DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20, as recited in an RCE filed on September 2, 2025, were previously pending and subject to a non-final office action filed on October 1, 2025 (the “October 1, 2025 Non-Final Office Action”). On January 30, 2026, Applicant submitted amendments to claims 1, 6, 7, 12, 16, and 19 and canceled claims 3 and 9 (the “January 30, 2026 Amendment”). As such, claims 1, 2, 4-8, and 10-20, as recited in the January 30, 2026 Amendment, are currently pending and subject to the final office action below.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 7-15, Claim Rejections - 35 U.S.C. § 101 Section, filed January 30, 2026, with respect to rejections of claims 1, 2, 4-8, and 10-20 under 35 U.S.C. § 101, have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance, provided by the USPTO, effective January 7, 2019 (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1, 2, 4-8, and 10-20 are maintained in this office action.
First, Applicant argues that the while the amended claims “may involve one or more abstract ideas, Claims 1 and 7, as now presented, are not merely “directed to” the alleged abstract ideas”. See Applicant’s Remarks, at p. 11. Examiner respectfully disagrees. 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. MPEP § 2106.04(a)(III). Applicant’s claims specifically recite mental steps, such as “calculating a pattern of prognosis”; “using statistical analysis to identify the calculated incident rate of complications for each of the types of tissue expanders used for surgery”; “predicting a result including a possibility of complication occurrence in a subject patient”; and “preparing appropriate treatment”. A human is reasonable capable of performing these calculations, predictions, and preparations of appropriate treatment in their mind, or with the aid of pen and paper, because these steps are merely observations, evaluations, judgments, and/or opinions.
The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another. MPEP § 2106.04(a)(III)(B). For instance, in CyberSource Corp. v. Retail Decisions, Inc., the court determined that the step of “constructing a map of credit card numbers” was a limitation that was able to be performed “by writing down a list of credit card transactions made from a particular IP address.” Id. In making this determination, the court looked to the specification, which explained that the claimed map was nothing more than a listing of several (e.g., four) credit card transactions. Id. The court concluded that this step was able to be performed mentally with a pen and paper, and therefore, it qualified as a mental process. Id.
Similarly, in the present case, Applicant’s specification demonstrates that the steps of calculating a pattern of prognosis and predicting a result including a possibility of complication occurrence in a subject patient are steps that a humans (e.g., doctors) have performed. For example, paragraph [0030] in Applicant’s specification as filed on June 2, 2023 explicitly teaches that capsular contracture [an example of a complication that may occur during breast reconstruction surgery] is identified and classified according to the clinical judgment of a doctor. Further, paragraph [0033] in Applicant’s specification as filed on June 2, 2023 also teaches that the predicted possibilities of complication occurrence are made by comparing patterns in clinical data. The Examiner asserts that comparing clinical data is a basic step that clinical researchers and doctors are capable of performing. Further, the Examiner asserts that humans (e.g., medical professionals) are capable of mentally and/or manually preparing “an appropriate treatment”, such as providing an antibiotic or recommending a surgical procedure for a patient depending on what type of illness/complications the patient is dealing with. Therefore, these paragraphs demonstrate that the steps recited in Applicant’s claims are capable of being performed mentally by a human. Accordingly, Applicant’s claims are directed to an abstract idea within the Mental Processes grouping of abstract ideas, and this argument is not persuasive.
Next, Applicant generally asserts that the limitations integrate any alleged abstract idea into a practical application by effecting a particular treatment or prophylaxis for a disease or medical condition arising from predicted complications following breast reconstruction surgery. See Applicant’s Remarks, at pp. 12-13. Examiner respectfully disagrees. This argument was addressed in a previous office action. See the October 1, 2025 Non-Final Office Action, at pp. 4-6. When determining whether a claim applies or uses a recited judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant: (1) the particularity or generality of the treatment or prophylaxis; (2) whether the limitation(s) have more than a nominal or insignificant relationship to the exception(s); and (3) whether the Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use. See MPEP § 2106.04(d)(2).
In analyzing the first factor, treatment or prophylaxis limitation must be “particular”, i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). See MPEP § 2106.04(d)(2). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. Id. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). Id. The claim also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” Id. This administration step is particular, and it integrates the mental analysis step into a practical application. Id. Conversely, consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” Id. This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Id. Thus, the administration step does not integrate the mental analysis step into a practical application. Id.
In the present case, Applicant’s claims do not describe a particular treatment or prophylaxis. Specifically, Applicant’s claims recite “preparing appropriate treatment for the subject based on the predicted result including when the complication is an infection providing a treatment of an antibiotic or a surgical operation and when the complication is a seroma providing a treatment of applying suction or a surgical procedure, or for other complications provide a second type of tissue expander for surgery different form the first type of tissue expander that is less likely to cause the predicted result”. However, this recitation is not deemed to be “a particular treatment”, because Applicant has not described the antibiotics, surgical operations/procedures, or the specific types of tissue expanders that are provided which are less likely to cause the predicted result. For example, the claims do not describe what type of treatment is provided to the patient (e.g., (I) administering a (a) specific type of antibiotic, such as (i) a first-generation cephalosporins to cover gram-positive bacteria, or (ii) a targeted intravenous antibiotic to address a severe infection from a biofilm-embedded microorganism, in (b) specific dosages and/or frequency; or (II) removing and/or replacing an implant using a specific type of medical procedure based on a specific type of complication). Therefore, under the first factor, Applicant has not described a particular treatment. Rather, Applicant has provided a broad list of “appropriate” treatments and surgical operations/procedures that could be prepared for a patient in a generic manner.
In analyzing the second factor, the treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). See MPEP § 2106.04(d)(2). In the present claims, the step for preparing appropriate treatment for the subject patient based on the predicted result, or providing a second type of tissue expander for surgery different from the first type of tissue expander that is less likely to cause the predicted result is not sufficiently tied to prognosis of breast reconstruction surgery. It seems that the claims are merely trying different treatments and tissue expanders on subject patients who a predicted to have the occurrence of a complication during breast reconstruction surgery (i.e., where the possibility of a complication occurrence is not well-defined by the claims). However, as analyzed under the first factor, the preparation of an appropriate treatment step does not describe a particular treatment because Applicant has not identified a specific treatment (e.g., a particular drug, doses, and/or durations of the treatment, or removing and/or replacing an implant). Applicant has claimed the preparation of an appropriate treatment in a generic manner. In fact, Applicant does not even claim the administration of a treatment, and rather merely claims the preparation of an appropriate, which could reasonably include writing down or ordering any type of treatment. Therefore, the step directed to preparing an appropriate treatment or providing a second type of tissue expander is deemed to be part of the abstract idea.
In analyzing the third factor, treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. See MPEP § 2106.04(d)(2). In the present case, the step directed to “preparing appropriate treatment for the subject patient based on the predicted result including when the complication is an infection providing a treatment of an antibiotic or a surgical operation and when the complication is a seroma providing a treatment of applying suction or a surgical procedure, or for other complications provide a second type of tissue expander for surgery different form the first type of tissue expander that is less likely to cause the predicted result”, described in claims 1 and 7, is part of the abstract idea. Again, Applicant has not described meaningful limits to the use of the appropriate treatment, such as (i) identifying a specific pharmaceutical drug, (ii) using specific doses for different subjects, (iii) describing specific durations that the subjects will take the pharmaceutical drug; or (iv) removing and/or replacing an implant. Therefore, Applicant has not imposed meaningful limits on the judicial exception.
As such, the limitation directed to “preparing appropriate treatment for the subject patient based on the predicted result including when the complication is an infection providing a treatment of an antibiotic or a surgical operation and when the complication is a seroma providing a treatment of applying suction or a surgical procedure, or for other complications provide a second type of tissue expander for surgery different form the first type of tissue expander that is less likely to cause the predicted result” for subjects with a predicted possibility of complication occurrence for breast reconstruction surgery using a first type of tissue expander is not indicative of applying or using a recited judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition under Prong Two of Step 2A of the Alice/Mayo Test as described in the 2019 Revised PEG.
Further, Applicant generally asserts that under Prong Two of Step 2A of the Alice/Mayo Test, the claims include limitations that are indicative of integrating an abstract concept into a practical idea, because the claims include meaningful limitations and additional elements which go beyond generally linking the judicial exception to a particular technological environment. See Applicants Applicant’s Remarks, at pp. 13-14. Examiner respectfully disagrees. This arguments was already made and addressed in a previous office action, where the additional elements in claims 1 and 7 (the system, processor, and the step directed to collecting/receiving the clinical data) were deemed as not providing a specific and tangible method for predicting a prognosis of breast reconstruction surgery. See the Non-Final Office Action filed on April 2, 2025, at pp. 3-4 and the October 1, 2025 Non-Final Office Action, at pp. 6-8. The system and processor represent generic computer components and the step directed to collecting/receiving the clinical data is a necessary data gathering step in order to perform the abstract idea. See the Non-Final Office Action filed on April 2, 2025, at p. 4 and the October 1, 2025 Non-Final Office Action, at p. 7. Despite Applicant’s assertion, Applicant’s claimed invention is merely using generic computer components as a tool to perform the abstract idea of making predictions related to a prognosis of breast reconstruction surgery. Therefore, the claims do not recite additional elements which impose any meaningful limits on the abstract idea.
Lastly, Applicant argues that the claims amount to significantly more than the abstract idea, because the claims recite an improvement in the field of conventional medical treatment by reciting specific actions to accomplish a specific desired result to improvement treatment and predicted outcomes of breast reconstruction surgery. See Applicant’s Remarks, at pp. 14-15. Examiner respectfully disagrees. This argument was also made in a previous office action. See the October 1, 2025 Non-Final Office Action, at pp. 8-9. When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity. MPEP § 2106.05(d). In this respect, the well-understood, routine, conventional consideration overlaps with other Step 2B considerations, particularly the improvement consideration (see MPEP § 2106.05(a)), the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)). Id. Thus, evaluation of those other considerations may assist examiners in making a determination of whether a particular element or combination of elements is well-understood, routine, conventional activity. Id.
In the present case, the additional elements recited in the claims represent well-understood, routine, and conventional activity. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). MPEP § 2106.05(d). Applicant’s claims were deemed to recite an abstract mental process (see above). A majority of the steps recited in the claims can be done by human analog. As described above, the additional elements (the system, processor, and the step directed to collecting/receiving the clinical data) represent generic component components and functions for implementing the abstract idea. Therefore, Applicant’s claims do not recite any additional elements which are deemed to provide significantly more than the abstract idea. For these reasons, this argument is not persuasive.
As such, the rejections of claims 1, 2, 4-8, and 10-20 under 35 U.S.C. § 101 are maintained in this office action. Please see the amended rejections to claims 1, 2, 4-8, and 10-20 under 35 U.S.C. § 101 below, for further clarification and analysis of the claims under the 2019 Revised PEG.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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, 2, 4-8, and 10-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1, 2, 4-6 and 18-20 are directed to a method of providing information to predict a prognosis of breast reconstruction surgery, which is also within one of the four statutory categories (i.e., a process). See MPEP § 2106.03. Claims 7, 8, and 10-17 are directed to a system for predicting a prognosis of breast reconstruction surgery, which is also within one of the four statutory categories (i.e., a machine or apparatus). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1, 2, 4-8, and 10-20 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1 and 7 include limitations that recite an abstract idea. Note that independent claim 1 is the method claim, while claim 7 covers the matching system claim. Specifically, independent claim 7 recites (and claim 1 substantially recites the following limitations):
A system for predicting a prognosis of breast reconstruction surgery, comprising:
a processor configured to:
receive clinical data including information on patients that have undergone breast reconstruction surgery, surgery-related information including a type of tissue expander inserted during the surgery for each of the patients, and treatment results of each of the patients following the surgery, wherein the treatment results include a removal of diseased cells with or without a complication;
classify the clinical data on the basis of the type of tissue expanders and the treatment results and calculate a pattern of prognosis of the patients following the surgery including the treatment results and a calculated incidence rate of complications in the patients;
apply a first type of tissue expander specified for surgery of a subject patient to the calculated pattern of prognosis of the classified clinical data using statistical analysis to identify the calculated incident rate of complications for each of the types of tissue expanders used for surgery and predict a result including a possibility of complication occurrence in the subject patient, where the type of tissue expanders include a micro-textured tissue expander or a macro-textured tissue expander; and
provide the predicted result as a prognosis of breast reconstruction surgery for the subject patient;
wherein when the predicted result for the subject patient includes complications following breast reconstruction surgery, the processor is further configured to at least one of prepare appropriate treatment for the subject patient based on the predicted result including when the complication is an infection providing a treatment of an antibiotic or a surgical operation and when the complication is a seroma providing a treatment of applying suction or a surgical procedure, or for other complications provide a second type of tissue expander for surgery different form the first type of tissue expander that is less likely to cause the predicted result.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., predicting a prognosis of breast reconstruction surgery, comprising: classifying clinical data on the basis of the type of tissue expanders and treatment results; calculating a pattern of prognosis for patients following the surgery; predicting a possibility of the occurrence of a complication for a subject by applying a first type of tissue expander; providing the predicted result as a prognosis of breast reconstruction surgery; and when the predicted result includes complications following breast reconstruction surgery (using the first type of tissue expander), (i) prepare appropriate treatment or (ii) provide a second, different type of tissue expander). That is, other than reciting some computer components and functions (the foregoing limitations in claim 7 which are not underlined), the context of claims 1 and 7 encompass concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., predicting a prognosis of breast reconstruction surgery, comprising: classifying clinical data on the basis of the type of tissue expanders and treatment results; calculating a pattern of prognosis for patients following the surgery; predicting a possibility of the occurrence of a complication for a subject by applying a first type of tissue expander; providing the predicted result as a prognosis of breast reconstruction surgery; and when the predicted result includes complications following breast reconstruction surgery (using the first type of tissue expander), (i) prepare appropriate treatment or (ii) provide a second, different type of tissue expander).
The aforementioned claim limitations described in claims 1 and 7 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompasses a person mentally and/or manually observing, evaluating, making judgments, opinions related to: (1) predicting a prognosis of breast reconstruction surgery (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally or manually predict the prognosis of a breast reconstruction surgery); (2) classifying clinical data on the basis of the type of tissue expanders and treatment results (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally or manually classify clinical data); (3) calculating a pattern of prognosis for patients following the surgery (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally or manually calculate a pattern for patients following the breast reconstruction surgery); (4) predicting a possibility of the occurrence of a complication for a subject by applying a first type of tissue expander (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally or manually predict a possibility of the occurrence of a complication for a subject by applying a first type of tissue expander); (5) providing the predicted result as a prognosis of breast reconstruction surgery (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could manually write down the predicted possibility of the occurrence of a complication for a subject by applying a first type of tissue expander); and (6) when the predicted result includes complications following breast reconstruction surgery (using the first type of tissue expander), (i) prepare appropriate treatment or (ii) provide a second, different type of tissue expander (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and manually write down an appropriate treatment or write down instructions for using a second, different type of tissue expander). Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106. Accordingly, claims 1 and 7 recite an abstract idea.
Examiner notes that the limitations directed to “calculating a pattern of prognosis”, described in claims 1 and 7 could also be interpreted to fall with the “Mathematical Concepts” (i.e., mathematical relationships and mathematical calculations) groupings of abstract ideas, because these limitations represent generic mathematical calculations. As such, claims 1 and 7 recite an abstract idea that falls within the Mental Processes and Mathematical Concepts categories.
Furthermore, Examiner notes that dependent claims 2, 4-6, 8, and 10-20 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 2, 8, and 13 provide limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A; and (2) dependent claims 4-6 and 10-20 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 4, 5, 10, 11, and 14-20 limit the abstract idea by narrowing the type of data that is part of the calculation and prediction steps (i.e., these steps are deemed to be reasonably performed mentally or manually using a pen and paper, because a person may reasonably make the calculations and predictions based on certain data (i.e., an observation of a certain type of data)). Similarly, claims 6 and 12 also further limit the abstract idea in narrowing the prediction that is made by reciting that the prediction is includes when the tissue expander used for the subject is a macro-textured tissue expander and the predicted possibility of complication occurrence is high (i.e., these steps are deemed to be reasonably performed mentally or manually using a pen and paper, because a person may reasonably make a prediction based on certain data (i.e., an observation of a certain type of data)).
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h).
In the present case, for independent claim 7, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A system (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) for predicting a prognosis of breast reconstruction surgery, comprising:
a processor configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
receive clinical data including information on patients that have undergone breast reconstruction surgery, surgery-related information including a type of tissue expander inserted during the surgery for each of the patients, and treatment results of each of the patients following the surgery, wherein the treatment results include a removal of diseased cells with or without a complication (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
classify the clinical data on the basis of the type of tissue expanders and the treatment results and calculate a pattern of prognosis of the patients following the surgery including the treatment results and a calculated incidence rate of complications in the patients;
apply a first type of tissue expander specified for surgery of a subject patient to the calculated pattern of prognosis of the classified clinical data using statistical analysis to identify the calculated incident rate of complications for each of the types of tissue expanders used for surgery and predict a result including a possibility of complication occurrence in the subject patient, where the type of tissue expanders include a micro-textured tissue expander or a macro-textured tissue expander; and
provide the predicted result as a prognosis of breast reconstruction surgery for the subject patient;
wherein when the predicted result for the subject patient includes complications following breast reconstruction surgery, the processor is further configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) at least one of prepare appropriate treatment for the subject patient based on the predicted result including when the complication is an infection providing a treatment of an antibiotic or a surgical operation and when the complication is a seroma providing a treatment of applying suction or a surgical procedure, or for other complications provide a second type of tissue expander for surgery different form the first type of tissue expander that is less likely to cause the predicted result.
However, the recitation of these generic computer components and functions in claims 1 and 7 are recited at a high-level of generality (i.e., using generic computer devices and software to: predict a prognosis of breast reconstruction surgery, comprising: classifying clinical data on the basis of the type of tissue expanders and treatment results; calculating a pattern of prognosis for patients following the surgery; predict a possibility of the occurrence of a complication for a subject by applying a first type of tissue expander; provide the predicted result as a prognosis of breast reconstruction surgery; and when the predicted result includes complications following breast reconstruction surgery (using the first type of tissue expander), (i) prepare appropriate treatment or (ii) provide a second, different type of tissue expander), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. v. CLS Bank Int’l – similarly, the current invention implements the commonplace medical business method of calculating patterns and predicting the possibility of a complication occurring as a result of a breast reconstruction surgery (i.e., the Examiner submits that the additional elements directed to the system that comprises a processor that is configured to implement the abstract idea, is a generic computer device with generic software).
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g., see Intellectual Ventures I LLC v. Capital One Bank (USA) – similarly, the current invention requires software components and the system and configured processor to perform the abstract idea.
- The following is an example of an insignificant extra-solution activity (e.g., see MPEP § 2106.05(g)):
- Example of Mere Data Gathering/Mere Data Outputting:
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the initial step directed to “collecting/receiving the clinical data”, described in claims 1 and 7, are necessary data gathering steps (i.e., collecting/receiving the clinical data is necessary in order to perform the abstract idea of: calculating the patterns and predicting the possibility of a complication occurring for a subject).
Thus, the additional elements in independent claims 1 and 7 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 4-6 and 10-20 do not recite any additional elements outside of those identified as being directed to the abstract idea described above. Examiner notes that dependent claims 2, 8, and 13 recite the following additional elements (in bold font below):
wherein the breast reconstruction surgery is two stage breast reconstruction surgery comprising: inserting a tissue expander; and exchanging the tissue expander for an implant (the Examiner submits that this additional element amounts to generally linking the abstract idea to a particular field of use or technological environment as noted below, see MPEP § 2106.05(h)) (as described in claims 2 and 8); and
further comprising a display device operatively coupled to the processor and configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) output the result of predicting the possibility of complication occurrence of the subject patient (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) (as described in claim 13).
As such, the additional elements in dependent claims 2, 8, and 13 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1, 2, 4-8, and 10-20: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1, 2, 4-8, and 10-20 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1, 2, 4-8, and 10-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claims 1, 2, 4-8, and 10-20 amount to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1-20, as recited, the system; processor; display device; and the steps of: “receiving/collecting clinical data including information on patients that have undergone breast reconstruction surgery, surgery-related information including a type of tissue expander inserted during the surgery for each of the patients, and treatment results of each of the patients following the surgery, wherein the treatment results include a removal of diseased cells with or without a complication”; “wherein the breast reconstruction surgery is two stage breast reconstruction surgery comprising: inserting a tissue expander; and exchanging the tissue expander for an implant”; and “outputting the result of predicting the possibility of complication occurrence of the subject patient”, are generic computer components and functions. See MPEP § 2106.05(d)(II).
- In regard to the system; processor; display device, and the step of: “wherein the breast reconstruction surgery is two stage breast reconstruction surgery comprising: inserting a tissue expander; and exchanging the tissue expander for an implant”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion – for example, Applicant discloses that the method of providing information to predict the prognosis of breast reconstruction surgery described above may be implemented as a system using a computer device. Applicant’s substitute specification as filed on June 2, 2023, paragraph [0037]. Further, Applicant discloses that “[t]he display unit 140 may be a separate display screen or may be a certain space in a conventional computer device in which the system 100 for prediction the prognosis is stored.” Applicant’s substitute specification as filed on June 2, 2023, paragraph [0053]. Still further, Applicant discloses that the processor is merely “a processor of a computer or server”. Applicant’s substitute specification as filed on June 2, 2023, paragraph [0062]. These paragraphs demonstrate that the system, processor, and display device any type of generic computing device. Therefore, Applicant’s disclosure provides evidence that the system, processor, and display device are well-understood, routine, and conventional devices previously known to the pertinent industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
- The Examiner submits that these limitations generally link the use of the judicial exception to a particular technological environment or field of use – for example, the limitations directed to “wherein the breast reconstruction surgery is two stage breast reconstruction surgery comprising: inserting a tissue expander; and exchanging the tissue expander for an implant” amount to limiting the abstract idea to the field of breast reconstruction surgery (see MPEP § 2106.05(h) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features of: “receiving/collecting clinical data including information on patients that have undergone breast reconstruction surgery, surgery-related information including a type of tissue expander inserted during the surgery for each of the patients, and treatment results of each of the patients following the surgery, wherein the treatment results include a removal of diseased cells with or without a complication” and “outputting the result of predicting the possibility of complication occurrence of the subject patient” - The following represents examples that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – the limitations directed to: “receiving/collecting clinical data including information on patients that have undergone breast reconstruction surgery, surgery-related information including a type of tissue expander inserted during the surgery for each of the patients, and treatment results of each of the patients following the surgery, wherein the treatment results include a removal of diseased cells with or without a complication” and “outputting the result of predicting the possibility of complication occurrence of the subject patient”, are similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere collection and transmission of data over a network (i.e., (i) “receiving/collecting clinical data” is the equivalent of collecting data over network, and (ii) “outputting the result of predicting the possibility of complication occurrence of the subject patient”, is the equivalent of transmitting data over a network to a display device).
Therefore, the additional described in claims 1, 2, 7, 8, and 13 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
Thus, taken alone, the additional elements of claims 1, 2, 7, 8, and 13 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 2, 7, 8, and 13 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 4-6 and 10-20 (which depend on claims 1 and 7 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 4-6 and 10-20 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1 and 7. Dependent claims 4-6 and 10-20 merely add limitations that further narrow the abstract idea described in independent claims 1 and 7. Therefore, claims 1, 2, 4-8, and 10-20 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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.
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686