DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/7/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant should note that the large number of references in the attached IDS from 11/7/2024 (13 pages) have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “artery selection element” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Based on Applicant’s specification, the artery selection element is shown as element 4609 in figure 46B, which is a display screen with a graphical user interface with a menu.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 2, 3, 4, 5, and 9 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by WO 2011/053984 A1 (Creighton et al., hereinafter Creighton).
In regards to claim 2, Creighton discloses a system that manipulates magnetic rotors in the circulatory system (see title and abstract; paragraphs [0007]-[0248]; figures 1A, 1B, 2, 3, 4A, 4B, 5, 6A-6C, 9, 10A-B, 21A-D, 25A-D). Creighton discloses the following:
at least one motor (element 120, figure 1A; paragraphs [0009]-[0029], [0109], [0114], [0115], [0125], [0132], [0139], and [0142]-[0146] ) ;
a magnet (element 102, figure 1A; paragraphs [0009]-[0029], [0109], [0114], [0115], [0125], [0132], [0139], and [0142]-[0146] ),
a controller (paragraphs [0009]-[0029], [0107]-[0109], [0113]-[0114], [0123]-[0129], [0132]-[0139], and [0149]), and
a user interface (paragraphs [0010], [0021], [0028], [0110], [0133], [0140], and [0212]);
wherein the controller is configured to cause the at least one motor to control a position and a movement of a magnetic field of the magnet (paragraphs [0009]-[0029], [0107]-[0109], [0113]-[0114], [0123]-[0129], [0132]-[0139], and [0149]);
wherein the controller is configured to cause magnetic nanoparticles to generate a fluidic current within a blood vessel proximal to a fluid obstruction (paragraphs [0011]-[0029], [0040], [0096],[0110], );
wherein the user interface is configured to enable an operator to select a therapeutic target (paragraphs [0010], [0021], [0028], [0110], [0133], [0140], and [0212]).
In regards to claims 3-4, Creighton discloses the limitations of claim 2. In addition, Creighton discloses targeting a vascular occlusion in a patient’s head and brain in paragraphs [0023], [0030], [0042], [0095], [0103], [0126], and [0135]. This would naturally include a hemisphere of a head/brain as the target would be in a hemisphere.
In regards to claim 5, Creighton discloses the limitations of claim 2. In addition, Creighton states that therapeutic targets include atherosclerotic plaques, coronary occlusion, arterial stenosis, arterial restenosis and arterial thrombi as some of the targets, which would be arterial targets in an arterial branch (abstract; paragraphs [0008], [0019], [0026], [0108], [0131], and [0138]).
In regards to claim 9, Creighton discloses the limitations of claim 2. In addition, Creighton states that the magnetic nanoparticles are injected in paragraphs [0010], [0021], [0029], [0110], [0112], [0133], [0152]-[0157], [0162], [0163], [0182], [0208], [0243], and [0244]) which would require the presence of an infusion system.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2011/053984 A1 (Creighton et al., hereinafter Creighton) as applied to claim 2 above, and further in view of US 2004/0171924 (Mire et al., hereinafter Mire).
In regards to claims 11, Creighton discloses the limitations of claim 2 but does not state that the interface is configured to enable he operator to input a head angle of a patient. In a related area, Mire discloses a method and apparatus used for preplanning a surgical procedure (title and abstract; figures 1, 3A, 3B, 5-7, 9, and 10; paragraphs [0046]-[0027]). Of particular note is paragraphs [0102]-[0103] which describes an input mechanism for a user interface for control of the device where the input includes angles of the patient in relation to a specific treatment procedure to ensure proper patient alignment in the procedure. Thus, it would have bene obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the system of Creighton to include an input for head angles, as taught Mire by in order to allow for proper patient alignment in a treatment procedure.
Claims 15 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2011/053984 A1 (Creighton et al., hereinafter Creighton) as applied to claim 2 above, and further in view of US 2010/0049188 (Nelson et al., hereinafter Nelson).
In regards to claim 15, Creighton discloses the limitations of claim 2. However, Creighton does not state that the user interface includes a start procedure icon. In a related area, Nelson discloses a system that provides therapy using a catheter (title; abstract; Figures 33A-E; paragraphs [0022]-[0358]). Of particular note are figures 33B which shows an interface in the system of interfaces that includes a start therapy/procedure button to start and control the therapy (paragraphs [0239]-[0242]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the device of Creighton to include a start procedure icon in the interface as taught by Nelson to enable the user to control the start of therapy.
In regards to claim 16, Creighton and Nelson disclose the limitations of claim 15. In addition, Creighton shows in paragraphs [0109]-[0114] and [0139] the control of the motor via the controller. Because this operation occurs during therapy, the start procedure icon being activated to start therapy would cause the controller to control the position and movement of the magnetic field of the magnet.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2011/053984 A1 (Creighton et al., hereinafter Creighton) and US 2010/0049188 (Nelson et al., hereinafter Nelson) as applied to claim 15 above, and further in view of US 2002/0038392 (De La Huerga).
In regards to claim 17, Creighton and Nelson disclose the limitations of claim 15. However, they do not state the presence of a stop magnet icon. In a related area, De La Huerga discloses a control of a treatment system. Of note are paragraphs [0278]-[0279] which show the use of buttons on an interface to stop or start a treatment. The buttons can be considered as a stop magnet icon (Note that there are no specifics about the interface and since an interface can have buttons, knobs, and switches, the buttons, knobs, or switches can be considered as icons). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to have modified the device of Creighton and Nelson to include a stop magnet icon, as taught by De La Huerga in order to stop a treatment.
Claims 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2011/053984 A1 (Creighton et al., hereinafter Creighton) in view of US 2010/0049188 (Nelson et al., hereinafter Nelson) in view of US 2002/0038392 (De La Huerga) as applied to claim 17 above, and further in view of US 2004/0111081 (Whitman et al., hereinafter Whitman)
In regards to claim 19, Creighton, Nelson, and De La Huerga disclose the limitations of claim 17. However, they do not disclose the presence of a countdown timer. In a related area, Whitman discloses the use of timer in the system in paragraph [0107]-[0108] in order to determine if time elapsed has exceeded a threshold to stop a treatment procedure. Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the system of Creighton, Nelson, and De La Huerga to include a countdown timer as taught by Whitman in order to determine if time elapsed has exceeded a threshold to stop a treatment procedure.
Allowable Subject Matter
Claims 6-8, 10, 12-14, 18, 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.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 6, the prior art does not teach or suggest a system, as claimed by Applicant, where the user interface includes an artery selection element and is configured to display a list of available selections upon selecting of the artery selection element.
Claims 7 and 8 are dependent on allowable matter from claim 6 and would be allowable.
In regards to claim 10, the prior art does not teach or suggest a system, as claimed by Applicant, where the user interface is configured to display an arrow predicting a direction of infusion from the infusion system.
In regards to claim 12, the prior art of record does not teach or suggest a system, as claimed by Applicant, where the user interface is configured to enable the operator to change the head angle of the patient during treatment.
In regards to claim 13, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the user interface is configured to display a bar slider to enable the operator to input the head angle
In regards to claim 14, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the user interface is configured to enable the operator to manipulate a head angle image to input the head angle.
In regards to claim 18, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the stop magnet icon is configured to appear on the interface after the start procedure icon is selected.
In regards to claim 20, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the countdown timer is paused upon selection of the stop magnet icon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791 /CARRIE R DORNA/Primary Examiner, Art Unit 3791
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