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
Applicant’s election without traverse of Group 1, claims 1-18, in the reply filed on 10/24/2025 is acknowledged.
Please note, that Group 1 encompasses claims 1-18, but only claims 1-15 and 17-18 are being presently examined because the claims set filed 10/10/2023 skips over claim 16 entirely.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claims 17-18 (and withdrawn claims 19-23) been renumbered as claims 16-17 and withdrawn claims 18-22, respectively.
Claims 1, 3-5, 8-12, 14-15, and 17-18 are objected to because of the following informalities:
Claim 1, line 5: “adapted to sealing engage rectal tissue” is not grammatically correct and should be amended to recite “adapted to sealingly engage rectal tissue” or “adapted to form a seal with rectal tissue” instead.
Claim 1, line 7: “the skin bumper a seal with the patient” is grammatically incorrect and should be amended to recite “the skin bumper to form a seal with the patient” or an equivalent thereof instead.
Claim 1, line 11: “and for a seal therewith” is grammatically incorrect and should be amended to recite “and form a seal therewith” instead.
Claim 3, line 2: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 3, last line: this claim does not end with a period, which is grammatically incorrect. It is recommended that the claim be amended such that it ends with a period.
Claim 4, lines 1, 3, and 4: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 4, line 4: “the portion” should be amended to recite “the first flange portion” to match the original naming basis.
Claim 5, lines 1 and 2: “a flange second portion” and “the flange second portion” are not grammatically correct and should be amended to recite “a second flange portion” and “the second flange portion” instead.
Claim 5, line 2: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 5, line 2: “the first flange” is believed to be an error and should be amended to recite “the first flange portion” instead.
Claim 8, line 2: “slidable received” is not grammatically correct and should be amended to recite “slidably received” instead.
Claim 9, line 2: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 10, line 2: “opening a first and second diameter” does not make sense. It is recommended that the claim be amended to recite “defining an opening comprising a first and second diameter” instead, or an equivalent thereof.
Claim 11, lines 3-4: “the locking tab second dimeter” should be amended to recite “the second diameter of the locking tab” instead.
Claim 12, line 1: “the hub” should be amended to recite “the central hub” to match the prior naming basis.
Claim 14, line 3: “compressed to retract movement” does not make sense, as PP [0037] does not describe any type of retraction movement caused by the bushing. It is recommended that this limitation be amended to recite “compressed to restrict movement” instead, which is supported by PP [0037] of the present specification.
Claim 15, line 1: “the rectal bumper include an inflatable cuff” is grammatically incorrect and should be amended to recite “the rectal bumper includes an inflatable cuff” instead.
Claim 15, line 2: “includes a channel therein include communications with the cuff” does not make sense and should be amended to recite “includes a channel therein in fluid communication with the cuff” instead.
Claim 17, lines 2 and 3: “the sheath” should match the original naming basis and be amended to recite “the flexible sheath” instead.
Claim 18, line 2: “portion and second longitudinal portion” is missing an article and should be amended to recite “and a second longitudinal portion” instead.
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: “locking mechanism” in claim 1.
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.
Claim 11 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 11, lines 4-5 recites “wherein when the locking tab is moved into the locking position, the” and then ends. Since this claim is incomplete, it is unclear what the limitation requires and claim 11 is therefore indefinite. It is recommended that this limitation be amended to either remove this incomplete limitation, or that the limitation be finished. Examination will continue disregarding this final limitation since it is unclear what it is attempting to claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 17 (please note that the claim 17 rejected below is marked as claim 18 on the claims filed 10/10/2023, but is referred to as claim 17 because the claim set skipped claim 16) are rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US PGPub 2020/0060719 A1) in view of Jasper et al. (US PGPub 2021/0315609 A1).
With respect to claim 1, Pacak et al. discloses an anorectal junction device (see Figs. 12A-21, see MPEP 2112.01, since the device contains all of the described functions it can be considered able to function as an anorectal junction device) comprising:
a guide tube (T in Fig. 12A) having a distal and proximal end defining a lumen there between (see lumen through T, see also Fig. 17), the lumen adapted to receive there through an endoscope (see lumen in Fig. 17, it is adapted to receive an endoscope);
a rectal bumper (204 in Fig. 12A) formed of a resilient material disposed on the guide tube distal end (see Fig. 12A, 204 is on a distal end of T), the rectal bumper (204) adapted to sealing engage rectal tissue when the guide tube (T) is inserted in a patient (PP [0127]: “for engaging the interior of the body of the patient”, see MPEP 2112.01);
a skin bumper (202) slidably disposed over the guide tube (T, see Figs. 12A-B, the skin bumper (202) being adapted to engage an intergluteal cleft of the patient (see MPEP 2112.01), the skin bumper (202) a seal with the patient (see MPEP 2112.01, 202 is configured to seal against a patient); and
a locking mechanism (207 interacting T, see Fig. 15) for selectively locking the position of the skin bumper (202) relative to the guide tube (T, see PP [0139]).
However, Pacak et al. fails to disclose a scope abutment apparatus disposed on the proximal end of the guide tube, the scope abutment apparatus adapted to selectively engage the endoscope and for a seal therewith.
In the same field of guide tubes to facilitate the insertion of endoscopes and other surgical tools (abstract), Jaspers et al. teaches a guide tube (6 in Fig. 8A) comprising a scope abutment apparatus (upper portion including 31, 52, and 55) disposed on the proximal end of the guide tube (6), the scope abutment apparatus (upper portion including 31, 52, and 55) adapted to selectively engage the endoscope and for a seal therewith (PP [0080]: “Turning the nut 55 will urge the ends 31a and 31b together, moving the sphere 11 to the locking position”, see Figs. 7A-B).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Pacak et al. device to incorporate the teachings of Jaspers et al. and include the abutment apparatus as claimed. One of ordinary skill in the art would have been motivated to perform this modification in order to enable selective anchoring of an inserted cannula or surgical instrument (such as an endoscope) within the guide tube, which would be desirable because doing so would help to stabilize the inserted instrument against the body during treatment, thus minimizing the risk of injury and improving efficiency of the procedure.
Regarding claim 2, Pacak et al. as modified by Jaspers et al. further discloses wherein the rectal bumper (204 in Fig. 12A of Pacak et al.) includes a collar secured to the guide tube distal end (inner surface of 203 which attaches to the trocar, see Figs. 12 and 17) and a flexible flange (body of balloon 204 is flexible and extends outwardly, therefore it is a flange) extending radially outward from the collar (the body of 204 extends radially outward from the inner surface of 203, see Figs. 12 and 17).
Regarding claim 3, Pacak et al. as modified by Jaspers et al. further discloses wherein the skin bumper (202 in Fig. 12A of Pacak et al.) includes a central hub (205-208 in Fig. 17) having a side wall defining an opening (209) through which the guide tube (T) extends, the hub (205-208) having a patient side (208) including a rounded top surface (see Fig. 21, 208 has a rounded surface).
Regarding claim 4, Pacak et al. as modified by Jaspers et al. further discloses wherein the hub (205-208 in Fig. 17 of Pacak et al.) has an opposed end (end of 207, see Figs. 20-21) having a generally flat end surface from which a generally elliptical shaped flange (212 and 213 are generally elliptical, see Figs. 20-21) extends, the flange (212 and 213) includes a first portion (212) extending from one side of the hub (205-208) and curves toward the guide tube distal end as the portion extends away from the hub (212 extends from the side of 207, which is part of the hub, and curves at its bottom edge, which is rounded, toward the distal end of the guide tube T, see Fig. 17).
Regarding claim 5, Pacak et al. as modified by Jaspers et al. further discloses wherein the flange includes a flange second portion (213 in Figs. 20-21 of Pacak et al.) extending from the hub (205-208) in a direction opposed to the first flange (212, 213 extends in all dimensions since it is a three-dimensional object, and furthermore 213 extends in a direction that does not align with 212, therefore 213 extends in a direction opposed to 212, see Fig. 20), the flange second portion (213) extends outwardly in a generally straight direction (see Fig. 20, 213 extends generally straight along the plane shown in this figure).
Regarding claim 6, Pacak et al. as modified by Jaspers et al. further discloses wherein the first and the second flange portions (212 and 213 in Figs. 20-21 of Pacak et al.) have a patient side surface (bottom surface of 212 and 213 with 300 therebetween) having an inverted V-shaped cross-section (a cross section of 212, 213, and 300 can be V-shaped when taken normal to the axis of the guide tube T, see splayed V-shape formed by 212 and 213, as well as the inverted V-shapes of the accordion folds of 300), the patient side surface tapers downwardly as the surface extends away from way from a flange centerline (this is broad language, the patient side surface tapers downwardly along the outer surfaces of 212 and 213, see Fig. 21 for the taper of the corner of 213, the edges of flanges 212 and 213 are also rounded and can be said to taper downwardly away from a flange centerline).
Regarding claim 7, Pacak et al. as modified by Jaspers et al. further discloses wherein a pad of a resilient material (300 in Figs. 20-21 of Pacak et al.) is adhered to the patient side surface of the flange (212 and 213) to aid in patient comfort and sealing (this is functional language, see MPEP 2112.01).
Regarding claim 8, Pacak et al. as modified by Jaspers et al. further discloses wherein the locking mechanism (207 in Fig. 15 of Pacak et al. interacting with T) includes a locking tab (241) slidable received in the central hub (205-208, 214 can slide inward relative to the hub 205-208), the locking tab (241) being selectively engageable with the guide tube (PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”, PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”).
Regarding claim 9, Pacak et al. as modified by Jaspers et al. further discloses wherein the locking tab (241 in Fig. 15 of Pacak et al.) has an unlocked position wherein the guide tube (T) slides freely within the hub (205-208, PP [0141]: “When the user applies sufficient thumb pressure to the button 241 to over-come the force of spring 243, the button 241 will engage the clamp 240 at point 251 causing the hinged clamp 240 to open-up and release its grip around the trocar. The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”) and a locked position wherein the locking tab (241) engages the guide tube (T) restricting movement (PP [0142]: “Releasing the thumb pressure from button 241 will cause the slidable collar 240 to clamp onto the trocar again”).
Regarding claim 10, Pacak et al. as modified by Jaspers et al. further discloses wherein the locking tab (241 in Fig. 15 of Pacak et al.) includes a surface (240) defining an opening (255) a first and second diameter (see Fig. 15, the opening 250 has a plurality of diameters defined by the level of compression of the wedge sections of the clamp 240), the first diameter being larger than the second diameter, the first diameter being larger than an outside diameter of the guide tube (PP [0141]: “The profile of the opening 252 in the tray portion 247 of the button 241 widens allowing the wedges 248 to move apart relative to the clamped position allowing the clamp space to open-up”).
Regarding claim 11, Pacak et al. as modified by Jaspers et al. further discloses wherein the locking mechanism (207 in Fig. 15 of Pacak et al. interacting with T) includes a plurality of longitudinally spaced annular grooves (see unmarked grooves on T in Fig. 17) formed on a guide tube outer wall (T), the grooves each having a diameter less than the outside diameter of the guide tube (see unmarked grooves on T in Fig. 17, there are portions with a smaller relative diameter than others), the locking tab (241) second dimeter being larger than the diameter of the grooves (see Fig. 17, when 241 is clamped the second diameter is larger than the grooves and does not bend or deform the trocar), wherein when the locking tab is moved into a locking position, the (see rejection above, this final limitation is not being examined because it is an incomplete sentence).
Regarding claim 12, Pacak et al. as modified by Jaspers et al. further discloses wherein the hub side wall (inner side wall of 205-208 in Fig. 17 of Pacak et al. defining opening 209) includes a pair of radially opposed slots (side slots defined by 256 which each wing of frame 247 is located in, see Fig. 15) in which the locking tab (241) slides across the central hub opening (209).
Regarding claim 13, Pacak et al. as modified by Krom et al. further discloses wherein the scope abutment apparatus (upper portion including 31, 52, and 55 in Fig. 8A, see also Figs. 7A-B) includes a resilient bushing (31) for receiving there through the endoscope (an endoscope can be inserted through ring 31), the bushing (31) having an adjustable inner diameter (see Figs. 7A-B, when 31a-b are compressed via knob 55 the inner diameter of bushing 31 changes).
Regarding claim 14, Pacak et al. as modified by Jasper et al. further discloses wherein the scope abutment apparatus (upper portion including 31, 52, and 55 in Fig. 8A, see also Figs. 7A-B) includes a base (31a-b) for receiving therein the bushing (31), a knob (55) is threadedly secured to the base (31a-b) wherein the knob (55) is movable between a compressed position where the bushing is compressed to retract movement of the endoscope (see Fig. 7B) and a released position wherein the bushing is not compressed to permit movement of the endoscope (see Fig. 7A).
Regarding claim 15, Pacak et al. as modified by Jasper et al. further discloses wherein the rectal bumper (204 in Fig. 12A of Pacak et al.) include an inflatable cuff (204 is an inflatable collar) and the guide tube (T) includes a channel therein include communication with the cuff (204) to provide a fluid connection to a fluid source for inflating and deflating the cuff (see helical duct 215 in Fig. 12A for providing fluid connection to 204).
Regarding claim 17 (which was incorrectly marked as claim 18 in the claim set filed 10/10/2025), Pacak et al. as modified by Jasper et al. further discloses wherein the guide tube (T in Fig. 12A of Pacak et al.) includes a first longitudinal portion and second longitudinal portion (portion above 202 and portion below 208), the first and second longitudinal portions (portion above 202 and portion below 208) being selectively joined and separated (this is functional language, see MPEP 2112.01, these portions are configured to be cut and then selectively joined and separated, note that the claim language does not describe any structural features that might enable a connection between multiple parts of the trocar).
Claim 16 (please note that the claim 16 rejected below is marked as claim 17 on the claims filed 10/10/2023, but is referred to as claim 16 because the claim set originally skipped claim 16) are rejected under 35 U.S.C. 103 as being unpatentable over Pacak et al. (US PGPub 2020/0060719 A1) in view of Jasper et al. (US PGPub 2021/0315609 A1), as applied to claim 1 above, and further in view of Piskun et al. (US PGPub 2008/0255519 A1).
Regarding claim 16 (which was incorrectly marked as claim 17 in the claim set filed 10/10/2025), Pacak et al. as modified by Jasper et al. fails to disclose a flexible sheath disposed within the guide tube and extending outwardly over the rectal bumper, the sheath retaining the rectal bumper in an insertion position and wherein removal of the sheath releases the rectal bumper to permit expansion of the rectal bumper.
In the same field of surgical access ports, Piskun et al. teaches a guide tube (see Figs. 2-3) and a flexible sheath (18, see PP [0101], the skirt is elastomeric and flexible) disposed within the guide tube (PP [0030]: “The skirt member is at least partially flexible and is attached to the body on the inner side thereof”) and configured to extend outwardly over a distal end of the guide tube (since skirt 18 is flexible, it is configured to invert to cover the distal end of the guide tube).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the combination of Pacak et al. and Jasper et al. to further incorporate the teachings of Piskun et al. and include the flexible sheath as taught such that the sheath retains the rectal bumper in an insertion position and wherein removal of the sheath releases the rectal bumper to permit expansion of the rectal bumper in order to “a protective barrier between laparoscopic instrument shafts (as well as their operative tips) and… wall tissues” (PP [0148], although this section refers to an alternate skirt embodiment it is still relevant to the embodiment of Figs. 2-3). Although the device of Piskun et al. is intended for deployment in an abdominal wall, it has separate utility in other various laparoscopic procedures (PP [0012]). Since the Piskun et al. reference shares a common goal with the alternate guide sheath devices of Pacak et al. and Jasper et al., combining these devices as proposed would constitute applying a known technique to improve similar devices in the same way, since adding the flexible sheath of Piskun et al. would add protection to the patient’s internal tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bridget E. Rabaglia whose telephone number is (571)272-2908. The examiner can normally be reached Monday - Thursday, 7am - 5pm.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771