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.
Status of Claims
This office action is responsive to the amendment filed 14 April 2026. As directed by the amendment claims 1, 7-8 and 10-14 have been amended, claims 17-20 have been added, and claims 6 and 9 have been cancelled. Thus, claims 1-5, 7-8 and 10-20 are presently pending in this application.
Claim Objections
Claims 1, 11 and 20 are objected to because of the following informalities:
In claim 1, lines 9-10 “until a determined volume is attained” should be amended to recite --until a predetermined volume is attained--. The phrase “determined volume” may be unclear because the claim does not specify how the volume is determined, by whom or according to what parameter.
In claim 20, lines 8-9 “until a determined volume is attained” should be amended to recite --until a predetermined volume is attained--. The phrase “determined volume” may be unclear because the claim does not specify how the volume is determined, by whom or according to what parameter.
Appropriate correction is required.
Claim 11 is objected to for reciting a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim). This limitation 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 11 recites the broad recitation “the bellows comprises between 3 and 15 elastically deformable convolutions”, and the claim also recites “preferably between 5 and 10 elastically deformable convolutions” which is the narrower statement of the range/limitation. The claim should be amended to only define one range.
Appropriate correction if required.
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 1-5, 7-8 and 10-20 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 claims 1 and 19, the limitation "wherein each convolution has the shape of a ‘greater than’ sign" renders the claim indefinite. When read in light of specification the plurality convolutions of the bellows correspond to the folds of an accordion bellow. The limitation renders the claim indefinite because accordion shaped bellows are formed of convolutions that alternate between “greater than” and “less than” signs.
Regarding claim 19, the limitation “deformed by flattening, thereby increasing the volume of the reservoir so as to compensate the variation in pressure in the fluid circuit, an angle formed between two branches of the "greater than" sign of each convolution in an event of overpressure in the fluid circuit being less than an angle formed between two branches of the "greater than" sign of each convolution when the second part is in a rest configuration” renders the claim indefinite because the phrase “deformed by flattening ” does not identify the direction or structural manner of flattening. Additionally, due to punctuation placement it is unclear if the claim intends for the deformed by flattening to be defined by the limitation following “an angle formed between two branches…” or if the limitation following “an angle formed between two branches…” is an independent limitation.
Regarding claim 20, the limitation “deformed by flattening, thereby increasing the volume of the reservoir so as to compensate the variation in pressure in the fluid circuit, two portions of a given convolution being adapted to come closer together” renders the claim indefinite because the phrase “deformed by flattening ” does not identify the direction or structural manner of flattening. Additionally, due to punctuation placement it is unclear if the claim intends for the deformed by flattening to be defined by the limitation following “two portions of a given convolution…” or if the limitation following “two portions of a given convolution…” is an independent limitation.
Regarding claim 20, the limitation “two portions of a given convolution being adapted to come closer together so as to reduce a volume of the convolution” renders the claim indefinite because the claim does not clearly define structural arrangement the convolutions, the two portions of the convolution, or the volume of the convolution for one of ordinary skill in the art to reasonable understand how the two portions are to come closer together to reduce the volume of the convolution.
Claims 2-5, 7-8 and 10-18 are rejected due to their dependency on a rejected claim. Due to the indefinite nature of claims 19 and 20 outlined above, prior art could not be applied. A lack of prior art rejection should not be taken as an indication of allowable subject matter.
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 1-5 and 7-8, 10-18 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]), wherein the second part comprises a movable wall (see figure 2, #6) and deformable bellows (see figure 2, #9) extending between the movable wall and the first part (see figure 2), wherein the bellows comprises a plurality of convolutions, wherein each convolution has the shape of a “greater than” sign when the second part is in a rest configuration (see figure 2). 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 convolutions of the bellows of the second part being elastically deformable, such that, when the second part is stationary relative to the first part, the convolutions are 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 convolutions 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.
The combination of Lamraoui, as modified by Wirbisky, teaches the bellows comprising a plurality of elastically deformable convolutions, wherein each convolution has the shape of a “greater than” sign 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 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 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 10: Lamraoui, as modified by Wirbisky, teaches 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 claims 13 and 17: 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 or 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 or 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]).
Referring to claim 18: 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 the stiffness constant being specifically between 1 and 4 N/mm. There is no evidence of record that establishes that changing the stiffness constant 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 stiffness constant since the bellows are constructed of the same material 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 stiffness constant of the bellows of Lamraoui, as modified by Wirbisky, to having a stiffness constant between 1 and 4 N/mm since such a modification would allow the bellows to function as intended.
Response to Arguments
Applicant's arguments filed 14 April 2026 have been fully considered but they are not persuasive. In response to applicant’s arguments presented on pages 10-12 with regards to claim 1, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Lamraoui explicitly teaches bellows formed of a plurality of convolutions in the form of “greater than” sign as outlined above in the current rejection. Additionally, as previously presented, 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]). None of the drawings of Lamraoui are being relied upon to teach elasticity of the convolutions. Wirbisky is being relied upon solely to show that it is obvious in the art modify the convolutions of Lamraoui to being flexible like taught by Wirbisky.
In response to applicant’s arguments presented on pages 12-13 with regards to claims 13-14, the examiner respectfully disagrees. Lamraoui explicitly teaches bellows constructed of the same material and having the same relative stiffness (k) as the claimed bellows of claim 14 therefore one of ordinary skill in the art would have understood that the device would have functioned as intended given the claimed thickness.
Applicant’s arguments with respect to new claim(s) 19-20 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.
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).
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 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
