraoui further teaches the actuator is adapted for controlling a linear movement of the movable wall of the second part, the bellows of the second part being adapted for extending or compressing according to said linear movement of the movable wall controlled by the actuator so as to vary a volume of the reservoir (see paragraphs [0105]-[0106], [0111] and [0131]-[0132]).
Referring to claim 8: Lamraoui further teaches the first part forms an outer wall of the reservoir extending substantially coaxially with a longitudinal axis, wherein the bellows of the second part forms an inner wall of the reservoir extending substantially coaxially with the longitudinal axis, and wherein the actuator is adapted for moving the movable wall in translation along the longitudinal axis (see figure 2; paragraphs [0105]-[0106], [0111] and [0131]-[0132]).
Referring to claim 9: Lamraoui, as modified by Wirbisky, teaches the bellows comprises a plurality of elastically deformable convolutions, and wherein, when the second part is stationary relative the first part, the convolutions are adapted for mechanically deforming so as to compensate the variation in pressure in the fluid circuit (see Lamraoui figure 2; paragraphs [0240]-[0242], [0247] and [0249]; Wirbisky figures 6A-6B, paragraphs [0028]-[0029]).
Referring to claim 10: Lamraoui, as modified by Wirbisky, teaches the bellows comprises a plurality of elastically deformable convolutions, wherein, when the second part is stationary relative the first part, the convolutions are adapted for mechanically deforming so as to compensate the variation in pressure in the fluid circuit (see Lamraoui figure 2; paragraphs [0240]-[0242], [0247] and [0249]; Wirbisky figures 6A-6B, paragraphs [0028]-[0029]) and wherein the convolutions are adapted for deforming in a direction of the longitudinal axis and/or in a radial direction with respect to the longitudinal axis (see Lamraoui figure 2; paragraphs [0105]-[0106], [0111] and [0131]-[0132]).
Referring to claim 11: Lamraoui, as modified by Wirbisky, further teaches the bellows comprises between 3 and 15 elastically deformable convolutions (see Lamraoui figure 2).
Referring to claim 12: Lamraoui further teaches the bellows are made of titanium (see paragraph [0094]).
Referring to claim 13: Lamraoui, as modified by Wirbisky, teaches flexible bellows constructed of titanium and having a stiffness constant of 5 N/mm (see Lamraoui paragraphs [0094], [0154] and [0179]), but is silent to the bellows specifically having a thickness between 0.01 mm and 0.3 mm, preferably between 0.03 mm and 0.15 mm. There is no evidence of record that establishes that changing the thickness of the bellows would result in a difference of function of the Lamraoui, as modified by Wirbisky, device. Further, a person having ordinary skill in the art, being faced with modifying the bellows of Lamraoui, as modified by Wirbisky, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness since the bellows are constructed of the same material and having the same stiffness as the claimed bellows. Therefore, it would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the bellows of Lamraoui, as modified by Wirbisky, to having a thickness between 0.01 mm and 0.3 mm, preferably between 0.03 mm and 0.15 mm, since such a modification would allow the bellows to function as intended.
Referring to claim 14: Lamraoui further teaches the bellows has a stiffness constant between 0.2 and 15 N/mm (see paragraphs [0154] and [0179]).
Referring to claim 15: Lamraoui further teaches the device is configured to be implanted in a human or animal body in order to selectively close an anatomical conduit of said human or animal body, taken from at least one of the following conduits: a urethra, a gastric conduit, a colon or a rectum (see paragraphs [0004], [0058] and [0075]).
Referring to claim 16: Lamraoui, as modified by Wirbisky, teaches the implantable system according to claim 1. Lamraoui, as modified by Wirbisky, is silent to a remote control adapted for being used by an individual in whom the system is implanted, wherein the implantable system and the remote control comprise communication means adapted for communicating between them, wherein the remote-control is adapted for controlling a movement of the second part by the actuator. However, Wirbisky further teaches a remote actuation device to facilitate remote triggering of the actuator to control selective inflating or deflating of the cuff (see paragraphs [0023], [0030], and [0033]-[0035]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Lamraoui, as modified by Wirbisky, with remote control of the actuator like taught by Wirbisky in order to the user control of the cuff for voiding (see Wirbisky paragraphs [0023], [0030], and [0033]-[0035]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jassawalla (US Patent No. 4,581,018); Sultan (US Patent No. 6,135,945); and Forsell (US Patent No. 6,482,145).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE R WILSON whose telephone number is (571)270-7517. The examiner can normally be reached Monday thru Friday 8 AM-5:00 PM ET.
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/KAYLEE R WILSON/ Primary Examiner, Art Unit 3700