DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 21, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on November 21, 2025. As directed by the amendment: claims 1, 3, 7, 10, 11, 28, and 30 have been amended. Thus, claims 1, 3-11, and 29-40 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed November 21, 2025, with respect to the rejection(s) of claim(s) 1 under 102(b) have been fully considered and are persuasive, specifically in regards to Bacich not teaching or disclosing the new claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments which the examiner finds raise new matter issues.
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 1, 3, 7-11, 28-33, and 39 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.
Regarding claim 1, the claim has been amended to recite that “a second sheath…is pressed axially against a proximal surface of the flange”. The originally filed specification does not provide support for such amendment. Paragraph 70 (of the published application) discloses that “The second sheath may then be axially held onto the first sheath and fixed there, for example by way of the push device according to the invention. Whilst the second sheath is pressed axially against the first sheath, the heart catheter may then be pushed through the second sheath into the first sheath and by way of this may be pushed into the blood vessel”. As such, there is support for the second sheath to be pressed axially against the first sheath but there is no disclosure of the second sheath to be axially pressed against a proximal surface of the flange. The examiner notes that fig. 14 of the Drawings shows a tubular member which encircles elongate body 10 and is pressed axially against a proximal surface of flange 6; however, this tubular member is disclosed to be guide body 29 and not the second sheath. Additionally, claim 30 claims that the holding element comprises recesses for one or more tear tabs of the second sheath. This disclosure is discussed in paragraph 76 of the published application which discloses “A holding unit/axial force introduction device may comprise recesses for tear tabs 65 of a second sheath, if the second sheath is designed as a so-called “peel-off sheath””. This disclosure makes it clear that the second sheath of claim 1 is not intended to mean the guide body 29 shown in fig. 14 but is, instead, a peel-away sheath. For these reasons, the amendments is drawn to new matter.
Regarding claim 3, the claim is drawn to a holding element configured to connect to the first sheath. This amendment was added to the claim after the filing date and is not part of the original disclosure. Paragraph 20 of the published application discloses that the “push device” is mechanically coupled to the sheath in the claimed manner. As such, the originally filed disclosure does not provide support for the holding element to connect to the first sheath in the claimed manner.
Claims 7-11, 28-33, and 39 are also rejected by virtue of being dependent on claim 1.
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.
Claims 3, 29, and 39 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.
Regarding claim 3, the claim is drawn to a holding element which is configured to connect to the first sheath. This claim is dependent on claim 1 which recites that a flange is located at a distal region of the holding element so that it is understood that the flange is a separate component to the holding element. Additionally, claim 1 recites that a distal surface of a distal-most end of the flange abuts a proximal surface of a proximal-most end of the first sheath. Therefore, it is unclear how the holding element can connect to the first sheath while the proximal and distal surfaces of the first sheath and the flange abut, respectively.
Regarding claim 29, the claim is drawn to the holding device configured to limit radial deflections of “the sheath”. It is unclear if this sheath is drawn to the first sheath or the second sheath.
Regarding claim 39, the claim is drawn to the push device system comprising “the sheath”. The examiner first notes that both the first and second sheaths are already positively recited in the claim. Additionally, it is unclear to which sheath this limitations refers.
Allowable Subject Matter
Claims 34-38 and 40 are allowed over the prior art of record.
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.
See Reasons for Allowance provided in the Final Rejection mailed on 6/30/2025.
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
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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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783
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