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 .
Claim Objections
Claims 19-20 and 27 are objected to because of the following informalities:
In claim 19, “a fluid delivery device in fluid connection, at a first end, with a blood vessel of a subject” should read “a fluid delivery device configured to be in fluid connection, at a first end, with a blood vessel of a subject.”
Please add this claim objection.
In claim 20, “fluid delivery device;” should read “fluid delivery device.”
In claim 27, the initial “PD” should read “photodetector (PD).”
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 limitations are: fluid delivery device in claim 19; a monitoring and measuring apparatus for direct real-time measurement in claim 19; wearable device in claim 29.
Claim 19 recites “fluid delivery device.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “device” and functional language “fluid delivery” without reciting sufficient structure to achieve the function.
Additionally, Claim 19 recites “a monitoring and measuring apparatus for direct real-time measurement.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “apparatus” and functional language “direct real-time measurement” without reciting sufficient structure to achieve the function.
Claim 29 recites “wearable device.” The limitation has been interpreted under 112f as a means plus function limitation because of the combination of a non-structural generic placeholder term “wearable device” and functional language “monitoring said change in trend of the whole blood parameter” without reciting sufficient structure to achieve the function.
Because these claim limitations 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.
Claim 19 regarding fluid delivery device is being interpreted as a catheter as set forth in Page 3, lines 25-26 and equivalents thereof. Additionally, Claim 19 regarding a monitoring and measuring apparatus for direct real-time measurement the specification does not clearly define/link the structure for the monitoring and measuring apparatus. Claim 29 regarding wearable device is being interpreted as element 300, which is illustrated in Figure 3A as set forth in Page 13 lines 18 – 24.
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.
Claims 19-27 are 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.
Regarding Claim 19, the originally filed disclosure fails to provide adequate written description for “monitoring and measuring apparatus for direct real-time measurement.” While Page 4 lines 1-4, Page 10 lines 22-24, and Page 11 lines 1-2 discuss of a monitor device the disclosure provides no details regarding the structure or clearly linking it to any specific structure, and therefore fails to provide adequate written description as required by 35 U.S.C 112(a) or pre-AIA U.S.C 112, first paragraph because an indefinite, unbound functional limitation would cover all ways of performing a function and applicant has not provided sufficient disclosure to show possession of the invention (see MPEP 2163.03 (vi)).
Regarding Claim 23, the originally filed disclosure fails to provide adequate written description for “external source.” While the claim states the external source sends commands to the system to examine the patient’s blood, the specification does not provide any literature regarding the structure nor its intended function. Therefore, claim 23 fails to provide adequate written description as required by 35 U.S.C 112(a) or pre-AIA U.S.C 112, first paragraph because an indefinite, unbound functional limitation would cover all ways of performing a function and applicant has not provided sufficient disclosure to show possession of the invention (see MPEP 2163.03 (vi)).
Regarding Claim 24, the originally filed disclosure fails to provide adequate written description for “blood sensor.” While the claim states a pump works in pulses with a time control via blood sensor and artificial intelligence system, the specification the specification does not provide any literature regarding the structure nor its intended function. Therefore, claim 24 fails to provide adequate written description as required by 35 U.S.C 112(a) or pre-AIA U.S.C 112, first paragraph because an indefinite, unbound functional limitation would cover all ways of performing a function and indicate that the inventor has not provided sufficient disclosure to show possession of the invention (see MPEP 2163.03 (vi)).
Regarding claims 23-24, the claims recite the function of “artificial intelligence” but the specification never discloses the necessary steps and/or flowcharts of how this occurs. The term “artificial intelligence” is treated as a black box and the specification does not describe the specifics of how to achieve the above-recited function(s) with this algorithm. For example, how many and what types of layers are there? How is the data propagated? What logics are programmed to help the artificial intelligence make a decision? Is the training supervised or unsupervised? What are the weightings? Are other training concepts used such as regression? It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
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 19-32 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
In Claim 19, the claim limitation “monitoring and measuring apparatus for direct real-time measurement” 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 disclosure is devoid of any structure that performs the function in the claim, and no association between the structure and the function can be found in the specification. 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.
In Claim 23, the claim limitation “external source” renders the claim indefinite because the limitation is unclear. In light of the specification, it is unclear how an external source conducts the function of sending commands to the system to examine the patient’s blood as no structure or details of external source are provided. For purposes of examination, the claim limitation is interpreted as a wired or wireless processor or computer that which sends commands to the system to examine the patient’s blood.
In Claim 23, the claim limitation “the system examines blood” and “blood” renders the claim indefinite because the limitation is unclear. It is unclear whether unclear if ‘examines blood’ is meant to refer to the entire functionality of the system as claimed 19 or a separate functionality. For example does ‘examines blood’ cover the function of the processor to analyze data. Additionally, does “blood” refer to “whole blood” as recited in claim 19 or not? For purposes of examination, the claim limitation is interpreted as the entire functionality of the system as claimed in claim 19 and “blood” is interpreted as “whole blood.”
In Claim 26, the claim limitation “teaches the system according to claim 19, wherein hemoglobin is detected between 535 and 560 nm, and wherein at least one LED outputs radiation at around 550 nm” renders the claim indefinite because the limitation is unclear. It is unclear what the intended effect on the scope of the invention is meant by the claim language. Regarding “hemoglobin is detected between 535 and 560 nm,” the claim limitation is merely reciting a fact of conventional hemoglobin measurement rather than an aspect of the claimed invention. This does create uncertainty regarding which statutory category is being claimed. For the purposes of this examination, it will not be given patentable weight. Regarding “at least one LED outputs radiation at around 550 nm,” the claim limitation is interpreted as the system could have an LED that emits radiation around the targeted wavelength range.
Regarding Claim 26, the term “around” is a relative term which renders the claim indefinite. The term “around” is 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. For purposes of examination, the claim limitation of “around” is interpreted as the wavelength range must contain a wavelength of 550mm.
In Claim 26, the claim limitation “at least one LED” renders the claim indefinite because the limitation is unclear. It is unclear whether the at least one LED is part of the system recited in claim 19. For purposes of examination, the claim limitation is interpreted as part of the system recited in claim 19.
In Claim 27, the claim limitations “the sensor” render the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a sensor” [Examiner’s note, the suggested change only needs to be done to the first recitation].
In Claim 27, the claim limitation “device initialization” renders the claim indefinite because the limitation is unclear. It is unclear what the device initialization is referring to. Which device is being initialized? Is this meant to be system initialization? For purposes of examination, the claim limitation is interpreted as the fluid delivering device is initialized with containing a zero level of hemoglobin detected.
In Claim 27, the claim limitation “the LED intensity” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a LED intensity.”
In Claim 27, the claim limitation “until the PD reaches its determined initial setpoint” renders the claim indefinite because the limitation is unclear. It is unclear what “its” referring to. For purposes of examination, the claim limitation is interpreted as “until the PD reaches a determined initial setpoint.”
In Claim 28, the claim limitation “said at least one dynamic trend” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “at least one dynamic trend.”
In Claim 28, 30, the claim limitation “a hemoglobin” and “at least one whole blood parameter selected from at least one of: a hemoglobin level, an albumin level…” renders the claim indefinite because the limitation is unclear. It is unclear whether the “a hemoglobin level” is the same recited in claim 28 under at least one whole blood parameter which includes hemoglobin levels. For purposes of examination, the claim limitation is interpreted as to mean the same.
In Claim 28, 31, the claim limitation “whole blood parameter” and “at least one whole blood parameter” renders the claim indefinite because the limitation is unclear. It is unclear whether there is a distinct difference between “whole blood parameter” versus “at least one whole blood parameter.” For purposes of examination, the claim limitation is interpreted as to mean the same.
In Claim 28, 31, the claim limitation “a trend” and “at least one trend” renders the claim indefinite because the limitation is unclear. It is unclear whether there is a distinct difference between “a trend” versus “at least one trend.” For purposes of examination, the claim limitation is interpreted as to mean the same.
In Claim 28, 31, the claim limitation “at least one change” and “one or more changes” renders the claim indefinite because the limitation is unclear. It is unclear whether there is a distinct difference between “at least one change” versus “one or more changes.” For purposes of examination, the claim limitation is interpreted as to mean the same.
In Claim 29, the claim limitation “said change in trend” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a change in trend.”
In Claim 29, the claim limitation “the whole blood parameter” renders the claim indefinite because the limitation is unclear. It is unclear whether this refers to “whole blood parameter” or “at least one whole blood parameter” as mentioned in claim 28. As mentioned earlier in Claim 28, “whole blood parameter” and “at least one whole blood parameter” is interpreted to mean the same. Therefore, for purposes of examination, the claim limitation is interpreted as to mean the same as “whole blood parameter” and “at least one whole blood parameter”.
In Claim 31, the claim limitation “at least one parameter,” “whole blood parameter” and “at least one whole blood parameter” renders the claim indefinite because the limitation is unclear. It is unclear whether there is a distinct difference between “at least one parameter” versus “whole blood parameter” versus “at least one whole blood parameter.” For purposes of examination, the claim limitation is interpreted as to mean the same.
In Claim 31, the claim limitation “said patient” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a patient.”
Claim Rejections - 35 USC § 101
Claims 19-32 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.
Each of Claims 19-32 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 19-32 recites at least one step or instruction for monitoring and measuring of whole blood from the patient, which is grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 19-32 recites an abstract idea.
Specifically, Claim 19 recites “A system for real-time monitoring and repetitive measuring of whole blood, the system comprising: a) a fluid delivery device in fluid connection, at a first end, with a blood vessel of a subject; b) a monitoring and measuring apparatus for direct real-time measurement of at least one parameter in a whole blood sample conveyed by said fluid delivery device from said subject; and c) a processor adapted to analyze data received from said monitoring and measuring apparatus to detect changes in said at least one parameter of said subject over time.”
A physician can attach a fluid delivery device onto the blood vessel of the patient; measure and identify the data collected from the whole blood; analyze the collected data to detect any changes in the parameters from the patient over time.
Independent Claim 28 recites “A diagnostic method for detecting at least one change in a trend of a whole blood parameter, the method comprising monitoring at least one whole blood parameter selected from at least one of: a hemoglobin level, an albumin level, an oxygen level, a sodium level, a potassium level, and pH and combinations thereof of a patient's whole blood; whereby at least one trend is monitored so as to detect one or more changes in said at least one dynamic trend in said whole blood.”
A physician can measure and monitor the parameters of the patient’s whole blood; produce a trend of that parameter; detect and analyze the changes in the trend.
Independent Claim 31 recites “A diagnostic method for detecting at least one change in a trend of a whole blood parameter, the method comprising: a. monitoring and transmitting at least one whole blood parameter; and b. detecting at least one of a hemoglobin level, a sodium level, an oxygen level, a potassium level, a pH and combinations thereof in a sample of blood; whereby at least one trend and at least one parameter is monitored from whole blood, without dilution thereof, so as to detect one or more changes in said at least one trend to reflect at least one of internal bleeding, external bleeding and combinations thereof in said patient.”
A physician can measure and monitor the parameters of the patient’s whole blood; produce a trend of that parameter; detect and analyze the changes in the trend and determine whether the patient is experiencing any bleeding.
Further, dependent Claims 20-27, 29, 30, and 32 merely include limitations that either further define the abstract idea (and thus don’t make the abs-tract 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 process steps are performed.
Specifically, dependent claim 20 recites, “The system according to claim 19, further comprising a valve device at a second end of said fluid delivery device.”
Dependent claim 21 recites, “The system according to claim 19, wherein the processor is further adapted to provide an alarm if bleeding is detected.”
Dependent claim 22 recites, “The system according to claim 19, wherein said whole blood sample is of a volume of less than 150 microliters.”
Dependent claim 23 recites, “The system according to claim 19, wherein the system examines blood by command sent by an external source or an artificial intelligence system and wherein the system is capable of operating continuously for at least 6 hours.”
Dependent claim 24 recites, “The system according to claim 19, wherein the system draws blood via a pump and wherein the pump works in pulses with a time control via a blood sensor and an artificial intelligence system.”
Dependent claim 25 recites, “The system according to claim 19, wherein the system further comprises an optical sensor including at least one LED.”
Dependent claim 26 recites, “The system according to claim 19, wherein hemoglobin is detected between 535 and 560 nm, and wherein at least one LED outputs radiation at around 550 nm.”
Dependent claim 27 recites, “The system according to claim 19, wherein the sensor is a photodiode placed in front a LED and therebetween is disposed a cuvette, a PD setpoint is determined at device initialization, at empty and filled states, wherein a working point is at the middle of a dynamic range of the sensor, at each state; and wherein during sampling, the LED intensity is automatically changed in defined steps until the PD reaches its determined initial setpoint.”
Dependent claim 29 recites, “The diagnostic method according to claim 28, further comprising providing a wearable device for monitoring said change in trend of the whole blood parameter.”
Dependent claim 30 recites, “The diagnostic method according to claim 29, comprising continuously monitoring only a hemoglobin level.”
Dependent claim 32 recites, “The diagnostic method according to claim 28, further comprising providing an alarm if bleeding is detected.”
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 19, 28, and 31 (and their respective dependent Claims 20-27, 29, 30, and 32 is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 19, 28, and 31), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: fluid delivery device, monitoring and measuring apparatus, processor, valve device, artificial intelligence system, pump, blood sensor, optical sensor, at least one LED, LED, sensor, photodiode, cuvette, external source, wearable device are generically recited computer elements in independent Claims 19, 28, and 31 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. 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. For at least these reasons, the abstract idea identified above in independent Claims 19, 28, and 31 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., processor, artificial intelligence system 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. 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. 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 Claims 19, 28, and 31 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 19, 28, and 31 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 19-32 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: fluid delivery device, monitoring and measuring apparatus, processor, valve device, artificial intelligence system, pump, blood sensor, optical sensor, at least one LED, LED, sensor, photodiode, cuvette, external source, wearable device.
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, 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, fluid delivery device which provides fluids to the subject via a vein or another blood vessel (Page 3, lines 25-26); monitoring and measuring apparatus for directing real-time measurement is being interpreted as a device that measures real-time data on different whole blood parameters in the patient (Page 4 lines 1 – 4); processor analyzes collected data and determines the change in the data (Page 5 lines 11-13); valve device connects the monitoring apparatus to the infusion bag (Page 3 lines 27-29); artificial intelligence system commands the system to withdraw blood from the user (Page 5 lines 21-24); pump is used to draw blood from the patient (page 10 lines 25-26); optical sensor transmits radiation, through the at least one LED and LED, which is absorbed by the hemoglobin (Page 22 lines 26-27; Page 23 lines 16-20); photodiode and sensor detects specific wavelengths to analyze the patient’s blood (Page 10 lines 18-19); cuvette is used to transport the tested whole blood to a waste reservoir (Page 12 lines 12-13); wearable device that monitors the whole blood on the user’s arm (Page 13 lines 18 – 20).
Accordingly, in light of Applicant’s specification, the claimed term processor and artificial intelligence system are 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 computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the external source, processor, and artificial intelligence system. 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 19-32 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 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. 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, 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 systems and methods of Claims 19-32 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 (ii) providing a technical solution to a problem in a technical field. None of Claims 19-32 provides 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.
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, 28, and 31 (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. That is, 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 specifically for data gathering or merely indicating a field of use. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. 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. Thus, Claims 19-32 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 19-32 amounts to significantly more than the abstract idea itself. Accordingly, Claims 19-32 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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.
Claims 28 and 31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rule (US 20090043171 A1).
Regarding Claim 28, Rule discloses a diagnostic method for detecting at least one change in a trend of a whole blood parameter (Paragraphs 0122-0123), the method comprising monitoring at least one whole blood parameter selected from at least one of: a hemoglobin level, an albumin level, an oxygen level, a sodium level, a potassium level, and pH and combinations thereof of a patient's whole blood (Paragraph 0106; [Examiner’s note, the hemoglobin level is monitored by the arrival sensor]); whereby at least one trend is monitored so as to detect one or more changes in said at least one dynamic trend in said whole blood (Paragraph 0242).
Regarding Claim 31, Rule discloses a diagnostic method for detecting at least one change in a trend of a whole blood parameter (Paragraph 0122-0123), the method comprising:
a. monitoring and transmitting at least one whole blood parameter (Paragraphs 0077, 0079, 0249); and
b. detecting at least one of a hemoglobin level, a sodium level, an oxygen level, a potassium level, a pH and combinations thereof in a sample of blood (Paragraph 0106; [Examiner’s note, the hemoglobin level is monitored by the arrival sensor.]); whereby at least one trend and at least one parameter is monitored from whole blood, without dilution thereof (Paragraph 0242, 0294), so as to detect one or more changes in said at least one trend to reflect at least one of internal bleeding in said patient (Paragraph 0344), external bleeding and combinations thereof in said patient.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 19-23, 25, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20090043171 A1) in view of Seetharaman et al. (US 20090160656 A1).
Regarding Claim 19, Rule discloses a system for real-time monitoring and repetitive measuring of whole blood (Paragraph 0159; [Examiner’s note, the system (400) is a continuous monitoring system for measuring an analyte in whole blood. Additionally, the monitoring device (120) comprises the system (400).]), the system comprising:
a) a fluid delivery device (fluid-handling system – element 404) in fluid connection, at a first end, with a blood vessel of a subject (fluid source – element 402; Paragraph 0079, 0080);
b) a monitoring and measuring apparatus (monitoring device – element 102; Paragraph 0063) for direct real-time measurement of at least one parameter in a whole blood sample conveyed by said fluid delivery device from said subject (Paragraphs 0077, 0079, 0249); and
c) a processor (algorithm processor – element 416) adapted to analyze data received from said monitoring and measuring apparatus to detect changes in said at least one parameter of said subject over time (Paragraph 0077, 0095-0095, 0242).
Rule does not explicitly disclose the in fluid connection, at first end with a blood vessel in the system (400). However, another embodiment of Rule teaches a fluid delivery device (Rule | fluid system – element 510) in fluid connection, at a first end (Rule | patient tube – element 512 (TI)), with a blood vessel of a subject (Rule | Paragraphs 0104-0105). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system (400) of Rule to incorporate the teachings of the fluid system (510) from Rule because the fluid connect between the fluid delivery device and the subject is used to analyze the whole blood parameters and collect necessary samples to determine the subject’s overall health (Rule | Paragraphs 0104-0105, 0115).
One skilled in the art can determine the algorithm processor can analyze data received and detect changes in a target parameter. Should it be found that the algorithm processor from Rule does not explicitly teach the processor detecting the parameter’s change over time; Seetharaman teaches a processor adapted to analyze data to detect changes in said at least one parameter of said subject over time (Seetharaman | Paragraph 0284). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Rule to incorporate the teachings of a processor that detects changes in a target parameter over time from Seetharaman. Doing so would allow the detected change, by the processor, in the target parameter being lower or higher than a target range can indicate the patient is experiencing a medical emergency, e.g. internal bleeding (Seetharaman | Paragraph 0271, If the Hb level of a patient goes down without an apparent external reason, the patient could be suffering from internal bleeding. Indeed, many ICU patients (some estimate as many as 10%) suffer from what appears to be spontaneous internal bleeding that may not be otherwise detectable until the consequences are too drastic to easily overcome).
Regarding Claim 20, Rule in view of Seetharaman teaches the system according to claim 19, further comprising a valve device at a second end of said fluid delivery device (Rule | Paragraph 0078).
Regarding Claim 21, Rule in view of Seetharaman teaches the system according to claim 19. Rule is silent in teaching the processor is further adapted to provide an alarm if bleeding is detected; Seetharaman teaches the processor is further adapted to provide an alarm if bleeding is detected (Seetharaman | Paragraph 0271, 0275-0276). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Rule in view of Seetharaman to incorporate the teachings of an alarm if bleeding is detecting from Seetharaman. Doing so will notify physicians that immediate emergency care is required because the patient may have internal bleeding (Seetharaman | Paragraph 0271, If the Hb level of a patient goes down without an apparent external reason, the patient could be suffering from internal bleeding. Indeed, many ICU patients (some estimate as many as 10%) suffer from what appears to be spontaneous internal bleeding that may not be otherwise detectable until the consequences are too drastic to easily overcome).
Regarding Claim 22, Rule in view of Seetharaman teaches the system according to claim 19, wherein said whole blood sample is of a volume of less than 150 microliters (Rule | Paragraph 0111, the sample (for example, 200 .mu.L or 100 .mu.L) is divided into multiple (e.g., more than two, five, or four) "slugs" of sample, each separated by a small amount of air).
Regarding Claim 23, Rule in view of Seetharaman teaches the system according to claim 19, wherein the system is capable of operating continuously for at least 6 hours (Rule | Figures 24-25; Paragraph 0242; [Examiner’s note, the graphs shown in Figures 24-24, are glucose concentration vs elapsed time in hours. The graphs show the system is capable of operating continuously for over 6 hours.]).
Rule in view of Seetharaman is silent in teaching the system examines blood by command sent by an external source (Rule | Paragraph 0313) or an artificial intelligence system; another embodiment of Rule teaches the system examines blood by command sent by an external source (Rule | Paragraph 0313) or an artificial intelligence system [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify system 400 of Rule in view of Seetharaman to incorporate an external source to send commands to the system to draw blood from Rule because a physician can control the external source to access a patient's drug dosage history. This allows them to determine the timing for the next administration and monitor parameters within the patient's whole blood (Paragraphs 0246, 0313).
Regarding Claim 25, Rule in view of Seetharaman teaches the system according to claim 19, wherein the system further comprises an optical sensor including at least one LED (Rule | Paragraph 0080, 0284) .
Regarding Claim 32, Rule discloses the diagnostic method according to claim 28. Rule is silent in disclosing an alarm if bleeding is detected. Seetharaman teaches an alarm if bleeding is detected (Seetharaman | Paragraph 0271, 0275-0276). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Rule to incorporate the teachings of an alarm if bleeding is detecting from Seetharaman. Doing so will notify physicians that immediate emergency care is required because the patient may have internal bleeding (Seetharaman | Paragraph 0271, If the Hb level of a patient goes down without an apparent external reason, the patient could be suffering from internal bleeding. Indeed, many ICU patients (some estimate as many as 10%) suffer from what appears to be spontaneous internal bleeding that may not be otherwise detectable until the consequences are too drastic to easily overcome).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20090043171 A1) in view of Seetharaman et al. (US 20090160656 A1) and Currie et al. (US 20030225362 A1).
Regarding Claim 24, Rule in view of Seetharaman teaches the system according to claim 19. Rule’s system 400 is silent in teaching wherein the system draws blood via a pump and wherein the pump works in pulses with a time control via a blood sensor and an artificial intelligence system. Another embodiment of Rule teaches the system draws blood via a pump (Rule | first pump – element 522; Paragraph 0104) and via a blood sensor (Rule | bubble sensor – element 535).
Rule in view of Seetharaman is silent in teaching the pump works in pulses with a time control via an artificial intelligence system; another embodiment of Rule teaches the pump (Rule | fluid system kit – element 2634; Paragraph 0253, the fluid system kit 2634 also includes a three-inch pigtail connector with a luer fitting for connection to one or more IV pumps) works in pulses with a time control (Rule | Paragraph 0258) via a system (Rule | Paragraphs 0255-0258).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify system 400 of Rule in view of Seetharaman to incorporate the pump works in pulses with a time control via an artificial intelligence system from Rule because a physician can access a patient's drug dosage history and allows them to curate a time control for the next drug dosage administration and monitor the patient (Paragraphs 0246, 0313).
Although another embodiment of Rule discusses the use of various software and programs but none explicitly disclose the use of AI or machine learning aspects for time control. Currie teaches an artificial intelligence system for time control (Currie | Paragraph 0104). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify system 400 of Rule in view of Seetharaman to incorporate the teachings of artificial intelligence from Currie because the time control in combination with artificial intelligence provides steady and consistent blood draws from the patient. Thus allowing physicians to analyze the blood parameters periodically and identify any changes that may be detrimental to their health (Currie | Paragraph 0104).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20090043171 A1) in view of Seetharaman et al. (US 20090160656 A1) as evidenced by Jenie et al. (“Review on Wavelength for Non-Invasive Blood Hemoglobin Level Measurement Optical Device,” 2019, U on PTO-892).
Regarding Claim 26, Rule in view of Seetharaman teaches the system according to claim 19, wherein at least one LED outputs radiation at around 550 nm (Rule | Paragraph 0298). Rule in view of Seetharaman is silent in teaching wherein hemoglobin is detected between 535 and 560 nm. Jenie teaches wherein hemoglobin is detected between 535 and 560 nm (Jenie | Page 3 Paragraphs 1 and 5; [Examiner’s note, the wavelength range for detecting blood hemoglobin level is between 200mm to 1000mm]). Therefore it would have been obvious to one of ordinary skill in the art to have modified the system 400 of Rule in view of Seetharaman to incorporate the teachings of the wavelength detection for hemoglobin from Jenie as its merely using known property value and if it is determined it’s not a known property, it would merely be choosing from a finite number of identified, predictable solution, with a reasonable expectation of success.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20090043171 A1) in view of Seetharaman et al. (US 20090160656 A1) and Mah et al. (US 20070197885 A1).
Regarding Claim 27, Rule in view of Seetharaman teaches the system according to claim 19. Rule in view of Seetharaman is silent in teaching the sensor is a photodiode placed in front a LED and therebetween is disposed a cuvette. Another embodiment of Rule teaches the sensor is a photodiode placed in front a LED and therebetween is disposed a sample holder (Rule | Paragraph 0124, portions of a fluidic system that directly contact fluid are incorporated into one or more removable portions (e.g., one or more disposable cassettes, sample holders, tubing cards, etc.). For example, a removable portion 710 can house at least a portion of the fluid system 510 described previously, including portions that contact sample fluids, saline, detergent solution, and/or anticoagulant; Paragraph 0126). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify to modify the system of Rule in view of Seetharaman to incorporate the teachings about the optical system 714 from another embodiment of Rule because the optical system measures optical properties of within a fluid (e.g. whole blood) sample. Therefore it would have been obvious to one of ordinary skill in the art to have tried other optical systems, shown in Rule, since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Additionally, Rule in view of Seetharaman is silent in teaching a PD setpoint is determined at device initialization, at empty and filled states, wherein a working point is at the middle of a dynamic range of the sensor, at each state; and wherein during sampling, the LED intensity is automatically changed in defined steps until the PD reaches its determined initial setpoint; cuvette as a sample holder.
Mah teaches a PD setpoint is determined at device initialization, at empty and filled states (Mah | Paragraphs 0070-0071, 0074, 0076; [Examiner’s note, the setpoints are determined by the regression model described in paragraph 0079,“the optical measurements provide estimates of the unique set of source-to-detector path lengths and other nuisance variable values which result each time the sample is placed in the apparatus.” Due to this equation, the light sources adjust the X and Y state settings in order for the photodetector to be initialized before and during data collection.]), wherein a working point is at the middle of a dynamic range of the sensor, at each state (Mah | Paragraph 0070-0073); and wherein during sampling, the LED intensity is automatically changed in defined steps until the PD reaches its determined initial setpoint (Mah | Paragraphs 0070-0071 and 0077); a cuvette as a sample holder (Mah | Paragraphs 0032 and 0074). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify system 400 of Rule in view of Seetharaman to incorporate the teachings of calibrating a photodetector and a cuvette from Mah because Calibrated photodetectors ensure accurate light intensity measurements with minimal drift to accurately measure light intensity from samples in cuvettes. Samples housed in cuvettes are then tested to monitor targeted analytes, enabling physicians to periodically assess patient health and identify detrimental changes (Mah | Paragraph 0138).
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Rule (US 20090043171 A1) in view of Zhang et al. (US 20180049650 A1).
Regarding Claim 29, Rule discloses the diagnostic method according to claim 28, further comprising providing a device for monitoring said change in trend of the whole blood parameter (Rule | Paragraph 0242). Rule is silent in disclosing the device specifically being a wearable device for monitoring said change in trend of the whole blood parameter; Zhang teaches device specifically being a wearable device for monitoring said change in trend of the whole blood parameter (Zhang | Paragraph 0046). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify to modify the system of Rule to incorporate the teachings of a wearable device from Zhang. Doing so would allow patients with a wearable device that provides real-time notification when their blood parameter is in an abnormal state, which allows the patient to receive adequate medical attention before it poses a health risk (Zhang | Paragraph 0046).
Regarding Claim 30, Rule in view of Zhang teaches the diagnostic method according to claim 29, comprising monitoring only a hemoglobin level (Rule | Paragraph 0294). Rule in view of Zhang is silent in teaching a continuous monitoring. Another embodiment of Rule teaches continuously monitoring (Rule | Paragraph 0249). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify method for detecting at least one change in a trend of a whole blood parameter of Rule to incorporate the teachings of continuous monitoring because the continuous monitoring provides insight on the overall health of the patient and the physician can easily determine when the patient falls within abnormal levels of a specific parameter. Additionally, the function of continuous monitoring can provide insight to physicians when a patient needs administration of a drug dosage (Rule | Paragraph 0262, 0264, 0275).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Thursday: 7:30-4:30 & Friday 7:30-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
Prosecution Insights