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 .
Remarks
Claims 1-12, filed 04/25/2024, are currently pending and are under consideration.
In the interest of compact prosecution, the non-compliant preliminary amendment filed 04/25/2024 is entered. Future amendments that do not comply with 37 CFR 1.121 will not be entered.
Claim Objections
Claims 3-5, 7, and 9 are objected to because of the following informalities:
Claim 3, line 1, “wherein the for each rotational speed” is incorrect.
Claim 3, line 4, “performing integral calculation” should read “performing an integral calculation” or “performing integral calculations”.
Claim 4, line 2, “the for each rotational speed” is incorrect.
Claim 5, line 1, “wherein the for each rotational speed” is incorrect.
Claim 7, line 5, “the for each current cycle” is incorrect.
Claim 9, page 79, line 7, “the obtaining first reference current values” should read “the step of obtaining first reference current values”.
Appropriate correction is required.
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.
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 “first obtaining module”, the “second obtaining module”, the “first determination module”, the “second determination module”, and the “third determination module” in claim 10. The obtaining modules will be understood to be any sensor or processor for obtaining data, and the determination modules will be understood as a processor that performs analysis.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “wherein prior to the obtaining a first correspondence” in lines 1-2. It is unclear is the “a first correspondence” is the same as the correspondence in claim 1. Examiner suggests changing this limitation to “wherein prior to the obtaining the first correspondence” or “wherein prior to the step of obtaining a first correspondence”.
Claims 7 and 8 are rejected based on their dependency on claim 6.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method and system for determining pump blood flow. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a method and claim 10 is directed towards an apparatus and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and 10 recite a method and system for determining pump blood flow, comprising obtaining a correspondence between current differences and pump blood flow values, obtaining reference current values, calculating differences between the reference current value and current value to determine a second current difference, determining a pump blood flow value corresponding to the second current difference, and determining a target pump blood flow value.
The limitation of determining pump blood flow, as drafted in claims 1-12, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper. For example, determining pump blood flow in the context of this claim encompasses a user obtaining a correspondence between current differences and pump blood flow values, obtaining reference current values, calculating differences between the reference current value and current value to determine a second current difference, determining a pump blood flow value corresponding to the second current difference, and determining a target pump blood flow value.
Further, claims 1 and 10 recite limitations that are mathematical relationships (e.g. calculating differences between the reference current value and current values at different moments). These limitations fall within the “Mathematical Concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2)(I)(A).
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As claimed and understood, the crux of the invention is the data analysis performed in order to determine the target pump blood flow. The steps of obtaining a correspondence between current differences and pump blood flow values and obtaining reference current values are considered to be the pre-solution activity of data gathering by no more than routine means. The steps of calculating differences between the reference current value and current value to determine a second current difference, determining a pump blood flow value corresponding to the second current difference, and determining a target pump blood flow value are considered to be data analysis steps.
The additional elements of the obtaining and determination modules are recited at a high level of generality (i.e., as generic computer components for inputting, processing, and storing data). Specifically, these additional elements are generically recited computing elements that perform the steps of gathering and analyzing data.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of obtaining and determination modules amounts to no more than generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-9, 11, and 12 depend on claim 1 and recite the same abstract idea as claim 1 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2-9 (i.e. further defining the processing steps) are further data analysis steps. The additional limitations recited in claims 11 and 12 (i.e. defining a device and storage medium for use with the method) simply provides generic components to perform the method. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter. Claim 12 recites a “readable storage medium”. None of the claims, specification or record disclose that the claimed “readable storage medium” is a non-transitory medium. The Examiner asserts that the claimed “readable storage medium” can be a transitory signal, which is non-statutory. The Examiner suggests that Applicant replace “readable storage medium” with “non-transitory readable storage medium”.
No prior art was found teaching individually, or suggesting all of the features of the claimed invention, specifically “for each current cycle at each rotational speed, calculating differences between the first reference current value and current values at different moments within the current cycle, so as to obtain an absolute value of at least one second current difference; for the absolute value of the at least one second current difference corresponding to each current cycle at each rotational speed, searching in the first correspondence to obtain a second pump blood flow value corresponding to the absolute value of the second current difference, wherein the absolute value of each second current difference corresponds to a second pump blood flow value; and for each rotational speed, determining a target pump blood flow value on the basis of at least one second pump blood flow value in each current cycle” as recited in claims 1 and 10. Casas (US 2016/0144092), the closest prior art of record, discloses monitoring operation of a blood pump including determining flow rate values based on a combination of first and second flow rate values with a weighting parameter, but does not disclose calculating differences between the first reference current value and current values at different moments within the current cycle to determine an absolute value of a second current difference, determining a second pump blood flow value by searching in the first correspondence, and determining a target pump blood flow valve for each rotational speed based on the second pump blood flow value as claimed in claims 1 and 10.
While there are no prior art rejections for claims 1-12, they are not indicated as allowable due to the rejection under 35 U.S.C. 101 and 35 U.S.C. 112(b), as explained above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ito (US 2020/0282120) is directed towards a motor for a blood pump.
Casas et al. (US 2012/0245681) is directed towards flow estimation in a blood pump.
Siess et al. (US 2020/0360582) is directed towards estimating blood flow in a blood pump.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796