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, see p. 7, filed 12NOV2025, with respect to Claims 12 and 13 have been fully considered and are persuasive. The 35 U.S.C. § 112 rejection of Claims 12 and 13 has been withdrawn.
Applicant’s arguments, see p. 7, filed 12NOV2025, with respect to Claims 1, 3, 7-10, 12-15, and 17-24 have been fully considered and are persuasive. The 35 U.S.C. § 101 rejection of Claims 1, 3, 7-10, 12-15, and 17-24 has been withdrawn.
Election/Restrictions
Newly submitted claims 25 and 26 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the newly submitted claims are directed to an embodiment wherein the barrier is disconnected from the central flow portion which differs from the embodiment previously elected wherein the barrier extends from the central flow portion (Claim 7).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 25 and 26 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
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, 3, 7, 8, 10, 12-15, and 17-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130123826 A1 (Kramer et al.).
Regarding claims 1, 3, and 7, Kramer teaches a shunt (300) (Figs. 3B-3D) comprising:
a central flow portion (325) [0127] sized to fit at least partially within an opening in a tissue wall and maintain the opening (as seen in Fig. 3D) in a tissue wall that is situated between a first anatomical chamber and a second anatomical chamber (as shown in Fig. 1D between lung tissue 116 and airway 100) to provide a blood flow path between the first anatomical chamber and the second anatomical chamber ([0094] describing a width of 1-10 mm which is suitable for a blood flow path); and
one or more anchoring arms (320) extending from the central flow portion (as seen in Figs. 3B and 3C), the one or more anchoring arms configured to anchor to the tissue wall (as shown in Fig. 3D); wherein
a barrier (330) positioned between the one or more anchoring arms and the tissue wall and outside the opening in the tissue wall (as seen in Figs. 3B-3D) ([0126] describing the barrier not fully covering the arms and therefore being considered to extend from said arms) configured to alter growth of tissue around the shunt [0122]; wherein
the barrier extends from the central flow portion (as seen in Figs. 3B and 3C).
Regarding claims 8 and 10, Kramer further teaches the barrier comprises a first portion positioned to extend over a first side of the tissue wall (Kramer Annotated Fig. 3B, in combination with Fig. 3D showing the device placed in a tissue wall 370); and
the barrier comprises a second portion configured to extend over a second side of the tissue wall (Kramer Annotated Fig. 3B, in combination with Fig. 3D showing the device placed in a tissue wall 370).
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Kramer Annotated Fig. 3B
Regarding claim 12, Kramer further teaches the first portion (Kramer Annotated Fig. 3B) forms at least a partial cone [0045] (the first portion being considered frustoconical) and is therefore considered to teach a tapered elliptical shape in which the first portion is sized to surround the opening (as seen in Figs. 3C and 3D).
Regarding claim 13, Kramer further teaches the first portion (Kramer Annotated Fig. 3B) does not extend over the opening (325) (as seen in Fig. 3C).
Regarding claim 14, Kramer further teaches a plurality of possible dimensions wherein the inner diameter of the central passage is in the range of 1-10 mm, an overall length is 1-20 mm [0094-0096], as well as a plurality of ranges for the ratios of physical dimensions [0097]. Additionally, the thickness of the shunt would reasonably be less than the overall width of the device. As the claim provides no reference points for the measure of length, width or thickness, Kramer is considered to teach a length of the first portion is greater than a width and thickness of the first portion.
Regarding claim 15, Kramer further teaches the first portion (Kramer Annotated Fig. 3B) has a shape of an at least partial elliptical ring (appearing circular in Fig. 3C) with a hollow middle portion sized to be aligned with the opening (as the device passes through the opening as seen in Fig. 3D).
Regarding claims 17 and 18, Kramer further teaches the barrier (330) extends from at least one of the one or more anchoring arms (as seen in Fig. 3B), wherein
the barrier is positioned to be situated between the one or more anchoring arms and the tissue wall (as seen in Fig. 3D).
Regarding claim 19, Kramer is considered to teach the central flow portion (325) is adapted to prevent in-growth of tissue within the opening [0081].
Regarding claim 20, Kramer further teaches the central flow portion (325) is adapted to expand in response to expansion of the tissue wall (the device having an expandable center section [0034]).
Regarding claim 21, Kramer teaches surgically creating an opening for placement of the shunt [0016], and is therefore considered to teach the tissue wall is burned, cut, removed, cauterized, scarred, and/or otherwise treated in an area surrounding the opening in the tissue wall.
Regarding claims 22-24, Kramer teaches a shunt (300) (Figs. 3B-3D) comprising:
a central flow portion (325) sized to fit at least partially within an opening in a tissue wall and maintain the opening (as seen in Fig. 3D) in a tissue wall that is situated between a first anatomical chamber and a second anatomical chamber (as shown in Fig. 1D between lung tissue 116 and airway 100), with [0094] describing a width of 1-10 mm which is suitable for providing a blood flow path;
one or more anchoring arms (320) extending from the central flow portion, the one or more anchoring arms positioned to anchor to the tissue wall (as seen in Figs. 3B and 3C); and
a barrier (330) positioned between the one or more anchoring arms and the tissue wall and outside the opening in the tissue wall (as seen in Figs. 3B-3D) ([0126] describing the barrier not fully covering the arms and therefore being considered to extend from said arms) configured to alter growth of tissue around the shunt [0122]; wherein
the tissue wall is burned, cut, removed, cauterized, scarred, and/or otherwise treated in an area surrounding the opening in the tissue wall, as Kramer teaches surgically creating an opening for placement of the shunt [0016]; and
the area surrounding the opening in the tissue wall has an elliptical shape [0045].
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kramer.
Regarding claim 9, Kramer fails to teach the first portion is configured to extend at an approximately 45-degree angle over the first side of the tissue wall in the embodiment of Figs. 3B-3D).
Kramer discloses an alternate embodiment shown in Fig. 2B wherein anchoring arm (202A) corresponds to the anchoring arm (320) of the device of claim 8. Kramer further teaches an angle A1 which may range from 30° to 60°, and is therefore considered to teach the first portion is configured to extend at an approximately 45-degree angle over the first side of the tissue wall.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the undisclosed angle of Kramer embodiment 3B with the approximately 45° of the alternate embodiment as it would be obvious to try when choosing from the finite number of arrangements taught by Kramer, with a reasonable expectation of successfully retaining the shunt MPEP 2143 I.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20180296335 A1 and US 20180256865 A1 disclose shunts comprising a central flow portion extending between two anatomical chambers.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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