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
The claims filed on November 12th, 2025 have been entered. Claim 1, 4- 10, and 13- 16 are pending in the application. The amendment to the specification has overcome the previous specification objection. The amendment to claims 1, 9, 10, and 16 has overcome the previous 112(b) rejection of claims 1- 16.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1, 4-8, and 10- 13 under 35 U.S.C. 102(a)(1) over Jones et al. (US 2013/0046326) has been withdrawn in light of applicant’s amendments; specifically Jones does not teach achieving, by the coiled implant, an increase in a coil volume in the aneurysm sac by at least approximately 7%, wherein a cost per coil, a coil length, and a coil shape of the coiled implant and the comparative device are approximately the same.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Examiner’s Note: Comparison is not considered to be a step within the method and is instead interpreted as an inherent property achieved by the structure of the claimed device, therefore when a device has a similar structure to the claimed device, it achieves what is required by the claim.
Examiner’s Note: Applicant defines primary wind diameter as an outer diameter, the analysis below uses outer diameter.
Claim(s) 1, 4- 10, and 13- 16 is/are rejected under 35 U.S.C. 103 unpatentable in view of Jones et al. (US 2013/0046326).
Regarding claim 1, Jones (Jones et al.) teaches a method for treating an aneurysm (abstract)(Figs. 4- 8), the method comprising: delivering, to an aneurysm sac (202), an occlusion device (10) comprising a coiled implant (embolic coil 56) releasably retained on the occlusion device and releasing the coiled implant in the aneurysm sac (Paragraph 0021).
Regarding the step of achieving, by the coiled implant, an increase in packing density in the aneurysm sac compared to a comparative device having an approximately equal coil length of the coiled implant, as discussed above comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as long as the device has a similar structure and characteristics to the claimed device, it is able to achieve an increase in packing density in the aneurysm sac as this is a result of the structure. As Jones teaches an implant (embolic coil 56) with similar structure to the claimed device (Paragraph 0019), it would accomplish the step of achieving.
Regarding increasing, by the coiled implant, a coil volume in the aneurysm sac by at least approximately 7%, as discussed above comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as long as the device has a similar structure and characteristics to the claimed device, it is able to achieve an increase in the coil volume of the aneurysm sac. Since Jones teaches an implant with a similar structure and dimensions of the claimed device (Paragraph 0019), it would accomplish this step of achieving. Furthermore, it would have been obvious to one of ordinary skill in the art that the coiled implant as taught by Jones would increase the coil volume in the aneurysm sac by at least approximately 7% compared to a generic device that has smaller dimensions.
Regarding wherein a primary wind diameter (PWD) of the coiled implant is at least approximately 0.001 inches larger than a PWD of the comparative device, the PWD of the coiled implant is at most approximately 0.002 inches larger than the PWD of the comparative device, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore Jones would have an increased outer diameter of at least 0.001 inches and at most 0.002 inches larger than the outer diameter of the comparative device as Jones teaches the coiled implant being able to have an outer diameter within the range set forth in applicant’s specification (Jones, Paragraph 0019; Applicant’s specification, Paragraph 0040).
Regarding wherein a cost per coil, a coil length, and a coil shape of the coiled implant and the comparative device are approximately the same, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device and as this limitation is broad, one of ordinary skill in the art could choose a comparative device that has the same cost per coil, coil length, and coil shape of the coiled implant as the coiled implant taught by Jones, and the embolic coil of Jones would accomplish the achieving steps set forth within claim 1.
Regarding claim 4, Jones teaches the method as discussed above.
Jones further teaches wherein the coiled implant comprises a primary wind diameter ranging from about 0.008 inches to about 0.018 inches (Paragraph 0019).
Regarding claim 5, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 40 cm and an implant outer diameter of about 0.015 inches, as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 40 cm and an implant outer diameter of 0.015 inches is anticipated (In re Peterson, 315 F.3d 1325).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 15% compared to a first comparative device comprising a first coil length of about 40 cm and a first outer diameter of about 0.014 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is known in the art as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.015 inches and a length of 40 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.014 inches and the same length.
Regarding claim 6, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 6 cm and an implant outer diameter of about 0.012 inches, as Jones teaches that the coil length can be chosen from a range of 1 cm to 150 cm and an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 6 cm and an implant outer diameter of 0.012 inches is anticipated (In re Peterson, 315 F.3d 1325).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 44% compared to a second comparative device comprising a second coil length of about 6 cm and a second outer diameter of about 0.010 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is commonly known as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.012 inches and a length of 6 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.010 inches and the same length.
Regarding claim 7, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 40 cm and an implant outer diameter of about 0.015 inches, as Jones teaches that the coil length can be chosen from a range of 1 cm to 150 cm and an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 45 cm and an implant outer diameter of 0.015 inches is anticipated (In re Peterson, 315 F.3d 1325).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 7% compared to a third comparative device comprising a first coil length of about 45 cm and a first outer diameter of about 0.014 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is known in the art as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.015 inches and a length of 45 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.014 inches and the same length.
Regarding claim 8, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 20 cm and an implant outer diameter of about 0.012 inches, as Jones teaches that the coil length can be chosen from a range of 1 cm to 150 cm and an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 20 cm and an implant outer diameter of 0.012 inches is anticipated (In re Peterson, 315 F.3d 1325).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 8% compared to a first comparative device comprising a first coil length of about 20 cm and a first outer diameter of about 0.010 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is known in the art as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.012 inches and a length of 20 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.010 inches and the same length.
Regarding claims 9 and 16, Jones teaches the method as discussed above.
Jones is silent to the method further comprising reducing a number of coiled implants delivered to the aneurysm sac compared to a number of comparative devices.
The step of reducing the number of coiled implants is considered to be a “result of” step that is dependent upon the structure of the implant, therefore as Jones teaches a coiled implant with a similar structure and dimensions as set forth within applicant’s specification, it would have been obvious to one of ordinary skill in the art before the effective filing date to reduce the number of coiled implants delivered to the aneurysm sac comparted to a number of comparative devices.
Alternatively, it would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the method of Jones to include reducing a number of coiled implants compared to a number of comparative devices. Jones discloses a similar method with the same dimensions as specified by applicant’s specification (Jones, Paragraphs 0019 and 0021; Applicant’s specification, Paragraph 0040). Thus, reducing a number of coiled implants delivered to an aneurysm sac would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 10, Jones (Jones et al.) teaches a method for treating an aneurysm (abstract)(Figs. 4- 8), the method comprising: delivering, to an aneurysm sac (202), a coiled implant (embolic coil 56) releasably retained on an occlusion device (10)(Paragraph 0021), positioning the coiled implant in the aneurysm sac (Paragraph 0021).
Regarding the step of achieving, by the coiled implant, an increase in packing density in the aneurysm sac compared to a comparative device having an approximately equal coil width of the coiled implant, as discussed above comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as long as the device has a similar structure and characteristics to the claimed device, it is able to achieve an increase in packing density in the aneurysm sac as this is a result of the structure. As Jones teaches an implant (embolic coil 56) with similar structure to the claimed device (Paragraph 0019), it would be able to achieve an increase in packing density in the aneurysm sac.
Regarding increasing, by the coiled implant, a coil volume in the aneurysm sac by at least approximately 7%, as discussed above comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as long as the device has a similar structure and characteristics to the claimed device, it is able to achieve an increase in the coil volume of the aneurysm sac. Since Jones teaches an implant with a similar structure and dimensions of the claimed device (Paragraph 0019), it would accomplish this step of achieving. Furthermore, it would have been obvious to one of ordinary skill in the art that the coiled implant as taught by Jones would increase the coil volume in the aneurysm sac by at least approximately 7% compared to a generic device that has smaller dimensions.
Regarding wherein a primary wind diameter (PWD) of the coiled implant is at least approximately 0.001 inches larger than a PWD of the comparative device, the PWD of the coiled implant is at most approximately 0.002 inches larger than the PWD of the comparative device, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore Jones would have an increased outer diameter of at least 0.001 inches and at most 0.002 inches larger than the outer diameter of the comparative device as Jones teaches the coiled implant being able to have an outer diameter within the range set forth in applicant’s specification (Jones, Paragraph 0019; Applicant’s specification, Paragraph 0040).
Regarding wherein a cost per coil, a coil length, and a coil shape of the coiled implant and the comparative device are approximately the same, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device and as this limitation is broad, one of ordinary skill in the art could choose a comparative device that has the same cost per coil, coil length, and coil shape of the coiled implant as the coiled implant taught by Jones, and the embolic coil of Jones would accomplish the achieving steps set forth within claim 10.
Regarding claim 13, Jones teaches the method as discussed above.
Jones further teaches wherein the coiled implant comprises an outer diameter ranging from about 0.008 inches to about 0.018 inches (Paragraph 0019)(Examiner’s note: a primary wind diameter is set forth in applicant’s specification as the outer diameter of a coiled implant (Applicant’s specification, Paragraph 0040). Therefore Jones teaches a primary wind diameter ranging from about 0.008 inches to about 0.018 inches.).
Regarding claim 14, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 42 cm and an implant outer diameter of about 0.015 inches, as Jones teaches that the coil length can be chosen from a range of 1 cm to 150 cm and an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 42 cm and an implant outer diameter of 0.015 inches is anticipated (In re Peterson, 315 F.3d 1325).
Jones is silent to an implant coil width of about 12 mm.
However, since Jones teaches a method for delivering an implant into an aneurysm and a coiled implant made of wire (Paragraph 0021), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant coil width of about 12 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 7% compared to a fifth comparative device comprising a fifth coil length of about 45 cm, a fifth coil width of about 12 mm and a fifth outer diameter of about 0.014 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the modified coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is known in the art as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.015 inches, a coil width of 12 mm and a length of 42 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.014 inches with the same width and a length of 45 cm due to the outer diameter being squared within the equation.
Regarding claim 15, Jones teaches the method as discussed above.
Regarding the coiled implant comprising an implant coil length of about 15 cm, an implant coil width of about 5 mm, and an implant outer diameter of about 0.015 inches, as Jones teaches that the coil length can be chosen from a range of 1 cm to 150 cm and an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), as Jones teaches a range for the coil length of 1cm to 150 cm and a range for an implant outer diameter of 0.008 inches to 0.050 inches (Paragraph 0019), and as the claimed values are within the range, the selection of the value of an implant coil length of about 15 cm and an implant outer diameter of 0.015 inches is anticipated (In re Peterson, 315 F.3d 1325).
Jones is silent to an implant coil width of about 5 mm.
However, since Jones teaches a method for delivering an implant into an aneurysm and a coiled implant made of wire (Paragraph 0021), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the implant coil width of about 5 mm, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding wherein the coiled implant increases the packing density in the aneurysm sac by increasing a coil volume by at least approximately 8% compared to a sixth comparative device comprising a sixth coil length of about 20 cm, a sixth coil width of about 5mm, and a sixth outer diameter of about 0.010 inches, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the modified coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. Also, as coil volume is known in the art as a mathematic equation of pi*(PWD/2)^2 (length), one of ordinary skill in the art would recognize that the outer diameter of the coiled implant with an implant outer diameter of 0.015 inches, a coil width of 5 mm and a length of 15 cm would have a greater impact on the coil volume compared to an implant that has an implant outer diameter of 0.010 inches with the same width and a length of 20 cm due to the outer diameter being squared within the equation.
Response to Arguments
Applicant's arguments filed November 12th, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 7- 8, regarding the 35 U.S.C. 112(b) rejection of claims 1-16 have been considered and are persuasive. The rejection has been withdrawn.
Applicant’s arguments, see Pages 8-9, regarding the rejection of claims 1-8 and 10- 13 under 35 U.S.C. 102(a)(1) have been fully considered but are moot as the rejection has been withdrawn. It is noted that Jones is still relied upon for the rejection.
Applicant’s arguments, see Pages 8-9, regarding the rejection of claims 9 and 14- 16 under 35 U.S.C. 103 over Jones and how Jones fails to teach or suggest comparing a coil volume in an aneurysm sac due to two separate coiled implant devices, this argument is not persuasive. As discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device, therefore as the modified coil of Jones has the same dimensions and structure required by the claim limitations (see above, Paragraph 0019), it would accomplish the percentage increase in coil volume. With the limitation wherein a primary wind diameter (PWD) of the coiled implant is at least approximately 0.001 inches larger than a PWD of the comparative device, the PWD of the coiled implant is at most approximately 0.002 inches larger than the PWD of the comparative device, as discussed above, Jones would have an increased PWD of at least 0.001 inches and at most 0.002 inches larger than the PWD of the comparative device as Jones teaches the coiled implant being able to have a diameter within the range set forth in applicant’s specification (Jones, Paragraph 0019; Applicant’s specification, Paragraph 0040). With the limitation wherein a cost per coil, a coil length, and a coil shape of the coiled implant and the comparative device are approximately the same, as discussed above, comparison is not considered to be a step and is instead interpreted as an inherent property achieved by the device existing with similar structure to the claimed device and as this limitation is broad, one of ordinary skill in the art could choose a comparative device that has the same cost per coil, coil length, and coil shape of the coiled implant as the coiled implant taught by Jones, and the embolic coil of Jones would accomplish the achieving steps set forth.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771