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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/15/2025 was filed after the mailing date of the Non-Final OA on 7/15/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the claim amendments filed on 10/15/2025. As directed by the amendment: claims 1-2, and 11 have been amended; and claims 21-39 have been added. Thus, claims 1-39 are presently pending in this application.
Election/Restrictions
Newly submitted claims 21-39 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Newly presented claim 21 does not required the limitations “confirming the sheath has access to the body space by advancing a probe into the body space; removing the probe from the body space and the sheath; positioning a cartridge having a material proximal the sheath; and delivering a second amount of the material into the sheath and/or the body space by advancing a second plunger” as required by method claim 11. Therefore, Examiner finds newly presented claim 21 to be independent and distinct from method claim 11.
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 Accordingly, claims 21-39 are withdrawn from consideration as being directed to a non-elected invention.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.
Response to Arguments
Applicant's arguments filed 10/15/2025 in regard to rejection under 35 USC § 112(b) to claim 13 is not found persuasive. Applicant is reminded although claims are read in light of the specification, limitations are not imported from the specification. Claim 13 is considered indefinite as the claimed threshold distance within the claim is unknown, and therefore the metes and bounds of the claim are indefinite and not clearly defined within the claim.
Applicant further argues on page 8 section A, Lee-Sepsick fails to teach the amended limitation “when in the second configuration the system is configured to resist the material from flowing in a retrograde direction into the system”. Second configuration with element 29 depressed considered so configured to resist material retrograde as the plunger is in the depressed position and would require significant enough pressure to push the plunger backwards to achieve the flow in the retrograde direction. Fig. 8c demonstrates the element 23 not even in contact with said lumen and therefore element 29 in the second, fully depressed configuration, is considered fully capable of resisting the material from flowing in a retrograde direction in the system. In the case the material was in contact with the delivery lumen it would further have to overcome the pressure threshold required to push plunger element 29 in the reverse direction. Said pressure threshold would come from the friction between the plunger end and the wall the plunger is held within. Examiner further notes with the relatively open 29body cavity environment element 23 is intended to be delivered into the plunger in the second configurations physical friction is considered fully capable of teaching the claimed resistance to retrograde flow.
Applicant further argues on page 8 section B, Lee-Sepsick fails to teach the amended limitation “separating the material from the second plunger; and resisting the material from flowing in a retrograde direction in into the sheath”. Lee-Sepsick teaches para. 62, 89 and 90, demonstration the second material separated from the second plunger and being prevented from flowing in a retrograde direction due to the “stopcock”.
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.
Claim 13 is 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 13 recites “an advanced distance that is greater than or equal to a threshold distance”. This renders the claim indefinite as the meets and bounds of the claim are not clearly understood within the claim as the threshold distance is unknown.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0024108 A1 to Lee-Sepsick et al.
In regard to claim 1:
Lee-Sepsick teaches in a first embodiment, a system comprising (Figs. 3A-3C): a sheath (Fig. 3A element 3), a sheath hub (see annotated Fig. 3c below), and a first space (see annotated fig. 3A below); and a handle (Fig. 2a element 5), and a second space (see annotated Fig. 3A below), comprises a first plunger (Fig. 3a element 29); and a material (Fig. 3a element 23), wherein the material is in contact with the handle in a first configuration (Fig. 3A element 23) and wherein the material is separate from the handle in a second configuration (Second configuration considered to be plunger element 29 fully depressed, para. 65-67 teach plunger being depressed to delivery element 23. Fig. 8c element 23, para. 91), and wherein when in the second configuration the system is configured to resist the material from flowing in a retrograde direction into the system (Second configuration with element 29 depressed considered so configured to resist material retrograde as the plunger is in the depressed position and would require significant enough pressure to push the plunger backwards to achieve the flow in the retrograde direction. Fig. 8c demonstrates the element 23 not even in contact with said lumen and therefore element 29 in the second, fully depressed configuration, is considered fully capable of resisting the material from flowing in a retrograde direction in the system).
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Lee-Sepsick teaches in a second embodiment, a system comprising (Figs. 2A-C): a sheath (Fig. 2A element 3), wherein the handle comprises a first plunger (see annotated Fig. 2B below), a second plunger (see annotated Fig. 2b below).
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It would have been obvious to one having ordinary skill in the art, prior to the effective date of filling to modify, the first plunger and space taught in the first embodiment to include two plungers as taught in the second embodiment. This would have been motivated by allowing the device to deliver two substances at a time without having to exchange syringes.
Lee-Sepsick teaches the invention essentially as claimed except for a handle removably attachable to the sheath hub. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the handle of Lee-Sepsick to be removable. Such a modification is generally considered to be within the level of ordinary skill in the art (SEE MPEP 2144.04(V)(C. Making Separable)). In the instant application it would be desirable to make the handle separable from the sheath to facilitate sterilization of the handle and replacement of the sheath.
In regard to claim 2:
The system of claim 1, further comprising a cartridge having the material (Fig. 3a elements 28. Para. 65 “a composition ampule (28) containing a composition (23); and, a delivery plunger (29).”).
In regard to claim 3:
The system of claim 2, wherein the material comprises a hydrogel (para. 122 “A further aspect of the current invention includes materials that are delivered in a solid or non-solid form which may be used to deliver or adhere materials that may be useful in promoting or forming occlusions or which may be useful in forming occlusions in and of themselves whereas such material may be resorbable or degradable or permanent. Such materials include dry compositions that hydrate and form crosslinked hydrogels,”)
In regard to claim 4:
The system of claim 2, wherein when the handle is removably attached to the sheath hub, the cartridge is in the first space and/or in the second space (See annotated Fig. 3a below cartridge in the first space. Fig. 3a element 28).
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In regard to claim 5:
The system of claim 2, wherein when the handle is removably attached to the sheath hub (see claim 1 rejection regarding removability), an opening of the cartridge is aligned with an opening of the sheath (Fig. 3a and 3c elements 28 opening aligned with sheath, see annotated Fig. 3c below)
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In regard to claim 6:
The system of claim 2, wherein when the handle is removably attached to the sheath hub (see claim 1 rejection regarding removability), a lumen of the cartridge is aligned with a lumen of the sheath (see annotated Fig. 3c below. Examiner notes with the combination above two syringes would be aligned with the sheath in a parallel manner as elements 26 are).
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In regard to claim 7:
The system of claim 1, further comprising a plunger tip, wherein the first plunger and the second plunger are connected to the plunger tip (para. 138 “Elements for providing the delivery composition include, but are not limited to, syringes and pressure systems, pumps, containers with plungers to force material into the catheters” (emphasis added). Gasket portion of plunger used to force material into the catheter considered to be the plunger tip. First and second plungers considered connected to respective first and second plunger tips (see claim 1 annotated Fig. 2b above, Lee-Sepsick teaches first and second plunger in second embodiment as described in claim 1 above).
In regard to claim 8:
The system of claim 7, Lee-Sepsick teaches in second embodiment as described in claim 1 above see claim 1 above for combination, wherein the first plunger (Fig. 2b element 14 see annotated Fig. 2b above under claim 1 rejection) has a first plunger retracted configuration (Fig. 2b element 14 fully retracted position of plunger) and a first plunger advanced configuration (Fig. 2b element 14 fully advanced position of plunger), and wherein the plunger tip is closer to the sheath when the first plunger is in the first plunger advanced configuration than when the first plunger is in the first plunger retracted configuration (Fig. 2b element 14 fully retracted position of plunger would be farther from the sheath than in the fully advance position).
In regard to claim 9:
The system of claim 8, Lee-Sepsick teaches in second embodiment as described in claim 1 above see claim 1 above for combination, wherein the second plunger (Fig. 2b element 14 see annotated Fig. 2b above under claim 1 rejection) has a second plunger retracted configuration (Fig. 2b element 14 fully retracted position of plunger) and a second plunger advanced configuration (Fig. 2b element 14 fully advanced position of plunger), and wherein the plunger tip is closer to the sheath when the second plunger is in the second plunger advanced configuration than when the second plunger is in the second plunger retracted configuration (Fig. 2b element 14 fully retracted position of plunger would be farther from the sheath than in the fully advance position).
In regard to claim 10:
The system of claim 9, further comprising a probe (Fig. 3a element 7)
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0024108 A1 to Lee-Sepsick et al in view of GB 2517962 to Filshie et al.
In regard to claim 11:
Lee-Sepsick teaches, a method of delivering a material to a body space comprising: advancing a sheath into the body space (para. 67 “For example, the system comprises introducing the delivery device transcervically with the delivery catheters contained within the introducer, each delivery catheter is moved into position and the balloon inflated, the composition is delivered, and the system withdrawn”); positioning a cartridge having a material proximal the sheath (Fig. 3a through 3c element 28); delivering a first amount of the material into the sheath and/or the body space by advancing a first plunger; and delivering a second amount of the material into the sheath and/or the body space by advancing a second plunger (para. 62 “A cartridge (14) containing a composition (23) is then connected to the delivery catheter fitting (11), and the plunger (18) is pressed into the barrel (17) of the cartridge to deliver the composition (23) into and through the catheter, and exiting through the delivery end of the catheter (7) toward the target location.”); separating the material from the second plunger (paras. 62, 89, and 90); and resisting the material from flowing in a retrograde direction into the sheath (para. 62, Fig. 2B element 12 “stopcock”).
Lee-Sepsick does not appear to explicitly teach the method of advancing the probe to confirm access to the body space as claimed. Filshie teaches, confirming the sheath has access to the body space by advancing a probe into the body space (Para. 26 “ a small scale camera located at the distal end of the probe for viewing the occlusive plug and its immediate surrounds within a patient's womb” Para. 69 “ The image sensor comprises an integrated circuit mounted at the end of the probe. This sends a video signal back along an electrical conductor to a video processing integrated circuit, within the casing of the applicator. The video circuit sends a video signal to the monitor screen at the end of the applicator so that the surgeon can view the end of the probe by looking directly at the screen.”) removing the probe from the body space and the sheath (Para. 32 “Subsequently, the probe member can be removed from the patient's body.”)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include advancing the probe to confirm access to the body space as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 12:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick does not appear to explicitly teach the method of advancing the probe to confirm access to the body space as claimed. Filshie teaches, wherein advancing the sheath into the body space comprises advancing the sheath into the body space while the probe is in the sheath space (Para. 26 “ a small scale camera located at the distal end of the probe for viewing the occlusive plug and its immediate surrounds within a patient's womb” Para. 69 “ The image sensor comprises an integrated circuit mounted at the end of the probe. This sends a video signal back along an electrical conductor to a video processing integrated circuit, within the casing of the applicator. The video circuit sends a video signal to the monitor screen at the end of the applicator so that the surgeon can view the end of the probe by looking directly at the screen.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include advancing the probe from the sheath space as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 13:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick does not appear to explicitly teach the method of confirming the sheath has access to the body space by advancing the probe a threshold distance as claimed. Filshie teaches, wherein confirming the sheath has access to the body space by advancing the probe into the body space comprises advancing the probe into the body space by an advanced distance that is greater than or equal to a threshold distance (Fig. 7 element 705 considered an advanced distance as it is distal to the sheath).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include the method of confirming the sheath has access to the body space by advancing the probe a threshold distance as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 14:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick does not appear to explicitly teach the threshold distance at claimed. Filshie teaches, wherein the threshold distance comprises 1.0 cm - 6.0 cm or 4.0 cm - 6.0 cm (para. 49 “there is a gap of around 15mm to 35mm between the end of the tube 104 and the housing 702.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include the threshold distance as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 15:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick does not appear to explicitly teach removal of the probe by disconnecting the housing as claimed. Filshie teaches, wherein removing the probe from the body space and the sheath comprises disconnecting a housing having the probe from a sheath hub having the sheath (para. 48 “ Referring to Figure 7 herein, there is shown in perspective view the distal end of the probe, covered by an outer sheath 120. The outer sheath is slidable over the nose of the probe so as to protect the probe and attached plug when entering or being withdrawn from the uterine cavity. The end of the sheath has a chamfered or angled end to assist in insertion into and removal from the uterine cavity.”)
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include removal of the probe by disconnecting the housing as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 16:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick teaches in a first embodiment, further comprising inserting the cartridge into a handle (Fig. 3c element 23), wherein the handle comprises the first plunger (Fig. 3c element 29) wherein advancing the first plunger comprises advancing a plunger tip relative to the cartridge via the first plunger (plunger tip considered distal tip of element 29. Fig. 3c element 29),
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Lee-Sepsick teaches in a second embodiment, and the second plunger (Fig. 2b elements 14), and wherein advancing the second plunger comprises advancing the plunger tip relative to the cartridge via the second plunger (Fig. 2b element 18 advanced relative to cartridge 17).
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It would have been obvious to one having ordinary skill in the art, prior to the effective date of filling to modify, the first plunger and space taught in the first embodiment to include two plungers as taught in the second embodiment. This would have been motivated by allowing the device to deliver two substances at a time without having to exchange syringes.
In regard to claim 17:
The method of claim 11, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick teaches, wherein the material comprises a first material (para. 79 “FIG. 6A depicts the introduction of an enzymatic, solvent, or other occlusion-degrading solution (46) to the site of the occlusion (25), such that the solution (46) degrades and removes the occlusion (25).”), the method further comprising: irrigating a second material through the sheath into the body space (Fig. 2b element 22 para. 92 “The distension medium (22) is provided to a balloon located at the delivery end (7) of the catheter to inflate it.” Considered within the body space as the balloon is within the body space); and aspirating the first material and the second material from the body space through the sheath (para. 12 “methods and devices may comprise suction of a portion of the conduit lining to remove an obstruction, growth or implant, or may comprise a wire or cutting catheter element or a material to dissolve, resolve, or liquefy an obstruction.”.)
In regard to claim 18:
The method of claim 17, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick does not appear to explicitly teach advancing the probe into the body space from an irrigation or aspiration lumen as claimed. Filshie teaches, wherein advancing the probe into the body space comprises advancing the probe into the body space from an irrigation lumen or an aspiration lumen of the sheath (Para. 52 “Internally of the distal end of the tube 104 is positioned a locating piece 711 through which the flexible rotatable drive shaft 109 and the cables for the light source and camera pass, and through which the fluid pipe passes.”), wherein confirming the sheath has access to the body space by advancing the probe into the body space comprises advancing the probe into the body space by an advanced distance that is greater than or equal to a threshold distance (Fig. 7 element 705 considered an advanced distance as it is distal to the sheath), and wherein the threshold distance comprises 1.5 cm-3.0 cm (para. 49 “there is a gap of around 15mm to 35mm between the end of the tube 104 and the housing 702.”).
It would have been obvious to one of ordinary skill in the art, prior to the effective date of filing, to modify the method taught by Lee-Sepsick to include advancing the probe into the body space from an irrigation lumen as taught by Filshie. This would have been motivated by improving physicians ability to check the surrounding tissue and therefore improve the patient’s treatment.
In regard to claim 19:
The method of claim 17, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick teaches, further comprising agitating the first material and/or the second material in the body space by moving the probe in the body space and/or by creating turbulence in the second material in the body space (para. 79 “FIG. 6A depicts the introduction of an enzymatic, solvent, or other occlusion-degrading solution (46) to the site of the occlusion (25), such that the solution (46) degrades and removes the occlusion (25).” Considered to read upon “creating turbulence” as the fluid exiting the lumen would experience turbulence at the outlet).
In regard to claim 20:
The method of claim 17, taught by Lee-Sepsick in view of Filshie as described in parent claim rejection above.
Lee-Sepsick teaches, further comprising simultaneously irrigating the second material through the sheath into the body space and aspirating the first material and the second material from the body space through the sheath for a minimum period of time, wherein the minimum period of time comprises 1 minute-10 minutes, wherein the first material comprises a hydrogel, and wherein the second material comprises sodium bicarbonate (para. 12 “methods and devices may comprise suction of a portion of the conduit lining to remove an obstruction, growth or implant, or may comprise a wire or cutting catheter element or a material to dissolve, resolve, or liquefy an obstruction.”.)
Conclusion
THIS ACTION IS MADE FINAL. 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 Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights