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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/5/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 12-15 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 12 recites, “a first coil”, “a second coil”, “a developing material”, “a polymer material” and “an anti-unwinding component” and it is unclear if these cited limitations are the same as the “first coil, “second coil”, “developing material”, “polymer material” and “anti-unwinding component” recited in claim 1, from which claim 12 depends, or whether these limitations seek to define additional coils, anti-unwinding components, developing material and polymer materials that are separate and distinct from those recited in claim 1. For the purposes of examination, the cited limitations are seen to refer to and further modify their respective counterparts recited in claim 1.
Claims 13-15 are also rendered indefinite due to their dependency from and further modification of claim 12.
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) 1-2, 5-6 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 112641484 A) in view of Hebert (US 2020/0268365 A1).
Regarding claim 1, Zhang discloses:
An occlusion implant (see Fig. 1), comprising:
a first coil (second spiral component 120, see Fig. 1);
a second coil (first spiral component 100, see Fig. 1), the second coil being arranged inside the first coil (see Fig. 2 and Para. [0046]), and the second coil comprising a developing material and a polymer material (see Para. [0009] and [0048]); and
an anti-unwinding component (shaping parts 130, see Fig. 2), the anti-unwinding component being connected to at least one of the first coil and the second coil (see Fig. 2 and Para. [0053]-[0055]).
However, while Zhang discloses several materials used to form the second spiral component (120) (see Para. [0049]-[0051]), Zhang does not expressly disclose:
the first coil being formed by weaving a woven material, the woven material comprising at least a first wire, and the first wire being an electrospun yarn prepared by electrospinning.
The stated technical effect/benefit from a woven material via electrospinning is described to be providing to be solved by a rough and porous texture and structure (see Para. [0043] of the Specification).
In providing a similar solution, Hebert teaches an occlusion device (see Fig. 1) comprising tubular bodies (see Fig. 1) formed from interlaced yarn segments (see Para. [0138]) which provide an optimal balance of porosity and fluid containment within the structure (see Para. [0138]); wherein the woven yarn structure can be manufactured from electrospun yarn prepared by electrospinning (see Para. [0138]) as a known method of formation which provides porosity (see Para. [0141]) and additionally aids in thrombus forming (see Para. [0139]).
Since Zhang does not expressly disclose a method of forming the second spiral component, one of ordinary skill in the art would have looked to similar elongate occlusion devices within the prior art for known methods of formation. It would have therefore been obvious to one of ordinary skill in the art to have formed the second spial component of Zhang from strands of woven electrospun yarn, prepared by electrospinning as taught and suggested by Hebert to, in this case, form the second spiral component with an optimal balance of porosity and fluid containment within the structure while additionally aid in thrombus formation (see Hebert Para. [0138]-[0139]).
Regarding claim 2, the combination of Zhang and Hebert disclose the invention of claim 1, Zhang further discloses wherein at least one of a proximal end and a distal end of the first coil is closed (see Fig. 2 showing a closed distal end of the second spiral member; see also Para. [0053] mentioning wherein the ball cap (150) is a closed end).
Regarding claim 5, the combination of Zhang and Hebert disclose the invention of claim 1, Zhang further discloses wherein at least part of the anti-unwinding component is arranged inside the second coil (see Figs. 1 and 3 showing the shaping parts (130) within the lumen of the first spiral component).
Regarding claim 6, the combination of Zhang and Hebert disclose the invention of claim 5, Zhang further discloses wherein the anti-unwinding component comprises an anti-unwinding section (inverted hook at the distal end (132) of the shaping component, see Fig. 2) and a connecting section (proximal end (134) of the shaping component, see Fig. 2), the anti-unwinding section is located inside the second coil (see Figs. 2-3), and the connecting section is located outside a proximal end of the second coil (see Para. [0053] mentioning wherein the proximal portion of the shaping part is arranged “on” the first spiral component and thus on an exterior surface thereof).
Regarding claim 9, the combination of Zhang and Hebert disclose all of the limitations of the invention of claim 1.
However, none of either Zhang or Hebert expressly disclose wherein a mass ratio of the developing material to the polymer material in the second coil is about 1:2 to 4:1.
Since Zhang is silent in regards to any specified mass ratios between the developing material and the polymer material used to form the first spiral element, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being “obvious to try” (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having formed the first spiral element of Zhang, already disclosed to be formed from a developing material and polymer material (see Para. [0009] and [0048]), to have a mass ratio between 1:2 and 4:1 as a matter of obviousness in selecting from a finite range of acceptable weight ratios. Since a weight ratio between the two materials would be inherent in the composite material, selecting from an acceptable finite range is within the skill set of one of ordinary skill in the art to achieve the resulting composite configuration. Further, Applicant appears to place no criticality of functional/operational purpose on the range claimed, reciting that the “ratio of developing material to the polymer material in the second coil is 1:2, 1:1, 2:1, 3:1, 4:1, or the like, which may be set by those skilled in the art according to a requirement, and is not limited herein” (Specification Para. [0055]) and thus one of ordinary skill in the art would have expected the first spiral element of Zhang to function appropriately should the weight ratio of developing material to polymer material be within the claimed range.
Regarding claim 10, the combination of Zhang and Hebert disclose all of the limitations of the invention of claim 1, Zhang further discloses wherein the polymer material in the second coil comprises a degradable filament (see Para. [0005], [0009], [0031], [0044] mentioning wherein the occluding device is formed from degradable/bioabsorbable materials), the degradable filament is wound into a spiral coil (see Figs. 1-3 and at least Para. [0006] mentioning wherein the first spiral member is formed as a spiral coil).
However, while Zhang discloses wherein the pitch of the coils forming the first spiral component may be uniform, or may be gradually changed along the length of the coil, and may also have different pitches in different sections of the coil (see Para. [0047]), Zhang does not expressly disclose wherein a ratio of a coil pitch of the degradable filament to a diameter of the degradable filament ranges from 1:1 to 4:1.
Since Zhang discloses wherein the pitch of the coils forming the first spiral component can have any desired ratio, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being “obvious to try” (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having formed the first spiral element of Zhang with a ratio of a coil pitch of the degradable filament to a diameter of the degradable filament ranges from 1:1 to 4:1 as a matter of obviousness in selecting from a finite range of acceptable pitch-to-diameter ratios. Since a coil pitch-to-diameter ratio would be inherent in the design of the first spiral element, and Zhang is expressly non-critical to the pitch of the first spiral element, selecting from an acceptable finite range is within the skill set of one of ordinary skill in the art to achieve. Further, Applicant appears to place no criticality of functional/operational purpose on the range claimed, reciting that the “ratio of the coil pitch of the second coil to the diameter of the non-degradable filament is 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1 or the like” (Specification Para. [0055]) and thus one of ordinary skill in the art would have expected the first spiral element of Zhang to function appropriately should the coil pitch-to-diameter ratio of the first spiral element of Zhang be within the claimed range.
Regarding claim 11, the combination of Zhang and Hebert disclose all of the limitations of the invention of claim 1, Zhang further discloses wherein the polymer material in the second coil comprises a non-degradable filament (see Para. [0047] mentioning wherein the first spiral member may be formed from one of platinum, iridium, gold, silver tantalum and/or tungsten), the non-degradable filament is wound into a spiral coil (see Figs. 1-3 showing wherein the first spiral member is formed as a spiraled coil).
However, while Zhang discloses wherein the pitch of the coils forming the first spiral component may be uniform, or may be gradually changed along the length of the coil, and may also have different pitches in different sections of the coil (see Para. [0047]), Zhang does not expressly disclose a ratio of a coil pitch of the non-degradable filament to a diameter of the non-degradable filament ranges from 2:1 to 8:1.
Since Zhang discloses wherein the pitch of the coils forming the first spiral component can have any desired ratio, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of being “obvious to try” (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having formed the first spiral element of Zhang with a ratio of a coil pitch of the non-degradable filament to a diameter of the non-degradable filament ranges from 2:1 to 8:1 as a matter of obviousness in selecting from a finite range of acceptable pitch-to-diameter ratios. Since a coil pitch-to-diameter ratio would be inherent in the design of the first spiral element, and Zhang is expressly non-critical to the pitch of the first spiral element, selecting from an acceptable finite range is within the skill set of one of ordinary skill in the art to achieve. Further, Applicant appears to place no criticality of functional/operational purpose on the range claimed, reciting that the “ratio of the coil pitch of the second coil to the diameter of the non-degradable filament is 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1 or the like” (Specification Para. [0055]) and thus one of ordinary skill in the art would have expected the first spiral element of Zhang to function appropriately should the coil pitch-to-diameter ratio of the first spiral element of Zhang be within the claimed range.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 112641484 A) in view of Hebert (US 2020/0268365 A1), further in view of Zhang, hereinafter referred to as “Zhang2” (US 2018/0214159 A1).
Regarding claim 3, the combination of Zhang and Hebert disclose all of the limitations of the
However, while Zhang, as modified by Hebert, discloses wherein the woven material comprises at least a first and second wire (see Hebert Para. [0138]), and wherein the spiral components may be formed from a number of different materials (see Zhang Para. [0009]-[0010]) none of either Zhang or Hebert expressly disclose wherein the woven material comprises at least the first wire and a second wire, and the first wire and the second wire have different degradation rates.
In the same field of endeavor, namely woven occluding devices comprising a plurality of wires, Zhang2 teaches a woven occluding device (see Figs. 1-3) comprised of a first weaving group made up of PLLA filaments (see Para. [0052]) and a second weaving group comprised of PLGA filaments (see Para. [0052]), wherein the complete degradation time of the two filaments are different (see Para. [0052]) so that degradation of the occluding device within a target site occurs gradually over a pre-defined time period, avoiding a concentrated release of a large amount of degradation products all at once (see Para. [0052]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the woven material of the second spiral component (as modified by Hebert) to be formed from woven fibers of different materials having different degradation rates as taught and suggested by Zhang2 to, in this case, allow the occluding device to degrade gradually over a pre-defined time period, avoiding a concentrated release of a large amount of degradation products all at once (see Zhang2 Para. [0052]).
Regarding claim 4, the combination of Zhang, Hebert and Zhang2 disclose the invention of claim 3, Zhang, as modified by Hebert and Zhang2, further disclose wherein the first wire is made of a material selected from at least one of poly-L-lactic acid and polycaprolactone (see Zhang Para. [0010] mentioning wherein one of the known materials used to form the second spiral component may be polycaprolactone), and the second wire is made of a material selected from at least one of polydioxanone, poly-DL-lactic acid and polyglycolic acid (see Zhang Para. [0010] mentioning wherein one of the known materials used to form the second spiral component may be polyglycolic acid). Since these are the known materials used to form the second spiral component and have different degradation rates, one of ordinary skill would have been able to select these components to form the resulting second spiral component, as modified by the teachings of Hebert and Zhang2, as a matter of obviousness.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 112641484 A) in view of Hebert (US 2020/0268365 A1), further in view of Descarrega (US 2019/0029684 A1).
Regarding claim 7, the combination of Zhang and Hebert disclose all of the limitations of the invention of claim 1.
However, Zhang discloses wherein the shaping parts (130) are formed from a shape memory material such as nitinol (see Para. [0055]) which allows the shaping part to be pre-shaped to improve the stability of the thrombus (see Para. [0055]) and thus does not expressly disclose wherein the anti-unwinding component is made of a degradable material.
In the same field of endeavor, namely occlusion treatment devices, Descarrega teaches wherein both nitinol and poly-L-lactide (PLLA) are interchangeable shape-memory materials used in the construction of occlusion device (see Para. [0063]).
Since Descarrega expressly discloses wherein nitinol and PLLA are interchangeable shape-memory materials, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substation of one known shape-memory material for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the shaping part(s) of Zhang from PLLA as disclosed by Descarrega. Since both PLLA and nitinol are disclosed to comprise shape-memory properties, the shape-memory properties of the shaping part(s) would be maintained. Further, because PLLA and nitinol are disclosed to be interchangeable materials, selecting of a known material from an array of interchangeable alternatives for a specific intended purpose has been held to be obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 8, the combination of Zhang, Hebert and Descarrega disclose the invention of claim 7, Zhang, as modified by Descarrega further discloses wherein the anti-unwinding component is made of a material selected from at least one of polydioxanone, poly-DL-lactic acid, polyglycolic acid, poly-L-lactic acid, poly lactic-co-glycolic acid, polycaprolactone, or poly-p-dioxanone (shaping parts formed from PLLA, as incorporated from the disclosure of Descarrega).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 112641484 A) in view of Hebert (US 2020/0268365 A1), further in view of Sathy (US 2024/0335586 A1), considered prior art because of a claim of priority to a foreign application filed 8/6/2021.
Regarding claim 12 (see 112(b) rejection above), the combination of Zhang and Hebert disclose all of the limitations of the invention of claim 1, Zhang, as modified by Hebert, further discloses:
A method for preparing the occlusion implant according to claim 1, comprising the following steps:
preparing a spinning film by electrospinning (see Hebert Para. [0138] and [0141] mentioning wherein the woven fibers forming the occluding device, as incorporated into the device of Zhang, are prepared and formed by electrospinning);
stretching the spinning film to form an electrospun yarn (see Hebert Para. [0138] and [0141] mentioning wherein the woven fibers forming the occluding device, as incorporated into the device of Zhang, are prepared and formed by electrospinning), and weaving the electrospun yarn to form a first coil (second spiral component 100, see Zhang Fig. 1; the second spiral component has been modified by the teachings of Hebert to be formed by electrospinning electrospun yarn to form the second spiral component; see Hebert Para. [0138] and [0141]);
preparing a second coil (first spiral component 100, see Zhang Fig. 1) with a developing material and a polymer material (see Zhang Para. [0009] and [0048]), and arranging the second coil inside the first coil (see Figs. 1-3 and Para. [0046]); and
shaping the first coil and the second coil (see Figs. 1-3 showing the first spiral member and second spiral member are shaped), and connecting an anti-unwinding component (shaping parts 130, see Fig. 2) to at least one of the first coil and the second coil (see Fig. 2 and Para. [0053]-[0055]).
However, while Hebert discloses wherein woven electrospun yarn is used to form the second spiral component of Zhang, Hebert does not expressly disclose a step of dissolving a degradable polymer material in a solvent to obtain a homogeneous solution.
In the same field of endeavor, namely electrospinning polymer materials to form a meshed structure, Sathy teaches wherein during an electrospinning process, one or more polymers are dissolved in a solvent to obtain a homogenous solution. This solution is then loaded into a contained and connected to a pump which performs the electrostatic spinning step to obtain the resulting fiber structure (see Para. [0085]-[0086]).
Since a step of dissolving polymers in a solvent to obtain a homogenous solution is understood to be an inherent/critical step during a typical electrospinning process in providing the initial material source used in the direct electrospinning step, (as evident by the disclosure of Sathy), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the electrospinning process of Hebert, in producing the woven structure of the second spiral member of Zhang, to have included the preparatory step of dissolving the degradable polymer materials used to form the second spiral member of Zhang in a solvent to obtain a homogenous solution before the direct electrospinning process takes place to prepare the initial solution used in said electrospinning process (see Sathy Para. [0085]-[0086] mentioning wherein the claimed dissolving step is an typical preparatory step in an electrospinning procedure).
Regarding claim 13, the combination of Zhang, Hebert and Sathy disclose the method of claim 12, Zhang further discloses a step of closing at least one of a proximal end and a distal end of the first coil by hot-melt closing (see Zhang Para. [0018], [0026], [0053] and [0066] mentioning wherein the distal end of the second spiral member is hot melted to form a closed cap as shown in Figs. 1-3).
Regarding claim 14, the combination of Zhang, Hebert and Sathy disclose the method of claim 13, Zhang further discloses the step(s) of applying a hot-melted degradable material to at least one of the proximal end and the distal end of the first coil, and then cooling the degradable material to close at least one of the proximal end and the distal end of the first coil (see Para. [0053] mentioning wherein additional material is added to and heat melted onto the distal end of the second spiral member to close the distal end thereof, forming the ball cap 150 which is then allowed to cool).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 112641484 A) in view of Hebert (US 2020/0268365 A1), further in view of Sathy (US 2024/0335586 A1), considered prior art because of a claim of priority to a foreign application filed 8/6/2021, further in view of Zhang (US 2019/0076136 A1), hereinafter referred to as “Zhang3”.
Regarding claim 15, the combination of Zhang, Hebert and Sathy disclose the method of claim 14, Zhang further discloses the step(s) of placing at least one of the proximal end and the distal end of the first coil at a set location, hot-melting at least one of poly-p-dioxanone, poly-DL-lactic acid, polyglycolic acid, poly-L-lactic acid, poly lactic-co-glycolic acid, polycaprolactone or polydioxanone (see para. [0010] mentioning wherein the second spiral member may be formed from polycaprolactone; see also Para. [0018], [0026], [0053] and [0066] mentioning wherein the distal end of the second spiral component is hot-melted to form the ball cap) in the set location, and then cooling to close at least one of the proximal end and the distal end of the first coil (see Para. [0053] mentioning wherein additional material is added to and heat melted onto the distal end of the second spiral member to close the distal end thereof, forming the ball cap 150 which is then allowed to cool).
However, Zhang does not expressly disclose wherein the heat-melting process occurs in a mold.
In the same field of endeavor, namely degradable occluder devices, Zhang teaches wherein during a heat-melting process, the heat-melted material/portion of a device is formed in a mold so that the desired shape of the resulting heat-melted material is maintained (see Para. [0053]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have placed the distal end of the second spiral component in a mold during the heat-melting process of the formation of the distal ball cap as taught and suggested by Zhang3 to, in this case, provide a pre-set mold shape that facilitates the ball cap is formed into a desired shape and the distal components of the second spiral component are not easily dispersed during this process (see Zhang3 Para. [0053]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s
disclosure. See the attached PTO-892 Notice of Reference Cited. Specifically, US 2024/0293127 A1 to Hewitt, US 2015/0289879 A1 to Bowman, US 2015/0057699 A1 to Lagodzki, US 2013/0131711 A1 to Bowman, US 2011/0184455 A1 to Keeley, US 2010/0268204 A1 to Tieu and US 2010/0081879 A1 to Frassica all disclose occluder devices comprising one or more spiral elements and an anti-unwinding component coupled thereto.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771