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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 11/19/2025.
Status of the claims:
Claims 1 – 20 are pending in the application.
Claims 10 – 20 are withdrawn.
Election/Restrictions
Claims 10 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species or Method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/19/2025.
Applicant's election with traverse of Group I Species G in the reply filed on 11/19/2025 is acknowledged. The traversal is on the ground(s) that:
“The Office has not established a search burden”, this is not found to be persuasive because, as stated in the Requirement for Restriction mailed on 09/22/2025, Group I is directed to a system for creating a lumen and Group II is directed to a method of creating a lumen in an artery; and because Group II specifically requires the system to be used in the arteries the prior art applicable to Group I would not necessarily be applicable to the invention of Group II since the system of Group I does not have to be used in a specific location within an organism or even in any part of an organism. In other words because the system of Group I is not restricted by location the field of search is much broader and requires a wider field of search than that of the invention of Group II. Therefore, the Examiner has established the required search burden.
“the discussion of the groups merely states that certain characteristics are mutually exclusive, without explaining why such differences would necessitate separate searches or examinations.”, this is not found to be persuasive because, each of the species requires a distinct field of search due to their mutually exclusive characteristics, which ultimately broadens the field of search and creates a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 5 and 7 are objected to because of the following informalities:
Claim 5 recites “at least one or more strips” in line 1, although the line is clear and does not rise to the level of being indefinite as the line is understood by the Examiner to read “as least one of the one or more strips” as the “one or more strips” were previously defined, the Examiner suggests the line be amended to read “at least one of the one or more strips” for the purpose of maintaining consistent language throughout the claims;
Claim 7 recites “where in” however this appears to be a typographical error, therefore the Examiner suggests the line be amended to read “wherein”;
Appropriate correction is required.
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.
(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.
Claims 1 – 4, 6, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shturman (US 5,181,911).
Regarding claims 1, 2, 6, and 7, Shturman discloses a system (perfusion balloon) for creating a lumen (abstract, col. 3 lines 1 – 12, col. 5 lines 40 – 54, and Fig. 16), comprising:
a balloon (helical balloon / tube 32) wound in a generally helical shape having an inner surface and an outer surface (col. 3 lines 1 – 12, col. 5 lines 40 – 54, and Fig. 16); and
a support (outer skin 93), [claim 2] with a continuous cylindrical shape, attached the outer surface of the generally helical shape and constraining the balloon in the generally helical shape (col. 5 lines 40 – 54 and Fig. 16);
[claims 6 and 7] wherein the support (outer skin 93) is attached to the outer surface of the generally helical shape by a connector (adhesive) and is a thin film (col. 5 lines 40 – 54);
wherein the balloon has a first diameter in a low-profile operating mode (mode when deflated) and the generally helical shape has a second diameter in a high-profile operating mode (mode when inflated), and the second diameter is larger than the first diameter (claim 1) (Examiner’s note: to inflate something is to make it bigger; because the balloon is inflatable it has an inflated state and a deflated state, and the helical balloon’s inflated diameter (i.e., the second diameter) will be bigger than its deflated diameter (i.e., the first diameter)).
Regarding claims 1, 3, 4, and 9, (alternate interpretation – changes italicized below) Shturman discloses a system (perfusion balloon) for creating a lumen (abstract, col. 3 lines 1 – 12, col. 4 lines 58 – 66, and Fig. 10), comprising:
a balloon (helical balloon / tube 32) wound in a generally helical shape having an inner surface and an outer surface (col. 3 lines 1 – 12, col. 4 lines 58 – 66, and Fig. 10); and
a support (straps 94) attached the outer surface of the generally helical shape and constraining the balloon in the generally helical shape (col. 4 lines 58 – 66, and Fig. 10);
[claim 3] wherein the support (straps 94) is discontinuous, and wherein the support includes one or more strips (straps 94) (Fig. 10) (Examiner’s note: the straps 94 are not attached to each other, thus the support is discontinuous);
[claim 4] wherein the one or more strips (straps 94) are attached to the outer surface of the generally helical shape (Fig. 10);
[claim 9] wherein the support (straps 94) includes a first support (one of the straps 94) on the inner surface of the generally helical shape (Fig. 10) and a second support (a second of the straps 94) on the outer surface of the generally helical shape (col. 4 lines 58 – 66, and Fig. 10);
wherein the balloon has a first diameter in a low-profile operating mode (mode when deflated) and the generally helical shape has a second diameter in a high-profile operating mode (mode when inflated), and the second diameter is larger than the first diameter (claim 1) (Examiner’s note: to inflate something is to make it bigger; because the balloon is inflatable it has an inflated state and a deflated state, and the helical balloon’s inflated diameter (i.e., the second diameter) will be bigger than its deflated diameter (i.e., the first diameter)).
Claims 1, 3 – 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly et al (US 2012/0245520 A1).
Regarding claims 1, 3 – 6, and 9, Kelly discloses a system (perfusion dilation balloon) for creating a lumen (abstract, paragraphs [0037], [0038], and Figs. 12,13), comprising:
a balloon (helical balloon 230) wound in a generally helical shape having an inner surface and an outer surface (paragraphs [0037], [0038], and Figs. 12,13); and
a support (support weave 990) attached the outer surface of the generally helical shape and constraining the balloon in the generally helical shape (paragraphs [0037], [0038], and Figs. 12,13);
[claim 3] wherein the support (support weaves 990) is discontinuous, and wherein the support includes one or more strips (support weave 990) (Figs. 12,13) (Examiner’s note: the support weaves 990 at the top and at the bottom are not attached to each other, thus the support is discontinuous);
[claim 4] wherein the one or more strips (support weaves 990) are attached to the outer surface of the generally helical shape (Fig. 12);
[claim 5] wherein at least one or more strips (support weaves 990) includes an end portion folded to the inner surface of the generally helical shape (Examiner’s note: as shown in Fig. 13 the end(s) of the support weave 990 at both the proximal end and the distal end weaves (i.e., folds) from the outer surface to the outer surface);
[claim 6] wherein the support (support weaves 990) is attached to the outer surface of the generally helical shape by a connector (Examiner’s note: the term “connector” is defined as anything that connects two things together. As stated in paragraph [0038] the support weave 990 comprises two filaments 1092A/B are secured to the outer surface of spiral balloon 230; and in order to secure the (i.e., attach / connect) the support weave 990 to the balloon it would be inherent for the system to comprise a connector in order to attach (i.e., secure) the support weave to the balloon as intended. Therefore, it is said that the teachings of Kelly encompasses the limitations above);
[claim 9] wherein the support (support weaves 990) includes a first support (one of the support weaves 990) on the inner surface of the generally helical shape (Fig. 13) and a second support (a second of the support weaves 990) on the outer surface of the generally helical shape (paragraph [0038] and Figs. 12,13);
wherein the balloon has a first diameter in a low-profile operating mode (mode when deflated) and the generally helical shape has a second diameter in a high-profile operating mode (mode when inflated), and the second diameter is larger than the first diameter (claim 1) (Examiner’s note: to inflate something is to make it bigger; because the balloon is inflatable it has an inflated state and a deflated state, and the helical balloon’s inflated diameter (i.e., the second diameter) will be bigger than its deflated diameter (i.e., the first diameter)).
Claims 1, 2, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bridgeman et al (US 2020/0054865 A1).
Regarding claims 1 and 2, Bridgeman discloses a system (perfusion catheter) for creating a lumen (abstract, paragraphs [0079 – 0080] and [0082 – 0083], and Fig. 15A/B), comprising:
a balloon (helical balloon 1528) wound in a generally helical shape having an inner surface and an outer surface (paragraphs [0079 – 0080] and Fig. 15A/B); and
a support (containment structure 1580), [claim 2] with a continuous cylindrical shape, attached the outer surface of the generally helical shape and constraining the balloon in the generally helical shape (paragraphs [0079 – 0080] and [0082 – 0083], and Fig. 15A/B) (Examiner’s note: as stated in paragraph [0082] and shown in Fig. 15A the containment structure 1580 is non-perforated and thus forms a continuous cylindrical shape);
wherein the balloon has a first diameter in a low-profile operating mode (mode when deflated) and the generally helical shape has a second diameter in a high-profile operating mode (mode when inflated), and the second diameter is larger than the first diameter (claim 1) (Examiner’s note: to inflate something is to make it bigger; because the balloon is inflatable it has an inflated state and a deflated state, and the helical balloon’s inflated diameter (i.e., the second diameter) will be bigger than its deflated diameter (i.e., the first diameter)).
Regarding claims 1 and 8, (alternate interpretation – changes are italicized below) Bridgeman discloses a system (perfusion catheter) for creating a lumen (abstract, paragraphs [0079 – 0080] and [0082 – 0083], and Fig. 15A/B), comprising:
a balloon (helical balloon 1528) wound in a generally helical shape having an inner surface and an outer surface (paragraphs [0079 – 0080] and Fig. 15A/B); and
a, [claim 8] perforated, support (containment structure 1580) attached the outer surface of the generally helical shape and constraining the balloon in the generally helical shape (paragraphs [0079 – 0080] and [0082 – 0083], and Fig. 15A/B) (Examiner’s note: as stated in paragraph [0082] the containment structure 1580 is perforated);
wherein the balloon has a first diameter in a low-profile operating mode (mode when deflated) and the generally helical shape has a second diameter in a high-profile operating mode (mode when inflated), and the second diameter is larger than the first diameter (claim 1) (Examiner’s note: to inflate something is to make it bigger; because the balloon is inflatable it has an inflated state and a deflated state, and the helical balloon’s inflated diameter (i.e., the second diameter) will be bigger than its deflated diameter (i.e., the first diameter)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gerdhardt et al (US 2018/0153692 A1) and Samson (US 5,370,691) teach a helical balloon wherein the helical shape is constrained by a support on the outer surface and/or the inner surface of the balloon.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771