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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on 12/02/2024. As directed by the amendment: claims 2-20 have been added. Thus, claims 1-20 are presently pending in this application.
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 “wherein one of said inner ring and said outer ring of each plane is connected to an inner ring or an outer ring, respectively, of an adjacent plane”, “wherein the outer ring of each of the plurality of C-shaped layers is connected to the outer ring of an adjacent C-shaped layer of the plurality of C-shaped layers”, and “wherein the inner ring of each of the plurality of C-shaped layers is connected to the inner ring of an adjacent C-shaped layer of the plurality of C-shaped layers” 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 14 is objected to because of the following informalities:
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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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “heater means for severing a tether” and “outer capsule means” in claim 20.
The claim limitation “heater means for severing a tether” does not invoke USC 112(f) as means is further modified by “heater” which is understood in the art to mean a heater element or coil.
The claim limitation “outer capsule means” does not invoke USC 112(f) as means is further modified by “outer capsule”, which is sufficient structure.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
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.
Claim(s) 1-7 and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowman (US 20150289879 A1), herein referenced to as “Bowman” in view of Ramzipoor et al (US 20060271097 A1), herein referenced to as “Ramzipoor”.
Claim 1
Bowman discloses: An implant delivery system (see Figs. 19-24, [0147]) comprising: a pusher 700 (see Figs. 19-24, [0147]); a heater capsule 701 + 702 + 704 (see Figs. 19-24, [0147] and [0152]) at a distal end distal end of 700 of the pusher 700 and including: an outer capsule 701 + 702 (see Fig. 19-24, [0152]); a heater element 704 (see Figs. 19-24, [0147]), said heater element 704 further having an electrical connection (see Fig. 20, [0147] and [0151]-[0152], 706 goes through 702 and 701, hence an electrical connection) to said outer capsule 701; a first lead wire 708 (see Figs. 19-20, [0149]) connected to said heater element 704; a second lead wire 706 (see Figs. 19-20, [0149]) connected to said outer capsule 701.
Bowman does not explicitly disclose: defining a plurality of planes, each plane including an inner ring and an outer ring, wherein one of said inner ring and said outer ring of each plane is connected to an inner ring or an outer ring, respectively, of an adjacent plane.
However, Ramzipoor in a similar field of invention teaches an implant delivery system (see Fig. 7) with a heater element 40 (see Fig. 7). Ramzipoor further teaches: defining a plurality of planes (see annotated Fig. 7 below), each plane (see annotated Fig. 7 below) including an inner ring a single c-shaped part of 70 (see Fig. 7, [0061], as 70 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape) and an outer ring a single c-shaped part of 40 (see Fig. 7, [0061], as 40 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape), wherein one of said inner ring 40 and said outer ring 70 of each plane is connected to an inner ring 40 or an outer ring 70, respectively, of an adjacent plane (see annotated Fig. 7 below, each of the interior plurality of planes has each inner ring 40 connects to an adjacent inner ring 40 and each outer ring 70 connects to another outer ring 70).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bowman to incorporate the teachings of Ramzipoor and teach an implant delivery system with the heater element defining a plurality of planes, each plane including an inner ring and an outer ring, wherein one of said inner ring and said outer ring of each plane is connected to an inner ring or an outer ring, respectively, of an adjacent plane. Motivation for such can be found in Ramzipoor as this allows for a focused erosion through the thickness of the electrically conductive portions (see [0046]).
Claim 2
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Bowman further discloses: wherein said first lead wire 708 comprises a positive lead wire (see [0149], the wires are oppositely polarized, such that when 706 is negative, 708 is positive).
Claim 3
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Ramzipoor further teaches: further comprising at least one insulative layer (see [0061], 40 is electrically insulated, hence the coil is covered with an insulated layer between its windings and the core conductive material, see also [0062]) disposed between two of said planes (see annotated Fig. 7 below claim 1).
Claim 4
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Bowman further discloses: wherein said heater element 704 defines an internal passage (see Figs. 19-20, 704 has an internal passage, which a tether can extend through, see also Fig. 26F, [0157]).
Claim 5
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 4, see 103 rejection above. Bowman further discloses: wherein said internal passage is sized to receive a tether 715 (see Figs. 19-20, 704 has an internal passage, which a tether can extend through, see also Fig. 26F, [0157]).
Claim 6
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Bowman further discloses: wherein said outer capsule 702 includes tabs distal 704b + slit of 702 (see Fig. 20, [0149] and [0151], meets the definition of a tab according to Merriam-Webster online dictionary as “a short projecting device: such as a small flap or loop by which something may be grasped or pulled”, in this case 704B is a loop and the slit of 702 forms flaps) used for electrically attaching said second lead wire 706 to said outer capsule 701.
Claim 7
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Bowman further discloses: wherein said heater element 704 includes tabs proximal 704B (see Fig. 20, [0149] and [0151], meets the definition of a tab according to Merriam-Webster online dictionary as “a short projecting device: such as a small flap or loop by which something may be grasped or pulled”, in this case 704B is a loop) used for electrically attaching said first lead wire 708 to said heater element 704.
Claim 10
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Ramzipoor further teaches: wherein each of the plurality of planes (see annotated Fig. 7 below) is comprised of a C-shape (as 70 + 40 forms a helical coils, when a transverse section is taken from it, it is not fully circular, they are not fully circular because their pitch has them angled at an angle less than 90 degrees from the longitudinal axis, hence when a transverse plane is taken, a c-shape is formed instead of a ring).
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Claim 11
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. Ramzipoor further teaches: wherein the C-shape (see annotated Fig. 7 below claim 1) is transverse to a longitudinal axis the longitudinal axis of 40 + 70 (see Fig. 7 of the heater element 40 + 70.
Claim 12
Bowman discloses: A heater capsule 701 + 702 + 704 (see Figs. 19-24, [0147] and [0152]) for an implant delivery system (see Figs. 19-24, [0147]), comprising: a heater element 704 (see Figs. 19-24, [0147]); and an outer capsule 701 + 702 (see Fig. 19-24, [0152]) at least partially surrounding the heater element 704 (see Fig. 20, 701 + 702 surrounds 704).
Bowman does not explicitly disclose: the heater element comprising a plurality of C-shaped layers; wherein each of the plurality of C-shaped layers comprises an outer ring and an inner ring.
However, Ramzipoor in a similar field of invention teaches an implant delivery system (see Fig. 7) with a heater element 40 + 70 (see Fig. 7) and an outer capsule 15 (see Fig. 7). Ramzipoor further teaches: the heater element 40 + 70 comprising a plurality of C-shaped layers (see annotated Fig. 7 below, as 70 + 40 forms a helical coils, when a transverse section/layer is taken from it, it is not fully circular, they are not fully circular because their pitch has them angled at an angle less than 90 degrees from the longitudinal axis, hence when a transverse plane is taken, each layer forms a c-shape is formed instead of a ring), wherein each of the plurality of C-shaped layers (see annotated Fig. 7 below) comprises an outer ring a single c-shaped part of 40 (see Fig. 7, [0061], as 40 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape) and an inner ring a single c-shaped part of 70 (see Fig. 7, [0061], as 70 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bowman to incorporate the teachings of Ramzipoor and teach a heater capsule with the heater element comprising a plurality of C-shaped layers; wherein each of the plurality of C-shaped layers comprises an outer ring and an inner ring. Motivation for such can be found in Ramzipoor as this allows for a focused erosion through the thickness of the electrically conductive portions (see [0046]).
Claim 13
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Ramzi further teaches: wherein the plurality of C-shaped layers (see annotated Fig. 7 below claim 12) define a slot a slot is formed through 32 extends in the middle of 40 and 70 (see Fig. 7) extending parallel to a longitudinal axis the longitudinal axis of 40 + 70 of the heater element 40 + 70.
Claim 14
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Ramzi further teaches: wherein the plurality of C-shaped layers (see annotated Fig. 7 below claim 12) are each transverse (see annotated Fig. 7 below claim 12, and claim 12 above) to a longitudinal axis the longitudinal axis of 40 + 70 of the heater element 40 + 70.
Claim 15
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Bowman further discloses: wherein the heater element 704 is electrically connected (see Fig. 20, [0147] and [0151]-[0152], 706 goes through 702 and 701, hence an electrical connection) to the outer capsule 701 + 702.
Claim 16
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Ramzipoor further teaches: wherein the outer ring a single c-shaped part of 40 of each of the plurality of C-shaped layers (see annotated Fig. 7 below claim 12) is connected to the outer ring an adjacent single c-shaped part of 40 of an adjacent C-shaped layer (see annotated Fig. 7 below claim 12) of the plurality of C-shaped layers (see annotated Fig. 7 below claim 12, 40 is a pitched coil hence it is connected series of c-shaped rings).
Claim 17
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Ramzipoor further teaches: wherein the inner ring a single c-shaped part of 70 of each of the plurality of C-shaped layers (see annotated Fig. 7 below claim 12) is connected to the inner ring an adjacent single c-shaped part of 70 of an adjacent C-shaped layer (see annotated Fig. 7 below claim 12) of the plurality of C-shaped layers (see annotated Fig. 7 below claim 12, 70 is a pitched coil hence it is connected series of c-shaped rings).
Claim 18
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. Ramzipoor further teaches: wherein, for each of the plurality of C- shaped layers (see annotated Fig. 7 below claim 12), the outer ring a single c-shaped part of 40 is connected to the inner ring a single c-shaped part of 70 (see Fig. 7, [0061] the two coils 40 + 70 are connected via 30, hence each outer ring 40 is indirectly connected to each inner ring 70).
Claim 19
The combination of Bowman and Ramzipoor teaches: The heater capsule of claim 12, see 103 rejection above. The combination of Bowman and Ramzipoor further teaches: wherein a distal-most outer ring distal 704B (see Fig. 20 of Bowman, [0149], 704b is also the distal-most ring of 704) of the plurality of C-shaped layers (modified by Ramzipoor to have C-shaped layers) includes a tab 704B (see Fig. 20, [0149] and [0151], meets the definition of a tab according to Merriam-Webster online dictionary as “a short projecting device: such as a small flap or loop by which something may be grasped or pulled”, in this case 704B is a loop), wherein the tab is electrically connected (see [0149], current is supplied to distal 704B via 706) to the outer capsule 701 + 702.
Claim 20
Bowman discloses: A heater capsule 701 + 702 + 704 (see Figs. 19-24, [0147] and [0152]) for an implant delivery system (see Figs. 19-24, [0147]), comprising: a heater means 704 (see Figs. 19-24, [0147]) for severing a tether 715 (see Fig. 26F, [0157]); and an outer capsule means 701 + 702 (see Fig. 19-24, [0152]) for protecting the heater means 704, wherein the outer capsule means 701 + 702 at least partially surrounds the heater means 704 (see Fig. 20, 701 + 702 surrounds 704); and wherein the heater means 704 is electrically connected (see Fig. 20, [0147] and [0151]-[0152], 706 goes through 702 and 701, hence an electrical connection) to the outer capsule 701 + 702.
Bowman does not explicitly disclose: wherein the heater means is comprised of a plurality of C-shaped layers; wherein each of the plurality of C-shaped layers comprises an outer ring and an inner ring.
However, Ramzipoor in a similar field of invention teaches an implant delivery system (see Fig. 7) with a heater means 40 + 70 (see Fig. 7) and an outer capsule means 15 (see Fig. 7). Ramzipoor further teaches: the heater means 40 + 70 is comprised of a plurality of C-shaped layers (see annotated Fig. 7 below, as 70 + 40 forms a helical coils, when a transverse section/layer is taken from it, it is not fully circular, they are not fully circular because their pitch has them angled at an angle less than 90 degrees from the longitudinal axis, hence when a transverse plane is taken, each layer forms a c-shape is formed instead of a ring), wherein each of the plurality of C-shaped layers (see annotated Fig. 7 below) comprises an outer ring a single c-shaped part of 40 (see Fig. 7, [0061], as 40 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape) and an inner ring a single c-shaped part of 70 (see Fig. 7, [0061], as 70 forms a helical coil, when a transverse section is taken from it, it is not fully circular, hence a c-shape).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bowman to incorporate the teachings of Ramzipoor and teach a heater capsule with the heater means comprising a plurality of C-shaped layers; wherein each of the plurality of C-shaped layers comprises an outer ring and an inner ring. Motivation for such can be found in Ramzipoor as this allows for a focused erosion through the thickness of the electrically conductive portions (see [0046]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bowman in view of Ramzipoor as applied to claim 1 above, and further in view of Dias et al (US 20170105739 A1), herein referenced to as “Dias”.
Claim 8 and Claim 9
The combination of Bowman and Ramzipoor teaches: The implant delivery system of claim 1, see 103 rejection above. The combination of Bowman and Ramzipoor does not explicitly teach: further comprising a stretch-resistant wire extending through said pusher to said outer capsule, wherein said outer capsule includes tabs used for attaching said stretch-resistant wire to said outer capsule.
However, Dias in a similar field of invention teaches a delivery device for an embolic coil 503 with an outer capsule 703 (see Figs. 7A-9E) and a pusher 907 (see Figs. 7A-9E, [0068], outer pusher assembly). Diaz further teaches: a stretch-resistant wire pull-wire (see annotated Fig. 8C below, [0061], pull-wire has tension, see [0019]) extending through said pusher 907 to said outer capsule 703, wherein said outer capsule 703 includes tabs (see annotated Fig. 8C below) used for attaching said stretch-resistant wire pull-wire (see annotated Fig. 8C below) to said outer capsule 703.
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Bowman and Ramzipoor to incorporate the teachings of Dias and have an implant delivery system with a stretch-resistant wire extending through said pusher to said outer capsule, wherein said outer capsule includes tabs used for attaching said stretch-resistant wire to said outer capsule. Motivation for such can be found in Dias as these tabs can prevent a small proximal force from unintentionally detaching the embolic coil (see [0064]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771