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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16, in the reply filed on 12/8/2025 is acknowledged. Claims 17-20 are withdrawn.
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.
Claims 1-16 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.
Claim 1 recites the limitation "the proximal retention bumper" in line 9. There is insufficient antecedent basis for this limitation in the claim. Therefore, it is unclear if claim 1 is positively requiring the proximal retention bumper as an element of the balloon catheter.
Claim 2 recites “further comprising a proximal retention bumper secured to the inner shaft proximal of the operational portion”. It is unclear if this recitation of a proximal retention bumper is referring to the same proximal retention bumper recited in claim 1, or an additional proximal retention bumper.
Claim 4 recites “a proximal retention bumper secured to the inner shaft proximal of the operational portion”. It is unclear if this recitation of a proximal retention bumper is referring to the same proximal retention bumper recited in claim 1, or an additional proximal retention bumper.
Claim 10 recites “formed integrally with a proximal retention bumper secured to the inner shaft proximal of the operational portion”. It is unclear if this recitation of a proximal retention bumper is referring to the same proximal retention bumper recited in claim 1, or an additional proximal retention bumper.
Claim 15 recites “located adjacent a proximal retention bumper”. It is unclear if this recitation of a proximal retention bumper is referring to the same proximal retention bumper recited in claim 1, or an additional proximal retention bumper.
In light of the issues with claims 1, 2, 4 and 15 above in regards to the proximal retention bumper, the Examiner will interpret claim 1 as only functionally requiring a hypothetical proximal retention bumper and the claimed reinforcing member only being capable of use with a proximal retention bumper since it appears a proximal retention bumper is then introduced and positively required in latter dependent claims 2, 4 and 15.
Claim 13 recites “a proximal multipart retention bumper” and “a distal multipart retention bumper”. It is unclear if 1) these multipart retention bumpers are new elements in addition to the proximal retention bumper and distal retention bumper of claim 1, or if 2) the proximal retention bumper of claim 1 is a proximal multipart retention bumper and distal retention bumper of claim 1 is a distal multipart retention bumper. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 13 as interpretation 2) above.
Claim(s) 3, 5-9, 11, 12, 14 and 16 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6, 9-16 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (US 2019/0125532).
Lee et al discloses the following limitations:
Claim 1. A balloon catheter (10) (Figs. 9-11, 15-17) for deploying a prosthetic valve (12) via balloon inflation, comprising:
an inner shaft (34) ([0088]);
an outer shaft (26) surrounding the inner shaft ([0088]);
a balloon (28) disposed at a distal end of the outer shaft defining a delivery portion of the balloon catheter and having an operational portion configured to receive the prosthetic valve (12) (Figs. 9-11, 15-17; [0086], [0088]);
a distal retention bumper (126) secured to the inner shaft distal of the operational portion ([0107]); and
a reinforcing member (124 or 140) configured to reinforce a portion of the balloon catheter between a proximal retention bumper and the distal retention bumper1, wherein the reinforcing member causes an increase in bending stiffness of the balloon catheter at a reinforced portion ([0112], [0114]; the mounting member 124 comprises a metal coiled wire which makes that portion of the catheter stiffer and with higher bending stiffness than a remaining portion of the catheter without the metal coiled wire; mounting member 140 comprises a relatively rigid material that does not radially compress and therefore increases the bending stiffness of the balloon catheter at that portion as compared with a portion without the relatively rigid member).
Claim 6. The balloon catheter of claim 1, wherein the increase in bending stiffness causes the reinforced portion to remain straighter than remaining portions of the delivery portion of the balloon catheter during curvature of the delivery portion due to the presence of the metal coiled wire or the relatively rigid member).
Claim 9. The balloon catheter of claim 1, wherein the reinforcing member includes a tube (140) disposed over the inner shaft over a length of the reinforced portion (Figs. 12-14; [0114]).
Claim 11. The balloon catheter of claim 1, wherein the reinforcing member (124) is configured with a variable stiffness profile (Fig. 8; [0112]; i.e. different spacing between the coils causes variable stiffness).
Claim 12. The balloon catheter of claim 1, wherein the reinforcing member (124 or 140) is a stiffened portion of the inner shaft. Applicant has not claimed how the inner shaft is stiffened. Therefore, the reinforcing member makes the portion of the inner shaft it occupies stiffened and is therefore a stiffened portion of the inner shaft.
Claim 14. The balloon catheter of claim 1, wherein the reinforced portion is capable of having that the prosthetic valve remains in radial alignment with the distal retention bumper during curvature of the delivery portion. Applicant discloses the presence of a reinforced portion allows for this to happen during delivery. Therefore, the metal coiled portion or rigid delivery member of the reinforced portion in Lee et al would be capable of performing the same.
Claim 16. The balloon catheter of claim 1, wherein operational portion is configured to receive the prosthetic valve crimped thereon ([0082]; Figs. 9-11, 15-17).
Under an alternative interpretation of Lee et al, the following is disclosed:
Claim 1. A balloon catheter (10) (Fig. 33) for deploying a prosthetic valve (12) via balloon inflation, comprising:
an inner shaft (313) ([0129]);
an outer shaft (312) surrounding the inner shaft ([0129]);
a balloon (314) disposed at a distal end of the outer shaft defining a delivery portion of the balloon catheter and having an operational portion configured to receive the prosthetic valve (12) ([0129]);
a distal retention bumper (see annotated figure below) secured to the inner shaft distal of the operational portion ([0130]); and
a reinforcing member (see annotated figure below; wherein the reinforcing member is structurally denoted from the distal retention bumper at the presence of the notch in stop member 320; the reinforcing member and retention bumper may be integrally formed as disclosed by Applicant in [0051] of the instant published application) configured to reinforce a portion of the balloon catheter between a proximal retention bumper (see annotated figure below) and the distal retention bumper, wherein the reinforcing member causes an increase in bending stiffness of the balloon catheter at a reinforced portion (Applicant discloses in [0041] of the instant published application – “It is not required that the reinforcing member 470, by itself, have a rigidity greater than the inner shaft 430. Combining the reinforcing member 470 with the inner shaft 430 results in a rigidity greater than the inner shaft 430 alone.” Therefore, the presence of the increased thickness of the annotated reinforcing member increases the bending stiffness of the balloon catheter at that portion as compared to a portion without the annotated reinforcing member).
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Claim 2. The balloon catheter of claim 1, further comprising a proximal retention bumper (see annotated figure from claim 1 above) secured to the inner shaft proximal of the operational portion.
Claim 3. The balloon catheter of claim 1, wherein the reinforcing member includes a first reinforcing member and a second reinforcing member (see annotated figure from claim 1 above).
Claim 4. The balloon catheter of claim 3, wherein the first reinforcing member extends distally (in a direction away from the user) of a proximal retention bumper secured to the inner shaft proximal of the operational portion and the second reinforcing member extends proximally (in a direction towards the user) of the distal retention bumper (see annotated figure from claim 1 above).
Claim 10. The balloon catheter of claim 3, wherein the first reinforcing member is formed integrally with a proximal retention bumper (all integrally part of stop member 318) secured to the inner shaft proximal of the operational portion and the second reinforcing member is formed integrally with the distal retention bumper (all integrally part of stop member 320) (see annotated figure from claim 1 above).
Claim 13. The balloon catheter of claim 3, wherein the first reinforcing member is formed from a reinforcing portion of a proximal multipart retention bumper (first reinforcing member + proximal retention bumper = proximal multipart retention bumper as seen in annotated figure from claim 1 above) and the second reinforcing member is formed from a reinforcing portion of a distal multipart retention bumper (second reinforcing member + distal retention bumper = distal multipart retention bumper as seen in annotated figure from claim 1 above).
Claim 15. The balloon catheter of claim 3, wherein the first reinforcing member is located adjacent a proximal retention bumper and the second reinforcing member is located adjacent the distal retention bumper (see annotated figure from claim 1 above).
Claim(s) 1-5, 9, 12-16 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gallagher et al (US 2003/0135256).
Gallagher et al discloses the following limitations:
Claim 1. A balloon catheter (Figs. 1-3) for deploying a prosthetic valve (stent 23 as shown in Fig. 1 may instead be a valve, which has not been positively recited as an element of the balloon catheter) via balloon inflation, comprising:
an inner shaft (45) ([0025]);
an outer shaft (43) surrounding the inner shaft ([0025]);
a balloon (44) disposed at a distal end of the outer shaft defining a delivery portion of the balloon catheter and having an operational portion configured to receive the prosthetic valve ([0025]);
a distal retention bumper (right marker band 46 in Fig. 2) secured to the inner shaft distal of the operational portion ([0026]); and
a reinforcing member (right transition sleeve 41 in Fig. 2) configured to reinforce a portion of the balloon catheter between a proximal retention bumper (left marker band 46 in Fig. 2) and the distal retention bumper, wherein the reinforcing member causes an increase in bending stiffness of the balloon catheter at a reinforced portion ([0025], [0026]; “The inner shaft 45 also includes a pair of transition sleeves 41 fabricated of a material to provide increased stiffness relative to the shafts 43, 45 and balloon 44,” “The purpose of these stiffness transitions is to smooth out the stiffness profile of the combined balloon catheter and stent thus reducing the risk of tracking and efficiency discontinuities resulting in the catheter getting hung-up or hinging”).
Claim 2. The balloon catheter of claim 1, further comprising a proximal retention bumper (left marker band 46 in Fig. 2) secured to the inner shaft proximal of the operational portion ([0026]).
Claim 3. The balloon catheter of claim 1, wherein the reinforcing member includes a first reinforcing member (left marker band 46 in Fig. 2) and a second reinforcing member (right marker band 46 in Fig. 2) ([0026]).
Claim 4. The balloon catheter of claim 3, wherein the first reinforcing member (left transition sleeve 41) extends distally (at portion 41a of the left transition sleeve) of a proximal retention bumper (left marker band 46 in Fig. 2) secured to the inner shaft proximal of the operational portion and the second reinforcing member (right transition sleeve 41 in Fig. 2) extends proximally (at portion 41a of the right transition sleeve) of the distal retention bumper (left marker band 46 in Fig. 2).
Claim 5. The balloon catheter of claim 4, wherein the first reinforcing member further extends proximally (at portion 41b of the left transition sleeve 41 in Fig. 2) of the proximal retention bumper.
Claim 9. The balloon catheter of claim 1, wherein the reinforcing member includes a tube (41; i.e. sleeve) disposed over the inner shaft over a length of the reinforced portion (Fig. 2; [0026]).
Claim 12. The balloon catheter of claim 1, wherein the reinforcing member is a stiffened portion of the inner shaft. Applicant has not claimed how the inner shaft is stiffened. Therefore, the reinforcing member makes the portion of the inner shaft it occupies stiffened and is therefore a stiffened portion of the inner shaft.
Claim 13. The balloon catheter of claim 3, wherein the first reinforcing member is formed from a reinforcing portion of a proximal multipart retention bumper (left transition sleeve 41 + left marker band 46 = proximal multipart retention bumper) and the second reinforcing member is formed from a reinforcing portion of a distal multipart retention bumper (right transition sleeve 41 + right marker band 46 = distal multipart retention bumper)
Claim 14. The balloon catheter of claim 1, wherein the reinforced portion is configured such that the prosthetic valve remains in radial alignment with the distal retention bumper during curvature of the delivery portion ([0026] - [0028]; Figs. 3a, 3b).
Claim 15. The balloon catheter of claim 3, wherein the first reinforcing member (left transition sleeve 41 in Fig. 2) is located adjacent a proximal retention bumper (left marker band 46 in Fig. 2) and the second reinforcing member (right transition sleeve 41 in Fig. 2) is located adjacent the distal retention bumper (left marker band 46 in Fig. 2).
Claim 16. The balloon catheter of claim 1, wherein operational portion is configured to receive the prosthetic valve crimped thereon ([0026]).
Allowable Subject Matter
Claims 7 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten to obviate the 35 U.S.C. 112 rejections above.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Lee et al and Gallagher et al, each discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed balloon catheter comprising, inter alia, the reinforcing member has a first reduced stiffness portion distal of the distal retention bumper and a second reduced stiffness portion proximal of the proximal retention bumper. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1 See 35 U.S.C. 112 rejection above in regards to the proximal retention bumper. The device of Lee et al is capable of use with a proximal retention bumper (318) as seen in Figs. 33 or proximal retention bumper (614) as seen in Fig. 47.