Prosecution Insights
Last updated: April 19, 2026
Application No. 17/636,578

POSITIONING DEVICE AND METHOD

Final Rejection §102§103§112
Filed
Feb 18, 2022
Examiner
RODJOM, KATHERINE MARIE
Art Unit
3771
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Holistick Medical
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
4y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
433 granted / 658 resolved
-4.2% vs TC avg
Strong +34% interview lift
Without
With
+34.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
26 currently pending
Career history
684
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
42.9%
+2.9% vs TC avg
§102
26.9%
-13.1% vs TC avg
§112
19.6%
-20.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 658 resolved cases

Office Action

§102 §103 §112
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 The amendment filed August 7, 2025 has been entered. Claims 16-19, 21-22, 24-29, and 31-32 are currently pending. 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 16-19, 21-22, 24-29, and 31-32 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 16 recites “the delivery device comprising: a positioning device for deploying the delivery device”. Since the delivery device is defined as comprising a positioning device, it is unclear how the positioning device can be used for deploying the delivery device or, in other words, how the positioning device can be used for deploying itself since it defines the delivery device. The Examiner suggests amending the claim to clarify the distinction between the delivery device and the positioning device. For example, define a delivery system comprising a delivery device and a positioning device, wherein the delivery device is for treatment of a defect and the positioning device is for deploying the delivery device. Claim 16 additionally recites: “wherein the positioning device comprises a mechanism to selectively expand said distal part” in lines 6-7 and further recites “wherein the positioning device comprises actuation mechanism to pull back the distal part of the positioning device in relation to a remaining part the positioning device” in lines 19-21. It is unclear if the claim is reciting two separate and distinct actuation mechanisms for selectively expanding the distal part or if the claim is attempting to define the “mechanism to selectively expand the distal part” as including pulling back the distal part of the positioning device in relation to a remaining part of the positioning device. For the purpose of examination, the limitation “wherein the positioning device comprises actuation mechanism to pull back the distal part of the positioning device in relation to a remaining part the positioning device” is interpreted as defining the “mechanism to selectively expand said distal part”. It is noted claims 17-19, 21-22, 24-29, and 31-32 are additionally unclear since they recite the preamble of “the delivery device of claim” and then recite further limitations of the positioning device. Claims 17-19, 21-22, 24-29, and 31-32 are rejected due to their dependency on claim 16. Claim 29 recites the limitation "the at least one strut" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 32 recites “further comprising a second expandable portion, arranged concentrically around the positioning device and immovable along the longitudinal axis with respect to the delivery device, and positioned proximally of the positioning device when the positioning device is deployed”. However, claim 16 recites “both the delivery device and the positioning device share a common longitudinal axis, wherein the delivery device is movable relative to the positioning device along the common longitudinal axis”. It is unclear how a second expandable portion arranged concentrically around the positioning device can be immovable along the longitudinal axis with respect to the delivery device when the delivery device is movable relative to the positioning device along the common longitudinal axis. For the purpose of examination claim 32 is interpreted such that the second expandable portion is mounted to the delivery device, as shown in the embodiment of Fig 11 of the instant application. 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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “mechanism to selectively expand said distal part” and “actuation mechanism” in claim 16, that is the generic placeholder “mechanism” coupled with the functional language “to selectively expand said distal part” and “to actuate…to pull back the distal part of the positioning device in relation to a remaining part of the positioning device”. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claim(s) 16, 18-19, 21-22, 25-27, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Havel et al. (US 2016/0158045, hereinafter “Havel”). Regarding claim 16, Havel discloses a delivery device (sheath 500) for treatment of a defect (Figs 12-13, 15-16), the defect being an atrial or septal defect (for treatment of a defect in a vessel – para [0002], fully capable of treating an atrial or septal defect), the delivery device comprising: a positioning device (1200) for deploying the delivery device, the positioning device comprising: a distal part (1220 – expandable region) that is adapted to be delivered through the defect (fully capable of being delivered through an atrial or septal defect), wherein the positioning device comprises a mechanism to selectively expand said distal part, said distal part being adapted such that before expansion (Fig 12), it can be deployed through said defect (fully capable of being deployed through defect due to smaller diameter profile), and upon expansion (Fig 13), is mechanically prevented from being retracted through the same defect, such that the positioning device is temporarily engaged at the defect site (fully capable of temporarily engaging defect site and being prevented from being retracted through the defect due to the larger diameter); and the distal part adapted to be retracted such that after the deployment, the positioning device can be retracted with the delivery device (entire device fully capable of being retracted together when positioning device returns to unexpanded state) wherein the delivery device (sheath 500) is mounted concentrically over the positioning device (1200), such that both the delivery device and the positioning device share a common longitudinal axis, wherein the delivery device is movable relative to the positioning device along the common longitudinal axis (sheath 500 retractable – para [0004, 0040]; see at least alternate embodiment Figs 5-8); further wherein the positioning device has a tubular structure, and wherein the positioning device comprises actuation mechanism to pull back the distal part of the positioning device in relation to a remaining part the positioning device (move inner cannula 1510 to expand/retract malecot wings 1240 – Figs 12-13; para [0047-0049]). Regarding claim 18, wherein the distal part (1220) of the positioning device comprises at least one wire (malecot wings 1240), said wire having a first (Fig 13) and a second (Fig 12) shape (para [0047-0049]). Regarding claim 19, wherein the second shape is substantially planar (Fig 12; para [0047-0049]). Regarding claim 21, wherein the positioning device is adapted such that the at least one wire is brought from its first shape (Fig 13) into its second shape (Fig 12) by actuating the actuation mechanism (para [0047-0049]). Regarding claim 22, wherein the second shape (Fig 12) is selected from a group comprising a spiral, a flat disk and a star (flat disk – Fig 12). In an alternate interpretation, the first shape may be interpreted as the configuration of Fig 12 and the second shape may be interpreted as the configuration of Fig 13, such that the second shape (Fig 13) is selected from a group comprising a spiral, a flat disk and a star (cross section interpreted as a star when malecot wings form several vertices extending from central axis; Fig 16). Regarding claims 25 and 27, wherein the tubular structure defines at least one slit (1230; para [0047]; Figs 12-13). Regarding claim 26, wherein the at least one slit (1230) is arranged such that it forms at least one strut (1240) that can extend away from the tubular structure (para [0047]; Figs 12-13). Regarding claim 31, Havel discloses a method of delivering a medical implant in the human body, comprising the steps: delivering a delivery device (sheath 500) according to claim 16, through an opening in a wall (through wall and into lumen of blood vessel); engaging the positioning device (1200) at the opening (expanding distal part 1220; engaging lumen of blood vessel); delivering the medical implant (stent 400); and disengaging the positioning device (Figs 12-13; para [0047-0049]). Claim(s) 16, 18, 25, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heesch (US 10,569,050, hereinafter “Heesch”). Regarding claim 16, Heesch discloses a delivery device (sheath 62) for treatment of a defect (Fig 2), the defect being an atrial or septal defect (for treatment of a defect in a vessel – fully capable of treating an atrial or septal defect), the delivery device comprising: a positioning device (14) for deploying the delivery device, the positioning device comprising: a distal part (split support wires 36) that is adapted to be delivered through the defect (fully capable of being delivered through an atrial or septal defect), wherein the positioning device comprises a mechanism to selectively expand said distal part, said distal part being adapted such that before expansion (collapsed shape — Figs 7, 11), it can be deployed through said defect (fully capable of being deployed through defect due to smaller diameter profile), and upon expansion (expanded shape - 6, 10), is mechanically prevented from being retracted through the same defect, such that the positioning device is temporarily engaged at the defect site (fully capable of temporarily engaging defect site and being prevented from being retracted through the defect due to the larger diameter); and the distal part adapted to be retracted such that after the deployment, the positioning device can be retracted with the delivery device (entire device fully capable of being retracted together when positioning device returns to unexpanded state) wherein the delivery device (sheath 62) is mounted concentrically over the positioning device (14), such that both the delivery device and the positioning device share a common longitudinal axis, wherein the delivery device is movable relative to the positioning device along the common longitudinal axis (Fig 3; col 7, ln 26-28); further wherein the positioning device has a tubular structure (catheter 14), and wherein the positioning device comprises actuation mechanism to pull back the distal part of the positioning device in relation to a remaining part the positioning device (col 7, ln 48 – col 8, ln 22). Regarding claim 18, wherein the distal part of the positioning device comprises at least one wire (split support wires 36), said wire having a first (collapsed shape — Figs 7, 11) and a second shape (expanded shape - 6, 10). Regarding claims 25 and 27, wherein the tubular structure (14) defines at least one slit (support wire recesses 23) (Fig 10). Regarding claim 28, wherein the at least one slit (23) is adapted such that the at least one wire (36) can be deployed through said slit (col 7, ln 48 – col 8, ln 22). Claim(s) 16 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubrul et al. (US 2010/0030256, hereinafter “Dubrul”). Regarding claim 16, Dubrul discloses a delivery device (outer catheter 16) for treatment of a defect (Figs 102-105), the defect being an atrial or septal defect (for treatment of a defect in a vessel, fully capable of treating an atrial or septal defect), the delivery device comprising: a positioning device (inner tubular member 22; Figs 99-100) for deploying the delivery device, the positioning device comprising: a distal part (24 – expandable region) that is adapted to be delivered through the defect (fully capable of being delivered through an atrial or septal defect), wherein the positioning device comprises a mechanism to selectively expand said distal part, said distal part being adapted such that before expansion (Fig 99), it can be deployed through said defect (fully capable of being deployed through defect due to smaller diameter profile), and upon expansion (Fig 100), is mechanically prevented from being retracted through the same defect, such that the positioning device is temporarily engaged at the defect site (fully capable of temporarily engaging defect site and being prevented from being retracted through the defect due to the larger diameter); and the distal part adapted to be retracted such that after the deployment, the positioning device can be retracted with the delivery device (entire device fully capable of being retracted together when positioning device returns to unexpanded state) wherein the delivery device (outer catheter 16) is mounted concentrically over the positioning device (22), such that both the delivery device and the positioning device share a common longitudinal axis, wherein the delivery device is movable relative to the positioning device along the common longitudinal axis (Figs 102-105); further wherein the positioning device has a tubular structure (22), and wherein the positioning device comprises actuation mechanism to pull back the distal part of the positioning device in relation to a remaining part the positioning device (move inner member 26 to expand/retract 24 – Figs 99-100; para [0249-0250]). Regarding claim 32, further comprising a second expandable portion (18), arranged concentrically around the positioning device and immovable along the longitudinal axis with respect to the delivery device (fixed to outer catheter 16), and positioned proximally of the positioning device when the positioning device is deployed (Fig 105; para [0253, 0256]). 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Havel et al. (US 2016/0158045), as applied to claim 16 above, further in view of Sogard et al. (US 2002/0045931, hereinafter “Sogard”). Havel disclose the invention substantially as claimed, as shown above, further including a self-expanding stent graft (400) (para [0038, 0047, 0049]). However, Havel fails to teach the positioning device further includes a balloon. Sogard discloses a stent device in a similar field of endeavor and teaches “Stents generally are open ended and are radially expandable between a generally unexpanded insertion diameter and an expanded implantation diameter which is greater than the unexpanded insertion diameter. Stents are often flexible in configuration, which allows them to be inserted through and conform to tortuous pathways in the blood vessels. The stent is generally inserted in a radially compressed state and expanded either through a self-expanding mechanism, or through the use of balloon catheters” (para [0003]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Havel such that the positioning device comprised a balloon for expanding the stent graft (400) since substitution of one known element (self-expanding stent) for another element (balloon catheter and balloon-expandable stent) providing the same function (stent expansion mechanism) to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Havel et al. (US 2016/0158045), as applied to claim 16 above, further in view of Dubrul (US 2010/0030256). Havel discloses the invention substantially as claimed, as shown above. However, Havel fails to disclose the tubular structure is made of shape memory material. Dubrul discloses a similar positioning device (10) comprising a distal part (16) that is configured to expand from a collapsed position (Fig 1) to an expanded position (Fig 2) and teaches the distal part comprises Nitinol “so that axial shortening causes radial expansion” and further teaches “all expandable mechanisms described heretofore, can be manufactured using shape memory materials so that they are self-expanding or even expandable when certain temperatures or thermal energies are delivered to the mechanisms. Such material characteristics can be accomplished with different programming methods such as, but not limited to Two Way Shape Memory (TWSM) alloys.” (para [0225]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Havel such that the tubular structure was made of shape memory material, such as Nitinol, for the purpose of ensuring axial shortening causes radial expansion or to make the distal part self-expandable, as taught by Dubrul. Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Havel et al. (US 2016/0158045), as applied to claim 16 above, further in view of Melsheimer et al. (US 2008/0058730, hereinafter “Melsheimer”). Havel discloses the invention substantially as claimed, as shown above, including at least one slit (1230) forming at least one strut (1240) that can extend away from the tubular structure (para [0047]; Figs 12-13). However, Havel fails to disclose the at least one slit (1230) extends spirally around the circumference and a longitudinal axis (L) of the tubular structure, such that the at least one strut can be extended away from the tubular structure, by a rotation of a part of the tubular structure. Melsheimer discloses a similar device comprising a positioning device having a tubular structure and an expandable distal part (Figs 1-7). Melsheimer teaches the tubular structure (sheath 20) comprises a slit (slots 24) forming at least one strut (arms 28) that can extend away from the tubular structure (para [0053]), wherein the at least one slit (24) extends spirally around the circumference and a longitudinal axis (L) of the tubular structure (Figs 1, 6), such that the at least one strut (28) can be extended away from the tubular structure, by a rotation of a part of the tubular structure (Figs 6-8; para [0055, 0057]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Havel such that the slits extended spirally around the circumference and a longitudinal axis (L) of the tubular structure to allow the struts to expand via rotation of a part of the tubular structure since substitution of one known element (parallel slits expanding struts via longitudinal movement) for another element (spiral slits expanding struts via rotational movement) providing the same function (expanding struts) to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). Response to Arguments Applicant's arguments filed August 7, 2025, regarding the rejection of claims 16, 18-19, 21-22, 25-26 under 35 U.S.C. 102(a)(1) as being anticipated by Havel (US 2016/0158045), have been fully considered but they are not persuasive. Applicant argues Havel teaches the positioning device having the expandable distal end is arranged on an outer surface of the delivery device. The Examiner respectfully disagrees and notes the delivery device may be interpreted as the sheath (500) such that the delivery device is mounted concentrically over the positioning device having the expandable distal portion (balloon 120 or malecot wings 1240). In response to applicant's argument that claim 16 is directed to a delivery device with a positioning device suitable for delivery of an implant for treatment of an atrial septal defect and the assertion there is no disclosure of treatment of atrial or septal defects, 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. Applicant’s arguments filed August 7, 2025, regarding the rejection of claim(s) 16, 18, 22-23, 25-26, and 29 under 35 U.S.C. 102(a)(1) as being anticipated by Melsheimer (US 2008/0058730), have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted Melsheimer fails to disclose the claimed delivery device mounted concentrically over the positioning device, as amended. However, the teachings of Melsheimer may be used to modify Havel as discussed above. Applicant's arguments filed August 7, 2025, regarding the rejection of claims 16, 18, 25, and 27-28 under 35 U.S.C. 102(a)(1) as being anticipated by Heesch (US 10,569,050), have been fully considered but they are not persuasive. Applicant argues Heesch fails to teach a delivery device mounted concentrically over the positioning device, as amended. The Examiner respectfully disagrees and notes the delivery device may be interpreted as the sheath (62) such that the delivery device is mounted concentrically over the positioning device having the expandable distal portion (Fig 3; col 7, ln 26-28). Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHERINE M RODJOM/ Primary Examiner, Art Unit 3771
Read full office action

Prosecution Timeline

Feb 18, 2022
Application Filed
May 03, 2025
Non-Final Rejection — §102, §103, §112
Aug 07, 2025
Response Filed
Nov 07, 2025
Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+34.3%)
4y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 658 resolved cases by this examiner. Grant probability derived from career allow rate.

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