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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/12/2026.
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 1-14 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 limitation "the central axis" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “configured to displace the pusher in longitudinally”. However, it is not necessarily clear what “in” as a direction is in reference to. For examination purposes, “in” will be interpreted as an upward direction as shown in Figs. 14-18, for example.
Claims 2-14 are rejected by virtue of their dependency on claim 1.
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, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gianotti (U.S. Patent 6,068,635, cited in IDS).
Claim 1: [Fig. 3 embodiment] Gianotti discloses a medical crimping device (50 - Fig. 3) comprising: a housing (60) having a first (left) end and a second (right) end; a funnel (generally nose portion 65) coupled to the first end of the housing, the funnel including a first opening (65’) and a second opening (67), the funnel tapers down from the first opening adjacent the first end of the housing to the second opening (Fig. 3 and column 4, lines 27-37); a piston cylinder (70) removably coupled to the second end of the housing (by threads 63’ - column 4, lines 6-9); and a piston (55, 58) disposed within the piston cylinder (through opening 72), wherein the piston is configured to slidably translate in the piston cylinder in a direction substantially parallel to the central axis (along Z/Z’); and a pusher (55) coupled to the piston, wherein the piston is configured to displace the pusher in longitudinally (direction Z) when the piston slidably translates in the piston cylinder.
[Fig. 6 embodiment] Gianotti discloses a medical crimping device (150) comprising: a housing (180) having a first (left) end and a second (right) end; a funnel (165) coupled to the first end of the housing, the funnel including a first opening (e.g. defined by 167/167’) and a second opening (e.g. defined by 166/166’), the funnel tapers down from the first opening adjacent the first end of the housing to the second opening (Fig. 6); a piston cylinder (160) removably coupled to the second end of the housing (implied in that it is arranged, supported, and mounted within the body 180 - column 6, lines 42-43; column 6, line 65 - column 7, line 1); and a piston (155) disposed within the piston cylinder, wherein the piston is configured to slidably translate in the piston cylinder in a direction substantially parallel to the central axis (along Z/Z’); and a pusher (156/158/159) coupled to the piston, wherein the piston is configured to displace the pusher in longitudinally (along Z) when the piston slidably translates in the piston cylinder (column 6, lines 43-45).
Claim 2: [Fig. 6 embodiment] The funnel is removably coupled to the housing (by two-part arrangement 170/170’ - column 6, lines 47-52).
Claim 10: [Fig. 3 embodiment] The piston cylinder comprises an interior wall and an exterior wall (any two walls of different radial and/or axial positions might be broadly considered as “interior” and “exterior”, such as the inner surface of hole 72, wall 71, and/or the inner surface engaging with threads 63’), wherein the piston is configured to be translated at least partially between the interior wall and the exterior wall (“partially between” being broad, the piston extends at least partially between the aforementioned walls in an axial and/or radial sense).
Claim 11: A piston chamber (62’) is bounded by the interior wall, the exterior wall (broad surfaces as noted above), and a piston head (55) of the piston (Fig. 3).
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti.
Claims 2-3: [Fig. 3 embodiment] The funnel as shown in Fig. 3 is not removably coupled to the housing, specifically via a threaded connection. However, the embodiment of Fig. 5 discloses a variant wherein the funnel is removably coupled to the housing via a threaded connection (column 5, lines 50-58). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have removably coupled the funnel to the housing since it would have been advantageously possible to screw a nose section 85 onto the outer thread 77' of the housing 80 as a function of the respective endoprosthesis which is to be introduced (column 6, lines 21-26).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Grabenkort (U.S. Patent 5,785,682).
[Fig. 3 embodiment] Gianotti discloses a device substantially as claimed except for wherein the housing is snap fit to the piston cylinder. Regarding the Fig. 3 embodiment, the housing is threaded to the piston cylinder. However, Grabenkort teaches that syringe components can be assembled alternatively by thread or snap fit (column 9, lines 28-30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have connected the housing via snap fit to the piston cylinder as a simple substitution of one known technique for another to achieve the predictable result of removably connecting the components together (MPEP 2143 I. B.).
Claims 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Cowan (U.S. PGPub 2005/0113754).
Claim 4: [Fig. 6 embodiment] Gianotti discloses a device substantially as claimed except for wherein the housing is snap fit to the piston cylinder (Gianotti is silent as to specifically how housing 180 and cylinder 160 are connected). However, Cowan teaches a connection between cylindrical portions of a syringe assembly wherein a housing (e.g. 500) snap fits to a cylinder (412 - paragraph 269). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have connected the housing via snap fit to the piston cylinder in order to have removably but selectively secured the components together.
Claim 5: [Either embodiment] Gianotti discloses a medical crimping device substantially as claimed except for wherein the housing includes a plurality of arms that extend towards the second end of the housing such that ends of the arms removably couple the housing to the piston cylinder. However, Cowan teaches a connection between cylindrical portions of a syringe assembly (12) wherein a housing (of 12) includes a plurality of arms (30) that extend towards a second end of the housing such that ends of the arms removably couple the housing to a mating cylindrical assembly (14, 22 - see paragraphs 231-232; Figs. 1, 6-7, 9, 14-15, 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided an analogous connection structure to the housing and piston cylinder of Gianotti since it distributes the attachment force of syringe 12 to ledge 29 equally around the syringe, for example (paragraph 233), and also generally allows for connection without regard for the specific orientation of the components (paragraph 9).
Claim 6: Referring to Cowan, the ends of the arms include retention clips (70 - e.g. Fig. 9) for removably coupling the housing to the piston cylinder.
Claim 7: Referring to Cowan, the piston cylinder includes a ledge (29), wherein the retention clips of the arms would removably couple the housing to the piston cylinder as implemented above (paragraph 232; Figs. 6-7, 9).
Claim 8: The ledge is a circumferential (annular) ledge extending around the entire perimeter of the cylindrical component (and thus analogously the piston cylinder) such that the housing would be configured to be removably coupled to the piston cylinder in any circumferential orientation (implied in paragraph 238).
Claim 9: The plurality of arms comprises at least two arms (paragraph 259), but not explicitly three arms. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided three arms since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Please note that in the instant application, paragraph 103, Applicant has not disclosed any criticality for the number of arms. Alternatively or additionally, Cowan also notes that the number of arms affects the flexibility and consequently the optimal functioning of the arms (Id.), and so it may be considered a result-effective variable. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the number of arms to be three, as it involves only adjusting the number of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to provided three arms as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gianotti.
Claim 12: Gianotti does not disclose seals between the piston head and the interior wall and between the piston head and the exterior wall. However, the examiner takes Official Notice that pistons and syringes alike typically incorporate seals (e.g. O-rings, gaskets) between various surfaces to prevent leakage, and so it would have been obvious to have provided seals between the piston head and the interior wall and between the piston head and the exterior wall for this purpose.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Morales (U.S. Patent 6,009,614, cited in IDS).
Claim 13: Gianotti discloses a medical crimping device substantially as claimed except for a fluid port in fluid communication with the piston chamber, wherein the fluid port is configured to deliver pressurized fluid to the piston chamber to translate the piston. The tool is instead actuated manually via a handle element (74 or 157). However, Morales teaches a medical crimping device comprising a fluid port (42) in fluid communication with a piston chamber (36), wherein the fluid port is configured to deliver pressurized fluid to the piston chamber to translate the piston (38 - column 6, lines 22-29). It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to have modified the device of Gianotti with a fluid port as taught by Morales to have hydraulically actuated the piston, thereby relieving the user of manual actuation of the device.
Claim 14: The fluid port of Morales extends through an exterior wall of a piston cylinder (24) and so it would have been obvious to have similarly provided the fluid port in Gianotti so as to allow communication of fluid from the exterior of the cylinder to the chamber.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P TRAVERS whose telephone number is (571)272-3218. The examiner can normally be reached 10:00AM-6:30PM.
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/Matthew P Travers/Primary Examiner, Art Unit 3726