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 .
Status of Claims
This action is in reply to the RCE filed on 04/27/26.
Claims 1, 3-7, 11, 15, 19, 21 have been amended and are hereby entered.
Claims 8, 12, 25 has been canceled.
Claims 2, 9, 10, 14, 16, 18, 20, 22 were previously canceled.
Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/27/26 has been entered.
Foreign Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. BR 10 2021 005819-6, filed on 03/25/21, and parent Application No. BR 10 2020 0021049 1, filed on 10/14/2020. Accordingly, a priority date of 10/14/2020 has been given to the instant application.
Affidavit/Inventor’s Declaration
The Affidavit (Inventor’s Declaration) under 37 CFR 1.132 filed 04/27/26s is insufficient to overcome the rejection of claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 based upon 35 USC 101 as set forth in the last Office action because: (1) the affiant’s arguments are directed to an ultimate legal conclusion and/or (2) the described “technical” problem is not a problem caused by the technological environment to which the claims are confined. These are further detailed in the Response to Arguments section, infra.
Claim Objections
Claim 1 recites, in part “wherein (a) the plurality of indicators (Io, IG) comprise an operator indicator (Io) associated with the optical instrument and a setting indicator (I) associated with the destination point” and Claim 5 recites “wherein the setting indicator to the health care setting manager (IG) is displayed via a display of the network device. It is unclear if “setting indicator (I)” and “setting indicator to the health care setting manager” (IG) are intended to be the same. It is unclear if “(I)” in Claim 1 is a typographical error intended to be (IG). Examiner notes that the parallel language in Claim 21 recites “setting indicator (IG)” and as such, is interpreting (I) in Claim 1 as (“IG”). Please correct or explain on the record.
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 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.
The newly added recitations of “setting indicator”, “wherein the status of non-compliance prevents a link between the product identifier code (2) to the patient identifier code (4)” and “responsive to detecting the status of compliance, storing, within a memory of the optical instrument, the patient identifier code (2), the product identifier code (4), and a plurality of indicators (Io, IG) as a set of consolidated data, wherein (a) the plurality of indicators (Io, IG) comprise an operator indicator (Io) associated with the optical instrument and a setting indicator (I) associated with the destination point” within Claims 1 and 21 appear to constitute new matter. Newly added recitation of “setting indicator” in Claim 5 appears to constitute new matter.
Examiner is unable to find any disclosure of the term “setting indicator” in the original disclosure or originally filed claims.
Regarding “wherein the status of non-compliance prevents a link between the product identifier code (2) to the patient identifier code (4)”, there does not appear to be any disclosure of “preventing” a link between a product identifier code and patient code when a status of non-compliance is detected. Paras. [0184]-[190] disclose determining that the product is non-compliant based on expiration date and current date, and providing various warnings to the operator and manager (e.g., sound signal, error message). However, the specification only provides support for providing an alert to notify a user/manager of an expired product, e.g., with the intent of making the user aware the product should not be used and does not appear to disclose preventing a link.
Regarding “responsive to detecting the status of compliance, storing, within a memory of the optical instrument, the patient identifier code (2), the product identifier code (4), and a plurality of indicators (Io, IG) as a set of consolidated data, wherein (a) the plurality of indicators (Io, IG) comprise an operator indicator (Io) associated with the optical instrument and a setting indicator (I) associated with the destination point”, [0192] teaches on determining a status of compliance, but does not teach on any further actions happening (e.g. storing consolidated data) in response to this. Examiner is unable to find support for these amended limitations pertaining to storing the consolidated data responsive to detection of compliance, either in the paragraphs cited by Applicant in remarks or elsewhere in specification.
As such, Applicant is respectfully requested to clarify the above issues and/or to specifically point out support for the newly added limitations in the originally filed specification and claims.
Dependent claims 2-7, 11, 15, 17, 19, 23, 24 are rejected as they inherit the deficiencies of parent claim 1.
Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 21 contain recitation of “setting indicator (IG)” which renders the metes and bounds of the claim indefinite. The specification uses “IG” to refer to “indicator” associated with/ to the “health care setting manager IG” (see at least paras. [0108], [0142], [0198]). For example, [0142] discloses, “at least one indicator to the health care setting manager IG”. Neither the original claims nor specification as originally filed disclose a “setting indicator”. It is unclear if this is a typographical error intended to be “setting manager indicator (IG)” or if this “setting indicator” is intended to refer to something else. Please amend claim language to clarify or explain on the record.
Dependent claims 2-7, 11, 15, 17, 19, 23, 24 are rejected as they inherit the deficiencies of parent claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (an abstract idea) without significantly more.
Step 1
Claims 1, 3-7, 11, 15, 17, 19, 23, 24 are drawn to a method, and Claim 21 is drawn to a system, both of which are within the four statutory categories. Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 are further directed to an abstract idea on the grounds set out in detail below.
Step 2A Prong 1
Claim 1 recites implementing the steps of:
receiving, at a destination point, a patient identifier code of a patient, wherein the patient identifier code comprises a first code adhered to a tag associated with the patient and the destination point is a health care setting of a network of health care settings, wherein the network of health care settings comprises a plurality of health care settings;
receiving a product identifier code of a medical technology product of the set of medical technology products, wherein the product identifier code comprises a second code adhered to the medical technology product that includes a medical technology product description data (DDESCR), a medical technology product batch data, and a medical technology product expiration date (DEXP) associated with the medical technology product; and
linking the product identifier code to the patient identifier code, wherein linking the product identifier code to the patient identifier code comprises:
(i) detecting a compliance status of the medical technology product based on the medical technology product expiration date (DEXP) and a current date (DCURRENT), wherein the compliance status comprises a status of compliance or a status of non-compliance, wherein the status of non-compliance prevents a link between the product identifier code to the patient identifier code
(ii) responsive to detecting the status of compliance, associating the patient identifier code, the product identifier code, and a plurality of indicators (Io, IG) as a set of consolidated data, wherein (a) the plurality of indicators (Io, IG) comprise an operator indicator (Io) associated with the optical instrument and a setting indicator (IG) associated with the destination point,
(iii) initiating a collection sequence (Sc) for the set of consolidated data (Dc)
These steps amount to managing personal behavior or relationships or interactions
between people and therefore recite certain methods of organizing human activity. Receiving patient-identifying data and product-identifying data, determining a compliance status of the product based on expiration date and current date, associating the patient identifying data, product identifying data, and various indicators together as consolidated data, and initiating a sequence for the set of consolidated data, are personal behaviors that may be performed by healthcare personnel when tracking containers used for collecting patient biological specimens.
Independent claim 21 recites substantially similar limitations and also recites an abstract idea under the same analysis.
The above claims are therefore directed to an abstract idea.
Step 2A Prong 2
This judicial exception is not integrated into a practical application because the additional
elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
The independent claims additionally recite:
an optical instrument as implementing the step of receiving, at a destination point, a patient identifier code (4) of a patient and receiving a product identifier code (2) of a medical technology product (Claim 1, 21)
machine readable code (Claim 1, 21) as the types of first and second codes received
a display of the optical instrument as implementing the step of initiating a collection sequence (Sc) for the set of consolidated data (Dc) (Claim 1, 21)
a first device comprising an optical instrument as implementing the step of reading the product identifier code of the medical technology product (Claim 21)
one or more processors as implementing the steps of the abstract idea (Claim 21)
The broad recitation of general purpose computing elements at a high level of generality only amounts to mere instructions to implement the abstract idea using computing components as tools.
Regarding the optical instrument, and first device comprising an optical instrument, per [0195], this is understood to be the camera of the first device, which is understood to be a cell phone per [0094] and [0144], which is given its broadest reasonable interpretation as a cell phone camera functioning in its ordinary capacity to read an identifier code. The display of the optical instrument is understood to be the screen/display of a cell phone per [0094] and [0144]. No particulars of the display are provided; therefore the display is given its broadest reasonable interpretation as a general purpose cell phone display functioning in its ordinary capacity. Regarding first and second “machine readable codes”, this is understood to be bar code or “Any optically readable code known in the prior art could be used (1D, 2D, QR, among others)” per para. [0089]. This only amounts to mere instructions to apply the abstract idea, e.g., using known machine readable code formats to provide data. Regarding the one or more processors, per paras. [0151], [0197], this is understood to be a general purpose computer processor functioning in its ordinary capacity to implement the steps of the abstract idea.
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
The independent claims additionally recite:
temporarily storing the patient identifier code within the optical instrument;
storing, within a memory of the optical instrument, a set of consolidated data
As stated in MPEP 2106.05(g), "[t]he term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim." In the present claim, the functions of temporarily storing the patient identifier code within the optical instrument and storing a set of consolidated data are only nominally or tangentially related to the process of tracking products used for collecting patient biological specimens and accordingly constitutes insignificant extra-solution activity.
The independent claims additionally recite:
automatically and periodically transmitting the set of consolidated data (Dc) from the optical instrument to a network device associated with the setting indicator (I)
This step only amounts to insignificant application of the abstract idea, as it only amounts to outputting results after performance of the abstract idea.
These elements are therefore not sufficient to integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to
more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1 and 21 only recite the aforementioned computing elements as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
B. Insignificant Extra-Solution Activity. MPEP 2106.05(g)
Likewise, as explained above, the step of temporarily storing the patient identifier code within the optical instrument only amounts to insignificant extra-solution activity and storing, within a memory of the optical instrument, a set of consolidated data and the step of automatically; and periodically transmitting the set of consolidated data (Dc) from the optical instrument to a network device associated with the setting indicator (IG) only amount to insignificant application of the abstract idea.
C. Well-Understood, Routine and Conventional Activities. MPEP 2106.05(d)
In addition to amounting to insignificant extra-solution activity the elements in Section B above constitute well-understood, routine and conventional activity. The steps of temporarily storing the patient identifier code within the optical instrument and storing, within a memory of the optical instrument, a set of consolidated data only amount to storing/retrieving data in memory, and the step of automatically and periodically transmitting the set of consolidated data (Dc) from the optical instrument to a network device associated with the setting indicator (IG) only amounts to receiving or transmitting data over a network, which have been previously held to be well-understood, routine and conventional when claimed at a high level of generality or as insignificant extra-solution activity. See MPEP 2106.05(d)(II).
Thus, taken alone, the additional elements do not amount to significantly more than the
above-identified judicial exception. Looking at the limitations as an ordered combination adds
nothing that is not already present when looking at the elements taken individually. Their
collective functions merely provide conventional computer implementation.
Depending Claims
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims:
Claim 3 recites limitations pertaining to wherein the operator indicator is displayed via the display of the optical instrument, which only amounts to mere instructions to apply the abstract idea on a computer (the display of the optical instrument). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 4 recites limitations pertaining to wherein the operator indicator (Io) correlates a plurality of medical technology products (1) with a plurality of users of the health care setting, which only narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 5 recites limitations pertaining to wherein the setting indicator (IG) is displayed via a display of the network device, which only amounts to mere instructions to apply the abstract idea on a computer (a display of the network device). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 6 recites limitations pertaining to wherein an indicator of the plurality of indicators (Io, IG) comprises a unique identifier code, which only narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 7 recites limitations pertaining to wherein the product identifier code (2) is associated with the medical technology product (1,160) through an adhesive means (30), wherein at least one portion (P) of the adhesive means (30) acts as a criticality classifier, wherein the criticality classifier indicates a criticality level of at least one of the medical technology product (1,160) or the patient, which only narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 11 recites limitations pertaining to wherein in the status of compliance, a first sound signal is issued via the optical instrument, in the status of non-compliance status, a second sound signal is issued via the optical instrument, wherein the first sound signal is different from the second sound signal, which only amounts to mere instructions to apply the abstract idea on a computer (the optical instrument). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 15 recites limitations pertaining to further comprising the step of: issuing an alert signal via the optical instrument, wherein the alert signal is set as at least a visual indication and an audible indication, which only amounts to mere instructions to apply the abstract idea on a computer (the optical instrument). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 17 recites limitations pertaining to wherein the medical technology product (1) is one of the following materials: a collection tube (1) ,a vaccine, and a needle. which only narrows the scope of the abstract idea as set out above. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 19 recites limitations pertaining to further comprising the step of: generating and displaying a control panel (Pc) via the optical instrument, wherein the control panel (Pc) is configured as a graphical indicator that correlates a specific period of time, a number of links generated, and a type of medical technology product. which only amounts to mere instructions to apply the abstract idea on a computer (the optical instrument). This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 23 recites limitations pertaining to a non-transitory computer-readable medium, the readable medium being characterized in that it stores instructions, which instructions when executed by a processor as implementing the steps of the abstract idea. Regarding the non-transitory CRM, per specification [0024], this is understood to be a general purpose computing element functioning in its ordinary capacity to implement the steps of the abstract idea. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
Claim 24 recites limitations pertaining to a computer readable memory containing instructions to perform the method as recited in claim 1. Regarding the computer readable memory containing instructions, per paras. [0194], [0210], this is understood to be a general purpose computing element functioning in its ordinary capacity to implement the steps of the abstract idea. This is not sufficient to integrate the judicial exception into a practical application or amount to significantly more than the judicial exception.
The dependent claims have been given the full two-part analysis including analyzing the additional limitations both individually and in combination. The dependent claims, when analyzed individually, and in combination, are also held to be patent ineligible under 35 U.S.C. 101 as they include all of the limitations of claim 1. The additional recited limitations of the dependent claims fail to establish that the claims do not recite an abstract idea because the additional recited limitations of the dependent claims merely further narrow the abstract idea. Beyond the limitations which recite the abstract idea, the claims recite additional elements consistent with those identified above with respect to the independent claims which encompass adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Dependent claims 3-7, 11, 15, 17, 19, 23, 24 recite additional subject matter which amounts to additional elements consistent with those identified in the analysis of Claim 1 above. As discussed above with respect to Claim 1 and integration of the abstract idea into a practical application, recitation of these additional elements (e.g., electronic storage medium, computing devices, processor, etc.) only amounts to invoking computers as a tool to perform the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Dependent claims 3-7, 11, 15, 17, 19, 23, 24, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
For the reasons stated, Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 3-6, 17, 19, 21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orkin (US Publication 20100044429A1) in view of Brown et. al. (US Publication 20090287584 A1), further in view of Godshall (US Publication 20090048870A1), and further in view of Fonseca et. al. (US Publication 20130166315A1).
Regarding Claim 1, Orkin discloses: A method (100) of tracking a set of medical technology products (Abstract, method of tracking a specimen acquired from a patient via specimen container), the method comprising the steps of:
receiving, via an optical instrument at a destination point ([0026], electronic reading means can be an “optical scanner” communicatively coupled with a computer via wired or wireless connection), a patient identifier code (4) of a patient, wherein the patient identifier code (4) comprises a first machine readable code adhered to a tag associated with the patient ([0027], teaching on storing in a computer storage of a computer, a first machine-readable code present on an identification means worn by a patient – if the first machine-readable is stored, it has necessarily been received) and the destination point is a health care setting ([0003]-[0005] teaches on collection of samples in a hospital setting/medical facility) ;
temporarily storing the patient identifier code (4) within the optical instrument ([0026], the optical scanner may be coupled to a computer; [0027], the first machine-readable code present on ID worn by the patient is stored in computer storage of a computer which is understood to be coupled to the optical scanner either wirelessly or via wired connection; Examiner interprets the combination of the scanner coupled to the computer as being an optical instrument);
receiving, via the optical instrument, a product identifier code (2) of a medical technology product of the set of medical technology products (1,160), wherein the product identifier code (2) comprises a second machine readable code adhered to the medical technology product that stores a medical technology product description data (DDESCR), a medical technology product [serial number] , and a medical technology product expiration date (DEXP)) associated with the medical technology product ([0027], teaching on receiving a “fourth” machine readable code which has been applied to a specimen container of a plurality of specimen containers all having machine readable codes thereupon, wherein the machine readable code includes a barcode encoding a unique serial number and expiration date of the container, understood to be obtained by the optical scanner of [0026]; Examiner interprets “fourth” machine readable code of Orkin as being analogous to the “second” code of the instant application as it is a different machine readable code and is adhered to the medical product; [0024] further teaches on the fourth machine readable code encoding for a unique serial number, expiration date and “color of a lid or cap that specifies the type of specimen the container is to be used for” which is interpreted as reading on broadest reasonable description of “medical technology product description data (DDESCR)); and
linking the product identifier code (2) to the patient identifier code (4) wherein linking the product identifier code (2) to the patient identifier code (4) comprises ([0027] as cited in detail for parts i-iii):
i)detecting a compliance status of the medical technology product based on the medical technology product expiration date (DEXP) and a current date (DCURRENT) ([0027] teaches on, after receiving the fourth machine readable code from the electronic reading means, a processor determines from the expiration date encoded in the machine readable code whether the specimen container is out of date, and if so, causing an alert to be generated; if the system can determine a container is “out of date” to cause an alert based on an expiration date, Examiner submits that a current date must be known to make this determination), wherein the compliance status comprises a status of compliance or a status of non-compliance ([0027] teaching on determining the specimen container is “out of date” which is interpreted as a status of “non-compliance” or “not out of date” which is interpreted as “compliance”), wherein the status of non-compliance prevents a link between the product identifier code (2) to the patient identifier code (4) ([0027] teaches on determining that the specimen container is out of date (non-compliant) and causes an alert signal to be generated; “otherwise, if the specimen container is not out of date” (compliant), the process continues to where a signal is generated to acquire a specimen from the patient and the machine-readable codes are stored – interpreted as reading on the claim language as the process stops with the alert being generated when a container is out of date (non-compliant); data is only stored to associate (link) the codes of the patient and the specimen container in storage when the container is “not out of date” (compliant);
(ii) responsive to detecting the status of compliance, storing, within a memory of the optical instrument, the patient identifier code (2), the product identifier code (4), and a plurality of indicators (Io, as a set of consolidated data, wherein (a) the plurality of indicators (Io, ) comprise an operator indicator (Io) associated with the optical instrument ([0027] teaching on, when it is determined that the specimen container is “not out of date” (status of compliance), the first-fourth machine readable codes are stored in a relational manner, where first code pertains to patient identifier, fourth code pertains to product identifier, and a “second machine readable code” pertains to “an order to obtain a specimen from the patient” which is interpreted as the operator indicator Io – per [0034] this second code pertains to an order number, type of specimen to be acquired, volume to be acquired, and a control number),
(iii) initiating, via a display of the optical instrument, a collection [instruction] for the set of consolidated data (Dc) ([0027] teaching on, when it is determined that the specimen container is “not out of date” (e.g., not expired; e.g., status of compliance), a signal is generated to acquire a specimen from the patient and to place the acquired specimen in the container), and
Orkin does not explicitly teach the following, but Brown, which is directed to system and methods for providing product information, teaches product batch data ([0050] teaches on manufacturing lot number and serial number both being ways to identify a product).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin with these teachings of Brown, to incorporate a product lot number for the medical technology product of Orkin, because the lot number can be used to retrieve specific information about the product (Brown [0050]).
Orkin/Brown do not disclose the following, but Godshall, which is directed to system and apparatus for medical error monitoring while tracking and monitoring samples collected from patients teaches:
an indicator (IG) comprise a setting indicator (IG) associated with the destination point ([0084] teaches on a web interface facilitating system administration functions; Figs. 16-26 illustrate exemplary screens which are displayed on administrator workstations; an administrator is interpreted as "manager of healthcare setting"; Examiner interprets the manager of the healthcare setting to be “associated with the destination point”; the administrator workstation is a different environment than the handheld device used by the operator (nurse/phlebotomist).
(iv) automatically and periodically transmitting the set of consolidated data (Dc) from the optical instrument to a network device associated with the setting indicator (IG) ([0084] teaches on a web interface facilitating system administration functions – an administrator workstation is interpreted as a network device associated with the setting indicator (IG); Figs. 16-26 illustrate exemplary screens which are displayed on administrator workstation (network device associated with IG); if the information is able to be displayed from the destination points (e.g. patient collections) to the administrator workstation, Examiner interprets this as inherently teaching that the data from the optical instrument has necessarily been transmitted in order for it to appear in administrator workstation; e.g. Fig. 16 shows STAT Pending collections for 2 patients and Routine pending collections for Peter Peterson in particular location with different colors/tests; Fig. 6 shows “Refreshes every 300 seconds” in upper left corner which is interpreted as having information automatically and periodically transmitted to the network device).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin/Brown with these teachings of Godshall, to include a setting indicator associated with the destination point and to transmit the consolidated data to a network device associated with the setting indicator, with the motivation of enabling a system administrator to view and track pending orders associated with multiple patients in a healthcare setting (Godshall [0084], Fig. 16 showing 3 patients).
Orkin/Brown/Godshall do not explicitly teach the following, but Fonseca, which is directed to systems, methods and media for laboratory testing, teaches:
a health care setting of a network of health care settings, wherein the network of health care settings comprises a plurality of health care settings ([0026] teaches on a network in communication with various devices associated with doctor offices and hospitals – interpreted as a network of health care settings comprising a plurality of healthcare settings)
initiating, via a display, a collection sequence (Sc) ([0093] teaches on presenting via computer system, information regarding the collection of samples from a patient; personnel in the sample collection facility can enter an order number associated with a patient and receive information regarding the collection of one or more samples; the collection information regarding the collection of one or more samples can include information such as “sampling order” (interpreted as “collection sequence”) as well as tube type, tube size, top color, etc.)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin with these teachings of Fonseca, to display a collection sequence to the operator of Orkin for collecting samples, with the motivation of providing instructions for making collection of samples easier, clearer and/or more accurate (Fonseca [0093]) and to implement the system of Orkin/Brown/Godshall within a plurality of healthcare settings, with the motivation of maintaining data in a central location (Fonseca Fig. 1, server 190 and datastore 195).
Regarding Claim 3, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin does not disclose, but Godshall further teaches wherein the operator indicator (Io) is displayed via the display of the optical instrument (Figs. 6-11, showing patient name, room, DOB, time and type of draws).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin/Brown/Godshall/Fonseca with these teachings of Godshall to display an operator indicator via the screen of the optical instrument to list the tests ordered for a particular patient (Godshall [0050]).
Regarding Claim 4, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin does not disclose, but Godshall further teaches wherein the operator indicator (Io) correlates a plurality of medical technology products (1) with a plurality of users of the health care setting ([0189] teaches on a display of a hand held unit ("first environment") showing orders in a priority/sequence order in which to draw blood to a user; per [0022] the user is understood to be a nurse or phlebotomist, e.g., an operator who is collecting the sample, e.g.,
lo; see Figs. 6-12 which are indicators presented to an operator in healthcare setting, such as the nurse/phlebotomist drawing blood).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin/Brown/Godshall/Fonseca with these teachings of Godshall to display an operator indicator correlating a plurality of medical technology products with users of the healthcare setting, with the motivation of showing orders assigned to each user via the handheld device (Godshall [0049]).
Regarding Claim 5, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin does not disclose, but Godshall further teaches wherein the setting indicator (IG) is displayed via a display of the network device ([0084] teaches on a web interface facilitating system administration functions; Figs. 16-26 illustrate exemplary screens which are displayed on administrator workstations; an administrator is understood to be "manager of healthcare setting"; the administrator workstation is a different environment than the handheld device used by the operator nurse/phlebotomist).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin/Brown/Godshall/Fonseca with these teachings of Godshall to display the setting indicator via the network device, with the motivation of enabling a system administrator to view and track pending orders associated with multiple patients in a healthcare setting (Godshall [0084], Fig. 16 showing 3 patients).
Regarding Claim 6, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin does not disclose, but Godshall further teaches wherein an indicator of the plurality of indicators (Io, IG) comprises a unique identifier code (Regarding IG, see Fig. 23, the order for patient includes "Accession#" which is understood to be a unique identifier code per [0026] and [0198]; Regarding lo, [0051] teaches on Fig. 6 showing a screen on handheld device for a particular accession number).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to modify Orkin/Brown/Godshall/Fonseca with these teachings of Godshall to include a unique identifier code within the plurality of indicators, with the motivation of using a unique identifier code such as an accession number to specify which tests and containers for a particular patient are required (Godshall [0041]).
Regarding Claim 17, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin further discloses wherein the medical technology product (1) is one of the following materials: a collection tube (1),a vaccine, and a needle (Abstract and [0006] teaching on “specimen container” and “vial” for patient samples, interpreted as synonymous with a “collection tube” as it is used for collecting patient biological samples e.g., blood, per [0012]).
Regarding Claim 19, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin does not disclose, but Godshall further teaches: further comprising the step of: generating and displaying a control panel (Pc) via the optical instrument ([0084], screens displayed on administrator workstation; See Fig. 16), wherein the control panel (Pc) is configured as a graphical indicator that correlates a specific period of time (Fig. 16 shows a table with day/time scheduled for individual tests and usage of particular containers, e.g., medical technology products), a number of links generated, and a type of medical technology product (Fig. 16 table shows different container types for different tests ordered - e.g., AERBC, BLUE, PURPLE; each test is understood to represent a link generated by using the patient identification information and container needed to create a label per [0026], [0042]; Fig. 23 shows graphic with Accession # column for patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Orkin/Brown/Godshall/Fonseca with these teachings of Godshall, to generate a control panel correlating a time period, links generated and type of product, with the motivation of enabling sorting of orders for patients by priority and or location, container, date/time, etc. (Godshall [0085]).
Regarding Claim 21, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Claim 21 recites limitations that are the same or substantially similar to Claim 1, and the discussion above with respect to Claim 1 is equally applicable to Claim 21.
Regarding Claim 24, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin further discloses a non-transitory computer-readable medium, the readable medium being characterized in that it stores instructions, which instructions when executed by a processor perform the method steps ([0043], teaching on system architecture).
Regarding Claim 24, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin further discloses A computer readable memory containing instructions to perform the method ([0043], teaching on system architecture).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orkin (US Publication 20100044429A1) in view of Brown et. al. (US Publication 20090287584 A1), further in view of Godshall (US Publication 20090048870A1), and further in view of Fonseca et. al. (US Publication 20130166315A1) as applied to Claim 1 above, and further in view of Muller et. al. (US Publication 20130129166A1).
Regarding Claim 7, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin further discloses wherein the product identifier code (2) is associated with the medical technology product (1,160) through an adhesive means (30) ([0065] teaches on the collection viables having preprinted vial barcode labels already attached thereto).
Orkin/Brown/Godshall/Fonseca do not teach, but Muller, which is directed to specimen container detection, teaches: wherein at least one portion (P) of the adhesive means (30) acts as a criticality classifier, wherein the criticality classifier indicates a criticality level of at least one of the medical technology product (1,160) or the patient ([0009] teaches on a self-adhering label on a sample collection tube which may be colored to indicate urgency, use of "urgency" sticker or handwritten note indicating urgency on existing labels; urgency is interpreted as reading on "criticality classifier").
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Orkin/Brown/Godshall/Fonseca with these teachings of Mueller, to include on the medical product adhesive means, an indication of criticality (urgency), with the motivation of indicating to an analyst a sample tube requiring immediate analysis (Muller [0009]).
Claim(s) 11, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orkin (US Publication 20100044429A1) in view of Brown et. al. (US Publication 20090287584 A1), further in view of Godshall (US Publication 20090048870A1), and further in view of Fonseca et. al. (US Publication 20130166315A1), as applied to Claim 1 above, and further in view of Burchell et. al. (US Publication 20070273507 A1).
Regarding Claim 11, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1 but do not teach the following. Burchell, which is directed to an apparatus and method for monitoring and communicating data associated with a perishable product, teaches:
wherein in the status of compliance, a first sound signal is issued via the optical instrument, in the status of non-compliance status, a second sound signal is issued via the optical instrument, wherein the first sound signal is different from the second sound signal ([0003] teaches on perishable products including vaccines and pharmaceuticals; [0024] teaches on monitoring "perishability or shelf-life" of products, which Examiner interprets to indicate "expiration" of a product; [0035] teaches on using audible signals to indicate shelf life of a product, where a "high pitch sound" is used to indicate a "fresh" product (interpreted as being within "compliance status") and a "low pitch sound" indicates a "spoiled" product (interpreted as "non-compliance status")).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Orkin/Brown/Godshall/Fonseca with these teachings of Burchell, to issue a first and second sound signal to indicate whether a product is in a compliant or non-compliant status, e.g., whether or not it is within its shelf life (expiration date), with the motivation of using different types of audio sound signals to signal shelf-life status to the user (Burchell [0006]).
Regarding Claim 15, Orkin/Brown/Godshall/Fonseca teach the limitations of Claim 1. Orkin further discloses further comprising the step of: issuing an alert signal via the optical instrument, ([0027] teaches on issuing an alert indicative of an out-of-date condition wherein the alert is generated by the electronic reading means).
Orkin does not disclose the following, but Burchell, which is directed to an apparatus and method for monitoring and communicating data associated with a perishable product, teaches:
issuing an alert signal wherein the alert signal is set as at least a visual indication and an audible indication ([0003] teaches on perishable products including vaccines and pharmaceuticals; [0007], visual signals and audible displays to indicate product data to a user such as shelf life; [0024] teaches on monitoring "perishability or shelf-life" of products, which Examiner interprets to indicate "expiration" of a product; [0035] teaches on using audible signals to indicate shelf life of a product, where a "high pitch sound" is used to indicate a "fresh" product (interpreted as being within "compliance status") and a "low pitch sound" indicates a "spoiled" product (interpreted as "non-compliance status") [0033] teaches on using green light to indicate fresh product (e.g., compliance/not expired) and red indicates spoiled (e.g., not compliant/expired); see also [0034] for visual indications as alerts).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to further modify the teachings of Orkin/Brown/Godshall/Fonseca with these teachings of Burchell, to issue audible and visual indications as an alert signal to indicate whether a product is in a compliant or non-compliant status, e.g., whether or not it is within its shelf life (expiration date), with the motivation of using different types of signals to signal shelf-life status to the user (Burchell [0006]).
Response to Applicant’s Remarks/Arguments
Please note: When referencing page numbers of Applicant’s response, references are to page numbers as printed.
112(a) Rejections
The 112(a) rejections detailed in Final Action are moot as the claims have been amended to remove the rejected language.
101 Rejections
Applicant’s remarks have been fully considered but are not persuasive. Regarding remarks pertaining to “transmission of invalid data through local compliance checking”, this is addressed in detail below. Regarding remarks at bottom of page 12 in which Applicant remarks that “digital tracking technique” is not an abstract idea. Examiner submits that the abstract idea of tracking medical supplies and determining a compliance status falls within an abstract idea, particularly certain methods of organizing human activity including managing personal behaviors.
Regarding remarks at page 13-14, pertaining to Step 2A Prong One, Examiner respectfully disagrees. MPEP 2106.04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). As shown above in the main 101 analysis section, Examiner has provided a detailed breakdown of which limitations fall within the scope of the abstract idea and explained how the steps are directed to certain methods of organizing human activities, specifically managing personal behavior of hospital staff or clinical laboratory technicians in tracking inventory samples.
Regarding portions emphasized by Applicant at page 14, Examiner submits that all of these portions are either within the scope of the abstract idea (e.g., detecting a compliance status), amount to mere instructions to apply the abstract idea (e.g., receiving, via an optical instrument, a patient identifier code), or amount to insignificant extra-solution activity which is well-understood, routine and conventional (e.g., temporarily storing the patient identifier). Please reference above 101 analysis section for detailed breakdown of every limitation.
Regarding remarks to Applicant’s SMED at page 15, at which Applicant argues that the steps of Claim 1 are directed to “a digitalized tracking system designed to improve network communications”. Examiner submits that there is no clear nexus between this assertion and any technical issues disclosed by the specification or recited by the claims, and there is no indication of any improvement to network communications in the claims themselves. Examiner further submits that tracking medical products and detecting whether a medical technology product has a status of compliance or non-compliance based on an expiration date of the medical technology product falls within the scope of an abstract idea; using a “digitalized” tracking system to perform these steps so only amounts to mere instructions to apply the abstract idea on a general purpose computing device. Examiner submits that may determining a step of compliance or non-compliance and using that as a preliminary means for determining whether or not to transmit data does not represent an improvement to network communications; by introducing the step of determining products in compliance and only transmitting those, network communications would inherently be improved, as reducing the amount of data to be transmitted through a sorting step necessarily reduces communication burden. Examiner prospectively notes that Applicant’s claim only recites “prevent a link between the product identifier code and the patient identifier code” which Examiner submits only recites the idea of a solution or outcome without reciting details of how a solution to a technical problem is actually accomplished. MPEP 2106.05(f). These arguments are not persuasive.
Regarding remarks at page 15 pertaining to Step 2A Prong Two, Applicant asserts that the claim recites a combination of additional elements that improves a technical field such that the claim as a whole integrates any alleged abstract idea into a practical application. Examiner respectfully disagrees. Applicant has not cited to, nor can Examiner find evidence, of how the combination of additional elements provides a technological improvement. As discussed above in 101 analysis section, the additional elements are understood to be general purpose computing devices (e.g. a cell phone per Applicant’s specification [0094]). Regarding assertion of “improving a technical field”, MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer (see Spec. Para. [0094], first device configured as a cell phone) and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine). While Applicant’s claimed invention recites other additional element(s) of such as “optical instrument” and “display” of the “optical instrument”, these additional elements only implement the steps of the abstract idea and there is no indication that these additional elements operate in a manner different than they normally operate (for example: initiating a collection sequence, interpreted as displaying data, on the screen of the optical instrument does not improve the screen or the optical instrument. They are operating as they normally operate. Operating another device in the manner it normally operates is insufficient to improve an other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present. This argument is not persuasive.
Examiner respectfully submits that any purported improvements may improvements to the abstract idea itself, e.g., an improved way of tracking medical technology products to ensure compliant status. Please see MPEP 2106.05(a) which states, “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” Applicant has not provided, nor can Examiner find evidence of, how any of the additional elements identified above in main 101 analysis section are providing an improvement over prior art systems. The additional elements are all understood to be general purpose computing components functioning in their ordinary capacities to implement the steps of the abstract idea.
Examiner prospectively notes the following paragraphs from the background of instant specification:
[0007] However, the current state of the art does not disclose an effective means to track collection tubes used in hospital settings.
[0008] More specifically, the state of the art does not disclose any means to manage the large amount of collection tubes used in hospital settings, so that, in some instances, expired collection tubes are still kept in use, because there is no way to manage, control and track the use of said tubes in hospital settings.
[0009] The present invention describes a methodology and system capable of managing and tracking collection tubes (or any other medical technology product) used in health care settings.
[0011] Furthermore, the present invention allows managing which collection tubes have expired, thus allowing the manager to exchange such tubes
[0014] The present invention is intended to propose a method of tracking medical technology product used in a health care setting;
[0015] The present invention is also intended to propose a method of tracking medical technology product, wherein the method comprises the step of reading a product identifier code of the medical technology product;
[0016] One object of the present invention is to propose a method that comprises the step of linking the product identifier code to the patient code;
[0017] The present invention is also intended to propose a method of tracking medical technology product that comprises the step of generating a plurality of indicators, wherein the indicators are associated at least with the health care setting operator and the health care setting manager;
[0018] The present invention is also intended to propose a method of tracking medical technology product, which comprises the step of comparing a data relative to the expiry date with the current date;
As described in the specification, particularly in the paragraphs above, it appears that the inventive concept and improvement are to managing and tracking collection tubes, and not to data transmission or network communication optimization. As previously stated, improvements to tracking medical products based on a compliance status in healthcare settings may provide an improvement to the abstract idea itself – e.g., an improved way of managing and tracking collection tubes – but are not technological improvements per MPEP 2106.05(a). These arguments are not persuasive.
Regarding remarks at page 16 pertaining to SMED and how the claimed invention “establishes coordinated operations…”, Examiner submits that using “an optical instrument”, e.g., the camera of a cell phone, to capture patient and product identifier codes only amounts to mere instructions to apply the abstract idea, e.g. using an electronic device functioning in its ordinary capacity to access and retrieve patient and product identifying information. Regarding remarks pertaining to “prevent the traffic of invalid data over the network”, please see remarks in paragraph above pertaining to SMED at page 15, which are equally applicable here. Examiner submits that detecting a status compliance and using that as a preliminary means for determining whether or not to transmit data does not represent an improvement to network communications; by introducing the step of determining products in compliance and only transmitting those, network communications would inherently be improved, as reducing the amount of data to be transmitted through a sorting step necessarily reduces communication burden. Regarding remarks directed to “automated transmission operations”, Examiner is unable to see a nexus between Applicant’s remarks (“reduces unnecessary data persistence operations, minimizing redundant storage events, controlling when and how data is transmitted across the network”) and any limitations in the claims. Examiner notes that reciting data is transmitted “periodically” is extremely broad and could literally entail any frequency from every second or every 24 hours and as such, the claim does not place any limits on how data transmission is controlled from a time perspective. This argument is not persuasive.
Regarding remarks at top of page 17 with respect to “operations on simple mobile devices with limited computational resources”, Examiner notes initially that there is no disclosure in the specification as originally filed pertaining to technological problems arising from using mobile devices. The claims and specification do not use the term “validation”, and as such, Examiner is interpreting Applicant’s remarks pertaining to “local validations” as best understood; Examiner interprets “local validations” to pertain to the determination of a compliance status prior to transmitting data. As discussed above, using the compliance status as a gate-keeping condition of whether or not to transmit data does not improve the functioning of the computer or another technology. Determining compliance based on an expiration date falls within the scope of an abstract idea; by filtering out non-compliant data and reducing the amount of data to transmit, Examiner submits that processing demands and network congestion would necessarily be reduced. This does not represent a technological improvement and does not integrate the judicial exception into a practical application. These arguments are not persuasive.
Regarding remarks at page 17 pertaining to Step 2B and Applicant’s assertion that, “the added limitations cannot be considered to be well-understood, routine or known within the industry at least because they do not appear to be taught by the prior art of record. As an initial matter, Examiner submits that in view of Applicant’s heavy amendments to the claims, prior art references have been applied. Further, Examiner submits that the “well understood, routine and conventional” consideration pertains to additional elements, and not to limitations in their entirety. MPEP 2106.05(I). Regarding the Step 2B analysis and novelty, please see MPEP 2106.05(I) which states, “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting "the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101"). As made clear by the courts, the "novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." This argument is not persuasive.
For all of the above reasons, Applicant’s arguments are not persuasive and the rejections of Claims 1, 3-7, 11, 15, 17, 19, 21, 23, 24 under 35 USC 101 are maintained.
Response to Affidavit
Affidavit has been considered but is not persuasive. Regarding remarks at paras. 5-11, Examiner submits that the problems discussed are not caused by the technological environmental of the claim, e.g., tracking tubes across multiple cites is not a problem caused by the computing device. The problem of tracking tubes across sites exists regardless of whether or not a computing device is used. Similarly, indicators for different users falls within the scope of the abstract idea; generating interfaces for product description and test data only amount to mere instructions to applying the abstract idea on a computer, e.g., using a general purpose computing device to output a collection sequence. See above remarks pertaining to technical improvements and MPEP 2106.05(a). Regarding remarks to “validation mechanisms”, Examiner submits that comparing a current date to an expiration date to determine whether a product status is compliant or non-compliant falls within the scope of the abstract idea. Examiner submits that the features cited by Applicant in para. 11 all amount to limitations within the scope of the abstract idea, or insignificant extra-solution activity which amounts to well understood, routine and conventional activity such as storing data and transmitting data over a network. These remarks are not persuasive.
Regarding remarks “Key Components and Architecture Innovations” (paras. 12-28): As an initial matter, Affiant appears to be arguing features and particular technological aspects beyond what was disclosed in the original specification and what is recited in the instant claims (e.g., paras. 14-21). Examiner will address as best understood and focus on remarks directly applicable to the instant claims. Regardless of the electronic devices being utilized, Examiner maintains the position as discussed above in response to 101 arguments section; reducing network congestion and processor workload based on filtering out data with a non-compliant status is not a technological improvement. Filtering out data so that the computer has less data to process will necessarily improve processing capability and reduce network congestion in addition to other purported benefits at para. 19. Examiner asserts that features cited by Applicant at para. 22 such as role-specific interfaces only amount to mere instructions to apply the abstract idea, e.g., using a computer to provide specific data to certain user levels based on a permission rule. Similarly, para. 23 enabling period-based data retrieval may be an improvement to the abstract idea but is not a technological improvement per MPEP 2106.05(a). Reducing computational overhead by limiting the scope of data is not a technological improvement; limiting data will necessarily reduce computational overhead. Similarly, warning messages (para. 24) falls within the scope of the abstract idea and improvements may be to the abstract idea, which is not sufficient to integrate the judicial exception into a practical application. Regarding para. 25 and reducing CPU and RAM usage, this has been addressed multiple times. Reducing the data a computer has to process by filtering out specific data is not a technological improvement; having less data to process inherently reduces CPU and RAM usage. Regarding para. 26, nothing in the instant claims requires multiple devices to independently send data; however, Examiner prospectively notes that the instant specification does not appear to disclose how Applicant has invented a way to send data from multiple devices which could not previously be performed. Regarding para. 27 and batch sending, this falls within the scope of an improvement to abstract idea. These remarks are not persuasive.
Regarding remarks “Objective Evidence of Infrastructure Optimization and Data Integrity” (paras. 29-42), Examiner is unable to see a nexus between the illustrations and information presented in this section and any improvement provided by the instant claims or presented in the specification, e.g., it is unclear how reducing the number of individual connections by processing atomic packets is a problem solved by the instant claims. These remarks are not persuasive.
Conclusion
In the interest of expediting prosecution, Examiner respectfully requests that Applicant provides citations to relevant paragraphs of specification for support for amendments in future correspondence.
The following relevant prior art not cited is made of record:
US Publication 20030004751, teaching on a system and method for tracking a blood collection kit in a blood collection facility
US Publication 20160356800A1, teaching on a Computer-implemented Point-of-care (POC) Sample Analysis Method For Determining Quality Compliance Of Biological Sample Testing Device such as Single-use Blood Test Cartridge
US Publication 20210182764, teaching on a management system for point of care testing
US Publication 20150209510A1, teaching on a system and method for assuring patient medication and fluid delivery at the clinical point of use
US Publication 20130056535, teaching on a system and method for medical data transfer from a mobile device carried by a healthcare provider to a server/EMR system
US Publication 20180300672A1 – location identifier of sample (blood), uploading to network device “associated with setting indicator” is super broad. We can say they’re associated if transmitting data to it.
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/ANNE-MARIE K ALDERSON/Primary Examiner, Art Unit 3682
Prosecution Insights