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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-19, drawn to a thrombectomy method.
Group II, claim(s) 20, drawn to a thrombectomy system.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Group I and Group II lack unity of invention because even though the inventions of these groups require the technical feature of the particulate media, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 2007/0282303 to Nash et al.. The shared technical feature, the particulate media, lacks novelty or inventive step because it is anticipated by the particulate media being used by Nash. Nash discloses the particulate media in paragraph 0070.
During a telephone conversation with Peter Yaghmaie on 11/06/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 15 objected to because of the following informalities: Claim 15 recites “wherein the particulate media the coating is…”. Appropriate correction is required.
Claim 17 objected to because of the following informalities: Claim 17 recites “introducing the distal portion is into the blood vessel”. Appropriate correction is required.
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.
Claim(s) 1-4, 7-8, 10, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0282303 to Nash et al. (Nash).
Nash teaches:
Claim 1: A thrombectomy method (Fig. 6-11), comprising:
delivering a distal portion of an elongate catheter (600, Fig. 6) into proximity with a thrombus in a blood vessel (426, Fig. 7);
engaging the distal portion with the thrombus (Fig. 8); and
directing a particulate media (para. 0070) towards the thrombus.
Claim 2: Further comprising aspirating the thrombus out of the blood vessel (para. 0114).
Claim 3: Directing the particulate media towards the thrombus comprises combining the particulate media with a pressurized fluid (para. 0066 describes pressurized infusate fluid and para. 0070 describes infusate fluid may include particulate).
Claim 4: Further comprising directing a fluid stream towards the thrombus (through port 606, Fig. 7, see para. 0114).
Claim 7: The particulate media is an abrasive mixture (because the infusate may include solids or semisolids material (para. 0070)/particulate media, it is said the particulate media is an abrasive mixture).
Claim 8: The particulate media comprises salt (para. 0070).
Claim 10: The particulate media comprises a contrast media (para. 0069 describes the infusate may be delivered as infusate and para. 0070 describes infusate fluid may include particulate).
Claim 17: Introducing the distal portion is into the blood vessel in a low-profile configuration, and wherein the method further comprises expanding the distal portion into a deployed configuration (para. 0113, the working head 600 before the rotation of helically wound wire 49 is said to be in a low profile configuration, as the result to the rotation of the helically wound wire 49, Fig. 6-7, the working head is said to be expanding, defecting away from the guide wire, to better treat the occlusive material, Fig. 8).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 2003/0104073 to Johansson et al. (Johansson).
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
The particulate media comprises a sugar.
Johansson teaches:
Method for enhancing fluid low through an obstructed vascular site comprises using acidic dissolution to dissolve an inorganic component in the target vascular lesion, where using agent such as salt, sugars and the like to increase the osmolarity of the acidic solution is employed (para. 0071-0073).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employed agents such as sugar as taught by Johansson into the particulate media of Nash in order to enhance dissolving an inorganic component in the target vascular lesion.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 2016/0262777 to Stigall et al. (Stigall).
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
Claim 5: The fluid stream is directed towards the thrombus with one or more fluid stream apertures and the particulate media is directed towards the thrombus with one or more particulate media apertures.
Claim 6: The fluid stream is carried within one or more fluid lumens in the elongate catheter and the particulate media is carried within one or more particulate media lumens in the elongate catheter.
Stigall teaches:
Methods and devices for thrombus dispersal comprises a device (10, Fig. 1) including a distal section having plurality of fluid delivery ports/fluid stream apertures (58, Fig. 12A) and plurality of fluid delivery lumens (30, Fig. 2). (Even if fluid and particulate are delivered through the same hole would still read on the claim because one hole could be used for the fluid and one could be used for the particulate).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the plurality of fluid stream apertures and delivery lumens as taught by Stigall into Nash in order to enhance irrigating and aspirating of the thrombus in the bodily vessel.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 2005/0245894 to Zadno-Azizi.
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
The particulate media comprises lactated ringers.
Zadno-Azizi teaches:
Methods and apparatuses for drug delivery to an intravascular occlusion comprises using lactated ringer’s solution to deliver a radioisotope to the site of an occlusion which has been treated with a therapy catheter to inhibit restenosis of the occlusion (para. 0083).
It would have been obvious to one of ordinary skill at the time of the invention was filed to employed lactated ringer’s solution as taught by Zadno-Azizi into Nash in order to deliver a radioisotope to the site of an occlusion which has been treated with a therapy catheter to inhibit restenosis of the occlusion (para. 0083).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 2003/0199865 to Knudson et al. (Knudson).
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
Claim 12: The particulate media comprises microparticles.
Claim 13: The particulate media comprises microbeads.
Knudson teaches:
In the same field as endeavor, thrombus treatment with emboli management comprises using microbeads/microparticles that can be ruptured by ultrasound application to release the solvent (para. 0059).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to use microbeads as taught by Knudson into Nash as a substitution of one known material for another that would yield predictable result of breaking up clot.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 2020/0261266 to Bley et al. (Bley).
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
Claim 14: The particulate media includes a coating configured to reduce dissolution of the particulate media within the body.
Claim 15: The particulate media coating is a lipid coating.
Bley teaches:
A medical device includes coating an agent with a barrier including biodegradable polymers, lipids, fatty acids to modify the agent release characteristics and/or mechanical properties (para. 0117)
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the particulate/agent with lipids coating in order to reduce dissolution or control the particulate/agent release characteristic to sustained agent effectiveness once the particulate/agent released into the body.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash in view of US 6620148 to Tsugita.
Nash teaches:
The method of claim 1 (see rejection of claim 1 above).
Nash fails to teach:
The blood vessel comprises a pulmonary artery.
Tsugita teaches:
In the same field as endeavor, a device for removing clot in the body vessels and the blood vessel comprises a pulmonary artery (Col. 4, ll. 32-37).
Nash is silence on the type of vessel the device is using in. However, Tsugita is teaching that the vessel is a pulmonary artery. It would have been obvious at the time of the invention was filed to employ the method of removing clot in the pulmonary artery and other areas as taught by Tsugita into Nash in order enhance surgeon to be able to removing clot in many areas in the body.
Allowable Subject Matter
Claims 16, 18 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 16, the cited prior art fails to disclose directing the particulate media further comprises: delivering a fluid to a mixing chamber; delivering the particulate media to the mixing chamber; and fluidizing the particulate media in the mixing chamber with the fluid. Regarding claim 18, the cited prior art fails to disclose directing the particulate media along at least two intersecting paths.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771