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 .
Specification
The amendment filed 2 August 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: new claim 34 sets forth an “agitator” which is not found in the Specification.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
Claim 34 is 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. Claim 34 sets forth an agitator, and no such device is disclosed in the Specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer
Claims 21-23, 28-33, 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/9421,929 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claims 21, 23, 33, 35, claim 21 of ’929 to Aklog claims a system comprising a cannula with an expandable member with a proximal and distal end with at least two moveable sections and a space therebetween, wherein the space is covered by an impermeable membrane extending from the proximal to distal ends, a secondary device placed therethrough (wherein the secondary device is a macerator), wherein the cannula is coupled to a vacuum source to pull or dislodge undesirable material.
With regard to claim 22, Applicant defines “mechanical” means in the Specification as direct manipulation of an undesirable material, including aspiration and maceration. As such, the claim is anticipated by ’929 claim 2.
With regard to claim 28, Applicant is setting forth the use of the claimed device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
With regard to claims 29-32, 40, claim 21 of Aklog ’929 claims that the secondary device comprises a macerator device configured to disrupt or dislodge the undersirable material, which may reduce its size (see also claim 16).
With regard to claim 36, claim 2 of Aklog ’929 sets forth that the secondary member is placed coaxially within the cannula, teaching that it moves freely within the cannula.
With regard to claim 37, see Aklog ’929 claim 39.
Claims 27, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/9421,929 (reference application) in view of US 9,402,938 to Aklog et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claims 27, 36, 38, 39 , Aklog ’929 sets forth the limitations of claims 21 and 33, but does not claim the secondary member as a tube or balloon. Claims 5, 8 of Aklog ’938 set forth an apparatus for removing undesirable material from a patient comprising a cannula with an expandable funnel shape and a balloon placed on a catheter within the cannula wherein the balloon catheter is movable independent of the cannula. Taken together the references reasonably suggest the limitations of the claims.
Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/9421,929 (reference application) in view of US2026/0076693 to Swift et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claim 37, Aklog ’929 sets forth the limitations of claim 21, but does not movable members with rounded edges. Claim 10 of Swift ’693 sets forth a device for removing undesirable material from a patient comprising an aspiration cannula with an expandable member comprising expansion members, wherein a distal section of the expansion member is substantially rounded. Taken together the references reasonably suggest the limitations of the claims.
Claims 21-25, 28-33, 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/985,608 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With regard to claims 21-25, claim 30 of Aklog ’608 claims a system comprising a cannula with an expandable member with a proximal and distal end with at least two reinforcement strips and a space therebetween, wherein the space is covered by an impermeable membrane extending from the proximal to distal ends (thereby forming a funnel), a secondary device placed therethrough (wherein the secondary device is configured to macerate undesirable material), wherein the cannula is coupled to a vacuum source to pull or dislodge undesirable material.
With regard to claim 22, Applicant defines “mechanical” means in the Specification as direct manipulation of an undesirable material, including aspiration and maceration. As such, the claim is anticipated by ’608 claim 30.
With regard to claim 28, Applicant is setting forth the use of the claimed device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
With regard to claims 29-32, 40, claim 30 of Aklog ’608 claims that the secondary device comprises a macerator device configured to disrupt or dislodge the undersirable material, which may reduce its size (see also claim 16).
Claims 27, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/985,608 (reference application) in view of US 9,402,938 to Aklog et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claims 27, 36, 38, 39 , Aklog ’608 sets forth the limitations of claims 21 and 33, but does not claim the secondary member as a tube or balloon. Claims 5, 8 of Aklog ’938 set forth an apparatus for removing undesirable material from a patient comprising a cannula with an expandable funnel shape and a balloon placed on a catheter within the cannula wherein the balloon catheter is movable independent of the cannula. Taken together the references reasonably suggest the limitations of the claims.
Claim 37 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/985,608 (reference application) in view of US2026/0076693 to Swift et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claim 37, Aklog ’608 sets forth the limitations of claim 21, but does not movable members with rounded edges. Claim 10 of Swift ’693 sets forth a device for removing undesirable material from a patient comprising an aspiration cannula with an expandable member comprising expansion members, wherein a distal section of the expansion member is substantially rounded. Taken together the references reasonably suggest the limitations of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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, Sarah Al-Hashimi can be reached on 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 14 April 2026
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