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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a system for occluding, classified in A61B17/12122.
II. Claims 16-20, drawn to a method for occluding, classified in A61B17/12172.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus of Invention I could be used in different methods than Invention II, such as clearing a drain or plugging a hole.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of the different classification. Invention I is classified in A61B17/12122 while Invention II is classified in A61B17/12172. The examiner would need to search in separate classifications to find both inventions, which would increase the scope and the duration of the search; and
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Invention I will need to cover products which have fundamentally different uses than in Invention II’s method, such as cleaning a drain or plugging a hole.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these 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.
During a telephone conversation with Glenn Seager on July 2nd, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 4-5 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.
Claim 4 recites the limitation “the plurality of different size expandable foam blocks” in line 3. There is insufficient antecedent basis for this limitation in the claim, as none of the claims had previously introduced different sizes for the foam blocks. Applicant should amend the claim to more clearly introduce the different sizes, such as “The system of claim 3, further comprising a plurality of expandable foam blocks of different sizes that a user can select from, where the one or more expandable elements comprise the expandable foam blocks selected from the plurality of expandable foam blocks.” Claim 5 is rejected for their dependency on claim 4.
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, 6-12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zarbatany et al. (Pub. No. 2022/0117555).
Regarding claim 1, Zarbatany et al. discloses a system for occluding a patient’s left atrial appendage (LAA) (10; FIGs. 1 and 8A-8C; [0099]), the system comprising:
an expandable frame (110; [0107]) moveable from a collapsed delivery configuration (FIG. 8A: 110 is collapsed within 500 for delivery) to an expanded deployment configuration in which the expandable frame is adapted to span across at least a portion of the LAA (FIG. 8B: 110 has expanded from within 500 to span across the opening of the LAA), the expandable frame defining an LAA volume distal of the expandable frame once deployed (FIG. 8B: 110 only covers the opening of the LAA and defines a distal volume within the LAA); and
one or more expandable elements (130a-130c; [0156]) adapted to be deployed behind the expandable frame in order to fill at least part of the LAA volume distal of the expandable frame (FIGs. 8B-8C and [0156] 130a-130c can expand when in contact with blood to fill the LAA after being delivered through 110), each of the one or more expandable elements adapted to expand subsequent to delivery (FIGs. 8B-8C: 130a-130c expand after being deployed within the LAA).
Regarding claim 2, Zarbatany et al. further discloses the one or more expandable elements are adapted to be delivered after the expandable frame is implanted (FIGs. 8B-8C: 130a-130c only expand after passing through the deployed 110).
Regarding claim 3, Zarbatany et al. further discloses at least some of the one or more expandable elements comprise expandable foam blocks ([0250] 130 can be a foam material) adapted to be delivered in a compressed configuration (FIG. 8B) and to expand once delivered into the expanded configuration (FIG. 8C).
Regarding claim 6, Zarbatany et al. further discloses the expandable foam blocks comprise cylindrical foam blocks that are compressed for delivery (FIG. 8B: 130 are cylindrical).
Regarding claim 7, Zarbatany et al. further discloses at least some of the one or more expandable elements are delivered into the volume distal of the expandable frames as a liquid ([0109] 130 can be an injectable material, such as a liquid hydrogel) that subsequently expands within the volume distal of the expandable frame ([0156] 130 expand in the LAA after delivery).
Regarding claim 8, Zarbatany et al. further discloses the liquid comprises a liquid foam ([0250] 130 can be a liquid foam).
Regarding claim 9, Zarbatany et al. further discloses the liquid comprises a hydrogel ([0109] 130 can be a hydrogel).
Regarding claim 10, Zarbatany et al. further discloses the one or more expandable elements comprise a shape memory foam plug ([0283] 130 can be a shape memory polymer foam) shaped to facilitate extending the shape memory foam plug through the expandable frame (FIGs. 8A-8B: 130 is shaped to go through 110).
Regarding claim 11, Zarbatany et al. further discloses the shape memory foam is shaped to include a sharp tip ([0314] the tip can be a J-tip with a sharp distal end) adapted to penetrate through a fabric layer (120) disposed on the expandable frame ([0314] the tip can go through 120).
Regarding claim 12, Zarbatany et al. discloses a kit for occluding a patient’s left atrial appendage (LAA) (10; FIGs. 1 and 8A-8C; [0099]), the kit comprising:
an expandable frame (110; [0107]) that is adapted to be deployed within the LAA in order to at least partially occlude at least part of the LAA (FIG. 8B: 110 only covers the opening of the LAA, and defines a distal volume of the LAA); and
a collection of expandable foam elements (130a-130c; [0156]), wherein expandable foam elements may be individually selected and then deployed distal of the expandable frame (FIGs. 8B-8C and [0156] 130a-130c can be selected and then delivered past 110 into the LAA volume);
wherein each of the individually selected expandable foam elements are adapted to expand upon deployment (FIGs. 8B-8C: 130a-130c expand after being delivered into the LAA volume).
Regarding claim 15, Zarbatany et al. further discloses at least some of the collection of expandable foam elements include cylindrical foam blocks that are compressed for delivery (FIG. 8B: 130 are cylindrical).
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) 4-5 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zarbatany et al. in view of Ortega et al. (U.S. Patent No. 11,141,164).
Regarding claims 4 and 13, Zarbatany et al. discloses the invention as claimed in claims 3 and 12, as discussed above, and further discloses a plurality of expandable foam blocks that a user can select from (FIG. 8B: the operator can select one or several of 130a-130c). Zarbatany et al. does not disclose the one or more expandable elements comprise the expandable foam blocks selected from the plurality of expandable foam blocks are different sizes or vary in their expanded volumes.
Ortega et al. discloses a process of treating an aneurysm (104; FIG. 2) involving filling the aneurysm with expandable shape memory polymer foam pieces (202a-202c), where the SMP foam pieces are different sizes (C6:L3-25) for the purpose of adapting the overall SMP foam to have less blood flow at the aneurysm neck and more blood flow at aneurysm fundus while optimizing the amount of SMP used (C6:L3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the expandable foam blocks of Zarbatany et al. comprise multiple size options, as taught by Ortega et al., for the purpose of adapting the overall SMP foam to have less blood flow at the aneurysm neck and more blood flow at aneurysm fundus while optimizing the amount of SMP used.
Regarding claims 5 and 14, Zarbatany et al. as modified by Ortega et al. further discloses the plurality of expandable foam blocks include one or more expandable foam blocks having a first expanded size (Ortega et al. FIG. 2: 202a has an expanded size) and one or more expandable foam blocks having a second expanded size (Ortega et al. FIG. 2: 202b and 202c have expanded sizes) different from the first expanded size (Ortega et al. FIG. 2: 202a-202c have different sizes when expanded).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Connor (Pub. No. 2021/0236139) discloses a similar frame and expandable elements in at least FIGs. 14-17; Dasnurkar et al. (Pub. No. 2018/0338767) discloses a similar system in at least FIGs. 18-19; Le et al. (Pub. No. 2026/0083456) discloses a similar system in at least FIGs. 3A-4C; and Otero et al. (Pub. No. 2025/0268605) discloses a similar system in at least FIGs. 12A-14E.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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, 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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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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