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 Notes
The allowance, and the Examiners amendment (see below), is based off of the claim set from 12/23/2024.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Within claim 1, lines 8-9: Applicant claims, “, such that an interval space is formed between the first tube and the second tube”; this claim clause appears to be incomplete on it’s own, it appears it should be merged with the clause before it (by deleting the comma at the beginning of the clause).
Within claim 1, lines 14-15: Applicant claims, “and in a circumferential direction of the outer tube,”; this claim clause appears to be incomplete on it’s own, it appears it should be merged with the clause after it (by deleting the comma at the end of the clause).
Within claim 1, lines 18-19: Applicant claims, “, with each corresponding to one another”; this claim clause appears to be incomplete on it’s own, it appears it should be merged with the clause before it (by deleting the comma at the beginning of the clause).
Within claim 1, line 20: Applicant claims, “in a circumferential direction of the inner tube,”; this claim clause appears to be incomplete on it’s own, it appears it should be merged with the clause after it (by deleting the comma at the end of the clause).
Within claim 1, line 26: Applicant claims, “, with each corresponding to one another”; ”; this claim clause appears to be incomplete on it’s own, it appears it should be merged with the clause before it (by deleting the comma at the beginning of the clause).
Appropriate correction is required.
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.
Claim(s) 1-6 is/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.
Within claim 1, lines 3-5: Applicant claims, “a plurality of unlocking structures; each unlocking structure comprises an unlocking tube and a traction strip which are interconnected,”, within the aforementioned clause Applicant is claiming a plurality of unlocking structures as such the claim requires a plurality of EACH of the unlocking tubes and the tractions strips; additionally, in claim 1, line 3-14: Applicant claims, “wherein the unlocking tube comprises a spring tube and a limiting structures, the limiting structure comprises a first tube, a second tube, and a connecting strip, the first tube and the second tube are coaxially arranged, the first tube and the second tube are spaced in an axial direction of the first tube, such that an interval space is formed between the first tube and the second tube, the first tube and the second tube are connected through the connecting strip, the spring tube is located in the interval space, an axis of the spring tube and an axis of the first tube are located on the same straight line, one end of the spring tube is connected to the first tube, an adjustment space is formed between the other end of the spring tube and the second tube, the traction strip is connected to the other end of the spring tube, and the unlocking structure is connected to a distal end of the outer tube through the traction strip”; in the aforementioned requirement Applicant is referring to singular substructures of the plurality of unlocking structures (ex: the unlocking tube, the limiting structure, the first tube, etc); as such, it is unclear, and therefore indefinite, if Applicant is referring to ALL of the substructures OR a subset of one of the substructures. For the purposes of examination Examiner is assuming the claim is meaning to refer to ALL of the substructures – in which case Examiner suggests amending claim 1, lines 4-5: from “each unlocking structure comprises an unlocking tube and a traction strip which are interconnected, wherein the unlocking tube comprises” to --each unlocking structure comprises an unlocking tube and a traction strip which are interconnected, within each unlocking structure:
the unlocking tube comprises--. Please note: claim(s) 2-6, which depend from claim 1, inherit all the problems associated with claim 1 (additionally, similar amendments will be required within claim 2-5 to mirror the amendment suggested by Examiner to claim 1).
Claim 5 recites the limitation "the natural state" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 6 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Within claim 6 Applicant is merely claiming a substructure, specifically the unlocking tube, of the heart valve delivery assembly of claim 1 and therefore does not further limit either the unlocking tube nor the heart valve delivery assembly. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim(s) 1-5 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 6 (if rewritten in independent form):
An unlocking tube as part of a heart valve delivery assembly wherein:
the unlocking tube comprises a spring tube and a limiting structure,
the limiting structure comprises a first tube and a second tube coaxially arranged and axially spaced from each other (creating an interval space therebetween), the first tube and the second tube are connected through the connecting strip,
the spring tube is located in the interval space (with one end connected to the first tube), an axis of the spring tube and an axis of the first tube are located on the same straight line, an adjustment space is formed between the other end of the spring tube and the second tube.
With respect to claim 1:
A heart valve delivery assembly comprising: an outer sheath, and outer tube apparatus, an inner tube apparatus, and a valve stent wherein:
the outer tube apparatus comprises an outer tube and a plurality of unlocking structures; each unlocking structure comprises an unlocking tube (with all the features as discussed above for claim 6) and a traction strip which are interconnected;
the inner tube apparatus comprising an inner tube and a plurality of hanging ears, each hanging ear extends through a second tube, spring tube, and first tube of a respective unlocking structure of the outer tube apparatus;
the valve stent comprising a stent within a valve therein, one end of the stent comprising hanging heads, each hanging head is connected to a respective hanging ear of the inner tube apparatus.
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
Examiner Preston made calls to Applicant’s attorney George Morgan on 12/5/25, 12/8/25, and 12/9/25 to discuss a potential examiner’s amendment; however, Examiner Preston was unable to reach Attorney Morgan.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CHENG (CN 216754724 U) discloses a heart valve delivery assembly comprising an outer sheath, an outer tube apparatus (within an unlocking structure), an inner tuber apparatus, and a valve stent. However, the unlocking structure of the outer tube apparatus does not disclose a two component unlocking tube comprising a spring tube and a limiting structure (with a first tube, second tube, and a connecting strip) nor the special relationship between the components of the spring tube and the limiting structure as required by claim 1 nor 6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/Examiner, Art Unit 3774