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
In response to the preliminary amendment filed on 2/20/2025, claims 1-20 have been canceled, and newly added claims 21-40 are pending.
Drawings
The drawings are objected to because in Fig, 4C, reference numbers 404 and 402 appear to be switched. Figs. 4A and 4B correctly label the distal wall marker 402 and proximal wall marker 404. However, in Fig. 4C, distal wall marker is incorrectly labeled as reference number 404 and proximal wall marker is incorrectly labeled as reference number 402.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 37 is objected to because of the following informalities: “the shape of the second radiopaque portion” should recite - - a shape of the second radiopaque portion - - to provide proper antecedent basis. Appropriate correction is required.
Applicant is advised that should claim 33 be found allowable, claim 40 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly added claim 38 recites the third radiopaque portion is closer to the second radiopaque portion than in the first image. However, the original specification has not disclosed the third radiopaque portion (406), disposed at or near the desired inversion plane, to be closer to the second radiopaque portion (404) in the second image than in the first image. From Fig. 4A to Fig. 4C, it can be seen that the second radiopaque portion of the occlusion member inverts downwards towards the first radiopaque portion. There is a discussion of the change in distance between the first radiopaque portion and the second radiopaque portion. However, there is no discussion of the change in distance between the third radiopaque portion and the second radiopaque portion. Therefore, claim 38 is considered new matter.
Newly added claim 39 similarly recites confirming the progression of the deployment of the occlusive member based on visualizing the third radiopaque portion being closer to the second radiopaque portion in the second image than in the first image. As discussed above, there is no discussion of the change in distance between the third radiopaque portion and the second radiopaque portion. Therefore, claim 39 is considered new matter.
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 21-30 and 39 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 21 recites “an occlusive member positioned within an aneurysm”. Claim 21 subsequently recites “a conduit having a distal portion positioned within an aneurysm”. It is unclear if the occlusive member and conduit are placed in the same aneurysm or different aneurysms. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the aneurysms to be the same and interpret the line 5 as - - a conduit having a distal portion positioned within the aneurysm - -.
Claim(s) 22-30 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim 39 recites the limitation "the third radiopaque portion". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 31, 32, 34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gorowchow et al (US 2020/0113576) in view of アボイテス et al (JP 2015512274; hereinafter as “JP”; wherein the English machine translation is cited below).
Claim 31. Gorowchow et al discloses a method for treatment of an aneurysm, the method comprising:
acquiring a first position (Fig. 3B) of an occlusive member (100) positioned within an aneurysm (10), the occlusive member including a first radiopaque portion (122) at a proximal wall (112) of the occlusive member and a second radiopaque portion (124) at a distal wall (124) of the occlusive member; and
acquiring a second position (Fig. 3F) in which the second radiopaque portion (124) is closer to the first radiopaque portion (122) than in the first position ([0044]-[0049]).
Gorowchow et al explicitly discloses the portions (122, 124) are radiopaque but fails to disclose their use in an imaging method of treating the aneurysm, specifically acquiring a first image visualizing the first position and acquiring a second image visualizing the second position.
However, in the same field of endeavor, JP teaches a method for imaging treatment of an aneurysm, wherein the steps including acquiring a first image visualizing an occlusive member having multiple radiopaque portions (242, 244) in a first position (during delivery, akin to the first position of Gorowchow et al), and acquiring a second image visualizing the occlusive member in a second position (after implantation, akin to the second position of Gorowchow et al) ([0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gorowchow et al to include the imaging steps of acquiring the first and second images as claimed based upon the teachings of JP to allow the user to monitor correct positioning during delivery and assess proper placement of the occlusive member after implantation.
Claim 32. Gorowchow et al as modified above discloses the invention substantially as claimed above, wherein the combination results in confirming progression of deployment of the occlusive member based on visualizing the second radiopaque portion being closer to the first radiopaque portion in the second image than in the first image. Gorowchow et al teaches proper placement is achieved by the second radiopaque portion (124) being closer to the first radiopaque portion (122) in its deployed state (Fig. 3F) and JP teaches using imaging to facilitate this process during delivery and after implantation ([0085]). Therefore, the combination encompasses the claimed limitation.
Claim 34. Gorowchow et al as modified above discloses the invention substantially as claimed, wherein the combination results in: in the first image (Fig. 3B of Gorowchow et al) and in the second image (Fig. 3F of Gorochow et al)(wherein the imaging was taught by JP), the second radiopaque portion (124) is disposed nearer to a dome (top) of the aneurysm than the first radiopaque portion (122).
Claim 35. Gorowchow et al as modified above discloses the invention substantially as claimed, wherein Gorowchow et al further discloses the first (122) and second (124) radiopaque portions are first and second radiopaque markers ([0039], [0043]).
Claim(s) 33, 36, 37 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gorowchow et al in view of JP as applied to claim 31 above, and further in view of Griffin (US 2019/0059909).
Claims 33 and 40. Gorowchow et al as modified discloses the invention substantially as claimed above, but fails to explicitly disclose acquiring the first image and acquiring the second image each comprises acquiring a fluoroscopic image. Both Gorowchow et al and JP discloses the portions are radiopaque (Gorowchow et al: [0039], [0043]; JP: [0085]).
However, in the same field of endeavor, Griffin teaches a method for imaging treatment of an aneurysm (10), wherein a radiopaque marker (16) is used for imaging using fluoroscopy ([0058]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination such that acquiring the images comprise acquiring fluoroscopic images based upon the teachings of Griffin since it is known in the art fluoroscopy is the appropriate imaging method for visualizing radiopaque materials.
Claim 36. Gorowchow et al discloses the invention substantially as claimed above, but fails to disclose the first and second radiopaque portions comprise the proximal and distal walls of the occlusive member. Instead, Gorowchow et al teaches the body of the occlusive member (100) may be made of a braided mesh (110) ([0039], [0053]).
However, Griffin further teaches the material itself of a braided mesh occlusive member can be made radiopaque and these materials are well known in the art ([0065] – [0068]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to have the first and second radiopaque portions comprise the proximal and distal walls of the occlusive member as taught by Griffin as this method is well known in the art and allows the user to visualize the boundaries of the occlusive member.
Claim 37. Gorowchow et al as modified discloses the invention substantially as claimed above, wherein the combination results in confirming progression of deployment of the occlusive member based on visualizing changes of the radiopaque portions during delivery. Gorowchow et al teaches proper placement is achieved by the second radiopaque portion (124) being closer to the first radiopaque portion (122) in its deployed state (Fig. 3F) as compared to the initial delivery state (Fig. 3B) and JP teaches using imaging to facilitate this process during delivery and after implantation ([0085]). However, the combination does not explicitly disclose visualizing changes in the shape of the second radiopaque portion since the second radiopaque portion (124) is a crimp band.
Gorowchow et al teaches the body of the occlusive member (100) may be made of a braided mesh (110) ([0039], [0053]). Griffin further teaches the material itself of a braided mesh occlusive member can be made radiopaque and these materials are well known in the art ([0065] – [0068]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to have the second radiopaque portion be of Gorowchow et al be made of a radiopaque material of the braided mesh itself as taught by Griffin as this method is well known in the art and allows the user to visualize the boundaries of the occlusive member. This modification would result in the combination visualizing changes in the shape of the second radiopaque portion as the radiopaque portion is now the wall of the occlusive member itself. Therefore, the combination encompasses the claimed limitations.
Allowable Subject Matter
Claims 21-30 would be allowed if rewritten to obviate the 35 U.S.C. 112 rejections as interpreted by the Examiner above.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Wallace (US 2003/0181927) discloses a method for imaging treatment of an aneurysm ([0044]), the method comprising: acquiring a first image (Fig. 2B) visualizing an occlusive member (12) positioned within an aneurysm (50), the occlusive member including a first radiopaque marker (24); and a conduit (16) having a distal portion positioned within the aneurysm (Fig. 2B), the distal portion of the conduit including a second radiopaque marker (22).
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, and acquiring a second image in which the first radiopaque marker is further from the second radiopaque marker than in the first image. Instead, Wallace discloses the first radiopaque marker (24) becomes closer to the second radiopaque marker (22) since second radiopaque marker is positioned proximal of the occlusive member. In contrast, Applicant’s invention involves the conduit and second radiopaque marker (400) being positioned distal of the occlusive member (Fig. 4A) and therefore when the occlusive member is deployed in the second image, the first radiopaque marker (402) is moved further from the second radiopaque marker (400) (Fig. 4C).
. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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