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 invention I (claims 1-17) in the reply filed on 10/24/25 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/24/25.
Claim Objections
Claims 3, 9, 13 are objected to because of the following informalities:
Claims 3 and 13 are objected to for referring to “a direction towards the first inflatable body” with improper antecedent basis.
Claim 9 is objected to for referring to “passing fluid” into the second chamber, but it is unclear if this is the same fluid or a different fluid as that mentioned in claim 8.
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.
Claims 3 and 13 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.
Claims 3 and 13 are indefinite for claiming the shoulder of the first inflatable body is “configured to impede movement of the expandable implant in a direction towards the first inflatable body”, since it is unclear how the shoulder on the inflatable body itself can impede movement of the implant towards itself. The specification [0050] uses the same language as is in the claim, meaning the Examiner is unsure if they aren’t understanding how the shoulder functions, or whether the impediment of movement might be towards a different inflatable body, or only towards one particular end of the first inflatable body, or some other explanation. Is it is, the Examiner cannot understand how the shoulder that is described by the specification and shown in the figures is able to impede movement of the implant towards itself.
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Santani et al. (US 20060265041 A1) hereinafter known as Santani.
Regarding claim 1 Santani discloses a system for expansion of an expandable implant (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Santani was considered capable of performing the cited intended use. See, for example the Abstract, which indicates the system is capable of delivering a stent into an ostium; [0002] the stent is expandable; Abstract: the balloons are expandable and located within the balloon to expand the stent. See also Figure 8 item 310), the system comprising:
a first inflatable body (Figure 8 item 322a) having a first outer diameter when in an inflated state (Figure 8), and
a second inflatable body (Figure 8 item 322b) positioned adjacent the first body and having an outer surface (Figure 8) configured to apply an expansion force to the implant (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Santani discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example the Abstract: a stent is provided surrounding the balloons, and the balloons are expandable.) and having a shape that tapers downward in a direction towards the first inflatable body (see Figure 8 around item 328b) to a narrow portion having a second outer diameter that is less than the first outer diameter when the second inflatable body is in an inflated state (Figure 8).
Regarding claim 2 Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the first inflatable body has a rounded profile when in the inflated state (Figure 1; see also Figure 8 which is understood to show a rounded profile).
Regarding claim 3, as is best understood, Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the first inflatable body includes a shoulder portion (Figure 8 shows a shoulder portion between end 236a and intermediate portion 328a) configured to impede movement of the implant in a direction towards the first inflatable body (this is stated as a functional limitation of the shoulder (see the explanation above). The shoulder is understood to impede the movement of the implant inward since it inflates outwardly).
Regarding claim 4 Santani discloses the delivery system of claim 3 substantially as is claimed,
wherein Santani further discloses the shoulder portion comprises a folded portion of the first body ([0033] the distal balloon 22a can have a tapered shape that increases or decreases between the ends 24a, 26a, and can have a taper transition from the intermediate portion 28a to the proximal and distal ends 24a, 26a. This indicate that the shape of the first inflatable body can include a fold at at least one location to form the taper transition).
Regarding claim 5 Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the first inflatable body has a bulb shape when in the inflated state (Figure 8 is understood by the Examiner to show a “bulb shape”).
Regarding claim 6 Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the second inflatable body include a shoulder portion (Figure 8 shows a shoulder formed between the outermost/top surface of 322b and the end 324b) configured to impede movement of the implant in a direction away from the first inflatable body (this is stated as a functional limitation of the shoulder (see the explanation above). The shoulder is understood to impede the movement of the implant proximally).
Regarding claim 7 Santani discloses the delivery system of claim 6 substantially as is claimed,
wherein Santani further discloses the shoulder portion comprises a folded portion of the second inflatable body (Figure 8 shows how the second inflatable body 322b extends upward from end 324b and folds back upon itself to reach end 326b).
Regarding claim 8 Santani discloses the delivery system of claim 7 substantially as is claimed,
wherein Santani further discloses the first inflatable body has a first interior chamber (Figure 8 item 323a) and the system comprises a first inflation lumen (Figure 8 item 318a) for passing fluid into the first chamber ([0028]).
Regarding claim 9 Santani discloses the delivery system of claim 8 substantially as is claimed,
wherein Santani further discloses the second inflatable body has a second interior chamber (Figure 8 item 323b), and the system comprises a second inflation lumen (Figure 8 item 318b) for passing fluid into the second chamber ([0028]).
Regarding claim 10 Santani discloses the delivery system of claim 9 substantially as is claimed,
wherein Santani further discloses the second chamber is sealed from the first chamber (Figure 8; [0034], [0032], [0028], [0037] the ends of the balloons are sealed via adhesives from one another and inflate via independent lumens).
Regarding claim 11 Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the system is a delivery system which functions as a delivery apparatus to deliver the implant to a location in a patient’s body (this is stated as a functional limitation (see the explanation in the rejection to claim 1 above). See also the Abstract and [0005], which indicates the system is capable of delivering a stent into an ostium),
and the system further includes an elongate shaft (Figure 1 item 12),
wherein the first inflatable body and second inflatable body are coupled to the elongate shaft (Figures 1-2, 8).
Regarding claim 12 see the rejection to claim 2 above.
Regarding claim 13 see the rejection to claim 3 above.
Regarding claim 14 see the rejection to claim 6 above.
Regarding claim 15 see the rejection to claim 7 above.
Regarding claim 16 Santani discloses the delivery system of claim 11 substantially as is claimed,
wherein Santani further discloses a portion of the first inflatable body overlaps the second inflatable body (Figure 8 shows the balloons overlapping at ends 324a, 326b).
Regarding claim 17 Santani discloses the delivery system of claim 11 substantially as is claimed,
wherein Santani further discloses the first inflatable body includes a first end (Figure 8 item 324a) and a second end (Figure 8 item 326a), with the first end coupled to the second inflatable body ([0037]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/11/25