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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites “synchronize, the hemodynamic waveform data and the ECG data”; the use of a comma in this clause is grammatically incorrect.
Appropriate correction is required.
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 5, 7, 8, 13, 21-24, 28 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 5 recites “a cuff blood pressure (DBP)”. It is unclear how a Cuff blood pressure is abbreviated as DBP; it appears this may refer to a specific blood pressure such as diastolic, but if so it should be properly defined in the claims. This is also found in claim 13, 21, and 28. Correction is required.
Claim 7 recites “wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based…”; there is no antecedent basis for this limitation in the claim. Claim 1 merely implies that these features are inherently present in the data, but does not include any performance of calculating these features. It is unclear if use of these features require calculations or if the intent is to describe identifying or otherwise finding these features. This issue is also found in claim 8, 23, 24. Clarification is required.
Claim 7 recites “calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform”. It is unclear if these are additional waveforms which must be acquired, or if these waveforms are derived from the already obtained hemodynamic waveform data, or generally how these new waveforms relate to any other part of the invention. The same issue is found in claim 23. Clarification is required.
Claim 8 recites that the calculating “is based on or supplemented with at least one of a flow or velocity waveform”. It is unclear how or where this supplemental waveform is obtained, nor is it clear what this waveform might represent as flow and velocity are presented without any identification of what they are measuring – flow of blood? Breath? Some other parameter? The same issue is found in claim 24. Clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14, 17-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving… hemodynamic waveform data and electrocardiogram (ECG) data,” “synchronizing… the hemodynamic waveform data and the ECG data,” and “calculating… a left ventricular end diastolic pressure (LVEDP).” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter; at best the recited processor merely links the use of the judicial exception to a particular technological environment or field of use. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are that the method steps are performed “by at least one processor of a computing apparatus.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-8 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Thus, claim(s) 1-8 is/are rejected under 35 U.S.C. 101.
Claim(s) 9-14 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 9 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 9 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive hemodynamic waveform data and ECG data,” “synchronize the hemodynamic waveform data and the ECG data,” and “calculate a left ventricular end diastolic pressure (LVEDP).” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter; at best the recited processor and memory merely link the use of the judicial exception to a particular technological environment or field of use. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a memory, at least one processor, and program instructions. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 9 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 10-14 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Thus, claim(s) 9-14 is/are rejected under 35 U.S.C. 101.
Claim(s) 17-24 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 17 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 17 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving… hemodynamic waveform data and electrocardiogram (ECG) data,” “determining… a time difference indicative of a delay between the hemodynamic waveform data and the ECG data,” and “calculating… a left ventricular end diastolic pressure (LVEDP).” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter; at best the recited processor merely links the use of the judicial exception to a particular technological environment or field of use. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are that the method steps are performed “by at least one processor of a computing apparatus.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 17 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 18-24 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Thus, claim(s) 17-24 is/are rejected under 35 U.S.C. 101.
Claim(s) 25-30 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 25 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 25 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive hemodynamic waveform data and ECG data,” “determine a time difference indicative of a delay between the hemodynamic waveform data and the ECG data,” and “calculate a left ventricular end diastolic pressure (LVEDP).” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter; at best the recited processor and memory merely link the use of the judicial exception to a particular technological environment or field of use. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a memory, at least one processor, and program instructions. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 25 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 26-30 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Thus, claim(s) 25-30 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 and 17-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marmor (US 2015/0265163).
Regarding claim 1, Marmor discloses a method to approximate left ventricular end diastolic pressure (L-VEDP) using electrocardiogram data and hemodynamic waveform data, the method comprising:
receiving, by at least one processor of a computing apparatus, hemodynamic waveform data and electrocardiogram (ECG) data (paragraphs [0114], [0126]);
synchronizing, by the at least one processor, the hemodynamic waveform data and the ECG data (paragraph [0076], [0085]; inherently required for use of both sets of data to be useful); and
calculating, by the at least one processor, a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data (paragraphs [0099]-[0102], [0126], [0127]).
Regarding claim 2, Marmor further discloses encoding the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output (paragraph [0135]).
Regarding claim 3, Marmor further discloses determining, by the at least one processor, at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data (paragraph [0133]).
Regarding claim 4, Marmor further discloses calculating, by the at least one processor, a contractility feature based on the hemodynamic waveform data (paragraphs [0056], [0063], [0096]).
Regarding claim 5, Marmor further disclose that calculating the LVEDP further comprises calculating the LVEDP as a function of the contractility feature and at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP) (paragraphs [0194]-[0208]).
Regarding claim 6, Marmor further discloses that calculating the contractility feature comprises determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies (paragraph [0009]).
Regarding claim 7, Marmor further discloses that calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform (paragraphs [0029], [0072]).
Regarding claim 8, Marmor further discloses that calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on or supplemented with at least one of a flow or velocity waveform (paragraphs [0080]).
Regarding claim 9, Marmor discloses an apparatus configured to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, comprising:
a memory and at least one processor coupled to the memory (paragraph [0216]), wherein the memory stores program instructions that when executed by the at least one processor cause the apparatus to:
receive hemodynamic waveform data and ECG data (paragraphs [0114], [0126]);
synchronize the hemodynamic waveform data and the ECG data (paragraph [0076], [0085]; inherently required for use of both sets of data to be useful); and
calculate a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data (paragraphs [0099]-[0102], [0126], [0127]).
Regarding claim 10, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to encode the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output (paragraph [0135]).
Regarding claim 11, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to determine at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data (paragraph [0133]).
Regarding claim 12, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate a contractility feature based on the hemodynamic waveform data (paragraphs [0056], [0063], [0096]).
Regarding claim 13, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP) (paragraphs [0194]-[0208]).
Regarding claim 14, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the contractility feature by determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies (paragraph [0009]).
Regarding claim 17, Marmor discloses a method to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, the method comprising:
receiving, by at least one processor of a computing apparatus, hemodynamic waveform data and electrocardiogram (ECG) data (paragraphs [0114], [0126]);
determining, by the at least one processor, a time difference indicative of a delay between the hemodynamic waveform data and the ECG data (paragraphs [0076], [0085]); and
calculating, by the at least one processor, a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data and the time difference (paragraphs [0099]-[0102], [0126], [0127]), the time difference being used to determine synchronized portions in time of the hemodynamic waveform data and the ECG data (paragraphs [0076], [0085]).
Regarding claim 18, Marmor further discloses encoding the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output (paragraph [0135]).
Regarding claim 19, Marmor further discloses determining, by the at least one processor, at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data (paragraph [0133]).
Regarding claim 20, Marmor further discloses calculating, by the at least one processor, a contractility feature based on the hemodynamic waveform data (paragraphs [0056], [0063], [0096]).
Regarding claim 21, Marmor further disclose that calculating the LVEDP further comprises calculating the LVEDP as a function of the contractility feature and at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP) (paragraphs [0194]-[0208]).
Regarding claim 22, Marmor further discloses that calculating the contractility feature comprises determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies (paragraph [0009]).
Regarding claim 23, Marmor further discloses that calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform (paragraphs [0029], [0072]).
Regarding claim 24, Marmor further discloses that calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on or supplemented with at least one of a flow or velocity waveform (paragraphs [0080]).
Regarding claim 25, Marmor discloses an apparatus configured to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, comprising:
a memory and at least one processor coupled to the memory (paragraph [0216]), wherein the memory stores program instructions that when executed by the at least one processor cause the apparatus to:
receive hemodynamic waveform data and ECG data (paragraphs [0114], [0126]);
determine a time difference indicative of a delay between the hemodynamic waveform data and the ECG data (paragraph [0076], [0085]); and
calculate a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data and the time difference (paragraphs [0099]-[0102], [0126], [0127]), the time difference being used to determine synchronized portions in time of the hemodynamic waveform data and the ECG data (paragraphs [0076], [0085]).
Regarding claim 26, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to encode the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output (paragraph [0135]).
Regarding claim 27, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to determine at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data (paragraph [0133]).
Regarding claim 28, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate a contractility feature based on the hemodynamic waveform data (paragraphs [0056], [0063], [0096]).
Regarding claim 29, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP) (paragraphs [0194]-[0208]).
Regarding claim 30, Marmor further discloses that the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the contractility feature by determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies (paragraph [0009]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11730376. Although the claims at issue are not identical, they are not patentably distinct from each other because:
18/634308
US 11730376
Common Subject Matter
1
1
A method to approximate left ventricular end diastolic pressure (L-VEDP) using electrocardiogram data and hemodynamic waveform data, the method comprising:
receiving, by at least one processor of a computing apparatus, hemodynamic waveform data and electrocardiogram (ECG) data;
synchronizing, by the at least one processor, the hemodynamic waveform data and the ECG data; and
calculating, by the at least one processor, a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data.
2
2
further comprising encoding the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output
3
3
further comprising determining, by the at least one processor, at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
4
4
further comprising calculating, by the at least one processor, a contractility feature based on the hemodynamic waveform data
5
5
wherein calculating the LVEDP further comprises calculating the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
6
6
wherein calculating the contractility feature comprises determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
7
7
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform
8
8
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on or supplemented with at least one of a flow or velocity waveform.
9
9
An apparatus configured to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, comprising: a memory and at least one processor coupled to the memory, wherein the memory stores program instructions that when executed by the at least one processor cause the apparatus to: receive hemodynamic waveform data and ECG data; synchronize, the hemodynamic waveform data and the ECG data; and calculate a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data.
10
10
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to encode the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output.
11
11
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to determine at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
12
12
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate a contractility feature based on the hemodynamic waveform data.
13
13
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
14
14
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the contractility feature by determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
Claims 1-14 and 17-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11957438. Although the claims at issue are not identical, they are not patentably distinct from each other because:
18/634308
US 11957438
Common Subject Matter
1
1
A method to approximate left ventricular end diastolic pressure (L-VEDP) using electrocardiogram data and hemodynamic waveform data, the method comprising:
receiving, by at least one processor of a computing apparatus, hemodynamic waveform data and electrocardiogram (ECG) data;
synchronizing, by the at least one processor, the hemodynamic waveform data and the ECG data; and
calculating, by the at least one processor, a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data.
2
2
further comprising encoding the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output
3
3
further comprising determining, by the at least one processor, at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
4
4
further comprising calculating, by the at least one processor, a contractility feature based on the hemodynamic waveform data
5
5
wherein calculating the LVEDP further comprises calculating the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
6
6
wherein calculating the contractility feature comprises determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
7
7
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform
8
8
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on or supplemented with at least one of a flow or velocity waveform.
9
9
An apparatus configured to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, comprising: a memory and at least one processor coupled to the memory, wherein the memory stores program instructions that when executed by the at least one processor cause the apparatus to: receive hemodynamic waveform data and ECG data; synchronize, the hemodynamic waveform data and the ECG data; and calculate a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data.
10
10
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to encode the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output.
11
11
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to determine at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
12
12
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate a contractility feature based on the hemodynamic waveform data.
13
13
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
14
14
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the contractility feature by determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
17
15
A method to approximate left ventricular end diastolic pressure (LVEDP) using hemodynamic waveform data and electrocardiogram data, the method comprising: receiving, by at least one processor of a computing apparatus, hemodynamic waveform data and electrocardiogram (ECG) data; determining, by the at least one processor, a time difference indicative of a delay between the hemodynamic waveform data and the ECG data; and calculating, by the at least one processor, a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data and the time difference, the time difference being used to determine synchronized portions in time of the hemodynamic waveform data and the ECG data.
18
16
further comprising encoding the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output.
19
17
further comprising determining, by the at least one processor, at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
20
18
further comprising calculating, by the at least one processor, a contractility feature based on the hemodynamic waveform data.
21
19
wherein calculating the LVEDP further comprises calculating the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
22
20
wherein calculating the contractility feature comprises determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
23
21
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on at least one of: carotid pressure waveform, aortic wall waveform, carotid vessel wall waveform, radial pressure waveform, radial vessel wall waveform, brachial pressure waveform, brachial vessel wall waveform, femoral pressure waveform, femoral vessel wall waveform, or a pulse oximetry (pulseOx) waveform.
24
22
wherein calculating the time features and waveform features of the hemodynamic waveform data and the ECG data is based on or supplemented with at least one of a flow or velocity waveform.
25
23
An apparatus configured to approximate left ventricular end diastolic pressure using hemodynamic waveform data and electrocardiogram data, comprising: a memory; and at least one processor coupled to the memory, wherein the memory stores program instructions that when executed by the at least one processor cause the apparatus to: receive hemodynamic waveform data and electrocardiogram (ECG) data; determine a time difference indicative of a delay between the hemodynamic waveform data and the ECG data; and calculate a left ventricular end diastolic pressure (LVEDP) based on time features and waveform features of the hemodynamic waveform data and the ECG data and the time difference, the time difference being used to determine synchronized portions in time of the hemodynamic waveform data and the ECG data.
26
24
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to encode the LVEDP as digital data for at least one of storage, transmission, or human-comprehensible output.
27
25
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to determine at least one of a pre-ejection period (PEP) or an isovolumic contraction time (ICT), based on simultaneous portions of the hemodynamic waveform data and the ECG data.
28
26
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate a contractility feature based on the hemodynamic waveform data.
29
27
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the LVEDP as a function of the contractility feature, at least one of the PEP and the ICT, and optionally a cuff blood pressure (DBP).
30
28
wherein the memory further stores instructions that when executed by the at least one processor cause the apparatus to calculate the contractility feature by determining at least one of a derivative of the hemodynamic waveform data or intrinsic frequencies.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791