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 “release element” 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.
Claim Objections
Claim 35 is objected to because of the following informalities:
Claim 17 recites “comprising” in line 2, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read “comprising:”;
Claim 35 recites “the actuation wheel has a tooth-like contour at its outer periphery” in line 2, although the line is understood by the Examiner to mean “the actuation wheel has a tooth-like contour at an outer periphery thereof” as the term “its” is understood to mean “the actuation wheel”, the Examiner suggests the line be amended to read “the actuation wheel has a tooth-like contour at an outer periphery thereof” for the purpose of maintaining consistent language throughout the claims;
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:
the generic placeholders are “a release element” in claim 1, which is coupled to the functional language “releasing the implant”, “a transmission element” in claim 1, which is coupled to the functional language “transmit movement to the release element“, and “an actuation element” in claim 1, which is coupled to the functional language “causing movement of the transmission element“. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “release element” in claim 1 will be read a middle catheter (which is the disclosed corresponding structure, as described in lines 28 – 30 on Page 2 of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way), the “transmission element” in claim 1 will be read as a rigid rod, flexible rod, chain, and/or a rigid rod, flexible rod, chain that encloses the release element (which is the disclosed corresponding structure, as described in lines 15 – 30 on Page 3 of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way), and the “actuation element” in claim 1 will be read as a wheel or a slidable knob (which is the disclosed corresponding structure, as described in lines 13 – 18 on Page 12 of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
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.
Claims 17 – 41 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.
Regarding claims 17 and 28, the phrase "a movement of the transmission element" in lines 11 and 3, respectively, renders the claim indefinite because it is unclear if Applicant is intending for the “movement of the transmission element”, defined in the lines above and caused by the actuation element, to be the same “movement” as the “movement of the transmission element” that is transmitted to the release element (defined in lines 7 – 8 of Claim 17) or if Applicant is intending for the “movement of the transmission element” caused by the actuation element to be different from the “movement of the transmission element” that is transmitted to the release element. For the purpose of examination, based on Applicant’s disclosure, the Examiner will read the “movement of the transmission element” caused by the actuation element to be the same “movement of the transmission element” that is transmitted to the release element. If Applicant is intending for the phrase to mean the same as the Examiner’s interpretation, the Examiner suggests the phrase “a movement of the transmission element” in lines 11 and 3 of claims 17 and 28, respectively, be amended to read “the movement of the transmission element”.
Regarding claim 23, the phrase “wherein the transmission element extends into the catheter at least before the start of the release of the implant” renders the claim indefinite because it is unclear if Applicant is intending to positively recite the “catheter”, which was only functionally recited in claim 17, or if Applicant is intending to only functionally require the catheter, such that the “transmission element is configured to extend into the catheter at least before the start of the release of the implant”. Furthermore, the phrase “before the start of the release of the implant” renders the claim indefinite because it is unclear at which point Applicant is intending to claim the device. For the purpose of examination, the Examiner will read the claim such that the “catheter” is positively recited, wherein the transmission element is within the catheter prior to the implant being released.
Claims 18 – 41 are rejected for being dependent on an indefinite claim.
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 17 – 19, 24, 27, 28, 32, 35, 40, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Logan et al (US 2021/0100672 A1).
Regarding claim 17, Logan discloses a hand-held unit (stent delivery device / system 10) for feeding an implant (stent 28) and for releasing the implant by means of a release element (deployment sheath 16) (abstract, paragraphs [0045 – 0057], and Figs. 1 – 6), said hand-held unit (stent delivery device / system 10) comprising:
a housing (handle 14) that has a housing opening (top opening through which actuation member 20 extends – Figs. 3 – 6) and a connection section (opening in the distal end of handle 14) for attaching an outer catheter layer (shaft 12) of a catheter (shaft 12) to the housing and for guiding the release element (deployment sheath 16) from an interior of the housing into the catheter so that the release element (deployment sheath 16) is movable relative to the outer catheter layer (shaft 12) (paragraphs [0049 – 0057], and Figs. 3 – 6),
a transmission element (threaded rod 36 and coupling member 46) [claim 18] configured as a rigid rod (threaded rod 36 is a rigid rod) that is connected to the release element (deployment sheath 16) in order to transmit a movement of the transmission element to the release element (paragraph [0051]), and
an actuation element (actuation member 20) [claim 27] configured as a rotatably supported actuation wheel that is rotatably supported in the housing (handle 14) and that can be actuated from outside the housing through the housing opening (paragraphs [0055 – 0057] and Figs. 3 – 6), wherein a movement of the actuation element causes a movement of the transmission element (threaded rod 36 and coupling member 46) (paragraphs [0055 – 0057] and Figs. 3 – 6);
[claim 19] wherein the transmission element (threaded rod 36 and coupling member 46) is provided with a plurality of engagement sections (threads) for a drive gear (gear 44) (paragraphs [0055 – 0057] and Figs. 3 – 6);
[claim 24] the actuation element (actuation member 20) partly projects through the housing opening (opening at the top of handle 14) (Figs. 3 – 6);
[claim 28] further comprising a drive gear (gear 44) that is rotatably supported in the housing and that is in engagement with the transmission element (threaded rod 36 and coupling member 46) to cause a movement of the transmission element (threaded rod 36 and coupling member 46) during a rotary movement of the drive gear (paragraphs [0055 – 0057] and Figs. 3 – 6), wherein the actuation wheel and the drive gear have corresponding torque transmission sections (contact surfaces) that are in engagement with one another (Examiner’s note: as stated in paragraphs [0051] and [0055 – 0057] the gear 44 is engaged with the actuation member 20 (i.e., the actuation wheel), and the gear 44 (when rotated by the actuation member 20) rotates the threaded rod 36. Therefore, because the torque from the actuation member 20 (i.e., the actuation wheel) transfers to the threaded rod 36 via the gear 44, the gear 44 and the actuation member 20 (i.e., the actuation wheel) must have corresponding surfaces that contact each other in order to transmit said torque and therefore, the two structures have corresponding torque transmission sections);
[claim 32] the housing (handle 14) comprises a guide (opening in the proximal end 42) for guiding an inner catheter layer (inner catheter 23) out of the interior of the housing (Examiner’s note: Applicant’s disclosure discloses the “guide” as the opening in the proximal face of the proximal end of the housing; therefore, to match what Applicant is considering as “the guide”, the Examiner is considering the opening in the proximal face of the proximal end of the handle, which receives a portion of the inner catheter 23, as the guide; and said opening is capable of guiding the inner catheter 23);
[claim 35] wherein the actuation wheel (actuation member 20) has a tooth-like contour at its outer periphery (Figs. 3 – 6);
[claim 40] the guide (opening in the proximal end 42) and the connection section (opening in the distal end of handle 14) are arranged at oppositely disposed ends of the housing (Figs. 3 – 6);
[claim 41] the transmission element (threaded rod 36 and coupling member 46) encloses the release element (deployment sheath 16) (Examiner’s note: as stated in paragraph [0060] the coupling member 46 encloses a portion the proximal end of the deployment sheath 16 (i.e., the release element) via aperture 52).
Claims 17 – 22, 24, 27, 33, 35, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Randall et al (US 2007/0060999 A1).
Regarding claims 17 – 22, 24, 33, 35, and 41, Randall discloses a hand-held unit (catheter system – Fig 1) for feeding an implant (stent – not shown; discussed in paragraph [0033]) and for releasing the implant by means of a release element (outer sheath 262) (abstract, paragraphs [0033 – 0034], [0047], [0050], and Figs. 1, 2), said hand-held unit (catheter system) comprising:
a housing (handle 210) that has a housing opening (side opening through which 660 extends – Fig. 2) and a connection section (opening in the distal end of handle 210) for attaching an outer catheter layer (protection sleeve 620) of a catheter (protection sleeve 620) to the housing and for guiding the release element (outer sheath 262) from an interior of the housing into the catheter so that the release element (outer sheath 262) is movable relative to the outer catheter layer (protection sleeve 620) (paragraphs [0050 – 0051], and Figs. 1,2),
a transmission element (belt/chain segment 670 and slide block 624) [claim 18] configured as a chain (paragraph [0052]) that is connected to the release element (outer sheath 262) in order to transmit a movement of the transmission element to the release element (paragraph [0052] and Fig. 2), and
an actuation element (knobs 640/650) [claim 27] configured as a rotatably supported actuation wheel that is rotatably supported in the housing (handle 210) (paragraph [0055] and Figs. 1,2) and that can be actuated from outside the housing through the housing opening (paragraph [0055] and Figs. 1,2), wherein a movement of the actuation element causes a movement of the transmission element (belt segment 670 and slide block 624) (paragraphs [0051 – 0052], [0054 – 0056], and Fig. 2);
[claim 19] wherein the transmission element (belt segment 670 and slide block 624) is provided with a plurality of engagement sections (links in the chain) for a drive gear (pulley 656) (Examiner’s note: as stated in paragraph [0052] the belt is a chain, and a chain comprises a plurality of links (i.e., engagement sections) that are moveable together; furthermore, as stated in paragraph [0056] and shown in Fig. 3A the belt wraps / is for the pully 656 (i.e., the drive gear));
[claim 20] wherein the transmission element (belt segment 670 and slide block 624) has a plurality of links that adjoin one another and are movable relative to one another (Examiner’s note: as stated above and in paragraph [0052] the belt 670 is a chain, and a chain is made up of multiple links adjoined together which are moveable relative to each other);
[claims 21 and 22] a guide element (idler pulley 638), which is arranged in the housing, for the transmission element (belt segment 670 and slide block 624) (paragraph [0053] and Fig. 2), wherein the guide element (idler pulley 638) has a deflection region (surfaces of idler pulley 638) arranged at one housing end (proximal end) (Examiner’s note: the idler pulley 638, as shown in Fig. 2, deflects the belt segment 670 from the proximal end of the handle towards the distal end of the handle);
[claim 24] the actuation element (knobs 640/650) partly projects through the housing opening (opening at the top of handle 210) (Examiner’s note: the knob axle 660 is a part of the knobs 640/650 (i.e., the actuation element) and extends through the side opening (i.e., the housing opening) as shown in Fig. 1);
[claim 33] the guide element (idler pulley 638) and the connection section (distal end of the handle 210) are arranged at oppositely disposed ends of the housing (Fig. 2);
[claim 35] wherein the actuation wheel (knobs 640/650) has a tooth-like contour at its outer periphery (paragraph [0055] and Fig. 1);
[claim 41] the transmission element (belt segment 670 and slide block 624) encloses the release element (outer sheath 626) (Examiner’s note: as stated in paragraph [0051] the slide block 624 comprises an enclosed passageway for the outer sheath 626; therefore, the transmission element encloses the release element as claimed).
Claims 17, 21, 22, 24 – 27, 29, 30, and 32 – 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez et al (US 2007/0168014 A1).
Regarding claims 17, 21, 22, 24 – 27, 32 – 35, and 40, Jimenez discloses a hand-held unit (stent delivery device / system 100) for feeding an implant (stent 160) and for releasing the implant by means of a release element (outer tubular member 124) (abstract, paragraphs [0043 – 0046], [0048], [0054 – 0064], and Figs. 1 – 4, 9 – 14), said hand-held unit (stent delivery device / system 100) comprising:
a housing (handle 102) that has a housing opening (top opening through which thumbwheel 106 extends – Figs. 1 – 3) and a connection section (opening in the distal end of handle 102 – Fig. 3) for attaching an outer catheter layer (stability sheath 122) of a catheter (stability sheath 122) to the housing and for guiding the release element (outer tubular member 124) from an interior of the housing into the catheter so that the release element (outer tubular member 124) is movable relative to the outer catheter layer (stability sheath 122) (paragraphs [0049 – 0057], and Figs. 1 – 4),
a transmission element (cord 180 and slider 152) that is connected to the release element (outer tubular member 124) in order to transmit a movement of the transmission element to the release element (paragraph [0055]), and
an actuation element (thumbwheel 106) [claim 27] configured as a rotatably supported actuation wheel that is rotatably supported in the housing (handle 102) and that can be actuated from outside the housing through the housing opening (paragraphs [0055 – 0058] and Figs. 1 – 10), wherein a movement of the actuation element causes a movement of the transmission element (cord 180 and slider 152) (paragraphs [0055 – 0058]);
[claims 21 and 22] to further comprising a guide element (anchor 148 of inner frame 146) with a deflection region (surface of anchor 148) at one end (proximal end) of the housing (handle 102) (paragraph [0069] and Figs. 2, 3, 14), which is arranged in the housing, for the transmission element (cord 180 and slider 152);
[claim 24] the actuation element (thumbwheel 106) partly projects through the housing opening (opening at the top of handle 102) (Figs. 1 – 3);
[claims 25, 26, and 34] wherein the housing (handle 102) has a second housing opening (bottom opening of the handle 102 – Figs. 1 – 3), wherein the actuation element (thumbwheel 106) can additionally be actuated from outside the housing through the second housing opening (the thumbwheel can be actuated from both sides), wherein the housing openings are arranged at oppositely disposed sides of the housing and wherein the actuation element (thumbwheel 106) partly projects through the second housing opening (Figs. 1 – 3);
[claim 32] the housing (handle 102) comprises a guide (opening in the proximal end) for guiding an inner catheter layer (inner tubular member 128 with rigid are 156) out of the interior of the housing (paragraph [0051] and Fig. 3) (Examiner’s note: Applicant’s disclosure discloses the “guide” as the opening in the proximal face of the proximal end of the housing; therefore, to match what Applicant is considering as “the guide”, the Examiner is considering the opening in the proximal face of the proximal end of the handle, which receives a portion of the inner tubular member 128, as the guide; and the opening is capable of guiding the inner tubular member 128);
[claim 33] wherein the guide element (anchor 148) and the connection section (distal end of handle 102) are arranged at oppositely disposed ends of the housing (Figs. 2 and 3);
[claim 35] wherein the actuation wheel (thumbwheel 106) has a tooth-like contour at its outer periphery (Figs. 1 – 3);
[claim 40] the guide (opening in the proximal end) and the connection section (opening in the distal end of handle 102) are arranged at oppositely disposed ends of the housing (Fig. 3).
Regarding claims 17, 29, 30, and 36 – 39, (alternate interpretation – changes italicized) Jimenez discloses a hand-held unit (stent delivery device / system 100) for feeding an implant (stent 160) and for releasing the implant by means of a release element (outer tubular member 124) (abstract, paragraphs [0043 – 0046], [0048], [0054 – 0064], and Figs. 1 – 4, 9 – 14), said hand-held unit (stent delivery device / system 100) comprising:
a housing (handle 102) that has a housing opening (top opening through which thumbwheel 106 extends – Figs. 1 – 3) and a connection section (opening in the distal end of handle 102 – Fig. 3) for attaching an outer catheter layer (stability sheath 122) of a catheter (stability sheath 122) to the housing and for guiding the release element (outer tubular member 124) from an interior of the housing into the catheter so that the release element (outer tubular member 124) is movable relative to the outer catheter layer (stability sheath 122) (paragraphs [0049 – 0057], and Figs. 1 – 4) (Examiner’s note: it should be understood that the phrase “connection section for attaching … and for guiding” is an intended use limitation, which requires only that the structure of the prior art (i.e., the connection section) be capable of functioning in the manner claimed),
a transmission element (cord 180 and slider 152) that is connected to the release element (outer tubular member 124) in order to transmit a movement of the transmission element to the release element (paragraph [0055]), and
an actuation element (deployment lever 108) that is displaceably supported in the housing (handle 102) and that can be actuated from outside the housing through the housing opening (paragraph [0067] and Figs. 1, 3 - 5), wherein a movement of the actuation element causes a movement of the transmission element (cord 180 and slider 152) (paragraph [0067]);
[claim 29] wherein the actuation element (deployment lever 108) is configured as a displaceably supported sliding knob (deployment lever 108) (paragraph [0067– 0069]);
[claim 30] wherein the sliding knob (deployment lever 108) is connected to the transmission element (cord 180 and slider 152) (paragraphs [0067 – 0069] and Fig. 9);
[claims 36, 37, and 38] wherein the sliding knob (deployment lever 108) has a contact surface (top surface – looking at Fig. 4) for actuation with a finger wherein the contact surface has a textured, knurled, surface (Examiner’s note: the definition of ‘knurled surface’ is a surface with a series of small ridges; and as shown in Fig. 4 the deployment lever 108 (i.e., the sliding knob) has a textured surface with a series of small ridges);
[claim 39] wherein the sliding knob (deployment lever 108) is connected to the transmission element (cord 108 and slider 152) in a form-fitting manner (Examiner’s note: as shown in Fig. 9 the passage 108A of the deployment lever 108 (i.e., the sliding knob) has a ridge / channel and an opening that matches the curvature and size of the cord 108 (i.e., the transmission element), therefore, the deployment lever 108 is connected by matching the form of the cord 108 (i.e., the transmission element); thus the connection is a form-fitting connection).
Claims 17, 18, 23, 29, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palermo (US 2022/0346994 A1) (priority date of March 4th 2020).
Regarding claims 17, 18, 23, 29, and 30, Palermo discloses a hand-held unit (deployment tool 20) for feeding an implant (vascular connector 10) and for releasing the implant by means of a release element (inner sheath 28) (abstract, paragraphs [0039 – 0042], and Fig. 2), said hand-held unit (deployment tool 20) comprising:
a housing (housing 22) that has a housing opening (proximal face opening – Fig. 2) and a connection section (opening in the distal end of housing 22 – Fig. 2) for attaching an outer catheter layer (outer sheath 26) of a catheter (outer sheath 26) to the housing and for guiding the release element (inner sheath 28) from an interior of the housing into the catheter so that the release element (inner sheath 28) is movable relative to the outer catheter layer (outer sheath 26) (paragraph [0039]),
a transmission element (proximal portion of inner sheath 28 with external threads 40 – Fig. 2) that is connected to the release element (inner sheath 28) in order to transmit a movement (sliding movement) of the transmission element to the release element (paragraphs [0039] and [0043]), and
an actuation element (nut drive 24) that is displaceably supported in the housing (housing 22) (Fig. 2) and that can be actuated from outside the housing through the housing opening (Examiner’s note: the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the actuation element (nut drive 24) can be actuated from the outside of the housing 22 via the opening in the proximal face), wherein a movement (sliding movement) of the actuation element (drive nut 24) causes a movement (rotational movement) of the transmission element (proximal portion of inner sheath 28 with external threads 40) (paragraphs [0039] and [0043] and Fig. 2);
[claim 18] wherein the transmission element (proximal portion of inner sheath 28 with external threads 40) is configured as a rigid rod or a flexible rod (Examiner’s note: the proximal portion of inner sheath 28 with external threads 40 is a rod and is either rigid or flexible there is no other option);
[claim 23] wherein the transmission element (proximal portion of inner sheath 28 with external threads 40) extends into the catheter (outer sheath 26) at least before the start of the release of the implant (Fig. 2);
[claim 29] wherein the actuation element (nut drive 24) is configured as a displaceably supported sliding knob (Examiner’s note: the nut drive 24 slides along the external threads of external thread portion of the inner sheath 28 in order to impart the rotation thereto; therefore, the nut drive 24 is a sliding knob);
[claim 30] wherein the sliding knob (nut drive 24) is connected to the transmission element (proximal portion of inner sheath 28 with external threads 40) (paragraph [0039] and Fig. 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 31 rejected under 35 U.S.C. 103 as being unpatentable over Palermo (US 2022/0346994 A1) (priority date of March 4th 2020).
Regarding claim 31, as discussed above, Palermo discloses the hand-held unit of claim 29, wherein the hand-held unit comprises a slidable knob (drive nut 24). Additionally, Palermo discloses wherein the housing (housing 22) has two grooves (guides 36) that extend along a direction of movement of the sliding knob (drive nut 24) and that engage with two tabs (projections 34) at oppositely disposed sides of the sliding knob (drive nut 24) in order to guide the sliding knob (paragraph [0039] and Fig. 2). Although, Palermo is silent regarding the tabs being on the housing and the grooves being on the sliding knob, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the housing of Palermo to have the tabs that extend into the grooves on the slidable knob of Palermo, as claimed, as the modification is merely reversing the location of the grooves and tabs, and one of ordinary skill in the art would have a reasonable expectation of success making such a modification as the results of the modification would have been predictable and led to the modified device being able to operate as intended.
Allowable Subject Matter
The following claim 17 drafted by the examiner and considered to distinguish patentably over the art, is presented to applicant for consideration:
17. A hand-held unit for feeding an implant and for releasing the implant by means of a release element, said hand-held unit comprising:
a housing that has a housing opening and a connection section coupling an outer catheter layer of a catheter to the housing and for guiding the release element from an interior of the housing into the catheter so that the release element is movable relative to the outer catheter layer,
a transmission element that is connected to the release element in order to transmit a movement of the transmission element to the release element, and
an actuation element that is rotatably or displaceably supported in the housing and that can be actuated from outside the housing through the housing opening, wherein a movement of the actuation element causes the movement of the transmission element ;
wherein the transmission element extends into the catheter prior to the implant being released by the release element; and
wherein the transmission element is provided with a plurality of engagement sections which encloses at least a portion of the release element.
The prior art alone or in combination with fails to teach or make obvious a hand-held unit for delivering a stent comprising, inter alia, a release element slidably received within a handle attached and an outer catheter attached to the handle, wherein the handle comprises an actuation element moveably supported therein configured to cause movement of a transmission element, located within the handle and connected to the release element, which is configured to transmit the movement to the release element; wherein the transmission element extends into the catheter and comprises a plurality of engagement sections that enclose a portion of the release element.
The closest prior art, those listed in the rejections above, teach a hand-held unit for delivering a stent comprising, inter alia, a release element slidably received within the handle attached and an outer catheter attached to the handle, wherein the handle comprises an actuation element moveably supported therein configured to cause movement of a transmission element, located within the handle and connected to the release element, which is configured to transmit the movement to the release element (see the rejections above for a more detailed description of how each of the prior arts teaches the above limitations). However, the prior art fails to teach or make obvious wherein the transmission element extends within the housing and into the outer catheter while also enclosing the release element within a plurality of sections. Furthermore, it would not be obvious to modify any of the above prior used in the rejections above, to have the transmission element and release element as proposed by the Examiner, as there is no motivation to do so. Additionally, no other references, or reasonable combination thereof, could be found which discloses or suggests these features in combination with other limitations in the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Longo et al (US 2021/0196494 A1), Wu et al (US 2005/0060016 A1), Lowe et al (US 2005/0232961 A1), Sawada (US 2013/0184805 A1), Morris et al (US 2013/0297011 A1), and Buzzard et al (US 2003/0167060 A1) teach medical device implant delivery systems comprising a handle, an (inner) release element, an outer catheter / tube, a transmission element, and an actuation element for transmitting movement to the transmission element and to the release element.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771