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 .
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.
Claim(s) 1-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-18 of U.S. Patent No. 11,986,175. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1, 12, 13, and 18 - Clm. 1 or 16 of the reference patent recite:
A medical device shaft, comprising:
a plurality of lumens, each of the plurality of lumens having a first, proximal opening and a second, distal opening; and
a distal tip at a distalmost end of the catheter, the tip comprising:
a distal delivery opening, a passage connecting at least one of the plurality of lumens to the distal delivery opening; and
an auger extending to the distal delivery opening, wherein the auger is rotatably disposed in the passage.
The instant claim 1 and the issued reference Claims 1 or 16 differ inasmuch as Claim 1 particularly requires the “shaft” to be a “catheter”, whereas the shaft in Claims 1 and 16 isn’t specifically recited as such. However, Examiner submits that the combination of a “medical system” comprising “a shaft” having a “plurality of lumens” defines a particular genus wherein a “catheter” is merely one tubular, medical article species found within that genus, particularly where “catheter” is a particularly broad species which covers “a tubular medical device to insertion into canals, vessels, passageways, or body cavities usually to permit injection or withdrawal of fluids or to keep a passage open” – see Merriam-Webster’s Online Dictionary and is essentially overlapping with the claimed “medical system” comprising a “shaft” comprising “a plurality of lumens” terminating in a “distal delivery opening”. It would have been clearly obvious to embody the instant “shaft” as a catheter in order to affect a specific and particularly well-known “medical system” “shaft” which comprises a tubular lumen used for “delivery”.
Regarding Claim 2, see Clm. 3 and 4 as well as Clm. 16 of the reference patent which affects the necessary hardware to “configure” the auger to move mixtures comprising distinctive agents based upon the recitation toward the plurality of containers.
Regarding Claim 3-4, see Clm. 1, 2, 3, 8, 12 and 16 of the reference patent.
Regarding Claim 5, see Clm. 1 and 16.
Regarding Claim 6, see Clm. 5
Regarding Claim 7, see Clm. 1, 2, 3, 8, 12, and 16.
Regarding Claim 8, see Clm. 7.
Regarding Claim 9, see Clm. 14, 15, 16, 17.
Regarding Claim 10, see Clm. 14, 15, 16, 17.
Regarding Claim 11, while the claims of the reference patent do not particularly recite that the “tip is removably attached to a distal end of the catheter”, constructing a component to be “removable” is not found to be distinctive, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding Claim 13-14, see Clm. 10, 11, and 16.
Regarding Claim 15, see Clm. 4 and 5.
Regarding Claim 16, see Clm. 5.
Regarding Claim 17, see Clm. 14-17.
Regarding Claims 19-20, see Clm. 14-17.
Claim Rejections - 35 USC § 112
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.
Claim(s) 18, and dependents, is/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.
Regarding Claim 18, Applicant recites “wherein a the first passage is configured…” However, this creates confusion as the use of both the definite article “the” and the indefinite article “a” in association with the “first passage” creates confusion as to whether this is a new structure, distinctive from the previous “a passage” recited earlier in the claim OR is intended to be made in reference to the “a passage” previously introduced. This is further exacerbated by later reference to “the passage” wherein if the “first passage” is distinctive from the “a passage” then it is unclear to what “the passage” the claim makes reference.
Claim Rejections - 35 USC § 102
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) 12, 18, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011/143577 (“Cronin”).
Regarding Claim 12, Cronin discloses a medical device shaft (826), comprising:
a catheter (Abstract) including a lumen (see Fig. 51 – i.e. the hollow interior of the shaft), wherein the lumen is configured to be fluidly coupled to a source of an agent (e.g. 922,838, 944); and
a distal tip (see Fig. 53) at a distalmost end of the catheter, the tip including a passage and an auger (892, 894) rotatably disposed in the passage, wherein the auger is configured to rotate to move the agent from the lumen to a distal delivery opening of the distal tip (Par. 245).
Regarding Claim 18, Cronin discloses a medical device shaft (826) comprising:
a catheter (Abstract); and
a tip (see Fig. 53) at a distalmost end of the catheter, the tip comprising:
a distal delivery opening, a passage connecting the catheter to the distal delivery opening, and an auger (892, 894) extending to the distal delivery opening (see Fig. 53), wherein the auger is rotatably disposed in the passage (Par. 245);
wherein a the first passage is configured to receive a first agent and a second agent (see e.g. the contents of 922, 838, 844), and wherein the auger is configured to move the first agent and the second agent within the passage toward the distal delivery opening (Par. 245), wherein the auger is configured to mix the first agent and the second agent (Par. 245).
Regarding Claim 19, Cronin discloses the tip includes a tapered portion tapering towards the distalmost end of the tip (see Fig. 53).
Claim(s) 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0119956 (“Leeflang”)
Regarding Claim 12, Leeflang discloses a medical device shaft (10) comprising:
A catheter (10) including a lumen (18), wherein the lumen is configured to be fluidly coupled to a source of an agent (see e.g. 60 or 54); and
a distal tip (20) at a distalmost end of the catheter, the tip including a passage (26) and an auger (276) rotatably disposed in the passage, wherein the auger is configured to rotate to move the agent from the lumen to a distal delivery opening (27) of the distal tip (Par. 68).
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.
Claim(s) 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2011/143577 (“Cronin”) as applied above, and further in view of U.S. Patent No. 5,263,959 (“Fischell”).
Regarding Claims 17 and 20, Cronin discloses wherein the auger includes a helical thread, the helical thread including a pitch and a diameter (see Fig. 53). However, Cronin fails to disclose that the auger includes a tapered portion at a distal end of the auger, and wherein the tapered portion of the auger is positioned within the tapered portion of the tip (see Fig. 53). However, Fischell discloses a related catheter and auger (see Fig. 1A) wherein the auger includes a tapered portion at a distal end of the auger, the tapered portion of the auger positioned within the distal tip of the catheter so as to extend therethrough (see Fig. 1A). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the auger of the invention of Cronin to extend through the distal, tapered tip with a tapering section of the auger, as disclosed by Fischell, in order to allow the auger to provide for distal cutting and breakup of tissue and not just lateral breakup of tissue as provided by the end effector (882, 898).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0119956 (“Leeflang”) as applied above.
Regarding Claim 13, Leeflang discloses in some embodiments (see Fig. 2) the lumen may comprise a first lumen and the agent may be a first agent (Par. 48) and the catheter may include a second lumen (76) configured to be fluidly coupled to a source of a second agent (Par. 48). While Leeflang does not explicitly disclose combining the embodiments Leeflang does suggest that various modifications to the disclosed embodiments are possible (Par. 99-101) and does appear to suggest that the auger concept might be optional for inclusion to the invention in general and not merely in the manner explicitly illustrated (see Par. 62). It would have been obvious for one having ordinary skill in the art at the time the invention was made to include an auger in association with a multi-lumen catheter embodiment of Leeflang, in order to allow for material to be moved proximally or distally within the distal tip section (Par. 64-68) including in configurations wherein multiple agents are provided via separate lumens in order to affect mixing in the distal section..
Claim(s) 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2005/0123485 (“Suzuki”) in view of U.S. Publication No. 2017/0119956 (“Leeflang”).
Regarding Claim 12, Suzuki discloses a medical device shaft (see e.g. Fig. 3), comprising: a catheter (Abstract) including a lumen (103, 105, 106), wherein the lumen is configured to be fluidly coupled to a source of an agent (Par. 58); and
a distal tip (see Fig. 3) at a distalmost end of the catheter, the tip including a passage. Suzuki discloses the invention substantially as claimed except that that the device further comprises an auger rotatably disposed in the passage, wherein the auger is configured to rotate to move the agent from the lumen to a distal delivery opening of the distal tip. Rather Suzuki appears to suggest that the agent is moved/mixed/agitated via the fluid flow alone (Par. 58, 59, 74). However, Leeflang discloses a related invention wherein a length of catheter tubing (10) is provided with a distal tip (20) at its distalmost end, the tip including a passage (26) with an auger ( 276) rotatably disposed in the passage, wherein the auger is configured to rotate to move the agent from the lumen to a distal delivery opening of the distal tip (Par. 63-68). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an auger to the distal passage of Suzuki, as disclosed by Leeflang, in order to selectively rotate to assist in moving/mixing/agitating the agents to be provided by the invention of Suzuki to thereby breakup, reduce the size, and prevent clogging of the agent within the distal passage thereby improving delivery.
Regarding Claims 13 and 18, Suzuki discloses the lumen is a first lumen and the agent is a first agent, wherein the catheter further includes a second lumen configured to be fluidly coupled to a source of a second agent (Par. 58).
Regarding Claim 14, Suzuki discloses the catheter further includes a third lumen (103) configured to be fluidly coupled to a source of a propellant fluid (Par. 56).
Regarding Claim 15, Suzuki discloses the propellant fluid is a gas (Par. 56).
Regarding Claim 16, Suzuki discloses the propellant fluid is configured to atomize the first agent and the second agent within the passage (Abstract).
Regarding Claim 17 and 19-20, Suzuki, as modified by Leeflang, discloses the tip includes a tapered portion that decreases in diameter toward the distal delivery opening, wherein the auger includes a helical thread, and wherein a diameter or pitch of the helical thread decreases at the tapered portion (see Fig. 5 – Leeflang).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/30/2026
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