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 Amendment
The Amendment filed March 13, 2026 has been entered. Claims 1-20 remain pending in the application.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3-4, 9-14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano et al. (US 5983125 A) (“Alfano”) in view of Hawkins, Jr. (US 4230123) (“Hawkins”).
Regarding claim 1, Alfano discloses A biopsy system comprising (Abstract and entire document):
a fluorescence endoscopy element (FIG. 7 optical probe);
a biopsy element for taking a sample of the tissue to be examined from an organic body (FIG. 7 biopsy needle 105); and
an insertion sleeve for placing a distal end of the fluorescence endoscopy element and/or the biopsy element in or on the tissue to be examined in the organic body (FIG. 7 hollow tube 103),
wherein the fluorescence endoscopy element comprises a distal section with distal decoupling of stimulation light as well as distal coupling in of fluorescence light (FIG. 7 optical probe, light source 13, means 51 and 53 for receiving the light),
wherein the distal section of the fluorescence endoscopy element is axially moveably positioned relative to the insertion sleeve and can be proximally removed from the insertion sleeve (As shown in FIG. 7),
wherein the biopsy element, with the distal section of the fluorescence endoscopy element removed, is configured to be placed through the insertion sleeve into or onto the tissue to be examined in the organic body (As shown in FIG. 7).
Alfano fails to disclose wherein the biopsy element has a greater radial extent than the distal section of the fluorescence endoscopy element and an inner diameter of the insertion sleeve is adjustable for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element.
However, in the same field of endeavor, Hawkins teaches wherein the biopsy element has a greater radial extent than the distal section of the fluorescence endoscopy element and an inner diameter of the insertion sleeve is adjustable for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element (FIG. 4 and associated paragraphs, see col. 3 lines 44-53 showing the adjustable diameter of the insertion sleeve showing variable diameters that fit within, including larger biopsy needle and smaller needle, or the fluorescence endoscope element as taught by the combination of the references).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano to include wherein the biopsy element has a greater radial extent than the distal section of the fluorescence endoscopy element and an inner diameter of the insertion sleeve is adjustable for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element as taught by Hawkins for insertion of multiple sizes of devices (col. 3 lines 44-53).
Regarding claim 3, Alfano as modified discloses The biopsy system according to claim 1, wherein on the proximal side, the insertion sleeve can be everted over the distal section of the fluorescence endoscopy element (Alfano As shown in FIG. 7).
Regarding claim 4, Alfano as modified discloses The biopsy system according to claim 1, Alfano fails to disclose wherein the inner diameter of the insertion sleeve is adjustable to a greater inner diameter for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element.
However, in the same field of endeavor, Hawkins teaches wherein the inner diameter of the insertion sleeve is adjustable to a greater inner diameter for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element (FIG. 4 and associated paragraphs, see col. 3 lines 44-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano to include wherein the biopsy element has a greater radial extent than the distal section of the fluorescence endoscopy element and an inner diameter of the insertion sleeve is adjustable for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element as taught by Hawkins for insertion of multiple sizes of devices (col. 3 lines 44-53).
Regarding claim 9, Alfano as modified discloses The biopsy system according to claim 1, wherein the distal section of the fluorescence endoscopy element as well as the biopsy element have longitudinal markings and/or an axially positionable stop for a defined reproducible relative axial position of the distal section or the biopsy element relative to the insertion sleeve (Alfano FIG. 7 shows a stop).
Regarding claim 10, Alfano as modified discloses The biopsy system according to claim 1, wherein the fluorescence endoscopy element is configured to optionally proximally couple in a first stimulation light and/or a second stimulation light, wherein the first stimulation light is on average shorter wave than the second stimulation light, and wherein the fluorescence endoscopy element is configured to optionally produce a first fluorescence signal from a first tissue area with the first fluorescence light stimulated with the first stimulation light and to receive a second fluorescence signal from a second tissue area from second fluorescence light stimulated with the second stimulation light (Alfano Col. 4 lines 37-61 discussing the wavelengths).
Regarding claim 11, Alfano as modified discloses The biopsy system according to claim 1, wherein the distal section of the fluorescence endoscopy element comprises a light guide with proximal coupling in of stimulation light and/or proximal decoupling of fluorescence light, wherein the distal end of the fluorescence endoscopy element distally decouples the stimulation light from the light source and/or distally couples the fluorescence light into the light guide (Alfano FIG. 7 optical probe).
Regarding claim 12, Alfano as modified discloses The biopsy system according to claim 11, wherein proximally, the fluorescence endoscopy element comprises an optical component which is detachably connectable or firmly connected to the distal section of the fluorescence endoscopy element, wherein the optical component comprises a beam splitter with an image path side and an illumination path side, wherein to decouple the fluorescence light an image sensor or a photodiode is detachably connectable or firmly connected to the image path side, and wherein to couple in the stimulation light, a light source is detachably connectable or firmly connected to the illumination path side (Alfano FIG. 4 and col. 3 line 65 – col. 4 line 8).
Regarding claim 13, Alfano as modified discloses The biopsy system according to claim 12 wherein the optical component has an optical longpass filter which transmits the fluorescence light more strongly to the image path side than the stimulation light, and/or comprises an optical shortpass filter which reflects the fluorescence light more strongly to the image path side than the stimulation light (Alfano Filters 55 and 59).
Regarding claim 14, Alfano as modified discloses The biopsy system according to claim 12, wherein the fluorescence endoscopy element comprises an operating unit signal-connected or connectable with the image sensor or the photodiode and/or the light source, wherein the operating unit comprises an optical or acoustic display component, a control and supply component and an operating component (Alfano Computer 69).
Regarding claim 18, Alfano as modified discloses The biopsy system according to claim 1, wherein on the distal side the distal section of the fluorescence endoscopy element comprises an LED for the decoupling of stimulation light and/or on the distal side an image or a photodiode for the coupling in of fluorescence light (Alfano FIG. 4-7 and Col. 4 lines 37-61 discussing optical guide and the wavelengths).
Regarding claim 19, the same rejections as applied to claim 1, apply to claim 20, the only difference appears to be the specific wording for the biopsy element and endoscopic element being different diameters.
Regarding claim 20, Alfano as modified discloses The biopsy system according to claim 1, Alfano as modified further discloses wherein the inner diameter of the insertion sleeve is configured to be adjustable to have a first inner diameter in a first state and a second inner diameter in a second state, the second inner diameter being greater than the first inner diameter, the insertion sleeve being configured to receive the distal section of the fluorescence endoscopy element and the biopsy element when the insertion sleeve is in the second state (Hawkins: FIG. 4 and associated paragraphs, see col. 3 lines 44-53 showing the adjustable diameter of the insertion sleeve showing variable diameters that fit within, including larger biopsy needle and smaller needle, or the fluorescence endoscope element as taught by the combination of the references, the first state, as the smaller state, fits fluorescence endoscopy element alone, as taught by Alfano, the expanded second state for the larger diameter device, fits both the smaller diameter and the larger diameter).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hawkins in further view of Mukherjee (US 2018/0228511 A1) (“Mukherjee”).
Regarding claim 2, Alfano discloses The biopsy system according to claim 1, Alfano fails to disclose wherein the insertion sleeve is more rigid than the distal section of the fluorescence endoscopy element.
However, in the same field of endeavor, Mukherjee teaches wherein the insertion sleeve is more rigid than the distal section of the fluorescence endoscopy element (FIG. 17 and associated paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano to include wherein the insertion sleeve is more rigid than the distal section of the fluorescence endoscopy element as taught by Mukherjee to properly navigate the endoscope ([0085]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hawkins in further view of Vazales et al. (US 2013/0030249 A1) (“Vazales”).
Regarding claim 5, Alfano as modified discloses The biopsy system according to claim 4, Alfano fails to disclose wherein the insertion sleeve is axially slit and expandable.
However, in the same field of endeavor, Vazales teaches wherein the insertion sleeve is axially slit and expandable (Claim 8 discussing the expandable material with varying diameter for multiple sizes of tubing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include wherein the insertion sleeve is axially slit and expandable as taught by Vazales to fit more sizes (claim 8).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hawkins in further view of Vazales in further view of Ramanujam et al. (US 2005/0203419 A1) (“Ramanujam”).
Regarding claim 6, Alfano as modified discloses The biopsy system according to claim 5, Alfano as modified fails to disclose for receiving the distal section of the fluorescence endoscopy element, the insertion sleeve is configured in a circumferentially overlapping manner, wherein when the biopsy element is received, the overlapping is smaller or no longer exists.
However, in the same field of endeavor, Ramanujam teaches for receiving the distal section of the fluorescence endoscopy element, the insertion sleeve is configured in a circumferentially overlapping manner, wherein when the biopsy element is received, the overlapping is smaller or no longer exists (As shown in FIG. 6-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include for receiving the distal section of the fluorescence endoscopy element, the insertion sleeve is configured in a circumferentially overlapping manner, wherein when the biopsy element is received, the overlapping is smaller or no longer exists as taught by Ramanujam to biopsy correct tissue ([0012], “By inserting the optical probe in the biopsy needle and examining the tissue surrounding the tip of the needle, the candidate tissue can be evaluated prior to the biopsy. This enables different and larger regions to be examined before the biopsy is taken, thus increasing the probability that the correct tissue is biopsied and that another biopsy will not be required.”).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hawkins in further view of Garcia (US 2003/0097079 A1) (“Garcia”).
Regarding claim 7, Alfano as modified discloses The biopsy system according to claim 4, Alfano as modified fails to disclose wherein the insertion sleeve comprises an inner sleeve and an outer sleeve, wherein for receiving the biopsy element, the inner sleeve is removable in the proximal direction from the outer sleeve.
However, in the same field of endeavor, Garcia teaches wherein the insertion sleeve comprises an inner sleeve and an outer sleeve, wherein for receiving the biopsy element, the inner sleeve is removable in the proximal direction from the outer sleeve (As shown in FIG. 1-6 and see [0045], “A metal sleeve is provided of diameter sufficient to closely fit over existing biopsy needles, while allowing it to be slid freely over and along the length of the existing biopsy needle. The length of the metal sleeve is less than the entire length of the biopsy needle, such that, once fitted onto the biopsy needle, it is flush with the proximal end of the biopsy needle (where-the biopsy needle junctures with the large "discharge unit" of the biopsy needle kit). The ends of the metal sleeve are preferably rounded, in contrast to the sharp-pointed end of the needle kit).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include wherein the insertion sleeve comprises an inner sleeve and an outer sleeve, wherein for receiving the biopsy element, the inner sleeve is removable in the proximal direction from the outer sleeve as taught by Garcia to slide flush ([0045]).
Regarding claim 8, Alfano as modified discloses The biopsy system according to claim 7, Alfano as modified fails to disclose wherein the inner sleeve has an inner diameter that essentially corresponds to an outer diameter of the distal section of the fluorescence endoscopy element, and the outer sleeve has an inner diameter that essentially corresponds to an outer diameter of the biopsy element.
However, in the same field of endeavor, Garcia teaches wherein the inner sleeve has an inner diameter that essentially corresponds to an outer diameter of the distal section of the fluorescence endoscopy element, and the outer sleeve has an inner diameter that essentially corresponds to an outer diameter of the biopsy element (As shown in FIG. 1-6 and see [0045], “A metal sleeve is provided of diameter sufficient to closely fit over existing biopsy needles, while allowing it to be slid freely over and along the length of the existing biopsy needle. The length of the metal sleeve is less than the entire length of the biopsy needle, such that, once fitted onto the biopsy needle, it is flush with the proximal end of the biopsy needle (where-the biopsy needle junctures with the large "discharge unit" of the biopsy needle kit). The ends of the metal sleeve are preferably rounded, in contrast to the sharp-pointed end of the needle kit).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include wherein the inner sleeve has an inner diameter that essentially corresponds to an outer diameter of the distal section of the fluorescence endoscopy element, and the outer sleeve has an inner diameter that essentially corresponds to an outer diameter of the biopsy element as taught by Garcia to slide flush ([0045]).
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hawkins in further view of Mueller, Jr. et al. (US 2004/0147846 A1) (“Mueller”).
Regarding claim 15, Alfano discloses The biopsy system according to claim 1, Alfano fails to disclose further comprising a template, positionable and fixable relative to the organic body, with at least one opening for selectively receiving the insertion sleeve and the biopsy element, wherein the insertion sleeve and/or the biopsy element in the at least one opening is fixed against lateral displacement and tilting through the template.
However, in the same field of endeavor, Mueller teaches further comprising a template, positionable and fixable relative to the organic body, with at least one opening for selectively receiving the insertion sleeve and the biopsy element, wherein the insertion sleeve and/or the biopsy element in the at least one opening is fixed against lateral displacement and tilting through the template (FIG. 1-2 and associated paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano to include further comprising a template, positionable and fixable relative to the organic body, with at least one opening for selectively receiving the insertion sleeve and the biopsy element, wherein the insertion sleeve and/or the biopsy element in the at least one opening is fixed against lateral displacement and tilting through the template as taught by Mueller for proper alignment (see abstract and entire document).
Regarding claim 17, Alfano as modified discloses The biopsy system according to claim 15, Alfano fails to disclose wherein the template comprises a plurality of openings, which are optionally available for receiving the insertion sleeve and the biopsy element.
However, in the same field of endeavor, Mueller teaches wherein the template comprises a plurality of openings, which are optionally available for receiving the insertion sleeve and the biopsy element (FIG. 1-2 and associated paragraphs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include wherein the template comprises a plurality of openings, which are optionally available for receiving the insertion sleeve and the biopsy element as taught by Mueller for proper alignment (see abstract and entire document).
Claim 16 rejected under 35 U.S.C. 103 as being unpatentable over Alfano in view of Hopkins in further view of Mueller in further view of Ramanujam et al. (US 2005/0203419 A1) (“Ramanujam”).
Regarding claim 16, Alfano as modified discloses The biopsy system according to claim 15, Alfano as modified fails to disclose wherein the insertion sleeve comprises a first part and a second part, wherein the first part fixes the distal section of the fluorescence endoscopy element in the at least one open against lateral displacement and tipping, and wherein the second part fixes the biopsy element in the at least one opening against lateral displacement and tipping.
However, in the same field of endeavor, Ramanujam teaches wherein the insertion sleeve comprises a first part and a second part, wherein the first part fixes the distal section of the fluorescence endoscopy element in the at least one open against lateral displacement and tipping, and wherein the second part fixes the biopsy element in the at least one opening against lateral displacement and tipping (As shown in FIG. 6-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Alfano as modified to include wherein the insertion sleeve comprises a first part and a second part, wherein the first part fixes the distal section of the fluorescence endoscopy element in the at least one open against lateral displacement and tipping, and wherein the second part fixes the biopsy element in the at least one opening against lateral displacement and tipping as taught by Ramanujam to biopsy correct tissue ([0012], “By inserting the optical probe in the biopsy needle and examining the tissue surrounding the tip of the needle, the candidate tissue can be evaluated prior to the biopsy. This enables different and larger regions to be examined before the biopsy is taken, thus increasing the probability that the correct tissue is biopsied and that another biopsy will not be required.”).
Response to Arguments
Applicant's arguments filed March 13, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding Alfano in view of Hawkins, for previous claim 4, and the subject matter included in newly amended claim 1, “wherein the biopsy element has a greater radial extent than the distal section of the fluorescence endoscopy element and an inner diameter of the insertion sleeve is adjustable for optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element.” However, and pointed out by the Applicant, on page 15 of the Remarks, Hawkins does show an insertion sleeve with an adjustable inner diameter as recited in the claim combination. Importantly, the claim recites, “optionally receiving the distal section of the fluorescence endoscopy element and the biopsy element.” In other words, the adjustability of Hawkins, admitted as being taught, is configured to fit multiple sizes of biopsy needles and elongated medical devices, or optionally receiving a larger biopsy needle and a smaller fluorescence endoscopy element. Both sized devices fit in the adjustable diameter. FIG. 4 shows the needle sheath with varying sizing to fit multiple sizes and accommodate both. The fluorescence endoscopy element is taught by the primary reference Alfano and the teaching is a combination of the references.
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). The disclosure of Alfano teaches the fluorescence endoscopy element. The teachings of Hawkins teaches the varying sizes of elements fitting into the adjustable diameter sheath, and the combination of the references teaches the limitation.
Thus, the arguments are not persuasive. Additional arguments appear to rely on this limitation and arguments and are thus moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fisher et al. (US 6,790,185 B1) discloses a coaxial insertion needle having an adjustable inner diameter.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791
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