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 Arguments
Applicant's arguments filed 05/11/26 have been fully considered but they are not persuasive.
On page 8 regarding claim objections, Applicant argues amendments overcome the objections of record.
The Examiner respectfully agreed and withdraws claim objections.
On page 9 regarding 112 rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully agrees and withdraws outstanding 112 rejections.
On pages 9-10 regarding prior art rejections, Applicant argues the amendments overcome the rejection of record since Santini’s balloons are flat.
The Examiner respectfully disagrees, referring to the rejection below regarding amended claims.
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 21 is 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 pre-AIA the applicant regards as the invention.
Claim 21 is indefinite for claiming the “delivery system for an expandable implant” comprises the expandable implant. It is unclear how the delivery system for the implant includes the implant itself.
Additionally, the Examiner notes it appears this is an attempt to positively claim the element the delivery system is intended to deliver, but if positively claimed, this would actually change the nature of the invention to claim a combination of both an implant and delivery system. If such a combination were presented in the originally filed claims, they would have been restricted out, since this belongs to a different category of invention and requires distinct searches from a delivery system alone. Accordingly, the Examiner is understanding this to be an issue of clarity as opposed to positively claiming the element the system is designed to deliver, since this would likely result in a withdrawing of the claim due to election by original presentation. However, clarification in the claims is required.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-17, 21 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), the first inflatable body being configured to inflate from a deflated state to the inflated state (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 Figure 5b: the balloons are contracted for delivery. The “deflated state” is considered to be any configuration of the balloons between that delivery state and the fully inflated state seen in Figure 8) and including a shoulder portion (Figure 8 shows a shoulder portion between end 236a and intermediate portion 328a), 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 when the expandable implant is positioned around the outer surface (This is also stated as a functional limitation as was described above, which Santini is capable of meeting. 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),
and wherein when the first inflatable body is in the deflated state, the shoulder portion is configured to impede movement of the expandable implant when positioned therearound (this is stated as a functional limitation of the shoulder (see the explanation above regarding functional limitations). The shoulder, in a deflated state, is considered capable of impeding movement of the implant when positioned therearound, if the implant is crimped and positioned in a manner that enacts this, since whether or not the shoulder impedes movement of the implant appears to depend on the structure of the implant and how the implant is applied on to the first inflatable body, as opposed to structurally or materially altering the claimed system itself. However, also see [0033] which indicates that the inflatable body have a tapered transition from the intermediate portion 28a to the proximal and distal ends 24a, 26a. When in the deflated state (i.e. NOT the fully inflated state), the taper transition would inherently produce some level of effect or friction to prevent movement of an implant positioned therearound. Additionally/alternatively, the material of the balloons are understood to provide at least some level of friction that impedes movement of anything applied tightly therearound).
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, Santani discloses the delivery system of claim 1 substantially as is claimed,
wherein Santani further discloses the first inflatable body includes first end and a second end, and wherein when the first inflatable body is in the deflated state, the shoulder portion is configured to contact an end of the expandable implant to impede movement of the implant in a direction towards the second end of the first inflatable body (this is stated as a functional limitation of the shoulder (see the explanation above). Whether or not the shoulder contacts a particular part of the implant and impedes its movement appears to depend on the structure of the implant and how the implant is applied on to the first inflatable body, as opposed to structurally or materially altering the claimed system itself. Also/alternatively, see [0033] which indicates that the inflatable body have a tapered transition from the intermediate portion 28a to the proximal and distal ends 24a, 26a. When in the deflated state (i.e. NOT the fully inflated state), the taper transition would inherently produce some level of effect or friction to prevent movement of an implant positioned therearound according to the taper. Additionally/alternatively, the material of the balloons are understood to provide at least some level of friction that impedes movement of anything applied tightly therearound).
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 indicates 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 is configured to inflate from a deflated state to the inflated state (this is stated as a functional limitation, as is detailed in the rejection to claim 1 above. See, for example Figure 5b: the balloons are contracted for delivery. The “deflated state” is considered to be any configuration of the balloons between that delivery state and the fully inflated state seen in Figure 8), and the second inflatable body includes a shoulder portion and a first end and a second end (Figure 8 shows how the second inflatable body 322b extends upward from end 324b and folds back upon itself to reach end 326b), and, when the second inflatable body is in the deflated state, the shoulder portion of the second inflatable body is configured to contact an end of the expandable implant to impede movement of the implant in a direction towards the first end of the second inflatable body (this is stated as a functional limitation of the shoulder (see the explanation above). Whether or not the shoulder contacts a particular part of the implant and impedes its movement appears to depend on the structure of the implant and how the implant is applied on to the first inflatable body, as opposed to structurally or materially altering the claimed system itself. Additionally/alternatively, the material of the balloons are understood to provide at least some level of friction that impedes movement of anything applied tightly therearound.).
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 a first 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 a second 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]).
Regarding claim 21 Santani discloses the delivery system of claim 11 substantially as is claimed,
wherein Santani further discloses the expandable implant configured to be positioned around the outer surface of the second inflatable body when the second inflatable body is a deflated state (the expandable implant is not part of the claimed “delivery system”.).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/20/26
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