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
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 8, 2026.
Applicant's election with traverse of Invention I, claims 1-9 in the reply filed on June 8, 2026 is acknowledged. The traversal is on the ground(s) that a search of both the invention identified as Invention I, claims 1-9 and Invention III, claims 19-20 would present no undue burden on the patent office [note that though Applicant refers to Invention III encompassing claims 18-20, this appears to be a typo as Invention III encompasses claims 19-20]. Specifically, Applicant asserts that dependent claim 20 is within the scope of claim 18 and, as shown by dependent claim 6, embodiments with a light source are within the scope of claim 1. Accordingly, Applicant submits there is no undue burden associated with searching both of invention I and III as identified by the Office Action.
This is not found persuasive because claim 6 sets forth additional elements, such as an energy converter configured to transform light pulses into electrical energy, one or more elongate member coupled to a switch to provide one or more antennas and a circuit to open and close the switch, etc., which Invention III does not require and claim 19 discloses that a circuit modulates the electromagnetic signals reflected by the marked “based at least in part on the light pulses” which Invention I does not require. Note that the narrower language of claim 6 would require different search terms required for searching claim 19 and further prior art applicable to the broader language of claim 19 may not necessarily be applicable to claim 6. Examiner therefore maintains that a search burden exists and as such the Restriction requirement is upheld.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
In claim 1, in lines 2-3, the limitation “a region of a patient’s” should be replaced with --- the region of the patient’s ---.
In claim 1, in line 2, it is suggested that --- configured and --- be inserted before “sized”.
In claim 1, line 4, “a patient’s” should be replaced with --- the patient’s ---.
In claim 1, in line 11, the word – configured --- should be inserted after the second occurrence of the word “processors”.
In claim 1, in line 12, the word --- the --- should be inserted before the word “probe”.
In claim 1, in line 17, the word --- the --- should be inserted before the word “probe”.
In claim 1, in line 21, the word --- the --- should be inserted before the word “probe”.
In claim 1, in line 24, the words --- plurality of --- should be inserted before the word “markers”.
In claim 1, in line 26, --- values --- should be inserted after “third set of distance”.
In claim 2, in line 3, the word “marker” should be replaced with --- markers ---.
In claim 3, in line 1, the word --- configured --- should be inserted after the word “further”.
In claim 3, in line 2, a comma should be inserted after the first occurrence of the word “model”.
In claim 3, in line 4, the word --- configured --- should be inserted after the word “display is “.
In claim 3, in line 3, the word –plurality of --- should be inserted before the word “markers”.
In claim 4, in line 1, --- wherein --- should be inserted before “the antenna”.
In claim 5, in line 6, --- the --- should be inserted before the first occurrence of the word “switch”.
In claim 6, in line 2, “a patient’s” should be replaced with --- the patient’s ---.
In claim 7, in line 1, the word --- configured – should be added after the word “further”.
In claim 7, in line 3, --- electromagnetic --- should be inserted before “signals”.
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 1-9 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.
With regards to claim 1, the claim refers to a “first aperture” in line 13, “a second aperture” in line 17 and “a third aperture” in line 21. It is unclear as to whether these apertures are respectively referring to one of the “plurality of apertures” as set forth in line 8 of the claim or referring to different apertures. For examination purposes, Examiner assumes the former.
Claim 3 recites the limitation "the body region" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
In claim 6, in line 2, the limitation “light pulses” is recited. However, it is unclear as to whether the limitation is referring to the same “light pulses” set forth in line 3 of claim 5 or referring to different “light pulses”. For examination purposes, Examiner assumes the former.
Claim 8 recites the limitation "the light pulses" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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 1-9 are 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).
With regards to claim 1, in lines 6-7, the limitation “plurality of markers implanted within the patient’s body” is recited, thus encompassing a human organism. It is suggested that language such as --- plurality of markers configured to be implanted within the patient’s body – be used instead.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fullerton et al. (US Pub No. 2014/0309522) in view of Werahera et al. (US Pub No. 2013/0310680).
With regards to claim 1, Fullerton et al. disclose a system for localization of a region within a patient's body, the system comprising:
a plurality of markers (120, 220) sized for implantation within a region of a patient's body (paragraphs [0143]-[0146], [0158], referring to the plurality of implantable markers or targets (120), wherein the markers may include a plurality of implantable elements sized for introduction through tissue into a region surrounding a lesion (142); paragraphs [0035], [0249], [0270]-[0273]; Figure 6-9, 11);
a probe (30, 130) (paragraph [0153], referring to the probe (30) which is placed against or otherwise adjacent to the patient’s skin (48) and transmits and receives signals into and from the tissue; paragraphs [0158], [0270]-[0273]; Figures 6-9; 11) comprising:
a transmit antenna (32) for transmitting electromagnetic signals into a patient's body (paragraphs [0022], [0027], [0119]-[0120], referring to the probe (30) having electromagnetic signal emitting and receiving capabilities and includes a transmit antenna (32); Figures 6-10);
a receive antenna (34) for receiving reflected signals from the plurality of markers implanted within the patient's body (paragraphs [0022], [0027], [0119]-[0120], referring to the probe (30) including a receive antenna (34); Figures 6-10);
one or more processors (36) coupled to the probe (paragraphs [0022], [0027], [0119]-[0120], referring to the one or more processors or controllers (36); Figures 6-11), the one or more processors to
process a first set of modulated reflected signals from the plurality of markers when probe is placed in a first location to determine a first set of distance values corresponding to distances from each of the plurality of markers to the distal end of the probe when in the first location (paragraph [0140], referring to the probe being positioned at “several locations” adjacent to the skin (48) and spatial information obtained which helps orient the surgeon relative to the lesion (42) in three dimensions; paragraphs [0153]-[0154], referring to the probe (30) being used to determine the distance (152) between the probe (30) and the markers (120), wherein the signals (31) emitted by the probe (30) may be received at the markers (120) and reflected back to a receiver in the probe (30) as signals (33), and the probe (30) may use the signals to determine the distance (152) between the patient’s skin (48) and the markers (120), wherein the probe (30) may be repositioned to locate the markers (120) around the periphery of the tissue specimen (146) and such a process of repositioning the probe and obtaining resulting distance measurements “may be repeated as often as desired…”; paragraphs [0222]-[0223], referring to the determination of the distance (L1) from the tip of the probe to the marker (521) and displaying the distance; paragraphs [0158]-[0159], referring to measuring a distance (L1) on one side of the breast and placing the probe at a second location (i.e. opposite side of the breast) to obtain a L2 measurement; paragraph [0044]; Figures 3-11);
process a second set of modulated reflected signals from the plurality of markers when probe is placed in a second location to determine a second set of distance values corresponding to distances from each of the plurality of markers to the distal end of the probe when in the second location (paragraph [0140], referring to the probe being positioned at “several locations” [which would include a “second location”] adjacent to the skin (48) and spatial information obtained which helps orient the surgeon relative to the lesion (42) in three dimensions; paragraphs [0153]-[0154], referring to the probe (30) being used to determine the distance (152) between the probe (30) and the markers (120), wherein the signals (31) emitted by the probe (30) may be received at the markers (120) and reflected back to a receiver in the probe (30) as signals (33), and the probe (30) may use the signals to determine the distance (152) between the patient’s skin (48) and the markers (120), wherein the probe (30) may be repositioned [i.e. second location] to locate the markers (120) around the periphery of the tissue specimen (146) and such a process of repositioning the probe and obtaining resulting distance measurements “may be repeated as often as desired…”; paragraphs [0222]-[0223], [0270], referring to the determination of the distance (L1) from the tip of the probe to the marker (521) and displaying the distance; paragraphs [0158]-[0159], referring to measuring a distance (L1) on one side of the breast and placing the probe at a second location (i.e. opposite side of the breast) to obtain a L2 measurement; paragraph [0045]; Figures 3-11);
process a third set of modulated reflected signals from the plurality of markers when probe is placed in a third location to determine a third set of distance values corresponding to distances from each of the plurality of markers to the distal end of the probe when in the third location (paragraph [0140], referring to the probe being positioned at “several locations” [which would include a “third location”] adjacent to the skin (48) and spatial information obtained which helps orient the surgeon relative to the lesion (42) in three dimensions; paragraphs [0153]-[0154], referring to the probe (30) being used to determine the distance (152) between the probe (30) and the markers (120), wherein the signals (31) emitted by the probe (30) may be received at the markers (120) and reflected back to a receiver in the probe (30) as signals (33), and the probe (30) may use the signals to determine the distance (152) between the patient’s skin (48) and the markers (120), wherein the probe (30) may be repositioned to locate the markers (120) around the periphery of the tissue specimen (146) and such a process of repositioning the probe and obtaining resulting distance measurements “may be repeated as often as desired…”, wherein such a repeating of repositioning the probe etc, would result in a “third location” of the probe; paragraphs [0222]-[0223], [0270], referring to the determination of the distance (L1) from the tip of the probe to the marker (521) and displaying the distance; paragraphs [0158]-[0159], referring to measuring a distance (L1) on one side of the breast and placing the probe at a second location (i.e. opposite side of the breast) to obtain a L2 measurement; paragraph [0046]; Figures 3-11);
determine three-dimensional coordinates for each of the markers relative to the skin/probe based on the first set of distance values, the second set of distance values, and the third set of distance (paragraph [0140], referring to the probe being positioned at “several locations” adjacent to the skin (48) and spatial information obtained which helps orient the surgeon relative to the lesion (42) in three dimensions, wherein such spatial information in “three dimensions” would provide 3D coordinates; paragraphs [0222]-[0223], referring to the determination of the distance information from the tip of the probe to the marker (521) and displaying the distance information on a display screen to inform the surgeon of the location of the marker (52), wherein the display screen (537) may display a graphical three-dimensional image depicting the marker, the distance from the tip of the probe (531) to the marker, and a physiological picture of hte body part containing the marker, wherein such a three-dimensional image of the marker and the picture of the body part containing the marker would provide/have been a result of a depiction/determination of three-dimensional coordinates for the markers relative to the skin/probe placement; Figures 3-11).
However, Fullerton et al. do not specifically disclose that their system further comprises an antenna placement template comprising a plurality of apertures sized to receive a distal end of the probe, each aperture positioned at a known location relative to each other aperture, and wherein the first, second and third locations correspond, respectively, to locations within first, second and third “apertures”.
Werahera et al. disclose a system and method for use in tissue analysis and therapy, wherein the system comprises an optical probe array (112) and optical system (115) including at least one light sensor and at least one light detector that transmits to and receives light from the optical probe array (112), and a template (111) or grid is placed against the perineum for aligning optical probes of an array (112) into a predetermined orientation relative to each other and relative to the tissue, wherein the template (111) includes columns of openings to accommodate the probes (paragraphs [0065]-[0069], in particular, see paragraph [0067] which refers to the probe (112) and the template (111); Figures 6-10). Light received by the optical system (115) is collected by the light sensor or detector, then digitized and processed to obtain diagnostic information, wherein the information obtained from the optical system is then combined with spatial information from the ultrasound probe (113) (paragraph [0067]; Figure 10). Once an acquisition has been performed, the probe array (112) can be moved/”re-insert”-ed to a new site within or adjacent the prostate to perform additional acquisitions, wherein the optical probes of the array (112) can be positioned adjacent the prostate/tissue through the grid template in order to create a 3D image of the prostate based on tissue fluorescence and/or based on any other type of light spectroscopy measurements (paragraphs [0067]-[0069], [0082], note that the template (111) thus serves as a probe placement template comprising a plurality of apertures/openings sized to receive a distal end of the probe (112), each aperture/opening positioned at a known location relative to each other aperture/opening, wherein there are at least three apertures (i.e. first, second and third apertures) which correspond to at least three different locations (i.e. first, second and third “new site” locations for the probe (112)) associated with a new site to which the probe array is moved/”re-insert”-ed to; Figure 10). With acquisitions covering sufficient volume of the prostate, a three-dimensional diagnostic imaging system (116) forms a 3D map of the imaged prostate gland based on the generated light signals and the identified position of the optical probe (112), wherein the 3D map can be displayed as an image on the display (117) and used to guide targeted therapeutic modalities to positions where lesions have been identified (paragraph [0067]; Figure 10).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the system of Fullerton et al. further comprise an antenna placement template comprising a plurality of apertures sized to receive a distal end of the probe, each aperture positioned at a known location relative to each other aperture, and wherein the first, second and third locations correspond, respectively, to locations within first, second and third “apertures”, as taught by Werahera et al, in order to provide controlled guidance of the antenna placement to specific desired regions of the tissue and align the antenna into a predetermined orientation relative to each other and relative to the tissue (paragraphs [0067], [0082]).
With regards to claim 2, Fullerton et al. disclose that their system further comprises a display (38) in communication with the one or more processors (36), the display to present an image of the plurality of marker using the three-dimensional coordinates (paragraphs [0222]-[0223], referring to the determination of the distance information from the tip of the probe to the marker (521) and displaying the distance information on a display screen to inform the surgeon of the location of the marker (52), wherein the display screen (537) may display a graphical three-dimensional image depicting the marker, the distance from the tip of the probe (531) to the marker, and a physiological picture of the body part containing the marker; paragraph [0119], Figure 10).
With regards to claim 3, Fullerton et al. disclose that the one or more processors are further configured to generate a model (i.e. “the display screen 537 may display a graphical image (e.g.,…three-dimensional image) depicting the marker…and…picture of the body part containing the marker (e.g., the breast)”) wherein the model comprises a three-dimensional representation of the body region showing the markers within the body region, and wherein the display is to present the model (paragraph [0223], wherein the “picture” of the body part/breast corresponds to a model of the body region).
With regards to claim 4, Werahera et al. disclose that the antenna placement template (111) comprises three apertures (see Figure 10, wherein there are at least three apertures/openings in the template (111)).
With regards to claim 5, Fullerton et al. disclose that each of the plurality of markers comprises an energy converter (1052; “power converter”/”plurality of photosensitive diodes capable of transforming incident light striking them into electrical energy”) configured to transform light pulses into electrical energy (paragraphs [0035]-[0037]; [0249], [0256], [0261]; Figures 64-66); one or more elongate members (i.e. “wires 1044”) coupled to a switch (1054) to provide one or more antennas (paragraphs [0257]-[0261], referring to the wires (1044) acting as an antenna and the switch (1054); Figures 64-66); and a circuit (circuitry elements of 1050) coupled to the energy converter and switch to open and close the switch to modulate electromagnetic signals reflected by the marker based at least in part on the light pulses (paragraphs [0256]-[0267], referring to light striking the diodes (1052) which generates a voltage across the gate (G) and source (S) to provide a control signal that may open and close the switch (1054), wherein changing the switch from closed to open significantly changes the reflection properties of the antenna provided by the wires (1044) (i.e. switch 1054 may change the polarity or otherwise modulate signals reflected from tag 1040as the switch 1054 is opened and closed); Figures 64-66).
With regards to claim 6, Fullerton et al. disclose that the probe further comprises a light source for delivering light pulses into a patient’s body (paragraphs [0251], [0267], referring to the probe including a light transmitter configured to transmit light pulses into tissue; Figures 63-66).
With regards to claim 7, Fullerton et al. disclose that the one or more processors are further configured to identify each of the plurality of markers based on modulation of the reflected signals (paragraphs [0035], [0188], [0249], [0266]-[0271, [0273] referring to the probe identifying/locating the tag (1040) using modulated reflected signals).
With regards to claim 8, Fullerton et al. disclose that the electromagnetic signals comprise a plurality of ultrawide band radar pulses generated in synchronization with the light pulses (paragraph [0186]-[0191], referring to the ultrawide broadband radar incident signal A; paragraphs [0270]-[0271], referring to the probe emitting the electromagnetic signals and simultaneously transmitting light pulses).
With regards to claim 9, Fullerton et al. disclose that the transmit antenna is a bowtie antenna and the receive antenna is a bowtie antenna that together form a single Maltese cross antenna (paragraphs [0024], [0240]-[0243]; Figures 57-60).
Double Patenting
***Note that the instant application is a Divisional of 17/089,440, Patent 12,178,565. However, the prohibition against nonstatutory double patenting rejections under 35 USC 121 does not apply as the claims of the instant application are drawn to the “same invention” as the elected group of the originally examined claims of 17/089,440. Specifically, note that instant claims 1-9 are identical to the originally examined elected claims 1-9 of 17/089,440 which were subject to the restriction requirement.****
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No.12,178,565. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is generic to all that is recited in claim 1 of the Patent. That is, claim 1 of the Patent falls entirely within the scope of instant claim 1, or in other words, instant claim 1 is anticipated by claim 1 of the Patent. Specifically, because claim 1 of the Patent claims the same structure (i.e. a system for localization of a region comprising a plurality of markers, a probe comprising a transmit and receive antenna, an antenna placement template, one or more processors that process the first, second and third sets of modulated reflected signals and determine three-dimensional coordinates for each of the markers relative to the antenna placement template based on the first, second and third set of distance values), as claimed in instant claim 1, the system of instant claim 1 is anticipated by claim 1 of the Patent.
With regards to instant claim 2, claim 2 of the Patent sets forth the same limitations.
With regards to instant claim 3, claim 3 of the Patent sets forth the same limitations.
With regards to instant claim 4, claim 4 of the Patent sets forth the same limitations.
With regards to instant claim 5, claim 5 of the Patent sets forth the same limitations.
With regards to instant claim 6, claim 6 of the Patent sets forth the same limitations.
With regards to instant claim 7, claim 7 of the Patent sets forth the same limitations.
With regards to instant claim 8, claim 8 of the Patent sets forth the same limitations.
With regards to instant claim 9, claim 9 of the Patent sets forth the same limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bharat et al. (US Patent No. 10,786,310) disclose an EM tracking configuration system wherein an EM calibration tool (80) is associated with a grid (120) for guiding interventional tools through the grid into an anatomical region (Abstract; column 6, lines 46-62; column 7, lines 14-38).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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