DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/28/2026.
Applicant’s election without traverse of claims 1-6 and 8-20 in the reply filed on 05/28/2026 is acknowledged.
Claim Objections
Claims 9 and 15 are objected to because of the following informalities:
Claim 9 (line 1) and claim 15 (line 1): “the protrusions” which should recite “the plurality of protrusions”.
Claim 2 (lines 1-2) and claim 17 (lines 1-2): “the outer diameter” which should recite “an outer diameter”.
Appropriate correction is required.
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:
“a locking member” in claims 1-3, 9-11, 13-14, 16-17, and 20. The limitation in claims 1, 11, and 16 fail to include sufficient structure to perform the recited function of “locking". In the specification, the locking member is described as an element comprising tabs that are configured to engage protrusions along the tether portion (para. 0039: “The locking member 206 includes tabs 210 that are configured to engage protrusions 208 along the tether portion 204”). Therefore, the limitation will be interpreted as an element comprising tabs or any structural equivalent thereof capable of engaging the protrusions along the tether portion.
“a release element” in claims 5 and 19. The limitation in claims 5 and 19 fail to include sufficient structure to perform the recited function of “releasing". In the specification, para. 0030 recites “A release element 212 may be slidably disposed through the locking member 206” and Figs. 2A-C illustrate the release element as a tubular element within the locking member. The specification further discusses another embodiment of the release element having radial apertures to “allow for the tabs 310 [of the locking member] to extend within the release element 312 to engage the protrusions 308 temporarily in the locked configuration” (para. 0041). Therefore, the limitation will be interpreted as a tubular element, a tubular element having radial apertures, or any structural equivalent thereof capable of moving “the tab into a constrained state disengaged from the one of the plurality of protrusions to shift the locking member into an unlocked configuration allowing the tether portion to translate in a proximal direction as well as a distal direction” as stated in claim 5.
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 § 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 1-6, 8-10, 11-15, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a device for securing tissue, the device comprising: a loop portion configured to be disposed on a distal end of a tubular wall of a delivery device” in lines 1-2 where the delivery device is functionally claimed. However, lines 7-8 of claim 1 recites “a tether portion extending from the loop portion…proximally through a lumen defined longitudinally through the tubular wall of the delivery device” where the delivery device is positively claimed as part of the claimed invention. It is unclear to the examiner if the claim is directed to the sub-combination of the device (the delivery device not positively claimed) or if it is directed to the combination of the device and the delivery device. For examination purposes, the limitation in lines 7-8 of claim 1 is interpreted as “a tether portion extending from the loop portion slidably through the locking member and configured to extend proximally through a lumen defined longitudinally through the tubular wall of the delivery device”.
Claim 2 recites “the loop portion has an inner diameter matching the outer diameter of the distal end of the delivery device” in lines 1-2. It is unclear to the examiner if the claim is directed to the sub-combination of the device (the delivery device not positively claimed) or if it is directed to the combination of the device and the delivery device. For examination purposes, the limitation in lines 1-2 of claim 2 is interpreted as “the loop portion has an inner diameter configured to match an outer diameter of the distal end of the delivery device”.
Claim 2 (lines 2-3) and claim 17 (line 2) recite the limitation "a delivery configuration". It is unclear to the examiner if “a delivery configuration” is meant to further define the delivery configuration introduced in claims 1 and 16 or introduce a new, additional, delivery configuration. For examination purposes, “a delivery configuration” is interpreted as “the delivery configuration”.
Claim 5 recites the limitation "the one of the plurality of protrusions" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the one of the plurality of protrusions” is interpreted as “one of the plurality of protrusions”.
Claim 11 recites the limitation "a distal end of the tubular wall of the delivery device" in lines 7-8. It is unclear to the examiner if “a distal end of the tubular wall of the delivery device” is meant to further define the distal end of the tubular wall of the delivery device introduced in claim 11, line 2 or introduce a new, additional, distal end. For examination purposes, “a distal end of the tubular wall of the delivery device” is interpreted as “the distal end of the tubular wall of the delivery device”.
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 1-6 and 8-14, 16, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-16, and 20 of U.S. Patent No. 12,114,860. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-6 and 8-14, 16, and 18-20 are under examination are anticipated, respectively, by claim 1, 2, 4-16, and 20 of the reference patent. Every limitation in the 18/830,928 application claims is recited in the conflicting 12,114,860 patent claims, and the differences between the claims are highlighted below by bolding all the limitations that differ and italicizing additional limitations (see table below).
Instant Application 18/830,928
U.S. Patent 12,114,860
1. A device for securing tissue, the device comprising:
[A] a loop portion configured to be disposed on a distal end of a tubular wall of a delivery device, external to and encircling an outer surface of the distal end of the tubular wall of the delivery device in a delivery configuration, and configured to be secured about the tissue in a deployed configuration;
[B] a locking member disposed on the loop portion; and[C] a tether portion extending from the loop portion slidably through the locking member and proximally through a lumen defined longitudinally through the tubular wall of the delivery device to a proximal end of the tubular wall of the delivery device, and proximally actuatable to move proximally through the lumen of the tubular wall of the delivery device to cause distal deployment of the loop portion off the outer surface of the distal end of the tubular wall of the delivery device and onto and encircling the tissue.
1. A device for securing tissue, the device comprising:
[A] a loop portion configured to be disposed on a distal end of a tubular wall of a delivery device, external to and encircling an outer surface of the distal end of the tubular wall of the delivery device in a delivery configuration, and configured to be secured about the tissue in a deployed configuration;
[B] a locking member disposed on the loop portion external to the tubular wall of the delivery device when the loop portion is in the delivery configuration; and
[C] a tether portion extending from the loop portion slidably through the locking member and proximally through a lumen defined longitudinally through the tubular wall of the delivery device to a proximal end of the tubular wall of the delivery device, and proximally actuatable to move proximally through the lumen of the tubular wall of the delivery device to cause distal deployment of the loop portion off the outer surface of the distal end of the tubular wall of the delivery device and onto and encircling the tissue.
2. The device of claim 1, wherein the loop portion has an inner diameter matching the outer diameter of the distal end of the delivery device and which cannot be decreased when in a delivery configuration encircling the outer surface of the distal end of the tubular wall of the delivery device, and the tether portion is thereby prevented from slidably extending proximally through the locking member when the loop portion is in the delivery configuration.
9. The device of claim 1, wherein the loop portion has an inner diameter matching the outer diameter of the distal end of the delivery device and which cannot be decreased when in a delivery configuration encircling the outer surface of the distal end of the tubular wall of the delivery device, and the tether portion is thereby prevented from slidably extending proximally through the locking member when the loop portion is in the delivery configuration.
3. The device of claim 1, wherein the locking member is shiftable between a locked configuration in which the locking member permits translation of the tether portion in a proximal direction and prevents translation of the tether portion in a distal direction, and an unlocked configuration in which the tether portion is free to translate both in the proximal direction as well as the distal direction.
2. The device of claim 1, wherein the locking member is shiftable between a locked configuration in which the locking member permits translation of the tether portion in a proximal direction and prevents translation of the tether portion in a distal direction, and an unlocked configuration in which the tether portion is free to translate both in the proximal direction as well as the distal direction.
4. The device of claim 1, wherein the loop portion includes a plurality of protrusions and the locking member comprises a tab extending radially inwardly within the locking member when in a locked configuration to engage one of the plurality of protrusions to inhibit distal translation of the tether portion.
4. The device of claim 1, wherein the loop portion includes a plurality of protrusions and the locking member comprises a tab extending radially inwardly within the locking member when in a locked configuration to engage one of the plurality of protrusions to inhibit distal translation of the tether portion.
5. The device of claim 4, further comprising a release element slidably disposable through the locking member between the plurality of protrusions and the tab to move the tab into a constrained state disengaged from the one of the plurality of protrusions to shift the locking member into an unlocked configuration allowing the tether portion to translate in a proximal direction as well as a distal direction.
5. The device of claim 4, further comprising a release element slidably disposable through the locking member between the plurality of protrusions and the tab to move the tab into a constrained state disengaged from the one of the plurality of protrusions to shift the locking member into an unlocked configuration allowing the tether portion to translate in a proximal direction as well as a distal direction.
6. The device of claim 5, wherein the release element comprises a tubular wall, with the plurality of protrusions slidably extendable therethrough.
6. The device of claim 5, wherein the release element comprises a tubular wall, with the plurality of protrusions slidably extendable therethrough.
8. The device of claim 1, wherein the loop portion includes a plurality of protrusions configured to at least partially embed into the tissue in the deployed configuration.
4. The device of claim 1, wherein the loop portion includes a plurality of protrusions and the locking member comprises a tab extending radially inwardly within the locking member when in a locked configuration to engage one of the plurality of protrusions to inhibit distal translation of the tether portion.
7. The device of claim 4, wherein the plurality of protrusions are configured to at least partially embed into the tissue in the deployed configuration.
9. The device of claim 8, wherein the protrusions are configured to interact with the locking member.
The limitation is encompassed by claim 4
10. The device of claim 1, wherein the locking member is disposed at an end of the loop portion.
8. The device of claim 1, wherein the locking member is disposed at an end of the loop portion.
11. A system for securing tissue, the system comprising:
[A] a delivery device having a distal end and comprising a tubular wall having a distal end and a proximal end and defining an outer surface and a lumen extending longitudinally therethrough between the distal end of the tubular wall and the proximal end of the tubular wall; and
[B] a securing element, the securing element comprising:
[C] a loop portion configured to be disposed on a distal end of the tubular wall of the delivery device, external to and encircling the outer surface of the distal end of the tubular wall of the delivery device in a delivery configuration and configured to be secured about the tissue in a deployed configuration;
[D] a locking member disposed on the loop portion; and
[E] a tether portion extending from the loop portion through the locking member and proximally through the lumen defined through the tubular wall of the delivery device to be pulled proximally through the lumen to transition the securing element from the delivery configuration to the deployed configuration encircling the tissue.
10. A system for securing tissue, the system comprising:
[A] a delivery device having a distal end and comprising a tubular wall having a distal end and a proximal end and defining an outer surface and a lumen extending longitudinally therethrough between the distal end of the tubular wall and the proximal end of the tubular wall; and
[B] a securing element, the securing element comprising:
[C] a loop portion configured to be disposed on a distal end of the tubular wall of the delivery device, external to and encircling the outer surface of the distal end of the tubular wall of the delivery device in a delivery configuration and configured to be secured about the tissue in a deployed configuration;
[D] a locking member disposed on the loop portion external to the tubular wall of the delivery device when the loop portion is in the delivery configuration; and
[E] a tether portion extending from the loop portion through the locking member and proximally through the lumen defined through the tubular wall of the delivery device to be pulled proximally through the lumen to transition the securing element from the delivery configuration to the deployed configuration encircling the tissue.
12. The system of claim 11, wherein the delivery device is an endoscope.
11. The system of claim 10, wherein the delivery device is an endoscope.
13. The system of claim 11, further comprising a plurality of protrusions disposed along the loop portion, the plurality of protrusions configured to translate with the tether portion in a direction through the locking member.
12. The system of claim 10, further comprising a plurality of protrusions disposed along the loop portion, the plurality of protrusions configured to translate with the tether portion in a direction through the locking member.
14. The device of claim 13, wherein the locking member is configured to engage the plurality of protrusions.
13. The device of claim 12, wherein the locking member comprises a tab configured to engage the plurality of protrusions.
16. A system for securing tissue, the system comprising:
[A] an end cap comprising a tubular wall defining a lumen longitudinally therethrough, and having a proximal end engageable with a distal end of an endoscope;
[B] a securing element having a delivery configuration, and configured to substantially close about a portion of the tissue in a deployed configuration, the securing element comprising:
[C] a loop portion configured to be disposed on the end cap, external to and encircling an outer surface of the tubular wall of the end cap in the delivery configuration;
[D] a locking member disposed on the loop portion; and
[E] a tether portion extending from the loop portion slidably through the locking member and proximally through the lumen defined longitudinally through the tubular wall of the end cap to a proximal end, and proximally actuatable through the lumen defined through the tubular wall of the end cap to cause distal deployment of the loop portion off the outer surface of the tubular wall of the end cap;
[F] wherein the end cap positions the securing element distal to and in view of an imaging device of the endoscope and is transparent and/or translucent to permit viewing of the securing element by the endoscope when the loop portion is encircling the outer surface of the tubular wall of the end cap.
14. A system for securing tissue, the system comprising:
[A] an end cap comprising a tubular wall defining a lumen longitudinally therethrough, and having a proximal end engageable with a distal end of an endoscope;
[B] a securing element having a delivery configuration, and configured to substantially close about a portion of the tissue in a deployed configuration, the securing element comprising:
[C] a loop portion configured to be disposed on the end cap, external to and encircling an outer surface of the tubular wall of the end cap in the delivery configuration;
[D] a locking member disposed on the loop portion external to the end cap when the loop portion is in the delivery configuration; and
[E] a tether portion extending from the loop portion slidably through the locking member and proximally through the lumen defined longitudinally through the tubular wall of the end cap to a proximal end, and proximally actuatable through the lumen defined through the tubular wall of the end cap to cause distal deployment of the loop portion off the outer surface of the tubular wall of the end cap;
[F] wherein the end cap positions the securing element distal to and in view of an imaging device of the endoscope and is transparent and/or translucent to permit viewing of the securing element by the endoscope when the loop portion is encircling the outer surface of the tubular wall of the end cap.
18. The system of claim 16, further comprising a catheter, the catheter comprising: a sheath having an inward tapered distal inner diameter; and a severing clip slidably disposed within the sheath and having edges extending radially inward at a distal end of the clip, the edges of the clip disposed about the tether portion such that distal translation of the clip with respect to the sheath causes the edges to sever the tether portion.
15. The system of claim 14, further comprising a catheter, the catheter comprising: a sheath having an inward tapered distal inner diameter; and a severing clip slidably disposed within the sheath and having edges extending radially inward at a distal end of the clip, the edges of the clip disposed about the tether portion such that distal translation of the clip with respect to the sheath causes the edges to sever the tether portion.
19. The system of claim 16, further comprising a catheter, wherein: the proximal end of the tether portion comprises a release element; the catheter comprises a plurality of arms at a distal end of the catheter; and a distal end of the plurality of arms has an inner diameter that is smaller than an outer diameter of the release element.
16. The system of claim 14, further comprising a catheter, wherein: the proximal end of the tether portion comprises a release element; the catheter comprises a plurality of arms at a distal end of the catheter; and a distal end of the plurality of arms arms has an inner diameter that is smaller than an outer diameter of the release element.
20. The system of claim 16, wherein the tether portion is extendable from the locking member proximally within the tubular wall of the end cap and the endoscope with which the end cap is engaged and is actuatable to cause deployment of the locking member with the loop portion off the distal end of the end cap and onto and encircling the tissue.
20. The system of claim 14, wherein the tether portion is extendable from the locking member proximally within the tubular wall of the end cap and the endoscope with which the end cap is engaged and is actuatable to cause deployment of the locking member with the loop portion off the distal end of the end cap and onto and encircling the tissue.
As shown in the mapping above, claims 1, 2, 4-16, and 20 of patent 12,114,860 includes all of the limitations of claims 1-6 and 8-14, 16, and 18-20 of the instant application, while also reciting further limitations.
Prior Art
The closest prior art of record, Bell et al. (US 20070225734) does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of independent claims 1, 11, and 16 which recites, inter alia “a tether portion extending….proximally through a lumen defined longitudinally through the tubular wall of the delivery device to a proximal end of the tubular wall of the delivery device, and proximally actuatable to move proximally through the lumen of the tubular wall of the delivery device to cause distal deployment of the loop portion off the outer surface of the distal end of the tubular wall of the delivery device and onto and encircling tissue”.
Regarding claim 1, Bell discloses a device for securing tissue (Figs. 25-30, para. 0072), the device comprising:
a loop portion 210 configured to be disposed on a distal end of a tubular wall of a delivery device 202, 208, external to and encircling an outer surface of the distal end of the tubular wall of the delivery device 202, 208 in a delivery configuration (see Figs. 25-26 which illustrates the loop portion 210 disposed on the distal end of the tubular wall of the tube 202 of the delivery device 202, 208, para. 0073: “a ligating catheter 208, which may be supported by the tube 202, bears, at its distal end, a ligating loop 210 that surrounds the tissue to be transected”), and configured to be secured about the tissue in a deployed configuration (Figs. 29-30, para. 0073: “As shown in FIG. 29, the ligating cord that forms the loop 210 is retracted in accordance with principles set forth above to ligate the tissue, e.g., the appendix”);
a locking member 302 disposed on the loop portion 210 (Figs. 31-33, para. 0093 discloses that the loop portion 210 may comprise a locking eye 302) and a tether portion 300 extending from the loop portion slidably through the locking member 302 (Fig. 33, para. 0093: “A locking eye 302 is connected to one end of the body 300, and at the opposite end 304 the body 300…The end 304 can be passed through the eye 302 to form the loop 210).
However, Bell fails to disclose a locking member comprising tabs or any structural equivalent thereof capable of engaging the protrusions along the tether portion (see 112(f) interpretation above).
Bell further teaches an alternative loop portion 452 comprising a locking member 454 disposed on the loop portion 452 (Figs. 36-37, para. 0109-0111 discloses that the loop portion may comprise a locking bevel 454 comprising spikes 464 that engage ratchet steps 466 of the loop portion to lock the loop portion around tissue; see 112(f) interpretation above).
The substitution of one known loop portion and locking member (ratcheted loop portion with locking member comprising spikes as shown in the embodiment shown in Figs. 36-37) for another (textured loop portion with locking eye as shown in the embodiment shown in Figs. 31-33) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the ratcheted loop portion with locking member comprising spikes shown in the embodiment shown in Figs. 36-37 would have yielded predictable results, namely, an alternative way to form the loop portion to inhibit ligation of tissue (para. 0109 of Bell); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Modified Bell further discloses that the tether portion is configured to extend proximally through a lumen defined longitudinally through a ligating catheter 208 surrounding the tube 202 of the delivery device 202, 208 (see Fig. 26 which illustrates the tether portion extending through a lumen of tube 208) to a proximal end of the ligating catheter 208 of the delivery device 202, 208, and proximally actuatable to move proximally through the lumen of ligating catheter 208 of the delivery device 202, 208 to cause distal deployment of the loop portion 210 off the outer surface of the distal end of the tubular wall of the tube 202 of delivery device 202, 208 and onto and encircling the tissue (Fig. 29, para. 0073: “As shown in FIG. 29, the ligating cord that forms the loop 210 is retracted in accordance with principles set forth above to ligate the tissue, e.g., the appendix”).
However, the claim requires that the loop portion is disposed on the same tubular wall which defines a lumen for the tether portion to be capable of extending through. Therefore, modified Bell fails to further disclose or suggest that the tether portion is capable of extending through a lumen defined longitudinally through the tubular wall of the inner tube 202 and therefore fails to disclose “a tether portion extending….proximally through a lumen defined longitudinally through the tubular wall of the delivery device to a proximal end of the tubular wall of the delivery device, and proximally actuatable to move proximally through the lumen of the tubular wall of the delivery device to cause distal deployment of the loop portion off the outer surface of the distal end of the tubular wall of the delivery device and onto and encircling tissue” as required in claim 1 and similarly in claims 11 and 16.
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tether portion in the device of modified Bell to proximally extend through the lumen of the inner tube 202 of Bell since it would require a substantial reconstruction and redesign of the elements shown in Bell as well as a change in the basic principle under which the modified Bell construction was designed to operate as the ligating catheter 208 moves relative to the tube 202 to push the loop forward (Fig. 28).
Because none of the prior art documents teach the device as claimed, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the technical solutions of claim 1 and similarly to claims 11 and 16 according to the prior art documents or a combination thereof. Therefore, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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