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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
1. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The “electrocardiogram measurement system” in claim 1 is being interpreted as a wearable electrocardiogram patch, a smartwatch, or a 6-lead electrocardiogram bar (Page 8 of the specification).
The “style-based electrocardiogram generation unit” of claim 1 is being interpreted as anything that can “extract a corresponding unique style while reflecting characteristics of the examinee and characteristics of a measurement method therein from the electrocardiogram data measured by the electrocardiogram measurement unit through an preconstructed electrocardiogram generation deep learning algorithm” since no structure has been provided.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
2. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claims 1-8, the claims recite the step of measuring ECG data from the patient and then using “a style-based electrocardiogram generation unit configured to extract a corresponding unique style while reflecting characteristics of the examinee and characteristics of a measurement method therein from the electrocardiogram data measured by the electrocardiogram measurement unit through an preconstructed electrocardiogram generation deep learning algorithm, wherein the electrocardiogram generation deep learning algorithm is preconstructed by being previously trained on training datasets including an electrocardiogram data having less noise for each lead and a unique style of the electrocardiogram data for each lead based on a large number of pieces of electrocardiogram data, and generate the electrocardiogram data of a specific lead style not containing noise by converting the electrocardiogram data through the extracted unique style”. However, the specification does not provide any working examples, guidance, or steps as to how this function is achieved. Rather, the specification only mentions the use of deep learning algorithms training. For instance, it is unclear how is this style-based ECG generation unit being is being applied to the ECG (other than via algorithms) to create a “unique style”. It is also unclear what exactly a unique style is and how it is being implemented in the claims.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
3. Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding the Undue Experimentation Factors (Wands factors):
(1) The breadth of the claims encompass measuring ECG data from the patient and then using a style-based electrocardiogram generation unit to extract a corresponding unique style from the electrocardiogram data measured by the electrocardiogram measurement unit (this being done with a preconstructed electrocardiogram generation deep learning algorithm previously trained on training datasets) and then generating the electrocardiogram data of a specific lead style not containing noise by converting the electrocardiogram data through the extracted unique style. The Applicant has not set forth what a “style-based electrocardiogram generation unit” is or what parameters make the extracted style “unique”. Applicant instead only cites the “style-based” generation unit broadly and they only describe the unique electrical signals as being of the heart and maintained from measured electrocardiogram data (Page 6 of the Applicant’s specification). Applicant does not state or describe any particular element of the ECG readings that would make these generations unique values, nor do they ever mention what exactly a style-based ECG generation unit is. Additionally, a POSITA would have no indication about what a style-based generation unit is or what makes a signal unique, seeing as the only mentions of these limitations are found in art by the Applicant themselves.
(2) The state of the prior art is best exemplified by Awasthi (US 20250046461 A1) and Zimmerman (US 20220384045 A1). Awasthi discloses a system and method for generating a profile about patient/user based on ECG readings using a trained model (Abstract). While this art teaches deriving characteristics from ECG readings then generating conditions/information about a patient from this reading, there is never any mention of a “style-based” analysis that can create a unique signal. Regarding Zimmerman, they also teach extracting characteristics from and ECG signal and then generating a risk analysis for a patient (this again being done using a trained model). However, there is still no mention of a “style-based” generation unit or generations of unique signals. The only mentions of a style-based ECG generations for creating unique ECG signals in the art comes from the Applicant themselves – see US 20240350067 A1, US 20240350094 A1, and US 20250134469 A1.
(3) Regarding the level of ordinary skill in the art, the Examiner notes that the skill of
a POSITA in the area of medical treatment/analysis is fairly high due to the complex nature of the subject matter and level of training involved with medical practitioners. However, the Applicant has not provided any structure or description of the style-based ECG generation unit is or given any indication about what makes the generated ECG signal, nor are there any examples of this in the art (see above). Thus, the POSITA would have no knowledge of how to use this style-based generation unit to generate a unique style of an ECG signal.
(4) Regarding the amount of direction provided by the inventor, the Examiner notes
the there is no instructions/guidance provided by the Applicant as to how to generate a unique style ECG signal from a style-based ECG generation unit. For instance, there are no instructions provided for how a user can gather ECG data and then run it through the style-based generation unit to create a unique ECG signal. Rather, the Applicant only mentions the use of models that have been previously trained on ECG signals with their noise removed. There are not even any mentions or examples given to how what makes the signal unique/how a user would be able to generate a unique signal.
Claims 2-8 are rejected by virtue of its dependency.
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.
4. Claims 1-9 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.
In regards to claim 1, the claim limitation “style-based electrocardiogram generation unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
In further regards to claim 1, The term “unique style” is a relative term which renders the claim indefinite. The term “unique style” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, it is unclear what exactly is meant by “a unique style of the electrocardiogram data”. When searching the art, there is nothing about a style-based electrocardiogram generation, let alone a unique style of an electrocardiogram. It is unclear what exactly the Applicant is claiming.
Claims 2-8 are objected based on virtue of dependency.
Prior Art Rejections
5. There are currently no art rejections applied to the claims. Per the MPEP 2173.06, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. The above rejections need to be addressed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached Monday-Friday, 7:30-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792