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 6/3/2024 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.
Specification
Examiner suggests applicant to update the parent application status as follows:
Under “CROSS-REFERENCE TO RELATED APPLICATIONS” in page 1:
-Line 2: After “2023, ” insert “now U.S. Patent No. 12,029,841, ”.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US
Patent No. 3,927,981 to Viannay et al. (hereinafter referred to as “Viannay”).
Regarding claim 1, Viannay teaches a system for cardiopulmonary bypass (CPB) (col. 2, lines 15-22), the system comprising:
an oxygenator (1) comprising a sealed housing configured to allow subatmospheric pressure to be provided in the oxygenator wherein the oxygenator is a microporous membrane oxygenator with a sealed housing (see col 2, lines 15-22; figures 1-2; oxygenator 1 with membrane 2; see also the oxygenator in a sealed housing (US Patent No. 5,11,548: col. 2, line 66 – col. 3, line 17); and
a positive-pressure relief fluidly connected to the oxygenator and configured to ensure against creation of positive pressures (see col 3, lines 31-37; fig 2: safety valve 17 i.e. positive pressure relief valve fluidly connected to the oxygenator 1).
Regarding claims 2-3, Viannay teaches that the positive-pressure relief comprises a positive-pressure relief valve (17) and the positive-pressure relief is configured to relieve pressure if a pressure is a positive pressure (see col 3, lines 31-37; figure 2: safety valve 17 i.e. positive pressure relief valve fluidly connected to the oxygenator 1).
Regarding claim 5, Viannay teaches a vacuum source (7) e.g., vacuum pump configured to provide the subatmospheric pressure in the oxygenator (see figure 1; col. 2, lines 54-58).
Claim Rejections - 35 USC § 103
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Viannay.
Viannay teaches the system for cardiopulmonary bypass of claim 1 as disclosed above.
Claim 4 differs from Viannay in reciting that the positive pressure is 0-15 mmHg.
Viannay teaches that the automatic safety valve (17) i.e. positive-pressure relief valve opens when the pressure of the gas stream rises to atmospheric pressure (see col. 3, lines 32-37).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the positive pressure of 0-15 mmHg, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,335,531. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 10,335,531 obviate the instant application claims are set forth below and any necessary comparison. In general, claims of U.S. Patent No. 10,335,531 differ from the instant application claims in the requirement that independent claim 1 of instant application require an oxygenator comprising a sealed housing configured to allow subatmospheric pressure to be provided in the oxygenator whereas claim 2/1 of U.S. Patent No. 10,335,531 does not. However, dependent claim 3 of U.S. Patent No. 10,335,531 sets forth such disclosure. It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the system of claim 2/1 for cardiopulmonary bypass (CPB) to further include the sealed housing from claim 3 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
Claims of
Application No. 18/731901
Claims of
U.S. Patent No. 10,335,531
Comparison
1
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
2
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
3
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,668,203. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 10,668,203 obviate the instant application claims are set forth below and any necessary comparison. In general, claims of U.S. Patent No. 10,668,203 differ from the instant application claims in the requirement that independent claim 1 of instant application require an oxygenator comprising a sealed housing configured to allow subatmospheric pressure to be provided in the oxygenator whereas claim 2/1 of U.S. Patent No. 10,668,203 does not. However, dependent claim 3 of U.S. Patent No. 10,668,203 sets forth such disclosure. It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the system of claim 2/1 for cardiopulmonary bypass (CPB) to further include the sealed housing from claim 3 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
Claims of
Application No. 18/731901
Claims of
U.S. Patent No. 10,668,203
Comparison
1
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
2
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
3
2/1 and 3
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 into the system of 2/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
Claims 1-3 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,029,841 in view of claim 3 of U.S. Patent No. 10,335,531 or US Patent No. 10,668,203.
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 12,029,841 in view of dependent claim 3 of US Patent No. 10,335,531 or US Patent No. 10,668,203 obviate the instant application claims are set forth below and any necessary comparison. In general, claims of U.S. Patent No. 12,029,841 differ from the instant application claims in the requirement that independent claim 1 of instant application require an oxygenator comprising a sealed housing configured to allow subatmospheric pressure to be provided in the oxygenator whereas claim 5/1 of U.S. Patent No. 12,029,841 does not. However, dependent claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 sets forth such disclosure: “The system of claim 1, wherein the oxygenator is a membrane oxygenator having a sealed housing.” It would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the system of claim 5/1 of U.S. Patent No. 12,029,841 for cardiopulmonary bypass (CPB) to further include the sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
Claims of
Application No. 18/731901
Claims of
U.S. Patent No. 12,029,841
Comparison
1
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
2
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
3
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
5
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
6
5/1 and 2
Additionally, it would have been obvious to a person of ordinary skill in the art to further include a manual open valve located downstream of the oxygenator and upstream of vacuum source from claim 2 into the system of 5/1 for the purpose of opening the valve in case of vacuum failure.
7
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
8
5/1 and 3
Additionally, it would have been obvious to a person of ordinary skill in the art to further include a manual open valve located downstream of vacuum meter from claim 3 into the system of 5/1 for the purpose of opening the valve in case of vacuum failure.
9
5/1
It would have been obvious to a person of ordinary skill in the art to further include sealed housing from claim 3 of U.S. Patent Numbers 10,335,531 or 10,668,203 into the system of 5/1 for the purpose of allowing subatmospheric pressure to be provided in the oxygenator.
10
5/1 and 4
Additionally, it would have been obvious to a person of ordinary skill in the art to further include the vacuum meter located upstream of the vacuum regulator from claim 4 into the system of 5/1 for the purpose of measuring vacuum pressure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 99/08734 teaches a CPB system (see figures 1-3, 9) comprising an oxygenator (254), a venous reservoir (234), vacuum source (262), vacuum regulators (264, 270, 280) and a pressure relief and vacuum stabilizer unit (300) including the pressure relief valve (306) (see figure 10)(see page 30, line 8 – page 11, line 26).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1772
JK
8/10/26
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