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 .
Priority
The instant application claims priority to U.S. Provisional App. no. 63/189,896 filed on 05/18/2021.
Claims 1-20 receive priority to the prior-filed application, filed on 05/18/2021.
Election/Restrictions
Applicant’s election of Species Group I, Example II; Group II, Example II; and Group III, Example I in the reply filed on 10/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 7, 9, and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/2025.
Claims 1-20 are pending in the instant application and in light of the response to restriction in which claims 7, 9, and 12, were withdrawn, claims 1-6, 8, 10-11, and 13-20 are examined on the merits herein.
Specification
The disclosure is objected to because of the following informalities:
The second conduit is referred to by an incorrect reference number (para. 023 ln. 1).
The left ventricle is referred to by an incorrect reference number (para. 025 ln. 4; para. 045 ln. 11; para. 082 ln. 2-3).
Appropriate correction is required.
The use of the term Impella (para. 085), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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Ex. Fig. 1 of Levin Fig. 8
Claims 1-3, 5, 8, 10, 14, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO/0197878 A1 to Levin.
Regarding claim 1, Levin discloses a device for delivering blood from a lower pressure region to a higher pressure region (Fig. 8; pg. 28 ln. 15-31 and pg. 29 ln. 1-10), the device comprising: a first conduit (Fig. 8, 10 first conduit) comprising: a first end having a first diameter (Ex. Fig. 1); a second end opposite the first end and having a second diameter (Ex. Fig. 1), wherein the first end and the second end are configured to be fluidly coupled to the higher pressure region (Ex. Fig. 1, first and second end coupled to 4 artery); and a narrow segment disposed between the first end and the second end and having a third diameter (Fig. 8, 50 venturi section), wherein the third diameter is less than the first diameter and the second diameter (Ex. Fig. 1, 50 venturi section comprising third diameter less than diameter of first and second end); and a second conduit (Fig. 8, 16 second conduit) comprising: a third end configured to be fluidly coupled to the lower pressure region (Ex. Fig. 1, third end coupled to 6 vein); and a fourth end opposite the third end (Ex. Fig. 1), wherein the fourth end is coupled to the first conduit at or near the narrow segment of the first conduit (Ex. Fig. 1, fourth end fluidly coupled to 10 first conduit at 50 venturi section of 10 first conduit).
Regarding claim 2, Levin discloses the invention of claim 1, Levin further discloses: wherein the first conduit further comprises a first transition segment disposed between the first end and the narrow segment (Ex. Fig. 1), wherein the first transition segment comprises a fifth end proximate the first end and a sixth end proximate the narrow segment (Ex. Fig. 1), wherein the fifth end has the first diameter and the sixth end has the third diameter (Ex. Fig. 1).
Regarding claim 3, Levin discloses the invention of claim 2, Levin further discloses: wherein the first conduit further comprises a second transition segment disposed between the second end and the narrow segment (Ex. Fig. 1), wherein the second transition segment comprises a seventh end proximate the second end and an eighth end proximate the narrow segment (Ex. Fig. 1), wherein the seventh end has the second diameter and the eighth end has the third diameter (Ex. Fig. 1).
Regarding claim 5, Levin discloses the invention of claim 1, Levin further discloses: wherein the first diameter and the second diameter are equal (Ex. Fig. 1).
Regarding claim 8, Levin discloses the invention of claim 1, Levin further discloses: wherein the narrow segment is disposed at a location closer to the first end than the second end or closer to the second end than the first end of the first conduit (Ex. Fig. 1, 50 venturi section disposed at a location closer to the first end than the second end).
Regarding claim 10, Levin discloses the invention of claim 1, Levin further discloses: wherein the narrow segment comprises a ninth end proximate the first end (Ex. Fig. 1), and a tenth end proximate the second end (Ex. Fig. 1), wherein the fourth end of the second conduit is coupled to the first conduit at a location closer to the ninth end than the tenth end or closer to the tenth end than the ninth end (Ex. Fig. 1, fourth end fluidly coupled to 10 first conduit closer to ninth end than the tenth end).
Regarding claim 14, Levin discloses a method of delivering blood from a lower pressure region to a higher pressure region (Fig. 8; pg. 28 ln. 15-31 and pg. 29 ln. 1-10), the method comprising: diverting, through a first conduit, a first portion of blood from the higher pressure region (Fig. 8, 10 first conduit), wherein a first end of the first conduit is fluidly coupled to the higher pressure region at a first location and a second end of the first conduit is fluidly coupled to the higher pressure region at a second location downstream of the first location (Ex. Fig. 1, first and second end coupled to 4 artery; pg. 28 ln. 15-31 and pg. 29 ln. 1-10); diverting, through a second conduit, a second portion of blood from the lower pressure region (Fig. 8, 16 second conduit), wherein a third end of the second conduit is fluidly coupled to the lower pressure region (Ex. Fig. 1, third end coupled to 6 vein) and a fourth end of the second conduit is fluidly coupled to a narrow segment of the first conduit (Ex. Fig. 1, fourth end coupled to 10 first conduit at 50 venturi section of 10 first conduit; pg. 28 ln. 15-31 and pg. 29 ln. 1-10), the narrow segment disposed between the first end and the second end (Ex. Fig. 1, 50 venturi section); drawing the second portion of blood from the second conduit into the first conduit (pg. 28 ln. 15-31 and pg. 29 ln. 1-10); and providing the first portion of blood and the second portion of blood to the higher pressure region at the second end of the first conduit (pg. 28 ln. 15-31 and pg. 29 ln. 1-10).
Regarding claim 18, Levin discloses the invention of claim 14, Levin further discloses: wherein drawing the second portion of blood from the second conduit into the first conduit comprises generating, with the narrow segment, a Venturi effect (pg. 28 ln. 15-31 and pg. 29 ln. 1-10).
Regarding claim 20, Levin discloses the invention of claim 14, Levin further discloses: wherein diverting, through the second conduit, the second portion of blood from the lower pressure region comprises drawing the second portion of blood from the lower pressure region with a pump, and wherein drawing the second portion of blood from the second conduit into the first conduit comprises pumping the second portion of blood from the second conduit to the first conduit with a pump (pg. 28 ln. 15-31 and pg. 29 ln. 1-10; Fig. 8, 8 pump).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 6, 13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levin as applied above.
Regarding claim 4, Levin discloses the invention of claim 3; however, Levin differs from the instantly claimed invention in that Levin fails to explicitly disclose that a length of the second transition segment and a length of the first transition segment are equal.
Levin discloses (pg. 27 ln. 30-31 and pg. 28 ln. 1-8) that the length and diameter of the venturi throat of the venturi section needs to be optimized for “the viscosity of the individual’s blood and pressures and flow available to operate the venturi desirably”. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Levin device to have a transition segments with lengths as claimed, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Levin by making the length of the first and second transition segments equal as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 6, Levin discloses the invention of claim 1; however, Levin differs from the instantly claimed invention in that Levin fails to disclose that the second conduit has the third diameter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second conduit of Levin to have the third diameter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Levin would not operate differently with the claimed diameter and since the second conduit of Levin is disclosed to connect to the first conduit through a lowered diameter region the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the configuration claimed, indicating simply that the diameter “may” be as claimed (specification para. 028).
Regarding claim 13, Levin discloses the invention of claim 1, Levin further discloses: a pump disposed along the first conduit between the first end and the second end (Fig. 8, 8 pump disposed on 10 first conduit between first and second end), wherein the pump is configured to draw blood from the lower pressure region and pump blood into the first conduit (pg. 28 ln. 15-31 and pg. 29 ln. 1-10); however, Levin differs from the instantly claimed invention in that Levin fails to disclose wherein the pump is disposed along the second conduit between the third end and the fourth end.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to provide the pump on the second conduit since there are only a finite number of predictable solutions (i.e. pump provided on one or the other conduit). Levin discloses the pump provided to augment flow in both the first conduit (10) and the second conduit (16) (pg. 28 ln. 15-31 and pg. 29 ln. 1-10). Thus, providing the pump on the second conduit would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 19, Levin discloses the method of claim 18, Levin further discloses: a Venturi effect generated with the narrow segment (pg. 28 ln. 15-31 and pg. 29 ln. 1-10; Fig. 8, 50 venturi section); however, Levin differs from the instantly claimed invention in that Levin fails to explicitly disclose inhibiting backflow of the first portion of the blood or the second portion of the blood with the Venturi effect generated with the narrow segment.
Regarding the limitations “inhibiting backflow of the first portion of the blood or the second portion of the blood with the Venturi effect generated with the narrow segment”, it would have been considered inherent that the device of Levin would perform the function of inhibiting backflow in either of the first or second portion of the blood, because Levin discloses substantially identical structure to that claimed for carrying out the claimed method; therefore, the claimed results are considered to be inherent. As supported in MPEP section 2112.02, “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Levin as applied above, and further in view of US/2017/0367820 A1 to Anand.
Regarding claim 11, Levin discloses the invention of claim 1; however, Levin fails to disclose a one-way valve disposed proximate the second end of the first conduit, proximate the third end of the second conduit, proximate the fourth end of the second conduit, or proximate an end of the narrow segment proximate the second end of the first conduit.
Anand teaches a conduit for delivering blood from a lower pressure region to a higher pressure region that comprises a one-way valve (Fig. 4, 30 conduit comprising 32-33 one-way valves; para. 0028).
Anand is considered to be analogous to the instantly claimed invention in that Anand discloses a conduit for delivering blood from one region of the body to another. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Levin to comprise a one-way valve along a section of conduit directly connected to the lower pressure region as taught by Anand, because Anand teaches that this allows for movement of the blood only in the desired direction (para. 0028).
Regarding claim 17, Levin discloses the method of claim 14; however, Levin fails to disclose inhibiting backflow of the first portion of blood or the second portion of blood with a one-way valve disposed in the first conduit or the second conduit.
Anand teaches a conduit for delivering blood from a lower pressure region to a higher pressure region that comprises a one-way valve (Fig. 4, 30 conduit comprising 32-33 one-way valves; para. 0028).
Anand is considered to be analogous to the instantly claimed invention in that Anand discloses a conduit for delivering blood from one region of the body to another. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Levin to comprise a one-way valve along a section of conduit directly connected to the lower pressure region as taught by Anand, because Anand teaches that this allows for movement of the blood only in the desired direction (para. 0028).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Levin as applied above, and further in view of U.S. Patent no. 5,965,089 A to Jarvik.
Regarding claims 15-16, Levin discloses the method of claim 14, Levin further discloses: coupling the first and second end of the first conduit to the higher pressure region (Ex. Fig. 1, first and second end of 10 first conduit coupled to 4 artery) and coupling the third end of the second conduit to the left atrium (Ex. Fig. 1, third end of 16 second conduit coupled to 6 vein); however, Levin differs from the instantly claimed invention in that Levin fails to explicitly disclose (Claim 15) wherein the lower pressure region comprises a left atrium of a heart and the higher pressure region comprises an aorta and (Claim 16) coupling the first and second end of the first conduit to the aorta and coupling the third end of the second conduit to the left atrium.
Jarvik discloses a system for delivering blood from a lower pressure region to a higher pressure region (Fig. 21; col. 17 ln. 9-24).
Jarvik is considered to be analogous to the instantly claimed invention in that Jarvik discloses a conduit for delivering blood from one region of the body to another. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Levin to be utilized between the left atrium and the aorta as taught by Jarvik, because Levin is directed to a method for decreasing the demand put on diseased hearts in heart failure (pg. 1 ln. 18-29 and pg. 2 ln. 1-5) and the placement of the system of Jarvik supports the functioning of a diseased heart in heart failure (col. 1 ln. 62-63; col. 17 ln. 9-24).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US/2011/0130619 A1 to Whisenant and U.S. Patent no. 4,995,857 A to Arnold disclose devices for delivering blood from the left atrium to the aorta.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781