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 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, 2, 4-8, 10, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al (US 20070270632).
Regarding claim 1, Nelson et al (hereafter Nelson) discloses a device (10) capable of at least partial insertion into a prostate, the device comprising: a first elongate member (12, 52, 60, 146, paragraph 0059) sized and shaped for positioning within a first side of an anatomical structure, the first elongate member extending along a central longitudinal axis between a first end portion and a second end portion (figures **); and a second elongate member (14, 60, paragraph 0071) extending along a central longitudinal axis between a first end portion and a second end portion (figures **), the second elongate member sized and shaped for positioning within a second side of an anatomical structure opposite the first side (paragraph 0071, implanted), and an insertion sheath (trocar, paragraph 0254) sized and shaped to be passed within the urethra, the insertion sheath configured to hold the first and second elongate members; wherein each of the first and second elongate members include at least one magnetizable or magnetic element (ferromagnetic material, paragraph 0059), such that the first and second elongate members are magnetizable to repel each other (paragraph 0072, repel, figure 9C), wherein the device can be inserted into a prostate parallel to and on opposing sides of a length of a urethra to be dilated, such that the central longitudinal axis of each of the first and second elongate members are substantially parallel to each other and to the length of the urethra to be dilated in order to dilate a urethra therebetween (functional language such as ‘ inserted into a prostate parallel to and on opposing sides of a length of a urethra to be dilated, such that the central longitudinal axis of each of the first and second elongate members are substantially parallel to each other and to the length of the urethra to be dilated’, ‘sized and shaped for positioning within a first/second side of a prostate’ and ‘to dilate a urethra therebetween’ is not given full patentable weight. As long as the prior art meets all of the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations. Paragraph 0239 discloses the magnets can be 1-2cm lengths, which would fit in the prostate and be capable of dilating a urethra therebetween).
Regarding claim 2, Nelson discloses all of the limitations set forth in claim 1, wherein the at least one magnetizable or magnetic element includes one or more magnetizable or magnetic elongate members (permanent magnets, figure 9C paragraph 0074, 0096)
Regarding claim 4, Nelson discloses all of the limitations set forth in claim 1, wherein the first and second elongate members comprise rods (146, figures 26A-26C).
Regarding claim 5, Nelson discloses all of the limitations set forth in claim 1, wherein the first and second elongate members comprise relatively equal lengths (figure 9C, figures 26A-26C).
Regarding claim 6, Nelson discloses all of the limitations set forth in claim 1, wherein one of the first and second elongate members is longer than the other (figure 9E; figure 28C 60, 60”, 60’).
Regarding claim 7, Nelson discloses all of the limitations set forth in claim 1, wherein at least one of the first and second elongate members comprise one or more arcuate sections (12 and 146, arcuate circular ends and outer surface; 52 coils)
Regarding claim 8, Nelson discloses all of the limitations set forth in claim 1, wherein at least one of the first and second elongate members comprises a lateral protrusion for inhibiting migration of the elongate members by pressing against or engaging a physiological structure (corners of 68 paragraph 0113; 86 paragraph 0125; portion at reference 90, figures 11 and 12).
Regarding claim 10, Nelson discloses all of the limitations set forth in claim 1, wherein at least one of the first and second elongate members includes a thickness varying along a length of at least a portion of the at least one of the magnetizable or magnetic elongate members (60, figure 12, thickness varies).
Regarding claim 11, Nelson discloses all of the limitations set forth in claim 1, wherein at least one of the first and second elongate members comprise multiple segments (figure 12).
Claims 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kugler et al (US 20040147801).
Regarding claim 13, Kugler et al (hereafter Kugler) discloses an apparatus for at least partial insertion into a prostate, the apparatus comprising: a first elongated member (100a) for positioning on a first side of the prostate (figure 60, paragraph 0006, urinary incontinence), including an angled distal tip to pierce into the prostate from a urethra (functional language is not given full patentable weight. As long as the prior art meets all of the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations); and a second elongate (100b) member for positioning on a second side of the prostate opposite the first side (Figure 60, the devices 100a, 100b, can be placed within the prostate such that one of the elongated members contacts one side of the prostate, and the other elongated member contacts an opposite side of the prostate), the second elongate member including an angled distal tip to pierce the prostate from the urethra), and an insertion sheath (delivery catheter, paragraph 0161) including a lumen (figure 60) sized and shaped to hold the first and second elongate members during insertion of the insertion sheath into a urethra, wherein each of the first and second elongate members include at least one magnetizable or magnetic element (105, paragraph 0101, paragraph 0162), such that the first and second elongated members are capable of being magnetized to repel each other to dilate a urethra therebetween (paragraph 0087, 0162). Functional language such as ‘ pierce the prostate from a urethra’ and ‘to dilate a urethra therebetween’ is not given full patentable weight. Kugler discloses the device can be sized and shaped for multiple uses, including urinary incontinence. As long as the prior art meets all of the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations.)
Regarding claim 14, Kugler discloses all of the limitations set forth in claim 13, further comprising one or more inflatable portions (1010) configured to move the first and second elongate members into patient anatomy when the insertion sheath is inserted (paragraph 0161).
Regarding claim 15, Kugler discloses all of the limitations set forth in claim 13, further comprising a magnetic applicator (permanent magnet, retention magnet 110) for magnetizing the first and second elongated members (magnetic field, paragraph 0101).
Regarding claim 16, Kugler discloses all of the limitations set forth in claim 15, wherein the magnetic applicator (110, paragraph 0163) is configured to be drawn through the insertion sheath to actuate the at least one magnetizable or magnetic elements to provide magnetic repulsion to encourage the first and second elongated members to repel each other (paragraph 0163).
Regarding claim 17, Holman discloses all of the limitations set forth in claim 15, wherein the magnetic applicator is configured to be applied externally to actuate the at least one magnetizable or magnetic elements provide magnetic repulsion to encourage the first and second elongated members to repel each other (paragraph 0163, the magnetic applicator can be applied externally. As long as the prior art meets all of the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations.)
Response to Arguments
Applicant's arguments filed September 18, 2025 have been fully considered but they are not persuasive in view of the rejections set forth above addressing the amendments and functional limitations to the claims. In response to applicant's arguments, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the rejections are being maintained and it is the examiner’s position that the prior art meets all of the claim limitations and applicant’s arguments are not persuasive.
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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/ Primary Examiner, Art Unit 3771