CTNF 18/902,557 CTNF 85823 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority: The current application has the effective filing date of 02/20/2020, claims 1-20 are pending. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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 1 recites “…initiate a suction response algorithm if…”; with regard to the limitation “suction response algorithm”, this limitation is indefinite because the claim does not explicitly disclose a particular equation or actual algorithm, nor does the claim disclose what actions or purpose said algorithm is intended to perform. According to the Applicant’s own Specification [0035], the “suction response algorithm” reduces the speed of an impeller of a pump based on certain criteria. The Specification also refers to copending app. no. 16/795929, but this app. only mentions controlling the speed of a pump (via a “speed response algorithm) and does not explicitly recite the term “suction response algorithm.” Accordingly, this recited claim term “suction response algorithm” is indefinite within the context of the claim because the language of the claim fails to clearly provide what this algorithm does or is intended to do. The Applicant is advised to add limitations to further define the recited “suction response algorithm.” Claims 11 and 20 also recite “initiat(ing) a suction response algorithm” and are thus rejected for the same rationale. Further regarding claim 1, lines 3-5 can be parsed differently for different interpretations, and thus the claim is rejected as indefinite because it is unclear which is the intended interpretation. The limitation is parsed below to clarify the different interpretations: a combination of , (1) a number of detected suction events multiplied by a suction event variable, and (2) a number of non-suction events multiplied by a non-suction event variable exceed a predetermined threshold; or a combination of, (1) a number of detected suction events multiplied by a suction event variable and (2) a number of non-suction events multiplied by a non-suction event variable, the combination of (1) and (2) exceed a predetermined threshold. For purpose of examination , both interpretations are applicable. The Applicant is required to amend the claim language to clarify. Regarding the limitation “combination”, this is interpreted to include any type of mathematical combination e.g. multiplication, adding, subtraction, division, summation, etc. As for “suction variable” and “non-suction variable”, these are interpreted as an arbitrary number(s). Independent claims 11 and 20 also recite similar limitations and are thus rejected under the same rationale. Dependent claims 2-10, 11-19 are also rejected as they depend on rejected independent claims. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of mathematical concepts , without significantly more. The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception. Under Step (1) : claims 1, 11 and 20 are each directed to either a controller (i.e. apparatus) for an implantable blood pump, or a method for operating a blood pump; thus, the claims fall under one of the four patent eligible categories. To Step 2(a) prong 1 : Claim 1 recites: A controller for an implantable blood pump, comprising: processing circuitry configured to initiate a suction response algorithm if: a combination of a number of detected suction events multiplied by a suction event variable and a number of non-suction events multiplied by a non-suction event variable exceed a predetermined threshold. Claim 1 recites a single structure: (i.e. bolded and underline limitation), which is a “controller” comprising “processing circuitry”. The claim does not positive recite an implantable blood pump, nor does the recited “controller” require the implantable blood pump to operate and/or carry out the recited limitations. The remaining limitations (i.e. italicized limitations) include: a “suction response algorithm”, a mathematical equation (“combination of … event variable”) and simple mathematical comparison (i.e. “…exceed a predetermined threshold”). Regarding the “suction response algorithm”, the claim does not specify its intended function, thus, is broadly interpreted as a mathematical algorithm . Thus, aside from the “processing circuity”, the entire claim is directed to mathematical concepts , which is a judicial exception, i.e. abstract idea. Independent claim 20 is similar to claim 1, and is thus also directed to a judicial exception. As for claim 11, this is a method claim which does not recite any structure, and the entire claim involves only a single step of “initiating a suction response algorithm if…” Thus, claim 11 is wholly directed to mathematical concepts, under the same rationale as discussed to claim 1 above. Dependent claims 2-9 and 12-19 recite additional elements of the mathematical equation(s)/concept(s) related to respective independent claims; thus, these dependent claims are also directed to mathematical concepts. Under Step 2(a) prong 2: The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. To all pending claims 1-20, the judicial exception is not integrated into a practical application because the claims recite using the result of the judicial exception (i.e. “a combination… exceed a predetermined threshold”) to perform another judicial exception (i.e. “initiate a suction response algorithm”). There is no clear indication that the “suction response algorithm” is tied to the recited implantable blood pump in the preamble, and there is not no clear discussion that it is intended for an evaluation of particular treatment for a disease or medical condition under MPEP 2106.05(e). In fact, none of the independent claims even positively recite outputting the results in a human perceivable manner. Specifically, to apparatus claim 1-10 and 20, these claims recite a “ controller ” comprising “ processing circuitry ”; however, this is a generic controller comprising generic processing circuitry; because the claims do not describe these structures as having distinguishing element(s) over their generic counterparts. Under MPEP 2106.05(f), mere instructions to implement an abstract idea on a generic computer, or merely uses a computer as a tool to perform an abstract idea, does not qualify as practical application of a judicial exception. Thus, under BRI, the positively recited “controller” and “processing circuitry”, and the non-positively recited “implanted blood pump” merely define the field of use for the claim. The dependent claims do not further recite other limitations that integrate a judicial exception into a practical application. Under Step 2b : The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any other limitations which have not been addressed above. Accordingly, the Berkheimer analysis will not be performed. Claims 1-20 are thus rejected under 35 USC 101 for discloses patent-ineligible subject matter, without significantly more . 07-30-03-h AIA Claim Interpretation To claims 1, 11 and 20, these claims recites “if” statements, which are contingent limitations according to the MPEP 2111.04 II: II. CONTINGENT LIMITATIONS The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B. The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. In Schulhauser, both method claims and system claims recited the same contingent step. When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, "[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed" (quotation omitted). Schulhauser at 10. When analyzing the claimed system as a whole, the PTAB determined that "[t]he broadest reasonable interpretation of a system claim having structure that performs a function, which only needs to occur if a condition precedent is met, still requires structure for performing the function should the condition occur." Schulhauser at 14. Therefore "[t]he Examiner did not need to present evidence of the obviousness of the [ ] method steps of claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met);" however to render the claimed system obvious, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations. Schulhauser at 9, 14. To claim 11, the following is the interpretation of the “if” statement: Condition A: if “a combination of … exceed a predetermined threshold” (claim 1, lines 3-5) is satisfied; then Step A “initiate a suction response algorithm” The claim does not recite a condition B or Step B. But under BRI, this is the opposite of the recited limitations: Condition B: if “a combination of … exceed a predetermined threshold”(claim 1, lines 3-5) is not satisfied; then Step B do not “initiate a suction response algorithm” Accordingly, under BRI, any applied reference can be interpreted to meet the claim if the method can be practiced to meet condition B and step B. As for claims 1 and 20, these claims are apparatus claims, and any applied reference must teach condition A and step A. The contingent limitation interpretation can be overcome by replacing “if” with “when” or “whether.” Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kudlik US 2019/0351116 A1 (hereinafter “Kudlik”) . Regarding claim 11 , as previously discussed under section titled “Claim Interpretation”, a method claim contingent limitation is met when the applied reference teaches Condition B as stated above. Thus, Kudlik meets the limitations of claim 11, under BRI based on the following rational. Kudlik discloses a system ( Figs.1-2 ) comprising an implantable blood pump ( Fig.2: pump 10 ) having a controller ( Fig.2: controller 12 ); the controller comprises a control circuit ( Fig.2: 14 ) for detecting suction condition/events, and for initiating suction response algorithm based on comparison to a threshold value; see [0047-0048]. Kudlik further discloses wherein the control circuit has further steps for adjusting the pump speed; see [0056]. Kudlik does not explicitly disclose the recited algorithm: a combination of a number of detected suction events multiplied by a suction event variable and a number of non-suction events multiplied by a non-suction event variable; but since Kudlik discloses algorithms for initiating a suction response algorithm under certain criteria, it is interpreted as an alternative to the recited claim algorithm. As for dependent claims 12-18, these claims further limit the elements of the algorithm recited in claim 11, and are thus rejected by Kudlik as an alternative to the recited claim algorithm. Conclusion Note to Applicant: there are no art rejections to claims 1-10 and 20, however all pending claims are rejected under both 35 USC 101 and 35 USC 112(b). The Applicant is invited to contact the Examiner to schedule an interview to discuss ways to expedite prosecution. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00. 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, Benjamin Klein can be reached at 571-270-5213. 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. /SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792 April 28, 2026 Application/Control Number: 18/902,557 Page 2 Art Unit: 3792 Application/Control Number: 18/902,557 Page 3 Art Unit: 3792 Application/Control Number: 18/902,557 Page 4 Art Unit: 3792 Application/Control Number: 18/902,557 Page 5 Art Unit: 3792 Application/Control Number: 18/902,557 Page 6 Art Unit: 3792 Application/Control Number: 18/902,557 Page 7 Art Unit: 3792 Application/Control Number: 18/902,557 Page 8 Art Unit: 3792 Application/Control Number: 18/902,557 Page 9 Art Unit: 3792 Application/Control Number: 18/902,557 Page 10 Art Unit: 3792
Prosecution Insights