DETAILED ACTION
This is a FINAL Office Action on the merits and is responsive to the papers filed on 11/20/2025. Claims 1-20 are currently pending and are examined below.
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 .
Response to Amendments
The amendments filed on 11/20/2025 in response to the initial rejection made on 08/20/2025 have been acknowledged and entered. Claims 1, 12, and 16 have been amended.
Rejections necessitated in response to the amendments made to the claims have been made. Responses to the Applicant’s arguments are written below.
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.
Claims 10-11, and 17 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.
Claim 10 recites the limitation “the microcontroller is at least partially contained in the housing” in lines 4 of the claim. The claim language of “partially” renders the claim as indefinite because a person having ordinary skill in the art would not know what the metes and bounds are as to avoid infringement.
Claim 11 recites the limitation “at least partially contained in the housing” in line 2 of the claim. The claim language of “partially” renders the claim as indefinite because a person having ordinary skill in the art would not know what the metes and bounds are as to avoid infringement.
Claim 17 recites the limitation “integrated into a case at least partially enclosing the insertion tool” in line 2 of the claim. The claim language of “integrated” and “partially” renders the claim as indefinite because a person having ordinary skill in the art would not know what the metes and bounds are as to avoid infringement.
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 1-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is directed to “an apparatus to provide feedback” (i.e. a machine);
Claim 12 is directed to “a system to provide feedback” (i.e. a machine); and
Claim 16 is directed to “a method to provide feedback” (i.e. a process).
The claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter).
Step 1 of the subject-matter eligibility analysis: Yes.
However, the claims are drawn to an abstract idea of “determine whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors meets a predetermined threshold value” either in the form of “certain methods of organizing human activity,” in terms of managing personal behavior or relationships or interactions between people (including social activities, teaching and following rules or instructions), or reasonably in the form of “mental processes,” in terms of processes that can be performed in the human mind (including an observation, evaluation, judgement or opinion) which are “performed on a computer” (per MPEP 2106(III)(C) “A Claim That Requires a Computer May Still Recite a Mental Process”).
The claims are reasonably understood as either “certain methods of organizing human activity” or “mental processes.” Independent claim 1, analyzed as the representative of the claimed subject matter, is reproduced below. The limitations determined to be abstract ideas are shown in italics. The additional elements recited at a high level of generality are shown in bold. The limitation(s) determined to be extra-solution activity are underlined.
Independent Claim 1: An apparatus to provide feedback for a chest tube insertion, the apparatus comprising:
[1] a case coupled to an insertion tool;
[2] one or more force-sensing resistors coupled to the case;
[3] one or more feedback output devices;
[4] a microcontroller communicatively coupled to the one or more force-sensing resistors and the one or more feedback output devices; and
[5] one or more memory devices configured to store instructions that, when executed by the microcontroller, cause the apparatus to:
[6] generate, an input signal representing a chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors,
[7] determine whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors meets a predetermined threshold value, and
[8] output, using the one or more feedback output devices, the feedback indicating whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors exceeds the predetermined threshold value.
These limitations simply describe a process of data gathering and manipulation, which is partially analogous to “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)). Hence, these limitations are akin to an abstract idea which has been identified among non-limiting examples to be an abstract idea.
Step 2A, Prong 1 of the subject-matter eligibility analysis: Yes.
Furthermore, the claims do not include additional elements that either alone or in combination are sufficient to claim a practical application because to the extent that, e.g., “output, using the one or more feedback output devices, the feedback indicating whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors exceeds the predetermined threshold value” are claimed, as these are merely claimed to add insignificant extra-solution activity to the judicial exception (e.g., data gathering) and/or do no more than generally link the use of a judicial exception to a particular technological environment or field of use. In other words, the claimed “determine whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors meets a predetermined threshold value” is not providing a practical application.
Step 2A, Prong 2 of the subject-matter eligibility analysis: No.
Likewise, the claims do not include additional elements that either alone or in combination are sufficient to amount to significantly more than the judicial exception because to the extent that, e.g. “a case;” “an insertion tool;” “force-sensing resistors;” “feedback output devices;” “a microcontroller;” and “memory devices” as claimed are all generic, well-known, and conventional computing elements. As evidence that these are generic, well-known, and conventional computing elements, Applicant’s specification discloses them in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a), per MPEP § 2106.07(a) III (a), which satisfies the Examiner’s evidentiary burden requirement per the Berkheimer memo.
The Specification describes the elements as follows:
A case “[0009] The case can be removably secured to the insertion tool;”
An insertion tool “[0009] The insertion tool can be a Kelly clamp tool;”
Force-sensing resistors “[0042] The one or more force-sensing resistor(s) 104 can detect pressure or force being applied by a user, such as a hand or finger pressing against the case 202” and “[0047] The force-sensing resistor(s) 104 can be Ohmite sensors for detecting between 20 grams and 5 kilograms of applied force”
Feedback output devices “[0048] In some examples, the audio speaker 124, the visual display 126, and/or other feedback output devices 122 are electrically connected to the microcontroller”
Microcontroller “[0033] The microcontroller 106 includes one or more memory device(s) 108 storing executable instructions (e.g., software and/or algorithm modules) that, when executed by a processor 110 of the microcontroller 106, cause the chest tube insertion test device 102 to perform the operations discussed herein” and “The microcontroller 106 can be an Arduino Uno board and can have 7-volt to 12-volt input ports and a 5-volt output port.”
Memory devices “[0054] At operation 608, the method 600 stores the input data in a data array (e.g., at the one or more memory devices 108)”
This elements are reasonably interpreted as a generic computer parts or generic devices which provides no details of anything beyond ubiquitous standard equipment with no additional technological improvement to the devices. As such, the claimed limitations as recited above are reasonably understood as not providing anything significantly more.
Step 2B, of the subject-matter eligibility analysis: No.
In addition, dependent claims 2-11, 12-15, and 17-20 do not provide a practical application and are insufficient to amount to significantly more than the judicial exception. As such, dependent claims 2-11, 12-15, and 17-20 are also rejected under 35 U.S.C. § 101, based on their respective dependencies to independent claims 1, 12, and 16.
Therefore, claims 1-20 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Response to Arguments
35 U.S.C. § 112(b):
Applicant recited on page 2 of the remarks that the terms “at least partially enclosing” and “portion of the insertion tool” are described in the instant application when referring to paragraph [0041]. Examiner withdraws 112(b) rejections made under indefiniteness for claims 8-9.
35 U.S.C. § 101:
Applicant states on page 2 of the remarks that independent claim 1 does not fall under a “certain method of organizing human activity” or “mental process”. The examiner respectfully disagrees.
The applicant asserts that the features of claim 1 cannot be performed in the human mind. However, it is important to note that for Step 2A prong 1, the analysis merely requires that the claim include, rather than consist entirely of, a mental process. Furthermore, a human could identify a whether a chest tube insertion force meets or exceeds a predetermined threshold mentally or with the aid of pen and paper given knowledge of the data gathered from the force-sensing resistors, feedback output devices, and a microcontroller.
Amended claim 1 recites “a case coupled to an insertion tool; one or more force-sensing resistors coupled to the case; one or more feedback output devices; a microcontroller communicatively coupled to the one or more force-sensing resistors and the one or more feedback output devices; and one or more memory devices configured to store instructions that, when executed by the microcontroller, cause the apparatus to: generate, an input signal representing a chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors, determine whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors meets a predetermined threshold value … the feedback indicating whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors exceeds the predetermined threshold value.” These limitations encompass determining data indicative of a determination of an insertion of a chest tube and whether the chest tube insertion force meets a predetermined threshold value and whether the chest tube insertion force exceeds a predetermined threshold value, with these limitations merely being pre-solution activity consisting of data gathering and do not encompass patent-eligible subject matter. See MPEP 2106.05(g) “An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent. An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent”. Furthermore, the limitation “generate, an input signal representing a chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors, determine whether the chest tube insertion force placed on the insertion tool and detected by the one or more force-sensing resistors meets a predetermined threshold value, output using the one or more feedback output devices, the feedback…” can practically be performed in the human mind and with a pen and paper.
The determining data indicative of a determination of an insertion of a chest tube and whether the chest tube insertion force meets a predetermined threshold value and whether the chest tube insertion force exceeds a predetermined threshold value can be practically performed in the human mind or with the aid of a pen and paper. The use of generic computer components (a case coupled to an insertion tool, one or more force-sensing resistors coupled to the case, one or more feedback output devices, a microcontroller, and one or more memory devices) to determine determination of an insertion of a chest tube and whether the chest tube insertion force meets a predetermined threshold value and whether the chest tube insertion force exceeds a predetermined threshold value does not make the claim limitation patent-eligible. See, MPEP 2106.04(A)(2)(III) states “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same) … The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer"). Mental processes recited in claims that require computers are explained further below with respect to point C.”
The applicant states on page 10 of the remarks that the “claims, as a whole, are integrated into a practical application”. The examiner respectfully disagrees. Amended claim 1 discusses an abstract idea to determine proper chest tube placement and force. Even if the determination is a new idea, “a claim for a new abstract idea is still an abstract idea.” Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151 (Fed. Cir. 2016) (emphasis omitted); see also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1321 (Fed. Cir. 2016) (“A narrow claim directed to an abstract idea, however, is not necessarily patent-eligible.”). Furthermore, when a claim directed to an abstract idea contains no restriction on how an asserted improvement is accomplished and the asserted improvement is not described in the claim, then the claim does not become patent eligible. See Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316 (Fed. Cir. 2016).
The applicant states on page 11 of the remarks that “the claim provides improved techniques for training personnel regarding this medical procedure by providing feedback based on the forced detected that is placed on the insertion tool”. The examiner respectfully disagrees. The applicants assert arguments for a more general improvement to an existing technological process. However, the applicant’s arguments are not persuasive because applicant’s claim 1 fails to recite (1) any limitations detailing “low demand services”, how to efficiently “uninstall and then reinstall a service” or how management of services are allowed to be more efficient, and (2) any limitations detailing how “allowing the service requester to receive a desired quality of service” or how “not experiencing a delay or difference in quality of service even if the requested service had its processing priority lowered and needed to be reconfigured” is achieved. When a claim directed to an abstract idea contains no restriction on how an asserted improvement is accomplished and the asserted improvement is not described in the claim, then the claim does not become patent eligible. SeeIntellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316 (Fed. Cir. 2016); see also MPEP 2106.04(d)(1) (“Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification”).
The applicant states on page 12 of the remarks that “Furthermore, to increase efficiency in examination, "a streamlined eligibility analysis can be used for a claim that may or may not recite a judicial exception but, when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it." MPEP §2105.06(a). Without conceding the Office's characterization of the claims as including an abstract idea, the Applicant respectfully submits that the claims clearly do not seek to preempt or tie up the purported abstract idea to which the Office asserts the claim is directed. To the contrary, there are numerous ways in which others may perform the purported abstract idea not recited in the claims.”. The applicant cites MPEP §2105.06(a), however, the correct citation for this evidence is MPEP §2106.06(a). Furthermore, MPEP §2105.06 states “The results of the streamlined analysis will always be the same as the full analysis, thus the streamlined analysis is not a means of avoiding a finding of ineligibility that would occur if a claim were to undergo the full eligibility analysis. Similarly, a claim that qualifies as eligible after Step 2A (Pathway B) or Step 2B (Pathway C) of the full analysis would also be eligible if the streamlined analysis (Pathway A) were applied to that claim” such that with either a streamlined analysis or a full analysis the same determination, that claim 1 is directed to an abstract idea, would have been made.
It is for these reasons the rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELWA A ALSOMAIRY whose telephone number is (703)756-5323. The examiner can normally be reached M-F 7:30AM to 5PM EST.
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715
/PETER S VASAT/Supervisory Patent Examiner, Art Unit 3715