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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 7/20/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new ground(s) of rejection of the newly amended claims is/are set forth hereinbelow.
Claim Objections
Claim 1 is objected to because of the following informalities: the positive recitation of “the probe” in lines 12 and 13 should apparently read “the optical probe” for antecedent clarity. 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 1-3, 5-7, and 11 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.
Claim 1 recites “…a blue laser (405 nm) for the fluorescence and a laser in the red or near infrared region (708 nm)…”. Claim 1 positively recites limitations within parentheses that are not reference numerals. The scope of the claims is unclear because it is ambiguous whether the limitations within parenthesis are required. The scope of claim 1 is indefinite because it is indeterminate if the “(405 nm)” and/or “(780 nm)” is/are explicitly, implicitly, inherently, and/or necessarily required or not within the scope of the claimed invention. Depending claims 2, 3, 5-7, and 11 inherit and do not remedy the indefiniteness.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-7, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hibner et al. (US 2011/0201965 A1, hereinafter Hibner).
For claim 1, Hibner discloses a probe-guide (38) configured for guiding, identifying, and harvesting a biopsy (Figs 2,3,8-13,19) ([0049-0087]),
the probe-guide is tube-shaped (Figs 2,3,8-13,19) ([0049-0053]), having a distal (distal end of 70) and a proximal end (proximal end of 52) , wherein the distal end is fully capable of insertion into brain tissue and the proximal end is for connection to an energy source (54 connects to power cord 18 via elements shown in Figs 2,3,8-13,19) (Fig 1),
wherein the wall of the probe-guide comprises a first (central opening 54) (Figs 2,3,8-13,19) ([0049-0053]) and a second (exterior openings about 70) (Figs 2,3,8-13,19) ([0049-0053]) opening, the first opening is arranged in the distal end or tip (central opening 54 extends to distal end of 70 in Fig 4) (Figs 2,3,8-13,19) ([0049-0053]), wherein the distal end is of U-shape (distal end of 70 is circular which may fairly and reasonably be considered at least a “U-shape”), and the second opening is arranged at a distance from the distal end or tip in the sidewall of the probe-guide (exterior openings about 70 are in sidewalls of 70 and circumferentially and longitudinally spaced from distal end) (Figs 2,3,8-13,19) ([0049-0053]), and
wherein the probe-guide is designed to receive another device into its lumen (Figs 2,3,8-13,19) ([0049-0053]), wherein said another device is:
ii) a removable biopsy needle (58) (Fig 4) ([0053]) for harvesting a biopsy, wherein the biopsy needle is removably arranged into the lumen of the probe-guide (Fig 4, 19) ([0083]) and configured to harvest a biopsy via the second opening (second openings assist in biopsy via securement),
wherein the probe and the biopsy needle are not arranged in the lumen of the probe-guide simultaneously (Fig 19) ([0083]).
For claim 5, Hibner discloses the probe-guide according to claim 1, wherein the material of the probe-guide and probe is medical steel ([0053]).
For claim 6, Hibner discloses the probe-guide according to claim 1, wherein a pointer (arrow marking Fig 8) for electromagnetic navigation is arranged into the lumen of the probe-guide (Figs 2,3,8-13,19) ([0049-0053]).
For claim 7, Hibner discloses the probe-guide according to claim 1, wherein the lumen is further configured to receive a device ([0083]) for delivering a medicament ([0083]) to a target site.
For claim 11, Hibner discloses the probe-guide according to claim 1, wherein at least one of the openings is configured for transmitting signals from a device (radiation therapy device of [0083]) arranged or inserted into the lumen of the probe-guide, for removal of tissue by vaporization, abrasion, or destruction (radiation therapy device of [0083]).
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hibner as applied to claims hereinabove.
For claims 2 and 3, Hibner discloses the probe-guide according to claim 1, wherein the diameter is in the range of 1.5-3 mm (particularly based on the 1cm biopsy needle accommodation through 70) (Fig 4) ([0014]).
For claims 2 and 3, Hibner discloses the structural equivalent of the claimed invention except for explicitly disclosing the length of the probe-guide is in the range of 100-300 mm and the length of the probe is in the range of 50-400 mm. However, Hibner is explicitly concerned with structuring a probe guide (38) to accommodate a biopsy needle and/or optical probe for medical tissue sampling and/or treatment, while being especially concerned with a variable Y-depth setting of the device, and thus the probe-guide and probe lengths, to achieve desired tissue sampling ([0049-0051]). It is well within the grasp and would have been obvious to one have ordinary skill in the art at the time of filing to try various lengths of probe-guides and probes because doping so would achieve the predictable result of providing structural integrity while conducting desired medical tissue sampling procedures and/or treatment.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 7/20/26, with respect to the newly amended claims obviating the previous 112(b) and 101 rejections have been fully considered and are persuasive. The prior rejections have been withdrawn.
Applicant's arguments filed 7/20/26 regarding the 102 rejection of the claims under Hibner have been fully considered but they are not persuasive, particularly to the extent the arguments are even applicable with respect to the newly amended claims being rejected anew under Hibner, and wherein Applicant argues the following:
Current claim 1 expressly requires a removable optical probe with optical fiber pairs, at least four fibers of 125-250 pm, a distal first opening for light transmission/reception, a removable biopsy needle for harvesting through the second opening, and non-simultaneous arrangement of the optical probe and biopsy needle in the probe-guide lumen.
Hibner is directed to a breast biopsy system used in the MRI environment. By contrast, Applicant's technology is directed for use in the brain, where MRI is used before the procedure to image the brain and calculate a target trajectory. The biopsy itself is taken outside the MRI scanner. Accordingly, the Applicant submits the two systems are fundamentally different in application and workflow. Hibner is concerned with MRI-guided breast biopsy inside or in connection with the MRI system, whereas Applicant's system uses pre-operative MRI data and then performs the intervention outside the MRI environment.
The Applicant notes that Hibner's distal tip is not the same as Applicant's rounded probe- guide tip. Hibner describes a "three-sided pyramidal shaped point" or similar sharpened tip, and this is also visible in Hibner Figure 4.
The Applicant's position is that these teachings of Hibner should not be treated as equivalent to Applicant's system, because Applicant's technology is not used inside the MRI scanner. In Applicant's workflow, MRI is used before the intervention, and the biopsy is performed outside the MRI environment. This is quite different from the workflow of Hibner.
The Applicant submits that metal components inside an MRI scanner can raise safety issues, including RF heating/SAR and movement risks, unless the device is properly MRI-safe or MRI-conditional. Hibner's material disclosure is tied to an MRI breast-biopsy device, whereas Applicant's device is not an MRI-inserted breast-biopsy instrument.
The Applicant notes that a pointer can be placed in the probe-guide, but in the claimed system this is done outside the MRI scanner, for electromagnetic neuronavigation. Applicant's pointer/navigation feature is directed to neuronavigation outside the MRI scanner, using pre- operative imaging and target trajectory planning, rather than MRI-guided breast biopsy.
This is materially different from an MRI-guided breast biopsy workflow as taught by Hibner. Accordingly, the Applicant submits that Hibner does not teach electromagnetic navigation outside of the MRI scanner as recited in the present claims.
The Examiner respectfully disagrees and in response notes the following:
Initially the Examiner notes that claim 1 does not require “a removable optical probe with optical fiber pairs, at least four fibers of 125-250 pm, a distal first opening for light transmission/reception, a removable biopsy needle for harvesting through the second opening, and non-simultaneous arrangement of the optical probe and biopsy needle in the probe-guide lumen”. Conversely, the claim requires “the probe-guide is designed to receive another device into its lumen, wherein said another device is selected from: i) a removable optical probe….. and/or ii) a removable biopsy needle”. Thus, the scope of claim 1 merely requires i) or ii). As set forth and cited hereinabove, Hibner is relied upon for disclosing “ii) a removable biopsy needle”. Although Hibner explicitly discloses use of the probe-guide, after use of the biopsy device, for other minimally invasive diagnostic imaging procedures and treatments without needing another insertion, this is not required for the scope of the claimed invention given the conditional selection of either the optical probe or biopsy needle recited in claim 1. Further, Hibner’s biopsy needle may be the sole arrangement within the probe-guide such that no other device is co-located therein during a tissue biopsy procedure.
Regarding Applicant’s argument with respect to Hibner, the Examiner respectfully notes Applicant appears to mischaracterize the nature of the rejection when referencing the distal tip to that of the biopsy needle. As set forth hereinabove, the distal end is that of element 38 and particularly the distalmost end of 70 as seen in Fig 4, which may more than fairly and reasonably be considered at least a tubular probe-guide that is U-shaped in cross-section, in a longitudinal direction and/or in a radial direction, and especially as broadly as structurally claimed. Indeed Hibner’s biopsy needle point may be a three-sided pyramidal shaped point that would not be considered U-shaped, however, this is not the relied upon structure to meet the claimed probe-guide.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e.,
“MRI is used before the procedure to image the brain and calculate a target trajectory. The biopsy itself is taken outside the MRI scanner”,
“Applicant's system uses pre-operative MRI data and then performs the intervention outside the MRI environment”,
“rounded probe- guide tip”,
“Applicant's technology is not used inside the MRI scanner”,
“Applicant's device is not an MRI-inserted breast-biopsy instrument”, “Applicant's pointer/navigation feature is directed to neuronavigation outside the MRI scanner, using pre- operative imaging and target trajectory planning, rather than MRI-guided breast biopsy”,
“electromagnetic navigation outside of the MRI scanner as recited in the present claims”,
“the lumen is configured to receive, alternatively and not simultaneously arranged in the lumen as (i) a removable optical probe configured to transmit and receive light via the first opening, and (ii) a removable biopsy needle configured to harvest a biopsy via the second opening”,
“probe-guide configured to alternately receive a removable optical probe and a removable biopsy needle in the same lumen, where the optical probe transmits and receives light through a distal first opening and the biopsy needle harvests tissue through a second opening spaced from the distal end”, and/or
“the claimed dual-use probe-guide lumen configured for alternate, non- simultaneous reception of a removable optical probe and a removable biopsy needle, with optical interrogation through the distal first opening and biopsy harvesting through the spaced second opening”)
are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Hibner does not disclose a technology for use in the brain, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, Hibner’s medical biopsy sampling and treatment system is fully capable of being used in a brain, especially as broadly as structurally claimed while consistent with the plain meaning of the claim terms in light of the instant Specification, and absent any special definition upon which Applicant doss not appear to rely.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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