DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Claims filed 3/4/26 have been entered. Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 3/4/26 have been fully considered but they are not persuasive.
The amendments have changed the scope of all claims. The scope of “the first and second arms extending alongside the housing so as not to protrude outward away from the housing in the collapsed configuration” is different from the previous “the first and second arms being alongside the housing and approximately parallel to the longitudinal axis”. As an example of this, Johnson/Johnson ‘553 disclosed the previous limitations (Johnson incorporates by reference Johnson ‘553 specifically for the details of the retention members on 7:1-19; e.g. Johnson ‘553 discloses that the retention members are fully flexible, collapse to be substantially perpendicular to the longitudinal axis of the housing, and are non-perpendicular upon intraluminal deployment, see Fig. 1A,1B,¶48-49; Also see ¶5-6,25,30,33-34,37,51,54, 85,87,89, as all embodiment involve expanding arms from approximately parallel to non-parallel deployment configurations), while it does not disclose the new limitations. The arms in Johnson do “protrude outward away from the housing in the collapsed configuration”, as they protrude away distally from the housing. Also note that the new limitations do find support in the original disclosure, as would be understood by phosita, in at least Fig. 3, which clearly shows the collapsed configuration with arms 12 and 14 extending alongside the housing the not protruding outward away from the housing, as do, for example, the expanded arms in Fig. 2. However, Huang teaches an analogous implantable physiological monitor device which proposes an equivalent expanding retention mechanism, whereby retention arms are folded alongside the cylindrical housing of the monitor and do not protrude away from the housing in their collapsed configuration (e.g. as shown in Fig. 1A, 2A, 3A, 10A, 13). Said retention mechanism includes a number of equivalent biasing means, including torsion springs (¶ 52). Thus, the combination of the retention mechanism proposed by Huang in the combination of Johnson/Johnson ‘553 would have been obvious as an equivalent retention mechanism.
The 112 rejections have been withdrawn in light of Applicant’s amendments.
Claims 7-9 are objected as dependent on rejected Claim 1. Claim 10 is allowable.
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.
The terms: a) “wireless transmitting means” in Claim 1, b) “means for securing” in Claim 7, c) “means for disengaging” in Claim 7, and d) “means for biasing” in Claim 8, have all been interpreted under 112f, as they include the word “means” coupled with functional language, without providing sufficient structure to perform the entirety of the respective function. The corresponding structures described in the specification are: a) “radio transmitter“ (¶26), b) “latch” (¶23), c) “release button” (¶23), d) “torsion springs” (¶23), and equivalents thereof.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 11-13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,278,675 to Johnson (“Johnson” herein) and incorporated by reference therein US 2014/0200553 to Johnson (“Johnson ‘553” herein), in view of US 2009/0005658 by Vinci and US 2022/0142566 by Huang.
Regarding Claim 1, Johnson discloses a wireless implantable device for monitoring internal physiological parameters of an animal (e.g. title, abstract, 6:56-63: wireless implantable device to detect estrus in animals), the device comprising:
a housing comprising a cylindrical external shape, a longitudinal axis, and an internal compartment, the housing being configured for implantation in the animal (e.g. Fig. 1A, 3:36-56: cylindrical housing 102 is configured for intravaginal or intrauterine implantation and includes sensors 108 in its interior);
first and second arms pivotally coupled to the housing (e.g. 3:42-46, Fig. 1A: retention members 104) to have a collapsed configuration and a deployed configuration, the first and second arms being alongside the housing and approximately parallel to the longitudinal axis in the collapsed configuration, expanded outward away from the housing and not parallel to the longitudinal axis in the deployed configuration, and biased toward the deployed configuration (Johnson incorporates by reference Johnson ‘553 specifically for the details of the retention members on 7:1-19; e.g. Johnson ‘553 discloses that the retention members are fully flexible, collapse to be substantially perpendicular to the longitudinal axis of the housing, and are non-perpendicular upon intraluminal deployment, see Fig. 1A,1B,¶48-49; Also see ¶5-6,25,30,33-34,37,51,54, 85,87,89, as all embodiment involve expanding arms from approximately parallel to non-parallel deployment configurations)
sensors associated [with] the housing for collecting physiological parameters of the animal, the sensors comprising a temperature sensor (e.g. 3:47-67, 7:38-41, Fig. 1B: sensor package 108 with sensors 120,122,124, which include “temperature sensors, conductivity sensors, color sensors, pulse sensors, activity sensors, mounting sensors, and pressure sensors”); and
wireless transmitting means within the compartment for wirelessly transmitting outputs of the sensors to a receiver while the housing is implanted internally within the animal and the receiver is located externally of the animal (e.g. Fig. 1B, 4, 6:56—7:19, 8:48--9:17: data is communicated between the implant and a base station 450 through networks, including ZIGBEE, via implant antenna 110 and associated circuitry).
Johnson does not explicitly disclose the first and second arms extending so as not to protrude outward away from the housing in the collapsed configuration, and means for biasing the first and second arms toward the deployed configuration (as interpreted under 112f).
However, Huang teaches an analogous implantable and intravaginal physiological monitoring device (e.g. ¶ 39-40, 45-46,48, 59: monitoring subject temperature, pH, and other physiological conditions), which includes an equivalent arm deployment retention mechanism with expendable arms configured to not protrude from a housing of the device in the collapsed configuration (e.g. ¶¶ 11, 51-54, and Figures 1A through 1C disclose and show the deployment of arms of an implantable housing 104, from a collapsed to an expanded configuration, wherein the arms do not protrude from the housing in the collapsed configuration), wherein the expandable arms are deployed based in part on spring torsion biasing means and other equivalents biasing means (¶ 52-53: torsion springs 108). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a biased arm deployment mechanism with arms not protruding outward away from the housing in a collapsed configuration, in a device according to the teachings of Johnson, as taught by Huang, as this would: a) only amount to an equivalent mechanism to predictably bias and expand retaining arms, thus predictably maintaining a low collapsed profile during insertion while predictably securing the device in place after insertion, and b) shorten the length of the device and reduce protrusions, thus lessening the chance for tissue damage and other complications during insertion.
Johnson does not explicitly disclose the sensors comprising an acoustic sensor.
However, Vinci teaches an analogous intravaginal implant for determining the physiological state of female mammals related to procreation (e.g. title, abstract, ¶20, Fig. 2), which includes multiple sensors, as well as acoustic sensors in order to detect heartbeat, movement or animal vocalizations (e.g. ¶87-88, Claim 8). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate acoustic sensors in a device according to the teachings of Johnson, as taught by Vinci, as this would predictably measure pulse rate of the female and the fetus, which is taught as desirable in both Johnson (3:59) and Vinci (¶87-88). This may be part of an equivalent substitution mechanism to predictably measure pulse rate, or part of an auxiliary measurement which would assist in verifying pulse rate in order to ensure accurate measurements. In addition, Vinci teaches that acoustic sensors may be used to predictably detect animal vocalizations or movement (¶87-88), useful in determining animal behavior and state as it relates to reproduction (Johnson, 1:30-35, 2:60—3:19; Vinci, ¶87-88).
Regarding Claim 2, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, wherein the temperature sensor is configured to sense a deep body temperature of the animal (e.g. 4:10-14: intravaginal or intrauterine temperature measurements are considered “deep body temperature” measurements) and the acoustic sensor is configured to sense deep body acoustics of the animal (e.g. Vinci, ¶87-88: heartbeat detection from the animal’s vagina is considered “deep body acoustics”).
Regarding Claim 3, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 2, wherein the acoustic sensor is configured to sense the pulse of the animal (e.g. Vinci, ¶88).
Regarding Claim 4, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, further comprising an optical sensor associated with the housing that includes a light emitter and a light receiver, the light sensor being configured to collect light data generated by light emitted by the light emitter for use in determining blood oxygen content of the animal (6:31-41: oxygen content is measured with an LED and a camera).
Regarding Claim 6, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, wherein in the deployed configuration each of the first and second arms is oriented at an acute angle to the longitudinal axis of the housing (e.g. Johnson ‘553, Fig. 1A, 2A: the proximal portion of arms 204 is oriented at an acute angle with the housing 202; In addition, the arms of all embodiments are fully flexible and the deployed state would depend on the anatomy of the subject, thus the arms would be capable of any angle and the deployed state when implanted can be the same as that of Fig. 1B, ¶83, ie. the claims do not specify sufficient conditions of the deployed state to preclude this).
Regarding Claim 11, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, further comprising edge computing circuitry within the compartment that at least preliminarily processes the outputs of at least one of the sensors (6:1-17: the accelerometer performs preprocessing with edge/threshold activity detection in order to save power).
Regarding Claim 12, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, wherein the first and second arms are parallel to the longitudinal axis in the collapsed configuration (as shown in Huang’s, Fig. 1A, the arms would be parallel to the long axis in the modified device).
Regarding Claim 13, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, further comprising supplying electrical power to the sensors and the wireless transmitting means (6:1-17, Fig. 2B: the fully implantable wireless device 200 with sensor package 208 has a battery), yet does not explicitly disclose that the battery is specifically within the compartment. However, Vinci teaches an analogous intravaginal sensor implant having a battery in an interior of the implant (¶43, Fig. 1: battery 4 in interior of implant 2). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a battery in the interior compartment of a device according to the teachings of Johnson, as taught by Vinci, as: a) this would only amount to a selection among known and limited options for predictably powering the device, which would be obvious to try, b) it has long been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70), and c) this would better protect the battery from mechanical or fluid damage.
Regarding Claim 15, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, wherein the device is sized and configured for placement in a vagina of a domestic animal (1:64-67;5:1-32, Fig. 4: domestic cattle).
Regarding Claim 16, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 15, wherein the domestic animal is a porcine sow (Johnson ‘553, ¶27,81: pig, porcine).
Claim 17 is a method claim requiring the apparatus of Claim 15. In the interest of brevity, the detailed explanation of how Johnson/Johnson ‘513 is the same as in Claims 1 and 15 (see above), is not repeated herein, and the claim is treated as are other dependent claims.
Regarding Claim 17, Johnson as modified in Claim 1 teaches the wireless implantable device according to claims 1 and 15, and also teaches a method comprising implanting the device in the vagina of a domestic animal (1:64-67;5:1-32, Fig. 4: domestic cattle).
Regarding Claim 18, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1 and also teaches the method according to claim 17, wherein the domestic animal is a porcine sow (Johnson ‘553, ¶27,81: pig, porcine).
Regarding Claim 19, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, and also teaches the method according to claim 17, further comprising wirelessly transmitting the outputs of the sensors to the receiver while the housing is implanted internally within the animal and the receiver is located externally of the animal (e.g. Fig. 1B, 4, 6:56—7:19, 8:48--9:17: data is communicated between the implant and a base station 450 through networks, including ZIGBEE, via implant antenna 110 and associated circuitry).
Regarding Claim 20, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, and also teaches the method according to claim 17, wherein the first and second arms are in the stowed configuration during the implanting the device, and the first and second arms are expanded to the deployed configuration after the device is implanted internally within the animal (Johnson ‘553, ¶5-6,25,30,33-34,37)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson/Johnson/Vinci/Huang, as applied to Claim 1, and further in view of US 2002/0156394 by Mehrotra.
Regarding Claim 5, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 1, yet does not teach the device further comprising a viscosity sensor configured to collect viscosity data of vaginal fluid of the animal for use in determining the onset of estrus of the animal. However, Mehrotra teaches an analogous intravaginal sensor implant device which includes a viscosity sensor to determine whether an animal is in estrus (e.g. abstract, ¶23,33,44, Fig. 1: wireless implant 18 includes sensors that measure heart rate, temperature, pH, viscosity and other parameters, wherein the viscosity is used to detect an onset of estrus as “just before estrus…the pH and the viscosity of the vaginal fluid changes”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate viscosity measurements to detect the onset of estrus in a device according to the teachings of Johnson, as taught by Mehrotra, in order to predictably determine and/or verify the onset of estrus, which is taught as being desirable by both Johnson (1:63-67) and Mehrotra (e.g. ¶18-19).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson/Johnson/Vinci/Huang, as applied to Claim 13, and further in view of US 2015/0119749 by Graf.
Regarding Claim 14, Johnson as modified in Claim 1 teaches the wireless implantable device according to claim 13, yet does not disclose further comprising a USB port disposed on the housing for charging the power source. However, Graf teaches an analogous fertility monitoring system with a wireless temperature sensor probe (e.g. abstract, ¶2,25, Fig. 1), which includes a USB port for recharging the probe (e.g. ¶27). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a USB charging port in a device according to the teachings of Johnson, as taught by Graf, in order to predictably enable recharging of the device, and thus extending the lifetime of the device without the need for battery replacement.
Allowable Subject Matter
Claim 10 is allowed.
The prior art does not reasonably teach, suggest or render obvious, either alone or in combination, claim 10 as a whole. The closest prior art of record is US 10278675 by Johnson, yet it fails to teach wherein the enclosure is inflatable to increase an effective length and/or cross-section of the first arm encased by the enclosure and that the arms do not protrude outward away from the housing in the collapsed configuration, in addition to the other limitations of Claim 10.
Claims 7-9 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.
In terms of Claim 7, Johnson as modified in Claim 1 fails to further teach a latch and release button (or equivalents thereof) for securing and releasing the arms, as presented in Claim 7. Regarding Claim 8, Johnson as modified in Claim 1 fails to further teach the torsion spring generating a force on each of the first and second arms of 2 to 3 ounces, in addition to the other limitations of Claim 1. Note here that the forces taught by Huang (¶¶ 104-105), refer to forces required for needle penetration, not forces to bias the arms, and thus do not provide teachings and motivation to limit the torsion spring biasing forces specifically to 2-3 ounces. Regarding Claim 9, Johnson as modified in Claim 1, fails to further teach wherein the enclosure is inflatable to increase an effective length and/or cross-section of the first arm encased by the enclosure and that the arms do not protrude outward away from the housing in the collapsed configuration. The foregoing apply in addition to the other limitations of Claim 1.
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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/MANOLIS PAHAKIS/Examiner, Art Unit 3796