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 Arguments
Applicant’s arguments, see page 2 filed 02/24/2026, with respect to the rejection(s) of claim(s) 21 under a 102 rejection over Sullivan have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. The examiner agrees that Sullivan fails to disclose “an auxiliary vacuum source connected to the vacuum generator independently of the tissue collector” as required in claim 21. Therefore, claims 21, 23-24, and 26-28 are in condition for allowance.
Applicant's arguments filed 02/24/2026, with respect to the rejection(s) of claim(s) 29 under a 102 rejection over Sullivan have been fully considered but they are not persuasive.
Applicant argues that Sullivan fails to disclose “a vacuum accumulator…configured to accumulate vacuum in response to the generation of vacuum by the vacuum generator, to store the accumulated vacuum, and to selectively release the stored, accumulated vacuum to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft” as required in claim 29. Applicant explains that while peristaltic pumps, vane pumps, and rotary pumps create vacuum, these pumps are not taught or suggested by Sullivan as, and would not be understood by those of skill in the art to be, vacuum accumulators. Further, these pumps have not been shown to be configured for or capable of "accumulating vacuum in response to the generation of vacuum by the vacuum generator" as recited in independent claim 29.
The examiner respectfully acknowledges applicant’s arguments in regards to independent claim 29. However, the peristaltic pumps, vane pumps, and rotary pumps described in para. 0068 of Sullivan were not relied upon for the interpretation of the vacuum accumulator as claimed. The external vacuum source such as a pump or syringe described in para. 0080 of Sullivan was relied upon as the interpreted vacuum accumulator. As previously explained, para. 0080 of Sullivan discusses the use of an external vacuum source such as a syringe or pump as an alternative to a pressure relief valve used to prevent build-up of pressure in the device within the specimen collection chamber. Therefore, the syringe or pump of para. 0080 is capable of accumulating the additional pressure through external connector 66 to thereby maintain the desired pressure differential within the device in response to the generation of vacuum by the vacuum generator. Furthermore, it is known in the art for a syringe to have a barrel in which accumulated vacuum may be stored. As stated in the last line of para. 0080, the user can selectively release the stored vacuum such that vacuum overrides both one-way valves to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft. Therefore, the rejection is maintained.
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 25 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.
Claim 25 recites the limitation "a tissue collector" in lines 2-3. It is unclear to the examiner if “a tissue collector” is meant to further define the tissue collector introduced in claim 21 or if the limitation is introducing a new, additional, tissue collector. For examination purposes, “a tissue collector” is interpreted as “the tissue collector” of claim 21.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 29-32, and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sullivan et al. (US 20180049729) [hereinafter Sullivan].
Regarding claim 29, Sullivan disclose a tissue resecting system 100’ (Fig. 5, para. 0062), comprising:
a housing 102’ (Fig. 5, para. 0062);
a shaft assembly 108’, 118’ extending distally from the housing 102’ and including at least one shaft 118’ configured to translate to cut tissue (Figs. 13-14, para. 0063-0064);
a drive assembly 120’ coupled to the at least one shaft 118’ and configured to drive the translation of the at least one shaft 118’ (Figs. 7, 9, para. 0077);
a vacuum generator 136’ coupled to the drive assembly 120’ and the at least one shaft 118’ (Figs. 7, 9, para. 0077), the vacuum generator 136’ configured to generate vacuum to suction the cut tissue through the shaft assembly 108’, 118’ (Figs. 7, 9, para. 0066, 0077);
a tissue collector 160, wherein the vacuum generator 136’ is configured to urge the cut tissue into the tissue collector (Fig. 8, para. 0069, 0071, 0073); and
a vacuum accumulator (interpreted as the external vacuum source such as a pump or syringe described in para. 0080) coupled to the vacuum generator (Figs. 6-7, para. 0080), the vacuum accumulator configured to accumulate vacuum in response to the generation of vacuum by the vacuum generator, to store the accumulated vacuum, and wherein the vacuum accumulator is configured to selectively release the stored, accumulated vacuum to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft (see note below).
Note: “configured to accumulate vacuum in response to the generation of vacuum by the vacuum generator, to store the accumulated vacuum, and wherein the vacuum accumulator is configured to selectively release the stored, accumulated vacuum to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft” is interpreted as functional language and intended use of the claimed invention. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing.
Since Sullivan discloses the structural component required i.e. a vacuum accumulator for the functional limitation, Sullivan thereby discloses the functional limitation of a vacuum generator capable of accumulating vacuum in response to the generation of vacuum by the vacuum generator, to store the accumulated vacuum, and wherein the vacuum accumulator is configured to selectively release the stored, accumulated vacuum to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft. For example, para. 0080 discloses “As a result, any tissue or fluid (including air) drawn into the device 100′ by the vacuum during trigger 126′ actuation is off-set by an equal volume of tissue and/or fluid that is ejected into the specimen collection chamber 142′ and the tissue trap 158 (which may have a pressure relief valve to prevent build-up of pressure in the device 100′ during restoration of trigger ‘126). Alternatively or additionally, the specimen collection chamber 142’ may be coupled by the external connector 166 to atmosphere outside of the tissue removal device 100′. In some embodiments, the external connector 166 may be coupled to an external vacuum source (not shown). In such embodiments, a valve (not shown) may selectively couple the external connection 166 to the external vacuum source such as a pump or a syringe. An example of such a valve may be a pinch valve with the external connector 166 passing therethrough. The external vacuum may generate a pressure differential that overrides and opens both the proximal and distal one-way valves 140′, 144′.”. In other words, as an alternative to a pressure relief valve used to prevent build-up of pressure in the device within the specimen collection chamber, Sullivan discusses the use of an external vacuum source such as a syringe or pump that is capable of accumulating the additional pressure through external connector 66 (See Figs. 7-9 which illustrate the fluid connection between the specimen collection chamber and the external connector) to thereby maintain the desired pressure differential within the device. Therefore, the external vacuum source such as the syringe is capable of accumulating vacuum in response to the generation of vacuum by the vacuum generator (as stated above), to store the accumulated vacuum (it is known in the art for a syringe to have a barrel in which vacuum may be stored) , and wherein the vacuum accumulator is configured to selectively release the stored, accumulated vacuum to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft (as stated in the last line of para. 0080, the user can selectively release the stored vacuum such that vacuum overrides both one-way valves to provide additional vacuum to the vacuum generator to increase suctioning of the cut tissue through the at least one shaft). The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 30, Sullivan disclose wherein the tissue collector 160 is a tissue collection cartridge configured to releasably engage with the housing (Fig. 8, para. 0074).
Regarding claim 31, Sullivan disclose wherein the vacuum generator 136’ is configured to suction the cut tissue into the vacuum generator 136’ during a first portion of the actuation of the drive assembly 120’ (interpreted as initial rotation of the trigger 126’ that actuates translation of the inner shaft 118’; Figs. 7, 9, para. 0065-0066, 0077, 0079).
Regarding claim 32, Sullivan disclose wherein the vacuum generator 136’ is configured to urge the cut tissue from the vacuum generator 136’ to a tissue collector 160 during a second, subsequent portion of the actuation of the drive assembly 120’ (interpreted as proximal motion of the drive assembly upon release of the trigger 126’; Figs. 7, 9, para. 0073, 0077-0078).
Regarding claim 34, Sullivan disclose wherein the auxiliary vacuum source (interpreted as the external vacuum source such as the syringe or pump described in para. 0080) is configured to releasably couple to the housing 102 (Fig. 5, para. 0062 discloses the housing 102’ comprises a pistol-like shape resulting in a handle 152 and illustrates the external connector 166 coupled to the housing; para. 0080 discloses that the external vacuum source may be selectively coupled to the external connector via. a valve. Since the external vacuum source is detachable from the external connector and the external connector is coupled to the housing, the external vacuum source is configured to releasably couple to the housing by way of their common connection to the external connector).
Regarding claim 35, Sullivan disclose wherein the vacuum accumulator (interpreted as external vacuum source such as a syringe, para. 0080) includes an accumulator tank (interpreted as barrel of syringe that is known in the art to store vacuum) configured to store the stored, accumulated accumulate vacuum therein (para. 0080) and a release actuator (interpreted as plunger of the syringe which is known in the art to actuate the release of vacuum within the syringe) configured to release the stored, accumulated vacuum to provide the additional vacuum (para. 0080).
Regarding claim 36, Sullivan disclose wherein the vacuum accumulator is configured to incrementally accumulate vacuum upon each actuation of the drive assembly (para. 0080 of Sullivan discloses that pressure accumulation is created each time the trigger restores to its un-actuated position. Therefore, the vacuum accumulator is capable of incrementally accumulate vacuum upon each actuation of the drive assembly. See note above in claim 29, in regards to “configured to” and functional language).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 33 is rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (US 20180049729) [hereinafter Sullivan] as applied to claim 29 above, and further in view of Panian (US 20180014840).
Regarding claim 33, Sullivan discloses all of the limitations set forth above in claim 29. As stated above, Sullivan further discloses an external vacuum source (such as a syringe or pump) coupled to the housing 102’ via. external connecter 166 (Figs. 5-8, para. 0062, 0080). However, Sullivan fails to disclose wherein the vacuum accumulator (claim 33) is disposed on or within the housing.
Panian in the same field of endeavor of aspiration devices 900 (Fig. 11, para. 0079) teaches that it is known in the art to have an external vacuum source 1001 disposed on a housing 1000 (Fig. 11, para. 0075).
The substitution of one known connection configuration (external vacuum source disposed on a housing as shown in Panian) for another (external vacuum source connected to a housing via. external connector as shown in Sullivan) would have been obvious to one of ordinary skill in the art before the effective filing date the vacuum accumulator of the claimed invention since the substitution of the connection configuration shown in Panian would have yielded predictable results, namely, a way to provide a direct connection between the vacuum accumulator and the housing (Fig. 11, para. 0075 of Panian); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Allowable Subject Matter
Claims 21, 23-24, and 26-28 are allowed (see explanation above in the response to arguments).
Claim 25 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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