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 .
This action is in response to the amendment filed on 08/29/2025 and RCE filed on 09/27/2025. Claims 1-4, 6-8, and 10-23 are pending. Claims 1, 11, and 16 are independent. Claims 16-20 are withdrawn. Claims 5 and 9 are canceled. Claims 21-23 have been newly added.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/17/2025 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the limitations are interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites the limitation “wherein the respective heads of each single arm of the plurality of arms are not circumferentially connected to one another” which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “wherein the respective heads of each single arm of the plurality of arms are not circumferentially connected to one another” is a negative limitation. According to MPEP 2173.05(i), “(a}ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion. However, a lack of literal basis in the specification for a negative limitation may not be sufficient to establish a prima facie case for lack of descriptive support. Ex parte Parks, 30 USPQ2d 1234, 1236 (Bd. Pat. App. & Inter. 1993). "Rather, as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.' ... While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure." Novartis Pharms. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013, 2022 USPQ2d 569 (Fed. Cir. 2022) (quoting Ariad Pharm. Inc. v. Eli Lilly & Co., 589 F.3d 1336, 1351, 94 USPQ2d 1161, 1172). Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. See MPEP § 2163 - § 2163.07(b) for a discussion of the written description requirement of 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph.” The specification does not describe that the respective heads of each single arm of the plurality of arms are not circumferentially connected to one another. The drawings along are not sufficient to support a negative limitation. Therefore, the limitation “wherein the respective heads of each single arm of the plurality of arms are not circumferentially connected to one another” is considered as new matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-8, 10, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US Pub. No.: 2020/0085600).
Regarding claim 1, Schwartz discloses, in one embodiment (Fig. 10), [claim 1] an interatrial shunting device (140. Fig. 10. Para. [0160], and Abstract, the shunting device 140 is fully capable to serve as a interatrial shunting device because it is configured to transport fluid from one bodily chamber to bodily chamber.) comprising: a tube (142, Fig. 10) defining a first end (146, Fig. 10) opposite a second end (148, Fig. 10), and a tube wall (tube wall of 142, Fig. 10) extending to and between the first and second ends, wherein the tube wall defines a lumen (144, Fig. 10) of the tube, the lumen being open at the first and second ends (Fig. 10); and an anchoring assembly (combination of 150, 152, 154, 156, 158, 160, 162, and 164, Fig. 10) carried by the tube and fully capable to secure the interatrial shunting device to a native atrial septum, wherein the anchoring assembly comprises a plurality of arms (combination of 150, 152, 154, 156, 158, 160, 162, and 164, Fig. 10) extending from the tube wall, wherein the plurality of arms comprises a first set of arms (150, 152, 154, 156, Fig. 10) extending from the first end of the tube and a second set of arms (158, 160, 162, and 164, Fig. 10) extending from the second end of the tube, wherein each single arm of the plurality of arms comprises an intermediate section (the middle/intermediate elongated narrow section of each arm, Fig. 10) terminating at a head (the enlarged head at the end of each arm, Fig. 10), wherein the intermediate section comprises a length extending from the tube wall and an arm width (Fig. 10), wherein the head comprises a head width that is larger than the arm width of the intermediate section (Fig. 10), wherein the anchoring assembly is configured to be transitionable between a delivery state and a deployed state (Para. [0160]), wherein the entirety of the heads of each of the plurality of arms comprise a solid surface (Fig. 10) that, when the anchoring assembly is in the deployed state, is fully capable to atraumatically interface with the native atrial septum (Fig. 100, the entirety of the heads of each of the plurality of arms comprise a solid surface that, when the anchoring assembly is in the deployed state, is fully capable to atraumatically interface with the native atrial septum), wherein the anchoring assembly, when in the deployed state, is fully capable to engage the native atrial septum directly between the respective heads of each single arm of the first set of arms and the corresponding respective heads of each single arm of the second set of arms (the anchoring assembly, when in the deployed state, is fully capable to engage the native atrial septum directly between the respective heads of each single arm of the first set of arms and the corresponding respective heads of each single arm of the second set of arms since the arms are configured to secure the device to the body tissue); However, Schwartz does not disclose that the tube wall is a solid body in the embodiment shown in Fig. 10.
Schwartz discloses, in another embodiment (Fig. 80), that [claim 1] the tube wall (tube wall of 592, Fig. 80) is a solid body (Fig. 80 and Para. [0168]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the tube wall of the embodiment shown in Fig. 10 of Schwartz to be a solid body as taught in the embodiment shown in Fig. 10 of Schwartz in order to obtain the advantage of reducing the risk of device fatigue and blood stasis (Para. [0168]).
Regarding claim 2, wherein the interatrial shunting device is characterized by the absence of material within the lumen (Fig. 10 and also see other embodiment such as shown in Figs. 75 and 76 for example).
Regarding claim 3, wherein the tube wall is solid in transverse cross-section across an entire length of the tube from the first end to the second end (Fig. 80 and Para. [0168]).
Regarding claim 4, wherein the tube wall is configured to prevent tissue ingrowth from an exterior of the tube into the lumen (Para. [0168] and [0163], metallic material like nitinol is configured to prevent tissue ingrowth from an exterior of the tube into the lumen).
Regarding claim 6, wherein the tube defines a longitudinal axis, and further wherein a footprint of the anchoring assembly in a plane transverse to the longitudinal axis in the delivery state is less than the footprint in the deployed state (Paras. [0160]).
Regarding claim 7, wherein the anchoring assembly is fully capable to assume the delivery state in response to an applied external force, and is further configured to self-transition to the deployed state upon removal of the applied external force (the anchoring assembly is fully capable to assume the delivery state in response to an applied external force, and is further configured to self-transition to the deployed state upon removal of the applied external force, Para. [0160]).
Regarding claim 8, wherein an outer diameter of the tube is substantially identical in the delivery state and the deployed state (Para. [0168]).
Regarding claim 10, wherein the delivery state includes the first set of arms extending away from the first end in a first direction and the second set of arms extending away from the second end in a second direction, the first direction being opposite the second direction (Fig. 10).
Regarding claim 21, wherein the respective heads of each single arm of the plurality of arms are not circumferentially connected to one another (Fig. 10)
Regarding claim 22, Schwartz further discloses, in another embodiment (Fig. 84), that an outer diameter of the intermediate section of each single arm of the plurality of arms in the delivery state is less than the outer diameter of the tube (Fig. 84, an outer diameter of the intermediate section of each single arm of the plurality of arms in the delivery state is less than the outer diameter of the tube because the arms are tapered inward toward the central axis of the device). Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the device of Schwartz shown in Fig. 10 in view of the device shown in Fig. 80 to include that an outer diameter of the intermediate section of each single arm of the plurality of arms in the delivery state is less than the outer diameter of the tube as taught in Fig. 84 of Schwartz such that the arms taper toward the central axis in the delivery state in order to facilitate the delivery of the device.
Regarding claim 23, wherein each single arm of the first set of arms is circumferentially aligned with a corresponding single arm of the second set of arms (Fig. 10).
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al. (US Pub. No.: 2020/0085600) in view of Ton et al. (US Pub. No.: 2006/0111771).
Regarding claim 11, Schwartz discloses, in one embodiment, a system for treating a heart of a patient, the system comprising: an interatrial shunting device (140. Fig. 10. Para. [0160], and Abstract, the shunting device 140 is fully capable to serve as a interatrial shunting device because it is configured to transport fluid from one bodily chamber to bodily chamber.) including: a tube (142, Fig. 10) defining a first end (146, Fig. 10) opposite a second end (148, Fig. 10), and a tube wall (tube wall of 142, Fig. 10) extending to and between the first and second ends, wherein the tube wall defines a lumen (144, Fig. 10) of the tube, the lumen being open at the first and second ends (Fig. 10), an anchoring assembly (combination of 150, 152, 154, 156, 158, 160, 162, and 164, Fig. 10) carried by the tube and fully capable to secure the interatrial shunting device to a native atrial septum, wherein the anchoring assembly comprises a plurality of arms extending from the tube wall (the anchoring assembly is fully capable to secure the interatrial shunting device to a native atrial septum, wherein the anchoring assembly comprises a plurality of arms extending from the tube wall the arms are configured to secure the device to the body tissue), wherein each single arm of the plurality of arms comprises an intermediate section (the middle/intermediate elongated narrow section of each arm, Fig. 10) terminating at a head (the enlarged head at the end of each arm, Fig. 10), wherein the entirety of the heads of each of the plurality of arms comprises a solid surface (Fig. 10); and a delivery device configured to retain the interatrial shunting device in a delivery state fully capable for delivery to a native atrial septum and to release the interatrial shunting device for implant at an opening in the native atrial septum in a deployed state (Para. [0160]).
Schwartz further discloses, in another embodiment (Fig. 80), that [claim 1] the tube wall (tube wall of 592, Fig. 80) is a solid body (Fig. 80 and Para. [0168]). accid
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the tube wall of the embodiment shown in Fig. 10 of Schwartz to be a solid body as taught in the embodiment shown in Fig. 10 of Schwartz in order to obtain the advantage of reducing the risk of device fatigue and blood stasis (Para. [0168]).
However, Schwartz does not disclose that the delivery device comprises an engagement unit configured to be connected to one or more arms of the plurality of arms of the interatrial shunting device and to retain the interatrial shunting device, wherein the engagement unit is configured to release the interatrial shunting device upon rotation of the engagement unit.
Ton teaches, in the same field of endeavor (implant delivery system), a system comprising: a delivery device (combination of delivery guide 1300 shown in Figs. 13A and 13B and sheath 180, Fig. 10B) comprises an engagement unit (1304, Figs 13A and 13B) configured to be connected to one or more arms (1314, Fig. 13B) of the plurality of arms of an implantable device and to retain the implantable device (Fig. 13B and Paras. [0136]-[0139]), wherein the engagement unit is configured to release the interatrial shunting device upon rotation of the engagement unit (Fig. 13B and Paras. [0136]-[0139] and [0090]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the delivery device of Schwartz to include an engagement unit configured to be connected to one or more arms of the plurality of arms of the interatrial shunting device and to retain the interatrial shunting device, wherein the engagement unit is configured to release the interatrial shunting device upon rotation of the engagement unit as taught by Ton in order to obtain the advantage of preventing accidentally moving/deploying of the implantable device prior to deployment (Ton, Paras. [0027] and [0100]).
Regarding claim 12, in the modified system, the delivery device includes: an outer sheath (Ton sheath 180, Fig. 10B) assembly including a capsule (Ton, distal end portion of sheath 180 serves as a capsule for containing the implantable device, Fig. 10B); and an inner shaft assembly (1304 and/or 1308 with 1310, Fig. 13A) slidably received within the outer sheath assembly and including the engagement unit (also see Fig. 10B); wherein the delivery device is configured to provide a delivery condition in which the engagement unit is connected to the interatrial shunting / implantable device and the capsule encompasses and retains the interatrial shunting / implantable device in the delivery state (Figs. 13B and 10B).
Regarding claim 13, in the modified system, the plurality of arms includes a first set of arms extending from the first end of the tube and a second set of arms extending from the second end of the tube (Schwartz, Fig. 10), and further wherein the delivery condition includes the interatrial shunting device located within the capsule such that the second set of arms extends distally from the tube and the first set of arms extends proximally from the tube and one or more arms of the first set of arms of is connected to the engagement unit (Ton, Fig. 10B or 11A).
Regarding claim 14, wherein the delivery device is further configured to be transitionable from the delivery state to a partial deployment arrangement in which the second set of arms is distal to the capsule as the second set of arms self-reverts to the deployed state, and the first set of arms is within the capsule and is retained in the delivery state (Schwartz, Fig. 10. Para. [0160]).
Regarding claim 15, in the modified invention, the delivery device is further fully capable to be transitionable from the partial deployment arrangement to the deployed state in which the first set of arms is distal to the capsule and is released from the engagement unit to self-revert to the deployed state (Ton, Fig. 13B and Paras. [0136]-[0139] and Schwartz, Fig. 10B).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 6-8, 10-15, and 21-23 have been considered but are moot in view of new ground(s) of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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/JING RUI OU/Primary Examiner, Art Unit 3771