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 .
Reopening Prosecution
In view of the Pre-Appeal Brief Request for Review filed on 10/02/25, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Response to Amendment
The Amendment filed 2/18/25 has been previously entered. Claims 2- 19 and 21- 25 are being addressed by this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2- 19, 21- 22 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites the limitation “wherein the primary shape of the helical coil further simultaneously forms a secondary shape when unconstrained” in lines 3- 4. There is no support in the original disclosure for this limitation. Specifically, the word “simultaneously” is not found in the Specification and is not supported by the drawings.
Claims 3- 11, 21 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being dependent off of claim 2.
Claim 12 recites the limitation “wherein the primary shape of the helical coil further simultaneously forms a secondary shape when unconstrained” in lines 4- 5. There is no support in the original disclosure for this limitation. Specifically, the word “simultaneously” is not found in the Specification and is not supported by the drawings.
Claims 13- 19 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being dependent off of claim 12.
Claim Rejections - 35 USC § 102
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.
Claim(s) 2, 5, 12- 14, 17, 19, 21- 22 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choh (WO 00/18325). Choh is cited in the Final Office Action, mailed 6/21/24.
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Regarding claim 2, Choh discloses an embolic coil for delivery within a patient, comprising:
a wire (12) (Figs. 1C, 1D) forming a primary shape of a helical coil (Fig. 1C) (p. 13, l. 18- 20 - -In its first configuration, shown in FIGS. 1A and 1 C, the spring is wrapped more tightly, having a longer length L1 and more coils 14 and thus a smaller diameter D than in the second configuration shown in FIGS. 1 B and 1 D);
wherein the primary shape of the helical coil (Fig. 1C) further simultaneously forms a secondary shape (Fig. 1D) (p. 13, l. 20- 23 - - In the second configuration, shown in FIGS. 1 B and 1 D, the diameter D2 is greater than D1 and L2 is less than L1 because the spring has expanded, becoming less tightly wound and having fewer coils 14; it is noted that the configuration in Fig. 1D, having a different diameter, length and number of coils, is interpreted as a different shape than the configuration in Fig. 1C; it is further noted that during the process of deploying the helical coil, the helical coil will have a partially deployed configuration, wherein the part of the helical coil remaining within the delivery catheter has a primary shape (Fig. 1C) and, simultaneously, the part of the helical coil distal to the distal end of the delivery catheter further forms the secondary shape (Fig. 1D)) when unconstrained, the secondary shape (Fig. 1D) comprising a first loop (L1) (See Annotated Fig. 1D), a second loop (L2) (See Annotated Fig. 1D), and an inflection portion (29) (Figs. 1C, 1D) between the first loop (L1) and the second loop (L2) wherein the inflection portion (29) comprises a change in wind direction of the first loop (L1) relative to the second loop (L2) when in the secondary shape (Fig. 1D) (p. 13, l. 6- 8 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29);
wherein the wire (12) along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2) (p. 13, l. 6- 9 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29. Each segment has a free end 30 in which the filament 12 terminates in a bulbous tab 18; it is noted that since the first loop (L1) and second loop (L2) include bulbous tabs 18, which have a wider diameter than the remainder of the wire (12), the wire (12) along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2) at the bulbous tabs 18).
Regarding claim 5, Choh further discloses wherein the first loop (L1) is wound in a first rotational direction and the second loop (L2) is wound in a second rotational direction (See Annotated Fig. 1D) (p. 13, l. 6- 8 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29).
Regarding claim 12, Choh discloses an embolic coil for delivery within a patient, comprising:
a wire (12) (Figs. 1C, 1D) forming a primary shape of a helical coil (Fig. 1C) (p. 13, l. 18- 20 - -In its first configuration, shown in FIGS. 1A and 1 C, the spring is wrapped more tightly, having a longer length L1 and more coils 14 and thus a smaller diameter D than in the second configuration shown in FIGS. 1 B and 1 D);
wherein the wire (12) has regions of a larger diameter (L1, L2) (See Annotated Fig. 1D) and one or more regions of a smaller diameter (29) (Figs. 1C, 1D) (p. 13, l. 8- 9 - - Each segment has a free end 30 in which the filament 12 terminates in a bulbous tab 18; it is noted that since the first loop (L1) and second loop (L2) include a bulbous tab 18, which has a wider diameter than the remainder of the wire (12), the wire (12) along the inflection portion (29) is a region of a smaller in diameter and first loop (L1) and second loop (L2) include regions of a larger diameter at the bulbous tab 18);
wherein the primary shape of the helical coil (Fig. 1C) further simultaneously forms a secondary shape (Fig. 1D) (p. 13, l. 20- 23 - - In the second configuration, shown in FIGS. 1 B and 1 D, the diameter D2 is greater than D1 and L2 is less than L1 because the spring has expanded, becoming less tightly wound and having fewer coils 14; it is noted that the configuration in Fig. 1D, having a different diameter, length and number of coils, is interpreted as a different shape than the configuration in Fig. 1C; it is further noted that during the process of deploying the helical coil, the helical coil will have a partially deployed configuration, wherein the part of the helical coil remaining within the delivery catheter has a primary shape (Fig. 1C) and, simultaneously, the part of the helical coil distal to the distal end of the delivery catheter further forms the secondary shape (Fig. 1D)) when unconstrained;
wherein the regions of larger diameter of the wire (L1, L2) form a plurality of loops of the secondary shape (1D); and wherein one or more inflection portions (29) (Figs. 1C, 1D) of the secondary shape (1D) are each located between two of the plurality of loops (L1, L2) and form a change in wind direction between the two of the plurality of loops (L1, L2) and comprise one of the one or more regions of smaller diameter of the wire (29) (p. 13, l. 6- 9 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29. Each segment has a free end 30 in which the filament 12 terminates in a bulbous tab 18; it is noted that since the first loop (L1) and second loop (L2) include bulbous tabs 18, which have a wider diameter than the remainder of the wire (12), the wire (12) along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2) at the bulbous tabs 18).
Regarding claim 13, Choh further discloses wherein the two of the plurality of loops (L1, L2) are wound in opposite rotational directions (p. 13, l. 6- 8 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29).
Regarding claim 14, Choh further discloses wherein the one or more inflection portions (29) are entirely comprised of the one or more regions of smaller diameter of the wire (12) (it is noted that the wire (12) along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2) at the bulbous tab 18).
Regarding claim 17, Choh further discloses wherein the plurality of loops are stacked on each other (p. 13, l. 1- 3 - - The filament is helically wrapped to form several individual coils 14 that comprise a spring having an interior 15).
Regarding claim 19, Choh further discloses wherein at least some adjacent loops of the plurality of loops are arranged at different angles relative to each other (p. 13, l. 6- 8 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29; it is noted that since the two segments 27 are wound in opposite directions and joined together by a bridge 29, at least some of the loops on either side of the bridge 29 are considered near or adjacent to one another and are arranged at different angles relative to each other).
Regarding claim 21, Choh further discloses wherein the smaller diameter of the inflection portion (29) reduces jumps or kicks during delivery from a delivery catheter relative to a uniform-wire-diameter embolic coil (p. 13, l. 23- 28 - - The alternate, double spring embodiment resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the single spring implant 10. The counter rotation of the oppositely wound spring segments 28 serves to slow the unwinding of the device, thereby providing control over the magnitude of injury experienced by the surrounding tissue; it is noted that since the embodiment of Figs. 1C, 1D resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the embodiment of Figs. 1A, 1B and since the embolic coil disclosed by Choh meets the structural limitations of claim 2, the smaller diameter of the inflection portion (29) is capable of at least contributing to reducing jumps or kicks during delivery from a delivery catheter relative to a uniform-wire-diameter embolic coil).
Regarding claim 22, Choh further discloses wherein the one or more regions of smaller diameter of the wire (29) reduce jumps or kicks during delivery from a delivery catheter relative to a uniform-wire-diameter embolic coil (p. 13, l. 23- 28 - - The alternate, double spring embodiment resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the single spring implant 10. The counter rotation of the oppositely wound spring segments 28 serves to slow the unwinding of the device, thereby providing control over the magnitude of injury experienced by the surrounding tissue; it is noted that since the embodiment of Figs. 1C, 1D resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the embodiment of Figs. 1A, 1B and since the embolic coil disclosed by Choh meets the structural limitations of claim 12, the one or more regions of smaller diameter of the wire (29) is capable of at least contributing to reducing jumps or kicks during delivery from a delivery catheter relative to a uniform-wire-diameter embolic coil).
Regarding claim 25, Choh further discloses wherein the wire along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2), thereby reducing kicks to a delivery catheter as the first loop (L1), the second loop (L2), and the inflection portion (19) are advanced out of the delivery catheter (p. 13, l. 6- 9; p. 13, l. 23- 28 - - FIGS. 1C and 1 D show an alternative spring implant embodiment 26 comprised of two segments 27 that are wound in opposite directions and joined together by a bridge 29. Each segment has a free end 30 in which the filament 12 terminates in a bulbous tab 18; it is noted that since the first loop (L1) and second loop (L2) include bulbous tabs 18, which have a wider diameter than the remainder of the wire (12), the wire (12) along the inflection portion (29) is smaller in diameter than the first loop (L1) and the second loop (L2) at the bulbous tabs 18; The alternate, double spring embodiment resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the single spring implant 10. The counter rotation of the oppositely wound spring segments 28 serves to slow the unwinding of the device, thereby providing control over the magnitude of injury experienced by the surrounding tissue; it is noted that since the embodiment of Figs. 1C, 1D resiliently expands from its restrained first configuration to its larger profile, second configuration more gradually than does the embodiment of Figs. 1A, 1B and since the embolic coil disclosed by Choh meets the structural limitations of claim 2, the one or more regions of smaller diameter of the wire (29) is capable of at least contributing to reducing jumps or kicks during delivery from a delivery catheter relative to a uniform-wire-diameter embolic coil).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choh (WO 00/18325) in view of Divino et al. (US Pub. No. 2013/0190801 A1). Divino is cited in the Non-Final Office Action, mailed 12/14/23.
Regarding claim 4, Choh discloses the apparatus of claim 2, but Choh does not disclose
(claim 4) wherein the wire is composed of segments of wires connected to each other.
However, Divino teaches an embolic coil used within a patient’s vasculature for the purposes of initiating/ encouraging tissue growth to repair vascular injury or disease in the same field of endeavor (Ps. [0001], [0005])
(claim 4) wherein the wire is composed of segments of wires connected to each other (P. [0177] - - first filament 302A may be coupled to the second filament 302B at a first coupling location 1502a…the coupling locations 1502a-c may be welds or weld joints between adjacent filaments 302A-D. In other embodiments, the coupling locations 1502a-c may be mechanical fasteners, adhesives, heat treated zones, combinations thereof, or the like, in order to couple adjacent filaments 302A-D together so as to create a contiguous coil winding. It will be appreciated that different materials, thicknesses, or diameters of the filaments 302A-D may be interspersed along the length of the coil 1504, without departing from the scope of the disclosure).
Divino further discloses that a coil composed of multiple segments of wire connected to each other is a structural equivalent of a coil composed of a single wire (P. [0175] - - coil 1504 may be formed by…one or more filaments 302). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute one known element (coil composed of multiple segments) for another (coil composed of a single wire) since the substitution would have yielded predictable results, namely, creating a contiguous coil winding (Divino - - P. [0177]). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Allowable Subject Matter
Claims 3, 6- 11, 15- 16 and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the wire is electropolished along the inflection portion.
Regarding claim 6, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the inflection portion comprises a larger primary wind diameter region than the first loop and the second loop.
Regarding claim 11, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the primary shape of the helical coil comprises hydrogel located along the first loop and the second loop; and wherein the inflection portion is free from hydrogel.
Regarding claim 15, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the one or more inflection portions are only partially comprised of the one or more regions of smaller diameter.
Regarding claim 16, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the primary shape of the helical coil is formed by winding the wire on a mandrel having at least two different diameters.
Regarding claim 18, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the helical coil has regions of larger primary wind diameter and regions of smaller primary wind diameter; wherein the regions of smaller primary wind diameter form the plurality of loops of the secondary shape; and wherein the regions of larger primary wind diameter form the one or more inflection portions of the secondary shape that are located between the two of the plurality of loops.
Reasons for Allowance
Claims 23- 24 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 23, the prior art does not teach or suggest, in combination with the remainder of the claim limitations, wherein the wire is electropolished along the inflection portion.
Regarding claim 24, the prior art does not teach or suggest, in combination with the remainder of the claim limitations, wherein the primary shape of the helical coil is formed by winding wire on a mandrel having at least two different diameters.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771