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 Amendment
In response to the preliminary amendment filed 6/19/2025, claim 1 is canceled and new claims 2-21 are added.
Specification
The disclosure is objected to because of the following informalities: “detachment junction 108” in [0056] should recite - - detachment junction 118 - -.
Appropriate correction is required.
Claim Objections
Claims 4, 5, 14 and 18 are objected to because of the following informalities:
In claim 4, “a teardrop shape” should recite - - the teardrop shape - - as the shape has already been introduced and defined in claim 2.
In claim 5, “a conical shape” should recite - - the conical shape - - as the shape has already been introduced and defined in claim 2.
In claim 14, “the disc” should recite - - the disc shape - - to keep the terminology consistent with claim 13.
In claim 18, “a conical shape” should recite - - the conical shape - - as the shape has already been introduced and defined in claim 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 2, 16 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marshburn (US 2016/0183977).
Marshburn discloses the following limitations:
Claim 2. An occlusion device (10) (Figs. 1, 2, 5-7, 9), comprising:
an elongated member (14) (Figs. 1 and 7); and,
an inflation member (12) that has an inflated configuration in a conical shape ([0033]); the inflation member having an attached state attached to the elongated member ([0036], [0040]; Fig. 7; attached via connector 18), and a detached state detached from the elongated member (Fig. 5, 6; [0040]).
Claim 16. An occlusion device (10) (Figs. 1, 2, 5-7, 9), comprising:
an elongated member (14) (Figs. 1 and 7); and,
a balloon (12) that has an inflated configuration in a conical shape ([0033]); the balloon being detachably connected to the elongated member (Figs. 5-7; [0036], [0040]; detachably connected via connector 18).
Claim 21. An occlusion device (10) (Figs. 1, 2, 5-7, 9), comprising:
an elongated member (14) (Figs. 1 and 7); and,
a means (12) for forming an inflated conical shape ([0033]); that is detachably connected to the elongated member (Figs. 5-7; [0036], [0040]; detachably connected via connector 18).
Claim(s) 2, 3, 5, 6, 12 and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chakraborty et al (US 2017/0042550).
Chakraborty et al discloses the following limitations:
Claim 2. An occlusion device (Figs. 1, 2, 7-12), comprising:
an elongated member ([0083]; e.g. the catheter of the catheter delivery system); and,
an inflation member (10, 410) that has an inflated configuration in a conical shape (Fig. 12) ; the inflation member having an attached state attached to the elongated member ([0083]); “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”), and a detached state detached from the elongated member ([0086], [0087]; “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”).
Claim 3. The occlusion device of claim 2, wherein the conical shape comprises a narrowed distal region (ridged region 462) and a proximal region (444) wider than the distal region (Fig. 12).
Claim 5. The occlusion device of claim 3, wherein the inflation member has the conical shape and a substantially linear transition (466) in width between the narrowed distal region and the proximal region (Fig. 12).
Claim 6. The occlusion device of claim 5, wherein the elongated member is connected to a proximal end (left side in Fig. 12) of the inflation member via a detachment joint (422) ([0087]).
Claim 12. The occlusion device of claim 5, further comprising a barrier (attachment method 422 including valves 426, 428) positioned adjacent to a proximal end of the inflation member and connected to the elongated member ([0087]; Fig. 12).
Claim 16. An occlusion device (Figs. 1, 2, 7-12), comprising:
an elongated member ([0083]; e.g. the catheter of the catheter delivery system); and,
a balloon (10, 410) that has an inflated configuration in a conical shape (Fig. 12); the balloon being detachably connected to the elongated member ([0083]); “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”), and a detached state detached from the elongated member ([0086], [0087]; “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”).
Claim 17. The occlusion device of claim 16, wherein the shape of the conical comprises a narrowed distal region (ridged region 462).
Claim 18. The occlusion device of claim 17, wherein the balloon has the conical shape (Fig. 12) and a substantially linear transition (466) in width between its distal (ridged region 462) and proximal regions (444).
Claim 21. An occlusion device (Figs. 1, 2, 7-12), comprising:
an elongated member ([0083]; e.g. the catheter of the catheter delivery system); and,
a means (10, 410) for forming an inflated conical shape (Fig. 12); that is detachably connected to the elongated member ([0083]); “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”), and a detached state detached from the elongated member ([0086], [0087]; “the occlusion device 410, in one or more embodiments, is attached to the catheter delivery system”).
Claim Rejections - 35 USC § 103
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakraborty et al in view of Figulla (WO 2007/140797)
Claim 4. Chakraborty et al discloses the invention substantially as claimed above, but fails to explicitly disclose wherein the inflation member has a teardrop shape and a rounded proximal region. However, Chakraborty et al does contemplate other suitable shapes and therefore indicates a singular shape is not critical to achieve occlusion ([0090]).
In the same field of endeavor, Figulla teaches an occlusion device for the left atrial appendage comprising an expandable member having a teardrop shape and a rounded proximal region (2) in its expanded state (Fig. 2). Therefore, since Chakraborty et al contemplates the use of alternative shapes for the occlusion device intended to occlude a left atrial appendage, it would have been obvious to one of ordinary skill in the art to modify the shape of the inflation member of Chakraborty et al to a teardrop shape and a rounded proximal region as taught by Figulla since this is a suitable shape for occluding the left atrial appendage.
Claim(s) 7, 8, 15, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakraborty et al in view of Nalgreiter et al (US 6379329).
Claims 7 and 8. Chakraborty et al discloses the invention substantially as claimed above, including an injection apparatus is used to inflate the inflation member but fails to disclose the details and therefore fails to disclose the elongated member includes an inner tubular member opening near a distal end of the inflation member (as per claim 7) and the elongated member includes an outer tubular member in communication to an internal chamber of the inflation member (as per claim 8).
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely an inflatable occlusion device, Nalgreiter et al teaches an occlusion device (Fig. 1), comprising an elongated member including an inner tubular member opening (distal opening of catheter adapter 50) near a distal end of the inflation member (52) (seen near distal end (right side) in Fig. 3; for inflating chamber of inner balloon 56 which is akin to inner chamber 464 of Chakraborty et al) (col. 4, ll. 60 – col. 5, ll. 4) and the elongated member includes an outer tubular member (4) in communication to an internal chamber (chamber of outer balloon 54; akin to chamber 466 of Chakraborty et al) of the inflation member (col. 4, ll. 34-40; col. 4, ll. 60 – col. 5, ll. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chakraborty et al to have the elongated member including an inner tubular element opening and outer tubular member as claimed in order to fluidly couple a fluid source and inflate the portions of the inflation member.
Claim 15. Chakraborty et al discloses the invention substantially as claimed above, but fails to disclose the inflation member further comprises an outer balloon having a plurality of pores and that is connectable to an adhesive supply, and an inner balloon located within the outer balloon and connectable to an inflation media supply.
However, Nalgreiter et al discloses an inflation member (52) comprising an outer balloon (53) having a plurality of pores (of porous material) and that is connectable to an adhesive supply, and an inner balloon (56) located within the outer balloon and connectable to an inflation media supply (col. 5, ll. 37-46). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inflation member of Chakraborty et al to include an outer balloon having a plurality of pores and an inner balloon as claimed as taught by Nalgreiter et al to bond and help secure the occlusion device to the occlusion site.
Claims 19 and 20. Chakraborty et al discloses the invention substantially as claimed above, including an injection apparatus is used to inflate the inflation member but fails to disclose the details and therefore fails to disclose the elongated member includes an inner tubular element opening near a distal end of the balloon (as per claim 19) and the elongated member includes an outer tubular member in communication to an internal chamber of the balloon (as per claim 20).
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely an inflatable occlusion device, Nalgreiter et al teaches an occlusion device (Fig. 1), comprising an elongated member including an inner tubular member opening (distal opening of catheter adapter 50) near a distal end of the balloon (52) (seen near distal end (right side) in Fig. 3; for inflating chamber of inner balloon 56 which is akin to inner chamber 464 of Chakraborty et al) (col. 4, ll. 60 – col. 5, ll. 4) and the elongated member includes an outer tubular member (4) in communication to an internal chamber (chamber of outer balloon 54; akin to chamber 466 of Chakraborty et al) of the balloon (col. 4, ll. 34-40; col. 4, ll. 60 – col. 5, ll. 4). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Chakraborty et al to have the elongated member including an inner tubular element opening and outer tubular member as claimed in order to fluidly couple a fluid source and inflate the portions of the balloon.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11564692 in view of Chakraborty et al.
Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12290266 in view of Chakraborty et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are broader in some respects and merely add an obvious feature absent from the patent claim in other respects. Claims 2, 16 and 21 of the instant application recites the additional feature of the inflation member/balloon/means having or forming an inflated conical or teardrop shape absent from the independent claims of the patents. However, in the same field of endeavor, Chakraborty et al teaches an occlusion device (Figs. 1, 2, 7-12), comprising: an elongated member ([0083]; e.g. the catheter of the catheter delivery system); and,
an inflation member/balloon/means (10, 410) that has an inflated configuration in a conical shape (Fig. 12). Chakraborty et al further contemplates other suitable shapes and therefore indicates a singular shape is not critical to achieve occlusion ([0090]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patent claims to include a conical shape as taught by Chakraborty et al to provide a shape suitable for occluding the left atrial appendage.
Allowable Subject Matter
Claims 9-11, 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the above double patenting rejections are obviated.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record, Chakraborty et al discloses the invention substantially as claimed above.
In regard to claim 9, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed occlusion device comprising, inter alia, the inner tubular member is located radially within at least some of the outer tubular member. Instead, the cited inner tubular member (50) of Nalgreiter et al is distal of the outer tubular member (4) as it is a catheter adaptor intended for insertion into the interior of the balloon (52).
In regard to claim 13, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed occlusion device comprising, inter alia, the barrier is mesh forming a flattened disc shape. Instead, the cited barrier (attachment 422 including its associated valves 426, 428) are shaped as they are disclosed in order to allow for attachment to an injection apparatus and allow one way inflation of the balloon chambers.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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