DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 11-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/12/2025.
Applicant's election with traverse of Group I, claims 1-10, in the reply filed on 06/12/2025 is acknowledged. The traversal is on the ground(s) that the groups are not patentably distinct and that their examination would not impose a serious burden. This is not found persuasive.
As recited, the inventions of Groups I, II, and III are patentably distinct. The invention of Group II requires a plurality of struts disposed adjacent to at least one other strut, which is not required by the invention of Group I. The invention of Group I further requires a rotatable impeller, which is not required by the invention of Group II. The invention of Group I further requires a self-expanding mesh structure defining distinct distal and proximal portions configured to minimize a fracture of the mesh structure in the distal portion while the mesh structure is being collapsed, which is not required by the invention of Group III. The invention of Group III requires an expandable cannula, which is not required by the invention of Group I. Further, the argument that examination of all the groups would not impose a serious burden is not found to be persuasive, because the groups are classified in different areas and would require different fields of searching (for example, searching different classes/subclasses or electronic resources, and/or employing different search queries).
The requirement is still deemed proper and is therefore made FINAL.
Remarks
This action is in response to the Remarks filed 06/12/2025.
Claims 1-10 are examined in the office action below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “hub structure” of claims 7 and 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7-8 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.
Claims 7 and 8 require a “hub structure”. This claimed limitation is not explained in the specification or labeled in the drawings. It is unclear what the hub structure is.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1, 2, and 4-10 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by McBride et al. (US Patent Application Publication 2008/0114339), hereinafter McBride.
Regarding claim 1, McBride discloses a catheter pump assembly (e.g. Abstract), comprising:
an elongate body having a distal end and a proximal end opposite the distal end (e.g. Par. [0135]: a blood pump 600; Fig. 14: blood pump shown with distal and proximal ends);
a cannula coupled with the distal end of the elongate body (e.g. Par. [0137]: cannula 625), the cannula comprising:
a self-expanding mesh structure (e.g. Par. [0144]: self-expanding mesh structure) that includes a plurality of nitinol members defining distinct distal and proximal portions respectively configured to minimize a fracture of the mesh structure in the distal portion while the mesh structure is being collapsed (e.g. Par. [0148]: can be made of nitinol; Fig. 15B: mesh structure 631 with distal and proximal portions; Par. [0145]), the proximal portion tapering from an expanded diameter to a smaller diameter at the distal end of the elongate body (e.g. Fig. 15B: the proximal portion by 660 tapers to a smaller diameter than at the distal end), and the distal portion defining a plurality of inlet spaces between the plurality of nitinol members to permit blood to enter the expandable cannula (e.g. Fig. 19: inlet spaces 642 to allow blood flow at the distal portion; Par. [0143]); and
a coating formed over the mesh structure and forming a conduit for the flow of blood from the distal portion to the proximal portion (e.g. Par. [0143]: coating may be applied for flow improvement); and
a rotatable impeller coupled with the distal end of the elongate body and extending in the proximal portion of the cannula for moving blood through the cannula while the cannula is expanded (e.g. Par. [0136]: impeller 605; Fig. 15A).
Regarding claim 2, McBride further discloses wherein the expanded diameter is at least 5 millimeters (e.g. Par. [0062]: diameter between 6-7mm).
Regarding claim 4, McBride further discloses wherein the distinct distal and proximal portions are collapsible from an expanded configuration to a delivery configuration having a delivery diameter for insertion into a patient or removal from the patient (e.g. Par. [0062]: insertion into patient; Par. [0175]: removal from patient).
Regarding claim 5, McBride further discloses wherein the coating comprises a biocompatible polymer (e.g. Par. [0143]: biocompatible coating).
Regarding claim 6, McBride further discloses wherein the plurality of nitinol members forms connection structures for securing the self-expanding mesh structure to the elongate body (e.g. Par. [0146]; Fig. 16: connectors 694).
Regarding claim 7, McBride further discloses wherein the connection structures secure the self-expanding mesh structure to the elongate body at a hub structure (e.g. Fig. 18: connector connected to structure 660, which is being considered the hub structure).
Regarding claim 8, McBride further discloses wherein the connection structures engage slots formed in the hub structure (e.g. Par. [0148]; Fig. 18).
Regarding claim 9, McBride further discloses wherein the connection structures comprise loop elements (e.g. Fig. 16: connection structures include loop elements).
Regarding claim 10, McBride further discloses McBride further discloses wherein the connection structures comprise linear elements (e.g. Fig. 16: connection structures include linear elements).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McBride et al. (US Patent Application Publication 2008/0114339), hereinafter McBride.
Regarding claim 3, McBride further discloses wherein the cannula proximal portion tapers at an angle in the range of 30 degrees to 40 degrees relative to a longitudinal axis of the elongate body (e.g. Fig. 15B: proximal portion tapers at an angle relative to longitudinal axis of the elongate body). McBride discloses the claimed invention except for the angle being in the range of 30 to 40 degrees. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention as taught by McBride with the angle being in the range of 30 to 40 degrees, 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].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pfeffer et al. (US 2009/0093764) is directed towards a catheter device.
Campbell et al. (US 2011/0004046) is directed towards a blood pump with an expandable cannula.
McBride et al. (US 2011/0071338) is directed towards a heart assist device with an expandable impeller pump.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
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