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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “first pumping element” and “second pumping element” in claim 1, and “a check element” in claims 9 and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
In regards to claim 1, the claim limitations “first pumping element” and “second pumping element” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For instance, paragraph 0061 indicates that a balloon refers to a “pumping element,” but is not limited thereto (i.e., that “pumping element” is a broader genus that includes other structures, but the specification is not clear as to what those other structures might be).
In regards to claims 9 and 15, the claim limitation “check element” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For instance, paragraph 0096 appears to indicate that the same structure provides pumping action and a checking function, and so it is unclear whether this limitation requires an actual additional structural feature (in addition to the pumping element(s)), and if so what the scope of that structure is.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 claims 1 and 16, “reduced cross-section” is vague because no basis of comparison is set forth. In other words, it is unclear whether the cross-section is reduced compared to one or more of the pumping element(s)/section(s), a different portion of the stent, or some other feature of the devices.
In regards to claim 16, “first pump section” and “second pump section” are vague. As the claim is drawn to a stent alone, it is unclear whether these sections require an adaptation or configuration to attach to a pump, contain a pump, having a pump upstream/downstream from the sections, or some other scope.
The remaining claims are rejected by virtue of their dependency.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 16-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ryan et al. (US 2024/0157117, hereinafter “Ryan”).
In regards to claim 1, Ryan discloses a heart assist pump (par. 0009) comprising:
a stent (Fig. 1, element 1602; par. 0083, “expandable member”),
a first pumping element (element 1616; par. 0082, “distal impeller”), and
a second pumping element (element 1606; par. 0082, “proximal impeller”);
wherein the stent comprises a reduced cross-section between the first pumping element and the second pumping element (Fig. 1, element 1604; par. 0084, “blood conduit”).
In regards to claim 2, the reduced cross-section is configured to be positioned with an aortic valve when deployed (e.g., Figs. 4 and 8; par. 0085, “the central region can be placed across a valve, such as an aortic valve”).
In regards to claim 3, the first pumping element is configured to pump fluid from a lower ventricle through the reduced cross-section (Figs. 1, 4 and 8; par. 0084, “The structure of the expandable member creates at least one inlet aperture to allow for inflow “I,” and at least one outflow aperture to allow for outflow “O.””).
In regards to claim 4, the second pumping element is configured to pump the fluid received from the reduced cross-section into an ascending aorta (par. 0084, “The structure of the expandable member creates at least one inlet aperture to allow for inflow “I,” and at least one outflow aperture to allow for outflow “O.””; par. 0112).
In regards to claim 5, the first pumping element is configured to directionally inflate (par. 0121; the examiner is considering one plain meaning of “inflate” to be to distend; swell or puff out; dilate).
In regards to claim 6, the first pumping element is configured to at least partially seal an inlet of the heart assist pump when partially inflated (Fig. 3D; the first pumping element 342 at least partially occludes the lumen, so “at least partially seal[s]”).
In regards to claim 7, the second pumping element is configured to directionally inflate (par. 0121; the examiner is considering one plain meaning of “inflate” to be to distend; swell or puff out; dilate).
In regards to claim 8, the second pumping element is configured to at least partially seal an outlet of the reduced cross-section when partially inflated (Fig. 3C; the second pumping element 343 at least partially occludes the lumen, so “at least partially seal[s]”).
In regards to claim 16, Ryan discloses a stent (Fig. 1, element 1602; par. 0083, “expandable member”) comprising:
a first pump section (portion surrounding element 1616; par. 0082, “distal impeller”),
a second pump section (portion surrounding element 1606; par. 0082, “proximal impeller”), and
a reduced cross-section (Fig. 1, element 1604; par. 0084, “blood conduit”);
wherein the reduced cross-section is located between the first pump section and the second pump section (Fig. 1).
In regards to claim 17, the reduced cross-section is configured to be positioned with an aortic valve when deployed (e.g., Figs. 4 and 8; par. 0085, “the central region can be placed across a valve, such as an aortic valve”).
In regards to claim 18, the stent comprises a fluid impermeable wall (par. 0084, “The conduits herein may be non-permeable”).
In regards to claim 19, the first pump section is configured to house a first pumping element; and wherein the first pumping element is configured to pump fluid through the reduced cross-section (element 1616; par. 0082, “distal impeller”).
In regards to claim 20, the second pump section is configured to house a second pumping element; and wherein the second pumping element is configured to pump the fluid received from the reduced cross-section (element 1606; par. 0082, “proximal impeller”).
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 (i.e., changing from AIA to pre-AIA ) 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.
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 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Kung et al. (US 5,643,172, hereinafter “Kung”).
Ryan discloses the essential features of the claimed invention including independent control of the first and second pumping elements (par. 0135; regarding claim 13 below), but does not expressly disclose that:
Regarding claim 9, the pumping device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an outlet of the heart assist pump into a second pump section;
Regarding claim 10, wherein the second pump section comprises the second pumping element;
Regarding claim 11, wherein the check element is inflatable;
Regarding claim 12, that the pumping device further comprises: a controller; wherein the controller is configured to keep the check element inflated while deflating the first pumping element and the second pumping element;
Regarding claim 13, further comprising: a controller; wherein the controller is configured to inflate the pumping element; or
Regarding claim 15, that the device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an inlet of the heart assist pump into a first pump section.
However, Kung in the same field of endeavor of circulatory assist device (col. 3, lines 18-21) teaches:
Regarding claims 9 and 10, the pumping device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an outlet of the heart assist pump (col. 4, lines 25-34; Ryan discloses the remaining features as set forth above);
Regarding claim 11, wherein the check element is inflatable (col. 3, lines 42-55);
Regarding claim 12, that the pumping device further comprises: a controller; wherein the controller is configured to keep the check element inflated while deflating the first pumping element and the second pumping element (col. 4, lines 18-34);
Regarding claim 13, further comprising: a controller; wherein the controller is configured to inflate the pumping element (col. 3, line 60 to col. 4, lines 8); and
Regarding claim 15, that the device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an inlet of the heart assist pump into a first pump section (col. 4, lines 10-24; when chamber 11 is closed) to provide the predictable results of providing improved ventricular assist with pulsatile assistance without the inherent medical complications of prior art devices with a simple and inexpensive tubular structure (col. 3, lines 18-28).
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 Ryan by substituting the first and second pumping elements with a first and second pumping element of King, thereby providing:
Regarding claims 9 and 10, the pumping device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an outlet of the heart assist pump (as taught by King) into a second pump section wherein the second pump section comprises the second pumping element (as described by Ryan);
Regarding claim 11, wherein the check element is inflatable;
Regarding claim 12, that the pumping device further comprises: a controller; wherein the controller is configured to keep the check element inflated while deflating the first pumping element and the second pumping element;
Regarding claim 13, further comprising: a controller; wherein the controller is configured to inflate the pumping element; and
Regarding claim 15, that the device further comprises: a check element; wherein the check element is configured to prevent fluid flow from an inlet of the heart assist pump into a first pump section to provide the predictable results of providing improved ventricular assist with pulsatile assistance without the inherent medical complications of prior art devices with a simple and inexpensive tubular structure, and thus arrive at the claimed subject matter.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Smith et al. (US 2022/0265989, hereinafter “Smith”). Ryan discloses the essential features of the claimed invention, but does not expressly disclose a graphical user interface (GUI) configured to display operational status and receive user inputs for controlling the heart assist pump.
However, Smith in the same field of endeavor of cardiac assist devices (par. 0002) teaches providing a graphical user interface (GUI) configured to display operational status and receive user inputs for controlling the heart assist pump (par. 0042) to provide the predictable results of allowing for manual adjustment of pump parameters by the user or automatic adjustment based on measured patient parameters (par. 0042).
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 Ryan by providing a graphical user interface (GUI) configured to display operational status and receive user inputs for controlling the heart assist pump to provide the predictable results of allowing for manual adjustment of pump parameters by the user or automatic adjustment based on measured patient parameters.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Charafeddine et al. (US 2021/0260361) is another example of a trans-aortic valve circulation assist device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792