DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 2, 2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/412490 and Application No. 61/292899, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional applications 61/412490 and 61/292899 fail to disclose the limitations set forth in claims 58 and 61, wherein the inflatable bladder is coated by a substantially slippery coating and a mesh is attached to the surface of the inflatable bladder, these limitation are only previously described in PCT/IL2011/000018. Therefore, the claims are given a priority of January 6, 2011.
Response to Arguments
Applicant's arguments filed July 22, 2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that Paz does not teach of suggest a plug that is detached from the inflatable bladder and that disconnects from the tube at the port of the bladder as the tube is withdrawn to plug the bladder, applicant’s arguments do specifically point out how the language of the claims patentably distinguishes them from the references. The applicant merely states that the neither of the references teach or suggest a plug that is detached from the inflatable bladder without pointing out how the art itself defines over the prior art. The applicant argues that it has not been shown that Paz teaches or suggests a plug that is "detached from the inflatable bladder and configured to seal the inflation port as the tube is withdrawn and the plug disconnected from the tube at the inflation port," as recited in claim 1. This limitation is a functional limitation. Paz sufficiently teaches in figure 1e that the plug is detached from the inflatable bladder, since all of the components are separated, this meets the amended limitations. Furthermore, the Paz discloses the plug is configured to seal the inflation port as the tube is withdrawn and the plug is disconnected from the tube at the inflation port to maintain the bladder in an inflated state in paragraphs 100 as cited by the examiner since Paz discloses utilizing a plug 30 (biodegradable sealing mechanism in figure 1e) and that a cutting catheter may be used to detach device from the guide. A recitation of the intended use of the claimed 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. Therefore, applicant’s argument that Paz does not teach all of the amended limitations is not persuasive.
In response to applicant’s argument that Lunsford does not teach of suggest a plug that is detached from the inflatable bladder and that disconnects from the tube at the port of the bladder as the tube is withdrawn to plug the bladder, applicant’s arguments are not persuasive in view of the rejection set forth below addressing the amendments to the claims.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 54-57, 59, 60, 62, and 75 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Paz et al (US 20080033471).
Regarding claim 54, Paz et al (hereafter Paz) tissue-dissecting device, comprising: an inflatable bladder (12) for inter-tissue or inter-organ spacing (tissue displacement or separation, title), the bladder defining an interior chamber and an inflation port (paragraph 0100) through which the interior chamber can be inflated; a tube (20, 22, paragraph 0099, figure 1e) detachably connected or connectable to the bladder such that in a connected state the tube is in fluid communication with the inflation port for inflating the bladder with a distal end of the tube disposed within the bladder; and a plug (30 or one-way valve in paragraph 100) detached from the inflatable bladder (in figure 1e, plug 30 is detached from bladder) and detachably connected to the distal end of the tube (22, paragraph 0102, figure 1e), the plug arranged to be disposed inside the bladder (14 is part of bladder 12, paragraph 0100, 0102) with the distal end of the tube inside the bladder (the limitation ‘when the distal end of the tube is inside the bladder’ is a functional limitation. Since tube 22 can be inserted into one-way valve, Paz meets the limitations. The plug is configured to seal the inflation port as the tube is withdrawn (one-way valve) and the plug is disconnected from the tube at the inflation port to maintain the bladder in an inflated state (paragraph 0102, guide catheter can be used to disconnect the tube).
Regarding claim 55, Paz teaches all of the limitations set forth in claim 54, wherein the bladder is in a rolled form in a deflated state (figure1b, paragraph 0042, 0071).
Regarding claim 56, Paz teaches all of the limitations set forth in claim 55, wherein the bladder in its rolled form fits inside an introducer tube (paragraph 0102) having an inner diameter of less than 10 millimeters (1-5mm in diameter, paragraph 0099).
Regarding claim 57, Paz teaches all of the limitations set forth in claim 54, further comprising a restrictor (28) connected to the bladder and configured to restrict, during or after inflation of the inflatable bladder (this is a functional limitation, and therefore since the restrictor is capable of restricting motion after a bladder is inflated and introduced therein, the prior art meets the limitations), motion of the bladder along a connection of the bladder to the restrictor (bladder is restricted within packaging tube 28 along the lumen of the restrictor when the bladder is confined therein, paragraph 0101-0102).
Regarding claim 59, Paz teaches all of the limitations set forth in claim 54, wherein the inflatable bladder comprises a mix of Poly Lactic Acid (PLA) and Poly Capra Lactone (paragraph 0036).
Regarding claim 60, Paz teaches all of the limitations set forth in claim 54, wherein the bladder is configured to laterally expand by inflation to dissect tissue (figure 1A, flattened shape, paragraph 0019) .
Regarding claim 62, Paz teaches all of the limitations set forth in claim 54, wherein the inflatable bladder comprises two opposing inner surfaces connected to each other by a connection that limits an inflated thickness of the inflatable bladder (flattened shape would have two inner surfaces opposing each other and would limit the inflated thickness to make a flat shape, paragraph 0019).
Regarding claim 75, Paz teaches all of the limitations set forth in claim 54, wherein the plug is configured to disconnect from the distal end of the tube as the tube is withdrawn to allow the plug to remain inside the bladder to seal the inflation port (the limitation ‘configured to disconnect from the distal end of the tube as the tube is withdrawn to allow the plug to remain inside the bladder to seal the inflation port’ is a functional limitation. Since tube 22 can be inserted into a one-way valve, Paz meets the limitations, The plug is configured to seal the inflation port as the tube is withdrawn (one-way valve) and the plug is disconnected from the tube to maintain the bladder in an inflated state).
Claims 54-5, 59, 60, 62, and 75 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lunsford et al (US 5779728).
Regarding claim 54, Lunsford et al (hereafter Lunsford) discloses tissue-dissecting device, comprising: an inflatable bladder (see image below) for inter-tissue or inter-organ spacing, the bladder defining an interior chamber and an inflation port through which the interior chamber can be inflated; a tube (515) detachably connected or connectable to the bladder such that in a connected state the tube is in fluid communication with the inflation port for inflating the bladder with a distal end of the tube disposed within the bladder; and a plug (521) detached from the inflatable bladder and detachably connected to the distal end of the tube (under BRI, all of the components can be taken apart and thereby detached or detachably connected to one another during assembly, such that the plug is arranged to be inside the bladder once assembled), the plug arranged to be disposed inside the bladder (all of the components in the image below are interpreted to form the bladder as a whole) with the distal end of the tube inside the bladder (figure 14), the plug configured to seal the inflation port (C:26, L:9-29, C:10, L:36-40, flapper valve can be sealed without an instrument to maintain seal) as the tube is withdrawn and the plug disconnected from the tube at the inflation port, to maintain the bladder in an inflated state (the limitation ‘as the tube is withdrawn and the plug disconnected from the tube…’ is a functional limitation. Since the plug is capable of being sealed simultaneously with disconnecting the tube by an user, the prior art meets the limitations).
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Regarding claim 58, Lunsford teaches all of the limitations set forth in claim 54, wherein the inflatable bladder is coated by a substantially slippery coating (distal end of inflatable bladder 512 is lubricated, C:36, L:46-57).
Regarding claim 75, Lunsford teaches all of the limitations set forth in claim 54, wherein the plug is configured to disconnect from the distal end of the tube as the tube is withdrawn to allow the plug to remain inside the bladder to seal the inflation port (the limitation ‘configured to disconnect from the distal end of the tube as the tube is withdrawn to allow the plug to remain inside the bladder to seal the inflation port’ is a functional limitation. Since the plug is capable of being sealed simultaneously with disconnecting the tube by an user, the prior art meets the limitations).
Regarding claims 54 and 63, according to an alternative interpretation, Lunsford et al (hereafter Lunsford) discloses tissue-dissecting device, comprising: an inflatable bladder (all of figure 7A is interpreted as the bladder) for inter-tissue or inter-organ spacing, the bladder defining an interior chamber (213) and an inflation port (231) through which the interior chamber can be inflated; a tube (E) detachably connected or connectable to the bladder such that in a connected state the tube is in fluid communication with the inflation port for inflating the bladder with a distal end of the tube disposed within the bladder (figure 8B); and a plug (206) detachably connected to the distal end of the tube and disposed inside the bladder (figure 7A), the plug configured to seal the inflation port as the tube is withdrawn, to maintain the bladder in an inflated state (Figure 7A), wherein the inflatable bladder defines a hole therethrough between opposite broad sides of the bladder (toroidal, figure 7A, 234).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 61 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Paz et al (US 20080033471) as applied to claim 54 above, and further in view of Litvack et al (US 20110270295).
Regarding claim 61, Paz teaches all of the limitations set forth in claim 54, and further teaches the surface of the inflatable bladder comprising surface structures such that when expanded a friction between the inflatable bladder surface and displaced tissue is increased without affecting the functionality of the device (paragraph 0074), but does not specifically teach a mesh attached to a surface of the inflatable bladder. Litvack et al (hereafter Litvack) teaches it was known in the art at the time of the invention to utilize mesh as a surface treatments on inflatable balloon structures to facilitate traction (paragraph 0022). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include a mesh attached to a surface of the inflatable bladder, as taught by Litvack, as a suitable art-recognized equivalent surface structure at the time of the invention to the surface structures taught by Paz, since it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
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 54-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 11918414 in view of Paz et al (US 20080033471). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 and 14 of Patent 11918414 (hereafter Patent ‘414) recites the claimed inflatable bladder (claim 1), inflation port, tube (introducer tube), and restrictor (claim 14). Patent ‘414 claims lack a plug detachably connected to the distal end of the tube and configured to seal the inflation port as the tube is withdrawn to maintain the bladder in an inflated state, the bladder is in a rolled form in a deflated state, and the bladder in its rolled form fits inside an introducer tube having an inner diameter of less than 10mm. Paz teaches an inflatable bladder comprising a plug detachably connected to the distal end of the tube and configured to seal the inflation port as the tube is withdrawn to maintain the bladder in an inflated state (paragraph 0102), the bladder is in a rolled form in a deflated state (figure1b, paragraph 0042, 0071), and the bladder in its rolled form fits inside an introducer tube having an inner diameter of less than 10mm (1-5mm in diameter, paragraph 0099). It would have been obvious to one with ordinary skill in the art at the time of the invention to modified the device in claim 1 of Patent ‘414 to include a plug detachably connected to the distal end of the tube and configured to seal the inflation port as the tube is withdrawn to maintain the bladder in an inflated state, as taught by Paz, in order to prevent deflation. It also would have been obvious to one with ordinary skill in the art at the time of the invention to modified the device in claim 1 of Patent ‘414 to include the bladder is in a rolled form in a deflated state and the bladder in its rolled form fits inside an introducer tube having an inner diameter of less than 10mm, as taught by Paz, in order to make it suitable for minimally invasive techniques.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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/ANH T DANG/Primary Examiner, Art Unit 3771