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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/2026 has been entered.
Claims 1, 3-4, and 8 are the current claims hereby under examination.
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of Applicant’s specification US 2024/0293111 A1.
Claim Interpretation
Claim 1 recites “a needle having a form of a hollow shaft comprising an outer wall around an inner cavity wherein the needle comprises an opening at a distal end of the needle in the form of a cut away in a side of its wall structure, the cut away extending up to the distal end of the needle, the opening of the needle corresponding with an opening, a cavity, or a notch on a side of the second surgical instrument” in lines 3-7. The specification nor the claims explicitly define what structure is required to make a generic hollow tube into a “needle” and as such the “needle” will be considered any object fulfilling the requirements set forth in the claims.
Claim Rejections - 35 USC § 112(b)
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, 3-4, and 8 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 line 18 and 19 each recite “the tissue” but it is unclear if this limitation is meant to refer to “non-removed tissue in front of a distal tip of the needle” of lines 9-10 or some other tissue. For the purposes of this examination, the limitation will be interpreted as referring to the non removed tissue in front of the device.
Claims 3-4 and 8 are rejected by virtue of their dependence on claim 1.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a sensor signal representative of an analyzed characteristic of the tissue, wherein the analyzed characteristic comprises a presence of unhealthy tissue of cancer cells within the tissue” but it appears that the specification describes such an analysis by incorporating by reference WO 2013/108194 A2 and WO 2017/142399 A1. However the analysis of the tissue to determine the presence of unhealthy tissue or cancer cells is considered essential subject matter and thus the incorporation by reference is not proper since it is not a US application being incorporated. Thus the specification is not considered to provide sufficient support for the recited analysis. It would appear that an amendment to the specification to incorporate the US publications of these international applications (US 2019/0041319 for WO 2017/142399 A1 and US 2015/0005765 for WO 2013/108194 respectively) alongside a statement that the subject matter in the US publication is identical to the WIPO publication and thus no new matter is entered, would be sufficient to overcome this rejection by properly incorporating the subject matter of the cited applications.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hendricks US Patent Application Publication Number US 2010/0317964 A1 hereinafter Hendricks in view of Philips US Patent Application Publication Number US 2015/0359525 A1 hereinafter Philips.
Regarding claim 1, Hendricks disclose a system comprising a first surgical instrument and a second surgical instrument (Abstract: the biopsy device; Paragraph 0041: the shaft is the first surgical instrument and the needle is the second surgical instrument; Fig. 2 references 210 and 240), the first surgical instrument comprising:
a needle having a form of a hollow shaft comprising an outer wall around an inner cavity wherein the needle comprises an opening at a distal end of the needle ( Fig. 2 references 210 and 240; Paragraph 0041-0042: The biopsy device shaft is configured to accommodate a needle for taking a biopt); and
a tissue analysis subsystem comprising an analysis sensor to optically analyze non-removed tissue in front of a distal tip of the needle, wherein the tissue analysis subsystem further comprises at least a first optic fiber and a second optic fiber, wherein both the first optic fiber and the second optic fiber extend from the analysis sensor to the distal tip of the needle, the first optic fiber and the second optic fiber being integrated in the outer wall of the needle, wherein a distal end of the first optic fiber and a distal end of the second optic fiber are positioned on opposite sides of the hollow shaft, on opposite sides of the distal tip of the needle (Annotated Fig. 2: the indicated optical fibers are on opposite sides of the shaft and opposite sides of the needle tip; Paragraphs 0041-0043: the optic fibers in the shaft, any fiber may be an emitter or receiver), and
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Annotated Fig. 2: The first and second optical fibers are the optical fibers interrogating the front of the shaft as indicated by the arrows.
wherein the tissue analysis subsystem is configured to provide a sensor signal representative of an analyzed characteristic of the tissue, wherein the analyzed characteristic comprises a presence of unhealthy tissue or cancer cells within the tissue (Fig. 2 references 210 and 220; Paragraphs 0041-0043: the biopsy device wall includes a fiber optic or a fiber optic bundle. The spectrograph which receives the collected light from the fibers. Fig. 3 reference 22; Paragraphs 0044-0046: real time tissue characterization of tissue at the distal end of the fiber; Paragraphs 0043-0045, 0047, and 0053: the optical spectroscopy is used to identify tissue and map the bounds of a tumor),
wherein the inner cavity of the needle provides a space for positioning the second surgical instrument coaxially to the needle at least partly inside the needle and movable with respect to the needle in an axial direction of the needle (Fig. 2 reference 240; Paragraph 0041: the shaft is configured to accommodate a needle for taking a biopt. The shaft accommodating the biopsy needle at least suggests that the biopsy needle is movable coaxially within the cavity of Hendricks)
wherein the second surgical instrument comprises: a tissue removal device arranged at a distal end of the second surgical instrument, the tissue removal device comprising the opening, the cavity, or the notch of the second surgical instrument (Fig. 2 reference 240 and the notch the biopt is in; Fig. 0041: the needle for taking the biopt)
Hendricks fails to further teach the system wherein the opening at the distal end of the needle is in the form of a cut away in a side of its wall structure, the cut away extending up to the distal end of the needle, the opening of the needle corresponding with an opening, a cavity, or a notch on a side of the second surgical instrument, the optical fibers being at opposing edges of the opening of the needle and wherein the second surgical instrument comprises: a discharge channel connected to the tissue removal device for discharge of removed tissue.
Philips teaches an interventional device, e.g. a Vacuum Assisted Biopsy (VAB) needle, incorporating optical fibers such that biological tissue in a volume at a side of the interventional device can be substantially completely optically probed by optical spectroscopy. In a VAB embodiment, a plurality of optical fiber pairs connected to respective optical ports, are placed at opposite positions along the suction cavity, and they are readout subsequently allowing to make a map of the tissue properties along the place where the tissue will be cut by the VAB needle. Based on decision software in an optical console, it can be determined whether the tissue present in the cutting cavity is completely normal tissue or not, prior to actually performing the biopsy on the tissue. In this way a well-defined end point for VAB is created. In one embodiment, the optical fibers are arranged in a wall structure of a thin sleeve which fits onto existing VAB needles, thus allowing the VAB needle to be upgraded with an optical probing capability (Abstract). Thus, Philips falls within the same field of endeavor as Applicant’s invention.
Philips teaches a vacuum assisted biopsy needle which can be used to resect and remove tissue from a tissue site after analysis (Paragraph 0010). A sleeve may be affixed outside of the biopsy needle and may define a hollow space into which the biopsy needle or other resection device fits. The sleeve may be formed with an opening in the wall structure (Paragraphs 0013-0014). Philips teaches that the distal end of a sleeve in the form of a cut away in a side of its wall structure, thus forming a cavity corresponding with a cavity or notch of the instrument comprising the tissue removal device (Paragraphs 0071-0073; Fig. 7A) Philips further discloses that the optical fibers may be configured to connect to optical ports at the distal end of the sleeve (Paragraph 0078). Philips teaches that the needle may be a vacuum assisted biopsy needle where an under pressure source serves to suck tissue into the notch and, after resection, carry the resected tissue away from the cutting site into a container (Paragraph 0010). The cut tissue is transported through a hose from the tissue site to a container (Paragraphs 0029 and 0063-0064; Fig. 5 reference H2)
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the system of Hendricks to use a vacuum assisted biopsy (VAB) needle as taught by Philips and to further configure the shaft to have a cutout corresponding to the notch of the vacuum assisted tissue removal tool similar to that of Fig. 7a-7b of Philips as taught Philips because Hendricks teaches that the needle may be used in association with a biopsy collecting needle (Hendricks: Fig. 2 Paragraph 0041) and thus it may be advantageous to use the vacuum assisted needle of Philips since the vacuum assisted needle can remove resected tissue from the site through an under pressure source (Philips: Paragraph 0010). Furthermore, configuring the shaft of Hendricks to have a cutout that corresponds to the notch of the vacuum assisted biopsy needle would allow the system of modified Hendricks to have the benefit of not requiring the VAB needle to penetrate as far ahead of the optical fibers to perform resection as would otherwise be required and thus may reduce the intrusiveness of the procedure. The benefit of such an arrangement is illustrated in annotated Fig. 8b below. Additionally, having the notch and thus the optic fibers located anywhere between the arrows illustrated by box 2 in annotated Fig. 8b would allow modified Hendricks to optically analyze the tissue about to be resected since Fig. 2 of Hendricks shows that there may be additional optical fibers facing
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inwards which would thus interrogate the tissue within the notch of the VAB needle prior to resection.
Annotated Fig. 8b: This annotated figure of Philips serves to illustrate the benefit of configuring the shaft of Hendricks to include the cutout as illustrated by Fig. 7a-7b of Philips. A shaft with the cutout may have the end of the optical fiber probes in any location between the arrows marked by box 1 while still allowing the full notch of the VAB needle to be exposed for resection. Such a configuration means that the tip of VAB needle may penetrate a smaller distance past the end of the optical fibers while still exposing the full notch of the VAB needle as illustrated by the arrow extending to the tip of the VAB needle. The arrow indicated by box 2 illustrates the location of the end of the optic fibers if no notch is present in the shaft. The corresponding arrow to the tip of the VAB needle illustrates that the tip of the VAB needle must penetrate a farther distance into the tissue to fully expose the notch in this configuration.
The reduced depth of penetration from the optical probes to the tip of configuration 1 may additionally reduce the amount of movement of the required between the shaft and VAB needle since the shaft does not need to be moved as far back to expose the resection site after interrogating the tissue at the tip of the VAB needle in configuration 1 as compared to configuration 2. This reduction in the amount of movement required may improve the usability of the device.
Regarding claim 8, Hendricks in view of Philips teaches the system of claim 1. Modified Hendricks further teaches the system wherein the first optic fiber and the second optic fiber both extend linearly to the distal tip of the needle (Figs. 2-3 references 210, 220, 30, and 40; Paragraphs 0041-0043 and 0046 The optic fibers appear to run linearly through the wall of the device and thus Hendricks at least suggests that they extend linearly to the distal tip).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hendricks US Patent Application Publication Number US 2010/0317964 A1 hereinafter Hendricks in view of Philips US Patent Application Publication Number US 2015/0359525 A1 hereinafter Philips as applied to claim 1 above further in view of Mak US Patent Application Publication number US 2017/0035399 A1 hereinafter Mak.
Regarding claim 3, Hendricks in view of Philips teaches the system of claim 1. Modified Hendricks further teaches the system wherein the analysis subsystem is configured to scan the tissue at a plurality of positions (Paragraphs 0044-0045: as the biopsy device is inserted spectra is recorded for a plurality of locations, the tissue characterization may be performed in real-time).
Modified Hendricks fails to further disclose the system further comprising an actuator to retract the needle while the tissue removal device is kept in place, and the plurality of positions being along the tissue removal device as the needle is retracted
Mak teaches an actuation mechanism which may trigger the acquisition of optical data and may further cause the optical system to be moved relative to a tissue removal device. The tissue removal device and optical system may be movable relative to each other such that the optical system can sample tissue at a distal end and move back to allow for tissue resection (paragraphs 0096-0097). Mak further teaches that the optical fiber and tissue removal device may be housed within single elongate body (Paragraph 0091).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the actuation mechanism of the optical system relative to the tissue resection system as taught by Mak into the system of modified Hendricks because having these two system be separately actuatable allows the system to identify tissue for resection and either extend or retract either the resection system or the optical system respectively such that the presence of the optical system does not interfere with the tissue resection and the tissue resection device does not cause damage to the optical system. Moreover, the combination of the independent actuation of these system combined with the recording of real-time tissue characterization at a plurality of location as taught by Hendricks is considered sufficient to render the limitation of scanning the tissue at a plurality of positions along the tissue removal device obvious since the real-time optical measurement system of Hendricks is capable of “scanning” a plurality of tissue locations as it is extended/retracted relative to the tissue resection device of modified Hendricks.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hendricks US Patent Application Publication Number US 2010/0317964 A1 hereinafter Hendricks in view of Philips US Patent Application Publication Number US 2015/0359525 A1 hereinafter Philips as applied to claim 1 above and further in view of Mark US Patent Application Publication number US 2010/0081964 A1 hereinafter Mark.
Regarding claim 4, Hendricks in view of Phan teaches the system of claim 2. Modified Hendricks fails to further teach the system further comprising a stylet, wherein the stylet fits inside the hollow shaft and the first surgical instrument is configured for cooperating successively with the stylet and the second surgical instrument.
Mark teaches a system for detecting abnormal tissue in a patient including an introducer cannula having a proximal opening and a distal opening. The system further includes a surgical instrument configured for selective insertion through the cannula. The surgical instrument further includes a tissue cutting opening positioned relative to the distal end of the introducer cannula when fully inserted through the introducer cannula. The system also includes a sensor configured to detect at least one property of the tissue of the patient. The sensor is located at a fixed distance relative to the distal end of the introducer cannula when the surgical instrument is inserted into the introducer cannula (Abstract). Thus, Mark falls within the same field of endeavor as Applicant’s invention.
Mark teaches a stylet, wherein the stylet fits inside the hollow shaft and the first surgical instrument is configured for cooperating successively with the stylet and the second surgical instrument (Paragraph 0066: the stylet for insertion which is removed to allow the resection device to be inserted).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the stylet for piercing tissue as taught by Mark into the system of modified Hendricks because the use of a stylet while piercing the tissue to reach the tissue site may reduce the strain placed on the needle, or biopsy device, of modified Hendricks during insertion and may further allow the system to pierce tissue more easily which improves usability. furthermore, the stylet may help keep the inner lumen of the biopsy device, or needle, clear and unobstructed during insertion and may be removed to allow access to for the resection devices of modified Hendricks and/or other instruments.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are not found to be persuasive.
In particular, Applicant argues that it is not possible for Hendricks to perform measurements at BIOPT before cutting the tissue and that Hendricks only mentions analysis after cutting.
This argument is not found to be persuasive because Hendricks paragraph 0041 recites:
“some other fiber ends orientated in the direction to the front or the side of the biopsy device, for optical guidance prior to biopsy”
Which explicitly indicates that some of the fibers, such as those oriented to the front of the device as shown in annotated Fig. 2 above, are configured for making measurements prior to resecting tissue. Additionally paragraphs 0046 and 0049 of Hendricks discuss performing analysis on the tissue surrounding the probe which has not yet been resected. Applicant’s arguments that Hendricks could not perform analysis on the BIOPT of Fig. 2 of Hendricks prior to resection are not commensurate in scope with the present claim language. The present claim language requires only the optic fibers analyze non-removed tissue in front of a distal tip which is taught by Hendricks paragraph 0041 above. There is no requirement of interrogating tissue within the notch of the second surgical instrument prior to resection. The forward facing fibers of Hendricks interrogate unremoved tissue in front of the device and satisfy the present claim limitations. Additionally, the combination of Hendricks in view of Philips newly presented above would satisfy such a requirement of interrogating the tissue within the notch of the second surgical instrument if it were present as the second set of fiber optics of Hendricks (Annotated Fig. 2 the fiber optics not being designated by the arrows and facing inwards) would interrogate the notch of the second instrument prior to resection since the combination of Hendricks in view of Philips teaches the corresponding notch in the shaft.
Applicant further argues that Hendricks does not teach two linearly extending fiber optics to the distal end of the needle. This argument is not found to be persuasive because the fiber optics of annotated Fig. 2 above from Hendricks clearly show first and second linearly extending fiber optics.
Applicant’s arguments with respect to Philips have been fully considered but are not directed towards the combination of Hendricks in view of Philips as previously presented or as newly presented. Philips is relied upon for the teachings of the cut away in the side wall. This structural configuration is applicable to Hendricks as it also surrounds a biopsy needle. The sleeve of Philips having curved optical fibers, not being slidably arranged with the VAB needle, and/or not having sufficient rigidity are all aspects of Philips that are not being relied upon in the previous or current rejection. The relevant teachings of Philips are the structural configuration of the cut away as illustrated in Fig. 7a-b and the use of a vacuum assisted biopsy needle. Applicant has not provided any argument directed towards how this structural configuration would be unobvious to implement into Hendricks to effectively remove a portion of the sidewall between the optical fibers of Fig. 2 of Hendricks (such as the portion of the sidewall going into or coming out of the page) in a configuration that aligns with the notch of the implemented VAB needle and thus Applicant’s arguments are not found to be persuasive as they are not directed towards the relied upon teachings of Philips or the combination of Hendricks in view of Philips.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW ERIC OGLES whose telephone number is (571)272-7313. The examiner can normally be reached M-F 8:00AM - 5:30PM.
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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