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/Restrictions
Applicant’s election without traverse of Species H, FIGS. 61, 62 (claims 1-7, 9-12, and 14-15) in the reply filed on March 24, 2025 is acknowledged. Claims 8 and 13 are withdrawn as being directed towards a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 60990242, 61045944, 61091233, 61095451, 61095921, 12323273, 61349771, 13118033, 13118138, 14040205, 61707782, 61774512, and 61709877 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, none of these applications teach the claim 1 limitation “a plurality of magnetic sensors disposed in the probe, each of the plurality of magnetic sensors configured to sense a magnetic field of the magnetic element of the needle assembly, wherein a portion of the probe is rendered non-magnetic via the inclusion of one or more components that include a magnetic permeability of about 1”. None of the applications utilize the terms “non-magnetic” or “permeability” or discuss details of the specific components or materials of the ultrasound probe that would make them non-magnetic or have a permeability of about 1 (e.g. screw, rivet, strain relief grommet, resistor, capacitor as in claim 3, or the materials of brass or aluminum as in claim 4). Applications 15842685 and 62434281 provide support for the claimed subject matter. As such, the earliest date of the claimed invention and effective filing date is December 14, 2016.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 30, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 is: “magnetic element” in claim 1.
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.
A review of the specification shows “magnetic element” corresponding to ferromagnets or electromagnetic coils (e.g. par. 000231). In the elected embodiment of Species H, the magnetic element is preferably a cylindrically shaped permanent magnet as shown by element 1630 in Figures 61-62.
If applicant does not intend to have this limitation 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 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities: In Claim 1, line 5, there is an extra “and”. Appropriate correction is required.
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 1-7, 9-12, 14-16 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 1, lines 10-11, the limitation “the needle assembly to be tracked by the guidance system” is confusing because the needle assembly is part of the guidance system, making it a circular reference. Should this be referring to the magnetic sensors as the tracking component?
Claims 2-7, 9-12, 14-16 are rejected based on their dependency from claim 1.
Claim Rejections - 35 USC § 103
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 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.
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.
Claims 1-7, 9-12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140046261 to Newman in view of US 4092867 to Matzuk.
Newman is available as prior art under USC 102(a)(1) because it is published more than one year before the effective filing date of December 14, 2016.
Regarding Claim 1, Newman discloses a guidance system (shown in Figure 19), comprising:
an ultrasound imaging device including a probe for ultrasonically imaging an internal body portion target of a patient (ultrasound probe 1140, Figure 19);
a needle assembly (needle 1200, Figure 19; shown in various arrangements as in Figures 65-70, needle assemblies 1880) comprising:
a hub (1884, Figures 65-70);
a cannula of a needle distally extending from the hub (1880, Figures 65-70), the cannula including a substantially non-magnetic material to render the cannula non-magnetic (par. 0206, alloy of nickel and chromium or stainless steel); and
a magnetic element included with at least one of the hub and the cannula (magnetic element 1830 is included with hub as in Figures 65-70; the magnetic element 1830 is a permanent magnet, par. 0240), the magnetic element configured to enable the needle assembly to be tracked by the guidance system [magnetic sensors disposed in the probe] during a procedure to insert the needle assembly into the internal body portion target of the patient;
a plurality of magnetic sensors disposed in the probe (magnetic sensors 1192, Figure 20), each of the plurality of magnetic sensors configured to sense a magnetic field of the magnetic element of the needle assembly (par. 0156); and
a processor that received magnetic field data sensed by the sensors to determine a position of the needle in three spatial dimensions (processor 1122 is part of console 1120, Figure 19, par. 0148, and takes the magnetic field strength data sensed by the sensors 1192 and computes real-time position and/or orientation of the magnetic element 1210, par. 0164).
Newman is silent with respect to “wherein a portion of the probe is rendered non-magnetic via the inclusion of one or more components that include a magnetic permeability of about 1”.
Matzuk teaches a handheld ultrasound scanning probe wherein a fastener within the probe construction is a brass screw (col. 9, lines 17-18) which one of ordinary skill in the art before the effective filing date of the claimed invention would have recognized as a convenient and easily accessible option for a fastener as indicated by Matzuk (col. 9, lines 17-18). Matzuk further teaches other components of the probe that have a magnetic susceptibility of about 1 (e.g. brass, plastics) such as the housing (brass), plates (vinyl), adhesives (silicone glue) (col. 8, line 45 – col. 9, line 22).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize inside the probe of Newman a brass screw fastener as indicated by Matzuk to be a convenient fastener option, especially advantageous in a device that utilizes circuitry and magnetic fields due to brass being magnetically insusceptible (i.e. magnetic permeability of about 1) and therefore less likely to interfere with the ultrasound transducer or magnetic sensors.
Regarding Claim 2, Newman further teaches a display that depicts the determined position of the needle together with the image of the target (Figures 23A-23B).
Regarding Claims 3-4, Newman in view of Matzuk teaches a brass screw in the combination used for the rejection of claim 1 above.
Regarding Claims 5-7, Newman further discloses wherein the cannula is composed of a material of a magnetic permeability of about 1, which is an alloy of nickel and chromium (par. 0206). The cannula would implicitly not distort a magnetic field of the magnetic element since it is made of a material with magnetic permeability of about 1.
Regarding Claim 9-12, Newman further discloses wherein the magnetic element is permanently mounted with the hub (light-cured adhesives, e.g. epoxy, are utilized to attach the magnetic element in the hub, par. 0228, 0242-0243; epoxy is considered a permanent mounting), is a permanent magnet including neodymium (par. 0207), and is cylindrically shaped and includes a central hole, a portion of the cannula received through the central hole of the magnetic element (1830 magnetic element with cannula 1882, Figure 69).
Regarding Claims 9-10, Newman further discloses wherein the cannula is composed of a material of a magnetic permeability of about 1, which is an alloy of nickel and chromium (par. 0206).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US5775322 to Silverstein and US20040143183 to Toyoda teaches permanent magnets on a medical instrument used for tracking its position. US10449330, 20200054858, 20140031674, 10524691, 20200138332, 12295714 to Newman may qualify as prior art and teach magnetic tracking systems by the same inventor. US10602958, 11529070 to Silverstein, US 10238418, 11123099 to Cox, US 10231753 to Burnside, US 20180116551, 20210353173 to Newman, US 20170215762, 20210259575 to Burnside share at least one common inventor and do not appear to qualify as prior art but teach many aspects of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Casler can be reached at (571)272-4956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799