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 .
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.
Claims 2 and 4 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 2 recites “the at least one deployable member is opposing members are biased to be adjacent to one another.” This is incorrect language. Examiner is unsure if Applicant intends to recite one deployable member or more than one deployable member. If Applicant only intends to recite one deployable member, it is unclear how a single deployable member could be “opposing members” and “biased to be adjacent one another…” However if more than one deployable member is intended to be recited, the claim should recite “the at least one deployable member comprises two opposing members…”
For purposes of this action, Examiner is interpreting the claim to recite two opposing members.
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.
Claims 1, 2, 8, 11, 12, 16, 18, 19, 22, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shikhman et al. (US 20200261707 A1).
Regarding claim 1, Shikhman et al. discloses a device for treating bleeding within a uterus (Fig. 21), the device comprising: a device body 218 comprising a vacuum connector 218c configured to be removably coupled to a suction tube 233c; an intrauterine portion (Fig. 21; 217, 214) coupled to the device body (Fig. 21) and comprising at least one deployable member 215, 214 defining a lumen (para. [0146]), and suction ports 223 disposed on the at least one deployable member (Fig. 22) and in fluid communication with the lumen (para. [0146], [0148]), wherein the intrauterine portion has an outer profile in an undeployed configuration that is sized and shaped to be directed through a body opening (Fig. 23 is the undeployed configuration) and positioned within the uterus (Fig. 23 i.e., sheathed), and wherein the intrauterine portion comprises a baffle 215 configured to occlude the suction ports with the intrauterine portion in the undeployed configuration (para. [0146] discloses by covering 217 with 215 as shown in Fig. 23 for example, the suction ports are occluded); and an actuator 216 (Fig. 20B) coupled to the device body (Fig. 20B) and the baffle and configured to receive an input from a user (para. [0146]), wherein the input to the actuator is configured to translate the baffle and deploy the intrauterine portion to a deployed configuration in which the outer profile of the intrauterine portion increases in size within the uterus and the suction ports on the at least one deployable member are spaced apart from the baffle (para. [0146]; i.e., and as shown in Figs. 19-24).
Regarding claim 2, Shikhman discloses the device of claim 1. Shikhman also discloses wherein the at least one deployable member is [two] opposing members 214a, 214b [wherein the two opposing members] are biased to be adjacent to one another in the undeployed configuration (Fig. 23 i.e., at least because of 215), and configured to be moved apart from one another in the deployed configuration based on the input to the actuator (i.e., Fig. 24 and para. [0146]-[0147]).
Regarding claim 8, Shikhman discloses the device of claim 1. Shikhman also discloses wherein the at least one deployable member is an adjustable loop comprising a first end fixedly coupled to the device body (para. [0147]), and a second end coupled to the actuator for the adjustable loop to be extended from the device body in the deployed configuration based on the input to the actuator (para. [0147]).
Regarding claim 11, Shikhman discloses the device of claim 1. Shikhman also discloses wherein the actuator comprises a slider 216 (para. [0146]) or a handle movably coupled to the device body, or a wheel rotatably coupled to the device body.
Regarding claim 12, Shikhman discloses the device of claim 1. Shikhman also discloses wherein the intrauterine portion further defines a channel 214 with the suction ports disposed within the channel (i.e., para. [0146]); and, optionally, wherein the channel is defined on an outer side of the intrauterine portion.
Regarding claim 16, Shikhman discloses the device of claim 1. Shikhman also discloses the actuator is configured to be moved between a first position with the intrauterine portion in the undeployed configuration (para. [0146] i.e., distally), a second position with the intrauterine portion in the deployed configuration (para. [0146] i.e., proximally), and positioned between the first and second positions to selectively establish an extent of deployment of the intrauterine portion (para. [0146]), and wherein the actuator comprises indicia configured to be exposed to provide information as to the extent of deployment of the intrauterine portion (i.e., amount traveled para. [0146]).
Regarding claim 18, Shikhman discloses the device of claim 1. Shikhman also discloses the intrauterine portion further comprises an inner tube 214 disposed within the lumen (Fig. 23) and defining openings 223, wherein the inner tube is configured to be rotated (para. [0146]) within the lumen to selectively align the openings with less than all of the suction ports to provide active clog management.
The device of Shikhman is fully capable of the inner tube being configured to rotate to selectively align the openings with less than all of the suction ports to provide active clog management, if one desired to do so - note that the limitations of claim 18 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 19, Shikhman et al. discloses a device for treating bleeding within a uterus (Fig. 21), the device comprising: a device body 218 comprising a vacuum connector 218c configured to be removably coupled to a suction tube 233c; an intrauterine portion (Fig. 21; 217, 214) defining a lumen 217b configured to be arranged in fluid communication with a vacuum source (para. [0146]), and suction ports 218c in fluid communication with the lumen (para. [0146]), wherein the intrauterine portion and comprises a baffle 215 coupled to a distal end of the intrauterine portion (Fig. 23) and configured to engage and occlude the suction ports with the intrauterine portion in an undeployed configuration (para. [0146]; Fig. 23); and an actuator 216 coupled to the device body and configured to receive an input from a user to move the intrauterine portion from the undeployed configuration to a deployed configuration (para. [0146]; Fig. 24) in which the intrauterine portion forms a loop (Fig. 24) defining the lumen (i.e., as shown in Fig. 24), and the suction ports positioned on an inner portion of the loop are spaced apart from the baffle (Fig. 24).
Regarding claim 22, Shikhman et al. discloses a device for treating bleeding within a uterus (Fig. 21), the device comprising: a device body 218 comprising a vacuum connector 218c configured to be removably coupled to a suction tube 233c; an intrauterine portion (Fig. 21; 217, 214) defining a lumen 217b configured to be arranged in fluid communication with a vacuum source (para. [0146]), and suction ports 218c in fluid communication with the lumen (para. [0146]); a cervical portion configured to seal a cervix (para. [0084]; also see para. [0103] which discloses a sealing member such as a balloon or plug 27 that is provided around the sheath. Although it is a different embodiment, it is compatible with the embodiment of Figs. 19-26); an actuator 216 coupled to the device body and configured to receive an input from a user to move the intrauterine portion from an undeployed configuration to a deployed configuration in which an outer profile of the intrauterine portion is increased (Figs. 19-27; para. [0146]); and an auxiliary suction source (i.e., vacuum source as disclosed for example by para. [0130]) coupled to the device body and comprising a first valve 150 positioned distal to the auxiliary suction source, and a second valve 160 positioned proximal to the auxiliary suction source (Fig. 17), wherein the vacuum connector is coupled proximal to the second valve (Fig. 17), and the auxiliary suction source is a bulb (i.e., para. [0076] discloses a Venturi vacuum pump and para. [0132] discloses a manual pump) disposed proximal to the cervical portion (Fig. 17) and configured to receive a manual input (para. [0132]) in which resilience of the bulb provides from a user to establish or maintain a vacuum and defines a reservoir in fluid communication with the lumen of the intrauterine portion to collect bodily fluids in an absence of a vacuum connector being coupled to a vacuum source (para. [0139], [0141], [0144]).
Regarding claim 25, Shikhman discloses the device of claim 22. Shikhman also discloses further comprising a relief port coupled to the device body and positioned distal to the first valve (para. [0036], [0164]; Fig. 33).
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.
Claims 4, 20, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Shikhman in view of Carson (US 20130165744 A1).
Regarding claim 4, Shikhman discloses the device of claim 2. Shikhman doesn’t directly disclose the intrauterine portion further comprises a collar to which the opposing members are coupled, the baffle being coupled to the collar, wherein the baffle is positioned between the opposing members and configured to occlude the suction ports in the undeployed configuration.
In the same field of endeavor, namely recovery and processing of human embryos formed in vivo, Carson discloses a similar device including deployable members 64,66 including a lumen (i.e., through 72) and including ports 72. Carson also discloses a baffle (i.e., each member 64, 66 are housed within their own channels 34 of the delivery cannula such that each of these channels forms a wall as seen in Figs. 45-49 such that when in the retracted position the wall of the channel acts as the baffle to occlude the ports)
Carson also discloses a collar 12 to which the opposing members are coupled (Figs. 21, 22, 45, 46), the baffle being coupled to the collar, wherein the baffle is positioned between the opposing members and configured to occlude the suction ports in the undeployed configuration (Figs. 45-49).
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 device of Shikhman to have the delivery cannula including the ports and collar of Carson for the purpose of acting as a seal to prevent fluid from leaking out of the uterus during the procedure (para. [0163]).
Regarding claim 20, Shikhman discloses the device of claim 19. Shikhman doesn’t directly disclose comprising a collar to which the loop is coupled, wherein the baffle is coupled to the collar and a distal end of the loop.
Carson also discloses a collar 12 to which the loop is coupled (Figs. 21, 22, 45, 46), wherein the baffle is coupled to the collar and a distal end of the loop (Figs. 45-49).
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 device of Shikhman to have the delivery cannula including the ports and collar of Carson for the purpose of acting as a seal to prevent fluid from leaking out of the uterus during the procedure (para. [0163]).
Regarding claim 21, Shikhman discloses the device of claim 20. Shikhman also discloses wherein the actuator is coupled to the baffle with the baffle configured to translate within the device body to draw the distal end of the loop proximally (para. [0146]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shikhman in view of Buster et al. (US 2014/0378756 A1)
Regarding claim 9, Shikhman discloses the device of claim 1. Shikhman also discloses wherein the intrauterine portion comprises an applicator 217, a head 225, and an inner tube 214 coupled to the head and the actuator (Fig. 21), and wherein the head is configured to resiliently expand (Figs. 23-24) when extended from the applicator based on the input to the actuator (para. [0163]).
Kochem doesn’t directly disclose that the head is formed from a compressible foam.
In the same field of endeavor of a uterine lavage, Buster discloses an applicator 10e that includes a head 18a made from compressible foam (para. [00122]).
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 device of Kochem to have a head of an applicator made from a compressible foam for purposes of sealing the uterine cavity from the external environment (para. [0122]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 19, 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(Toth (US 2011/0112433A1) discloses a similar device including a device (Fig. 3, i.e., 114 and 135) comprising a vacuum connector 145 configured to be removably coupled to a suction tube 136 (Fig. 2-3); an intrauterine portion 110 (Fig. 2) coupled to the device body (i.e., 114; see Fig. 2) and defining a lumen (para. [00238]).
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 RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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