DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 9 April, 2025.
Claims 1 – 20 are currently pending and have been examined.
The present application is a continuation-in-part of co-pending application number 18/795,908.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11, line 6 recites “a hemorrhoid treatment coupled to the computing device,”; however, it appears that the word “device” is missing. The claim should recite: “a hemorrhoid treatment device coupled to the computing device,”. Appropriate correction is required.
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 – 7 and 11 - 17 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), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
Claim 1 is representative. Claim 1 recites:
A method for monitoring usage of a hemorrhoid treatment device comprising:
registering with a backend server the hemorrhoid treatment device provided to a patient treatment center;
registering with the backend server a physician at the patient treatment center to operate the hemorrhoid treatment device;
coupling the hemorrhoid treatment device to a computing device at the patient treatment center, with the computing device including operational treatment software configured to communicate with the backend server;
logging into the operational treatment software on the computing device by the physician, with the operational treatment software verifying with the backend server that the physician is registered to operate the hemorrhoid treatment device;
operating the hemorrhoid treatment device by the physician to treat a patient with hemorrhoids;
monitoring usage of the hemorrhoid treatment device by the physician via the operational treatment software; and
generating a treatment summary report via the operational treatment software after the patient with hemorrhoids has been treated.
Claim 11 recites a system that executes the steps of the method recited in Claim 1.
STEP 1
The claims are directed to a method and system which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
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.
The limitations that encompass the abstract method of organizing human activity include:
registering the hemorrhoid treatment device provided to a patient treatment center;
registering a physician at the patient treatment center to operate the hemorrhoid treatment device;
logging into the operational treatment software on the computing device by the physician, with the operational treatment software verifying with the backend server that the physician is registered to operate the hemorrhoid treatment device;
monitoring usage of the hemorrhoid treatment device by the physician; and
generating a treatment summary report after the patient with hemorrhoids has been treated.
The claims recite registering a hemorrhoid treatment device and a physician to operate the device, and verifying that the physician is registered to operate the device upon logging in. The claims recite monitoring the usage of the hemorrhoid treatment device and generating a treatment summary report. According to the specification, the prior art teaches that it is conventional for patient treatment centers to monitor the usage of a medical treatment handpiece (i.e. device) for treating hemorrhoids on each patient, to self-report the usage of each device by the medical treatment center to a facility center, and to generate and provide a treatment summary report to the facility center. Usage is reported as a total time of operation of the device for a patient, and the treatment summary report is used to invoice or bill the patient treatment center for each patient treated. (@ 0094, 0095).
This claimed process is typical in medicine, where a treatment center verifies a physician’s registration to operate the treatment device, tracks treatment device usage and reports the summary of usage to a facility center; and merely organizes this human activity – i.e. managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions. Verifying the physician’s registration manages insures that the physician is following rules established by the treatment center administrator, who enters such registrations manually. Similarly, monitoring device usage and generating summary reports in order to invoice or bill the patient is a fundamental economic activity, and a commercial or legal interaction including agreements in the form of contracts; business relations. (See MPEP 2016.04 (a)(2) II C).
As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
The claims, as illustrated by Claim 1, further recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion, including:
registering the hemorrhoid treatment device provided to a patient treatment center;
registering a physician at the patient treatment center to operate the hemorrhoid treatment device;
verifying with the backend server that the physician is registered to operate the hemorrhoid treatment device;
monitoring usage of the hemorrhoid treatment device by the physician; and
generating a treatment summary report after the patient with hemorrhoids has been treated.
The claims recite monitoring the usage of a hemorrhoid treatment device and generating a treatment summary report. According to the specification, the prior art teaches that it is conventional for patient treatment centers to monitor the usage of a medical treatment handpiece (i.e. device) for treating hemorrhoids on each patient, to self-report the usage of each device by the medical treatment center, and to generate and provide a treatment summary report to a facility center. The treatment summary report is used to invoice or bill the patient treatment center for each patient treated. (@ 0094, 0095). The broadest reasonable interpretation of these features includes tracking the time a device is used manually, and manually generating a summary report. Similarly, the specification discloses that registering a device and a physician is performed by an administrator. An administrator registering a device and a physician involves entering information, which is an ordinary mental process. As such, the claims recite an abstract idea within the mental process grouping.
STEP 2A PRONG TWO
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
a backend server;
coupling the hemorrhoid treatment device to a computing device at the patient treatment center, with the computing device including operational treatment software configured to communicate with the backend server;
operating the hemorrhoid treatment device by the physician to treat a patient with hemorrhoids;
monitoring usage via the operational treatment software; and
generating a treatment summary report via the operational treatment software.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The backend server and computing device at the patient treatment center, coupled to the treatment device, and including software to communicate with the backend server, are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment.
The claims include operating the hemorrhoid treatment device by the physician to treat a patient with hemorrhoids, presumably after logging in and being verified. Operating the device includes pressing a button to activate the current used for treatment (after a delay), and to start a timer. The timer may accumulate the time that the device is operated during a treatment session with a patient – i.e. the amount of time that current is being applied. As such, the device is operated in its normal capacity, and is relied on for data gathering. Like Mayo, where a doctor administers a drug to a patient in order to gather data with respect to a resulting physiological parameter, here the physician operates the treatment device in order to gather data about its usage.
Nothing in the claim recites specific limitations directed to an improved technology or technological process. Similarly, the specification is silent with respect to these kinds of improvements. For example, the specification describes the problem with self-reported usage being that the facility center cannot verify the accuracy of the usage summary report. This is surely not a technological problem, even where the problem may be solved using a technological solution. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract usage monitoring process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract usage monitoring process. Coupling a hemorrhoid treatment device to a computer configured to communicate with a server is a conventional arrangement. For example, the specification discloses prior art that encompasses a medical treatment handpiece coupled to a base unit having a controller and software for monitoring usage of the device, and coupled to an external controller. Further, the disclosure of these techniques is at a high level of generality indicating that they are well-known in the art. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract usage monitoring process, or an inventive concept.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the content of the summary report (Claim 6, 16);
those that recite additional abstract ideas such as:
generating an invoice and sending the invoice to the patient; (Claims 3, 4, 13 and 14);
those that recite well-understood, routine and conventional activity or computer functions such as:
providing the summary report to a server (Claims 2, 12);
performing a self-test (Claims 5, 15);
or those that are an ancillary part of the abstract idea such as:
powering the device by the computer and coupling a probe to deliver current; (Claim 7, 17).
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 11 – 17 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, Claims 1 – 7 and 11 – 17 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
CLAIMS 8 – 10 and 18 – 20
The U.S.C. §101 rejection does not encompass Claims 8 – 10 and 18 – 20. For example, Claims 8 and 18 recite adjusting the output voltage to compensate for fluctuations in body resistance of the patient. Here, Examiner notes that claims reciting this feature should include “determining fluctuations in body resistance, and adjusting the output voltage to compensate for the determined fluctuations in body resistance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 4, 6, 7, 11 – 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al.: (US 9,179,966 B2) – as disclosed by the applicant – in view of Horvath et al.: (US PGPUB 2007/0027459 A1).
CLAIMS 1 and 11
Newton discloses a system and method for monitoring the use of a medical device that includes the following limitations:
A method for monitoring usage of a hemorrhoid treatment device; (Newton Abstract); comprising:
coupling the hemorrhoid treatment device to a computing device at the patient treatment center, with the computing device including operational treatment software configured to communicate with the backend server; (Newton col. 2 line 10 – 13, 43 – 47; col. 3 line 35 – 43; col. 3 line 58 to col. 4 line 3; col. 4 line 10 – 28; Figure 1, Figure 3);
operating the hemorrhoid treatment device by the physician to treat a patient with hemorrhoids; (Newton col. 2 line 57 – 60);
monitoring usage of the hemorrhoid treatment device by the physician via the operational treatment software; and generating a treatment summary report via the operational treatment software after the patient with hemorrhoids has been treated; (Newton col. 2 line 36 – 38, col. 3 line 22 – 31; col. 4 line 3 – 9, 48 – 65).
Newton discloses a system and method for monitoring the use of a hemorrhoid treatment instrument in the form of a medical instrument handpiece, (i.e. a hemorrhoid treatment device). Newton couples the handpiece to a base unit equipped with a processing module, (i.e. a computing device at the patient treatment center), that is further coupled to a finance company, dealer or servicing agent, (i.e. a backend server), to monitor the cumulative current and time of a treatment session for billing, (i.e. a treatment summary).
With respect to the following limitations:
registering with a backend server the hemorrhoid treatment device provided to a patient treatment center; registering with the backend server a physician at the patient treatment center to operate the hemorrhoid treatment device; logging into the operational treatment software on the computing device by the physician, with the operational treatment software verifying with the backend server that the physician is registered to operate the hemorrhoid treatment device; (Horvath Abstract, 0013, 0014, 0019, 0035, 0038 – 0043, 0054).
Newton does not disclose registering device and physicians, or verifying that the physician is registered to operate the device – i.e. that the physician is authorized to operate the device. Horvath discloses a system and method for configuring a surgical device that includes determining whether the surgeon user is authorized to use the surgical device when the surgeon logs on to the device. Authorization is determined based on an analysis of surgeon data, patient data and device data stored in memory, (i.e. registering). Horvath is directed to devices used in ophthalmic surgery; however, the invention is not so limited, but may be applied generally to other areas of surgery or any other type of surgical equipment. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the surgical device monitoring system of Newton so as to have included registering devices and users to determine if a user is authorized to use the device, in accordance with the teaching of Horvath, in order to reduce the likelihood of mistakes (Horvath @ 0059).
With respect to Claim 11, Newton further discloses the following limitations:
A hemorrhoid treatment system comprising: a backend server; a computing device at a patient treatment center, with the computing device including operational treatment software in communications with the backend server; and a hemorrhoid treatment device coupled to the computing device; (Newton col. 2 line 10 – 13, 43 – 47; col. 3 line 35 – 43; col. 3 line 58 to col. 4 line 3; col. 4 line 10 – 28; Figure 1, Figure 3).
CLAIMS 2 - 4 and 12 - 14
The combination of Newton/Horvath discloses the limitations above relative to Claims 1 and 11. Additionally, Newton discloses the following limitations:
providing the treatment summary report to the backend server; (Newton col. 3 line 26 – 29; col. 4 line 55 – 65; col. 6 line 40 – 45);
wherein the backend server generates an invoice for the patient treatment center in response to receiving the patient treatment report; wherein the backend server sends the invoice to the patient treatment center; (Newton col. 3 line 29 – 31, 50 - 57; col. 5 line 1 - 2);
Newton discloses providing a treatment summary to a billing service and generating and sending invoices.
CLAIMS 6, 7, 16 and 17
The combination of Newton/Horvath discloses the limitations above relative to Claims 1 and 11. Additionally, Newton discloses the following limitations:
wherein the treatment summary report includes identification of the patient, how many hemorrhoids were treated, and how long current was delivered to the hemorrhoids by the hemorrhoid treatment device; (Newton col. 3 line 22 – 31, 50 – 57; col. 4 line 4 – 10).
wherein the hemorrhoid treatment device is powered by the computing device; (Newton col. 6 line 49 – 57, Figure 6); and
a probe electrode is coupled to the hemorrhoid treatment device to deliver a monopolar direct current to the hemorrhoids being treated on the patient; (Newton col. 1 line 10 – 13).
Newton discloses a device powered by the base unit computer, and having a probe to deliver monopolar current. Newton’s report includes the patient information and how long current was applied. Other data is “content” that does not distinguish over the prior art.
Claims 8 - 10 and 18 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al.: (US 9,179,966 B2) – as disclosed by the applicant – in view of Horvath et al.: (US PGPUB 2007/0027459 A1) in view of Suzuki et al.: (US 2,866,461).
CLAIMS 8 – 10 and 18 - 20
The combination of Newton/Horvath discloses the limitations above relative to Claims 1 and 11. Additionally, Newton discloses the following limitations:
delivering an output voltage to a probe electrode coupled to the hemorrhoid treatment device, with the probe electrode to contact the hemorrhoid being treated; wherein the hemorrhoid treatment device comprises a voltage output configured to deliver the output voltage to the probe electrode; (Newton col. 6 line 49 – 57, Figure 6);
positioning a grounding pad to contact the patient, with the grounding pad being coupled to the hemorrhoid treatment device; (Newton col. 2 line 10 – 13; col. 6 line 29 – 32, 49 – 57).
Newton discloses delivering output voltage to a probe in contact with the hemorrhoid in conjunction with a grounding pad. With respect to the following limitations:
adjusting the output voltage to compensate for fluctuations in body resistance of the patient so that a level of current being delivered to the [tissue] matches a set level of current; (Suzuki col. 1 line 58 – 70; col. 2 line 49 – 53; col. 3 line 9 – 22; col. 4 line 24 - 31);
a variable resistance network coupled to the voltage output, and operating the hemorrhoid treatment device comprises: changing resistance of the variable resistance network to adjust the output voltage to compensate for the fluctuations in body resistance of the patient so that the set level of current being delivered to the [tissue] is consistent; (Suzuki col. 1 line 58 – 70; col. 2 line 49 – 53; col. 3 line 9 – 22; col. 4 line 24 - 31);
a grounding pad to be used in determining the fluctuations in body resistance of the patient; (Suzuki col. 1 line 33 – 35; col. 3 line 52 – 62).
Newton discloses controlling voltage and current to provide a predetermined output, but does not disclose adjusting the output based on body resistance. Suzuki discloses a system and method for providing an electrical anesthesia, although the invention is not limited to this use, that includes a variable resistance network for controlling the voltage output to compensate for variations (i.e. fluctuations) in body resistance measured using a negative electrode (i.e. a grounding pad). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the surgical device monitoring system of Newton/Horvath so as to have included a variable resistance network for controlling voltage to be constant despite variations in body resistance, in accordance with the teaching of Suzuki, in order to allow precise control of applied voltage and current.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al.: (US 9,179,966 B2) – as disclosed by the applicant – in view of Horvath et al.: (US PGPUB 2007/0027459 A1) in view of Official Notice.
CLAIMS 5 and 15
The combination of Newton/Horvath discloses the limitations above relative to Claims 1 and 11. With respect to the following limitations:
performing a self-test on the hemorrhoid treatment device before the physician logs into the operational treatment software.
Newton/Horvath does not disclose self-testing the device. Nonetheless, Examiner takes Official notice that self-test procedures are old and well-known and many fields of endeavor, including for medical devices. Any computerized device performs a self-test. It would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the surgical device monitoring system of Newton/Horvath so as to have included self-testing medical devices, in accordance with the Official Notice taken, in order to ensure proper use.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
In particular, the prior art discloses systems and method for determining if a user, such as a doctor or surgeon, is authorized to use a particular medical device:
US 6,259,657 B1 to Swinney, Robert discloses determining if a physician is authorized to use a medical device based on stored lists.
US PGPUB 2006/0265031 A1 to Skwarek et al. discloses determining if a user is authorized to use a medical device based on an authentication code or biometric.
US PGPUB to Zipnick et al. discloses a method and system for determining if the use of a medical device is approved.
US PGPUB 2020/0218817 A1 to Thrower discloses a system and method for medical device use authorization based on a device and user identification.
US PGPUB 2025/0025033 to Zhong et al. discloses checking whether an authenticated clinician is authored to use a medical device.
US PGPUB 2001/0037270 A1 to Melo et al. teaches generating an invoice based on device usage according to contract rules.
GB 2 206 796 A to Norman et al discloses a hemorrhoid treatment device using electric current to treat the hemorrhoid.
“Direct current electrotherapy for internal haemorrhoids: experience in a tertiary health institution”; Olatoke et al.; 6/17/2014; discloses treating hemorrhoids with electric current based on grade.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 13 October, 2026
