HDETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Notice of Amendment
The Amendment filed 12/12/2025 has been entered. Claims 1, 3-20 are pending in the application with claims 1, 14, 18 amended and claim 2 cancelled.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3-9, 11 and 18-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Munoz (US Patent No. 6,146,402).
In regard to claim 1, Munoz discloses a hysteroscope (10, Fig. 1), comprising:
a shaft (14,16) including a straight section (114 and a distal section (16) that is a preformed bent section having a fixed deflection angle with respect to the straight section (Fig. 1), the distal section terminating in a distal end of the shaft (Fig. 1), the shaft defining one or more channels that extend through the straight section and the distal section with shaft defining openings to the channels at the distal end of the shaft (Fig. 1 illustrates a working channel extending therethrough), the shaft configured for insertion through a vagina and cervix into a uterine cavity of a patient (the shaft (14,16) is capable of insertion through a vagina and cervix into a uterine cavity of patient);
a housing (20) attached to the shaft (Fig. 1),
a light source connector (40) integrated with the housing, the light source connector operably connected to the distal end of the shaft by way of one of the one or more channels (Fig. 1); and
a viewing portion (30) attached to the housing, the viewing portion operably connected to the distal end of the shaft by way of one of the one or more channels (Fig. 1);
wherein the straight section of the shaft and the distal section of the shaft are made of a unitary piece of rigid material (Fig. 1).
In regard to claim 3, Munoz teaches wherein the viewing portion is positioned further away from the distal end of the shaft than the light source connector (Fig. 1).
In regard to claim 4, Munoz teaches wherein the fixed deflection angle of the bent section of the shaft is in a fixed curve direction and the light source connector is located on the housing in the curve direction (Figs. 1,2).
In regard to claim 5, Munoz teaches wherein the one or more channels includes an optics channel (working channel of the shaft) operably connected to the light source connector to provide light at the distal end of the shaft with the light source connector (Fig. 1).
In regard to claim 6, Munoz teaches wherein the one or more channels includes an optics channel (working channel of the shaft) operably connected the viewing portion to allow viewing out the distal end of the shaft with the viewing portion (Fig. 1).
In regard to claim 7, Munoz teaches wherein the one or more channels includes an optics channel (working channel of the shaft) operably connected to the light source connector and operably connected to the viewing portion to provide light at the distal end of the shaft with the light source connector and allowing viewing out the distal end of the shaft with the viewing portion (Fig. 1).
In regard to claim 8, Munoz teaches wherein the one or more channels includes a fluid inflow channel (working channel of the shaft) and the housing defines a fluid inlet (34) operably connected to the fluid inflow channel for supplying fluid to the distal end of the shaft (Fig. 1).
In regard to claim 9, Munoz teaches wherein the one or more channels (working channel of the shaft) includes an operating channel configured for introduction of a device therethrough (Fig. 1).
In regard to claim 11, Munoz teaches wherein the housing and shaft are of unitary construction (Fig. 1).
In regard to claim 18, Munoz discloses a hysteroscope (10, Fig. 1), comprising:
a shaft (14, 16) having a proximal end and a distal end (Fig. 1), the shaft defining a fluid inflow channel (via central channel within the shaft (12)) and an optics channel (60) extending from the proximal end to the distal end (Figs. 1-2), the shaft having a straight section (14) that includes the proximal end, and shaft having a bent section (16, 5) that includes the distal end, the bent section at a fixed deflection angle with respect to the straight section (Fig. 1), the shaft configured for insertion through a vagina and cervix into a uterine cavity of a patient (the shaft (14,16) is capable of insertion through a vagina and cervix into a uterine cavity of patient);
a light transmitter (48) integrated with the shaft, the light transmitter configured to provide light at the distal end of the shaft (Fig. 1);
a housing (20) attached to the shaft, the housing defining a fluid inlet operably connected to the fluid inflow channel (Fig. 1); and
a light source connector (40) integrated with the housing and in communication with the light transmitter via the optics channel to thereby allow the light transmitter to provide light at the distal end of the shaft (Fig. 1);
wherein the shaft is made of rigid material such that the fixed deflection angle of the bent section is maintained in the distal end of the shaft during insertion and manipulation of the shaft within a patient (Fig. 1).
In regard to claim 19, Munoz teaches and further comprising a viewing portion (30) attached to the housing, the viewing portion in communication with the optics channel (60) to thereby allow viewing out the distal end of the shaft (Fig. 1).
In regard to claim 20, Munoz teaches wherein the viewing portion is positioned further away from the distal end of the shaft than the light source connector (Fig. 1).
Claims 1, 3, 5-9, 11, 14-16 and 18-20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Eisele (US Patent Application Publication No. 2010/0298643).
In regard to claim 1, Eisele discloses a hysteroscope (1, Fig. 1), comprising:
a shaft (2) including a straight section (6) and a distal section (4, 5) that is a preformed bent section (via tilted section (5)) having a fixed deflection angle with respect to the straight section (Fig. 1), the distal section terminating in a distal end of the shaft (Fig. 1), the shaft defining one or more channels that extend through the straight section and the distal section with the channels open at the distal end of the shaft (Par. 50, via working channel for instruments, working channels for gases and liquids and a channel for the image conductor (53) and light conductors (60,61)), the shaft configured for insertion through a vagina and cervix into a uterine cavity of a patient (the shaft (2) is capable of insertion through a vagina and cervix into a uterine cavity of patient);
a housing (3) attached to the shaft (Fig. 1),
a light source connector (12) integrated with the housing, the light source connector operably connected to the distal end of the shaft by way of one of the one or more channels (Par. 56); and
a viewing portion (21) attached to the housing, the viewing portion operably connected to the distal end of the shaft by way of one of the one or more channels (Par. 50);
wherein the straight section of the shaft and the distal section of the shaft are made of a unitary piece of rigid material (Fig. 1, Par. 48).
In regard to claim 3, Eisele teaches wherein the viewing portion is positioned further away from the distal end of the shaft than the light source connector (Fig. 1).
In regard to claim 5, Eisele teaches wherein the one or more channels includes an optics channel operably connected to the light source connector to provide light at the distal end of the shaft with the light source connector (Par. 56).
In regard to claim 6, Eisele teaches wherein the one or more channels includes an optics channel operably connected the viewing portion to allow viewing out the distal end of the shaft with the viewing portion (Par. 50).
In regard to claim 7, Eisele teaches wherein the one or more channels includes an optics channel operably connected to the light source connector and operably connected to the viewing portion to provide light at the distal end of the shaft with the light source connector and allowing viewing out the distal end of the shaft with the viewing portion (the light conductors (60,61) and image conductor (53), shown in Fig. 5, extend through the shaft adjacent each other).
In regard to claim 8, Eisele teaches wherein the one or more channels includes a fluid inflow channel and the housing defines a fluid inlet operably connected to the fluid inflow channel for supplying fluid to the distal end of the shaft (Par. 50).
In regard to claim 9, Eisele teaches wherein the one or more channels includes an operating channel configured for introduction of a device therethrough (Par. 50).
In regard to claim 11, Eisele teaches wherein the housing and shaft are of unitary construction (Fig. 1).
In regard to claim 14, Eisele discloses a hysteroscope (1, Fig. 1), comprising:
a shaft (2) including a straight section (6) and a distal section (4, 5) that is a preformed bent section (via tilted section (5)) having a fixed deflection angle with respect to the straight section (Fig. 1), the distal section terminating in a distal end of the shaft (Par. 50, via working channel for instruments, fluid channels for gases and liquids and a channel for the image conductor (53) and light conductors (60,61)), the shaft configured for insertion through a vagina and cervix into a uterine cavity of a patient (the shaft (2) is capable of insertion through a vagina and cervix into a uterine cavity of patient);
a housing (3) attached to the shaft, the housing defining a fluid inlet operably connected to the fluid channel, and an operating inlet operably connected to the operating channel (Par. 50 teaches of fluid channels with corresponding connections);
a light source connector (12) integrated with the housing, the light source connector operably connected to the optics channel (Par. 56); and
a viewing portion (21) attached to the housing, the viewing portion operably connected to the optics channel (Par. 50);
wherein the operating inlet is configured for introduction of a device through the operating channel to exit at the distal end of the shaft (Par. 50).
In regard to claim 15, Eisele teaches wherein the shaft is made of a rigid material (Par. 11).
In regard to claim 16, Eisele teaches wherein the viewing portion is positioned further away from the distal end of the shaft than the light source connector (Fig. 1).
In regard to claim 18, Eisele discloses a hysteroscope (1, Fig. 1), comprising:
a shaft (2) having a proximal end and a distal end (Fig. 1), the shaft defining a fluid inflow channel and an optics channel extending from the proximal end to the distal end (Par. 50, via channels for gases and liquids and a channel for the image conductor (53) and light conductors (60,61)), the shaft having a straight section (6) that includes the proximal end, and shaft having a bent section (4, 5) that includes the distal end, the bent section at a fixed deflection angle with respect to the straight section (Fig. 1), the shaft configured for insertion through a vagina and cervix into a uterine cavity of a patient (the shaft (2) is capable of insertion through a vagina and cervix into a uterine cavity of patient);
a light transmitter (60,61) integrated with the shaft, the light transmitter configured to provide light at the distal end of the shaft (Fig. 5, Par. 56);
a housing (3) attached to the shaft, the housing defining a fluid inlet operably connected to the fluid inflow channel (Par. 50 teaches of fluid channels with corresponding connections); and
a light source connector (12) integrated with the housing and in communication with the light transmitter via the optics channel to thereby allow the light transmitter to provide light at the distal end of the shaft (Fig. 5, Par. 56);
wherein the shaft is made of rigid material such that the fixed deflection angle of the bent section is maintained in the distal end of the shaft during insertion and manipulation of the shaft within a patient (Fig. 1, Par. 11).
In regard to claim 19, Eisele teaches and further comprising a viewing portion (21) attached to the housing, the viewing portion in communication with the optics channel to thereby allow viewing out the distal end of the shaft (Par. 50, Fig. 5).
In regard to claim 20, Eisele teaches wherein the viewing portion is positioned further away from the distal end of the shaft than the light source connector (Fig. 1).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Eisele (US Patent Application Publication No. 2010/0298643), as applied to claim 1, and further in view of Lessen (US Patent No. 3,858,586).
In regard to claim 4, Eisele is silent with respect to wherein the fixed deflection angle of the bent section of the shaft is in a fixed curve direction and the light source connector is located on the housing in the curve direction.
Lessen teaches a fiber optic scope (140, Fig. 12) for insertion within a cervix (147) of a patient. The scope includes a sheath assembly (141) having a curved distal end to align with a fallopian tube (148). The scope includes a light source connector at a proximal end thereof that connects to a light source (143).
It would've been obvious to one of ordinary skill in the art at the time of the invention to modify the light source connector of Eisele with the configuration of the light source connector (143, Fig. 12) of Lessen as a matter of design choice since providing the position of the light source connector can provide a physician with a frame of reference for the direction of the bend at the distal end of the shaft. There being no unexpected results in modifying the position of the light source connector of Eisele with that of Lessen.
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Eisele (US Patent Application Publication No. 2010/0298643), as applied to claim 1, and further in view of Hiltebrandt (US Patent No. 4,392,485).
In regard to claim 10, Eisele does not expressly teach wherein each of the one or more channels have a central longitudinal axis parallel to and spaced a distance from a central longitudinal axis of the shaft.
Hiltebrandt teaches an analogous endoscope comprising a handle containing an ocular (7), light post (5) and working channel inlet (2). Fiber light conductors (4) and optics (3) extend from the handle to a distal end of the shaft (1) with the channel that houses the fiber light conductors and optics extended parallel to the longitudinal axis of the shaft and spaced away from the longitudinal axis.
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to modify the endoscope of Eisele with the fiber light conductors and optics positioning with the shaft as taught by Hiltebrandt as a matter of design choice to minimize the overall size of the shaft and providing a larger diameter working channel within the shaft.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Eisele (US Patent Application Publication No. 2010/0298643) in view of Muller et al. (US Patent No. 5,199,417).
In regard to claim 17, Eisele does not expressly teach wherein the one or more channels includes an optics channel operably connected to the light source connector and operably connected to the viewing portion to provide light at the distal end of the shaft with the light source connector and allowing viewing out the distal end of the shaft with the viewing portion, wherein each of the one or more channels have a central longitudinal axis parallel to and spaced a distance from a central longitudinal axis of the shaft, wherein the fluid inlet is positioned further away from the distal end of the shaft than the operating inlet.
Muller teaches an analogous endoscope comprising a handle (40) containing an eyepiece (62), a light post (54), and an operating inlet (50) and a fluid inlet (48). Muller illustrates that the fluid inlet (48) is positioned further away from the distal end of the shaft than the operating inlet (50). Each of the inlets (48, 50) comprises a shoulder (44, 46) and are positioned at predetermined relationships to each other on the same side of the handle enabling the surgeon to easily access the inlets (Col. 11, Lines 33-41).
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to modify the endoscope of Eisele with the fluid inlet (48) and operating inlet (50) configuration of Muller as a matter of design choice since the inlets positioned at predetermined relationships to each other enables the surgeon to easily access the channels via the inlets (Col. 11, Lines 33-41).
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues Munoz and Eisele are designed to be inserted through the mouth of a patient and therefore do not reasonably read on a hysteroscope that is inserted through a vagina and cervix into a uterine cavity of a patient.
The examiner disagrees since the claims are directed towards product claims in which the prior art device merely needs to be capable of performing the intended function and does not require any teaching of the device actually performing the function. Munoz and Eisele teach of scopes having generally straight shafts with a bent or tilted section near the distal end of the shaft which would allow for the shaft to be inserted through a vagina and cervix into a uterine cavity of a patient. The examiner also would like to note that the devices of Munoz and Eisele do not need to be optimized to be used within the uterine cavity, but rather just be capable of use within the uterine cavity.
Applicant further argues that the endocervical canal, which must be traversed to reach the uterine cavity is 7 to 8 mm at its widest in reproductive aged women which is much smaller than the average inner diameter of the human trachea which is 1.5 to 2 cm. Therefore, since hysteroscopes advance through much more narrow regions in the female anatomy than a device for placing an intubation tube, which would make an intubation placement device wholly or inappropriate for hysteroscopies.
The examiner disagrees since the typical scope used for intubation procedures is within a range of 4.9 to 6 mm and does not encompass the entire diameter of the trachea therefore still providing the capability of the scope to be introduced to the uterine cavity.
Applicant further argues the hysteroscope of the present invention is designed to be rotated after insertion with the bent tip at the distal end facilitating viewing of both sides of the uterus as well as allowing manipulation and maneuvering to view and access side walls or cornual areas of a uterus after insertion.
The examiner would like to note that the arguments pertain to features of they hysteroscope which is not being claimed and therefore the argument are moot.
Applicant argues that Munoz fails to teach the insertion passageway (34) as being a fluid inflow channel since the insertion passageway of Munoz is used to deliver a guide line (11) instead of fluid.
The examiner disagrees since fluid being delivered through the channel is merely intended use and the channel is capable of being used for fluid flow or insertion of instrumentation. Additionally, the examiner notes that the claim recites “for supplying fluid” instead of “configured to”.
Applicant argues that Munoz and Eisele fails to teach the housing and handle are of unitary construction.
The examiner disagrees since multiple parts fixed together meets the constraints of what can be defined as “unitary construction”.
Allowable Subject Matter
Claims 12-13 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 March 4, 2026