DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on March 18, 2025. As directed by the amendment: claims 1, 7, 10, 29, 31, 34, 35, and 39 have been amended, claim 6 has been cancelled, and claim 40 has been added. Thus, claims 1, 3, 7-11, and 28-40 are presently pending in this application.
Response to Arguments
Applicant’s arguments on pgs. 6-8, filed March 18, 2025, with respect to the rejections under 112(b) have been fully considered and are persuasive. The 112(b) rejection of claims 1, 6, 8, and 11 (and associated dependent claims) has been withdrawn.
Applicant’s arguments on pgs. 12-12, filed March 18, 2025, with respect to the rejection under 103 to claim 39 have been fully considered and are persuasive. The 103 rejection of claim 39 has been withdrawn.
With regards to the 102(b) rejection to claims 1 and 6, Applicant's arguments filed March 18, 2025 have been fully considered but they are not persuasive.
Applicant argues on pg. 10 of the Remarks that “Bacich does not even include the word "sheath," let alone suggest that, for example, inner catheter 15 could be replaced with a sheath”. The examiner respectfully disagrees and notes that the “sheath” is merely a functional component of the claimed system so that a distal-most end of the flange merely needs to be capable of abutting a proximal-most end of a sheath. Additionally, the specifics of the sheath are not further defined. Thus, it is the examiner’s position that the distal surface defined below and in the previous rejection is fully capable of performing the claimed function since there is nothing regarding the structure of the distal surface which would prevent the capability of the distal surface to abut some sort of sheath.
Applicant further argues on pg. 12 of the Remarks that “Bacich utilizes entirely different components (e.g., a catheter instead of sheath and an endoscope instead of a blood pump), it is not reasonable to assume, as asserted in the Office Action, that this system is capable of allowing a blood pump to withstand the specific push force currently recited in claim 1 without buckling”. The examine respectfully disagrees and notes that the “blood pump” is a functional limitation so that the claimed holding element merely needs to be capable of performing the function on a blood pump. The examiner further notes that the specifics (specifically the material and dimensions) are not further defined in the claim. The ability of the blood pump to withstand the push force without buckling would be dependent on both the clamping tool and the specifics (material and the dimensions) of the blood pump. Since these specifics are not claimed, the examiner maintains that the clamping tool of Bacich is fully capable of performing the function. Additionally, it seems that Bacich already contemplates these features since Bacich discloses that the wheels are configured to frictionally grip the instrument and longitudinally drive the instrument without damaging the instrument (7:47-51).
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3, 7-10, 28-30 and 33 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bacich (Patent No. 5,389,100).
Regarding claim 1, Bacich discloses a push device system (11, fig. 1) for axial insertion of a blood pump into a sheath, the sheath comprising proximal-most and distal-most ends and an inner lumen configured to receive the blood pump through the proximal-most end, the push device system comprising:
a holding element (55/59/61, fig. 2) having comprising proximal (proximal region, fig. 2 below) and distal regions (distal region, fig. 2 below) and a radial clamping tool (79 in fig. 2), wherein the clamping tool is configured to be pressed onto the blood pump in a radial direction to produce an adhesion to the blood pump for applying a push force in an axial direction of the blood pump (6:29-39; the examiner notes that the “blood pump” is functional so that the clamping tool merely needs to be capable of performing the claimed function), and wherein the holding element is configured to allow the blood pump to withstand the push force without buckling (6:29-39; see response to arguments above); and
a flange (59 in fig. 2) at the distal region of the holding element (see fig. 2 below), wherein a distal-most end of the flange (distal end of 59) comprises a distal surface (distal surface, fig. 3 below) that is configured to abut a proximal surface of the proximal-most end of the sheath to couple the holding element directly to the proximal-most end of the sheath (the examiner notes that the “sheath” is functional so that the surface below merely needs to be capable of abutting a sheath; see response to arguments above).
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Regarding claim 3, Bacich discloses wherein the holding element (55/59/61) is configured to connect to the sheath by way of a central thread (threads on 59, see Col. 6, lines 13-17 and Col. 8, lines 32-34) , by way of a bayonet closure, by way of a fit surface, by way of adhesion forces, by way of a magnetic device, by way of an eccentric screw connection, by way of a gluing connection, by way of acone connection, by way of a snap connection, by way of an electrostatic connection, by way of elastic holding elements, or by way of inserting a fit piece of the sheath into a fittingly shaped recess of the holding.
Regarding claim 7, Bacich discloses wherein the clamping tool (81/83) is configured to roll on the blood pump (see Col. 6, lines 29-39).
Regarding claim 8, Bacich discloses wherein the clamping tool (81/83) comprises, at least two friction wheels (see Col. 6, lines 35-37), and wherein the at least two friction wheels (81/83) at least partly lie opposite one another with respect to the-blood pump (see Fig. 3 illustrating 81 and 83 opposite one another).
Regarding claim 9, Bacich discloses wherein the at least two friction wheels (81/83) are controllable with regard to their rotation (see Col. 6, lines 58-68 and Col. 7, lines 1-10).
Regarding claim 10, Bacich discloses wherein the clamping tool (81/83) comprises clamping jaws (81/83, thefreedictionary.com defines “jaw” as “ one of two or more parts, as of a machine, that grasp or hold something or that attach to or mesh with similar parts” and 81 and 83 grasp 19), and wherein at least one of the clamping jaws (81/83), is movable, in a guided manner in the axial direction the blood pump (see Col. 6, lines 36-43).
Regarding claim 28, Bacich discloses wherein the holding element (55/59/61) is further configured to apply an axial push force on a catheter coupled to the blood pump (see Col. 6, lines 29-39).
Regarding claim 29, Bacich discloses wherein the holding element (55/59/61) is configured to limit radial deflections of the sheath by minimizing a distance between (i) where an axial push force is applied onto the blood pump and (ii) the proximal-most end of the sheath (see Col. 6, lines 29-57, it is the Examiner’s position that as a result of elements 81/83 exerting a force on 19 to move 19, 81/83 limit radial deflection of 19; hence, 81/83 of the holding element are capable of limiting radial deflections of a sheath by minimizing a distance between (i) where an axial push force is applied onto a blood pump and (ii) a proximal-most end of the sheath).
Regarding claim 30, Bacich discloses wherein the holding element (55/59/61) further comprises one or more recesses (hollow space within 61 where 19 moves) for one or more tear tabs of a second sheath surrounding a catheter coupled to the blood pump (it is the Examiner’s position that a tear tab of a second sheath surrounding a catheter is capable of moving through the hollow space of 61 where 19 moves).
Regarding claim 33, Bacich discloses wherein the holding element (55/59/61) further comprises a push cylinder (81/83, see Fig. 2 where 81 and 82 are cylinders and Col. 6, lines 29-39 where 81 and 83 push 19).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 11 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bacich.
Regarding claim 11, Bacich discloses wherein the clamping jaws (81/83) are formed by way of two or more parts (90, Fig. 5) of a hollow housing (housing formed by 90, see Col. 6, lines 46-59), which is divided into segment bodies (see Col. 6, lines 46-59), and wherein the hollow housing receives the-blood pump (90 is capable of receiving a blood pump just as 90 receives 19).
However, Bacich does not specifically teach that the two or more parts are of a hollow cylinder.
It would have been obvious to one of ordinary skill in the art to modify the shape of the housing formed by 90 by forming the housing as a cylinder because applicant has not disclosed that having a cylindrical shape provides an advantage, is used for a particular purpose or solves a stated problem. Further, one of ordinary skill in the art would expect the housing of Bacich to perform equally well having a cylindrical shape. In addition, it has been held that a change in shape involves only routine skill in the art.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 7-9, and 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, and 16-18 of U.S. Patent No. 11235125 (see table).
Regarding claim 1, all of the claimed elements of claims 1 of the instant application can be found in claim 16 of the issued patent. The difference between the claims of the instant application and the claims of the issued patent lie in the fact that the issued patent claims include more elements and is thus more specific. Thus the invention of claim 16 of the issued patent is in effect a “species” of the “generic” inventions of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman. 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 16 of the issued patent, it is not patentably distinct from claim 16 of the issued patent.
Instant Claim
Issued Claim
1
1
7
17
8
18
9
18
39
1
Allowable Subject Matter
Claims 34-38 and 40 are allowed over the prior art of record.
Claim 39 would be allowable with the filing of a terminal disclaimer to overcome the double patenting rejection, as set forth in this Office action, and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The claims in this application are allowed because the prior art of record fails to disclose either singly or in combination the claimed push device system.
The closest prior art of record is Bacich.
Regarding independent claim 34, Bacich fails to teach among all the limitations or render obvious one end of the push cylinder comprises a disk with a centric opening surrounded by a peripheral, movable lip, and wherein the opening is dimensioned in a manner such that an edge of the lip lies on the blood pump as the blood pump is advanced through the opening, in combination with the total structure and function as claimed.
Regarding independent claim 35, Bacich fails to teach among all the limitations or render obvious the holding element further comprises a guide body and a drive body, wherein the guide body comprises a guide rail for receiving the blood pump, wherein the drive body comprises a recess for receiving the blood pump, and wherein pressing the drive body against the blood pump in a radial direction produces an adhesion to the blood pump, which serves for applying a push force in an axial direction of the blood pump, in combination with the total structure and function as claimed.
Regarding claim 39, Bacich fails to teach among all the limitations or render obvious a system as claimed in claim 1 further comprising a blood pump and sheath, in combination with the total structure and function as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783