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 2 in the reply filed on 04/17/2026 is acknowledged. Claims 1-2, 7-17, 19-21 will be examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-2, 7-16 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 1, 16 set forth a energy-delivering device…to apply therapeutic energy to a treatment site. Which appears for including a human organism as part of the claimed device. The examiner recommends amendment the claims to reflect “energy-delivering device comprising an energy-delivering assembly with an energy-delivering region along which an energy field is generated configured to apply…..”.
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 1-2, 7-17, 19-21 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.
In claims 1, 13, it is unclear if the limitation of determining a treatment protocol is performed by the system or not; it appears this limitation is a functional limitation that is performed outside the system, i.e. a user.
In claim 17, it is set forth that the properties or characteristics of the treatment site are determined; however, the very next step only set forth properties; it is unclear as to whether the characteristics are used in order to affect the treatment as claimed.
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) 1-2, 7-17, 19-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balbierz (US 2006/0241577).
With respect to claims 1, 13, 17 Balbierz discloses a method and apparatus facilitating identification, characterization, and/or location of a site treated by application of therapeutic energy thereto, said apparatus comprising
an energy-delivering assembly having an energy-delivering region along which an energy field is generated to apply therapeutic energy to a treatment site (see para. 0043, “FIG. 1 shows an embodiment of a tissue biopsy and treatment apparatus 10 configured to optically biopsy and treat a tumor mass 5'' in a target tissue site 5' by volumetrically sampling the tissue mass and delivering energy or other treatment to produce an ablation volume 5av. Referring now to FIGS. 1 and 2, an embodiment of biopsy treatment apparatus 10 comprises an elongated member or introducer 12 having a lumen 13, a proximal portion 14, a distal end 16, one or more resilient members 18 positionable in lumens 13 and one or more sensing members 22m positionabe in lumens 72 disposed within members 18. Distal end 16 may be sufficiently sharp to penetrate tissue including fibrous and/or encapsulated tumor masses, bone, cartilage and muscle. Lumens 13 may extend over all or a portion of the length of introducer 12. Members 18 can comprise a plurality 18pl of resilient members 18 configured to be positionable in lumen 13 and advanceable in and out of distal end 16 by an advancement device 15 or advancement member 34 or other means described herein. Resilient members 18 can be deployed with curvature from introducer 12 to collectively define a volume 5av in target tissue site 5'. In an embodiment all, or a portion, of one or more members 18 can be an energy delivery device or energy delivery member 18e described herein. Energy delivery device 18e can be coupled to an energy source or power supply 20 and can also include one or more lumens 72.”; and
a device configured to characterize the treatment site for assessment by a medical professional in determining a treatment protocol generating an energy field with said energy-delivering region (see para. 0072, “In addition to identifying tissue types, apparatus 10 and sensor arrays 22a can also be employed to monitor the progression of an ablative procedure including the progression of an ablation volume 5av resulting from the delivery of energy to target tissue volume 5. Referring now to FIGS. 14a and 14b, emitters 22a and detectors 22md can be configured to monitor the moving boundary layer of cell necrosis 55 and/or thermal fronts 55t of a developing ablation volume 5av. This can be achieved by monitoring for the presence of metabolic chomophores 33 or markers 9 indicative of cell necrosis or ablation described herein. The spectral signal intensity 19s (at one or more wave lengths 7) for a volume of tissue between one or more emitters 22me and detector 22md can be monitored over time. An endpoint for ablation can be determined based on either a selectable threshold value 19ts of signal 19s or an inflection point or change in slope 19ds (e.g. a derivative) of curve 19s or a combination of both. In an embodiment signal 19s can comprise the subtraction of a baseline (or reference) spectral measurement 19sb1 of a nearby, but non-ablated tissue volume, from a real time measurement 19srt of the target tissue volume during the time course of ablation. This compensates for any signal or tissue hysteresis over time. Signal/curve 19s can include both spectral, thermal and impedance measurements. Values for 19ts and 19s can be input and stored in logic resource 19lr coupled to spectrophotometer 19 or incorporated into an electronic algorithm controlling the delivery of energy which can be stored in a controller or processor 338 coupled to power supply 20.”.
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With respect to claim 2 Balbierz further discloses wherein said device is configured to deploy a deployable marker at the treatment site (see para. 0043, 0045).
With respect to claim 7 Balbierz further discloses wherein the marker is carried by said energy- delivering assembly (see para. 0006).
With respect to claim 8 Balbierz further discloses wherein the marker is delivered to the treatment site as a part of said energy-delivering assembly and separated from said energy-delivering assembly to be deployed at the treatment site (see para. 0006).
With respect to claim 9 Balbierz further discloses wherein the marker is carried over said energy- delivering assembly and slidable off said energy-delivering assembly to be deployed at the treatment site (see para. 0006).
With respect to claim 10 Balbierz further discloses, wherein said energy-delivering assembly defines a housing in which the marker is carried to the treatment site and from which the marker is released to be deployed at the treatment site (see para. 0006).
With respect to claim 11 Balbierz further discloses wherein said device profiles a characteristic of the treatment site (see para. 0043).
With respect to claim 12 Balbierz further discloses wherein said device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map properties of the treatment site (para. 0058, 0072).
With respect to claim 14 Balbierz further discloses, wherein said device uses one or more of elastography, magnetic resonance electrical impedance tomography, or hyperspectral imaging to map properties of the treatment site, and said system further comprises a processor configured to receive information from said device and to develop models of the treatment site based on the received information (see para. 0058, 0072).
With respect to claim 15 Balbierz further discloses wherein said device is configured to deploy a deployable marker at the treatment site (see para. 0006).
With respect to claim 16 Balbierz further discloses wherein said deployable marker is identifiable after an energy field has been applied to the treatment site and the device has been removed from the treatment site (see para. 0059).
With respect to claim 19 Balbierz further discloses further comprising deploying a marker during or after application of therapeutic energy to the treatment site wherein determining properties or characteristics comprises determining the location of the treatment site using the marker (see para. 0059, 0061).
With respect to claim 20 Balbierz further discloses further comprising using the determined properties to create a three-dimensional map of the properties of the treatment site (see para. 0045).
With respect to claim 21 Balbierz further discloses further comprising using the map of the properties of the treatment site to aid prediction and measurement of therapeutic energy to be applied to a treatment site (see para. 0045).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Guttman (US 9,439,735) which discloses RI guided cardiac interventional systems are configured to generate dynamic (interactive) visualizations of patient anatomy and medical devices during an MRI-guided procedure and may also include at least one user selectable 3-D volumetric (tissue characterization) map of target anatomy, e.g., a defined portion of the heart.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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, Anne M. Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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