DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 2 March 2026. Claims 1-31 are now pending. The Examiner acknowledges the amendments to claims 1-5, 7, 11, 13, 15-24, 26-31.
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 Objections
Claims 2, 4-6, 9, 11, 15, 17-18, 20, 22, 25, 26, 28-31 objected to because of the following informalities:
-Claim 2 recites “the cervix” in line 5. Examiner recommends amending to –a cervix—
-Claim 4 recites “the funnel” in line 1. Examiner recommends amending to –the removable funnel—
-Claim 4 recites “and wherein in the loading configuration the sleeve” in lines 2-3. Examiner recommends amending to –and wherein in the loading configuration, the sleeve—
-Claim 5 recites “in the loading configuration the channel portion of the funnel” in lines 1-2. Examiner recommends amending to –in the loading configuration, the channel portion of the funnel—
-Claim 5 recites “the funnel” in line 2. Examiner recommends amending to –the removable funnel—
-Claim 6 recites “in the loading configuration the cap” in lines 1-2. Examiner recommends amending to –in the loading configuration, the cap—
-Claim 9 recites “the funnel” in line 2. Examiner recommends amending to –the removable funnel—
-Claim 11 recites “the shell” in line 2. Examiner recommends amending to –the clam shell arrangement—
-Claim 15 recites “a cervix” in line 5. Examiner recommends amending to –the cervix—
-Claim 17 recites “The system of claim 9 wherein” in line 1. Examiner recommends amending to –The system of claim 9, wherein—
-Claim 18 recites “The system of claim 9 wherein” in line 1. Examiner recommends amending to –The system of claim 9, wherein—
-Claim 20 recites “an other side” in line 6. Examiner recommends –another side—
-Claim 22 recites “or rotatable hoop” in line 3. Examiner recommends deletion of this recitation.
-Claim 25 recites “the funnel” in line 2. Examiner recommends amending to –the removable funnel—
-Claim 26 recites “the funnel” in line 4. Examiner recommends amending to –the removable funnel—
-Claim 28 recites “the funnel” in lines 15 and 20. Examiner recommends amending to –the removable funnel—
-Claim 28 recites “cap; inserting” in lines 18-19. Examiner recommends amending to –cap; and inserting—
-Claim 29 recites “to compression of the reservoir” in lines 2-3. Examiner recommends amending to –to compress the reservoir—
-Claim 30 recites “is adjacent the cervix” in lines 7-8. Examiner recommends amending to –is adjacent to the cervix—
-Claim 30 recites “the funnel” in lines 4 and 6. Examiner recommends amending to –the removable funnel—
-Claim 31 recites “and wherein the reservoir” in line 2. Examiner recommends deletion of and to read –wherein the reservoir—
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claims 1, 28 recite “release mechanism” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be operable by a user to deploy the implant from the housing. According to the specification the release mechanism includes a rotatable knob/hoop and threaded member [Pg. 6, lines 1, 12-13] and equivalents thereof.
-Claims 1, 28 recite “a translation mechanism” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to translate a deployment operation of the release mechanism to movement of the implant out of the housing. According to the specification the translation mechanism includes a ball-and-socket joint and an implant actuator [Pg. 6, lines 4-5] and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 13 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 13 recites “sufficiently low stiffness” in line 2. It is unclear what is required by this limitation in terms of what constitutes low stiffness. Further clarification should be provided.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 14, 16, 25, 30-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanner (U.S. 20150196324).
Regarding Claim 1, Kanner teaches a system for assisted conception [0028; “aiding conception”], the system comprises: an implant [Fig. 1, element 13 (cervical cap)]; an elongate curved housing fully enclosing the implant [Fig. 1, element 11 (inserter)] and [0029; “the cervical cap can be contained within an inserter,”]; a release mechanism attached at a proximal end of the housing and arranged to be operable by a user to deploy the implant from the housing [0012; “A latch, lever, button, or other mechanism in the inserter allows the user to open the cervical cap, effectuate semen release, then release the cervical cap, or at least to open the jaws to permit semen presentation.”] and [0012; “Alternatively, the device may be withdrawn immediately but the cervical cap left behind,”] a translation mechanism within the housing arranged to translate a deployment operation of the release mechanism to movement of the implant out of the housing [0012; “The semen is therefore expressed upward into a cavity 27 inside the transfer top 24 and thence through an injector 28 into a cervical cap preloaded on the inserter.”]; and a removable funnel attached at a distal end of the housing and arranged to deliver semen to the implant [Fig. 2, element 24 (transfer top)]—distal end of apparatus interpreted to be depicted by end indicated as element 28 and [0012]—which describes the semen expressed into cavity, 27, to inside the transfer top, 24, and then through the injector, 28, into the cervical cap, 13. Also see Fig. 4, element 41 for removable aspect of the funnel/condom.
Regarding Claim 2, Kanner teaches wherein the system is configured to move from a loading configuration in which semen can be loaded into the implant, through a delivery configuration in which the implant is sealed closed, to an open configuration in which the implant is separated from the housing and is unsealed such that it can deliver the semen to the cervix [0024]—describes the loading configuration where the inserter and cap are loaded with semen out of transfer top and is sealed where the injector passed through and along the cervical cap rim surfaces and [0026]—describes the inserter being positioned to release semen to migrate through the cervix.
Regarding Claim 3, Kanner teaches wherein the implant comprises a reservoir and a cap [Fig. 3, element 36 (cervical cap)] and [0013]—reference to reservoir of the cervical cap, and wherein the reservoir is attached to and in fluid communication with the cap [0013; “Piston 38 applies pressure to condom 31 forcing the semen 32 up through inserter 39 to the reservoir of the cervical cap 36.”]
Regarding Claim 4, Kanner teaches wherein the funnel comprises a channel portion and a sleeve concentrically arranged around a channel portion, [Fig. 2, elements 22 (receptacle) and 28 (injector)] and wherein in the loading configuration the sleeve is attached to an outer distal end of the housing and the channel portion is positioned concentrically with the housing [Fig. 2, depicts injector attached to distal end of the inserter] and [0012; “Initially, the injector 28 is interposed within the flexible material of the cervical cap, preserving a seal between the squeezed sides of the cervical cap preventing loss of semen from the cervical cap.”]—due to the concentric and circular nature of the cap, since the injector is provided with sealing between sides of the cervical cap, it is interpreted to be positioned concentrically within the inserter housing.
Regarding Claim 5, Kanner teaches wherein in the loading configuration the channel portion of the funnel is directly connected to and is in fluid communication with the reservoir of the implant [0012; “The semen is therefore expressed upward into a cavity 27 inside the transfer top 24 and thence through an injector 28 into a cervical cap preloaded on the inserter.”]—where direct connection involving fluid communication is achieved through elements 28, 27, and 24.
Regarding Claim 6, Kanner teaches wherein in the loading configuration the cap is folded within an annulus between the channel portion and the housing [Fig. 2, element 27 (cavity)] and [0022; “The piston thus raises the closed, distal end of the condom up, into the sealed inner cavity of the transfer top, and presses the condom fully onto the surface of the inner cavity.”]
Regarding Claim 14, Kanner teaches wherein the reservoir is configured to be at least partially compressed by the translation mechanism, and the translation mechanism is further arranged to translate the deployment operation of the release mechanism to compression of at least a portion of the reservoir [0022-0023]—describes a downward motion causing the piston to move in the opposite direction causing the condom to press fully onto the surface of the cavity with a subsequent pressure build up and transfer of contained semen through the injector.
Regarding Claim 16, Kanner teaches wherein the reservoir comprises a proximal end and a distal end, See annotated Fig. 11.
And wherein the proximal end comprises a substantially flat flange portion configured to be stiffer than a portion of the reservoir, [0012]—reference to only the cervical cap being of a flexible material.
such that pressing of the flat flange portion by the translation mechanism causes compression of the portion of the reservoir [0028]—references sliding the carrier and pushing down on elements of the structure and [0031]—which describes the transfer of semen by lowering the condom over the outer perimeter of the reservoir/receptacle (interpreted as pressing down), to transfer semen from closed distal end through passage by everting the open proximal end of the condom.
Regarding Claim 25, Kanner teaches configured such that the system can stand upright on the release mechanism and position the funnel in a substantially vertical arrangement [Fig. 4]—depicts the inserter sitting upright and vertically with no independent assistance.
Regarding Claim 30, Kanner teaches a method of concentrating semen at a cervix, [0010] the method comprising the steps of: providing a system according to claim 1; providing the semen to the implant by delivering the semen to the funnel when the system is in a loading configuration; [0011; “transfer of semen…to the inserter.”] removing the funnel from the distal end of the housing; [0011; “removably attached to cervical cap…holds the semen and condom.”] inserting the system into a vagina such that the distal end of the housing is adjacent the cervix; [0012; “The inserter can then be inserted vaginally…comfort.”] and performing the deployment operation of the release mechanism to move and release the implant from within the housing [0012; “A latch…allows user to…effectuate semen release”].
Regarding Claim 31, Kanner teaches wherein the implant comprises a reservoir and a cap [Fig. 3, element 36 (cervical cap)] and [0013]—reference to reservoir of the cervical cap, and wherein the reservoir is attached to and in fluid communication with the cap [0013; “Piston 38 applies pressure to condom 31 forcing the semen 32 up through inserter 39 to the reservoir of the cervical cap 36.”], and wherein the step of performing a deployment operation of the release mechanism compresses at least a portion of the reservoir to move semen closer towards the cervix or into the cap [0028]—references sliding the carrier and pushing down on elements of the structure and [0031]—which describes the transfer of semen by lowering the condom over the outer perimeter of the reservoir/receptacle (interpreted as pressing down), to transfer semen from closed distal end through passage by everting the open proximal end of the condom.
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.
Claim(s) 7-13, 17, 20-24, 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanner (U.S. 20150196324) in view of DaSilva (U.S. 10932819).
Regarding Claim 7, Kanner is silent on wherein the cap comprises: a shell; a rim; a proximal end; and a distal end; and wherein in the loading configuration the rim of the cap is folded in a clam shell arrangement with two diametrically opposite points around a circumference of the rim toward the distal end of the cap. DaSilva teaches wherein the cap comprises: a shell; a rim; a proximal end; and a distal end [Fig. 5, elements 152 (body), 154 (rim), 158 (proximal end), 121 (distal end)] and wherein in the loading configuration the rim of the cap is folded in a clam shell arrangement with two diametrically opposite points around a circumference of the rim toward the distal end of the cap [Fig. 8] and [Col 7, lines 49-52]—includes description of the cup folding upon itself.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for a collapsed configuration of the inserted device as taught by DaSilva to allow for insertion and positioning over the cervix as suggested by Kanner, as Kanner discusses delivering semen at or near the cervix [0010] with DaSilva because DaSilva teaches the ability to insert the cup into a vaginal entryway of a relatively small size [Col 7, lines 52-54].
Regarding Claim 8, Kanner is silent on wherein in the loading configuration the rim of the cap is biased towards the channel portion at the distal end of the cap and biased towards the housing at the proximal end of the cap. See annotated Fig. 8 below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biased state of the inserted device as taught by DaSilva to include when determining the size and shape of the device as suggested by Kanner, as Kanner discusses these aspects in relation to insertion and deposition of the device [0034] with DaSilva because DaSilva teaches this reduced size configuration to avoid the user having to cut the vaginal wall to allow for insertion of the device [Col 3, lines 4-13].
Regarding Claim 9, Kanner teaches wherein in the delivery configuration, the funnel is not attached to the distal end of the housing, [Fig. 4, element 41]—for removable aspect of the funnel/condom.
Kanner is silent on and the rim of the cap is folded in a closed clam shell arrangement within the housing such that the cap seals the implant closed. DaSilva teaches and the rim of the cap is folded in a closed clam shell arrangement within the housing such that the cap seals the implant closed [Fig. 8] and [Col 7, lines 49-52]—includes description of the cup folding upon itself.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for a collapsed configuration of the inserted device as taught by DaSilva to allow for insertion and positioning of the device and unattached funnel over the cervix as suggested by Kanner, as Kanner discusses delivering semen at or near the cervix [0010] with DaSilva because DaSilva teaches the ability to insert the cup into a vaginal entryway of a relatively small size [Col 7, lines 52-54].
Regarding Claim 10, Kanner is silent on wherein in the delivery configuration, the rim of the cap is biased towards the housing at the proximal end of the cap. DaSilva teaches wherein in the delivery configuration, the rim of the cap is biased towards the housing at the proximal end of the cap. See annotated Fig. 8 below.
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biased state of the inserted device as taught by DaSilva to include when determining the size and shape of the device as suggested by Kanner, as Kanner discusses these aspects in relation to insertion and deposition of the device [0034] with DaSilva because DaSilva teaches this reduced size configuration to avoid the user having to cut the vaginal wall to allow for insertion of the device [Col 3, lines 4-13].
Regarding Claim 11, Kanner is silent on wherein in the open configuration the shell is substantially hemispherical and the rim is of greater diameter than a diameter of the housing. DaSilva teaches wherein in the open configuration the shell is substantially hemispherical [Fig. 8]—depicts cup flexing to point where its size is divided in half, and the rim is of greater diameter than a diameter of the housing [Col 2, lines 22-23]—recites diameter range of the cup to be 2.5-4.0 cm and the shaft of the housing having an inner diameter of 0.1-0.15 inches.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the cup diameter to expand to a diameter greater than the housing shaft diameter as taught by DaSilva to include when incorporating the cap into the device as suggested by Kanner, as Kanner discusses an insertion device fitted with a cervical cap [0013] with DaSilva because DaSilva teaches selected cup sizes based on a range of vaginal and uterine anatomical feature sizes [Col 7, lines 17-19].
Regarding Claim 12, Kanner is silent on wherein the cap is of a resilient material and the rim has a greater stiffness than the shell. DaSilva teaches wherein the cap is of a resilient material [Col 8, lines 10-14] and the rim has a greater stiffness than the shell [Col 2, lines 17-20; “In certain embodiments, one or more materials from which the colpotomizer cup is formed have an elastic modulus in a range of about 5.5 MPa to about 171 MPa and 20 a hardness in a range of 85 Shore A to 100 Shore A.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a resilient material and incorporate elements of varying elasticity and hardness as taught by DaSilva to include in design of the flexible cervical cap as suggested by Kanner, as Kanner discusses these properties as means to provide a seal to prevent unintended loss of semen [0012] with DaSilva because DaSilva teaches preventing the cup from shifting and tilting when this portion of the device is within the shaft [Col 9, lines 58-61].
Regarding Claim 13, Kanner is silent on wherein the reservoir is of a resilient material of sufficiently low stiffness that it can be resiliently deformed by vaginal walls of the user. DaSilva teaches wherein the reservoir is of a resilient material of sufficiently low stiffness that it can be resiliently deformed by vaginal walls of the user [Col 2, lines 31-36]—describes the deformable colpotomize cup being deformable to be inserted into a vaginal canal, and [Col 2, lines 45-47]—with the reservoir considered part of the cup and including the one or more materials mentioned with the specified elastic modulus.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the use of a deformable reservoir and incorporate elements of varying elasticity and hardness as taught by DaSilva to include in design of the flexible cervical cap as suggested by Kanner, as Kanner discusses these properties as means to provide a seal to prevent unintended loss of semen [0012] with DaSilva because DaSilva teaches preventing the cup from shifting and tilting when this portion of the device is within the shaft [Col 9, lines 58-61].
Regarding Claim 17, Kanner is silent on wherein the release mechanism comprises: a rotatable knob; and a threaded member; and wherein the threaded member is configured to register with a corresponding internal thread on the housing. DaSilva teaches wherein the release mechanism comprises: a rotatable knob; and a threaded member; [Fig. 3, elements 119 (cam roller), 182 (threaded member/guide surface) and wherein the threaded member is configured to register with a corresponding internal thread on the housing [Col 8, lines 41-44; “opposing receptacles 178 that receive the thumb lock 176, opposing projections 180 to which the thumb lock 176 can be snap fitted, and a guide surface 182 that appropriately guides the sleeve 148 along the shaft 102 and supports the shaft 102 for contact with the thumb lock 176.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the incorporate a roller and locking surface guide as taught by DaSilva to position the body of the device and aspects of the device as suggested by Kanner, as Kanner discusses using the insertion device to position the top of the transfer top on the transfer body to create an internal pressure [0012] with DaSilva because DaSilva teaches using this mechanism to lock the assembly into a desired position [Col 8, lines 46-50].
Regarding Claim 20, Kanner is silent on wherein the translation mechanism comprises: a ball-and-socket joint; and an implant actuator; wherein the ball-and-socket joint is connected on one side to the threaded member and on an other side to the implant actuator, and wherein the implant actuator is arranged to move within the housing into abutment with the implant as the user turns the rotatable knob. DaSilva teaches wherein the translation mechanism comprises: a ball-and-socket joint; and an implant actuator; [Fig. 3, element 180 (projections), 112 (implant actuator)] and wherein the ball-and-socket joint is connected on one side to the threaded member and on an other side to the implant actuator, See annotated Fig. 3 below. and wherein the implant actuator is arranged to move within the housing into abutment with the implant as the user turns the rotatable knob [Col 5, lines 27-29; “The expandable balloon 106 can be rapidly inflated and rapidly deflated by syringe actuation that occurs at the manipulator handle 112.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include integrate the described components to cause an actuation or translation of the components of the device as taught by DaSilva to bring the actuator in contact with the implant as suggested by Kanner, as Kanner discusses using pressure and mechanical movement created by a piston to bring components of the device in contact with the implant [0023] with DaSilva because DaSilva teaches the use of a button actuation mechanism to inflating and deflating the expandable balloon implant [Col 6, lines 20-23].
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Regarding Claim 21, Kanner further teaches wherein the implant actuator is further arranged to move within the housing to compress at least a portion of the reservoir within the housing, thereby being configured to move semen closer to a cervix or into the cap [0028]—references sliding the carrier and pushing down on elements of the structure and [0031]—which describes the transfer of semen by lowering the condom over the outer perimeter of the reservoir/receptacle (interpreted as pressing down), to transfer semen from closed distal end through passage by everting the open proximal end of the condom, where the implant actuator is interpreted as the piston.
Regarding Claim 22, Kanner further teaches wherein the implant actuator is further arranged to move within the housing to push the implant out from the housing [0022]—describes the piston preparing the device for implant deployment and [0024]—which discloses the user pulling the implant out of the transfer top and off the injector.
Kanner is silent on as the user turns the rotatable knob or rotatable hoop. DaSilva teaches as the user turns the rotatable knob or rotatable hoop [Col 8, lines 59-60; “as the cam roller 184 is rotated towards the shaft 102 of the uterine manipulator 100.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a roller or dial as an actuation means as taught by DaSilva to deploy the implant as suggested by Kanner, as Kanner discusses the device used to deliver the implant at or near the cervix [0010] with DaSilva because DaSilva teaches the cam roller contacting the shrink tube surrounding the shaft to lock to assembly [Col 8, lines 51-54].
Regarding Claim 23, Kanner further teaches wherein the rim of the cap is arranged to open and unseal when the implant is pushed out from within the housing [0026; “The inserter can then be inserted vaginally to position the cervical cap over the cervix, where the cap can be opened and the semen released so that the sperm are allowed to migrate through the cervix.”] taking into account [0021]—where the rim is described as sealed prior to use.
Regarding Claim 24, Kanner further teaches wherein the implant is arranged to detach from the housing when the system is moved to the open configuration in which the implant is unsealed and is not enclosed within the housing [0033; “The insertion means can include means for removably attaching the object to the insertion means, and means for releasing the object from the insertion means so as to deposit the object at a desired location.”]
Regarding Claim 26, Kanner is silent on wherein the threaded member and housing are arranged such that longitudinal axes of the threaded member and housing are at an angle to each other, thereby causing an angle of tilt in the system such that when the system stands upright on the release mechanism, the funnel is substantially vertical. DaSilva teaches wherein the threaded member and housing are arranged such that longitudinal axes of the threaded member and housing are at an angle to each other, thereby causing an angle of tilt in the system such that when the system stands upright on the release mechanism, the funnel is substantially vertical. See annotated Fig. 3 and dotted lines indicating axes and interpretation that the funnel indicated by element 154, is substantially vertical in reference to the handle of the device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vertical and flexible hybrid design of the structure as taught by DaSilva to prevent loss of fluid as suggested by Kanner, as Kanner discusses the orientation of the device to produce a proper seal and prevent loss of semen [0012] with DaSilva because DaSilva teaches the use of this orientation to optimize visibility of the base of the uterus during procedures [Col 3, lines 23-25].
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Regarding Claim 27, Kanner is silent on wherein the angle of tilt is one of less than 2 degrees, 2-4 degrees, or greater than 4 degrees. DaSilva teaches wherein the angle of tilt is one of less than 2 degrees, 2-4 degrees, and greater than 4 degrees [Col 9, lines 58-61]—describes the angle of tilt being substantially zero.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vertical and flexible hybrid design of the structure as taught by DaSilva to prevent loss of fluid as suggested by Kanner, as Kanner discusses the orientation of the device to produce a proper seal and prevent loss of semen [0012] with DaSilva because DaSilva teaches this angle or lack of tilt as appropriate for guiding a cutting of the uterus with and even distribution of tissue [Col 9, lines 63-26].
Regarding Claim 28, Kanner teaches a method of arranging a system for assisted conception, [0015]—reference to artificial insemination, the method comprising the steps of: providing an elongate curved housing comprising a proximal end and a distal end [Fig. 1, element 11 (inserter)]; attaching a release mechanism at the proximal end of the housing; configuring the release mechanism such that the release mechanism can perform a deployment operation; [0012] providing a resilient implant comprising a cap and a reservoir, [Fig. 3, element 36 (cervical cap)] and [0013]
providing a removable funnel comprising a sleeve and a channel portion, [Fig. 2, elements 22 (receptacle) and 28 (injector)] wherein the sleeve and channel portion are configured concentrically to provide an annulus therebetween [Fig. 2, depicts injector attached to distal end of the inserter] and [0012; “Initially, the injector 28 is interposed within the flexible material of the cervical cap, preserving a seal between the squeezed sides of the cervical cap preventing loss of semen from the cervical cap.”]—due to the concentric and circular nature of the cap, since the injector is provided with sealing between sides of the cervical cap, it is interpreted to be positioned concentrically within the inserter housing; attaching the channel portion of the funnel to the reservoir such that the channel portion and the reservoir are in fluid communication [0013; “Piston 38 applies pressure to condom 31 forcing the semen 32 up through inserter 39 to the reservoir of the cervical cap 36.”]; inserting the distal end of the cap into the annulus [Fig. 2, element 27 (cavity)] and [0022; “The piston thus raises the closed, distal end of the condom up, into the sealed inner cavity of the transfer top, and presses the condom fully onto the surface of the inner cavity.”] attaching the sleeve of the funnel to the distal end of the housing such that the implant becomes fully enclosed within the housing [0029; “the cervical cap can be contained within an inserter,”] and [Fig. 3]—shows attachment means to enclose the implant within the housing, and providing a translation mechanism configured to translate a deployment operation of the release mechanism to movement of the implant out of the housing [0012; “The semen is therefore expressed upward into a cavity 27 inside the transfer top 24 and thence through an injector 28 into a cervical cap preloaded on the inserter.”]
Kanner is silent on wherein the cap comprises: a rim; a shell; a proximal end; and a distal end and folding the resilient implant in a clam shell arrangement such that two diametrically opposite points around the rim are folded toward the distal end of the cap;
DaSilva teaches wherein the cap comprises: a rim; a shell; a proximal end; and a distal end [Fig. 5, elements 152 (body), 154 (rim), 158 (proximal end), 121 (distal end)] and folding the resilient implant in a clam shell arrangement such that two diametrically opposite points around the rim are folded toward the distal end of the cap; [Fig. 8] and [Col 7, lines 49-52]—includes description of the cup folding upon itself.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for a collapsed configuration of the inserted device as taught by DaSilva to allow for insertion and positioning over the cervix as suggested by Kanner, as Kanner discusses delivering semen at or near the cervix [0010] with DaSilva because DaSilva teaches the ability to insert the cup into a vaginal entryway of a relatively small size [Col 7, lines 52-54].
Regarding Claim 29, Kanner further teaches wherein the translation mechanism is further configured to translate the deployment operation of the release mechanism to compression of the reservoir. [0028]—references sliding the carrier and pushing down on elements of the structure and [0031]—which describes the transfer of semen by lowering the condom over the outer perimeter of the reservoir/receptacle (interpreted as pressing down), to transfer semen from closed distal end through passage by everting the open proximal end of the condom.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanner (U.S. 20150196324) in view of Conti (U.S. 11291535).
Regarding Claim 15, Kanner is silent on wherein the reservoir comprises a lower reservoir section, an intermediate reservoir section and an upper reservoir section, and wherein: the intermediate reservoir section is configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to a cervix; or the intermediate reservoir section and the lower reservoir section are configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to the cervix; or the lower reservoir section is configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to the cervix. Conti teaches wherein the reservoir comprises a lower reservoir section, an intermediate reservoir section and an upper reservoir section, [Fig. 6A, elements 46 (upper reservoir section), 42 (intermediate reservoir section), 44 (lower reservoir section].
and wherein: the intermediate reservoir section is configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to a cervix;
or the intermediate reservoir section and the lower reservoir section are configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to the cervix; or the lower reservoir section is configured to be compressed by the translation mechanism to move semen out of the reservoir or closer to the cervix [Col 16, lines 46-55]—all reservoir sections (upper, middle and lower) are interpreted as being compressed by the translation mechanism since all reservoirs are compressed and compacted to fit the implant within the insertion member and according to [Col 3, lines 33-35] the fluid contained within vaginal insert device is moved closer to the cervix after deployment and insertion into the vagina.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include compression of the reservoir parts as taught by Conti to contribute to the delivery of semen as suggested by Kanner, as Kanner discusses the device used to deliver semen at or near the cervix [0010] with Conti because Conti teaches the use of a menstrual cup design to create suction on the cervix surface and prevent fluid loss [Col 45, lines 25-26].
Claim(s) 18, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanner (U.S. 20150196324) in view of DaSilva (U.S. 10932819) and in further view of Sepsick (U.S. 20190336325).
Regarding Claim 18, Kanner and DaSilva are silent on wherein the release mechanism comprises: a rotatable hoop; and a threaded member; wherein the threaded member is configured to register with a corresponding internal thread on the housing. Sepsick teaches wherein the release mechanism comprises: a rotatable hoop; and a threaded member; [Fig. 6B, elements 630 (rotatable hoop), 666(a, b) (rachet teeth)] wherein the threaded member is configured to register with a corresponding internal thread on the housing [Fig. 6B, element 667 (rachet pawls)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hollow loop plunger component to interface with the threaded portion of the housing as taught by Sepsick to contribute aid in placement and positioning of the components of the device as suggested by Kanner and DaSilva, as Kanner discusses the device handle as an integral component to positioning transfer components of the device [0012] and DaSilva which discloses the difficulties in placement of devices within the easily torn or lacerated vaginal vault [Col 3, lines 12-17] with Sepsick because Sepsick teaches the use of a finger aperture to ease movement by operator’s thumb or finger to control movement of the plunger and associated pawls and fingers [0031].
Regarding Claim 19, Kanner and DaSilva are silent on wherein the rotatable hoop comprises a ring portion comprising a central aperture configured to receive one of a finger and a thumb of the user. Sepsick teaches wherein the rotatable hoop comprises a ring portion comprising a central aperture [Fig. 6B—hollow portion of 630 depicted] configured to receive one of a finger and a thumb of the user [0031].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hollow loop plunger component to interface with the threaded portion of the housing as taught by Sepsick to contribute aid in placement and positioning of the components of the device as suggested by Kanner and DaSilva, as Kanner discusses the device handle as an integral component to positioning transfer components of the device [0012] and DaSilva which discusses the use of a manipulator to ensure proper placement of the implant [Col 11, lines 46-50] with Sepsick because Sepsick teaches the use of a finger aperture to ease movement by operator’s thumb or finger to control movement of the plunger and associated pawls and fingers [0031].
Response to Arguments
Applicant's arguments filed 2 March 2026 with respect to the drawing, specification and abstract objections have been fully considered and are persuasive in light of the amendments.
Applicant's arguments filed 2 March 2026 with respect to the claim objections have been fully considered and are persuasive however, new rejections are presented in light of the amendments.
Applicant's arguments filed 2 March 2026 with respect to 35 U.S.C. 112(b)
rejections for claims 1-12, 14-18, 20-31 have been fully considered and are persuasive in light of the amendments.
Regarding Claim 13, Applicant contends that “a material of sufficiently low stiffness” is clear. Examiner presents that this limitation still lacks clarity because sufficiently low stiffness is not defined and could encompass any material. “That it can be resiliently deformed by vaginal walls” does not further define sufficiently low stiffness because it represents an intended use claim. In view of the foregoing, this rejection has been maintained.
Further, a new rejection of claim 19 is presented in light of the amendments.
Applicant’s arguments filed 2 March 2026 with respect to the rejection of
claims 1-6, 14, 16, 25, and 30-32 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Applicant contends that Kanner does not teach the amended limitation found within claims 1 and 28 of “an elongate curved housing fully enclosing the implant.” The examiner has provided reference to [0029] in which the cited reference discloses that the cervical cap (implant) can be contained within the housing. In view of the foregoing, the previously presented rejections citing Kanner are maintained.
Applicant’s arguments filed 2 March 2026 with respect to the rejection of
claims 7-11, 15, 17-24, and 26-29 under 35 U.S.C.103 have been fully considered but are not persuasive. In view of the foregoing, the previously presented rejections for claims 7-11, 17, 20-25, and 26-29 citing Kanner in view of DaSilva, claim 15 citing Kanner in view of Conti, and Claims 18 and 19 citing Kanner in view of DaSilva and in further view of Sepsick are maintained.
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.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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