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 .
Acknowledgments
In the reply, filed on April 10, 2026, Applicant amended claims 1, 6-8, 13-15, and 20-21.
Applicant cancelled claims 5, 12, and 19.
In the non-final rejection of January 12, 2026, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant listed some, but not all, of the indicated references in a new information disclosure statement. Concern is maintained.
Examiner noted that the information disclosure statement filed January 21, 2023, fails to comply with 37 CFR 1.98(a)(3)(i). Applicant provided English translations for some, but not all, of the indicated foreign patent documents. Concern is maintained.
Examiner noted that the information disclosure statement filed February 17, 2024 (24 pages), fails to comply with 37 CFR 1.98(a)(2). Applicant provided English translations for the indicated foreign patent documents; however, copies of the indicated foreign patent documents have not been provided. Concern is maintained.
Examiner noted that the information disclosure statement filed February 17, 2024 (24 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant recited the indicated non-patent literature document citation with a date (with at least the year). Concern is withdrawn.
Examiner noted that the information disclosure statement filed February 17, 2024 (40 pages), fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant recited the indicated patent document citation with the correct name of patentee. Concern is withdrawn.
Examiner noted that the information disclosure statement filed February 17, 2024 (40 pages), fails to comply with 37 CFR 1.98(a)(2). Applicant provided an English translations for the indicated foreign patent document; however, a copy of the indicated foreign patent document has not been provided. And Applicant provided copies of some, but not all, of the indicated non-patent literature documents. Concern is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 1, 5-8, 12-15, and 19-21. Applicant amended claims 1, 6-8, 13-15, and 20-21, and cancelled claims 5, 12, and 19. Objection is withdrawn.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
U.S. Patent Publication No. 2016/0331951 (paragraph [0087])
The information disclosure statement filed January 21, 2023, 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 translations have been provided for understanding of foreign patent documents 5-7
The information disclosure statement filed February 17, 2024 (24 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 copies have been provided of foreign patent documents 4, 8-11, and 15
The information disclosure statement filed February 17, 2024 (40 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 has been provided of foreign patent document 7
No copy has been provided of non-patent literature document 2
The information disclosure statement filed April 10, 2026, 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 copies have been provided of foreign patent documents 1 and 4-9
Claim Objections
Claims 1, 8, and 20-21 are objected to because of the following informalities:
In regards to claim 1, line 18, “the calculating of” should be changed to “the calculating”.
In regards to claim 8, line 20, “the at least one processor being” should be changed to “the at least one processor”.
In regards to claim 20, line 3, “the one or more instructions to” should be changed to “the one or more instructions that”.
In regards to claim 21, line 3, “the one or more instructions to” should be changed to “the one or more instructions that”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6-11, 13-16, 18, and 20-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, lines 18-20 recite: wherein the calculating of the estimated actual flow rate of the at least one medical fluid in the fluid path is based on… “a time lag”; however, such is new matter not described in the Specification. Claims 2-4 and 6-7 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 22-23 recite: “wherein the time lag is compensated by applying a correction algorithm that accounts for system capacitance and injection parameters”; however, such is new matter not described in the Specification. Claims 2-4 and 6-7 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 25-26 recite: “the time constant being derived based on system characteristics and injection conditions”; however, such is new matter not described in the Specification. Claims 2-4 and 6-7 are rejected by virtue of being dependent upon claim 1.
In regards to claim 8, lines 20-22 recite: wherein the at least one processor being programmed or configured to calculate the estimated actual flow rate of the at least one medical fluid in the fluid path is based on… “a time lag”; however, such is new matter not described in the Specification. Claims 9-11 and 13-14 are rejected by virtue of being dependent upon claim 8.
In regards to claim 8, lines 24-25 recite: “wherein the time lag is compensated by applying a correction algorithm that accounts for system capacitance and injection parameters”; however, such is new matter not described in the Specification. Claims 9-11 and 13-14 are rejected by virtue of being dependent upon claim 8.
In regards to claim 8, lines 27-28 recite: “the time constant being derived based on system characteristics and injection conditions”; however, such is new matter not described in the Specification. Claims 9-11 and 13-14 are rejected by virtue of being dependent upon claim 8.
In regards to claim 15, lines 21-23 recite: wherein the one or more instructions to cause the at least one processor to calculate the estimated actual flow rate of the at least one medical fluid in the fluid path are based on… “a time lag”; however, such is new matter not described in the Specification. Claims 16, 18, and 20-21 are rejected by virtue of being dependent upon claim 15.
In regards to claim 15, lines 25-26 recite: “wherein the time lag is compensated by applying a correction algorithm that accounts for system capacitance and injection parameters”; however, such is new matter not described in the Specification. Claims 16, 18, and 20-21 are rejected by virtue of being dependent upon claim 15.
In regards to claim 15, lines 28-29 recite: “the time constant being derived based on system characteristics and injection conditions”; however, such is new matter not described in the Specification. Claims 16, 18, and 20-21 are rejected by virtue of being dependent upon claim 15.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6-11, 13-16, 18, and 20-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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