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 .
Information Disclosure Statement
The information disclosure statement filed March 6, 2024 (28 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 20120116168 has been provided with the incorrect name of patentee of Moellstam et al. The correct name of patentee for US 20120116168 is Mollstam et al. Thus, it is unclear whether Applicant is intending to cite US 20120116168 or another document to Moellstam et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed March 6, 2024 (37 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because:
The citation for US 6843099 has been provided with the incorrect name of patentee of Daw et al. The correct name of patentee for US 6843099 is Derek et al. Thus, it is unclear whether Applicant is intending to cite US 6843099 or another document to Daw et al
The citation for US 7981073 has been provided with the incorrect name of patentee of Moellstam et al. The correct name of patentee for US 7981073 is Mollstam et al. Thus, it is unclear whether Applicant is intending to cite US 7981073 or another document to Moellstam et al
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed March 6, 2024 (37 pages), fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered:
No English translation for understanding of JP 01087708 has been provided
No English translation for understanding of JP 05293114 has been provided
The information disclosure statement filed March 6, 2024 (37 pages), fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy of WO 9956639 has been provided
Claim Objections
Claim 10 is objected to because of the following informalities:
In regards to claim 10, line 1, “wherein the wherein the” should be changed to “wherein the”.
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 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.
In regards to claim 1, line 3 recites “a medical device”. Claim 1, line 1 previously recites “a medical device”. It is unclear whether the two recitations are the same or different. Claims 2-8 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, line 8 recites “the medical device”. Claim 1, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 1, line 8. Claims 2-8 are rejected by virtue of being dependent upon claim 1.
In regards to claim 2, line 2 recites “the medical device”. Claim 2 depends upon claim 1. Claim 1, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 2, line 2.
In regards to claim 5, line 2 recites “the medical device”. Claim 5 depends upon claim 1. Claim 1, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 5, line 2. Claim 6 is rejected by virtue of being dependent upon claim 5.
In regards to claim 7, line 2 recites “the medical device”. Claim 7 depends upon claim 1. Claim 1, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 7, line 2. Claim 8 is rejected by virtue of being dependent upon claim 7.
In regards to claim 9, line 3 recites “a medical device”. Claim 9, line 1 previously recites “a medical device”. It is unclear whether the two recitations are the same or different. Claims 10-11 are rejected by virtue of being dependent upon claim 9.
In regards to claim 9, line 6 recites “a patient’s body”. Claim 9, line 1 previously recites “a body of a patient”. It is unclear whether the two recitations are the same or different. Claims 10-11 are rejected by virtue of being dependent upon claim 9.
In regards to claim 9, line 9 recites “the medical device”. Claim 9, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 9, line 9. Claims 10-11 are rejected by virtue of being dependent upon claim 9.
In regards to claim 12, line 3 recites “a medical device”. Claim 12, line 1 previously recites “a medical device”. It is unclear whether the two recitations are the same or different. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 3 recites “the medical device”. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 12, line 3. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 4 recites “the pump”. There is insufficient antecedent basis for this limitation in the claim. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 4-5 recite “the fluid management system”. There is insufficient antecedent basis for this limitation in the claim. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 8 recites “a fluid management system”. Claim 12, lines 4-5 previously recite “the fluid management system”. It is unclear whether the two recitations are the same or different. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 8-9 recite “the fluid management system”. Claim 12, lines 4-5 previously recite “the fluid management system” and line 8 previously recites “a fluid management system”. It is unclear which fluid management system is referred to in claim 12, lines 8-9. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 10 recites “a pump”. Claim 12, line 4 previously recites “the pump”. It is unclear whether the two recitations are the same or different. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, lines 10-11 recite “the fluid management system”. Claim 12, lines 4-5 previously recite “the fluid management system” and line 8 previously recites “a fluid management system”. It is unclear which fluid management system is referred to in claim 12, lines 10-11. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 13 recites “the pump”. Claim 12, line 4 previously recites “the pump” and line 10 previously recites “a pump”. It is unclear which pump is referred to in claim 12, line 13. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 12, line 17 recites “the medical device”. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 12, line 17. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
In regards to claim 14, line 2 recites “the pump”. Claim 14 depends upon claim 12. Claim 12, line 4 previously recites “the pump” and line 10 previously recites “a pump”. It is unclear which pump is referred to in claim 14, line 2.
In regards to claim 15, line 2 recites “the medical device”. Claim 15 depends upon claim 12. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 15, line 2.
In regards to claim 15, line 3 recites “the fluid management system”. Claim 15 depends upon claim 12. Claim 12, lines 4-5 previously recite “the fluid management system” and line 8 previously recites “a fluid management system”. It is unclear which fluid management system is referred to in claim 15, line 3.
In regards to claim 16, line 2 recites “a distal end of the medical device”. Claim 16 depends upon claim 12. Claim 12, line 6 previously recites “a distal end of the elongate shaft”. It is unclear whether the two recitations are the same or different.
In regards to claim 16, line 2 recites “the medical device”. Claim 16 depends upon claim 12. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 16, line 2.
In regards to claim 17, line 2 recites “a distal end of the medical device”. Claim 17 depends upon claim 12. Claim 12, line 6 previously recites “a distal end of the elongate shaft”. It is unclear whether the two recitations are the same or different.
In regards to claim 17, line 2 recites “the medical device”. Claim 17 depends upon claim 12. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 17, line 2.
In regards to claim 17, line 2 recites “the fluid management system”. Claim 17 depends upon claim 12. Claim 12, lines 4-5 previously recite “the fluid management system” and line 8 previously recites “a fluid management system”. It is unclear which fluid management system is referred to in claim 17, line 2.
In regards to claim 20, line 2 recites “a predetermined condition”. Claim 20 depends upon claim 12. Claim 12, line 16 previously recites “a predetermined condition”. It is unclear whether the two recitations are the same or different.
In regards to claim 20, line 2 recites “the data”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 20 depends upon claim 12. Claim 12, line 3 previously recites “a first set of data” and line 8 previously recites “a second set of data”. It is unclear whether “the data” of claim 20 refers to one of “a first set of data” or “a second set of data” of claim 12 or is different.
In regards to claim 20, line 2 recites “the medical device”. Claim 20 depends upon claim 12. Claim 12, line 1 previously recites “a medical device” and line 3 previously recites “a medical device”. It is unclear which medical device is referred to in claim 20, line 2.
In regards to claim 20, line 3 recites “the fluid management system”. Claim 20 depends upon claim 12. Claim 12, lines 4-5 previously recite “the fluid management system” and line 8 previously recites “a fluid management system”. It is unclear which fluid management system is referred to in claim 20, line 3.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites “receiving a first set of data from a medical device; receiving a second set of data from a fluid management system, the second set of data being a same type of data as the first set of data; comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient”. This judicial exception is not integrated into a practical application because the claim steps are capable of being performed in the human mind as a mental process. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because: though the claim step “receiving a first set of data from a medical device” recites a medical device, said medical device only sends a first set of data that is capable of being received by the human mind as a mental process; though the claim step “receiving a second set of data from a fluid management system” recites a fluid management system, said fluid management system only sends a second set of data that is capable of being received by the human mind as a mental process; and the claim steps of “comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient” can all be performed by the human mind as a mental process. Thus, claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 2-8 are rejected by virtue of being dependent upon claim 1.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites “receiving a first set of pressure data from a medical device; receiving a second set of data at a processing device, the second set of data being a same type of data as the first set of data and representative of a pulsatile pressure generated within a patient’s body; comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient”. This judicial exception is not integrated into a practical application because the claim steps are capable of being performed in the human mind as a mental process. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because: though the claim step “receiving a first set of pressure data from a medical device” recites a medical device, said medical device only sends a first set of data that is capable of being received by the human mind as a mental process; though the claim step “receiving a second set of data at a processing device” recites a processing device, said processing device only sends a second set of data that is capable of being received by the human mind as a mental process; and the claim steps of “comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient” can all be performed by the human mind as a mental process. Thus, claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 10-11 are rejected by virtue of being dependent upon claim 9.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites “receiving a first set of data from a medical device, the medical device comprising: an elongate shaft in fluid communication with the pump of the fluid management system; a pressure sensor disposed at a distal end of the elongate shaft; and a handle coupled to a proximal end of the elongate shaft; receiving a second set of data from a fluid management system, the fluid management system comprising: a pump configured to pump fluid from a fluid supply source through the fluid management system at a fluid flow rate; and a processing device including a user interface, the processing device configured to control the pump to maintain a target fluid flow rate based on a set of system operating parameters; comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient”. This judicial exception is not integrated into a practical application because the claim steps are capable of being performed in the human mind as a mental process. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because: though the claim step “receiving a first set of data from a medical device, the medical device comprising: an elongate shaft in fluid communication with the pump of the fluid management system; a pressure sensor disposed at a distal end of the elongate shaft; and a handle coupled to a proximal end of the elongate shaft” recites a medical device, said medical device only sends a first set of data that is capable of being received by the human mind as a mental process, and the elongate shaft, the pressure sensor, and the handle of the medical device are not used in a practical application in the claim; though the claim step “receiving a second set of data from a fluid management system, the fluid management system comprising: a pump configured to pump fluid from a fluid supply source through the fluid management system at a fluid flow rate; and a processing device including a user interface, the processing device configured to control the pump to maintain a target fluid flow rate based on a set of system operating parameters” recites a fluid management system, said fluid management system only sends a second set of data that is capable of being received by the human mind as a mental process, and the pump and the processing device including a user interface of the fluid management system are not used in a practical application in the claim; and the claim steps of “comparing the first set of data with the second set of data; and if the first set of data and the second set of data meet a predetermined condition, determining the medical device is within the body of the patient” can all be performed by the human mind as a mental process. Thus, claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 13-20 are rejected by virtue of being dependent upon claim 12.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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