DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This office action is responsive to the preliminary amendment filed on April 20, 2023. As directed by the amendment: no claims have been amended, claims 1-18 have been cancelled, and claims 19-36 have been added. Thus, claims 19-36 are presently pending in this application.
Information Disclosure Statement
3. The information disclosure statement filed April 20, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered because foreign patent document 1 does not include an English translation or summary.
Claim Interpretation
4. 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.
5. 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.
6. 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:
“output unit” in claim 21 line 2.
“thorax compression device” in claim 22 lines 2 and 3, claim 23 line 2, claim 24 line 2, claim 28 lines 3 and 11, and claim 29 line 3 are interpreted as a compression head which is advanceable and retractable along an axis or the like according to page 9 lines 1-2 of the specification.
“output device” in claim 23 line 2.
“guide device” in claim 25 line 2 and claim 36 line 10 are interpreted as an optical marking, a haptic design, or the like according to page 19 lines 12-13 of the specification. The “guide device” in claim 26 line 1 and claim 27 line 1 are provided with sufficient structure and are not interpreted under 112f.
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
7. 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.
8. Claim(s) 25-36 is/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.
Regarding claims 25¸ the limitation “a thorax of a patient being compressed along the search path within the scope of a cardiopulmonary resuscitation” in lines 2-4 makes the claim indefinite because the recited limitation appears to be a method step thereby making it unclear if the claim is directed to a device or a method. The claim is being interpreted as –the cardiac massage is configured to compress a thorax of a patient along the search path--.
Regarding claim 28¸ the limitation “outputting an instruction to a human aider and/or controlling a thorax compression device“ in lines 2-3 is indefinite because the following limitation “outputting a previously determined measure as an instruction to the human aider controlling the thorax compression device” in lines 10-11 suggests the instructions must be provided to a human aider, however, in the case the instructions are only provided to the thorax compression device there would be no human aider. The limitation is being interpreted as –outputting an instruction to a human aider for controlling a thorax compression device--.
Regarding claim 35¸ the limitation “component-by-component” in line 2 is indefinite because it is unclear what components are being referred to. The limitation is being interpreted as –including an optimization of the position and direction of the action of force on the thorax of a patient--.
Any remaining claims are rejected as being dependent upon a rejected based claim.
9. Claim limitations “output unit” in claim 21 line 2 and “output device” in claim 23 line 2 invoke 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 disclosure is devoid of any structure that performs the function in the claims. 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.
Claim Rejections - 35 USC § 101
10. 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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
11. Claims 19-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 19-24 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 19-24 recites at least one step or instruction for analyzing data and performing a calculation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). The claimed limitations involve data analysis and evaluation which are examples of mental processes in MPEP 2106(a)(2)(III).
Accordingly, each of Claims 19-24 recites an abstract idea.
Specifically, Claim 19 recites “at least one computing unit; at least one sensor interface for establishing a connection to at least one sensor; and a memory” (additional element);
“wherein the computing unit is configured to ascertain success of a cardiac massage, and wherein a measure for adjusting at least one parameter of the cardiac massage is derivable from the ascertained success.” (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
Further, dependent Claims 20-24 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claim 19 (and their respective dependent Claims 20-24) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 19), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: a computing unit, a sensor interface, a sensor, a memory, a control device, an output unit, and an output device as recited in independent claim 19 and its dependent claims are generically recited computer elements in independent Claim 19 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 19 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., computing unit or control device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 19 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 19 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 19-24 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: a computing unit, a sensor interface, a sensor, a memory, a control device, an output unit, and an output device as recited in independent Claim 19 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the computing unit is recited to aid in monitoring the success of the cardiac massage over time (see specification page 24 lines 11-13), the control device is recited to control a ventilator (see specification page 24 lines 1-2)
Accordingly, in light of Applicant’s specification, the claimed term “computing unit” and “control device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing unit or control device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 19-24 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claims 19-24 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
In re-evaluating the additional elements under step 2B, the sensor in claim 1 line 4, ventilation apparatus in claim 20 line 2, and thorax compression device in claim 22 lines 2-3, claim 23 line 2, and claim 24 line 2 appears to be routine and conventional in the art as exhibited by Kelly (US 5,496,257) discloses a portable apparatus for assisting CPR and states blood flow sensors which use ultrasonic transducers are well known in the art (see col. 7, lines 12-14). Ferrero Lindlau (US 2022/0362101) discloses a device for cardio-pulmonary resuscitation of a patient and states that known devices include a ventilation mask which can be considered a ventilation apparatus (see paragraph [0005]), and Havardsholm et al. (US 2007/0270724) discloses a resuscitation system with a chest compression device and states that there are previously known automatic chest compression devices (see paragraph [0007]).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 19-24 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 19-24 amounts to significantly more than the abstract idea itself. Accordingly, Claims 19-24 are not patent eligible and rejected under 35 U.S.C. 101.
12. Claims 25-27 and 36 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 25 and 36 recite the limitation “a thorax of a patient being compressed along the search path within the scope of a cardiopulmonary resuscitation” in claim 25 lines 2-4 and claim 36 lines 10-11. The term “a thorax of a patient” is being positively claimed and therefore falls under the scope of human organisms.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 102
13. 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.
14. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
15. Claim(s) 19-20, 22, and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Härdig et al. (US 2019/0117499) hereinafter Hardig.
Regarding claim 19¸ Hardig discloses an apparatus for cardiopulmonary resuscitation (fig. 1, CPR device 100), comprising: at least one computing unit (fig. 1, controller 102); at least one sensor interface for establishing a connection to at least one sensor (fig. 1, communication between controller 102 and angles sensors 142 and 146, and communication with pressure sensor 150); and a memory (fig. 1, memory 122), wherein at least one vital parameter of a patient is rendered acquirable by the at least one sensor (fig. 1, physiological parameter sensor 138 can detect blood pressure, oxygen saturation, ventilation, temperature, and pulse, see [0040]), wherein the acquired measured values of the at least one vital parameter are storable in the memory ([0036] states the memory can store patient data), wherein the computing unit is configured to ascertain success of a cardiac massage ([0042] states that the controller 102 can receives pressure signals from the pressure sensor and determine if the contact surface should be adjusted, [0011] states an optimal position for chest compression differs between patients, and [0012] states that compression depth should be maintained where the optimal position and depth are defined as the ascertained success), and wherein a measure for adjusting at least one parameter of the cardiac massage ([0042] states that when it is determined that the orientation of the contact surface should be adjusted, the contact surface moves to contact the chest at an alternative orientation) is derivable from the ascertained success ([0042] the contact surface adjusts to maintain a proper depth, [0012]).
Regarding claim 20, the device of Hardig reads on the limitations of claim 19 and further reads on a ventilation apparatus (fig. 1, other medical device 132 can be a ventilator, see [0038]) for ventilating the patient ([0038] further states ventilation can be coordinated during CPR) and a control device for controlling the ventilation (fig. 1, controller 102 includes communication module 128 which communicates with another medical device 132 according to [0038]).
Regarding claim 22, the device of Hardig reads on the limitations of claim 19 and further reads on a thorax compression device (fig. 1, chest compression device 104 includes piston 106 and contact member 154) for compressing the thorax of the patient ([0034] states the contact member 154 is for contacting the patient’s chest) and a control device (fig. 1, controller 102) for controlling the thorax compression device ([0033] states that controller 102 communicates with the chest compression device 104).
Regarding claim 24, the device of Hardig reads on the limitations of claim 22 and further reads on the thorax compression device (fig. 1, chest compression device 104) is configured so that a direction of the action of force on the thorax of the patient is modifiable ([0042] states that an orientation of the contact surface on the patient can be adjusted) based on a measure that is determinable by the computing unit ([0042] states that controller 102 receives pressure signal 152 to determine if the orientation of the contact surface 116 should be adjusted).
Claim Rejections - 35 USC § 103
16. 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.
17. Claim(s) 19, 21, and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gold (US 2018/0338887) in view of Siedenburg (US 2018/0369065).
Regarding claims 19 and 21, Gold discloses an apparatus for cardiopulmonary resuscitation (fig. 1, CPR training apparatus 10) comprising: at least one computing unit (fig. 2A, controller 12 can be incorporating into prompting device 13); at least one sensor interface for establishing a connection (fig. 2A, bridge 18) to at least one sensor (fig. 2A, distributed sensor 11); and a memory ([0028] states a target compression location can be stored which inherently requires some sort of storage unit), wherein the computing unit is configured to ascertain success of a cardiac massage ([0028] states the provided therapy is compared to a stored value to determine if the compression location is adequate), and wherein a measure for adjusting at least one parameter of the cardiac massage is derivable from the ascertained success ([0028] states the compression location can be compared, [0034] states a sensed force is compared to an ideal force, and [0038] states the controller can compare the frequency of the provided compressions to a recommended frequency), further comprising an output unit for the optical (fig. 2A, light emitting elements 16) and/or acoustic output (fig. 2A, audio device 20) of instructions for a human aider ([0032]-[0033] states that performance information can be delivered which includes instructions). The apparatus of Gold does not expressly disclose that at least one vital parameter of a patient is acquired by at least one sensor and is stored in memory.
However, Siedenburg teaches of a non-invasive blood pressure system for determining an efficacy of administered cardiopulmonary resuscitation (see abstract and fig. 2, non-invasive blood pressure device 200) which acquires various vital parameters ([0039] states that vital signs can be detected, see fig. 2, vital signs module 208) and a memory for storing data ([0022] states that fig. 2, memory 206, can store data and instructions) for the purpose of assessing the efficacy of the CPR and providing feedback regarding altering the position of the compressions ([0039]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the apparatus of Gold with the non-invasive blood pressure device of Siedenburg to further provide instruction to the user about optimal compression depth, rate, and position based on the vital parameters of the patient (Siedenburg [0039]).
Regarding claim 25, the modified apparatus of Gold as presented in the rejection to claim 21 above reads on the limitations of claim 19 and further reads on a guide device that defines a search path (Gold fig. 2A, distributed sensor 11 senses chest compression applied throughout the surface area, where pressure is concentrated, and an angle of pressure, see [0026], where the entire sensor can be defined as a search path), a thorax of a patient being compressed along the search path within the scope of a cardiopulmonary resuscitation (Gold [0026] states that chest compressions are delivered over the distributed sensor 11).
Regarding claim 26¸ the modified apparatus of Gold reads on the limitations of claim 25 and further reads on the guide device is realized by an optical marking (Gold fig. 2B, pad 5 can further include placement aide 14 to fit under a sternum) on the pad (Gold fig. 2B, pad 5).
18. Claim(s) 19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gold in view of Siedenburg and Itnati (US 2010/0198118).
Regarding claims 19 and 23, Gold discloses an apparatus for cardiopulmonary resuscitation (fig. 1, CPR training apparatus 10) comprising: at least one computing unit (fig. 2A, controller 12 can be incorporating into prompting device 13); at least one sensor interface for establishing a connection (fig. 2A, bridge 18) to at least one sensor (fig. 2A, distributed sensor 11); and a memory ([0028] states a target compression location can be stored which inherently requires some sort of storage unit), wherein the computing unit is configured to ascertain success of a cardiac massage ([0028] states the provided therapy is compared to a stored value to determine if the compression location is adequate), and wherein a measure for adjusting at least one parameter of the cardiac massage is derivable from the ascertained success ([0028] states the compression location can be compared, [0034] states a sensed force is compared to an ideal force, and [0038] states the controller can compare the frequency of the provided compressions to a recommended frequency), and an output device for outputting instructions to a human aider (fig. 2A, light emitting elements 16 and audio device 20). The apparatus of Gold does not expressly disclose that at least one vital parameter of a patient is acquired by at least one sensor and is stored in memory, and is silent on a thorax compression device.
However, Siedenburg teaches of a non-invasive blood pressure system for determining an efficacy of administered cardiopulmonary resuscitation (see abstract and fig. 2, non-invasive blood pressure device 200) which acquires various vital parameters ([0039] states that vital signs can be detected, see fig. 2, vital signs module 208) and a memory for storing data ([0022] states that fig. 2, memory 206, can store data and instructions) for the purpose of assessing the efficacy of the CPR and providing feedback regarding altering the position of the compressions ([0039]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the apparatus of Gold with the non-invasive blood pressure device of Siedenburg to further provide instruction to the user about optimal compression depth, rate, and position based on the vital parameters of the patient (Siedenburg [0039]).
Regarding a thorax compression device, Itnati teaches of an external massage device for CPR ([0119]) which comprises a motor (fig. 1A, 14) and a plate-plunger (fig. 1A, 38).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the apparatus of Gold with the external massage device of Itnati in order to ensure force, rate, and duration of compressions are steady and limit fatigue to the operator (Itnati [0036]).
19. Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gold in view of Siedenburg as presented in claim 25 above, and further in view of Votel (US 2009/0234255).
Regarding claim 27¸ the modified device of Gold reads on the limitations of claim 25, but is silent on the guide device being a guide rail that extends along the search path and in which a handle is displaceably mounted so that an action of force on the handle at a respective position along the search path is transferred to the thorax of the patient.
However, Votel teaches of a CPR device (fig, 1, 100) that includes a compression element (fig. 1, 152) and frame elements (fig. 1, 164 and 166) where the compression element 152 is longitudinally adjustable along the compression member frame 150 ([0029]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the apparatus of Gold with the CPR device of Votel to minimize risk to the practitioner and improve the effectiveness of the compressions (Votel [0002] states that a practitioner’s hands are not optimal and performing CPR on a gurney includes injury risks).
20. Claim(s) 28-33 and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardig in view of Siedenburg.
Regarding claim 28, Hardig discloses a method for controlling an apparatus for cardiopulmonary resuscitation (fig. 8), comprising the steps of: controlling a thorax compression device for purposes of starting a cardiac massage (fig. 8, step 806 performs CPR compressions of a patient, the first cycle of which can be defined as starting) with starting parameters including a starting position, a starting angle, a starting compression depth, and a starting frequency ([0006] states that CPR chest compression machines can be programmed with a recommended frequency and depth, and there is inherently a starting position and angle when the device is applied, see [0011]); acquiring at least one vital parameter of a patient ([0060] states a physiological parameter, an input from another medical device, or an input by a user can be used to advise step 802) and the compression depth and the frequency of the cardiac massage ([0035] states the controller can control the rate and depth of the chest compression); determining a measure that corresponds to an adjustment of at least one of the parameters of a position of an action of force, direction of the action of force ([0061] states that in step 804, after receiving instruction, the device can pivot the contact member or adjust a leg of the device to a second position); and further discloses the contact surface being moved, but does not expressly disclose that the success of the cardiac massage is ascertained and then instructions are outputted to a human aider.
However, Siedenburg teaches of a method for using a non-invasive blood pressure device for controlling chest compression ([0039]) which measures the efficacy of CPR based on vital signs and subsequently output user instruction for adjusting treatment CPR feedback ([0039]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the direct communication between the instructions and the thorax compression device of Hardig with a user instruction for administering treatment as taught by Siedenburg as a simple substitution of one known element for another to obtain a predictable result of communicating instructions between a computer and thorax compression device.
Similarly, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the instruction generating portion of step 802 of Hardig with the vital sign evaluation of Siedenburg as is contemplated by Hardig (Hardig [0060] states that instructions received may be based on physiological parameters or from another medical device).
Regarding claim 29, the modified method of Hardig reads on the limitations of claim 28 and further reads on the outputting of the previously determined measure to a human aider and/or the controlling of a thorax compression device (Siedenburg [0039] states CPR feedback is provided to a user) is followed by an acquisition of at least one vital parameter of the patient (Siedenburg [0039] evaluates vital signs to create CPR feedback), and a success of the measure is ascertained in a further method step (Siedenburg [0039] states that vital signs are used to determine efficacy of the CPR prior to providing CPR feedback), and a determination of a subsequent measure is implemented in a further method step (Hardig fig. 8, after the device is adjusted in step 804 and compressions are performed in step 806, further adjustments can be made in a subsequent step 802).
Regarding claim 30, the modified method of Hardig reads on the limitations of claim 29 and further reads on implementing the determination of the subsequent measure (Hardig fig. 8, step 802 occurs when instructions are received, see [0060]) based on the success of the preceding measure (Siedenburg [0039] states that an efficacy of CPR applied can be found based on measured vital signs which is then communicated to alter CPR values).
Regarding claim 31, the modified method of Hardig reads on the limitations of claim 28 and further reads on optimizing at least one of the parameters of the position of the action of force on the thorax of the patient (Hardig [0061] states that the CPR device can adjust at least one leg of the device, fig. 1, 110, which would inherently change the position of the contacting surface), the direction of the action of force on the thorax of the patient (Hardig [0061] states that the contact member can pivot relative to the piston which would alter the direction of the force), the compression depth (Siedenburg [0039] states that compression depth can be altered in response to CPR feedback, and Hardig [0035] states the device can operate at various rate and depths), and the frequency of the cardiac massage (Siedenburg [0039] states that compression frequency can be altered in response to CPR feedback, and Hardig [0035] states the device can operate at various rate and depths) by determining the measures and ascertaining the success of the respective measure (Siedenburg [0039] states that vital signs can be monitored to determine efficacy of applied CPR).
Regarding claim 32, the modified method of Hardig reads on the limitations of claim 31 and further reads on implementing the optimization of the position of the action of force on the thorax of the patient and/or the optimization of the direction of the action of force on the thorax of the patient is implemented along a search path (Hardig fig. 1, where the search path are the potential positions allowed by the pivoting of contact member 154 and legs 110 as suggested by [0061]), with a traversal of the search path being followed by ascertainment of the position and/or direction of the action of force on the thorax of the patient where success was greatest (Siedenburg [0039] states that efficacy is evaluated based on vital signs for giving CPR feedback, therefore if efficacy was greatest in a previous position, the CPR feedback would inherently advise returning to a point where efficacy is greatest).
Regarding claim 33, the modified method of Hardig reads on the limitations of claim 32 and further reads on the search path is specified (Hardig [0061] states the contact head can be moved from a first to second orientation and at least one leg can move from a first to second position) and loaded from a memory at a start of the method (Hardig [0036] states that instructions are stored in the memory to be read by the processor), with the subsequent measure being given by a next point on the search path (Hardig [0061] where the next point is defined as the second orientation and second position), at least during the optimization of the parameters of the position of the action of force on the thorax of the patient (Siedenburg [0039] states that CPR feedback can be given regarding compression element position) or a joint optimization of the position and direction of the action of force on the thorax of the patient (Hardig [0061] states that the contact member can pivot with respect to the piston thereby adjusting direction and additionally can move at least one leg of the device thereby adjusting the position).
Regarding claim 35, the modified method of Hardig reads on the limitations of claim 31 and further reads on a component-by-component optimization (Siedenburg [0039] states that the efficacy of CPR is determined and then CPR feedback is provided for adjusting the device) of the parameters of position and direction of the action of force on the thorax of a patient (Hardig [0061] states that the contact member can pivot relative to the piston for adjusting direction, and the legs of the device can move which adjusts position).
Regarding claim 36, the modified method of Hardig reads on the limitations of claim 28 and further reads on using an apparatus for cardiopulmonary resuscitation that comprises: at least one computing unit (fig. 1, controller 102); at least one sensor interface for establishing a connection to at least one sensor (fig. 1, communication between controller 102 and angles sensors 142 and 146, and communication with pressure sensor 150); and a memory (fig. 1, memory 122), wherein at least one vital parameter of a patient is rendered acquirable by the at least one sensor (fig. 1, physiological parameter sensor 138 can detect blood pressure, oxygen saturation, ventilation, temperature, and pulse, see [0040]), wherein the acquired measured values of the at least one vital parameter are storable in the memory ([0036] states the memory can store patient data), wherein the computing unit is configured to ascertain success of a cardiac massage ([0042] states that the controller 102 can receives pressure signals from the pressure sensor and determine if the contact surface should be adjusted, [0011] states an optimal position for chest compression differs between patients, and [0012] states that compression depth should be maintained where the optimal position and depth are defined as the ascertained success), and wherein a measure for adjusting at least one parameter of the cardiac massage ([0042] states that when it is determined that the orientation of the contact surface should be adjusted, the contact surface moves to contact the chest at an alternative orientation) is derivable from the ascertained success ([0042] the contact surface adjusts to maintain a proper depth, [0012]).
21. Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardig in view of Siedenburg as presented in claim 32 above, and further in view of Kaufman et al. (US 2015/0265497).
Regarding claim 34, the modified method of Hardig reads on the limitations of claim 32 and further reads on optimizing the direction of the action of force on the thorax of the patient (Siedenburg [0039] states that calculated efficacy can advise adjustment of the compression element) at based on an optimization process (Siedenburg [0039] uses vital signs data to measure efficacy) and ascertaining an interaction of position and direction of the action of force on the thorax of the patient with the greatest success (Siedenburg [0039] states that efficacy is evaluated based on vital signs for giving CPR feedback, therefore if efficacy was greatest in a previous position, the CPR feedback would inherently advise returning to a point where efficacy is greatest), but does not expressly disclose that the direction of action force is optimized for each position, and that the position and direction with the greatest success is ascertained following the traversal of the search path.
However, Kaufman teaches of a CPR chest compression system that uses a method to determine the optimum compression regimen ([0040]) where a series of test compressions are performed with varying parameters before determining which one has the best aortic pulse pressure waveform ([0040]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the modified method of Hardig with the determination of an optimal compression regimen as taught by Kaufman to provide the patient with optimal starting parameters
The further modified method of Hardig reads on optimizing the direction of the action of force (Hardig [0061] states the angle of the contact member can be adjusted) on the thorax of the patient at each point (Hardig [0061] the points are the differing position orientations of the legs of the device which influence the position of the contact member) along the search path (Kaufman [0040] states that test compressions are performed with differing parameters), and the position and direction of the action of force on the thorax of the patient with the greatest success following the traversal of the search path (Kaufman [0040] states that after the test compressions, the compression regimen with the best aortic pulse pressure waveform is optimal).
Conclusion
22. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jamal (US 2022/0062098) discloses a portable CPR robot that can adjust position using the arm of the robot. Freeman et al. (US 2018/0092803) discloses a cardiac resuscitation system that uses an adhesive patch and handheld compressor. Chapman et al. (US 2018/0168922) discloses a CPR machine that can compress at different sites. Woerlee et al. (US 2013/0184618) discloses an automated cardiopulmonary resuscitation device that uses light projection to find an optimal position. Johnson et al. (US 2012/0010543) discloses a system for cardiac resuscitation that makes minor adjustments to the target depth and observes how the change in depth affects physiological parameters before further adjustments. Dussault et al. (US 2018/0161238) discloses an apparatus for assisting cardiopulmonary resuscitation that uses a pad with a centered force transmission unit.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785