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 Arguments
As to the arguments directed to the prior art rejections:
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Zhang () is not longer relied upon to disclose the amended limitations of “wherein the anti-unwinding component is formed by an anti-unwinding filament that is folded in half so that two ends of the anti-unwinding filament are merged together, the merged end of the two ends of the anti-unwinding filament is referred to as a distal end of the anti-unwinding filament, and the anti-unwinding filament forms a ring-shaped structure that is referred to as a proximal end of the anti-unwinding filament, the distal end of the anti-unwinding filament is threaded along an interior of the first coil from the proximal end to the distal end, the distal end of the anti-unwinding filament is fixed to a distal end of the first coil, and the ring-shaped structure is formed outside a proximal end of the first coil”.
As to the arguments directed to the rejections under - 35 USC § 112, Applicant argues:
Applicant’s arguments, see “Remarks”, filed 5/19/2026, with respect to the 35 U.S.C. 112(b) rejection of claim 1 for reciting “a first coil”, “a second coil”, “a developing material”, “a polymer material” and “an anti-unwinding component” have been fully considered and are persuasive in light of Applicant’s amendments to claim 12 to correct the antecedent basis for the cited limitations to now recite “the first coil”, “the second coil”, “the developing material”, “the polymer material” and “the anti-unwinding component” which more clearly designate the cited limitations are further modifying the limitations previously defined in claim 1. The 35 U.S.C. 112(b) rejection of claims 12-15 has been withdrawn.
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 Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record).
Regarding claim 1, Kang discloses:
An occlusion implant (see Fig. 1), comprising:
a first coil (first coil 111, see Fig. 1) comprising at least a first wire (see Fig. 1 showing wherein first coil 111 is formed from a spiral wire; see also Para. [0043]); and
an anti-unwinding component (core 112, see Figs. 1-2 and 5) connected to at least one of the first coil or the second coil (see Figs. 1 and 5; see also Para. [0042], [0052] and [0056] mentioning wherein one end of the core 112 forms a tip-ball (TB) that is in direct abutment with the first coil 111);
wherein the anti-unwinding component is formed by an anti-unwinding filament (see Figs. 1-2 and 5 showing wherein core 112 is in the form of a filament; wherein the filament may be nitinol, see Para. [0050]) that is folded in half so that two ends of the anti-unwinding filament are merged together (see Fig. 5 showing wherein two ends of the core 112 are merged together to form the tip-ball (TB); see also Para. [0052], [0054] and [0056]), the merged end of the two ends of the anti-unwinding filament is referred to as a distal end of the anti-unwinding filament (tip-ball (TB) is herein referred to as the “distal end” of the core 112; see Figs. 1-2 and 5), and the anti-unwinding filament forms a ring-shaped structure that is referred to as a proximal end of the anti-unwinding filament (see Figs. 1-2 and 5 showing wherein the opposing end of the core 112 forms a loop, hereinafter referred to as the “proximal end” of the core 112; see also Para. [0053]), the distal end of the anti-unwinding filament is threaded along an interior of the first coil from the proximal end to the distal end (see Figs. 1-2 and 5 showing wherein the core 112 is threaded through the entire length of the first coil 111), the distal end of the anti-unwinding filament is fixed to a distal end of the first coil (see Figs. 1-2 and 5; see also Para. [0056]), and the ring-shaped structure is formed outside a proximal end of the first coil (see Figs. 1-2 and 5).
However, Kang does not expressly disclose:
Wherein the first coil is formed by weaving a woven material that comprises at least a first wire that is an electrospun yarn prepared by electrospinning; and
A second coil arranged inside the first coil; the second coil comprising a developing material and a polymer material.
Regarding the limitation “Wherein the first coil is formed by weaving a woven material that comprises at least a first wire that is an electrospun yarn prepared by electrospinning”, the stated technical effect/benefit of providing a coil layer formed from woven material produced via electrospinning is described to be providing a rough and porous texture and structure that “can speed up formation of thrombus, contribute to a good thrombogenic effect, promote the rapid formation of thrombus in a short term, effectively reduce packing density at positions such as arterial fistulas and aneurysms, improve occlusion efficiency, reduce an amount of the occlusion implant, and reduce high pressure of blood vessel wall or tumor wall during surgery” (see Specification Para. [0043]).
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]).
It would have therefore been obvious to one of ordinary skill in the art to have formed the first coil 111 of Kang from strands of woven electrospun yarn, prepared by electrospinning as taught and suggested by Hebert to, in this case, form the first coil 111 with an optimal balance of porosity and fluid containment within the structure while retaining desired heat-set shape and additionally aiding in thrombus formation (see Hebert Para. [0138]-[0139]).
Regarding the limitations of “A second coil arranged inside the first coil; the second coil comprising a developing material and a polymer material”, in the same field of endeavor, namely implantable coil occlusion devices, Zhang teaches:
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 (see Para. [0009], [0022] and [0046] mentioning wherein the first spiral component is formed from a radiopaque material; iodine contrast agent may be used as a developing radiopaque 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]).
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 device of Kang to comprise an additional second coil arranged inside the first coil 111 as taught and suggested by Zhang to, in this case, provide increased strength and rigidity to the occluding implant while providing a radiopaque structure, allowing a user to track and determine the location of the implant within an anatomical space (see Zhang Para. [0009], [0022] and [0046]).
Regarding claim 2, the combination of Kang, Hebert and Zhang disclose the invention of claim 1, Kang further discloses wherein at least one of the proximal end and the distal end of the first coil is closed (see Figs. 1 and 5 showing wherein the distal end of the first coil 111 is closed by the tip-ball (TB); see also Para. [0054] and [0056]).
Regarding claim 5, the combination of Kang, Hebert and Zhang disclose the invention of claim 1, Kang, as modified by Zhang, further discloses wherein at least part of the anti-unwinding component is arranged inside the second coil (see Zhang Figs. 2-3 showing wherein the second coil, as incorporated into the device of Kang, is arranged exterior to and radially surrounding the anti-unwinding components 130 (i.e., the anti-unwinding components of Zhang are arranged within the second coil); the second coil of Zhang is understood to be disposed radially outward of and encompassing the core 112 of Kang in the resulting combination to maintain the known dual-wire/anti-unwinding component configuration).
Regarding claim 6, the combination of Kang, Hebert and Zhang disclose the invention of claim 5, Kang further discloses wherein the anti-unwinding component comprises an anti-unwinding section and a connecting section, the anti-unwinding section is located inside the second coil, and the connecting section is located outside a proximal end of the second coil (see Examiner’s Diagram of Kang Fig. 5 below showing wherein the looped proximal end of the core 112, extending outside of the coil body, is designated as the “connecting section” while the portion of the core 112 within the lumen of the coil body is designated as the “anti-unwinding section”).
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Examiner’s Diagram of Kang Fig. 5
Regarding claim 9, the combination of Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1.
However, none of the combination 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, as incorporated into the device of Kang, 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, as incorporated into the device of Kang, already disclosed to be formed from a developing material and polymer material (see Zhang 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, as incorporated into the device of Kang, to function appropriately should the weight ratio of developing material to polymer material be within the claimed range.
Regarding claim 10, the combination of Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1, Kang, as modified by Zhang, further discloses wherein the polymer material in the second coil, as incorporated into the device of Kang, comprises a degradable filament (see Zhang Para. [0005], [0009], [0031], [0044] mentioning wherein the occluding device, including the first spiral component as incorporated into the device of Kang, is formed from degradable/bioabsorbable materials), the degradable filament is wound into a spiral coil (see Zhang Figs. 1-3 and at least Para. [0006] mentioning wherein the first spiral member, as incorporated into the device of Kang, is formed as a spiral coil).
However, none of either Kang or Zhang 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, as incorporated into the device of Kang, 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 Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1, Kang, as modified by Zhang, further discloses wherein the polymer material in the second coil comprises a non-degradable filament (see Zhang Para. [0047] mentioning wherein the first spiral member, as incorporated into the device of Kang, 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 Zhang 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 Zhang 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, as incorporated into the device of Kang, 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 Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record), further in view of Zhang, hereinafter referred to as “Zhang2” (US 2018/0214159 A1) (previously of record).
Regarding claim 3, the combination of Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1.
However, the combination does not expressly disclose wherein the woven material of the first wire 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 first coil 111 of Kang (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 Kang, Hebert, Zhang and Zhang2 disclose the invention of claim 3, Kang, 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 first coil (111) of Kang 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 first coil (111) of Kang 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 first coil 111 of Kang, 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 Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record), further in view of Descarrega (US 2019/0029684 A1) (previously of record).
Regarding claim 7, the combination of Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1.
However, Kang discloses wherein the core 112 is formed from a shape memory material, such as nitinol (see Para. [0050]), 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 core 112 of Kang from PLLA as disclosed by Descarrega. Since both PLLA and nitinol are disclosed to comprise shape-memory properties, the shape-memory properties of the core 112 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 Kang, Hebert, Zhang and Descarrega disclose the invention of claim 7, Kang, 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 (core 112 of Kang is formed from PLLA, as incorporated from the disclosure of Descarrega).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record), further in view of Sathy (US 2024/0335586 A1) (previously of record), considered prior art because of a claim of priority to a foreign application filed 8/6/2021.
Regarding claim 12, the combination of Kang, Hebert and Zhang disclose all of the limitations of the invention of claim 1, Kang, as modified by Hebert and Zhang, further discloses:
A method for preparing the occlusion implant according to claim 1, comprising:
preparing a spinning film by electrospinning (see Hebert Para. [0138] and [0141] mentioning wherein the woven fibers forming the occluding device, as incorporated into first coil 111 of Kang, 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 first coil 111 of Kang, are prepared and formed by electrospinning);
weaving the electrospun yarn to form the first coil (first coil 111 of Kang, see Kang Figs. 1-2 and 5; the first coil 111 has been modified by the teachings of Hebert to be formed by electrospinning electrospun yarn to form the first coil 111; see Hebert Para. [0138] and [0141]);
preparing the second coil (first spiral component 100 of Zhang, as incorporated into the device of Kang; 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 Zhang Figs. 1-3 and Para. [0046]; the first spiral component of Zhang, as incorporated into the device of Kang, is disposed within the lumen of the first coil 111 of Kang to maintain the same configuration shown in Zhang Figs. 1-2 in which the first spiral component is the “inner coil”); and
shaping the first coil and the second coil (see Kang Figs. 1-2 and 5 showing wherein first coil 111 is shaped; see also Zhang Figs. 1-3 first spiral member 100 is shaped), and connecting the anti-unwinding component (core 112, see Kang Figs. 1-2 and 5) to at least one of the first coil and the second coil (see Kang Para. [0052], [0054] and [0056] mentioning wherein the tip-ball (TB) of the core 112 is connected to the distal end of the first coil 111).
However, while Hebert discloses wherein woven electrospun yarn is used to form the first coil 111 of Kang, 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 first coil 111 of Kang, to have included the preparatory step of dissolving the degradable polymer materials used to form the first coil 111 of Kang 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 Kang, Hebert, Zhang and Sathy disclose the method of claim 12, Kang further discloses closing at least one of the proximal end and the distal end of the first coil by hot-melt closing (see Para. [0056] mentioning wherein the tip-ball (TB) of the core 112 may be attached to the distal end of the first coil 111 by welding; wherein welding includes hot-melting of materials to form a securement).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record), further in view of Sathy (US 2024/0335586 A1) (previously of record), further in view of Descarrega (US 2019/0029684 A1) (previously of record).
Regarding claim 14, the combination of Kang, Hebert, Zhang and Sathy disclose the method of claim 13, Kang, as modified by Zhang, further discloses the step(s) of applying a hot-melted material to at least one of the proximal end and the distal end of the first coil, and then cooling the material to close at least one of the proximal end and the distal end of the first coil (see Para. [0056] mentioning wherein welding is utilized to secure the tip-tall (TB) ) of the core 112 to the distal end of the first coil 111; wherein welding includes hot-melting of materials to form a securement before allowing the two components to cool down).
However, Kang discloses wherein the core 112 is formed from nitinol (see Para. [0050]) and thus does not expressly disclose wherein the tip-ball (TB) of the core 112 is formed from 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 core 112 of Kang from PLLA as disclosed by Descarrega. Since both PLLA and nitinol are disclosed to comprise shape-memory properties, the shape-memory properties of the core 112 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)).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 2011/0092997 A1) in view of Hebert (US 2020/0268365 A1) (previously of record), further in view of Zhang (CN 112641484 A) (previously of record), further in view of Sathy (US 2024/0335586 A1) (previously of record), further in view of Descarrega (US 2019/0029684 A1) (previously of record), further in view of Zhang (US 2019/0076136 A1), hereinafter referred to as “Zhang3”.
Regarding claim 15, the combination of Kang, Hebert, Zhang, Sathy and Descarrega disclose the method of claim 14, Kang, as modified by Descarrega, 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 Kang Para. [0056] mentioning wherein the tip-ball (TB) is welded (i.e., hot-melted) to form a securement to the distal end of the first coil 111; as modified by Descarrega, the tip-ball (TB) is formed from PLLA) 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. [0056]; once the weld has been set, the tip-ball and first coil are allowed to cool).
However, Knag does not expressly disclose wherein the heat-melting process occurs in a mold.
In the same field of endeavor, namely degradable occluder devices, Zhang3 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 first coil 111 of Kang in a mold during the welding/heat-melting process of the formation of the tip-ball 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 References Cited. Specifically, US 2011/0295303 A1 to Freudenthal, US 2018/0228493 A1 to Aguilar and US 2017/0119399 A1 to Aguilar all disclose implantable coil occluding devices comprising two nested coils forming the body of the implant and an anti-unwinding tool extending therethrough.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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