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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “actuator” and “exit” and “relative rotation angle” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-Fig. 15 and 16 include element 1545 which in not found within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because:
-Lines 4-5 recites “press-fixation.” It is possible this should read “press-fit fixation.”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
-[0024] recites “patience.” Should possibly read “patients.”
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 2-9 are objected to because of the following informalities:
-Claim 2-9 recite “claim x, wherein” in line 1. Examiner recommends amending to “claim x, wherein.”
-Claim 3 recites “set of set of” in line 3. Examiner recommends amending to “set of serial couples compression stages.”
-Claim 3 recites “said compression stage” in lines 3-4. Examiner recommends amending to “said set of serial coupled compression stages.”
--Claim 4 recites “said serial coupled compression stages” in lines 1-2. Examiner recommends amending to “said set of serial coupled compression stages.”
-Claim 5 recites “said compression stage” in lines 2-3. Examiner recommends amending to “said compression facility.”
-Claim 6 recites “said separation” in line 3. Examiner recommends amending to “said separation distance.”
-Claim 7 recites “said rotation angle” in line 3. Examiner recommends amending to “said relative rotation angle.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 1 recites “control” which is a generic placeholder. There is no sufficient
structure for this limitation provided in the claims. The function of this limitation is
for initiating said size-decreasing action. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 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 “a size” in line 5. It is unclear whether the size referred to is the same or different from “a size” referenced in line 1.
-Claim 4 recites “an exit” in line 4. It is unclear what this recitation is referring to in terms of either structure of function. Further clarification should be provided to identify what the exit entails.
-Claim 7 recites “them” in line 2. It is unclear what them is referring to. Further clarification should be provided to identify whether this is the pair of unit holders, the size-decreasing structure or a separate embodiment.
-Claim 7 recites “relative rotation angle” in line 2. It is unclear what is meant by this recitation. Further clarification should be provided to define what the relative rotation angle encompasses in relationship to the unit holders or corresponding structure.
-Claim 8 recites “said size” in line 1. It is unclear whether the size being referred to corresponds to the size of the unit of a compressible connective tissue referenced in claim 1, lines 1-2 or whether this is referring to a size of the compressible structure in claim 1, lines 5-6.
-Claim 9 recites “a size” in line 4. It is unclear whether the size referred to is the same or different from “a size” referenced in line 1.
-Claim 10 recites “said size” in line 1. It is unclear whether the size being referred to corresponds to the size of the unit of a compressible connective tissue referenced in claim 9, lines 1-2 or whether this is referring to a size of the compressible structure in claim 9, lines 5-6.
Claim limitation “control” in claim 1 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. The specification provides reference to [0094; “Movement may be controlled by a drive rod 515 having a knob 520.”] however, it is unclear whether this is the control initiating said size-decreasing action. 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.
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.
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.
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:
Claim(s) 1, 3, 8, 9, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perreault (U.S. 20050229670).
Regarding Claim 1, Perreault teaches an apparatus for decreasing a size of a unit of a compressible connective tissue, [0009]-include grafts and stent grafts and [0061]-references the stent reduced in diameter.
comprising: a compressor configured to receive the unit within a size-decreasing structure, [0020; “Actuation devices may include any combination of motors such as… pneumatic actuation devices, air compressors, and so forth.”] and [0017; “In some embodiments, multiple crimping sections may be arranged to be driven by a common drive device.”]-With crimping sections interpreted as the size-decreasing structure.
said compressor including an actuator coupled to said size-decreasing structure with said actuator configured to operate said compressor to decrease a size of the compressible connective tissue using a size-decreasing action of said compressor; [0017; “Each section may have its own actuation or drive device which is capable of rotating the mount or otherwise causing the blades to move, thereby altering the size of the chamber.”] This interpretation taking into account the previous recited compressor and actuation systems referenced in [0020].
a control, coupled to said actuator, initiating said size-decreasing action [0020; “Actuation of the independent sections… or the sections may be automatically actuated, such as by a control system”]
Regarding Claim 3, Perreault teaches wherein said size-decreasing structure includes a set of serial coupled compression stages [0071; “the device shown in FIG. 8 includes independently operable crimping sections… the device may include 4, 5, 6, 7, up to 80 or more independently operable crimping sections 15.”]
and a compression driver coupled to the unit moving the unit through said set of set of serial coupled compression stages, [0072]-with the spline gear system considered the compression driver.
each said compression stage including a compression facility incrementally compressing the unit as it is driven through by said compression driver [0075]-Describes article moving through crimping sections and held within the chamber to reduce size of the article, with the compression facility represented by the chamber.
Regarding Claim 8, Perreault teaches wherein said size includes a diameter [0061].
Regarding Claim 9, Perreault teaches a method for decreasing a size of a unit of a compressible connective tissue, [0009] and [0061] and [0089]-refers to a method of reducing the diameter of an article.
comprising: receiving the unit within a size-decreasing structure of a compressor, [0020] and [0017]
said compressor including an actuator coupled to said size-decreasing structure with said actuator configured to operate said compressor to decrease a size of the compressible connective tissue using a size-decreasing action of said compressor: [0020] and [0017]
and operating said actuator to initiate said size-decreasing action. [0089]-Includes reference to reducing diameter of an article and actuating crimping sections to reduce size of the chamber of the device and subsequently apply force to accomplish the described reduction in diameter.
Regarding Claim 10, Perreault teaches wherein said size includes a diameter [0089].
Claim Rejections - 35 USC § 103
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 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) 2, 4, 5, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perreault (U.S. 20050029670) in view of Straubinger (WO 2010130789).
Regarding Claim 2, Perreault is silent on wherein said size-decreasing structure includes one or more graft sleeves coupled to a housing, each graft sleeve defining a conical internal sleeve structure into which a collet chuck is positioned, further including a threaded collet nut positioned over said collet chuck and installed onto said sleeve by use of a threaded end of said graft sleeve.
Straubinger teaches wherein said size-decreasing structure includes one or more graft sleeves coupled to a housing,
each graft sleeve defining a conical internal sleeve structure into which a collet chuck is positioned, [Fig. 44b., element 120 (conical internal sleeve housing structure) and 110.1 to 110.n (clamping jaw/chuck)] and [Pg. 73, lines 29-32]-reference discusses internal conical housing structure and [Pg. 72, lines 15-29]-reference to the housing having a sleeve-like member, and [Pg. 15, lines 9-12;] reference to the actuation mechanism utilizing a “clamping chuck” which is interpreted to embody the collet chuck.
further including a threaded collet nut positioned over said collet chuck and installed onto said sleeve by use of a threaded end of said graft sleeve [Pg. 46, lines 9-14; “the circumferential surface of the at least partly cylindrical housing part 54 …. is threaded at least partly such as to clamp the first end section … to the at least partly cylindrical housing part 54 of the compressing mechanism 10a.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perreault which discusses varying diameters of a stent and increasing flexibility during the crimping process [0006-0007] with Straubinger because Straubinger teaches the simplification of the compression process by providing the clamping, funnel-shaped interior area, and rotation of the compressing area [Pg. 19, lines 6-12].
Regarding Claim 4, Perreault is silent on wherein a last compression stage in said serial coupled compression stages includes an exit producing a compressed unit further comprising a storage unit coupled to said exit configured to receive said compressed unit as a received compressed unit and further configured to retain said received compressed unit in a compressed mode.
Straubinger teaches wherein a last compression stage in said serial coupled compression stages includes an exit producing a compressed unit further comprising a storage unit coupled to said exit configured to receive said compressed unit as a received compressed unit [Pg. 76-77, lines 35-2] and [Fig. 11a, elements 105, 107]—In this embodiment, the stent is ejected from device 10 (the compressing device) and loaded out of an exit of 10 into the catheter tip (the storage unit).
and further configured to retain said received compressed unit in a compressed mode. [Pg. 76-77, lines 35-2; “The distal end….compressed to its final diameter can be introduced into stent holder…by means of compressing mechanism 10.”]
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perreault which discusses varying diameters of a stent and increasing flexibility during the crimping process [0006-0007] with Straubinger because Straubinger teaches the simplification of the compression process by providing the clamping, funnel-shaped interior area, and rotation of the compressing area [Pg. 19, lines 6-12].
Regarding Claim 5, Perreault teaches wherein each said compression facility includes a set of rollers, [Fig. 11, element 70]
each said roller including an arcuate indentation, [Fig. 9, element 21 (mount), 43 (teeth]
with said set of rollers of each said compression stage defining a size-decreasing aperture [0072; “The mount 21 may comprise a gear and include teeth 42 which fit in corresponding teeth 43 in the spline gear 45.”] and [0074]-Describes rollers being in mechanical communication with the mount of each crimping section. In this interpretation, the rollers and mounts are considered to define a size-decreasing aperture both rolling mechanisms of 70 and 21 are considered to be of an arcuate indentation since they comprise teeth to interface.
Regarding Claim 6, Perreault is silent on wherein said size-decreasing structure includes a pair of unit holders having a separation distance between them and a force applicator configured to increase said separation wherein an increase of said separation is configured to produce a size-decreased unit responsive to a tensioning of the unit.
Straubinger teaches wherein said size-decreasing structure includes a pair of unit holders having a separation distance between them [Pg. 42, lines 4-6]-reference describes clamping jaws, considered the unit holders, displaced in a longitudinal direction.
and a force applicator configured to increase said separation [Pg. 42, lines 4-6]-includes tensioning screw, interpreted as the force applicator, which moves in a longitudinal axis to interact with the clamping jaws
wherein an increase of said separation is configured to produce a size-decreased unit responsive to a tensioning of the unit [Pg. 15, lines 21-25]-Describes the tensioning screw and clamping jaw interaction to enable cross-sectional diameter to match that of a set value. [Pg. 44, lines 24-31]-Includes reference to the cross-section of the stent reduced as a result of the compressing mechanism described.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perreault which discusses varying diameters of a stent and increasing flexibility during the crimping process [0006-0007] with Straubinger because Straubinger teaches the simplification of the compression process by providing the clamping, funnel-shaped interior area, and rotation of the compressing area [Pg. 19, lines 6-12].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perreault (U.S. 20050029670) in view of Dancu (U.S. 20090007923).
Regarding Claim 7, Perreault is silent on wherein said size-decreasing structure includes a pair of unit holders having a relative rotation angle between them and a force applicator configured to increase said rotation angle wherein an increase of said rotation angle is configured to produce a size-decreased unit responsive to a torsioning of the unit.
Dancu teaches wherein said size-decreasing structure includes a pair of unit holders having a relative rotation angle between them [0097]-In this interpretation, the mounting tubes and positions are considered the unit holder with described axis of rotation included.
and a force applicator configured to increase said rotation angle [Fig. 7A-C, element 17] with the drive system providing axial torsion on these mounting systems.
wherein an increase of said rotation angle is configured to produce a size-decreased unit responsive to a torsioning of the unit [0096]-Includes rotation angle increasing up to 360° but also can be limited to avoid the structure stretching to the point that the diameter decrease and causes buckling. And [0099] which includes the torsion/twisting movement along the Y axis.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perreault which describes a rotation mechanism corresponding to the mount in which movement can be driven by a drive device [0053] with Dancu because Dancu teaches mount positions being movable in up to 3 dimensions [0097].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Nir et al. (U.S. 11547544)-Includes storage means for a crimped valve.
-Nyull et al. (WO 2013177684)-Describes an actuation mechanism to decrease a discrete section of an implant.
-Davis et al. (WO 2012177777)-Reference describes a device and method of loading a stent into a crimping device to compress its diameter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791