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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a fluid delivery device/system for performing a procedure, classified in A61M25/0026.
II. Claims 16-20, drawn to a method of regulating fluid, classified in A61M25/007.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be utilized in a materially different process of using that product, such as a process of aspirating material and/or an endoscopic procedure.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require different fields of search including different search queries and art applicable to one invention would likely not apply to another.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Karen Horowicz on 8/27/26 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are 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 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) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levy et al. (US 20190307971).
Regarding claim 1, Levy et al. discloses a fluid delivery device (device of fig. 5A-E) configured to deliver pressurized fluid through a fluid delivery port (port at the end of 728a) at an end thereof (end in the region of 728) to a target site within a patient, wherein: said fluid delivery device defines therethrough a fluid delivery lumen (lumen comprising 772, 732, 720, and 728a) fluidly couplable with a pressurized fluid source (as illustrated in fig. 1, applied to the embodiment of fig. 5A-E), and at least a first additional lumen (comprising 773, 734) configured for delivery of one of a device, a contrast fluid, a guidewire, or a wire filament configured for cutting tissue (fully capable of performing the claimed function); and a side orifice 730 (see fig. 5C-D) through a wall of said fluid delivery device defining said fluid delivery lumen (see fig. 5C-D), the side orifice defined proximal to the fluid delivery port and adjacent thereto to provide pressure relief upon partial or complete obstruction of the fluid delivery port (see fig. 5C-D, fully capable of performing the claimed function).
Regarding claim 2, Levy et al. discloses the fluid delivery lumen extends longitudinally along said fluid delivery device and said fluid delivery port extends out a distal end of said fluid delivery device to deliver fluid longitudinally out the fluid delivery device (see fig. 5A-E).
Regarding claim 3, Levy et al. discloses the fluid delivery lumen has a first diameter from a proximal end of the fluid delivery device to a narrowed region within the fluid delivery lumen having a second diameter smaller than the first diameter (two diameters of 720, see fig. 5C).
Regarding claim 4, Levy et al. discloses wherein the narrowed region is upstream of the side orifice (see narrowed region of 720 vs position of 730, fig. 5C).
Regarding claim 5, Levy et al. discloses the narrowed region creates a Venturi effect causing entrainment of fluid at the target site into the side orifice (par. 0041).
Regarding claim 6, Levy et al. discloses the entrained fluid is redirected back out the fluid delivery port of the fluid delivery system (par. 0044).
Regarding claim 7, Levy et al. discloses the first additional lumen is configured for passage of a guidewire therethrough and a further instrument over the guidewire to the target site (fully capable of receiving a guidewire/instrument as claimed, at a position at a target site).
Regarding claim 8, Levy et al. discloses a second additional lumen 728b is defined through said fluid delivery device configured for delivery of one of a device, a contrast fluid, a guidewire, or a wire filament configured for cutting tissue (fully capable of performing this claimed function).
Regarding claim 9, Levy et al. discloses a third additional lumen 728c is defined through said fluid delivery device configured for delivery of one of a device, a contrast fluid, a guidewire, or a wire filament configured for cutting tissue (fully capable of performing the claimed function).
Regarding claim 10, Levy et al. discloses the first additional lumen is configured for passage of a guidewire therethrough and a further instrument over the guidewire; the second additional lumen is configured for passage therethrough of a wire filament configure for cutting tissue; and the third additional lumen is configured for delivery therethrough of a contrast fluid to the target site (the lumens are fully capable of performing the claimed functions).
Regarding claim 11, Levy et al. discloses the side orifice 730 is in fluid communication with a return lumen 774 to provide pressure relief upon partial or complete obstruction of the fluid delivery port by delivering fluid outside the patient via the return lumen (fully capable of performing the claimed function).
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.
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) 12, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. in view of Thomas et al. (US 20210060292).
Regarding claims 12 and 15, Levy et al. discloses system (system of fig. 5A-E) for performing a procedure past an orifice within a patient’s body, said system comprising: a fluid delivery device (see fig. 5A-C) defining a fluid delivery lumen therethrough (lumen comprising 772, 732, 720, and 728a) ending at a distal fluid delivery port (port at the end of 728a), the fluid delivery device having a side port 730 proximal to the fluid delivery port and adjacent thereto (see fig. 5C) to provide pressure relief upon partial or complete obstruction of the fluid delivery port (fully capable of performing the claimed function); except for disclosing an additional instrument configured to be inserted along the fluid delivery device and inserted through the orifice within the patient’s body; wherein the fluid delivery device defines an additional lumen therethrough for delivery of the additional instrument therethrough. However, Thomas et al. teaches providing an additional lumen 122c in a multi-lumen catheter for insertion of an instrument (see fig. 7; par. 0130, instrument being a guidewire). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Levy et al. to include an additional lumen and a guidewire, as taught by Thomas et al., for the purpose of providing sufficient structure for placing the device via guidewire.
Regarding claim 14, Levy et al. discloses the fluid delivery lumen is couplable with a pressurized fluid source (as illustrated in fig. 1, applied to the embodiment of fig. 5A-E); and the diameter of the fluid delivery lumen decreases upstream and adjacent the side port to create a Venturi effect causing entrainment of fluid at the target site into the side port (see narrowed region of 720 vs position of 730, fig. 5C; par. 0041).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. in view of Thomas et al., and further in view of Lampropoulos et al. (US 5772639).
Regarding claim 13, Levy et al. in view of Thomas et al. teaches the system as claimed, except for a delivery device comprising a tubular delivery element configured to deliver said fluid delivery device therethrough. However, Lampropoulos et al. teaches utilizing a sheath 14 as a mechanism for placing other tubular devices, such as 12 (see fig. 1-3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Levy et al. in view of Thomas et al. to utilize a tubular delivery element, as taught by Lampropoulous et al., for the purpose of providing sufficient structure to guide the tubular delivery element to target tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
St Goar et al. (US 20010023334) – numerous lumens with various purposes (see fig. 1B for example), utilization of individual lumens for multiple purposes (par. 0076)
Hjalmarsson (US 20050288623) – two lumens, side ports, increasing/decreasing internal lumen diameter, instrument placement therethrough (see fig. 2)
Margolis (US 20150112307) – adding a lumen to receive a stiffening member
Glickman (US 20150290421)
Moehle et al. (US 20090118661)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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