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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/11/2026 has been entered.
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 17 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 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” (i.e. a machine), claim 12 is directed to “a system” (i.e. a machine), and claim 16 is directed to “a method” (i.e. a process), hence 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… 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” and/or “mental process.” Independent claim 1, analyzed as the representative of the claimed subject matter, is reproduced below. The limitations determined to be abstract ideas are 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:
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, and
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, wherein the output comprises at least one of an instruction to increase force, decrease force, or maintain force.
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., "a case," "an insertion tool," "force-sensing resistors," "feedback output devices," "a microcontroller," and "memory devices" 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… 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" are claimed these 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.
Specifically, the Applicant’s claimed "a case," "an insertion tool," "force-sensing resistors," "feedback output devices," "a microcontroller," and "memory devices" are described in the following paragraphs:
“[0009] The case can be removably secured to the insertion tool;”
“[0009] The insertion tool can be a Kelly clamp tool;”
“[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”
“[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”
“[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.”
“[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)”
These element(s) are reasonably interpreted as a generic computer which provides no details of anything beyond ubiquitous standard equipment, or as generic elements that are well known in the art to aid in the data collection. As such, the claimed limitation of "a case," "an insertion tool," "force-sensing resistors," "feedback output devices," "a microcontroller," and "memory devices" are reasonably understood as not providing anything significantly more.
Step 2B, o of the subject-matter eligibility analysis: No.
In addition, dependent claims 2-11, 13-15, 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, 13-15, 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’s amendments to claims 10 and 11 have overcome the rejection set forth under 35 U.S.C. § 112(b). Applicant states on page 1 of the remarks that claim 17 has been amended; however, claim 17 has not been amended and therefore the rejection is maintained.
35 U.S.C. § 101:
Applicant states on page 2 of the remarks that “The claim does not merely gather information and display a result. Rather, the claim requires a particular physical apparatus configured to sense force on an insertion tool and to generate operative feedback in the form of force-adjustment instructions.” The Examiner respectfully disagrees. The claim under BRI requires the user to use the apparatus and the apparatus collects data of the use and then generates feedback for the user based on the results of the user using the apparatus. Furthermore the MPEP states “Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II).” A student enrolled in medical school or other healthcare training programs would follow similar steps in learning how to determine force needed with chest tube insertions. The 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.”
Applicant further states that the elements are not “computing elements;” however, the Examiner respectfully disagrees. The claims are looked at as a whole and each element is looked at separately and then together as a whole. The elements the applicant listed as not “computing elements” are the case, the insertion tool, and the force-sensing resistors. Computers have cases, and force-sensors are used in touch or pressure-based input controls on computers, and an insertion tool, that may be a Kelly clamp, is used to collect the data. A further explanation of where the sensors are placed and how the case is shaped into the claims would make the record clearer.
Conclusion
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/SELWA A ALSOMAIRY/
Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715
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