DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, drawn to a device, classified in A61M60/422.
II. Claims 11-20, drawn to a method, classified in A61B17/12109.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process such as a treating cardiac dysfunction, congestive heart failure, reduced renal blood flow, increased renal vascular resistance, arterial hypertension, and kidney dysfunction.
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:
a different field of search: where it is necessary to search for one of the inventions in a manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching different classes/subclasses or electronic resources, or employing different search queries), a different field of search is shown, even though the two are classified together. Here, different search queries are required for the method including increasing flow through the innominate vein.
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 Adam Schoen on June 15, 2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-10. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-20 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 § 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.
Claims 1-10 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.
Claim 1 lines 5-6 recite “…such that a medicament released from the medicament lumen flows through the inlet and impeller assembly.”. MPEP 2173.05(p) recites that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). It is not clear if lines 5-6 recite a method of using the device. For purposes of examination, the above is interpreted as “…such that a medicament released from the medicament lumen during use is configured to flow[[s]] through the inlet and the impeller assembly.”. Claims 2-10 are rejected at least because they depend from claim 1.
Claim 4 recites the limitation "the port" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a port”.
Claim 5 recites the limitation "the impeller housing" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “an impeller housing”.
Claim 5 recites in line 3 “…inlets into the impeller housing…”. It is not clear if these inlets include the inlet of claim 1, or are different inlets. For purposes of examination, the inlets of claim 5 are interpreted to include the inlet of claim 1.
Claim 6 recites the limitation "the flexible tube" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the tube”.
Claim 6 recites the limitation "the port" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a port”.
Claim 9 recites the limitation "the impeller cage" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “an impeller cage”.
Claim 9 recites a method use. MPEP 2173.05(p) recites that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). For purposes of examination, the device of claim 9 is interpreted to be configured for use as recited.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nash et al. (Nash) US 6,936,056 B2.
Regarding claim 1, Nash discloses a device comprising: a catheter (catheter 22; see Figs. 2-5); an impeller assembly (impeller 44, axle 36, shroud 56) mounted at a distal portion of the catheter (“axle 36 is supported in a central bore of a bushing 38 fixedly mounted at the distal end of the catheter's jacket 34 by an encircling mounting band 40” – see para beginning line 42 col. 7); and a medicament lumen (interior of 34) extending through the catheter and terminating substantially at an inlet (grooves 46) of the impeller assembly such that a medicament (“infusate liquid”) released from the medicament lumen during use is configured to flow through the inlet and the impeller assembly (Figs. 2-5, para beginning line 10 col. 8).
Regarding claim 2, Nash discloses the device of claim 1, wherein the catheter and impeller assembly are dimensioned for insertion through a jugular vein of a patient (system for opening a lumen of an occluded blood vessel c 4 ln 11-15, fully capable of insertion through a jugular vein of a patient), the device further comprising a reservoir (source 82, c 9 ln 29 and shown in Fig. 1) in fluid communication with the medicament lumen.
Regarding claim 3, Nash discloses the device of claim 2, wherein the impeller assembly comprises an impeller housing (shroud 56, c 8 ln 1-2) with an impeller (impeller 44, c ln 46) rotatably disposed therein, the device further comprising a motor (turbine 70, c 9 ln 8) connected to a proximal end of the catheter (Fig. 1) and operably connected to the impeller via a drive cable (drive cable 42, c 7 ln 52) extending through the catheter (Fig. 2).
Regarding claim 4, Nash discloses the device of claim 3, wherein a port (window or port 64, c 8 ln 57) is located at the impeller housing, proximal to the impeller.
Regarding claim 5, Nash discloses the device of claim 1, wherein the catheter comprises a tube (catheter 22 is in the form of a flexible tubular body, c 6 ln 28) with a drive cable (drive cable 42, c 7 ln 52) extending there through (Fig. 2) with a cap (bushing 38, c 7 ln 49) connected around a terminal portion of the tube (Fig. 3), with an impeller housing (shroud 56, c 8 ln 1-2) mounted to the cap by a plurality of struts to define inlets into the impeller housing (plurality of struts formed by the structure of bushing 38 that define inlets into radial ports 48, c 8 ln 10-21).
Regarding claim 6, Nash discloses the device of claim 5, wherein the cap seals a terminus of the tube to a shaft of the impeller (shank 36), wherein a port (annular recess 50, c 8 ln 16) is located in the cap.
Potentially Allowable Subject Matter
Claims 7-10 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, as well as overcoming the §112(b) rejections above.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed device.
The closest prior art is Nash et al. (Nash) US 6,936,056 B2.
Regarding claim 7, Nash fails to teach among all the limitations or render obvious a device as claimed, which includes wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlets and out of the impeller assembly via the outlets, in combination with the total structure and function of the device as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific 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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.A.D./
Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights