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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
-Fig. 3A contains elements 136a and 136b which are not found within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
-[Pg. 14, line 26-27] recites “the another communication interface”. Should possibly read “the other communication interface”
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 19, 27, 30, 37, 38, 42, 43 are objected to because of the following informalities:
-Claims 1, 2, 37, recite “the baby”. Examiner recommends amending to –the human baby—
-Claims 1, 19, 30 recite “the bladder”. Examiner recommends amending to –the inflatable bladder—
-Claim 2 recites “the processor” in line 6. Examiner recommends amending to –wherein the processor—
-Claim 27 recites “of claim 3” in line 1. Examiner recommends amending to –of claim 2—since claim 3 was previously cancelled.
-Claim 38 recites “bonded human” in line 5. Examiner recommends amending to –bonded human; and—
-Claim 38 recites “the detected biological parameters” in line 8-9. Examiner recommends amending to –the detected one or more biological parameters—
-Claim 42 recites “the first communication interface connected to the smart device” in lines 2-3. Examiner recommends deletion of “connected to the smart device.”
-Claim 43 recites “the detected biological parameters” in line 3. Examiner recommends amending to –the detected one or more biological parameters—
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 “heartbeat simulation system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to stimulate a heartbeat of the bonded human. According to the specification the fluid handler includes a pump [Pg. 12, lines 7-9] and equivalents thereof.
-Claim 1 recites “fluid handler” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for causing transport of the fluid in and out of the bladder. According to the specification the fluid handler includes a pump [Pg. 18, lines 13] and equivalents thereof.
-Claim 1 recites “temperature control system” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for controlling a temperature of the fluid transported by the fluid handling system. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 2, and 38 recites “first communication interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for transmitting and receiving information. According to the specification the communication interfaces include a wired connection or wireless transceiver [Pg. 13, lines 19-20] and equivalents thereof.
-Claim 9, and 38 recites “second communication interface” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to communicatively connect to a smart device. According to the specification the communication interfaces include a wired connection or wireless transceiver [Pg. 13, lines 19-20] and equivalents thereof.
-Claim 9 and 11 recites “smart device” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to measure and transmit the one or more biological parameters and communicatively connect to a global communication network. According to the specification the smart device includes wearable technology, jewelry and clothing for fitness and health monitoring [Pg. 14, lines 10-15] and equivalents thereof.
-Claim 38 recites “one or more sensors” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to detect one or more biological parameters of the bonded human. According to the specification the one or more sensors includes heart rate and temperature, sensors [Pg. 13, lines 34-35, and Pg. 14, lines 2-3] and equivalents thereof.
-Claim 39 recites “wireless transceiver” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to connect to the global communication network. According to the specification the wireless transceiver includes Bluetooth, WiFi, RFID, Cellular [Pg. 13, lines 19-20] 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 44 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no mention of a computer, non-transitory computer memory medium, machine readable instructions, algorithm, program, or compiled information other than “It should be understood that any of the algorithms as described herein may be embodied on computer readable media readable by an associated processor for causing the simulator 100, portion thereof, or other components described herein to operate as described.” Further description on the algorithm, and computer readable mediums are not provided. While it is conveniently understood that an algorithm or program is stored in a computer medium, the specification does not provide written description or sufficiently describe how this function is performed or how the result is achieved for “the algorithm or program stored in the computer medium is programmed with information compiled from information corresponding to a plurality of living humans.”
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 4, 6, 12, 19, 22, 30, 36, 37, 38, 42 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.
-The term “relatively” in claim 1 is a relative term which renders the claim indefinite. The terms “relatively inflated and relatively deflated” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
-Claim 2 recites “a first communication interface” in line 3. It is unclear whether this interface is associated with the simulator portion, smart device or the system in general. Further clarification should be provided.
-Claim 2 recites “first communication interface” in lines 4-5. It is unclear whether this is the same or different from the first communication interface originally introduced in claim 2, line 3.
-Claim 2 recites “one or more biological parameters” in lines 11-12. It is unclear whether this is the same or different from the one or more biological parameters originally introduced in claim 2, lines 9-10.
-Claim 2 recites “information relating to operation of the human simulator” in lines 19-20. It is unclear whether this is the same or different from the information relating to operation of the human simulator originally introduced in claim 2, lines 8-9.
-Claim 6 recites “the contoured outer layer of the housing” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 19 recites “outer layer” in line 2. It is unclear whether this is the same or different from the outer layer originally introduced in claim 1, line 3.
-Claim 22 recites “at least portions of the fluid handling system” in lines 2-3. It is unclear what this claim limitation encompasses in terms of at least portions of the fluid handling system. Further clarification should be provided to identify what portions constitute and to what degree a portion fulfills in regard to the limitations of the claim.
-The term “relatively” in claim 30 is a relative term which renders the claim indefinite. The terms “relatively inflated and relatively deflated” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
-Claim 30 recites “the respiration step” in line 12. It is unclear what the respiration step comprises. Further clarification should be provided to identify whether this includes all of the limitations recited within “activating a respiration….respiration rate” or a separate embodiment.
-Claim 30 recites “one or more sensors” in line 12. It is unclear whether these are the same or different from the one or more sensors originally introduced in claim 30, line 9.
-Claim 36 recites “the heartbeat step” in line 1. It is unclear what the heartbeat step comprises. Further clarification should be provided to identify whether this includes all of the limitations recited within “activating a heartbeat….heart rate of the bonded human” or a separate embodiment.
-A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 37 recites the broad recitation “at least one of the baby and the bonded human”, and the claim also recites “displaying information…of the baby and the bonded human” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
-Claim 37 recites “one or more sensors” in line 1. It is unclear whether these are the same or different from the one or more sensors originally introduced in claim 30, line 9.
-Claim 38 recites “a second communication interface” in line 10. It is unclear whether this interface is associated with the simulator portion, smart device or the system in general. Further clarification should be provided.
-Claim 42 recites “a second communication interface” in line 3. It is unclear whether this is the same or different from the second communication interface originally introduced in claim 38, line 10.
-Claim 42 recites “a second communication interface” in line 3. It is unclear whether this interface is associated with the simulator portion, smart device or the system in general. Further clarification should be provided.
Claim limitation “temperature control system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification provides function description of a temperature controller on Pg 11, lines 4-8 however, there is no structural description contained within the specification. There is no corresponding structure provided regarding a second communication interface. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. These limitations appear to be identical to those introduced in claim 30, lines 8-11. Further clarification should be provided.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 44 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) series of mental processes used for compiling data for a plurality of living humans. This judicial exception is not integrated into a practical application because the computer system is recited as performing the generic computer function of communicating with another system to activate them. The non-transitory computer memory readable instructions being configured to cause a processor to activate is a generic function of computer-readable media. Further, mere instructions to apply a judicial exception using a generic computer does not impose meaningful limits on practicing the abstract idea. The claim 44 does not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition.
An analysis of the claims is shown below:
Step 1: Claim 44 is directed to a non-transitory computer memory medium, which is an article of manufacture and thus a statutory category of invention.
Step 2A, prong 1: Claim 44 recites limitations that are directed to an abstract idea. Claim 44 recites instructions for causing the heartbeat simulation system and the respiration simulation system to be activated and the algorithm or program stored in the computer medium is programmed with information compiled from information corresponding to a plurality of living humans. These limitations, under their broadest reasonable interpretation, fall within the mental processes grouping of abstract ideas. It would be practically performable in a human's mind, or with pen and paper, to compile information and determine when simulation systems should be activated. Analyzing information, decision making and compilation of data based on received information is akin to an observation, evaluation or judgement that defines the mental process grouping. Thus, claim 44 is directed to a judicial exception, an abstract idea.
Step 2A, prong 2: Claim 44 does not recite additional elements that integrate the judicial exception into a practical application. Claim 44 recites the following additional elements: a program or algorithm.
The non-transitory memory medium programmed with machine readable instructions are all recited at a high level of generality. The computer system is recited as performing the generic computer function of communicating with another system. The non-transitory memory medium and machine readable instructions being configured to cause a processor to execute steps is a generic function of computer-readable media. Further, mere instructions to apply a judicial exception using a generic computer (the computer system and non-transitory computer-readable memory having instructions thereon that are configured to cause a processor to execute steps) does not impose meaningful limits on practicing the abstract idea.
Thus, claim 44 does not integrate the abstract idea into a practical application.
Step 2B: When considered individually and in combination, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of the computing system, non-transitory computer memory, non-transitory computer memory having machine readable instructions thereon, and simulation system are all recited at a high level of generality. The computer system is recited as performing the generic computer function of communicating with another system. The non-transitory computer-readable memory's instructions being configured to cause a processor to execute steps is a generic function of computer-readable media. Mere instructions to apply a judicial exception using a generic computer (the computer system and non-transitory computer-readable memory having instructions thereon that are configured to cause a processor to execute steps) does not impose meaningful limits on practicing the abstract idea. Furthermore, the instructions can be considered as nonfunctional descriptive material because there are no elements that show how the instructions interact with the computer system or non-transitory computer-readable memory, which can make the instructions read on MS word files, pdf files, or text files that merely show instructions to a user (MPEP 2111.05).
This judicial exception is not integrated into a practical application because the claims, as written, can be performed in a physician or surgeon's mind, or implemented with pen/paper. While claim 44 recites the additional elements of an algorithm or program these additional elements are not sufficient to amount to significantly more than the judicial exception because the mental steps of "causing the..to be activated" and "programmed with…humans" are merely being implemented on generic computer elements and thus do not add a meaningful limitation to the abstract idea since they simply amount to implementing the abstract idea on a generic computer and computer component (memory containing an application which is essentially an on/off switch and data storage element.
And with respect to the recitation of "an algorithm or program”, where in the algorithm or program is programmed with information compiled from information corresponding to a plurality of living humans," this likewise amounts to an added generic step of "apply it" (or equivalent thereof) by simply reciting using an algorithm or program, which could be implemented using a generic computer application "program" lacking any further specification. However, such a program is well-understood and conventional in the art as suggested by Groves in U.S. Pub. No. 20080201855 [0031].
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.
Claim(s) 1, 2, 4, 6, 9, 11, 19, 22, 25, 30, 36, 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anabalon (U.S. 20140330070).
Regarding Claim 1, Anabalon teaches a human simulator configured to simulate interaction between a human baby and a bonded human [0041]; , the simulator comprising: a housing having an outer layer configured to contact the baby [0099; “Mattress 60 has a lying area 61 with a foot end 62, a head end 63, and long sides 65. A hollow space 68 with a plurality of openings 69 are provided on both of the opposite long sides 65 of lying area 61.”] and [Fig. 15, element 66 (surface of the body)]—interpreted to be the outer layer, the housing having a surface contoured to simulate a torso of the bonded human [Fig. 1, element 61]—depicting the outer surface having a shape similar to a curved torso;
a respiration simulation system positioned at least in part within the housing and configured to simulate a respiration motion of the bonded human[0103]—describes lying area and mattress that raises and lowers according to chest breathing movements of the mother;
a heartbeat simulation system positioned at least in part within the housing and configured to simulate a heartbeat of the bonded human [0129]—reference to the second bladder generating body-borne sound;
wherein the respiration simulation system comprises a bladder system comprising an inflatable bladder having a relatively inflated state and a relatively deflated state [0031] and [0131]-discussions on the inflatable bladders expanding and filling with fluid to mimic a mother’s chest, and a fluid handling system configured to move fluid into or out of the inflatable bladder between the relatively inflated state and relatively deflated state to simulate the respiration motion [0029]—describes the components of the fluid handling system including bladders, lying area, control unit, pump, compressor and control bladder; and
wherein the fluid handling system comprises a fluid handler for causing transport of the fluid in and out of the bladder [0033]—reference to a pump, a power supply for operating the fluid handler [0033]—reference to devices for power transfer, and a temperature control system for controlling a temperature of the fluid transported by the fluid handling system [0134; “The elastic material of body 66 has in particular as high a thermal conductivity as possible in order to enable uniform temperature control within an incubator 22 (cf. FIG. 2).”]—where the material of the body and the incubator are interpreted to be the temperature control system.
Regarding Claim 2, Anabalon teaches wherein the human simulator further comprises: a first communication interface [0100; “A first data stream 27 is transmitted from sensor unit 30 to control unit 80.”] configured for transmitting and receiving information with at least one second communication interface external to the simulator [0100; “second data stream 28 is transmitted from control unit 80 to sensor unit 30.”], first communication interface including a wireless transceiver [Fig. 9, element 87 (receiver)];
a processor coupled to the first communication interface [Fig. 9, element 90 (processor)], the processor is configured to: receive, via the first communication interface, information relating to operation of the human simulator and information relating to one or more biological parameters of the baby in contact with the outer layer [0122]—describes the sensory stimuli generated by the first data stream of the control unit, and controlled via the data processing device (processor) to vary the volume of the control bladder according to breathing movements acquired by the reference person.
receive, via the first communication interface, an input relating to one or more biological parameters of the bonded human, including at least a measured respiration rate and a measured heartrate [0122]—as described above and including the reference to the measured heart sounds acquired from the reference person used in addition to the respiration sounds to control fluid input to the bladder system;
activate the respiration simulation system based on the received input [Fig. 10, element 104 (generating a sensory stimulus)], including activating the respiration simulation system in a timed sequence in conformance with the measured respiration rate of the bonded human [0103; “First bladders 72 are provided and designed for low frequency raising and lowering of lying area 61 according to the chest breathing movements of mother 20.”]; and
activate the heartbeat simulation system based on the received inputs [Fig. 10, element 104 (generating a sensory stimulus)] including activating the heartbeat simulation system in a timed sequence in conformance with the measured heart rate of the bonded human [0103; “Second bladder 73 is provided and designed for generating body-borne sound or vibrations in lying area 61, particularly according to the heart sounds of mother 20.”]; and
a display connected to the processor and configured to display information relating to operation of the human simulator and information relating to the one or more biological parameters of the baby [Fig. 5, element 45 (display)] and [0107]—referencing displaying infant information including “its state of health…blood oxygen saturation and other parameters.”, the bonded human, or a combination thereof.
Regarding Claim 4, Anabalon teaches wherein the outer layer comprises material having one or more properties selected to simulate human skin, the outer layer further comprising an anti-microbial material [0065]—describes the elastic material similar to that of the human body including materials known to have antimicrobial properties such as latex.
Regarding Claim 6, Anabalon teaches wherein the housing extends along a length between a first end portion and a second end portion [Fig. 1, elements 62 (foot end) 63 (head end)], the contoured outer layer of the housing including a concave area for receiving a head portion of the human baby [Fig. 1, element 61 (lying area)]—depicted as showing a contour that fits the shape of the human baby and includes a portion for receiving a head portion of the baby on head end, element 63 (head portion), and wherein the contoured outer layer further comprises a pillow for providing support to the head portion and a neck portion of the human baby [Fig. 12, element 63 (head end)]—depicting an area to support and prop the head of the infant in the incubator.
Regarding Claim 9, Anabalon teaches wherein the wireless transceiver is communicatively connected to the at least one second communication interface [Fig. 9, element 87 (receiver)], wherein the at least one second communication interface is embodied in or communicatively connected to a smart device [Fig. 8, element 30]—where element 30 is a wearable device [0098], configured to measure and transmit the one or more biological parameters of the bonded human to the human simulator [Fig. 8, elements 43 (sensors), 47 and 48 (receiver and transmitter)].
Regarding Claim 11, Anabalon teaches wherein the one or more biological parameters are detected by one or more sensors embodied in the smart device [0113], the smart device configured to communicatively connect to a global communication network or to a mobile device [0113]—reference to WLAN, Wifi GSM, UMTS for data streaming also [0057]—reference to transmission channel for both devices comprising “the Internet…and/or other technologies”.
Regarding Claim 19, Anabalon teaches wherein the bladder and outer layer are separate components positioned adjacent each other [0030], with the bladder extending along a length of the outer layer [Fig. 15, elements 72/73 (first and second bladders)].
Regarding Claim 22, Anabalon teaches wherein the human simulator is positionable within an incubator [0028], and at least portions of the fluid handling system, are disposed external to the incubator [0033]—reference to control bladders, pumps, etc. disposed outside of the incubator.
Regarding Claim 25, Anabalon teaches wherein the heartbeat simulation system is configured to provide a simulated heart rate as a pulsed vibration [0030], a predetermined series or sequence of pulsed vibrations [0030], an auditory signal [0117]—reference to signal provided via microphone and loudspeaker, or a combination thereof.
Regarding Claim 30, Anabalon teaches a method of using a human simulator configured to simulate interaction between a human baby and a bonded human[0041], the steps comprising:
positioning the human baby on an outer layer of the human simulator [Fig. 1, element 21 (infant), 61 (lying area)]; activating a respiration simulation system to simulate a respiration motion of the bonded human via activating a fluid handling system to transport fluid into and out of an inflatable bladder to move the bladder between a relatively inflated state and a relatively deflated state at a predetermined respiration rate [0103], [0031], 0131]-discussions on the inflatable bladders expanding and filling with fluid to mimic a mother’s chest and [0029]—describes the components of the fluid handling system including bladders, lying area, control unit, pump, compressor and control bladder;
activating a heartbeat simulation system to simulate a heartbeat of the bonded human via detecting [0129]—reference to the second bladder generating body-borne sound, via one or more sensors disposed adjacent the bonded human [0113], a heart rate of the bonded human [0017]—corresponds to heart sounds, and activating the heartbeat simulation system to simulate a heart rate based on the detected heart rate of the bonded human [0103; “Second bladder 73 is provided and designed for generating body-borne sound or vibrations in lying area 61, particularly according to the heart sounds of mother 20.”]; and
wherein the respiration step further includes detecting, via one or more sensors disposed adjacent the bonded human [0113]—reference to sensors acquiring stimuli information from the reference person, a body temperature of the bonded human [0119; “Alternatively or in addition, in first step 101 the body temperature of reference person 20 can be acquired.”], and activating a temperature controller for the fluid handling system to control a temperature of the fluid based on the detected body temperature of the bonded human [0134; “The elastic material of body 66 has in particular as high a thermal conductivity as possible in order to enable uniform temperature control within an incubator 22 (cf. FIG. 2).”]—where the material of the body and the incubator are interpreted to be the temperature control system.
Regarding Claim 36, Anabalon teaches wherein the heartbeat step includes detecting [0129], via one or more sensors disposed adjacent the bonded human [0113], a heart rate of the bonded human [0017], and activating the heartbeat simulation system to simulate a heart rate based on the detected heart rate of the bonded human [0103].
Regarding Claim 37, Anabalon teaches further comprising detecting, via one or more sensors, one or more biological parameters of at least one of the baby [0123] and the bonded human [0113], and displaying information relating to the one or more biological parameters of the baby and the bonded human [0051]—interpreting this limitation to only require displaying biological parameters related to the baby since the previous limitation requires at least one of the baby and the bonded human.
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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anabalon (U.S. 20140330070) in view of Olmstead (U.S. 20150302776).
Regarding Claim 27, Anabalon is silent on wherein the display comprises a capacitive or pressure touch screen user interface integrated into the display. Olmstead teaches wherein the display comprises a capacitive or pressure touch screen user interface integrated into the display [0094]—reference to the user interface displayed on a touch screen tablet or smart phone.
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 display to be touch screen as taught by Olmstead to receive input from the user on the user interface as suggested by Anabalon as Anabalon discusses the use of a keyboard or some other user interface [0119] with Olmstead because Olmstead teaches using conventional inputs to tie directly into a patient’s record [0094].
Claim(s) 28, 44, 38, 39, 41, 42, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anabalon (U.S. 20140330070) in view of Holsti (U.S. 20170252532).
Regarding Claim 28, Anabalon is silent on wherein the housing is mounted on a base configured to support at least the housing, such that the housing is elevated relative to the base, and wherein the housing is pivotable about a pivot axis between a first position and a second position, wherein in the first position, the housing is parallel to the base and in the second position, the housing is oriented obliquely relative to the base. Holsti teaches wherein the housing is mounted on a base configured to support at least the housing [Fig. 1, elements 12 (housing), 20 (base)], such that the housing is elevated relative to the base [0104; “One or more actuators 22 may be operated to pivot platform 22 about the horizontal axis with the result that the other end of platform 20 moves with the desired substantially-vertical motion at the nominal position where an infant's head would be placed.”], and wherein the housing is pivotable about a pivot axis between a first position and a second position [0107; “In some embodiments platform 20 is arranged so that it is tilted. In some embodiments a degree of tilt of platform 20 is adjustable either stepwise or continuously. Platform 20 may comprise a drain located in an area that is low when the platform is tilted.”], wherein in the first position, the housing is parallel to the base and in the second position [Fig. 1], the housing is oriented obliquely relative to the base [0104 and 0107].
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 tilt of the platform and base assembly as taught by Holsti to provide accessibility to the infant as suggested by Anabalon as Anabalon discusses using outer circumferential slits to provide accessibility [0105] with Holsti because Holsti teaches using means such as doors to facilitate access to an infant [0093].
Regarding Claim 44, Anabalon is silent on a non-transitory computer memory medium programmed with machine readable instructions for operating the human simulator of claim 1, the machine readable instructions comprising instructions for causing the heartbeat simulation system and the respiration simulation system to be activated in accordance with an algorithm or program stored in the computer memory medium, and wherein the bonded human is a simulated human, and the algorithm or program stored in the computer medium is programmed with information compiled from information corresponding to a plurality of living humans.
Holsti teaches a non-transitory computer memory medium programmed with machine readable instructions for operating the human simulator the machine readable instructions comprising instructions for causing the heartbeat simulation system and the respiration simulation system to be activated in accordance with an algorithm or program stored in the computer memory medium, and wherein the bonded human is a simulated human [0173; “The program product may comprise any non-transitory medium which carries a set of computer-readable instructions which, when executed by a data processor in a control system for apparatus as described herein cause the data processor to control the apparatus to execute a method of the invention.”], and the algorithm or program stored in the computer medium is programmed with information compiled from information corresponding to a plurality of living humans [0052; “a memory storing pre-recorded digitized heartbeat sounds or a sound generator configured to generate simulated heartbeat sounds.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include programming for the system as taught by Holsti to allow for activation and operation of the device as suggested by Anabalon as Anabalon discusses using volatile and non-volatile memories coupled with the device [0117] with Holsti because Holsti teaches using these automated features as part of routines that can be used in a variety of different ways [0171].
Regarding Claim 38, Anabalon teaches a monitoring system for use with a human simulator configured to simulate interaction between a human baby and a bonded human [Fig. 1, element 30 (sensor unit)] and [0041], the monitoring system comprising: a smart device Fig. 8, element 30]—where element 30 is a wearable device [0098] having a first communication interface [0100; “A first data stream 27 is transmitted from sensor unit 30 to control unit 80.”];
one or more sensors configured to detect one or more biological parameters of the bonded human [0113];
at least one processor [0111]—reference to the sensor unit having a data processing device;
and to transmit a signal corresponding to the detected biological parameters of the bonded human from the first communication interface via a global communication network to a second communication interface connected to the human simulator [0100], [0113]—reference to WLAN, Wifi GSM, UMTS for data streaming also [0057]—reference to transmission channel for both devices comprising “the Internet…and/or other technologies”.
Anabalon is silent on wherein the at least one processor is programmed with machine readable instructions to activate the one or more sensors. Holsti teaches wherein the at least one processor is programmed with machine readable instructions to activate the one or more sensors [0173] and [Fig. 4, elements 32 and 34]-depicting the system activating sensors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to activate the sensing portion of the device as taught by Holsti to enable feedback from the device as suggested by Anabalon as Anabalon discusses using this feedback to facilitate bidirectional interaction between the reference person and baby [0052] with Holsti because Holsti teaches using certain feedback from the sensors to enable automatic control of the apparatus [0119].
Regarding Claim 39, Anabalon teaches wherein the smart device comprises wearable technology [0098], and wherein the first communication interface is a wireless transceiver configured to connect to the global communication network, a mobile device, or a combination thereof [Fig. 9, element 87 (receiver)]; [0113]—reference to WLAN, Wifi GSM, UMTS for data streaming also [0057]—reference to transmission channel for both devices comprising “the Internet…and/or other technologies”.
Regarding Claim 41, Anabalon teaches wherein the at least one processor includes a local processor embodied in the smart device, the local processor being connected to the first communication interface and the one or more sensors [0111; “Transmitter 47 and receiver 48 can each have a data processing device, for example, for analog-to-digital conversion, for digital-to-analog conversion, for data compression, or for data decompression.”] and [Fig. 8, elements 47 (transmitter), 48 (receiver), 42 (sensors).
Regarding Claim 42, Anabalon teaches wherein the at least one processor includes an external processor for interfacing the first communication interface connected to the smart device and a second communication interface connected to the human simulator [Fig. 9, element 90 (processing unit)].
Regarding Claim 43, Anabalon teaches wherein the mobile device comprises a computer memory medium [0117]. Anabalon is silent on programmed with instructions for storing and analyzing the detected biological parameters of the bonded human. Holsti teaches programmed with instructions for storing and analyzing the detected biological parameters of the bonded human [0173].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include programming for the system as taught by Holsti to allow for activation and operation of the device as suggested by Anabalon as Anabalon discusses using volatile and non-volatile memories coupled with the device [0117] with Holsti because Holsti teaches using these automated features as part of routines that can be used in a variety of different ways [0171].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Cloud (U.S. 10201236)-includes a soothing system/pillow for simulating breathing and heartbeat patterns of a mother.
-Devroey (U.S. 20130096368)-directed towards a uterine simulation device
-Cummins (U.S. 4066072)-references a cushion with fluid bladders and heartbeat/respiratory alarms.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791