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 .
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.
Response to Arguments
Applicant's arguments filed August 4, 2025 have been fully considered but they are not persuasive.
Regarding the 112f and subsequent 112b for the term ‘suction apparatus’. No structure was added to the claim to avoid the 112f interpretation. The claims are still directed to a placeholder term + function without sufficient structure to perform the function. The 112f therefore is maintained. With regards to the 112b no structure is ever provided for the term and it would appear that it would potentially be new matter to add any, so the 112b is maintained.
Regarding the 101:
Examiner notes the processing of the signal is merely comparing data to a threshold. That is fully within the realm of what can be done in the mind of a human. A human can compare two numbers. A human can compare multiple numbers. A human can select an appropriate threshold for comparison based on the medical data. The processing is claimed at a high level of generality.
Examiner notes it is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II. Applicant relies on the judicial exception to show the alleged improvement. Further the additional elements merely indicate a field of use and do not provide significantly more. Examiner notes the following were considered additional elements: “The additional elements recited include ‘a drain system comprising a tube’ in claims 24 and 43, ‘at least one sensor configured for sensing’ in claims 24-29 and 43, ‘a processor’ in claims 24 and 43, ‘a transmitter configured for transmitting’ in claims 24 and 43, ‘a notification system’ in claims 24, 37-39, and 43, ‘a suction apparatus’ in claim 35, and ‘a display unit’ in claim 40.” These additional elements were examined to see if they provide significantly more. They were determined they do not. They are all claimed at a high level of generality. The recitations regarding the generic computing components for process, receive, select, compare, determine, and generate merely invoke a computer as a tool. Each of the additional element limitations are recited at a high level of generality (i.e., as a generic processor performing a generic computer function or as a generic sensor performing a mere extra-solution data gathering) such that it amounts to no more than mere instructions to apply the judicial exception using a generic computer component or generic sensor component. Further the sensor unit is merely an additional element that performs extra-solutionary data gathering that would be necessary for the performance of the abstract idea and therefore does not provide significantly more. Examiner notes that the drain system is claimed at a high level of generality that it is merely indicating a field of use or technological environment in which to apply the abstract idea and therefore does not provide significantly more (MPEP 2106.05(h): “Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);”). The additional elements were not considered abstract ideas. The additional elements are claimed at a high level of generality and no particular machine is being claimed. Conventional elements/structures claimed at a high level of generality are not considered particular machines. No specialized sensor is claimed. Merely at least one sensor is claimed. No specific structure to this sensor is claimed.
Per MPEP 2106.05(a):
Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality:
i. Generating restaurant menus with functionally claimed features, Ameranth, 842 F.3d at 1245, 120 USPQ2d at 1857;
ii. Accelerating a process of analyzing audit log data when the increased speed comes solely from the capabilities of a general-purpose computer, FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095, 120 USPQ2d 1293, 1296 (Fed. Cir. 2016);
iii. Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential);
iv. Recording, transmitting, and archiving digital images by use of conventional or generic technology in a nascent but well-known environment, without any assertion that the invention reflects an inventive solution to any problem presented by combining a camera and a cellular telephone, TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747;
v. Affixing a barcode to a mail object in order to more reliably identify the sender and speed up mail processing, without any limitations specifying the technical details of the barcode or how it is generated or processed, Secured Mail Solutions, LLC v. Universal Wilde, Inc., 873 F.3d 905, 910-11, 124 USPQ2d 1502, 1505-06 (Fed. Cir. 2017);
vi. Instructions to display two sets of information on a computer display in a non-interfering manner, without any limitations specifying how to achieve the desired result, Interval Licensing LLC v. AOL, Inc., 896 F.3d 1335, 1344-45, 127 USPQ2d 1553, 1559-60 (Fed. Cir. 2018);
vii. Providing historical usage information to users while they are inputting data, in order to improve the quality and organization of information added to a database, because “an improvement to the information stored by a database is not equivalent to an improvement in the database’s functionality,” BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1287-88, 127 USPQ2d 1688, 1693-94 (Fed. Cir. 2018); and
viii. Arranging transactional information on a graphical user interface in a manner that assists traders in processing information more quickly, Trading Technologies v. IBG LLC, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019).
Examples that the courts have indicated may not be sufficient to show an improvement to technology include:
i. A commonplace business method being applied on a general purpose computer, Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1976; Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015);
ii. Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017);
iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;
iv. Delivering broadcast content to a portable electronic device such as a cellular telephone, when claimed at a high level of generality, Affinity Labs of Tex. v. Amazon.com, 838 F.3d 1266, 1270, 120 USPQ2d 1210, 1213 (Fed. Cir. 2016); Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016);
v. A general method of screening emails on a generic computer, Symantec, 838 F.3d at 1315-16, 120 USPQ2d at 1358-59;
vi. An advance in the informational content of a download for streaming, Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1263, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016); and
vii. Selecting one type of content (e.g., FM radio content) from within a range of existing broadcast content types, or selecting a particular generic function for computer hardware to perform (e.g., buffering content) from within a range of well-known, routine, conventional functions performed by the hardware, Affinity Labs of Tex. v. DirecTV, LLC, 838 F.3d 1253, 1264, 120 USPQ2d 1201, 1208 (Fed. Cir. 2016).
As noted above any alleged improvement is not reflected in the claims and the alleged improvement appears to merely be “Gathering and analyzing information using conventional techniques and displaying the result” which would not provide significantly more.
Thus the 101 rejection remains.
Regarding the 103: After review of the amendments, the Ivey and Harper references were found to teach the newly added limitations.
Response to Amendment
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-a notification system configured to receive…select…analyze…determine…generate’ in claims 24 and 43 interpreted to be a processor per Paragraph 0068 of the specification.
-‘a suction apparatus…configured to draw the fluids’ in claim 35
-‘an analyzer for analyzing’ in claim 38 interpreted to be a processor per Paragraph 0068 of the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 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.
Claim 35 is 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.
Claim limitation “suction apparatus” 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. No structure is provided for the suction element 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.
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 24-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 24-43 are all within at least one of the four categories (claims 24-43 all being apparatuses).
Regarding Step 2, the independent claims 24 and 43 recite:
process a signal generated by the at least one sensor unit
receive the processed signal,
select a threshold based on at least one of a baseline value or a trend of the at least one infection biomarker,
compare the processed signal to the selected threshold,
determine that the processed signal exceeds the selected threshold,
determine a stage of infection based on a duration or a rate of change of the biomarker signal relative to the selected threshold, and
generate a stage-specific indication of the infection in response to determining the stage of infection.
The above claim limitations are tied to the abstract idea of mental processes in that they are concepts that can be performed in the human mind. This group encompasses concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
The claimed steps of process, receive, select, compare, determine, and generate can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas. These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output/processing that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
The additional elements recited include ‘a drain system comprising a tube’ in claims 24 and 43, ‘at least one sensor located within the tube, the at least one sensor configured to sense’ in claims 24-29 and 43, ‘a processor’ in claims 24 and 43, ‘a transmitter configured for transmitting’ in claims 24 and 43, ‘a notification system’ in claims 24, 37-39, and 43, ‘a suction apparatus’ in claim 35, and ‘a display’ in claim 40.
This judicial exception is not integrated into a practical application because:
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims amount to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for process, receive, select, compare, determine, and generate merely invoke a computer as a tool. Each of the additional element limitations are recited at a high level of generality (i.e., as a generic processor performing a generic computer function or as a generic sensor performing a mere extra-solution data gathering) such that it amounts to no more than mere instructions to apply the judicial exception using a generic computer component or generic sensor component. Examiner notes those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for extra solution data-gathering and computing, as demonstrated by the prior art as in the IDS teaching said components. The claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum. The sensor unit is merely an additional element that performs extra-solutionary data gathering that would be necessary for the performance of the abstract idea and therefore does not provide significantly more. Examiner notes that the drain system is claimed at a high level of generality that it is merely indicating a field of use or technological environment in which to apply the abstract idea and therefore does not provide significantly more (MPEP 2106.05(h): “Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016);”).
The additional elements do not provide an improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for process, receive, select, compare, determine, and generate.
The drain system with a tube and a sensor within the tube merely amounts to use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) and thus does not integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole 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.
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.
Claim(s) 24, 29, 33-35, and 38-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704).
Regarding claim 24, Luxon teaches a system for detecting early signs of post-surgery infection in a patient (Abstract; Paragraph 0003), the system comprising:
a drain system comprising a tube configured to drain fluids from a surgery site (Figure 1; Paragraph 0061);
at least one sensor (25) located within the tube (Figure 6), the at least one sensor configured to sense a presence of at least one infection biomarker selected from lactic acid, immune-modulating mediators, pancreas enzymes, inflammatory parameters, metabolic parameters, or combinations thereof (Figure 6; Paragraph 0069; ‘pH, nitrate, oxygen, hemoglobin and or temperature sensor(s) 25’; Paragraph 0103);
a processor configured to process a signal generated by the at least one sensor (console 11; Paragraph 0062);
a transmitter configured to transmit the processed signal (console 11; Paragraph 0062); and
a notification system (console 11; Paragraph 0062) configured to generate an indication on the infection in response to determining the infection (Paragraph 0102).
Luxon is silent on the comparison of the signal to a threshold that is selected and generating a stage-specific indication.
Mansour teaches a drain system (100) with sensors (108) for measuring infection biomarkers (Paragraph 0031) and a notification system (122) configured to receive the processed signal, compare the processed signal to the selected threshold, determine that the processed signal exceeds the selected threshold, determine an infection, and generate an indication on the infection in response to determining the infection (Paragraphs 0014-0015, 0034-0037, and 0041; constant comparison of data over time and display of data; Examiner notes this can be applied to the teachings of Luxon to specifically show infection status).
Mansour teaches determine a stage of infection based on a duration or rate of change of the biomarker signal relative to the selected threshold (Paragraph 0037; a threshold of some sorts is taught implicitly).
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Mansour because tracking changes over time which is important during critical postoperative periods (Paragraph 0011) and further comparing physiological/medical data to thresholds and providing a warning as needed is conventional in the art and doing so would yield predictable results.
Harper teaches select a threshold based on at least one of a baseline value or a trend of the at least one biomarker (Paragraph 0281; ‘the rate of change threshold and the time period associated with the rate of change may be selected and adjusted by the user or a health care provider.’), determine a medical issue based on a duration or rate of change of the biomarker signal relative to the selected threshold (Paragraph 0281), and generate an indication (Paragraph 0281; alarm)
Ivey teaches determining biomarkers for stage of infection and generate a stage-specific indication of infection in response to determining the stage of infection (Paragraph 0009-0011 and 0014 and 0110)
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Harper because Harper teaches this allowing for looking at trends to predict potential issues and that the specific threshold chosen is a design choice up to the user or a health care provider (Paragraph 0281 of Harper), thus selecting a threshold and using that for the alarm would yield predictable results.
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Ivey because it allows for understanding the progression of the issue and thus allowing for more appropriate intervention thus reducing the progression (Paragraphs 0008-0009 of Ivey).
Regarding claim 29, Luxon is silent on wherein the at least one sensor comprises at least a first sensor and a second sensor. But it would have been obvious to one of ordinary skill in the art to have modified Luxon to have multiple sensors since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. MPEP 2144.04(VI-B).
Regarding claim 33, Luxon teaches wherein the at least one infection biomarker is a metabolic parameter including glucose (Paragraph 0103).
Regarding claim 34, Luxon teaches wherein the at least one infection biomarker includes lactic acid, IL-6, glucose, or combinations thereof (Paragraph 0103; glucose)
Regarding claim 35, Luxon teaches wherein the drain system further comprises a suction apparatus coupled to the tube and configured to cause high or low pressure in order to draw the fluids from the surgery site through the tube and into a container (Paragraph 0122).
Regarding claim 38, Luxon teaches wherein the notification system comprises an analyzer for analyzing a processed signal (Paragraphs 0061-0062) and determining presence of the infection (Paragraphs 0102-0103)
Regarding claim 39, Luxon is silent on determining a stage of the infection. Mansour teaches wherein the analyzer further determines a stage of the infection (Paragraphs 0035, 0037, and 0041).
Regarding claim 40, Luxon teaches wherein the indication is displayed on a display (Paragraph 0062-0063).
Regarding claim 41, Luxon teaches wherein the at least one sensor senses the presence of the at least one infection biomarker continuously (Paragraph 0102)
Regarding claim 42, Luxon is silent on the sensing being periodically. Mansour teaches wherein the at least one sensor senses the presence of the at least one infection biomarker periodically (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Mansour because tracking changes over time which is important during critical postoperative periods (Paragraph 0011) and further comparing physiological/medical data to thresholds and providing a warning as needed is conventional in the art and doing so would yield predictable results.
Regarding claim 43, Luxon teaches system for detecting early signs of post-surgery infection in a patient (Abstract; Paragraph 0003), the system comprising:
a drain system comprising a tube configured to drain fluids from a surgery site (Figure 1; Paragraph 0061);
at least one sensor (25) located within the tube (Figure 6), the at least one sensor configured to sense a presence of at least one infection biomarker selected from lactic acid, IL-6, glucose, or combinations thereof (Figure 6; Paragraph 0069; ‘pH, nitrate, oxygen, hemoglobin and or temperature sensor(s) 25’; Paragraph 0103);
a processor configured to process a signal generated by the at least one sensor (console 11; Paragraph 0062);
a transmitter configured to transmit the processed signal (console 11; Paragraph 0062); and
a notification system (console 11; Paragraph 0062) configured to generate an indication on the infection in response to determining the infection (Paragraph 0102).
Luxon is silent on the comparison of the signal to a threshold that is selected and generating a stage-specific indication.
Mansour teaches a drain system (100) with sensors (108) for measuring infection biomarkers (Paragraph 0031) and a notification system (122) configured to receive the processed signal, compare the processed signal to a selected threshold, determine that the processed signal exceeds the selected threshold, determine an infection in, and generate an indication on the infection in response to determining the infection (Paragraphs 0014-0015, 0034-0037, and 0041; constant comparison of data over time and display of data; Examiner notes this can be applied to the teachings of Luxon to specifically show infection status).
Mansour teaches determine a stage of infection based on a duration or rate of change of the biomarker signal relative to the selected threshold (Paragraph 0037; a threshold of some sorts is taught implicitly).
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Mansour because tracking changes over time which is important during critical postoperative periods (Paragraph 0011) and further comparing physiological/medical data to thresholds and providing a warning as needed is conventional in the art and doing so would yield predictable results.
Harper teaches select a threshold based on at least one of a baseline value or a trend of the at least one biomarker (Paragraph 0281; ‘the rate of change threshold and the time period associated with the rate of change may be selected and adjusted by the user or a health care provider.’), determine a medical issue based on a duration or rate of change of the biomarker signal relative to the selected threshold (Paragraph 0281), and generate an indication (Paragraph 0281; alarm).
Ivey teaches determining biomarkers for stage of infection and generate a stage-specific indication of infection in response to determining the stage of infection (Paragraph 0009-0011 and 0014 and 0110).
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Harper because Harper teaches this allowing for looking at trends to predict potential issues and that the specific threshold chosen is a design choice up to the user or a health care provider (Paragraph 0281 of Harper), thus selecting a threshold and using that for the alarm would yield predictable results.
It would have been obvious to one of ordinary skill in the art to have modified Luxon with Ivey because it allows for understanding the progression of the issue and thus allowing for more appropriate intervention thus reducing the progression (Paragraphs 0008-0009 of Ivey).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) and in further view of Li et al. (US 2009/0171170).
Regarding claim 25, Luxon is silent on wherein the at least one sensor comprises a memory. Li teaches wherein said at least one sensor comprises a memory (Paragraph 0023). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Li because it helps to facilitate or enhance communication of data (Paragraph 0023 of Li).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) and in further view of Holm-Kennedy (US Patent No. 7692219).
Regarding claim 26, Luxon is silent on wherein the at least one sensor comprises a heating resistor for controlling a temperature within the at least one sensor. Holm-Kennedy teaches wherein the at least one sensor comprises a heating resistor for controlling a temperature within the at least one sensor (Figure 7; Column 13, Lines 4-10). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Holm-Kennedy because it provides superior performance and enables temperature control when sensor measurement requires it (Column 12, Lines 34-37 of Holm-Kennedy).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) and in further view of Sadik et al. (US 2013/0183750).
Regarding claim 27, Luxon is silent on the sensor having an illumination source and photodetector. Sadik teaches wherein the at least one sensor comprises an illumination source and a photodetector (Paragraph 0029). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Sadik it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the sensor of Luxon with that of Sadik.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) and Sadik et al. (US 2013/0183750) in further view of Bright et al. (US 2010/0001185).
Regarding claim 28, Luxon is silent on the sensor having a sol-gel material between an illumination source and photodetector. Bright teaches wherein the at least one sensor further comprises a sol-gel material located between the illumination source and the photodetector (Paragraphs 0063 and 0114). It would have been obvious to one of ordinary skill in the art to have modified Luxon in view of Sadik with Bright it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the sensor of Luxon in view of Sadik with that of Bright.
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) in further view of Blakely et al. (US 2012/0329070).
Regarding claim 30, Luxon is silent on the specific biomarkers claimed. Blakely teaches wherein the at least one infection biomarker is an immune-modulating mediator selected from IL-1, IL-6, IL-10, TNF-a, or combinations thereof (Paragraphs 0050 and 0072). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Blakely because these are common in the art bacterium for types of injuries (Paragraphs 0050 of Blakely) and would yield predictable results (i.e. testing for certain biomarkers over others as is common in the medical arts).
Regarding claim 31, Luxon is silent on the specific biomarkers claimed. Blakely teaches wherein the at least one infection biomarker is a pancreas enzyme including amylase (Paragraph 0050; Table 1). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Blakely because these are common in the art bacterium for types of injuries (Paragraphs 0050 of Blakely) and would yield predictable results (i.e. testing for certain biomarkers over others as is common in the medical arts).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) in further view of Young et al. (US 2016/0231320).
Regarding claim 32, Luxon is silent on the specific biomarkers claimed. Young teaches wherein the at least one infection biomarker is an inflammatory parameter including Lipopolysaccharide Binding Protein (Paragraph 0127). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Young because these are common in the art analytes to test for (Paragraphs 0127 of Young). and would yield predictable results (i.e. testing for certain biomarkers over others as is common in the medical arts).
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luxon et al. (WO 2014/043650 A2) in view of Mansour et al. (US 2008/0269582) and Ivey et al. (US 2004/0096917) and Harper et al. (US 2011/0193704) in further view of Sebastian et al. (US 2007/0275423).
Regarding claim 36, Luxon wherein the system further comprises another sensor configured for sensing at least a second infection biomarker (Paragraph 0103; sensor in the collection reservoir) but is silent on the specific biomarkers claimed. Sebastian teaches a sensor unit configured for sensing a biomarker selected from Escherischia coli, Pseudomonas spp., Pseudomonas aeruginosa, Pseudomonas putida, Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp., Enterococcus spp., Klebsiella spp., Proteus spp., Serratia spp., Morganella s pp., Enterobacteriaceae, or combinations thereof (Paragraph 0036). It would have been obvious to one of ordinary skill in the art to have modified Luxon with Sebastian because these are common in the art bacterium for wounds (Paragraphs 0014 and 0036 of Sebastian) and would yield predictable results (i.e. testing for certain biomarkers over others as is common in the medical arts).
Regarding claim 37, Luxon teaches wherein the notification system comprises an analyzer for analyzing signals detected by the at least one sensor and the another sensor (Paragraphs 0061-0062) and determining presence of the infection (Paragraphs 0102-0103).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cameron et al. (US 2011/0225112)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791