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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
Response to Amendment
The amendment filed 04/07/2026 has been entered. Claims 16 and 18-30 remain pending in the application and claims 1-15 and 17 are cancelled. Applicant’s amendments to the claims have overcome the claim objections previously set forth in the Final Office Action mailed 01/16/2026, however has not overcome the interpretation of the prior art rejection.
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
With regards to Applicant’s remarks on page 6 that it would not be possible for Wallace to disclose a controlling line which is carried by the blood flow because the wire is always surrounded by the catheter, the Office respectfully disagrees. This limitation is functional and Wallace discloses in paragraphs 34-35 “the apparatus 105 may be introduced through the catheter 100 with the help of the wire 160 after the catheter 100 is directed to the targeted aneurysm site… Once the distal end 135 of the catheter 100 is delivered to the aneurysm 107, the apparatus 105 may be deployed within the aneurysm 107. This may be accomplished by advancing the pusher wire 160 distally through the catheter 100.” Thus, the controlling line 160 is capable of moving passively and being carried by the blood flow inside the aneurysm once the catheter is delivered to the aneurysm site and the controlling line 160 is pushed distally through the catheter 100, therefore not “always being surrounded by the catheter” as Applicant states. Therefore, the rejection is maintained.
With regards to Applicant’s remarks on page 6 that if the catheter of Wallace is considered part of the claimed device (and possible the controlling line), then Wallace would not disclose wherein the device can be steered by the magnetic element when guided by an external actuator. The Office respectfully disagrees. The catheter is not being interpreted as being part of the claimed device, as the claimed device comprises the filling element (coils), the magnetic element 200, the controlling line 160, and the release mechanism 250. As stated above and disclosed in paragraphs 34-35, the controlling line 160 is pushed distally through the catheter, and therefore not always being surrounded by the catheter. Therefore, the rejection is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “release mechanism” in claim 1, and “activation mechanism” in claim 25.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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.
Claims 16, 18-19 and 23-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US PGPub 2002/0087077), hereinafter known as “Wallace.”
With regards to claim 16, Wallace discloses (Figures 1-2) a device 205 for treatment of a vessel in a patient (Abstract, paragraph 27), comprising:
- a filling element (coils in between the magnetic elements 200),
- a magnetic element 200 (paragraph 31; figure 2),
- a controlling line 160, to which the filling element (coils) and the magnetic element 200 are attached (paragraphs 30, 32 and 34-35),
- a release mechanism 250 (see Note below; paragraph 32),
wherein the filling element (coils) is at least partially attached to, attachable to, or formed by to the magnetic element 200 (paragraph 31; figure 2), and wherein the release mechanism 250 is adapted to release the magnetic element 200 and the filling element such as to be separated from the controlling line 160 (paragraphs 32 and 37),
wherein the magnetic element 200 is adapted to be guided by an external actuator such as to steer the device 205 along a vessel path (paragraph 30 – “catheter 100 may also include any well-known steering assembly in the art for delivering the magnetic embolization apparatus 105 to the targeted aneurysm 107”),
wherein the filling element is adapted to, when placed in the vessel to be treated, reduce a volume of a portion of said vessel (figure 2 – coils inserted into the aneurysm reduce the volume within the aneurysm),
wherein the controlling line 160 is adapted to position the device 100 by being loosened or pulled (functional limitation – paragraphs 32 and 37 – line 160 is capable of being loosened or pulled as the line is attached to the release mechanism 250 and may be detached from the release mechanism 250), the controlling line 160 being flexible (figure 2 - line 160 is bent inside the catheter) so as to, when pushed, not impair the navigation induced by a blood flow (functional limitation – paragraphs 32, 34-35 and 37 - line 160 pushes the device 205 distally through the catheter and then detached from the device 205 via the release mechanism 250, thereby the line 160 not impairing the navigation of the device 205 induced by blood flow), wherein
the controlling line 160 is adapted to be carried by the blood flow and move passively in the blood flow after an insertion into the vessel (functional limitation – paragraphs 34-35 – “the apparatus 105 may be introduced through the catheter 100 with the help of the wire 160 after the catheter 100 is directed to the targeted aneurysm site… Once the distal end 135 of the catheter 100 is delivered to the aneurysm 107, the apparatus 105 may be deployed within the aneurysm 107. This may be accomplished by advancing the pusher wire 160 distally through the catheter 100” controlling line 160 is capable of moving passively and being carried by the blood flow inside the aneurysm once the catheter is delivered to the aneurysm site and the controlling line 160 is pushed distally through the catheter 100).
Note – 112(f) interpretation – Applicant’s release mechanism is a string, adhesive, or element allowing for localized rupture within the device (page 15 line 18 – page 16 line 16; Wallace’s release mechanism is a mechanical detachment mechanism or an electrolytic detachment mechanism that detachably coupled the controlling line 160 to the coil assembly 205 (paragraph 32); therefore both release mechanisms are equivalent in allowing for localized rupture within the device.
With regards to claim 18, Wallace discloses wherein the filling element comprises at least one of a thrombogenic shape, a thrombogenic material (paragraphs 31 and 33; coils are a thrombogenic shape and material as they fill the aneurysm 107).
With regards to claim 19, Wallace discloses wherein the filling element comprises at least one defined shape which is at least partially curved (figure 2 – coils are curved).
With regards to claim 23, Wallace further discloses further comprising a protective coating 100 (paragraphs 28-29; figures 1-2).
With regards to claim 24, Wallace discloses wherein the filling element (coils) is arranged radially on the outside of the magnetic element 200 (figure 2 – coils are arranged outside of the magnetic element 200 and extend radially).
With regards to claim 25, Wallace discloses wherein the release mechanism 250 is arranged in between the controlling line 160 and at least one of the filling element (coils) and the magnetic element 200.
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.
Claims 16 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dacey, JR et al. (US PGPub 2005/0119687), hereinafter known as “Dacey,” in view of Wallace.
With regards to claim 16, Dacey discloses (Figures 1-3B and 15A-15B) a device 30 for treatment of a vessel in a patient (Abstract, paragraph 40), comprising:
- a filling element 36 (paragraph 40; figures 2 and 15A-15B),
- a magnetic element 34 (paragraph 41; figures 2 and 15A-15B),
wherein the magnetic element 34 is adapted to be guided by an external actuator (paragraph 48 – functional limitation – “Instead of, or in addition to, being engagable by a magnetic gradient, the embolization device 30 can be magnetically orientable” – therefore capable of being guided by an external actuator) such as to steer the device 30 along a vessel path (paragraphs 41, 45 and 49),
wherein the filling element 36 is adapted to, when placed in the vessel to be treated, reduce a volume of a portion of said vessel (paragraph 44 and figure 15B).
Dacey is silent to a controlling line, to which the filling element and the magnetic element are attached,
- a release mechanism,
wherein the filling element is at least partially attached to, attachable to, or formed by to the magnetic element, and wherein the release mechanism is adapted to release the magnetic element and the filling element such as to be separated from the controlling line,
wherein the controlling line is adapted to position the device by being loosened or pulled, the controlling line being flexible so as to, when pushed, not impair the navigation induced by a blood flow, wherein
the controlling line is adapted to be carried by the blood flow and move passively in the blood flow after an insertion into the vessel.
However, in a similar field of endeavor of vessel treatment, Wallace teaches (Figures 1-2) a controlling line 160, to which the filling element (coils) and the magnetic element 200 are attached, (paragraphs 30 and 32),
- a release mechanism 250 (see Note below; paragraph 32),
wherein the filling element (coils) is at least partially attached to, attachable to, or formed by to the magnetic element 200 (paragraph 31; figure 2), and wherein the release mechanism 250 is adapted to release the magnetic element 200 and the filling element (coils) such as to be separated from the controlling line 160 (paragraphs 32 and 37),
wherein the controlling line 160 is adapted to position the device 100 by being loosened or pulled (functional limitation – paragraphs 32 and 37 – line 160 is capable of being loosened or pulled as the line is attached to the release mechanism 250 and may be detached from the release mechanism 250), the controlling line 160 being flexible (figure 2 - line 160 is bent inside the catheter) so as to, when pushed, not impair the navigation induced by a blood flow (functional limitation – paragraphs 32, 34-35 and 37 - line 160 pushes the device 205 distally through the catheter and then detached from the device 205 via the release mechanism 250, thereby the line 160 not impairing the navigation of the device 205 induced by blood flow), wherein
the controlling line 160 is adapted to be carried by the blood flow and move passively in the blood flow after an insertion into the vessel (functional limitation – paragraphs 34-35 – “the apparatus 105 may be introduced through the catheter 100 with the help of the wire 160 after the catheter 100 is directed to the targeted aneurysm site… Once the distal end 135 of the catheter 100 is delivered to the aneurysm 107, the apparatus 105 may be deployed within the aneurysm 107. This may be accomplished by advancing the pusher wire 160 distally through the catheter 100” controlling line 160 is capable of moving passively and being carried by the blood flow inside the aneurysm once the catheter is delivered to the aneurysm site and the controlling line 160 is pushed distally through the catheter 100).
Note – 112(f) interpretation – Applicant’s release mechanism is a string, adhesive, or element allowing for localized rupture within the device (page 15 line 18 – page 16 line 16; Wallace’s release mechanism is a mechanical detachment mechanism or an electrolytic detachment mechanism that detachably coupled the controlling line 160 to the coil assembly 205 (paragraph 32); therefore both release mechanisms are equivalent in allowing for localized rupture within the device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Dacey to include the controlling line and release mechanism as taught by Wallace for the purpose of helping introduce the device through the catheter and directing the device to the targeted aneurysm site (paragraph 34 of Wallace).
With regards to claim 22, Dacey further discloses wherein the filling element 36 comprises a compressed foam which is adapted to expand into an expanded shape (paragraph 42), wherein the expanded shape substantially corresponds to the shape of an aneurysm (paragraph 44).
With regards to claim 23, Dacey further discloses further comprising a protective coating 32 (paragraphs 40 and 49; figure 1).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace.
With regards to claims 20-21, Wallace discloses the device as claimed in claim 16. Wallace is silent to the figures 1-2 embodiment to further comprising a configurable line (claim 20); and wherein the configurable line is adapted to be formed into a predefined configuration (claim 21).
However, Wallace teaches in figure 4 a configurable line 256 (paragraph 33); and wherein the configurable line 256 is adapted to be formed into a predefined configuration (paragraph 33 – functional limitation – line 256 is capable of forming into a predefined configuration by the base 258).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wallace to include the configurable line as taught by the figure 4 embodiment of Wallace for the purpose of concentrating the magnetic field near a central part of the dome of the aneurysm to help draw the magnetically controllable embolic deeper into the aneurysm, away from a neck of the aneurysm (paragraph 33 of Wallace).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Jacobsen et al. (US Patent 6,530,934), hereinafter known as “Jacobsen.”
With regards to claim 26, Wallace discloses the device as claimed in claim 16. Wallace is silent to further comprising an anchoring element adapted to provide attachment between at least a part of the device with at least one of a blood vessel wall and a blood clot.
However, in a similar field of endeavor of vessel treatment, Jacobsen teaches (Figures 1-3A) an anchoring element 42/44 adapted to provide attachment between at least a part of the device 10 with at least one of a blood vessel wall 26 (Col 8 lines 4-30).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wallace to include an anchoring element as taught by Jacobsen for the purpose of preventing migration of the embolic device once inserted (Col 7 lines 56-59 of Jacobsen).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Garibaldi et al. (US Patent 6,315,709), hereinafter known as “Garibaldi,” and further in view of Callister et al. (US PGPub 2006/0009798), hereinafter known as “Callister.”
With regards to claim 27, Wallace discloses a system (figure 1) for treatment of a vessel in a patient (Abstract), comprising the device according to claim 16, further comprising a controlling unit 130/150.
Wallace is silent to further comprising a magnetic actuator.
However, in a similar field of endeavor of vessel treatment, Garibaldi teaches (Figures 1 and 3) a magnetic actuator 14 (Col 4 lines 37-65).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wallace to include a magnetic actuator as taught by Garibaldi for the purpose of generating and applying a magnetic field to further attract and group the objects needed to occlude the vessel (Col 4 lines 37-65 and Col 6 lines 12-34 of Garibaldi).
Wallace/Garibaldi are silent to at least one controlling line driver.
However, in a similar field of endeavor of vessel treatment, Callister teaches (Figures 36-38) a controlling line driver 202 (paragraphs 178-179).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wallace/Garibaldi to include a controlling line driver for the purpose of easy gripping and manual sliding (paragraph 182 of Callister) of the controlling line.
With regards to claim 28, the combination of Wallace/Garibaldi/Callister further discloses further wherein the magnetic actuator (Garibaldi: 14) is adapted to generate a magnetic field (Garibaldi: 52) at a location in order to steer the device (Wallace: 205) in a direction (Wallace: paragraph 37), wherein the controlling unit (Wallace: 130/150) is adapted to balance at least three forces applied on the device (Wallace: 205; functional limitation – controlling unit 130/150 operates to introduce/remove the magnetically controllable embolization substance via 165, as well as provide a power port 170 to connect the catheter 100 to a power supply, and thus is capable of balancing various forces applied to the medical device 205), and to operate at least one of the controlling line driver (Callister’s controlling line driver 202 is positioned on the catheter 200 which is akin to Wallace’s controlling unit 130/150, therefore the controlling line driver 202 of Callister located on the catheter 130/150 of Wallace would read on the claim language of the controlling unit 130/150 of Wallace operating the controlling line driver 202 of Callister).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Garibaldi.
With regards to claim 29, Wallace discloses a method of treating a vessel in a patient using a medical device 205, the medical device 205 being the device according to claim 16 (see rejection to claim 16 above), comprising the steps of:
releasing at least a part of the medical device 205 (via 250; paragraph 32).
Wallace discloses in paragraph 30 “The catheter 100 may also include any well-known steering assembly in the art for delivering the magnetic embolization apparatus 105 to the targeted aneurysm 107.”
Wallace is silent to the device being magnetically guidable, comprising the steps of magnetically guiding the medical device through a vasculature to a target site.
However, in a similar field of endeavor of vessel treatment, Garibaldi teaches (Figures 1 and 3) a magnetically guidable medical device 54, comprising the steps of magnetically guiding the medical device 54 through a vasculature to a target site 22 (via magnet system 14 and magnetic field 52; Col 4 lines 37-65 and Col 6 lines 12-34).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wallace to include the device being magnetically guidable, and magnetically guiding the medical device through a vasculature to a target site as taught by Garibaldi for the purpose of directing the magnetic devices to the desired branch after they have left the distal tip of the catheter (Col 6 lines 39-42).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace in view of Garibaldi, and further in view of Lee et al. (US PGPub 2004/0098023), hereinafter known as “Lee.”
With regards to claim 30, Wallace/Garibaldi disclose the method as claimed in claim 29. The combination is silent wherein the steps of the method are repeated at least once.
However, in a similar field of endeavor of vessel treatment, Lee teaches wherein the steps of the method are repeated at least once (paragraph 59).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wallace/Garibaldi to include wherein the steps of the method are repeated at least once as taught by Lee for the purpose of achieving a desired number of vaso-occlusive devices to be placed within the body cavity (paragraph 59 of Lee).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 05/21/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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