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 .
Election/Restrictions
Claims 70-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026.
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.
Claim 56 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 56, the claim recites “… the tissue separator can be disposed”, see ll. 3-4. The use of “can be” implies the limitations are not required, rendering the claim indefinite because it is unclear whether or not Applicant actually intends to claim these limitations. For examination purposes, this limitation has been interpreted as “… the tissue separator is configured to be disposed”.
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.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Stern (US 2011/0224492) in view of Diamond et al. (US 6142957) (hereinafter Diamond).
Regarding claim 54, Stern discloses a tissue collection instrument (Fig. 5A, endoscopic device 270) comprising: a tissue separator device (forceps instrument 300) comprising: an elongate shaft (Fig. 3, shaft 310); and a separator disposed at a distal end of the elongate shaft, the separator having a storage volume (grasping end 320; para. 55; para. 62, last sentence); and a tissue retrieval device (snare 400) comprising: a tissue shuttle (Fig. 4, snare end 420); and a retriever connected to the tissue shuttle and disposed radially outside of the elongate shaft to retract the tissue shuttle away from the tissue separator device (shaft 410; para. 51).
Stern does not disclose the tissue shuttle is configured to be storable in the storage volume. Instead, the tissue shuttle of Stern appears to be too large to be stored in the storage volume. Diamond, however, teaches a multiple biopsy sampling device (Abstract) wherein a tissue shuttle (Fig. 2, barb 31) is small enough to be storable in a storage volume of a separator (jaw members 20, 20a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Stern such that the tissue shuttle is configured to be storable in the storage volume. Making this modification would be useful for grasping smaller biopsy samples.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Diamond, further in view of Burbank et al. (US 7651511) (hereinafter Burbank).
Regarding claim 55, Stern in view of Diamond does not teach the tissue separator device is at least partially transparent.
Burbank, however, teaches a vascular clamp (Abstract; Fig. 1) wherein a floating jaw 20 may include a portion transparent to sensing energy, a passage, a window, or other feature allowing operation of a sensor 30 (Col. 8, ll. 21-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Stern in view of Diamond such that the tissue separator device is at least partially transparent. Making this modification would be useful for allowing operation of a sensor within the jaw portion, as taught by Burbank.
Claims 56-57 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Stern in view of Diamond, further in view of Hameed (US 2010/0049162).
Regarding claim 56, Stern discloses an endoscope (Fig. 5A, endoscopic instrument 270) comprising: an elongate working shaft having a first lumen from in which the tissue separator device is configured to be disposed (Fig. 5B-D, channel 220).
Stern does not disclose a viewing device configured to view the tissue separator device distal of the first lumen. Hameed, however, teaches device for tissue collection including a visualization system (Abstract) comprising a viewing device configured to view the tissue separator device distal of the first lumen (Fig. 4C, camera 110; para. 49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Stern in view of Diamond to include a viewing device configured to view the tissue separator device distal of the first lumen. Making this modification would be useful for providing a 360-degree camera that can be positioned from proximal to distal a target site and can also do a U-turn about its axis of extension, as taught by Hameed (Abstract).
Regarding claim 57, Stern discloses the retriever includes an elongate body comprising a flexible tether (para. 60 discloses shaft 410 may be flexible).
Regarding claim 61, Stern discloses the retriever extends alongside of the elongate working shaft (Figs. 5B-D, shaft of snare 400 extends alongside channel 220).
Allowable Subject Matter
Claims 58-60 and 62-69 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In the closest prior art, Stern and Diamond do not teach or suggest the retriever extends through the elongate working shaft (claim 58); guides to attach the retriever to the elongate working shaft (claim 62); the tissue shuttle is mounted within the forceps (claim 64), in combination with other limitations.
Conclusion
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/A.A.G./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796