DETAILED ACTION
Applicant' s arguments, filed 04/24/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/26/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
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.
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 .
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 § 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),
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 an opening, cavity, or notch of a side of the second surgical instrument (Fig. 2 reference 240 and the notch the biopt is in; Paragraph 0041: the needle for taking the biopt)
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 configured to optically analyze non-removed tissue in front of a distal tip of the needle, through 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 non-removed tissue, wherein the analyzed characteristic comprises a presence of unhealthy tissue or cancer cells within the non-removed 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)
Hendricks fails to further teach the system wherein the second surgical instrument comprises: a discharge channel connected to the tissue removal device for discharge of removed tissue; 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 the opening, the cavity, or the notch on the side of the second surgical instrument; the analysis sensor configured to optically analyze non-removed tissue in the opening, the cavity, or the notch, of the second surgical instrument; and the optical fibers being at opposing edges of the opening of the needle.
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 that correspond to the cavity or notch of the VAB needle. The sleeve includes optical fibers which allow for optical probing of the tissue in the cavity (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 of Hendricks 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 and may improve the accuracy of the resection. The benefit of such an arrangement is illustrated in annotated Fig. 8b below. Additionally, such a cutout implemented into the needle of Hendricks would allow the forward facing fibers of Hendricks (Hendricks: Fig. 2: the fiber that face the distal end of the needle tip) to interrogate the tissue in the notch of the biopsy needle prior to resection similar to the analysis performed by Philips (Philips: paragraph 0014) since the tissue in the notch will be between the distal ends of the fibers. Such a configuration would allow the system to ensure that the desired tissue is within the cavity of the resection device prior to resection.
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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 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 and 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 amendments to the specification have been entered and are considered sufficient to overcome the previously presented rejection under 35 USC 112(a). The rejection is withdrawn.
Applicant’s arguments filed 07/24/2026 with respect to the 35 USC 103 rejections of claims 1, 3-4, and 8 have been considered but are not found to be persuasive.
In particular, with regards to claim 1, Applicant argues that the claimed configuration of fibers is not taught or reasonably suggested by the prior art of record. Applicant argues that Hendricks does not teach tissue analysis at a tissue removal notch. Applicant argues that the front facing fibers of Hendricks cannot interrogate the tissue in the notch because they cannot interrogate tissue that is lateral to the fibers. Applicant argues that the forward facing optical fibers of Hendricks are for optical guidance and cannot analyze tissue within or lateral to a tissue removal cavity.
Applicant further argues that Philips does not teach fibers extending to the distal tip of the needle for analysis of tissue in a cavity. Applicant argues that the fibers of Philips are positioned along the length of the sleeve wall at the cavity rather than at the distal tip. Applicant argues that the probing of Philips requires multiple optical port pairs. Applicant then asserts that the combination of Hendricks in view of Philips fails to produce the claimed configuration because the supposed claimed combination would produce a device with a forward facing fiber that measures tissue distally in front of the device and curved fibers at various positions along the cavity walls that measure the tissue laterally in the notch. Applicant states that nothing in Hendricks would suggest that fibers would pass along an opening in a tube such as the one taught by Philips. Applicant asserts that the supposed combination cannot yield the claimed configuration.
Applicant argues that the reason for combining Hendricks and Philips is Hindsight reasoning and the reasoning is not disclosed or suggested by either of Hendricks or Philips. Applicant further argues that there is no teaching in Philips or Hendricks that fibers extending to the distal end of the device have lateral analysis capabilities.
Applicant’s argument are not found to be persuasive. In particular, Applicant’s arguments directed towards the forward facing optical fibers of Hendricks being unable to interrogate lateral tissues are not found to be persuasive because optical sensors interrogate the media that lies between the emitter and receiver. Thus, the tissues analyzed by any emitting and receiving optical fiber set are the tissues disposed between the pair and for a certain distance in front of the pair. Such a property is intrinsic to optical analysis as light takes a variety of paths through the tissue. Moreover, Philips teaches that optical sensors are capable of detecting properties of tissue that are lateral to the sensor detector pair in paragraph 0014 and Figs. 4a-c which teach:
“Especially, the sleeve may be formed with an opening in the wall structure, thus forming a cavity in the sleeve shaped and positioned to fit a corresponding cavity or notch of an associated VAB needle, and wherein the optical fibers end in optical ports positioned in the wall structure, so as to allow optical probing of biological tissue when present in the cavity. Especially, at least a first optical port may be arranged at a surface part of the wall, so as to direct light outside the sleeve in a direction perpendicular to a longitudinal extension of the sleeve, upon application of an optical signal. Further, at least a second optical port may be arranged at another surface part of the wall, so as to allow receipt of an optical response to said light from biological tissue present in a volume positioned to a side of the sleeve”
Thus, Philips directly teaches that optical sensors interrogate a volume of tissue between the emitter and detector which include tissue that is laterally disposed between the emitter and detector since the emitter and receivers are arranged perpendicular to the longitudinal axis of the needle and are configured to interrogate the tissue disposed in the cavity between the coplanar emitter and receiver. It is thus established that emitter and detectors interrogate a volume of tissue disposed therebetween which includes portions of the volume lateral to the emitter and detector.
It is further noted that Applicant’s arguments are not commensurate in scope with the claim language. In particular, a variety of Applicant’s arguments are directed towards the forward facing fibers measuring tissue laterally disposed between the fibers. Applicant’s claims do not require such lateral measurement. Applicant’s claims require only that the forward facing fibers measure tissue “in the opening, the cavity, or the notch of the second surgical instrument”. The cavity of the second surgical instrument may extend in front of the distal end of the fibers as illustrated in annotated Fib. 8b above, the distal ends of the fibers may be disposed at a plurality of locations along the length of the cavity and thus measuring tissue distally to the optical fibers would also measure tissue within the cavity, opening, and/or notch of the VAB needle.
Applicant’s arguments that the forward facing fibers of Hendricks are for optical guidance rather than tissue interrogation are not found to be persuasive because Hendricks recites that the optical guidance is in the form of autofluorescence or Raman spectroscopy which are used to detect anomalies in the tissue (Hendricks: Paragraph 0043).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant’s arguments towards the combination of Hendricks in view of Philips are not found to be persuasive. In particular, Applicant states that the forward facing fibers of Hendricks, when the needle of Hendricks is configured with a cutout as taught by Philips, could not interrogate the non-removed tissue in the VAB needle because such interrogation is not contemplated by Hendricks. This argument is not found to be persuasive because the forward facing fibers of Hendricks when disposed on either side of the cutout would straddle the cavity of the VAB needle and, as described above, optical interrogation between these fibers would inherently interrogate the tissue in front of and between the two fibers which includes tissue distal to the tip of the needle and tissue between the fibers that is disposed in the notch of the VAB needle.
Applicant’s arguments directed towards Hendricks not being able to be modified to include a cutout similar to the one disclosed by Philips because Hendricks does not teach the optical fibers running past such a cutout is not found to be persuasive. The needle containing the optical fiber of Hendricks and the sleeve of Philips perform similar purposes of interrogating tissue around the biopsy probe. There is no reason that the needle of Hendricks could not be configured in the described manner of having a portion of its sidewall removed without changing the configuration of the optical fibers.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The above presented combination is made using teachings of art and knowledge generally available to one of ordinary skill in the art.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine is in the knowledge generally available to one of ordinary skill in the art. As laid out in the above annotated figures, the cutout of Philips implemented into the system of Hendrick would allow the forward facing fibers of Hendricks to analyze tissues within the cavity of the biopsy needle similar to how the optical fibers of Philips are able to analyze the tissue in the VAB needle. Additionally, the notch allows 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 and may improve the accuracy of the resection.
Applicant argues that claim 8 is non-obvious because linearity alone is not the distinguishing feature of the claim but the linearity combined with tissue measurement in front of the fibers and in the notch. Applicant argues that the linear fibers of Hendricks cannot measure tissue within the notch.\
Applicant’s arguments are not found to be persuasive because, as described above, Hendricks as modified by Philips teaches the needle of Hendricks with a notch that corresponds to the notch in the VAB needle. Thus the distal ends of the linear fibers of Hendricks interrogate not only tissue in front of the fibers but the tissue disposed in the VAB needle notch that is disposed between the distal ends of the fibers.
Applicant arguments that the helical routing of the fibers of Philips is what allows the fibers to interrogate tissue laterally are not found to be persuasive. Philips does not describe the helical routine of the fibers as the principle that allows the lateral sampling of tissue. Philips merely describes the helical arrangement as how the fibers are routed and does not teach that the measurement area of the fibers are affected by the shape of the routing. Additionally, as described above, the present claims do not require lateral tissue sampling using the forward facing fibers. The forward facing fibers may measure tissue ahead of them that is within the notch of the VAB needle.
In regards to claim 3, Applicant argues that Mak teaches a two point measurement system rather than the claimed scanning at multiple tissue locations. Applicant argues that Hendricks multi-location recording occurs as the entire biopsy device is advanced and records positions along the needles trajectory. Applicant asserts that the claimed scanning functionality is fundamentally different since the scanning requires moving only the outer needle while the second surgical instrument is kept in place to produce a spatial map of the tissue along the notch of the tissue removal device. Applicant asserts that the provided combination of Hendricks in view of Philips further in view of Mak does not yield the claimed scanning system.
Applicant’s arguments are not found to be persuasive because Hendricks teaches the recording of tissue spectra at various locations in paragraphs 0044-0045 and Map teaches the independent movement of an optical system relative to a resection system. Thus, their combination is considered to teach the independent movement of the needle of Hendricks which may perform the tissue characterization at a variety of locations along the length of the resection device since the needle can only move axially along the resection device disposed therein.
In regards to claim 4, Applicant argues that Mark does not cure the deficiencies of Hendricks in view of Philips and that Mark does not include a tissue analysis subsystem and that the Examiner does not explain how or why one of ordinary skill in the art would incorporate a stylet into modified Hendricks.
This argument is not found to be persuasive because it does not particularly argue any point in the rejection of claim 4. Applicant does not argue that the proposed reason to combine, which is that a stylet may allow the system to pierce tissue more easily and keep the inner lumen of the needle clean, is improper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
