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 disclosure is objected to because of the following informalities: reference to a claim in the specification is improper as the subject matter can change during prosecution and/or the claim be canceled. See pages 1, 2 of specification referencing claim 1. 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 1-11 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 limitations “means for constricting” and “means for cutting” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is not evident how apparatus can constrict or cut into tissue with this capability with just being positioned on a wire. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The terms “firmly” and “loosely” in claim 8 are relative terms which render the claim indefinite. The terms “firmly” and “loosely” are 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 claim fails to define with any specificity how the loop is “firmly” connected nor detail how an end of the loop is loose to guide it for adjusting a diameter.
Claim 11 recites the limitation "the threads" in lines 2,4. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims carry the indefinite issues of the independent claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6,9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kilemnik (WO 2015/101975). Figs. 1A-C show an implant 100, for the treatment of a urinary tract of a person (pages 1,9 of document) by applying a local ischemic pressure to the tissue of urinary organs by means of a wire structure having at least two wires 102A, 102B wherein the implant can be introduced into the urethra in a folded state (page 8 of doc) with a distal end in the lead and unfolds in the urethra to form the wire structure for the treatment of the tissue. It can also be seen (Figs. 1A-C) at least one further means 102C for constricting or cutting into tissue (page 11, lines4-6), wherein this means is positioned on the wire structure in such a way that it exerts a local ischemic pressure (page 8 of doc) on a median lobe of the person. Regarding claim 2, Kilemnik discloses (page 10, lines 5,6) the wires of the implant are shape memory material. Regarding claim 3, Fig. 2A shows the wire can be introduced into the urethra in a folded state relative to the implant and unfolds in the urethra so as to form a predetermined angle with the wire structure. Regarding claim 4, it can be seen (Figs. 1b,C) that the means to constrict or cut are intertwined with a wire of the wire structure. Regarding claim 5, Figs. 1B,C show the wire is bent at least in some section or sections (distal end and proximal end region), wherein the wire is bent convexly relative to a longitudinal axis of the implant, thus enabling the bent wire to be laid around the median lobe when in use. Regarding claim 6, the examiner takes official notice that wires are known in the art to also be considered threads of material. It can be seen (Fig. 1C) that the thread forms a loop in the structure. With respect to claim 10, it can be seen (Fig. 1B) that the implant include a further wire 104 arranged on the wire structure and this wire is aligned in such a way that it raises the median lobe during a treatment use. Regarding claim 11, it can be seen (Figs. 1B,C) all the wires are brought together at a proximal end of the implant and the loose wires are fixed there.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 7,8 are rejected under 35 U.S.C. 103 as being unpatentable over Kilemnik (WO 2015/101975) in view of Rogers et al. (WO 2014/200764). Kilemnik is explained supra. However, Kilemnik did not disclose the loop can be varied to change the diameter. Rogers et al. teach (Figs. 16,18,19) an implant structure that the loop can be adjusted. Rogers teaches (page 17, lines 13-15) that tightening of a loop can constrict within a vessel. It would have been obvious to one of ordinary skill in the art to incorporate a loop that can be varied in diameter as taught by Rogers et al. in the implant device of Kilemnik such that one can tighten onto or constrict a vessel if needed. Regarding claim 8, see page 20 of Rogers teaching how a loop is firmly connected at one end of an implant and the other end is loose to enable a proximal end of the implant to permit adjustment of a diameter of the loop by pulling on a loose end of a thread.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799