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(s) 1-2 is objected to because of the following informalities:
Within claim 1, line 1: “Apparatus” should be replaced with “An apparatus”.
Within claim 2, line 2: “the cut in the urethra” should be replaced with --the cut in the inner surface of the urethra-- (in order to keep claim terminology consistent).
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.
Claim(s) 21-22, 29-31, 39 is/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.
Within claim 21, lines 1-3: Applicant claims, “wherein subsequently to the tissue cutter forming the cut in the inner surface of the urethra, the one or more implant carrier arms are configured to release the implant into the cut”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement (due to the claiming of the ordering of the steps during use) is directed to the method of use; however, the scope of the claim (which is determined by the preamble) is directed to the apparatus alone; as such, it is unclear, whether Applicant is trying to claim the apparatus OR the method of using the apparatus.
Within claim 22, line 2: Applicant claims, “the implant carrier arms”; it is unclear, and therefore indefinite, how the many implant carrier arms are required by the claim – within the aforementioned claim requirement the “arms” is plural – therefore there are at least 2; however, within claim 20, line 2 Applicant only required “one or more implant carrier arms” (there maybe only one); as such, its unclear, how many carrier arms are required.
Within claim 22, lines 3: Applicant claims, “the implant carrier arm”; it is unclear, and therefore indefinite, which one of the implant carrier arm(s) is being referred to – a single specific carrier arm OR all of the previous carrier arms?
Within claim 22, lines 3-4: Applicant claims, “the implant holder”; it is unclear, and therefore indefinite, which one of the implant holders is being referred to – a single specific implant holder OR all of the previous implant holders?
Within claim 22, lines 7-8: Applicant claims, “the implant is released by the implant carrier arms into a cut within the urethra”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the aforementioned claim requirement (due to the claiming of the implants release) is directed to the method of use; however, the scope of the claim (which is determined by the preamble) is directed to the apparatus alone; as such, it is unclear, whether Applicant is trying to claim the apparatus OR the method of using the apparatus.
Within claim 22, lines 7-8: Applicant claims, “a cut within the urethra”; it is unclear, and therefore indefinite, if this is the same OR in addition to the cut in the inner surface of the urethra (from claim 1, line 11).
Within claim 29, line 2: Applicant claims, “the implant carrier arms”; it is unclear, and therefore indefinite, how the many implant carrier arms are required by the claim – within the aforementioned claim requirement the “arms” is plural – therefore there are at least 2; however, within claim 27, line 2 Applicant only required “one or more implant carrier arms” (there maybe only one); as such, it is unclear, how many carrier arms are required. Claim(s) 30-31, which depend from claim 29, inherit all the problems associated with claim 29.
Within claim 39, line 9: Applicant claims, “the implant carrier arms”; it is unclear, and therefore indefinite, how the many implant carrier arms are required by the claim – within the aforementioned claim requirement the “arms” is plural – therefore there are at least 2; however, within claim 39, line 7 Applicant only required “one or more implant carrier arms” (there maybe only one); as such, it is unclear, how many carrier arms are required.
Within claim 39, lines 15: Applicant claims, “the implant carrier arm”; it is unclear, and therefore indefinite, which one of the implant carrier arm(s) is being referred to – a single specific carrier arm OR all of the previous carrier arms?
Claim 39 recites the limitation "the inner surface of the urethra" in line 18. There is insufficient antecedent basis for this limitation in the 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-8, 11-13, 17-21, 23-28 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bar-On et al. (US 2014/0012192 A1 – as cited by Applicant).
With respect to claim 1:
Bar-On et al. discloses an apparatus comprising:
a device for treatment of a urethra that is constricted due to benign prostatic hyperplasia (BPH) (paragraph [0091]), the device comprising:
a delivery tool (device 300 with sheath, as can be seen in fig. 3), having a proximal portion (end closer to hand piece 302) and a distal portion (end closer to dilation device 312), the distal portion (end closer to dilation device 312) configured to be advanced to a location in an area of the urethra that is to be treated (paragraphs [0149, 0153]), and the distal portion (end closer to dilation device 312) comprising:
an expandable element (dilation device 312) that is configured to expand within the urethra such as to enlarge the urethra in the area to be treated, the expandable element (dilation device 312) defining an outer surface (paragraph [0153]);
a tissue cutter (cutting mechanism 314) disposed outside the outer surface of the expandable element (dilation device 312), the tissue cutter (cutting mechanism 314) configured to form a cut (cut) in an inner surface of the urethra, subsequent to the expandable element (dilation device 312) having expanded such as to dilate the urethra (paragraphs [0171, 0207, 01233-0237]); and
an implant (implant 318) that comprises a shape-memory material (resilient material) (paragraphs [0142-0143]), and being configured to maintain the urethra in a dilated state, by being implanted within the cut (cut) in the inner surface of the urethra (paragraph [0147]),
the implant (implant 318), as can be seen in figs. 2Q-2P, comprising two end sections (two sides of triangular frame with free ends) and a middle section (side of triangular frame in the middle/ with no free ends) disposed between the two end sections (two sides of triangular frame with free ends) (paragraph [0141]), and the shape memory-material (resilient material) being shape set such that in an unconstrained configuration (fully relaxed condition) of the implant (implant 318), the middle section (side of triangular frame in the middle/ with no free ends) is substantially straight (due to the “generally triangular shape” the one side of the triangular frame is considered to the “substantially straight”) (paragraphs [0141, 0147]).
With respect to claim 2:
Wherein the implant (implant 318) is configured to be implanted within the cut in the urethra such that the middle section (side of triangular frame in the middle/ with no free ends) of the implant (implant 318) is constrained into a curved shape (only achieves a partially relaxed condition) (paragraph [0147]).
With respect to claim 5:
Wherein the implant (implant 318) is configured to be maintained in a spiral shape (266), as can be seen in fig. 2R, while the implant (implant 318) is disposed within the delivery tool (device 300 with sheath) (paragraphs [0138, 0143]).
With respect to claim 6:
Wherein the implant (implant 318) has a length of 40-80 mm (the implant (318) is configured to create a complete loop, which must at least surround the dilation device (312) when expanded, as this will approximate the desired diameter of the urethra; therefore, if the diameter of the dilation device (312) is 1-100mm, then the diameter of the implant lust also have a diameter of 1-100mm; in which case the length of the implant (318), measured from free end to free end, which will form a generally triangular loop around the dilation device (312) will be 3.14-314mm) (paragraph [0164]).
With respect to claim 7:
Wherein the implant has a thickness of 0.01-1mm (0.05-0.5 mm thick) (paragraph [0140]).
With respect to claim 8:
Wherein the implant has a width of 0.5-4 mm (0.1-10 mm wide) (paragraph [0140]).
With respect to claim 11:
Wherein the tissue cutter (cutting mechanism 314) has a length (depth) of 3-10mm (2-5 mm) (paragraph [0207]).
With respect to claim 12:
Wherein the tissue cutter (cutting mechanism 314) is configured to form the cut at an angle of 90 degrees (approximately 90 degrees) with respect to a longitudinal axis of the delivery tool (device 300 with sheath) (paragraph [0169]).
With respect to claim 13:
Wherein the tissue cutter (cutting mechanism 314) is configured to form the cut at an angle other than 90 degrees (approximately 90 degrees is inclusive of angles not EXACTLY 90 degrees, additionally the hinge that connects the cutting mechanism 314 may be prevented from opening fully to exactly 90 degrees) with respect to a longitudinal axis of the delivery tool (device 300 with sheath) (paragraph [0169]).
With respect to claim 17:
Wherein the expandable element (dilation device 312) has a length of 3-100 mm (5-100mm) (paragraph [0164]).
With respect to claim 18:
Wherein the expandable element (dilation device 312) is configured to be inflated to an internal pressure of 1-20 atm (0.1-20 ATM) (paragraph [0164]).
With respect to claim 19:
Wherein the expandable element (dilation device 312) comprises a balloon (paragraph [0157]).
With respect to claim 20:
Further comprising one or more implant carrier arms (connection mechanism between the shaft 1406 and implant 1402), as can be seen in fig. 14, extending from a shaft (shaft 1406) of the delivery tool (device 300 with sheath) and being disposed outside the outer surface of the expandable element (dilation device 312) (paragraph [0194]).
With respect to claim 21:
Wherein subsequently to the tissue cutter (cutting mechanism 314/ 1400) forming the cut (cut) in the inner surface of the urethra, the one or more implant carrier arms (connection mechanism between the shaft 1406 and implant 1402) are configured to release the implant (implant 318/ 1402) into the cut (paragraph [0198]).
With respect to claim 23:
Wherein the delivery tool (device 300 with sheath) further comprises an optical element (optical imaging arrangement/ optical system), and wherein the one or more implant carrier arms (connection mechanism between the shaft 1406 and implant 1402) and the expandable element (dilation device 312) are configured so as to allow the optical element to visualize the urethra (paragraphs [0151, 0155, 0232]).
With respect to claim 24:
Bar-On et al. discloses a method for treating a urethra that is constricted due to benign prostatic hyperplasia (BPH) (paragraphs [0091, 0116, 0228-0240]) comprising:
identifying a constricted area of the urethra requiring treatment (desired location) (paragraphs [0060, 0116, 0232]);
inserting into the urethra a delivery tool (device 300 with sheath), as can be seen in fig. 3, that includes an expandable element (dilation device 312) that defines an outer surface, and a tissue cutter (cutting mechanism 314) disposed outside the outer surface of the expandable element (dilation device 312) (paragraphs [0153, 0171, 0207, 0232]);
using the delivery tool (device 300 with sheath), delivering, to the identified constricted area of the urethra (desired location), an implant (implant 318), as can be seen in figs. 2Q-2P, that includes a shape-memory material (resilient material) (paragraphs [0142-0143]) and has two end sections (two sides of triangular frame with free ends) and a middle section (side of triangular frame in the middle/ with no free ends) disposed between the two end sections (two sides of triangular frame with free ends) (paragraph [0141]), the shape memory-material (resilient material) being shape set such that in an unconstrained configuration (fully relaxed condition) of the implant (implant 318), the middle section (side of triangular frame in the middle/ with no free ends) is substantially straight (due to the “generally triangular shape” the one side of the triangular frame is considered to the “substantially straight”) (paragraphs [0141, 0147]);
expanding the urethra by expanding the expandable element (dilation device 312) in the identified constricted area of the urethra (desired location) (paragraph [0233]);
subsequently, forming a cut in an inner surface of the urethra using the tissue cutter (cutting mechanism 314) (paragraph [0236]); and
releasing the implant (implant 318) into the cut to maintain the urethra in a dilated state (paragraph [0237]).
With respect to claim 25:
Wherein delivering the implant (implant 318) to the identified constricted area of the urethra (desired location) comprises delivering the implant (implant 318) while the implant (implant 318) is compressed into a spiral configuration, as can be seen in fig. 2R (paragraphs [0138, 0143]).
With respect to claim 26:
Wherein releasing the implant (implant 318) into the cut to maintain the urethra in a dilated state, comprises releasing the implant (implant 318) into the cut while the middle section (side of triangular frame in the middle/ with no free ends) of the implant (implant 318) is constrained into a curved shape (only achieves a partially relaxed condition) (paragraph [0147]).
With respect to claim 27:
Wherein the delivery tool (device 300 with sheath) further includes one or more implant carrier arms (connection mechanism between the shaft 1406 and implant 1402), as can be seen in fig. 14, extending from a shaft (shaft 1406) of the delivery tool (device 300 with sheath) and being disposed outside the outer surface of the expandable element (dilation device 312) (paragraph [0194]), and wherein delivering the implant (implant 318) to the identified constricted area of the urethra (desired location) comprises delivering the implant (implant 318) while the implant (implant 318) is in a removably coupled state with respect to the one or more implant carrier arm s(connection mechanism between the shaft 1406 and implant 1402) (paragraphs [0194, 0198, 0237]).
With respect to claim 28:
Wherein releasing the implant (implant 318) into the cut comprises releasing the implant (implant 318) from the one or more implant carrier arms (connection mechanism between the shaft 1406 and implant 1402) (paragraphs [0194, 0198, 0237]).
Allowable Subject Matter
Claim(s) 3 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 22, 29-31 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.
Claim(s) 39 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 3:
An apparatus (as required by claim 1) wherein the substantially straight middle section makes up such a large proportion of the implant (specifically at least 50% of the length).
With respect to claim 22:
An apparatus (as required by claim(s) 1 and 20) wherein the device includes one or more implant holders and coupled to respective one or more implant carrier arms; wherein the implant is configured to be held/ positioned between respective one or more implant holders the one or more implant carrier arms during delivery and the implant is configured to be released/ implanted by proximally retracting the one or more implant carrier arms.
With respect to claim 29:
A method of treating a urethra (as required by claim(s) 24 and 27) wherein the device includes one or more implant holders and coupled to respective one or more implant carrier arms; wherein the implant is held/ positioned between respective one or more implant holders the one or more implant carrier arms during delivery.
With respect to claim 39:
A method for treating a urethra comprising:
identifying a constricted area of the urethra requiring treatment;
inserting into the urethra a longitudinal delivery tool that includes (ALL of the following four structures):
an expandable element,
a tissue cutter disposed outside an outer surface of the expandable element,
one or more implant carrier arms extending from a shaft of the delivery tool, and
one or more implant holders coupled to the respective one or more implant carrier arms, and
an implant disposed between the one or more implant carrier arms and the one or more implant holders (thus the implant is held in place by the one or more implant carrier arms and the one or more implant holders);
delivering the implant for deployment at the identified constricted area of the urethra;
releasing a distal portion of the implant by retracting one of the one or more implant holders proximally with respect to the respective one or more implant carrier arms;
expanding the urethra using the expandable element at the identified constricted area of the urethra;
forming a cut in the inner surface of the urethra; and
releasing a proximal portion of the implant by retracting one of the one or more implant holders proximally with respect to one of one or more implant carrier arms, thereby releasing the implant into the cut.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/Examiner, Art Unit 3774