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 lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2, 3, 11, 17, 22, 26-28, 30, 32, 33, 35, and 38 are objected to because of the following informalities:
In claim 2, line 7: “comprise” should apparently read --comprises--.
In claim 3, line 8: “plurality spaced” should apparently read --plurality of spaced--.
In claim 11, lines 2-3: “without longitudinal seam” should apparently read --without a longitudinal seam--.
In claim 11, line 7: “fibres” should apparently read --fibers--.
In claim 17, line 2: “of” should apparently be deleted (to merely read “solid elastomeric material”).
In claim 22, line 5: “integrated storage” should apparently read --integrated fluid storage--.
In claim 26, line 2: there should not be a space between “element” and the subsequent comma.
In claim 26, line 4: “hardness” should apparently read --hardnesses--.
In claim 27: each instance of “moulding” should apparently read --molding--.
In claim 27, line 6: there should not be a space between “end” and the subsequent semi-colon.
In claim 27, line 11: “nerve cutting” should apparently read --nerve by cutting--.
In claim 27, line 14: “together;” should apparently read --together; and--.
In claim 27, line 15: “provide the integrated storage” should apparently read --providing the integrated fluid storage--.
In claim 28, line 2: “moulding” should apparently read --molding--.
In claim 28, line 2: there should not be a space between “connector” and the subsequent comma.
In claim 28, line 7: “integrated storage” should apparently read --integrated fluid storage--.
In claim 30, line 2: there should not be a space between “element” and the subsequent comma.
In claim 30, line 3: “integrated storage” should apparently read --integrated fluid storage--.
In claim 30, line 3: “00)” should apparently be deleted.
In claim 30, line 3: “moulded” should apparently read --molded--.
In claim 30, line 9: there should not be a space between “connector” and the subsequent comma.
In claim 32: each instance of “moulding” should apparently read --molding--.
In claim 32, line 12: “in length” should apparently read --in a length--.
In claim 32, line 15: “integrated storage” should apparently read --integrated fluid storage--.
In claim 33, line 3: “, and” should be deleted following “longer length.”
In claim 35: each instance of “moulding” should apparently read --molding--.
In claim 38, line 3: “integrated storage” should apparently read --integrated fluid storage--.
In claim 38, line 3: “moulded” should apparently read --molded--.
Appropriate correction is 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 1-3, 9, 11, 14, 15, 17, 19, 21, 22, 25-28, 30, 32, 33, 35, and 38 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.
Claim 1 recites the limitations "the cavernous body" in line 1, “the type” in line 2, “the use” in line 4, “the axial direction” in line 10, and “the scrotal sacs” in line 13. There is insufficient antecedent basis for these limitations in the claim.
Claim 1 also recites the limitation “its production procedure” in line 2. This is indefinite for several reasons. First, it is not clear what “its” refers to; it is taken herein to refer to the prosthetic device. Second, this appears to attempt to claim both an apparatus and method steps in a single claim, which renders the claim indefinite. See MPEP 2173.05(p).
Claim 1 also recites the limitation “it” in line 3. It is not clear what this refers to; e.g., does it refer to the device or the cylinders or something else?
Claim 1 also recites the limitation “a wide range of patients” in lines 3-4. The term “wide” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range that would meet the claim are not clear.
Claim 1 also recites the limitation “a low volume” in line 4 and again in line 6. The term “low” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range that would meet the claim are not clear.
Claim 1 also recites the limitation “fluid” in line 5. It is not clear if this is intended to refer to the same fluid as recited in line 3 or to separate fluid.
Claim 1 also recites the limitation “it” in line 5. It is not clear what this refers to; e.g., does it refer to the device or the cylinders or something else?
Claim 1 also recites the limitation “[a low volume of] fluid” in line 6. It is not clear if this is intended to refer to the same fluid as recited in line 3, the low volume of fluid recited in lines 4-5, or to separate fluid.
Claim 1 also recites the limitation “an axially extensible and foldable longitudinal nerve” in line 7. Where Applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “nerve” in claim 1 is used by the claim to mean “a cylindrical structure” or something similar, while the accepted meaning is “a bundle or group of fibers in the body that chemically or electrically sends and receives signals between the body and the brain.” The term is indefinite because the specification does not clearly redefine the term.
Claim 1 also recites the limitation “the fluid” in line 11. It is not clear if this is intended to refer to the same fluid as recited in line 3, the low volume of fluid recited in lines 4-5 or in line 6, or to separate fluid.
Claim 2 recites the limitation "said optimized means of continuous lateral supply" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim; claim 1 previously recites “optimized means for continuous lateral supply.”
Claim 2 also recites the limitation "the proximal portion" in line 3. There is insufficient antecedent basis for this limitation in the claim; claim 1 previously recites a “proximal section.”
Claim 2 also recites the limitation “having said” in line 5. It is not clear what is meant by this limitation.
Claim 2 also recites the limitation “an axial axis” in lines 5-6. It is not clear if this is meant to be the same as the previously recited “axial direction” or to be separate.
Claim 3 recites the limitation “a longitudinal robust body” in line 2. It is not clear what characteristics the body must have to be considered “robust.”
Claim 3 also recites the limitation “a reduction in its mass” in line 4. It is not clear what is meant by this; does this portion somehow weigh less at some times relative to other times?
Claim 3 also recites the limitation “said distal section has different preset lengths” in line 6. It is not clear how this is possible in a single device.
Claim 3 also recites the limitations "the rest" in line 8 and “the portion” in line 10. There is insufficient antecedent basis for these limitations in the claim.
Claim 3 also recites the limitation “which in turn” in line 8. It is not clear what this refers to; e.g., is it the intermediate section, the axial core, or the rest of the nerve?
Claim 3 also recites the limitation “its” in line 10. It is not clear what this refers to; e.g., does it refer to the intermediate section or the microperforated structure or the portion?
Claim 3 also recites the limitation “its” in line 12. It is not clear what this refers to; e.g., does it refer to the intermediate section or the surface or the successive radial depressions or the accordion shaped portion?
Claim 9 recites the limitation “the intermediate portion has different present lengths” in line 2. It is not clear how this is possible in a single device.
Claim 11 recites the limitation “allows high pressure and rigidity” in line 3. It is not clear how the silicone allows rigidity. Further, the term “high” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range that would meet the claim are not clear.
Claim 11 also recites the limitation “its” in line 4. It is not clear what this refers to; e.g., does it refer to the membrane or the fabric or the silicone?
Claim 11 also recites the limitation “sealing and impermeability conditions” in line 4. It is not clear what is meant by these conditions; e.g., what conditions cause permeability vs. impermeability?
Claim 11 also recites the limitations "the tubular tissue" in line 6, “the longitudinal” in lines 6-7, and “the concentric fibres” in line 7. There is insufficient antecedent basis for these limitations in the claim.
Claim 11 also recites the limitation “a normally corrugated state” in line 7. It is not clear what is meant by “normally” in this context.
Claim 11 also recites the limitation “both directions” in line 8 and again in line 9. It is not clear what directions are meant by this.
Claim 14 recites the limitation “its proximal end” in line 2. It is not clear what “its” refers to; e.g., the proximal end of the membrane or of the intermediate connector?
Claim 14 also recites the limitation “its distal end” in line 3. It is not clear what “its” refers to; e.g., the distal end of the membrane or of the tip element?
Claim 15 recites the limitations "the outer surface" in lines 2-3, “the inner surface” in line 3, and “the lateral openings” in line 6. There is insufficient antecedent basis for these limitations in the claim.
Claim 15 also recites the limitation “it” in line 3. It is not clear what this refers to; e.g., does it refer to the device or the chamber or the cylindrical space?
Claim 15 also recites the limitation “limits with” in line 4 (two instances). It is not clear what is meant by this limitation in this context; e.g., what is limiting or being limited and how?
Claim 15 also recites the limitation “its” in line 5. It is not clear what this refers to.
Claim 15 also recites the limitation “proximal area” in line 5. It is not clear if this is meant to be the same as the previously recited proximal zone or to be separate areas.
Claim 17 recites the limitation "the central opening" in line 4. There is insufficient antecedent basis for this limitation in the claim; this has been taken herein to be the same as the previously recited central axial opening.
Claim 21 recites the limitation “a preferably cylindrical body” in line 2. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the claim requires the anchor rod to be a cylindrical body or if this is merely a preference.
Claim 21 also recites the limitation “it” in line 3 (two instances) and “its” in line 4. It is not clear which component these limitations refer to.
Claim 22 recites the limitation “lateral compression which allows to” in line 3. It is not clear what is meant by this in the context of the claim.
Claim 22 also recites the limitation "the pressurizable chambers" in line 4. There is insufficient antecedent basis for this limitation in the claim; only a single pressurizable chamber has been previously recited.
Claim 22 also recites the limitation "the erectable portions" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim; only a single erectable portion has been previously recited. This limitation also appears in line 7 and line 11, which may need to be amended in kind.
Claim 22 also recites the limitation “a pressure relief valve” in line 6. A pressure relief valve is typically a safety valve that serves to control or limit the build-up of pressure within a system by relieving excess pressure. However, based upon the present specification, this valve appears to be a more typical valve that simply controls fluid communication within the system by being controllably opened and closed. It is not clear which type of valve is meant to be recited here.
Claim 22 also recites the limitation "said integrated unit" in line 8. There is insufficient antecedent basis for this limitation in the claim; this has been taken herein to be the same as the previously recited integrated fluid storage and pressurization unit.
Claim 22 also recites the limitation “the scrotal sac” in line 8. It is not clear which of the multiple previously recited sacs this refers to.
Claim 22 also recites the limitation "the other" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitations "the flexible conduits" in line 2, “the valve” in line 2, “the lower opening” in line 3 and “the intermediate connectors” in line 3. There is insufficient antecedent basis for these limitations in the claim; only a single intermediate connector has been previously recited.
Claim 26 recites the limitation “such as” in line 3. This phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 26 also recites the limitation “each element” in line 4. It is not clear which elements this refers to.
Claim 27 recites the limitation “which allows to obtain” in line 2. It is not clear what is meant by this in the context of the claim.
Claim 27 also recites the limitations "the size" in line 3, “the distal section of excess length” in lines 4-5, “the final length” in line 11, “the joints” in line 14, “the pieces” in line 14, “the final size” in line 16, “the prosthesis” in line 16, and “the intermediate connectors” in line 17. There is insufficient antecedent basis for these limitations in the claim; only a single intermediate connector has been previously recited.
Claim 27 also recites the limitation “it” in line 3. It is not clear this limitation refers to; e.g., the procedure or the device or the implantation or something else?
Claim 27 also recites the limitation “manufacturing the membrane with … an undetermined length” in lines 8-9. It is not clear how the length can be undetermined.
Claim 27 also recites the limitation “moulding the anchor rod of … an undetermined length” in line 10. It is not clear how the length can be undetermined.
Claim 27 also recites the limitation “membrane” in line 12. It is not clear if this is intended to refer to the previously recited membrane or to a separate component.
Claim 27 also recites the limitation “its” in line 16. It is not clear what this refers to.
Claim 28 recites the limitation “its” in line 2, line 3, line 4, and line 6. It is not clear what this refers to in each instance.
Claim 28 also recites the limitations "the distal end" in lines 2-3, “the outer diameter” in line 3, “the proximal end” in line 3, “the cross section” in line 4, “the tubular membrane” in line 4, “the proximal face” in line 5, “the diameter” in line 5, “the lower opening” in lines 5-6, “the upper end” in line 6, and “the flexible conduit” in lines 6-7. There is insufficient antecedent basis for these limitations in the claim.
Claim 30 recites the limitations "the flexible reservoir " in line 3, “the distal end” in line 6, “the distal end” in line 6, “the tubular membrane” in line 6, “the central axial opening” in line 7, “the proximal end” in line 7, “the central cavity” in line 8, “the connector” in line 8 (also recited in line 9, line 10, and lines 11-12, which may need to be amended in kind), “the proximal end” in line 8, “the coaxial annular groove” in line 9, “the distal end” in line 9, “the central recess” in line 10, “the upper end” in line 10, “the flexible conduit” in line 11, “the integrated unit” in line 11, and “the lower opening” in line 11. There is insufficient antecedent basis for these limitations in the claim.
Claim 30 also recites the limitation “preferably a medical grade silicone polymer” in line 4. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the claim requires the elastomeric material to be a medical grade silicone polymer or if this is merely a preference.
Claim 30 also recites the limitation “in suitable matrices for each piece” in lines 4-5. It is not clear what is meant by this in the context of the claim; what are the matrices and what pieces are being referred to?
Claim 32 recites the limitation "The production procedure of claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites a prosthetic device, not a production procedure.
Claim 32 also recites the limitation “which allows to obtain” in line 2. It is not clear what is meant by this in the context of the claim.
Claim 32 also recites the limitation “a wide range of patients” in lines 2-3. The term “wide” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the range that would meet the claim are not clear.
Claim 32 also recites the limitation “it” in line 3. It is not clear this limitation refers to; e.g., the procedure or the device or the implantation or something else?
Claim 32 also recites the limitations "the size" in line 3, “the total length” in line 5, “the joints” in line 14, “the pieces” in line 14, “the final size” in line 16, and “the intermediate connectors” in line 17. There is insufficient antecedent basis for these limitations in the claim; only a single intermediate connector has been previously recited.
Claim 32 also recites the limitation “moulding the nerve according to at least three different predefined lengths” in line 4. It is not clear how a single component can be at least three different predefined lengths.
Claim 32 also recites the limitation “its” in line 5, line 6, and line 16. It is not clear what this refers to in each instance.
Claim 32 also recites the limitation “manufacturing the membrane with … an undetermined length” in lines 9-10. It is not clear how the length can be undetermined.
Claim 32 also recites the limitation “moulding the anchor rod of … an undetermined length” in line 11. It is not clear how the length can be undetermined.
Claim 32 also recites the limitation “membrane” in line 12. It is not clear if this is intended to refer to the previously recited membrane or to a separate component.
Claim 32 also recites the limitation “each prosthesis” in line 16. It is not clear which components this is intended to refer to.
Claim 35 recites the limitation “its” in line 2, line 3, line 5, line 6, line 7, and line 8. It is not clear what this refers to in each instance.
Claim 35 also recites the limitations "the diameter" in line 3, “the lowered end” in line 3, “the cross section” in line 4 (also recited in lines 6-7, which may need to be amended in kind), “the distal end” in line 5, “the outer diameter” in lines 5-6, “the proximal end” in line 6, “the proximal face” in line 7, “the diameter” in line 8, “the lower opening” in line 8, “the upper end” in line 9, and “the flexible conduit” in line 9. There is insufficient antecedent basis for these limitations in the claim
Claim 38 recites the limitation “preferably a medical grade silicone polymer” in line 4. The phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is not clear if the claim requires the elastomeric material to be a medical grade silicone polymer or if this is merely a preference.
Claim 38 also recites the limitation “in suitable matrices for each piece” in lines 4-5. It is not clear what is meant by this in the context of the claim; what are the matrices and what pieces are being referred to?
Claim 38 recites the limitations “the distal end” in line 6, “the perimeter recess” in line 6, “the distal end” in line 7, “the outer annular groove” in lines 7-8, “the proximal end” in line 8, “the central cavity” in lines 8-9, “the proximal end” in line 9, “the coaxial annular groove” in line 10, “the connector” in line 10 (also recited in line 11 and line 12, which may need to be amended in kind), “the distal end” in line 10, “the central recess” in line 11, “the upper end” in line 11, “the flexible conduit” in lines 11-12, “the integrated unit” in line 12, and “the lower opening” in line 12. There is insufficient antecedent basis for these limitations in the claim.
Claims 2, 3, 9, 11, 14, 15, 17, 19, 21, 22, 25-28, 30, 32, 33, 35, and 38 are rejected by virtue of their dependence upon at least one rejected base claim.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 9, 14, 15, 17, 25, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trick et al. (U.S. No. 4,726,360; cited in the IDS filed 07 October 2022; hereinafter known as “Trick”).
Regarding claim 1, Trick discloses a prosthetic device 10 implantable within the cavernous body of a penis with erectile dysfunction and its production procedure where the device is of the type formed by two cylinders that are inflatable with a fluid allowing it to be implanted in a wide range of patients depending on the length of the penis and optimizes the use of a low volume of fluid to achieve a functional erection (Abstract; Figs. 1-7; col. 5, lines 11-15); wherein it comprises an erectable portion of variable length composed of a pressurizable chamber 22 with a low volume of fluid formed between an expandable membrane 23 and an axially extensible and foldable longitudinal nerve 17 which extend between a distal tip element 16 and an intermediate connector 14a from which emerges a cuttable anchor rod 14 (col. 3, lines 21-51; col. 5, lines 23-37; col. 5, lines 47-52), where said nerve is in one piece that is formed by a distal section of variable length, an intermediate section that is foldable and extensible in the axial direction, and a proximal section that includes optimized means for continuous lateral supply of the fluid towards the pressurizable chamber (col. 5, lines 23-35; the nerve may be made of silicone elastomer and provide a limited amount of expansion/distension; the distal section may be the portion connected to the distal tip element, the proximal section may be the portion connected to the intermediate connector, and the intermediate section may be the portion between the distal and proximal sections); said device also having an integrated fluid storage and pressurization unit 12/13 implantable in the scrotal sacs (col. 4, lines 3-7).
Regarding claim 9, Trick discloses that the intermediate section has a single length or the intermediate section has different present lengths (e.g., single length).
Regarding claim 14, Trick discloses that the membrane is attached to the intermediate connector through its proximal end and is attached to the tip element through its distal end (Fig. 1).
Regarding claim 15, Trick discloses that the pressurizable chamber is formed by a cylindrical space radially comprised between the outer surface of the nerve and the inner surface of the membrane, and axially it has a distal zone that limits with the tip element and a proximal zone that limits with the intermediate connector (Figs. 1, 4, 6), and wherein the pressurizable chamber begins to fill or empty from its proximal area with the fluid that emerges or enters through the lateral openings of the nerve (Fig. 8; col. 3, lines 52-63).
Regarding claim 17, Trick discloses that the tip element is solid of elastomeric material (col. 5, line 64 – col. 6, line 5), it has a rounded distal end and a proximal portion with a straight edge comprising a central axial opening, or a central axial opening and an outer annular groove coaxial to the central opening (Fig. 8).
Regarding claim 25, Trick discloses that each of the flexible conduits comprises a lower end for connection to the valve and an upper end connection opposite with the lower opening of each of the intermediate connectors (Fig. 1; col. 3, line 66 – col. 4, line 7).
Regarding claim 26, Trick discloses that the nerve, the tip element, the intermediate connector, and the anchor rod are made of biocompatible elastomeric material, such as a medical grade silicone polymer, applied in different thicknesses and hardness for each element (col. 5, line 64 – col. 6, line 5).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Trick as applied to claim 1 above, and further in view of Walch (U.S. Pub. No. 2010/0036196 A1). Trick discloses the invention as claimed, see rejection supra, and further discloses that the nerve is formed by a longitudinal robust body with a continuous outer surface, a distal end, and a proximal end between which the proximal, intermediate, and distal sections extend, where the proximal section is partially hollow and the distal section has a mantle of variable length, or said distal section has a cuttable distal end, to adjust the length of the nerve, or said distal section has different preset lengths and includes a distal perimeter recess (Figs. 1, 4). Trick fails to expressly disclose that the intermediate section has a reduction in its mass and wherein said intermediate section has an axial core of smaller diameter than the rest of the nerve, which in turn, comprises a plurality spaced annular nerves forming a corrugation that folds and extends axially, or said intermediate section has a microperforated structure that weakens the portion and allows its folding and axial extension, or said intermediate section has a surface with successive radial depressions forming an accordion shaped portion that allows its folding and axial extension. Walch discloses a similar prosthetic device (Abstract; Figs. 1, 6, 10) wherein an intermediate section has a reduction in its mass and is either corrugated via a plurality of spaced annular portions or is accordion shaped via successive radial depressions, allowing folding and axial extension, in order to increase flexion during expansion/compression with only a small amount of fluid required ([0046]-[0049]). 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 invention of Trick with such an intermediate section as taught by Walch in order to increase flexion during expansion/compression with only a small amount of fluid required.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Trick as applied to claim 1 above, and further in view of Kuyava (U.S. Pub. No. 2009/0124851 A1). Trick discloses the invention as claimed, see rejection supra, but fails to disclose that the expandable membrane is a textile membrane formed by a continuous tubular fabric without longitudinal seam, embedded in medical grade silicone that allows high pressure and rigidity ensuring its expandable characteristic under sealing and impermeability conditions, which comprises an open distal end, an open proximal end , an inner surface, and an outer surface-wherein the tubular tissue of said membrane is formed by an orthogonal mesh where both the longitudinal and the concentric fibres present a normally corrugated state that allows the expansion of the membrane in both directions, or the tubular fabric of said membrane is formed by a diagonal mesh that allows the expansion of the membrane in both directions; though Trick does teach that the nerve may comprise silicone coated tubular fabric that is woven or knit. Kuyava discloses a similar prosthetic device (Abstract; Figs. 1-5) comprising a textile membrane formed by a continuous tubular fabric without longitudinal seam, embedded in medical grade silicone that allows high pressure and rigidity ensuring its expandable characteristic under sealing and impermeability conditions ([0019]), which comprises an open distal end, an open proximal end , an inner surface, and an outer surface wherein the tubular tissue of said membrane is formed by an orthogonal mesh where both the longitudinal and the concentric fibres present a normally corrugated state that allows the expansion of the membrane in both directions in order to accommodate both radial and longitudinal expansion ([0020]-[0021]; [0024]; [0026]-[0027]). 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 invention of Trick with such a textile membrane as taught by Kuyava in order to accommodate both radial and longitudinal expansion.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Trick as applied to claim 1 above, and further in view of Hakky (U.S. No. 4,594,997). Trick discloses the invention as claimed, see rejection supra, and further discloses that the anchor rod is a preferably cylindrical body, with a cuttable rear end and a front end through which it joins to the intermediate connector (Fig. 1; col. 5, lines 47-52). Trick fails to disclose that it comprises a series of annular grooves regularly spaced from each other that determine cutting points to cut its length. Hakky discloses a similar prosthetic device (Abstract; Fig. 8) comprising an anchor rod 26 that comprises a cylindrical body with a cuttable rear end and that comprises a series of annular grooves 134 regularly spaced from each other that determine cutting points to cut its length in order to configure the device to the appropriate size for the penis into which it is implanted (col. 9, lines 43-55). 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 invention of Trick with such an anchor rod as taught by Hakky in order to configure the device to the appropriate size for the penis into which it is implanted.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Trick as applied to claim 1 above, and further in view of Felton et al. (U.S. Pub. No. 2018/0318085 A1; hereinafter known as “Felton”). Trick discloses the invention as claimed, see rejection supra, and further discloses that the integrated fluid storage and pressurization unit comprises a single reservoir 32 which has a flexible structure in the form of lateral compression which allows to contain and pump sufficient fluid to pressurize each one of the pressurizable chambers of each one of the erectable portions of the device (col. 4, lines 3-9; col. 5, lines 11-15), wherein the integrated storage and pressurization unit also includes a pressurization control means which comprises a pressure relief valve 33 that establishes a controlled fluid communication between the erectable portions of the device and said reservoir, where said integrated unit has a size that allows it to be placed in the scrotal sac, and wherein the valve is connected on one side to the reservoir and on the other it is connected to a pair of flexible conduits 13 that transfer the fluid between the reservoir and each of the erectable portions of the device (col. 4, lines 3-15). Trick fails to disclose that the reservoir is in the form of a bellows. Felton discloses a similar prosthetic device (Abstract; Fig. 8) comprising a reservoir 201 placed in the scrotal sac ([0033]-[0034]; [0054]), wherein the reservoir is in the form of a bellows 1095-1195, in order to facilitate actuation of the reservoir ([0086]). 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 invention of Trick with a reservoir in the form of a bellows, as taught by Felton, in order to facilitate actuation of the reservoir.
Allowable Subject Matter
Claims 2, 19, 27, 28, 30, 32, 33, 35, and 38 would be allowable if rewritten 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 to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 2, none of the prior art of record teaches or reasonably suggests such an internal axial channel in the proximal portion of the nerve, which has an open end and a pointed opposite inner end which branches laterally in a horizontal axis of the nerve forming lateral channels that flow into corresponding lateral openings, having said lateral channels an inclined path with respect to an axial axis of the nerve, in combination with such a prosthetic device. Regarding claim 19, none of the prior art of record teaches or reasonably suggests such an intermediate connector that is a solid piece with a distal end that has a central cavity, an annular groove coaxial to the central cavity, a proximal end with a central recess and an inner channel, wherein said inner channel is curved and has an open front end that connects with the central cavity and a lower curved end that flows out in a lower opening, in combination with such a prosthetic device. Regarding claims 27, 28, 30, 32, 33, 35, and 38, none of the prior art of record teaches or reasonably suggests such production procedures of such a prosthetic device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Uson (U.S. No. 4,009,711) teaches a similar prosthetic device with a longitudinal nerve surrounded by an expandable membrane, wherein the nerve includes a plurality of lateral apertures for expanding the membrane via fluid flow. Cowen (U.S. No. 5,067,485) and Forsell (U.S. Pub. No. 2012/0022323 A1) each teach similar prosthetic devices that include an inflatable portion that is corrugated/accordion-shaped.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791