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 .
Applicant’s amendments have been considered; however, upon reconsideration of the amended independent claims, the Examiner finds that a new issue under 35 U.S.C. § 112(a) is raised by the current claim language. Accordingly, prosecution is reopened to apply the new rejection set forth below. The earlier indication that certain dependent claims would be allowable if incorporated into an independent claim was made on the prior record and is withdrawn to the extent inconsistent with the present rejection.
Claim Objections
Claim 24 is objected to because of the following informalities: after “configured” insert –to-- .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 15-20, 22-27, and 30-35 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. The originally filed specification does not reasonably convey to one of ordinary skill in the art that Applicant had possession, at the time of filing, of the claimed two-filament arrangement in which both claimed filaments are arranged on, and wind onto or unwind from, the first handling tube.
The originally filed disclosure consistently describes a tubular instrument in which:
a first connecting unit includes a first filament connecting unit connected to the first handling tube; and
a second connecting unit includes a second filament connecting unit connected to the second handling tube.
See, e.g., paragraphs [0015], [0018], [0031]–[0033], [0039], [0063]–[0065], and [0075]–[0082]. Original claims 1, 7, 10, and 11 likewise describe the first filament structure on the first handling tube and the second filament structure on the second handling tube.
The specification repeatedly teaches that the first filament(s) wind onto or unwind from the first handling tube, while the second filament(s) wind onto or unwind from the second handling tube. See paragraphs [0033]–[0034], [0075]–[0077], and [0090].
However, present independent claim 15 recites, among other things:
a first filament holding sleeve arranged non-rotatably on the first handling tube;
a second filament holding sleeve arranged non-rotatably on the first handling tube;
a first filament configured to wind onto or unwind from the first handling tube; and
a second filament configured to wind onto or unwind from the first handling tube.
The originally filed disclosure does not describe the claimed two-filament combination in which both filament systems are fixed to sleeves on, and wind onto or unwind from, the first handling tube. Rather, the disclosure presents the two-filament arrangement as distributed between the first and second handling tubes.
Although the specification describes additional embodiments having a further connecting unit 9.3 with filament connecting unit 22 connected to a further tube connection interface 23 that may be located on the first handling tube 2, see paragraphs [0085]–[0088], that disclosure does not provide written description support for the presently claimed two-filament arrangement in which both claimed filaments are arranged on the first handling tube. The originally filed disclosure presents that additional structure only in the context of an additional filament arrangement, not as a rearrangement of the originally disclosed two-filament system such that both claimed filaments are on the first handling tube.
Accordingly, the specification does not reasonably convey possession of the subject matter of claims 15, 22–24, 26, and 35.
Claims 16–20, 25, 27, and 30–34 are rejected under 35 U.S.C. 112(a) as being dependent upon.
Claim 15, which is rejected under 35 U.S.C. 112(a)Claim 22 is rejected under 35 U.S.C. 112(a) because the originally filed specification does not provide adequate written description support for the recited combination in which:
a second end of the first filament is detachably fixed with the first connection interface (6a); and
a second end of the second filament is detachably fixed with the second connection interface (6c),
within the claim 15 arrangement in which both claimed filaments wind onto the first handling tube.
The originally filed disclosure does describe detachable fixation generally. See paragraphs [0004], [0019], [0020], [0064], [0073], [0080]. It also discloses interface 6c in connection with an additional filament arrangement associated with further tube connection interface 23. See paragraphs [0085]–[0087]. However, the originally filed disclosure does not describe the presently claimed two-filament combination in which the two claimed filaments of claim 15 are detachably fixed at 6a and 6c, respectively, while both are part of a first-handling-tube arrangement. Thus, the originally filed disclosure does not reasonably convey possession of the claimed combination now recited in claim 22.
Claim 23 is rejected under 35 U.S.C. 112(a) because the originally filed specification does not provide adequate written description support for the limitation requiring:
the first filament to extend between the first connection interface (6a) and the first filament holding sleeve (14) with a first radial directional component and a first axial directional component; and
the second filament to extend between the second connection interface (6c) and the second filament holding sleeve (23) with a second radial directional component and a second axial directional component,
where both claimed filaments are part of the claim 15 arrangement on the first handling tube.
The specification supports a filament extending from 6a to sleeve 14 with radial and optional axial components. See paragraph [0064]. The specification also supports an additional filament extending from 6c to tube connection interface 23 with radial and optional axial components. See paragraph [0085]. However, the originally filed disclosure does not describe these features together as the claimed two-filament arrangement in which both claimed filaments are associated with the first handling tube under claim 15. Instead, the structure associated with 6c and 23 is disclosed only as part of an additional filament arrangement. See paragraphs [0085]–[0088].
Accordingly, the specification does not reasonably convey possession of the presently claimed subject matter.
Claim 24 is rejected under 35 U.S.C. 112(a) because the originally filed specification does not provide adequate written description support for the recited arrangement requiring:
a first filament holding sleeve (14) including a first plurality of axial bores configured to receive the first filament; and
a second filament holding sleeve including a second plurality of axial bores configured to receive the second filament,
where both sleeves are part of the claim 15 arrangement on the first handling tube.
The specification describes the first filament holding sleeve 14 with a plurality of axial bores 14a. See paragraph [0073]. The specification also states that filament holding sleeve 19 may analogously be provided with a plurality of axial bores. See paragraph [0082]. However, sleeve 19 is disclosed on the second handling tube 3, not on the first handling tube. See paragraphs [0080]–[0082].
While additional tube connection interfaces such as 23 may in some embodiments be formed by further filament holding sleeves, see paragraph [0088], the originally filed specification does not describe the presently claimed two-sleeve, two-filament arrangement of claim 15 in which both sleeves are on the first handling tube and both receive respective filaments winding onto the first handling tube.
Thus, written description support is lacking.
Claim 26 is rejected under 35 U.S.C. 112(a) because the originally filed specification does not provide adequate written description support for the limitation that:
the control interface is configured to actuate rotation of the first handling tube such that the first filament and the second filament are configured for uniform radial contraction of the self-expanding prosthetic heart valve.
The originally filed disclosure describes uniform radial contraction generally, including by coordinated winding of filaments at multiple structural connection interfaces and, in preferred examples, by counter-rotation of the first and second handling tubes. See paragraphs [0034], [0040]–[0042], [0069]–[0070], [0079], [0081], [0091].
However, the specification does not describe the specific claimed arrangement now recited in claim 26, which depends from claim 15 and requires the claimed first filament and claimed second filament to both be part of the first-handling-tube arrangement. Rather, the originally filed disclosure teaches uniform contraction through coordinated action of filament systems distributed across different tube structures. See paragraphs [0075]–[0077], [0090]–[0091].
Accordingly, the originally filed disclosure does not reasonably convey possession of the subject matter of claim 26.
Claim 35 is rejected under 35 U.S.C. 112(a) because the originally filed specification does not provide adequate written description support for the limitation requiring:
a tubular assembly including a first handling tube and a second handling tube nested within the first handling tube;
a filament assembly including a first filament and a second filament;
the first filament being configured to wind onto or unwind from the first handling tube; and
the second filament also being configured to wind onto or unwind from the first handling tube.
The specification supports that the second handling tube may be nested within the first handling tube. See paragraphs [0002], [0017], [0058]. The specification also supports that the first filament winds onto the first handling tube. See paragraphs [0015], [0064]–[0065].
However, the specification does not support the claimed two-filament arrangement in which the second filament also winds onto or unwinds from the first handling tube. Instead, the originally filed disclosure repeatedly teaches that the second connecting filament 15.1 winds onto or unwinds from the second handling tube 3. See paragraphs [0033], [0075]–[0077], [0090].
For the reasons set forth above with respect to claim 15, the originally filed specification does not reasonably convey possession of the subject matter of claim 35.
Claims 36 and 37 are rejected under 35 U.S.C. 112(a) because the originally filed specification does not reasonably convey to one of ordinary skill in the art that Applicant had possession, at the time of filing, of the presently claimed embodiment requiring first, second, and third filaments arranged on the first handling tube, with each filament configured to wind onto or unwind from the first handling tube.
The originally filed disclosure consistently describes a multi-filament arrangement in which the filament systems are distributed among different handling tubes. In particular, the specification describes:
a first filament connecting unit associated with the first handling tube; and
a second filament connecting unit associated with the second handling tube.
See, e.g., paragraphs [0015], [0031]–[0033], [0064]–[0065], and [0075]–[0082]. The specification repeatedly teaches that the first filament winds onto or unwinds from the first handling tube, whereas the second filament winds onto or unwinds from the second handling tube. See paragraphs [0033], [0065], [0075]–[0077], and [0090].
Although the specification additionally discloses a further connecting unit 9.3 having filament connecting unit 22 associated with a further tube connection interface 23, which in some embodiments may be located on the first handling tube 2, see paragraphs [0085]–[0088], this disclosure does not provide written description support for the presently claimed configuration in which the first filament, second filament, and third filament are all arranged on, and configured to wind onto or unwind from, the first handling tube.
At most, the originally filed disclosure supports:
a first filament on the first handling tube;
a second filament on the second handling tube; and
in certain additional embodiments, a third filament on a further interface that may be on the first handling tube.
The specification does not describe the now-claimed arrangement in which the disclosed multi-filament system is reorganized such that the first, second, and third filaments are all arranged on the first handling tube. Nor does the originally filed disclosure identify a three-filament embodiment in which all three filaments wind onto or unwind from the first handling tube as presently claimed.
Accordingly, the originally filed specification does not reasonably convey possession of the subject matter of claims 36 and 37.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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/TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771
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