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 .
Response to Arguments
Applicant's arguments below filed 3/16/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on pages 19-21 of the Remarks:
“As stated in M.P.E.P. §2173.05(b), terms such as "substantially" are not automatically indefinite under 35 U.S.C. § 112(b). (citing Seattle Box Co., Inc. v. Industrial Crating & Packaging, Inc., 731 F.2d 818, 221 USPQ 568 (Fed. Cir. 1984)). MPEP 2173.05(b) states:
"when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree...If the specification does not provide some standard for measuring that degree, a determination must be made as to whether one of ordinary skill in the art could nevertheless ascertain the scope of the claim..."
Therefore, acceptability of such terms vis-a-vis the requirements of 35 U.S.C. § 112 depends on whether one of ordinary skill in the art would understand what is claimed. Indeed, the Patent Trial and Appeal Board has stated "[p]ointing to the absence of a strict numerical boundary does not persuade us that one skilled in the art would not be able to determine the scope of the claimed invention in terms of a specified dimensional or percentage value. See In re Mattison 509 F 2d 563, 565 (CCPA 1975); In re Marosi, 710 F. 2d 799, 803-4 (Fed. Cir. 1983)." (Ex parte Leslie Thomas Long, Appeal No. 2010-005239, Application No. 10/955,435, page 4, middle).
The Federal Circuit has interpreted the term "substantially" as definite in multiple instances. See Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed. Cir. 2001) (noting that terms such as "substantially" are used ubiquitously in patent claims to avoid a strict numerical boundary to the specified parameter); Verve, LLC. v. Crane Cams, Inc., 311 F.3d 1116, 1120 (Fed. Cir. 2002) (stating that the term "substantially" is used to "accommodate the minor variations."). As explained in Ex Parte Gattei, the Patent Trial and Appeal Board noted that terms, such as "substantially parallel," are "used to account for minor variations and to indicate that mathematical precision is not required." (Appeal No. 2017-008339, page 4, middle.) The Board continued noting that "we are not aware of any requirement that the Specification identify a specific range in order for a term of degree to be definite." Id. Furthermore, in Ex Parte Draudt et al., the Board stated that the term "substantially parallel" does not render the claims indefinite even though "the Specification does not expressly recite 'substantially parallel."' Appeal No 2014- 006627, page 4, middle. Instead, the Board pointed to the drawings to show that "one of ordinary skill in the art would readily understand the claim language 'substantially parallel,' in light of the ordinary meaning of 'substantially' and when read in the context of the Specification..." Id.
The undersigned attorney respectfully submits that one of ordinary skill in the relevant art would understand that which is claimed by each of claims 17 and 18 in light of the description given in the specification (see, e.g., paragraphs [0060] through [0065]) and the referenced drawings (see, e.g., FIGS. 7 and 8). Accordingly, the undersigned attorney respectfully requests that the Examiner withdraw this rejection of claims 17 and 18 under 35 U.S.C. §112(b).”
In response the examiner respectfully asserts that the paragraphs [0060] through [0065] do not provide clarity for what can be considered to be substantially straight. As cited by applicant in the remarks “terms such as "substantially" are used ubiquitously in patent claims to avoid a strict numerical boundary to the specified parameter…the term "substantially" is used to "accommodate the minor variations."… terms, such as "substantially parallel," are "used to account for minor variations and to indicate that mathematical precision is not required."”. Therefore the term substantially can be used for minor variations however as seen in the unexpanded configuration shown in FIG. 7 the curvature of the cutting members appear to be at a midway point between being completely straight and having the curvature shown in the expanded configuration. Therefore it is unclear what can be considered to be substantially straight and therefore the metes and bounds of the claimed limitation of claim 17 remain unclear.
The Applicant asserts on pages 22-24 of the Remarks:
“Independent claim 2 requires while the patient is positioned within the magnetic resonance scanner used to scan the first portion of the patient, advancing a medical device into a bodily passage and to the tissue.
[…]
At no point does the Examiner point to any explicit teaching within Tsonton or Fichtinger as disclosing the required limitations. Rather, the Examiner stated in conclusory fashion that "one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner." Id.
When addressing the notice requirement, the Federal circuit has noted that:
"the PTO carries its procedural burden of establishing a prima facie case when its rejection satisfies 35 U.S.C. § 132, in 'notify[ing] the applicant... [by] stating the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of [the] application.' 35 U.S.C. § 132. That section 'is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.' Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990)." (In re Jung, 637 F.3d 1356 (Fed. Cir. 2011)).
The Federal Circuit indicated that "all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132." Id at 1363. The undersigned attorney respectfully submits that the Examiner has failed to meet this burden.
For at least these reasons, the undersigned attorney respectfully submits that the Examiner has failed to satisfy the notice requirement by identifying how each limitation required by independent claim 2 is rendered obvious by the teachings of Tsonton and Fichtinger. Therefore, the Examiner has failed to present a prima facie showing of obviousness for independent claim 2, and any claim that depends from independent claim 2. Accordingly, the undersigned attorney requests that the Examiner withdraw the rejection of claims 2 through 4, 8, 10, and 11.”
In response the examiner respectfully asserts that the examiner cited the abstract of the Tsonton reference which discloses that the “localization mechanism, or fixture, is used in conjunction with a breast coil for breast compression and for guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines”. Therefore the device and method disclosed in the specification of Tsonton can be performed in an open MRI machine. One with ordinary skill in the art of magnetic resonance imaging would be aware of the structure of an open bore scanner and would therefore understand that a patient would not have to be removed from the bore to advance the sleeve to the tissue location. This would eliminate the need to remove and insert the patient into the bore each time a device needs to be inserted or withdrawn from the patient.
The Applicant asserts on pages 24-26 of the Remarks:
“Even if the Examiner maintains that the notice requirement has been met, the undersigned attorney respectfully submits that neither of Tsonton or Fichtinger, taken alone or in combination, teaches or suggests each limitation required by independent claim 2. Specifically, independent claim 2 requires:
scanning a first portion of the patient using the magnetic resonance scanner;
while the patient is positioned within the magnetic resonance scanner used
to scan the first portion of the patient, advancing a medical device into a
bodily passage and to the tissue;
scanning a third portion of the patient that includes the biopsy device using
the magnetic resonance scanner; and
scanning a fourth portion of the patient that includes the treatment device
using the magnetic resonance scanner.
When addressing these limitations, the Examiner asserted:
"([0118] - 'a suspicious lesion is located within the image and a point
thereon selected')" (Office Action, page 4, middle);
"([0111] - 'locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location', Abstract - 'guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines', one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner)" (Office Action, page 4, bottom
through page 5, top);
"Fichtinger discloses...(pg. 93 first paragraph - 'We also developed real- time tracking and guidance for the device, using solely the MRI scanner, without external tracking instruments', pg. 93 - 'While the actuation of the device is in progress, the MRI scanner is collecting images in continuous mode and sends them immediately to treatment monitoring computer', pg. 94 last paragraph - 'The end-effector is composed of a tubular obturator that translates and rotates in a thin rigid sheath', as seen in Fig. 3 the end- effector and needle are connected therefore they are both together interpreted as the biopsy device and the sheath is interpreted as the medical device)" (Office Action, page 6, bottom through page 7, top); and
"([0126] - 'The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker. During this reimaging, the sleeve 22 is sealed with the obturator or stylet 24')" (Office Action, page 6, middle).
As illustrated above, the Examiner relied upon both open and closed magnetic resonance imagining machines when addressing the limitations required by independent claim 2, which prevents a single magnetic resonance scanner from being utilized as required by the claim (e.g., the magnetic resonance scanner). Specifically, the Examiner relied on Tsonton paragraph [0118] ("[t]he gantry is advanced into the MRI machine bore to image the localization fixture 16 and breast tissue"), Tsonton paragraph [0111] (the Examiner asserted that "one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner)" (Office Action, page 4, bottom through page 5, top), Fichtinger page 93 (Fichtinger is directed only on closed MRI scanners - See title: "Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under RealTime Image Guidance"), and Tsonton paragraph [0126] ("[t]he patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker"). As a result, the Examiner relied upon teachings describing multiple, different magnetic resonance imagining machines to address the claim limitations.
For at least these reasons, neither of Tsonton and Fichtinger, either taken alone or in combination, teaches or suggests each limitation required by any rejected claim. As a result, neither of these references, either taken alone or in combination with each other, presents a primafacie showing of the obviousness of any rejected claim. Therefore, the undersigned attorney respectfully requests that the Examiner withdraw this rejection of claims 2 through 4, 8, 10, and 11.”
In response the examiner respectfully asserts that the portion cited from paragraph [0118] simply recites that a suspicious lesion is located within the image. The portion of paragraph [0126] of Tsonton was only cited to teach that a fourth portion of the patient is scanned with a MRI scanner that includes the treatment device. The examiner as cites the abstract of Tsonton which discloses that an open bore MRI can be used for the biopsy procedures to teach that advancement of a medical device into a bodily passage and to the tissue can occur while the patient is positioned within the magnetic resonance scanner. Tsonton does not teach that only specific portions of the procedure can be performed in an open MRI scanner therefore one with ordinary skill in the art would find it obvious that the entire disclosure of Tsonton that is performed in an MRI scanner can be performed in an open MRI scanner. When the cited portions of Fichtinger are combined with the teachings of Tsonton one with ordinary skill in the art would find it obvious to use one scanner (open MRI scanner) for an entire procedure that is done in one visit by the patient. Therefore the remarks are found to be not persuasive and the claims remain rejected under 35 USC § 103.
The remarks regarding claim 4 on pages 27-29 are very similar to the remarks regarding claim 2. Therefore in light of the remarks above the remarks are found to be not persuasive and claim 4 remains rejected under 35 USC § 103.
In light of the examiner’s response above the remarks regarding claims 5-7, 9, 12-19 are also found to be not persuasive and claims remain rejected under 35 USC § 103.
The remarks regarding independent claims 20 and 21 on pages 36-38 are very similar to the remarks regarding claim 2. Therefore in light of the remarks above the remarks are found to be not persuasive and claims 20 and 21 remain rejected under 35 USC § 103.
The Applicant asserts on page 39 of the Remarks:
“The Examiner rejected a number of claims on the ground of nonstatutory double patenting.
With respect to the rejection of claims 2, 14, 15, and 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. 12,201,321, each of independent claims 2 and 21 requires "scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner." In the Office Action, the Examiner failed to address these limitations relative to the double patenting rejection. Therefore, the undersigned attorney respectfully requests that this rejection be withdrawn.”
In response the examiner respectfully asserts that the claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 teach scanning a fourth portion. The fourth portion of U.S. Patent No. US 12201321 B2 is a portion of the body that includes the biopsy device and the tissue. Claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 also teach that an anchor device is advanced after the biopsy device is withdrawn and while the patient remains positioned within the magnetic resonance scanner. Claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 also teach that a treatment device is advanced to the tissue. Therefore one with ordinary skill in the art would find it obvious to scan the patient while the patient remains positioned within the magnetic resonance scanner to scan any portion including the treatment device. The remarks regarding the remainder of the claims are the same therefore the remarks are not persuasive and the claims remain rejected under the ground of nonstatutory double patenting.
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 17 and 18 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 17, claim 17 recites “each cutting member of the plurality of cutting members has a first, substantially straight configuration when disposed within the tubular member”. The term “substantially” in claim 17 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how straight the cutting members are in the unexpanded configuration. For examination purposes substantially straight will be interpreted as a curvature allowed the diameter of the tubular member.
Claim 18 is also rejected due to its dependency.
Claim Rejections - 35 USC § 103
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 2-4, 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829), and further in view of Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance”.
Regarding claim 2, Tsonton discloses a method of performing treatment under magnetic resonance imaging ([0002] – “an improved method for positioning a biopsy probe with respect to a magnetic resonance imaging (MRI) breast coil for acquiring subcutaneous biopsies and for removing lesions”, [0010] – “clinical flexibility is achieved by being able to perform a number of therapeutic and diagnostic procedures”) comprising:
positioning a patient within a magnetic resonance scanner ([0118] – “The gantry is advanced into the MRI machine bore to image the localization fixture 16 and breast tissue”);
scanning a first portion of the patient using the magnetic resonance scanner ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
obtaining a magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
identifying a tissue that has predefined characteristics using the magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
while the patient is positioned within the magnetic resonance scanner used to scan the first portion of the patient, advancing a medical device into a bodily passage and to the tissue ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, Abstract – “guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines”, one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner);
scanning a second portion of the patient that includes the medical device using the magnetic resonance scanner ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, [0122] – “the patient is imaged again to confirm placement of the sleeve 22 with respect to the suspicious lesion”);
advancing a biopsy device through the medical device and to the tissue ([0123] – “the probe 100 may latch onto the track 98 or sleeve 22 to confirm full insertion”, [0169] – “obturator, stylet or probe of an MRI biopsy device inserted coaxially in the sleeve 1522”, [0162] – “the probe side aperture of the probe of the MRI biopsy device”),
collecting a tissue sample from the tissue using the biopsy device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample”);
withdrawing the biopsy device and the tissue sample through the medical device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample…removing the probe 100 from the sleeve 22”);
determining whether the tissue sample meets a predefined criterion (Tsonton is disclosing a method for biopsy, one with ordinary skill in the art would understand biopsy samples typically are taken to determine if a tissue is cancerous);
if the tissue sample meets the predefined criterion, advancing a treatment device to the tissue ([0125] – “Additional steps or combinations of steps may be performed at this point, such as using the probe 100, a specialized obturator 24 (e.g., stylet), or merely the sleeve 22 to guide various agents to the surgical site of the biopsy”, [0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”, it would be obvious to one of ordinary skill in the art to perform the additional steps if the tissue is cancerous);
scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner ([0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker. During this reimaging, the sleeve 22 is sealed with the obturator or stylet 24”);
manipulating the tissue using the treatment device ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”);
withdrawing the treatment device (it would be obvious to one with ordinary skill in the art to remove the stylet after the tissue has been treated with the therapeutic agent);
withdrawing the medical device from the bodily passage ([0110] – “a sleeve 22, advantageously attaches to the localization fixture 16”, [0126] – “Thereafter, the localization fixture 16 is removed, the patient is bandaged and removed from the gantry, and the disposable portions of the MRI compatible biopsy system 10 are disposed of as medical waste”).
Conversely Tsonton does not teach scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner;
However Fichtinger discloses scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner (pg. 93 first paragraph – “We also developed real-time tracking and guidance for the device, using solely the MRI scanner, without external tracking instruments”, pg. 93 – “While the actuation of the device is in progress, the MRI scanner is collecting images in continuous mode and sends them immediately to treatment monitoring computer”, pg. 94 last paragraph – “The end-effector is composed of a tubular obturator that translates and rotates in a thin rigid sheath”, as seen in Fig. 3 the end-effector and needle are connected therefore they are both together interpreted as the biopsy device and the sheath is interpreted as the medical device);
Fichtinger is an analogous art considering it is in the field of MRI biopsy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the imaging of the biopsy device within the body of Fichtinger to achieve the same results. One would have motivation to combine because it would allow for the patient to remain within the MRI scanner during the entire biopsy procedure and therefore minimize movement of the patient.
Regarding claim 3, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses wherein each step is completed during a single patient visit (As seen in paragraphs [0118] which discloses the patient being imaged to locate the suspicious lesion through paragraph [0126] which discloses the localization fixture including the sleeve being removed all steps are completed in a single patient visit).
Regarding claim 4, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses wherein each step is completed without removing the patient from the magnetic resonance scanner (Although Tsonton discloses withdrawing the patient from the scanner Tsonton also discloses in the abstract that both open and closed Magnetic Resonance Imaging machines can be used for guiding a core biopsy instrument during prone biopsy procedures. One with ordinary skill in the art would find it obvious to complete each step without removing the patient from the magnetic resonance scanner when an open bore MRI machine is used because it would eliminate any unnecessary movement).
Regarding claim 8, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses wherein manipulating the tissue using the treatment device comprises introducing a material into the tissue ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”).
Regarding claim 10, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses wherein the medical device is a cannula ([0141] – “A sleeve 422 includes a hollow shaft (or cannula)”).
Regarding claim 11, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses wherein the medical device has a distal cutting edge (claim 2 – “a piercing tip formed of an MRI compatible material attached to a distal end of a selected one of the cannula and the obturator”, claim 6 – “wherein the piercing tip comprises a proximal cone having a distal portion transitioning to a blunter angle terminated by a lateral cutting edge”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Quick (US 20040167428).
Regarding claim 5, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach wherein collecting the tissue sample from the tissue using the biopsy device is repeated.
However Quick discloses wherein collecting the tissue sample from the tissue using the biopsy device is repeated ([0042] – “FIGS. 9A and 9B, 10A and 10B and 11A and 11B schematically illustrate the operation of the device 11…This series of sketches depict the sequencing of taking tissue specimens… the procedure for cutting the tissue specimen is repeated”).
Quick is an analogous art considering it is in the field of a biopsy device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the collecting of tissue being repeated of Quick to achieve the same results. One would have motivation to combine because it would allow one to take multiple specimens so that multiple specimens can be tested which would lead to more accurate results.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Rosenbluth (WO 2002055146).
Regarding claim 6, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach wherein manipulating the tissue using the treatment device comprises removing a portion of the tissue using the treatment device.
However Rosenbluth discloses wherein manipulating the tissue using the treatment device comprises removing a portion of the tissue using the treatment device (pg. 11 paragraph I. – “at least a portion of the clot or other obstructive matter becomes located within the obstructive matter-receiving portion of the obstructive matter-capturing receptacle”, pg. 2 paragraph c. – “clot capturing receptacle or clot disrupting apparatus is used to aspirate, capture & remove, disrupt or ablate the offending clot”).
Rosenbluth is an analogous art considering it is in the field of removing tissue from the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include removing a portion of the tissue of Rosenbluth to achieve the same results. One would have motivation to combine because by removing the tissue it may eliminate the possibility of further treatments.
Claims 7 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Vetter (US 20140180302).
Regarding claim 7, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach wherein manipulating the tissue using the treatment device comprises removing the entirety of the tissue that meets the predefined criterion.
However Vetter discloses wherein manipulating the tissue using the treatment device comprises removing the entirety of the tissue that meets the predefined criterion ([0030] – “Embodiments enable a complete removal of target tissues or foreign bodies in a single percutaneous entry pass”).
Vetter is an analogous art considering it is in the field of removing tissue from the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the removing the entirety of the target tissue of Vetter to achieve the same results. One would have motivation to combine because by removing the tissue it may eliminate the possibility of further treatments.
Regarding claim 16, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach wherein the treatment device comprises: an elongate member moveable between a first, unexpanded configuration and a second, expanded configuration, the elongate member having a lengthwise axis, a proximal end, a distal end, a main body, and a plurality of cutting members attached to the main body, the main body extending from the proximal end to a location disposed between the proximal end and the distal end, the plurality of cutting members extending from the location to the distal end, each cutting member of the plurality of cutting members having a cutting member proximal end, a cutting member distal end, and a cutting member main body that defines a predefined curve; and
a tubular member partially disposed over the elongate member.
However Vetter discloses wherein the treatment device comprises: an elongate member moveable between a first, unexpanded configuration and a second, expanded configuration (see Figs. 7A-7D, [0058] – “FIGS. 7A-7D illustrate different side views of the distal end of one embodiment in various modes of operation”, Abstract – “The rod elements may then assume a second released and expanded configuration”), the elongate member having a lengthwise axis, a proximal end, a distal end, a main body, and a plurality of cutting members attached to the main body, the main body extending from the proximal end to a location disposed between the proximal end and the distal end (See Fig. 5, Abstract – “cutting rod elements”, [0085] – “increases curved tip side cutting efficiency” rod element 2 is the cutting member), the plurality of cutting members extending from the location to the distal end, each cutting member of the plurality of cutting members having a cutting member proximal end, a cutting member distal end, and a cutting member main body that defines a predefined curve (See Fig. 1); and
a tubular member partially disposed over the elongate member (See Figs. 7A-7D, [0055] – “six tube chambers 3, each of which contains a rod element 2, arranged around a central tube 7, which may be configured to be free to move proximally or distally with relation to surrounding tube chambers, all of which may be enclosed in an outer tube/barrel 9”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the treatment device for cutting target tissue of Vetter to achieve the same results. One would have motivation to combine because by cutting and removing the tissue it may eliminate the possibility of further treatments.
Regarding claim 17, Tsonton, Fichtinger, and Vetter disclose all the elements of the claimed invention as cited in claims 2 and 16.
Conversely Tsonton does not teach wherein each cutting member of the plurality of cutting members has a first, substantially straight configuration when disposed within the tubular member and a second, curved configuration when free of the tubular member.
However Vetter discloses wherein each cutting member of the plurality of cutting members has a first, substantially straight configuration when disposed within the tubular member and a second, curved configuration when free of the tubular member (See Figs. 1 and 5, rod element 2 is the cutting member).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the cutting member having a straight configuration when disposed in the tubular member of Vetter to achieve the same results. One would have motivation to combine because it would provide a smaller diameter of the distal end of the device when the device is entered into the body.
Regarding claim 18, Tsonton, Fichtinger, and Vetter disclose all the elements of the claimed invention as cited in claims 2, 16, and 17.
Conversely Tsonton does not teach further comprising: moving the elongate member from the first, unexpanded configuration to the second, expanded configuration; applying torque to the elongate member such that it rotates relative to the tissue and the plurality of cutting members cuts the tissue; and moving the elongate member from the second, expanded configuration to the first, unexpanded configuration.
However Vetter discloses further comprising: moving the elongate member from the first, unexpanded configuration to the second, expanded configuration (See Figs. 1 and 7A-7D); applying torque to the elongate member such that it rotates relative to the tissue and the plurality of cutting members cuts the tissue (Abstract – “delivery device may comprise one or more rotating, penetrating and cutting rod elements. The rod elements may be configured to advance from a stored and confined first position and rotate about an axis, while being simultaneously revolved about a central axis”); and moving the elongate member from the second, expanded configuration to the first, unexpanded configuration ([0064] – “withdrawing curved tips 5 into their respective tube chambers 3”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the method of rotating the cutting members of Vetter to achieve the same results. One would have motivation to combine because “Embodiments enable a complete removal of target tissues or foreign bodies in a single percutaneous entry pass, while at the same time leaving behind an optimized spherical or other three dimensionally shaped cavity for further treatment methods” (Vetter [0030]).
Regarding claim 19, Tsonton, Fichtinger, and Vetter disclose all the elements of the claimed invention as cited in claims 2 and 16.
Conversely Tsonton does not teach wherein the treatment device includes a plurality of markers disposed on the elongate member.
However Vetter discloses wherein the treatment device includes a plurality of markers disposed on the elongate member ([0059] – “As also shown in FIG. 7D, a central tube 7, which may have graduation marks along its length, similar to graduations on the outer tube”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the markings of Vetter to achieve the same results. One would have motivation to combine because it allows one to be aware of the accurate depth of the device within the body.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Mitra (US 20210077077).
Regarding claim 9, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach wherein collecting the tissue sample from the tissue using the biopsy device is accomplished while performing an ultrasound.
However Mitra discloses wherein collecting the tissue sample from the tissue using the biopsy device is accomplished while performing an ultrasound ([0035] – “The MR-compatible ultrasound probe 132 may be an ultrasound probe configured for use in combination with the MR imaging system 10”, [0037] – “The biopsy system 152, as discussed in greater detail below, may be guided by images obtained via the MR imaging system 10 in combination with images obtained via the ultrasound imaging system 90”, [0038] – “a biopsy stage or procedure (e.g., interventional/therapy phase) where ultrasound imaging occurs”).
Mitra is an analogous art considering it is in the field of performing a biopsy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the performance of ultrasound while using the biopsy device of Quick to achieve the same results. One would have motivation to combine because “real-time alignment using multi-modality imaging techniques provides guidance during the biopsy and post-biopsy system” (Mitra – Abstract).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Lopez (US 20120232658).
Regarding claim 12, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Conversely Tsonton does not teach further comprising:
advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage;
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage; and
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage.
However Lopez discloses advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage (Abstract – “A first dilator tube with a first longitudinal axis is provided”, in combination with the teachings of Tsonton it would be obvious to one with ordinary skill in the art the advance the first dilator tube over the medical device of Tsonton to provide dilation);
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A second dilator tube may be introduced over the first”); and
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A third dilator tube may be introduced over the second”).
Lopez is an analogous art considering it is in the field of inserting treatment devices through lumens of other devices to reach a target tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the dilation sheaths of Lopez to achieve the same results. One would have motivation to combine because it would provide an appropriate dilation to insert a particular device instead of making any additional incisions.
Regarding claim 13, Tsonton, Fichtinger, and Lopez disclose all the elements of the claimed invention as cited in claims 2 and 12.
Conversely Tsonton does not teach further comprising:
withdrawing the first inner sheath from the bodily passage;
withdrawing the second inner sheath from the bodily passage;
wherein advancing the treatment device to the tissue comprises advancing the treatment device through the outer sheath and to the tissue;
wherein withdrawing the treatment device comprises withdrawing the treatment device from the outer sheath; and
withdrawing the outer sheath from the bodily passage.
However Lopez discloses further comprising:
withdrawing the first inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
withdrawing the second inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
wherein advancing the treatment device to the tissue comprises advancing the treatment device through the outer sheath and to the tissue (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”, [0089] – “It is also anticipated that in some embodiments, the access cannula 30 can be eliminated from the introducer or modified”, one with ordinary skill in the art would recognize that if access cannula is eliminated it would be obvious to leave the third dilator tube in place and advance the surgical instrument through the third dilator tube, additionally the access cannula can be interpreted as an outer sheath);
wherein withdrawing the treatment device comprises withdrawing the treatment device from the outer sheath (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the surgical device through the cannula when the surgical procedure is completed); and
withdrawing the outer sheath from the bodily passage (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the access cannula from the body when the surgical procedure is completed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the dilation sheaths of Lopez to achieve the same results. One would have motivation to combine because it would provide an appropriate dilation to insert a particular device instead of making any additional incisions.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829) and Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” as applied to claim 2 above, and further in view of Ayala (US 20150011834).
Regarding claim 14, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claim 2.
Tsonton further discloses advancing an anchor member through the medical device through which the biopsy device was advanced and to the tissue ([0125] – “Additional steps or combinations of steps may be performed at this point, such as using the probe 100, a specialized obturator 24 (e.g., stylet), or merely the sleeve 22 to guide various agents to the surgical site of the biopsy. Examples include inserting a marker for subsequently locating the site of the biopsy”, [0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker”);
securing the anchor member to the tissue ([0179] – “to eject a tool such as an inserted marker deployment tool 1769”);
removing the anchor member from the tissue (it would be obvious to one with ordinary skill in the art to remove the marker [anchor member] from the tissue when it is no longer needed);
withdrawing the anchor member from the bodily passage (it would be obvious to one with ordinary skill in the art to remove the marker [anchor member] from the body when it is no longer needed);
wherein advancing the treatment device to the tissue comprises advancing a treatment device through the […] device ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”);
wherein withdrawing the treatment device comprises withdrawing the treatment device from the access device (it would be obvious to one with ordinary skill in the art to remove the stylet after the tissue has been treated with the therapeutic agent);
Conversely Tsonton does not teach advancing an access device over the anchor member and toward the tissue;
advancing a treatment device through the access device;
withdrawing the access device from the bodily passage.
However Ayala discloses advancing an access device over the anchor member and toward the tissue ([0019] – “the primary access device being subsequently advanced over the wire to perform a first medical operation that is diagnostic and/or therapeutic in nature”);
advancing a treatment device through the access device (as cited above Tsonton discloses a treatment device introduced into a sleeve and Ayala discloses [0022] – “the primary access device may be left in place at the work site after disengagement with the wire guide to serve as an introduction pathway or conduit for a second wire guide”, therefore one with ordinary skill in the art would find it obvious to insert the treatment device through the access device);
withdrawing the access device from the bodily passage (It would be obvious to one with ordinary skill in the art to withdraw the access device from the body when it is no longer needed).
Ayala is an analogous art considering it is in the field of MRI imaging during introduction of medical devices.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the access device of Ayala to achieve the same results. One would have motivation to combine because it would provide additional support within the bodily passage to minimize tissue movement while other devices are being inserted through the access device.
Regarding claim 15, Tsonton and Fichtinger disclose all the elements of the claimed invention as cited in claims 2 and 14.
Tsonton further discloses wherein advancing the anchor member through the medical device through which the biopsy device was advanced and to the tissue is accomplished while the patient remains positioned within the magnetic resonance scanner ([0125] – “Additional steps or combinations of steps may be performed at this point, such as using the probe 100, a specialized obturator 24 (e.g., stylet), or merely the sleeve 22 to guide various agents to the surgical site of the biopsy. Examples include inserting a marker for subsequently locating the site of the biopsy”, [0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker”, Abstract – “guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines”, one with ordinary skill in the art would find it obvious to complete each step without removing the patient from the magnetic resonance scanner when an open bore MRI machine is used because it would eliminate any unnecessary movement).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829), and further in view of Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” and Lopez (US 20120232658).
Regarding claim 20, Tsonton discloses a method of performing treatment under magnetic resonance imaging ([0002] – “an improved method for positioning a biopsy probe with respect to a magnetic resonance imaging (MRI) breast coil for acquiring subcutaneous biopsies and for removing lesions”, [0010] – “clinical flexibility is achieved by being able to perform a number of therapeutic and diagnostic procedures”) comprising:
positioning a patient within a magnetic resonance scanner ([0118] – “The gantry is advanced into the MRI machine bore to image the localization fixture 16 and breast tissue”);
scanning a first portion of the patient using the magnetic resonance scanner ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
obtaining a magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
identifying a tissue that has predefined characteristics using the magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
while the patient is positioned within the magnetic resonance scanner used to scan the first portion of the patient, advancing a medical device into a bodily passage and to the tissue ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, Abstract – “guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines”, one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner);
scanning a second portion of the patient that includes the medical device using the magnetic resonance scanner ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, [0122] – “the patient is imaged again to confirm placement of the sleeve 22 with respect to the suspicious lesion”);
advancing a biopsy device through the medical device and to the tissue ([0123] – “the probe 100 may latch onto the track 98 or sleeve 22 to confirm full insertion”, [0169] – “obturator, stylet or probe of an MRI biopsy device inserted coaxially in the sleeve 1522”, [0162] – “the probe side aperture of the probe of the MRI biopsy device”),
collecting a tissue sample from the tissue using the biopsy device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample”);
withdrawing the biopsy device and the tissue sample through the medical device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample…removing the probe 100 from the sleeve 22”);
determining whether the tissue sample meets a predefined criterion (Tsonton is disclosing a method for biopsy, one with ordinary skill in the art would understand biopsy samples typically are taken to determine if a tissue is cancerous);
if the tissue sample meets the predefined criterion, advancing a […] device to the tissue ([0125] – “Additional steps or combinations of steps may be performed at this point, such as using the probe 100, a specialized obturator 24 (e.g., stylet), or merely the sleeve 22 to guide various agents to the surgical site of the biopsy”, [0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”, it would be obvious to one of ordinary skill in the art to perform the additional steps if the tissue is cancerous);
withdrawing the medical device from the bodily passage ([0110] – “a sleeve 22, advantageously attaches to the localization fixture 16”, [0126] – “Thereafter, the localization fixture 16 is removed, the patient is bandaged and removed from the gantry, and the disposable portions of the MRI compatible biopsy system 10 are disposed of as medical waste”);
scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner ([0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker. During this reimaging, the sleeve 22 is sealed with the obturator or stylet 24”);
manipulating the tissue using the treatment device ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”);
withdrawing the treatment device […] (it would be obvious to one with ordinary skill in the art to remove the stylet after the tissue has been treated with the therapeutic agent); and
wherein each step is completed during a single patient visit (As seen in paragraphs [0118] which discloses the patient being imaged to locate the suspicious lesion through paragraph [0126] which discloses the completion of the procedure and all steps are completed in a single patient visit).
Conversely Tsonton does not teach scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner;
advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage;
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage;
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage;
withdrawing the first inner sheath from the bodily passage;
withdrawing the second inner sheath from the bodily passage;
advancing a treatment device through the outer sheath and to the tissue;
withdrawing the treatment device from the outer sheath; and
withdrawing the outer sheath from the bodily passage;
However Fichtinger discloses scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner (pg. 93 first paragraph – “We also developed real-time tracking and guidance for the device, using solely the MRI scanner, without external tracking instruments”, pg. 93 – “While the actuation of the device is in progress, the MRI scanner is collecting images in continuous mode and sends them immediately to treatment monitoring computer”, pg. 94 last paragraph – “The end-effector is composed of a tubular obturator that translates and rotates in a thin rigid sheath”, as seen in Fig. 3 the end-effector and needle are connected therefore they are both together interpreted as the biopsy device and the sheath is interpreted as the medical device);
Fichtinger is an analogous art considering it is in the field of MRI biopsy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the imaging of the biopsy device within the body of Fichtinger to achieve the same results. One would have motivation to combine because it would allow for the patient to remain within the MRI scanner during the entire biopsy procedure and therefore minimize movement of the patient.
Conversely Tsonton and Fichtinger do not teach advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage;
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage;
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage;
withdrawing the first inner sheath from the bodily passage;
withdrawing the second inner sheath from the bodily passage;
advancing a treatment device through the outer sheath and to the tissue;
withdrawing the treatment device from the outer sheath; and
withdrawing the outer sheath from the bodily passage;
However Lopez discloses advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage (Abstract – “A first dilator tube with a first longitudinal axis is provided”, in combination with the teachings of Tsonton it would be obvious to one with ordinary skill in the art the advance the first dilator tube over the medical device of Tsonton to provide dilation);
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A second dilator tube may be introduced over the first”);
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A third dilator tube may be introduced over the second”);
withdrawing the first inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
withdrawing the second inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
advancing the treatment device through the outer sheath and to the tissue (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”, [0089] – “It is also anticipated that in some embodiments, the access cannula 30 can be eliminated from the introducer or modified”, one with ordinary skill in the art would recognize that if access cannula is eliminated it would be obvious to leave the third dilator tube in place and advance the surgical instrument through the third dilator tube, additionally the access cannula can be interpreted as an outer sheath);
withdrawing the treatment device from the outer sheath (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the surgical device through the cannula when the surgical procedure is completed); and
withdrawing the outer sheath from the bodily passage (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the access cannula from the body when the surgical procedure is completed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the dilation sheaths of Lopez to achieve the same results. One would have motivation to combine because it would provide an appropriate dilation to insert a particular device instead of making any additional incisions.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tsonton (US 20050277829), and further in view of Fichtinger NPL 2002 “Transrectal Prostate Biopsy Inside Closed MRI Scanner with Remote Actuation, under Real-Time Image Guidance” and Ayala (US 20150011834).
Regarding claim 21, Tsonton discloses a method of performing treatment under magnetic resonance imaging ([0002] – “an improved method for positioning a biopsy probe with respect to a magnetic resonance imaging (MRI) breast coil for acquiring subcutaneous biopsies and for removing lesions”, [0010] – “clinical flexibility is achieved by being able to perform a number of therapeutic and diagnostic procedures”) comprising:
positioning a patient within a magnetic resonance scanner ([0118] – “The gantry is advanced into the MRI machine bore to image the localization fixture 16 and breast tissue”);
scanning a first portion of the patient using the magnetic resonance scanner ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
obtaining a magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
identifying a tissue that has predefined characteristics using the magnetic resonance image of the first portion of the patient ([0118] – “a suspicious lesion is located within the image and a point thereon selected”);
while the patient is positioned within the magnetic resonance scanner used to scan the first portion of the patient, advancing a medical device into a bodily passage and to the tissue ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, Abstract – “guiding a core biopsy instrument during prone biopsy procedures in both open and closed Magnetic Resonance Imaging (MRI) machines”, one with ordinary skill in the art would recognize that an open bore MRI machine would allow one to advance the sleeve to the location while the patient is positioned within the magnetic resonance scanner);
scanning a second portion of the patient that includes the medical device using the magnetic resonance scanner ([0111] – “locating a suspicious lesion by Cartesian coordinates within breast tissue referenced to the localization fixture 16 and to thereafter position an instrument (e.g., sleeve 22) to this location”, [0122] – “the patient is imaged again to confirm placement of the sleeve 22 with respect to the suspicious lesion”);
advancing a biopsy device through the medical device and to the tissue ([0123] – “the probe 100 may latch onto the track 98 or sleeve 22 to confirm full insertion”, [0169] – “obturator, stylet or probe of an MRI biopsy device inserted coaxially in the sleeve 1522”, [0162] – “the probe side aperture of the probe of the MRI biopsy device”),
collecting a tissue sample from the tissue using the biopsy device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample”);
withdrawing the biopsy device and the tissue sample through the medical device ([0124] – “the MRI compatible biopsy system 10 may take tissue samples by activating a cutter mechanism in conjunction with vacuum assist, withdrawing the cutter and withdrawing a tissue sample…removing the probe 100 from the sleeve 22”);
determining whether the tissue sample meets a predefined criterion (Tsonton is disclosing a method for biopsy, one with ordinary skill in the art would understand biopsy samples typically are taken to determine if a tissue is cancerous);
if the tissue sample meets the predefined criterion, advancing an anchor member through the medical device through which the biopsy device was advanced and to the tissue ([0125] – “Additional steps or combinations of steps may be performed at this point, such as using the probe 100, a specialized obturator 24 (e.g., stylet), or merely the sleeve 22 to guide various agents to the surgical site of the biopsy. Examples include inserting a marker for subsequently locating the site of the biopsy”, [0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker”, it would be obvious to one of ordinary skill in the art to perform the additional steps if the tissue is cancerous);
securing the anchor member to the tissue ([0179] – “to eject a tool such as an inserted marker deployment tool 1769”);
withdrawing the medical device from the bodily passage ([0110] – “a sleeve 22, advantageously attaches to the localization fixture 16”, [0126] – “Thereafter, the localization fixture 16 is removed, the patient is bandaged and removed from the gantry, and the disposable portions of the MRI compatible biopsy system 10 are disposed of as medical waste”);
removing the anchor member from the tissue (it would be obvious to one with ordinary skill in the art to remove the marker [anchor member] from the tissue when it is no longer needed);
withdrawing the anchor member from the bodily passage (it would be obvious to one with ordinary skill in the art to remove the marker [anchor member] from the body when it is no longer needed);
advancing a treatment device to the tissue through the […] device ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”);
scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner ([0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker. During this reimaging, the sleeve 22 is sealed with the obturator or stylet 24”);
manipulating the tissue using the treatment device ([0138] – “a stylet 298 may be inserted into the sleeve 222…the stylet 298 may be used to insufflate the surgical site or used for other purposes such as draining bodily fluids or inserting therapeutic or diagnostic agents”);
withdrawing the treatment device from the access device (it would be obvious to one with ordinary skill in the art to remove the stylet after the tissue has been treated with the therapeutic agent);
wherein each step is completed during a single patient visit (As seen in paragraphs [0118] which discloses the patient being imaged to locate the suspicious lesion through paragraph [0126] which discloses the completion of the procedure and all steps are completed in a single patient visit).
Conversely Tsonton does not teach scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner;
advancing an access device over the anchor member and toward the tissue;
advancing a treatment device through the access device;
withdrawing the access device from the bodily passage.
However Fichtinger discloses scanning a third portion of the patient that includes the biopsy device using the magnetic resonance scanner (pg. 93 first paragraph – “We also developed real-time tracking and guidance for the device, using solely the MRI scanner, without external tracking instruments”, pg. 93 – “While the actuation of the device is in progress, the MRI scanner is collecting images in continuous mode and sends them immediately to treatment monitoring computer”, pg. 94 last paragraph – “The end-effector is composed of a tubular obturator that translates and rotates in a thin rigid sheath”, as seen in Fig. 3 the end-effector and needle are connected therefore they are both together interpreted as the biopsy device and the sheath is interpreted as the medical device);
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the imaging of the biopsy device within the body of Fichtinger to achieve the same results. One would have motivation to combine because it would allow for the patient to remain within the MRI scanner during the entire biopsy procedure and therefore minimize movement of the patient.
Conversely Tsonton and Fichtinger do not teach advancing an access device over the anchor member and toward the tissue;
advancing a treatment device through the access device;
withdrawing the access device from the bodily passage.
However Ayala discloses advancing an access device over the medical device and toward the tissue ([0019] – “the primary access device being subsequently advanced over the wire to perform a first medical operation that is diagnostic and/or therapeutic in nature”);
advancing a treatment device through the access device (as cited above Tsonton discloses a treatment device introduced into a sleeve and Ayala discloses [0022] – “the primary access device may be left in place at the work site after disengagement with the wire guide to serve as an introduction pathway or conduit for a second wire guide”, therefore one with ordinary skill in the art would find it obvious to insert the treatment device through the access device);
withdrawing the access device from the bodily passage (It would be obvious to one with ordinary skill in the art to withdraw the access device from the body when it is no longer needed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tsonton to include the access device of Ayala to achieve the same results. One would have motivation to combine because it would provide additional support within the bodily passage to minimize tissue movement while other devices are being inserted through the access device.
Double Patenting
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.
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Claims 2, 14, 15, and 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the independent claims 2 and 21 of the current application are more broad than the independent claims of U.S. Patent No. US 12201321 B2.
The differences between the independent claims of U.S. Patent No. US 12201321 B2 and claim 2 of the current application is that the independent claims of U.S. Patent No. US 12201321 B2 include advancing an anchor member and an access device and advancing a treatment device within the access device. Therefore by not claiming the anchor member and access device limitations in the current application claim 2 of the current application is obvious in view of the independent claims of Patent No. US 12201321 B2. Claims 14 and 15 are not identical to the independent claims of U.S. Patent No. US 12201321 B2 but they are not patentably distinct from each other because claims 14 and 15 are reciting the limitations of the anchor member and access device and independent claim 2 is broader than the independent claims of US 12201321 B2. The differences between the independent claims of U.S. Patent No. US 12201321 B2 and claim 21 of the current application is that claim 21 of the current application is more broad than the independent claims of U.S. Patent No. US 12201321 B2 and the independent claims of U.S. Patent No. US 12201321 B2 include limitations defining the treatment device.
Claims 3, 4, 8, 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Tsonton (US 20050277829).
As seen in the 35 USC § 103 rejections of claims 3, 4, 8, 10, and 11 Tsonton teaches the limitations of claims 3, 4, 8, 10, and 11.
Tsonton is an analogous art considering it is in the field of MRI imaging during a biopsy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the teachings of Tsonton to achieve the same results. One would have motivation to combine because it would “facilitate minimally invasive procedures guided by diagnostic imaging by providing improvements in confirmation of sleeve placement and hands free continued access through the sleeve for a myriad of diagnostic and therapeutic procedures” (Tsonton [0008]).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Quick (US 20040167428).
As seen in the 35 USC § 103 rejection of claim 5 Quick teaches the limitations of claim 5.
Quick is an analogous art considering it is in the field of a biopsy device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the collecting of tissue being repeated of Quick to achieve the same results. One would have motivation to combine because it would allow one to take multiple specimens so that multiple specimens can be tested which would lead to more accurate results.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Rosenbluth (WO 2002055146).
As seen in the 35 USC § 103 rejection of claim 6 Rosenbluth teaches the limitations of claim 6.
Rosenbluth is an analogous art considering it is in the field of removing tissue from the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include removing a portion of the tissue of Rosenbluth to achieve the same results. One would have motivation to combine because by removing the tissue it may eliminate the possibility of further treatments.
Claims 7 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Vetter (US 20140180302).
As seen in the 35 USC § 103 rejection of claims 7 and 16-19 Vetter teaches the limitations of claims 7 and 16-19.
Vetter is an analogous art considering it is in the field of removing tissue from the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the teachings of Vetter to achieve the same results. One would have motivation to combine because by removing the tissue it may eliminate the possibility of further treatments.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Mitra (US 20210077077).
As seen in the 35 USC § 103 rejection of claim 9 Mitra teaches the limitations of claim 9.
Mitra is an analogous art considering it is in the field of performing a biopsy.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the performance of ultrasound while using the biopsy device of Quick to achieve the same results. One would have motivation to combine because “real-time alignment using multi-modality imaging techniques provides guidance during the biopsy and post-biopsy system” (Mitra – Abstract).
Claims 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Lopez (US 20120232658).
As seen in the 35 USC § 103 rejection of claims 12 and 13 Lopez teaches the limitations of claims 12 and 13.
Lopez is an analogous art considering it is in the field of inserting treatment devices through lumens of other devices to reach a target tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the dilation sheaths of Lopez to achieve the same results. One would have motivation to combine because it would provide an appropriate dilation to insert a particular device instead of making any additional incisions.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 in view of Tsonton (US 20050277829) and Lopez (US 20120232658).
Claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 teach all of the limitations of claim 21 of the current application except for the limitations of scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner;
advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage;
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage;
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage;
withdrawing the first inner sheath from the bodily passage;
withdrawing the second inner sheath from the bodily passage;
advancing a treatment device through the outer sheath and to the tissue;
withdrawing the treatment device from the outer sheath; and
withdrawing the outer sheath from the bodily passage;
wherein each step is completed during a single patient visit.
However Tsonton discloses scanning a fourth portion of the patient that includes the treatment device using the magnetic resonance scanner ([0126] – “The patient is then typically drawn back into the MRI machine bore for reimaging to confirm removal of at least a portion of the suspicious lesion and possibly placement of a marker. During this reimaging, the sleeve 22 is sealed with the obturator or stylet 24”);
wherein each step is completed during a single patient visit (As seen in paragraphs [0118] which discloses the patient being imaged to locate the suspicious lesion through paragraph [0126] which discloses the completion of the procedure and all steps are completed in a single patient visit).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the teachings of Tsonton to achieve the same results. One would have motivation to combine because it would “facilitate minimally invasive procedures guided by diagnostic imaging by providing improvements in confirmation of sleeve placement and hands free continued access through the sleeve for a myriad of diagnostic and therapeutic procedures” (Tsonton [0008]).
Conversely Claims 1, 2, and 4 of U.S. Patent No. US 12201321 B2 and Tsonton [0008] do not teach advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage;
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage;
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage;
withdrawing the first inner sheath from the bodily passage;
withdrawing the second inner sheath from the bodily passage;
advancing a treatment device through the outer sheath and to the tissue;
withdrawing the treatment device from the outer sheath; and
withdrawing the outer sheath from the bodily passage.
However Lopez discloses advancing a first inner sheath over the medical device and toward the tissue to dilate the bodily passage (Abstract – “A first dilator tube with a first longitudinal axis is provided”, in combination with the teachings of Tsonton it would be obvious to one with ordinary skill in the art the advance the first dilator tube over the medical device of Tsonton to provide dilation);
advancing a second inner sheath over the first inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A second dilator tube may be introduced over the first”);
advancing an outer sheath over the second inner sheath and toward the tissue to dilate the bodily passage (Abstract – “A third dilator tube may be introduced over the second”);
withdrawing the first inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
withdrawing the second inner sheath from the bodily passage (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”);
advancing the treatment device through the outer sheath and to the tissue (Abstract – “An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula”, [0089] – “It is also anticipated that in some embodiments, the access cannula 30 can be eliminated from the introducer or modified”, one with ordinary skill in the art would recognize that if access cannula is eliminated it would be obvious to leave the third dilator tube in place and advance the surgical instrument through the third dilator tube, additionally the access cannula can be interpreted as an outer sheath);
withdrawing the treatment device from the outer sheath (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the surgical device through the cannula when the surgical procedure is completed); and
withdrawing the outer sheath from the bodily passage (As cited above the surgical instrument is advanced through the access cannula, one with ordinary skill in the art would find it obvious to withdraw the access cannula from the body when the surgical procedure is completed).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified U.S. Patent No. US 12201321 B2 to include the dilation sheaths of Lopez to achieve the same results. One would have motivation to combine because it would provide an appropriate dilation to insert a particular device instead of making any additional incisions.
Conclusion
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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