DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 2 June 2026. Claims 1, 3-15, 19-22, 24 are now pending. The Examiner acknowledges the amendments to claims 1, 4, 6, 9, 10, 11, 12, 13, 14, 15, 19, 20, 21, 22, 24.
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 .
Drawings
The drawings were received on 2 June 2026. These drawings are acceptable.
Claim Objections
Claim 1 is objected to because of the following informalities:
-Claim 1 recites “wherein and” in line 11. Examiner recommends amending to –and wherein—
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:
-Claim 1 recites “microcontroller” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to operate the one or more pumps to deliver a predetermined volume of the fluid. According to the specification the microcontroller includes CC1310 SimpleLink™ Ultra-Low-Power Sub-1 GHz Wireless MCU (Texas Instruments™), and communication interfaces [0066] and equivalents thereof.
-Claim 3 recites “retention 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 retain the housing in the body cavity during use. According to the specification the retention mechanism comprises a pair of opposing
members 36(1) and 36(2) configured to be folded into the housing and to provide an external pressure away from housing 12 against the body cavity during use [0046] and equivalents thereof.
-Claim 4 recites “opposing members” 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 folded into the housing and to provide an external pressure away from the housing against the body cavity during use. According to the specification the opposing members includes pair of semi-rigid wings, [0046] and equivalents thereof.
-Claim 5 recites “extraction 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 allow for removal of the housing from the body cavity. According to the specification the extraction mechanism includes a coil or string [0047] and equivalents thereof.
-Claim 14 recites “first component” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to house the one or more pumps, the microcontroller and a battery. According to the specification the first component includes a front component and anchor for luer lock connections [0044] and equivalents thereof.
-Claim 15 recites “second component” 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 coupled to the first component and removably receive the one or more reservoirs. According to the specification the second component includes a back component providing a hard plastic case [0045] 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
Claims 1, 3-15, 19-22, 24 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.
-Claims 1 recite “an area external to the housing” in line 17. It is unclear whether this is the same or different from “an area external to the housing” originally referenced in claim 1, lines 7-8.
-Claim 20 recites “the subject” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 3-14, 19, 21, 22, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jellie (U.S. 20020045883) in view of Athayde (U.S. 5672167).
Regarding Claim 1, Jellie teaches a device comprising:
a housing configured to be inserted into a body cavity [Fig. 13, element 12] and [0177], the housing comprising a front component and a back component [Fig. 13, element 10 (front component) and 11 (back component)];
reservoirs located within the back component and configured to store a fluid [Fig. 13, element 13] and [0189]—references reservoirs containing the substances;
one or more pumps coupled to the reservoirs [Fig. 13, element 15] and [0189; “reservoirs…piezo pumps”], the one or more pumps configured to deliver the fluid stored in the reservoirs to an area external to the housing during use [0199]—discloses pumps connected to an outlet;
and a microcontroller coupled to the one or more pumps [Fig. 13, element 18 (pressure device controlling mechanism)], the microcontroller configured to operate the one or more pumps to selectively deliver a predetermined volume of the fluid stored in the reservoirs to an area external to the housing [0206]—reference to volume of fluid being dispensed and [0200]—reference to substance being pumped from the reservoir through the conduits.
Jellie is silent on a bladder configured to seal the housing and comprising a first portion attached to the back component and a second portion disposed within the back component and external to the reservoirs, wherein and the bladder is configured to deform inward with respect to the back component during operation of the one or more pumps and in response to negative pressure generated by displacement of the fluid during the delivery of the fluid stored in the reservoirs to the area external to the housing.
Athayde teaches a bladder [Fig. 7, element 3 (pouch)] configured to seal the housing [Fig. 7, element 11 (seal), 7 (housing)] and [Col 15, lines 60-66] and comprising a first portion attached to the back component and a second portion disposed within the back component and external to the reservoirs [Fig. 7, element 1 (chamber/back component), 44 (first portion attached/line), 2 (second portion/permeant), 3/4 (reservoirs)], wherein and the bladder is configured to deform inward with respect to the back component during operation of the one or more pumps [Fig. 9A, element 58 (collapsed tube)] and in response to negative pressure generated by displacement of the fluid during the delivery of the fluid stored in the reservoirs to the area external to the housing [Col 22, lines 11-18] and [Col 3, lines 47-52]—describing force generated on the device that causes ejection of fluid out 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 bladder, seal, and necessary forces as taught by Athayde to cause fluid ejection as suggested by Jellie, as Jellie discusses withstanding forces of internal peristaltic waves within an animal’s body cavity [0067] with Athayde because Athayde teaches the use of this device with permeation of water from the environment [Col 3, lines 49-52].
Regarding Claim 3, Jellie further teaches wherein the housing further comprises a retention mechanism configured to retain the housing in the body cavity during use [0051]—description of multiple arms capable of retaining device within the cavity.
Regarding Claim 4, Jellie further teaches wherein the front component comprises a pair of opposing members [Fig. 12, element 3 (arms)] and [0062]—reference to extendible telescoping arms, configured to fold toward the housing during insertion of the device into the body cavity and to extend away from the housing to thereby provide an external pressure against the body cavity during use and [Fig. 11, element 3 (arms)] and [0078]—reference to pressure of the walls (external pressure) relied upon to maintain the arms in parallel arranged with the device.
Regarding Claim 5, Jellie further teaches wherein the housing further comprises an extraction mechanism to allow for removal of the housing from the body cavity [0081]—describes a removable band that maintains the longitudinal alignment of the retention arms of the device and [0083]—describes removal of the device involves realignment of the arms to withdraw the device.
Regarding Claim 6, Jellie further teaches wherein the extraction mechanism is configured to extend from the housing to outside of the body cavity during use [0062]—reference to the extraction mechanism in a passage of the body.
Regarding Claim 7, Jellie further teaches wherein the one or more pumps are coupled to the one or more reservoirs by a mechanical coupling mechanism [Fig. 13, element 14 (connection lines)].
Regarding Claim 8, Jellie further teaches wherein the one or more pumps are negative pressure pumps [0189]—reference to piezo pumps.
Regarding Claim 9, Jellie further teaches further comprising: delivery tubing coupled to the one or more pumps to deliver the fluid to the body cavity [Fig. 13, element 16 (flexible conduit)].
Regarding Claim 10, Jellie further teaches wherein the housing is configured to be inserted into the body cavity intravaginally [0047]—discloses the device retained to impede the flow of bodily secretions including intravaginal mucus and [0002].
Regarding Claim 11, Jellie further teaches wherein the microcontroller is further configured to operate the one or more pumps to deliver the predetermined volume of the fluid based on a biological hormone administration schedule [0212]—reference to different doses of hormones administered over predetermined times and dates in reference to oestrus.
Regarding Claim 12, Jellie further teaches wherein each of the reservoirs is independently accessed by one of the one or more pumps to allow independent fluid delivery from each of the reservoirs during use [Fig. 13, elements 13 (reservoirs), 15 (pumps)]—with connection lines (element 14) shown independently connected to each separate reservoir.
Regarding Claim 13, Jellie further teaches wherein the one or more pumps are configured to release a same amount of the fluid from the reservoirs over different amounts of time [0114]—refers to actively releasing a rate and volume of a substance and controlling such parameters.
Regarding Claim 14, Jellie further teaches wherein the front component houses the one or more pumps, the microcontroller, and a battery [Fig. 13, elements 10 (front component), 15 (pumps), 18 (microcontroller) and 19 (battery)]—while the battery is not shown within segment 10, it is still located towards the front the device with place within at least the first ½ front portion of the device.
Regarding Claim 19, Jellie further teaches further comprising:
one or more sensors coupled to the housing and the microcontroller [0148]—discusses sensors which monitor environment or the device itself and communicate this information to the microprocessor,
wherein the microcontroller is further configured to: receive data from the one or more sensors [0148; “This information may be then acted upon by the microprocessor to control the delivery apparatus to introduce those substances.”];
and adjust the operation of the one or more pumps based on the received data to adjust delivery of the fluid to the body cavity [0149-0150]—discloses sensing bodily fluid factors and eliciting an accurate response, such as altering the dosage and timing of the device substance delivery.
Regarding Claim 21, Jellie further teaches wherein the data comprises physiological data [0149]—reference to physiological indicators.
Regarding Claim 22, Jellie further teaches wherein the operation of the one or more pumps is adjusted in real-time based on estrous behavior determined based on the physiological data [Fig. 20], [0146] and [0212]—discusses dispensation defined by date of oestrus.
Regarding Claim 24, Jellie further teaches a method for providing automated fluid delivery in a body cavity [0042]—reference to a substance delivery device, the method comprising:
and inserting the device into the body cavity [0042]—reference to device inserted into a body cavity of an animal, wherein, upon insertion, the microcontroller operates the one or more pumps [Fig. 13, element 18 (pressure device controlling mechanism), 15 (pumps)] to deliver the predetermined volume of the fluid stored in the one or more reservoirs to the body cavity at a scheduled time [0206]—reference to volume of fluid being dispensed and [0200]—reference to substance being pumped from the reservoir through the conduits at a predetermined time.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jellie (U.S. 20020045883) in view of Athayde (U.S. 5672167) and in further view of Portner (U.S. 4265241).
Regarding Claim 15, Jellie further teaches wherein the front component is sealed to prevent other fluids from entering the front component 0207; “This seal prevents the dosing chamber…reservoir 13.”], the back component is configured to be coupled to the front component [0040]. Jellie and Athayde are silent on and the back component is configured to removably receive the reservoirs. Portner teaches and the back component is configured to removably receive the reservoirs [Fig. 4, element 16 (reservoir), 12 (housing)] and [Col 3, lines 62-63]—in this interpretation, the housing portion is interpreted to be the front component and the reservoir portion is interpreted to be the back component in which the reservoir can be detached from.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to removable mechanisms for the reservoirs as taught by Portner in response to the separable structure as suggested by Jellie and Athayde, as Jellie discusses the design of this structure tailored to the specific body cavity the device is to be inserted into [0045] and Athayde which discloses the use of a removable flexible pouch [Col 3, lines 15-18] with Portner because Portner teaches this feature as a safety latch mechanism to delivery substances to the body only when intended [Col 2, lines 38-42].
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jellie (U.S. 20020045883) in view Athayde (U.S. 5672167) and in further view of John (U.S. 20060204532).
Regarding Claim 20, Jellie and Athayde are silent on wherein the microcontroller is further configured to determine a posture of the subject based on the received data, the received data provides position information for the device within the body cavity, and the operation of the one or more pumps is adjusted based on the posture and the position information. John teaches wherein the microcontroller is further configured to determine a posture of the subject based on the received data [0008] and [0066], the received data provides position information for the device within the body cavity [0062], and the operation of the one or more pumps is adjusted based on the posture and the position information [0038].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use sensing and monitoring data as taught by John to control positioning aspects of the device as suggested by Jellie and Athayde, as Jellie discusses aspects of forces within the body cavity effecting positioning of the device [0048] and Athayde which discloses positioning of the components of the device with respect to fluid dynamic conditions in the device [Col 6, lines 40-45] with John because John teaches this feature to monitor a pregnant female or fetus [0142].
Response to Arguments
Applicant's arguments filed 2 June 2026 with respect to the drawing, specification
and claim objections have been fully considered and are persuasive in light of the
amendments.
Applicant's arguments filed 2 June 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered and are persuasive however, new rejections are
presented in light of the amendments.
Applicant’s arguments filed 2 June 2026 with respect to the rejection of
claims 1, 3-5, 7-14, 19, 21, 22, and 24 under 35 U.S.C.102 have been fully considered and are persuasive, however, new 35 U.S.C. 103 rejections are presented above in light of the amendments for claims 1, 3, 4, 5, 6, 7-14, 19, 21, 22, 24 citing Jellie in view of Athayde, for claim 15 citing Jellie in view of Athayde and in further view of Portner, and for claim 20 citing Jellie in view of Athayde and in further view of John for claim 20.
Regarding Claim 1, applicant contends that Jellie, Agrophysics, Portner and Jones do not disclose “a bladder…external to the housing.” Examiner agrees with this assertation and presents new grounds of rejection citing Jellie in view of Athayde in light of the amendment.
Regarding Claim 20, applicant contends that Jellie, Agrophysics, Portner and Jones do not disclose “wherein the microcontroller…the position information.” Examiner agrees with this assertion and presents new grounds of rejection citing Jellie in view of Athayde and in further view of Jones in light of the amendment.
Regarding Claim 22, applicant contends that Jellie, Agrophysics, Portner and Jones do not disclose “wherein the operation…based on physiological data”. This argument is not persuasive because the oestrus behavior is interpreted as physiological data based on hormonal and reproductive cycles. The referenced rejection cites hormone dose administration distributed over predetermined times in correlation with the date of oestrus. Examiner further presents reference to the abstract and [0037] which describes the apparatus being actively controlled to deliver substances to an outlet. In view of the foregoing, the previously presented rejections citing Jellie in view of Athayde 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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