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 .
CLAIM INTERPRETATION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘fluid openings’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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 1 and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10-13 of U.S. Patent No. 12,303,151. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 10 under examination are anticipated, respectively, by claims 1 and 10 of the reference patent. Every limitation in the application under examination is recited in the conflicting reference patent claims and the differences between the claims are highlight below by bolding all limitations that differ and having explanations in parentheses. As shown in the mapping below, claim 1 of the reference patent includes all of the limitations of claim 1 of the instant application, while also reciting further limitations.
Instant Application
U.S. Patent No. 12,303,151
1. An aspiration medical device, comprising: a catheter shaft having an aspiration lumen defined therein; an aspiration member disposed within the aspiration lumen, the aspiration member having a plurality of fluid openings formed therein; wherein at least one of the plurality of fluid openings is angled proximally; and a wall support region disposed along the catheter shaft at a position opposite at least one of the plurality of fluid openings, the wall support region being configured to support the integrity of the catheter shaft when fluid is passed through the plurality of fluid openings.
1. An aspiration medical device, comprising: a catheter shaft having a distal end region and defining an inflow orifice adjacent to the distal end region (does not affect the ability of fluid being passed through the fluid openings and angled proximally); an aspiration member disposed within the catheter shaft, the aspiration member having a plurality of fluid openings formed therein; and a wall support member disposed along an inner surface of the catheter shaft at a position opposite at least one of the fluid openings (the wall support on the inner surface is capable of supporting the catheter shaft when fluid is pass therethrough due to enhanced strength, resistance and load-bearing capacity).
2. The aspiration medical device of claim 1, wherein at least one of the plurality of fluid openings is angled proximally.
10. A medical device, comprising: a catheter shaft having an aspiration lumen defined therein; a fluid infusion tube disposed within the aspiration lumen, the fluid infusion tube having a first fluid opening formed therein and a second fluid opening formed therein that is axially spaced from the first fluid opening; and wherein the catheter shaft includes a support region extending along a position opposite the first fluid opening, the support region being configured to support the catheter shaft when fluid is passed through the first fluid opening.
10. A medical device, comprising: a catheter shaft having a distal end region and defining an inflow orifice adjacent to the distal end region; a fluid infusion tube disposed within the catheter shaft (a lumen is defined by the catheter shaft), the fluid infusion tube having a plurality of axially-spaced openings formed therein; and a support member disposed within the catheter shaft, the support member having a wall support region disposed along an inner surface of the catheter shaft at a position opposite at least one of the axially-spaced openings (the wall support on the inner surface is capable of supporting the catheter shaft when fluid is pass therethrough due to enhanced strength, resistance and load-bearing capacity).
11. The medical device of claim 10, wherein the first fluid opening is angled proximally.
11. The medical device of claim 10, wherein at least one of the plurality of axially-spaced openings is angled proximally.
12. The medical device of claim 10, wherein the first fluid opening is oriented in a direction that is substantially normal to a longitudinal axis of the fluid infusion tube.
12. The medical device of claim 10, wherein at least one of the plurality of axially-spaced openings is oriented in a direction that is substantially normal to a longitudinal axis of the fluid infusion tube.
13. The medical device of claim 10, wherein the first fluid opening is angled proximally and wherein the second fluid opening is oriented in a direction that is substantially normal to a longitudinal axis of the fluid infusion tube.
13. The medical device of claim 10, wherein the plurality of axially-spaced openings includes a first opening and a second opening disposed distally of the first opening, wherein the first opening is angled proximally, and wherein the second opening is oriented in a direction that is substantially normal to a longitudinal axis of the fluid infusion tube.
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, 7-11, and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanson et al. (US 2019/0209745A1, “Hanson”).
Regarding claim 1, 10, 11, and 19, Hanson discloses an aspiration medical device including a catheter shaft (12; Fig. 1) having a distal end region. The catheter shaft includes an open distal end [0014, 0057] and an outflow orifice (24) disposed proximally of the open distal end [0005, 0045] an aspiration lumen (129; Fig. 4) defined therein. An aspiration member/fluid infusion tube (128; Fig. 4, 11) is disposed within the aspiration lumen. The aspiration member has a plurality of fluid openings/axially-spaced fluid jets (138; second opening/fluid jet disposed distally of first opening/fluid jet) formed therein. At least one of the plurality of fluid openings is angled proximally (Fig. 4). A wall support region/reinforcement (840; Fig. 11) is disposed along the catheter shaft at a position opposite at least one of the plurality of fluid openings. The wall support region/reinforcement is capable of supporting the integrity of the catheter shaft when fluid is passed through the plurality of fluid openings/fluid jets.
Regarding claim 7, Hanson discloses that the aspiration member has a closed distal end (Fig. 4, 11).
Regarding claims 8 and 17, Hanson discloses that the catheter shaft has an open distal end (Fig. 7; [0014, 0057]).
Regarding claims 9 and 18, Hanson discloses that at least some of the plurality of fluid openings (first and second fluid openings) are circumferentially offset from one another [0011].
Allowable Subject Matter
Claims 2-6, 14-16 and 20 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shmulewitz et al. (US 6,569,145) discloses a device including a catheter shaft, a fluid infusion tube and a plurality of fluid openings.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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