DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of each species/subspecies, identified below, in the reply filed on 08/23/2024, is acknowledged.
A. Sleeve:
Species b: Sleeve 15 as illustrated in Fig. 127.
B. Aft Balloon:
Species c: Aft Balloon 20A as illustrated in Figs.
124 and 125.
C. Fore Balloon:
Species a: Fore Balloon 35 as illustrated in Fig. 1;
D. Push Tubes:
Species b: Push tubes 30 configured to move independently from each other as illustrated in Fig. 126.
E. Base:
Species b: Base 25A as illustrated in Figs. 20-25;
i. Body type
Species 1. C-shaped body 220 illustrated in Figs. 23, 25 and 31;
ii. Knobs
Species 1. Knob 240 illustrated in Fig. 26
F. Inflation Mechanism:
Species d: Hand Inflator 300
i. Valve
Species 1. Multi-valve 345 as illustrated in Figs. 39-58;
ii. Aft Balloon Indicator 355 and Fore Balloon Indicator 350 Mechanisms
Species 1. Piston 385 with tubular pliable extension 400 as illustrated in Figs. 50-[51];
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/2025 has been entered.
Response to Amendment
The amendment filed 11/26/2025 has been entered. In the present application, claims 41, 46, and 48-63 are currently pending in the application. Claims 1-40, 42-45, and 47 have been canceled. Claims 61 and 62 have been amended. Claim 63 is newly added.
Response to Arguments
Applicant’s arguments, dated 11/26/2025, regarding the pending claims have been considered. Claims 41, 46, and 48-60 were previously identified as allowable in previous office action. Applicant has not amended Claims 41, 46, and 48-60.
However, Applicant has amended independent claims 61 and 62, thus changing the scope of the remaining pending claims 61-63. Therefore, the objections and rejections regarding claims 61-63 and identified in the final office action dated 05/28/2025 have been withdrawn.
However, upon further consideration, a new ground of rejection is made below. Please see section 35 U.S.C. §103 below for further clarification.
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:
Inflation mechanism in claims 58 and 63, which has structural support in the specification, starting on page 34 line 22 stating, “ …inflation mechanism 40 comprises a hand inflator 300 also formed in accordance with the present invention. Hand inflator 300 generally comprises a housing 305 carrying a bulb or "pump" 310, an aft balloon inflation line 315 (for connection to fitting 46 of apparatus 5, see Fig. 1), a fore balloon inflation line 320 (for connection to fitting 56 of apparatus 5, see Fig. 1), and internal pneumatic apparatus 325 (Fig. 42) for directing air between pump 310 and aft balloon inflation line 315 and fore balloon inflation line 320 (and for venting air from aft balloon inflation line 315 and fore balloon inflation line 320), all as will hereinafter be discussed.”
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.
Allowable Subject Matter
Claims 41, 46, and 48-60 are allowed.
The following is an examiner statement of reasons for allowance:
The prior art fails to teach, among other features, an apparatus comprising: a sleeve adapted to be slid over an exterior of an endoscope, the sleeve comprising a proximal end and a distal end; a pair of push tubes slidably mounted to the sleeve, the pair of push tubes each comprising a proximal end and a distal end; a fore balloon secured to the distal end of the pair of push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition; and a push tube handle secured to the proximal end of the pair of push tubes for moving the pair of push tubes relative to the sleeve; and a base secured to the sleeve at the proximal end of the sleeve, wherein the base is configured to support and guide the push tube handle as the push tube handle moves the pair of push tubes relative to the sleeve; wherein the base comprises an extension having a center slot and a pair of side slots, and further wherein the extension comprises at least one fitting for inflating or deflating the fore balloon; wherein the push tube handle comprises a C-shaped body having a center locking element and a pair of finger grips mounted thereto such that the push tube handle can be (i) locked in position relative to the extension by the center locking element, whereby to lock the fore balloon in position, and (ii) moved distally or proximally relative to the extension, whereby to move the fore balloon distally or proximally; wherein the center locking element comprises a screw shaft and a screw knob, and further wherein the push tube handle is mounted within the extension of the base so that the screw shaft is slidably received in the center slot of the extension and so that the pair of finger grips are slidably received in the pair of side slots in the extension; and wherein torsion can be applied to the fore balloon by moving one of the pair of finger grips distally while pulling the other of the pair of finger grips proximally.
Gad Turliuc (US7963911) teaches the above apparatus except for a base secured to the sleeve at the proximal end of the sleeve, wherein the base is configured to support and guide the push tube handle as the push tube handle moves the pair of push tubes relative to the sleeve; wherein the base comprises an extension having a center slot and a pair of side slots, and further wherein the extension comprises at least one fitting for inflating or deflating the fore balloon; wherein the push tube handle comprises a C-shaped body having a center locking element and a pair of finger grips mounted thereto such that the push tube handle can be (i) locked in position relative to the extension by the center locking element, whereby to lock the fore balloon in position, and (ii) moved distally or proximally relative to the extension, whereby to move the fore balloon distally or proximally; wherein the center locking element comprises a screw shaft and a screw knob, and further wherein the push tube handle is mounted within the extension of the base so that the screw shaft is slidably received in the center slot of the extension and so that the pair of finger grips are slidably received in the pair of side slots in the extension; and wherein torsion can be applied to the fore balloon by moving one of the pair of finger grips distally while pulling the other of the pair of finger grips proximally.
There is no reason or suggestion provided in the prior art to modify the above prior art to have the additional features as claimed above, and the only reason to modify the references would be based on Applicant’s disclosure, which is impermissible hindsight reasoning.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 61-63 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Skerven et al. (US2007/0270897) hereinafter Skerven, in view of Boris Reydel (US2012/0232342) hereinafter Reydel.
Regarding Claim 61, Skerven discloses an apparatus (Fig. 2) comprising:
an endoscope (Fig. 2 cholangioscope 50, [0034] “Lumen 28 is sized to be disposed on an exterior surface of a first endoscope, such as cholangioscope 50 of FIG. 2.”) having a distal end (Fig. 2 distal end 54), a proximal end (Fig. 2 near hub module 80) and an exterior surface (Figs. 2, 4 surface of cholangioscope 50) extending between the distal end (Fig. 2 distal end 54) and the proximal end (Fig. 2 near hub module 80);
at least one push tube (Fig. 4 cuff member 22’) slidably mounted ([0037] “…cuff member 22′ may be movable when disposed on cholangioscope 50. In this embodiment, cuff member 22′ preferably has a more rigid configuration, e.g., manufactured from rigid plastic or stainless steel. Cuff member 22′ preferably has a non-variable inner diameter that is slightly larger than an external diameter of cholangioscope 50 and is disposed for longitudinal movement with respect to cholangioscope 50…”) to the exterior surface (Figs. 2, 4 surface of cholangioscope 50) of the endoscope (Fig. 2 cholangioscope 50), the at least one push tube (Fig. 4 cuff member 22’) comprising a proximal end (Fig. 4 proximal end 25’) and a distal end (Fig. 4 distal end 26’); and
a balloon (Fig. 4 balloon 30) secured to the distal end (Fig. 4 distal end 26’) of the at least one push tube (Fig. 4 cuff member 22’);
wherein the at least one push tube (Fig. 4 cuff member 22’) comprises a handle (Fig. 2 proximal end of push rod 78 via actuation device 46) for moving ([0037, 0051]) the at least one push tube (Fig. 4 cuff member 22’) relative to the endoscope (Fig. 2 cholangioscope 50) so as to move the balloon (Fig. 4 balloon 30) distal to the distal end (Fig. 2 distal end 54) of the endoscope (Fig. 2 cholangioscope 50), wherein the balloon (Fig. 4 balloon 30) is capable of assuming a deflated condition and an inflated condition ([0028] “ Distal end 42 of inflation means 40 is in fluid communication with balloon 30 and includes an inflation lumen for the passage of an inflation fluid that may be used to selectively inflate and deflate the balloon.”, [0037], [0051]), and further wherein (i) when the balloon (Fig. 4 balloon 30) is in the deflated condition ([0028]), an axial opening (Fig. 1 axial opening of lumen 28 near reference numeral 28 of Fig. 1) extends through the balloon (Fig. 4 balloon 30) for receiving the endoscope (Fig. 2 cholangioscope 50) therein (Fig. 2 illustrates balloon 30 circumferentially surrounds cholangioscope 50, [0034] “Lumen 28 is sized to be disposed on an exterior surface of a first endoscope….”, [0051]), and the balloon (Fig. 4 balloon 30) is moved distal to the distal end (Fig. 2 distal end 54) of the endoscope (Fig. 2 cholangioscope 50) and inflated to the inflated condition ([0051] “… balloon 30 may be inflated and deflated multiple times during the stone removal procedure…then cuff member 22′ may be retracted and advanced independently of cholangioscope 50 to help urge stone fragments 85 into duodenum D.”)
Skerven discloses the balloon capable of inflating/deflating and longitudinal movement along the distal end of the endoscope ([0028,0037,0051]) but fails to explicitly disclose where (ii) when the balloon is inflated to the inflated condition, the axial opening is closed down.
However Reydel, in the same field of endeavor, teaches a balloon (Reydel – Fig. 12A dome 1210, [0050] “FIGS. 12 a and 12 b show yet another embodiment of a transparent dome 1210 in the form of a balloon…”) capable of being inflated/deflating (Reydel –[0050-0054]) and when the balloon (Reydel – Fig. 12A dome 1210) is inflated to the inflated condition ([0052] hyper-inflated), the axial opening (Reydel – Fig. 12a, [0052] “The transparent dome 1210 is shown in FIG. 12 a as being hyper-inflated to a first level of inflation such that the transparent dome 1210 extends to be more distal than, and generally surrounds, the distal tip of the catheter 1224, and the therapeutic device 1226. By surrounding the distal tip of the catheter 1224 and the therapeutic device 1226, the scope 120 and hyper-inflated transparent dome 1210 may be more easily and safely further inserted into a bodily cavity. Thus, after hyper-inflating the transparent dome as shown in FIG. 12 a, the user may further insert the scope 120 and hyper-inflated transparent dome 1210 into the bodily cavity.”) is closed down (Reydel – [0052]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Skerven to include (ii) when the balloon is in the inflated condition, the axial opening is closed down as taught by Reydel to have the benefit of “safely further insert[ing] … the scope…into the body cavity” (Reydel – [0052]).
Regarding Claim 62, Skerven discloses a method (abstract) for performing a procedure in a body lumen and/or body cavity, the method comprising:
providing an apparatus (Fig. 2) comprising:
an endoscope (Fig. 2 cholangioscope 50, [0034] “Lumen 28 is sized to be disposed on an exterior surface of a first endoscope, such as cholangioscope 50 of FIG. 2.”) having a distal end (Fig. 2 distal end 54), a proximal end (Fig. 2 near hub module 80) and an exterior surface (Figs. 2, 4 surface of cholangioscope 50) extending between the distal end (Fig. 2 distal end 54) and the proximal end (Fig. 2 near hub module 80)
at least one push tube (Fig. 4 cuff member 22’) slidably mounted ([0037] “…cuff member 22′ may be movable when disposed on cholangioscope 50. In this embodiment, cuff member 22′ preferably has a more rigid configuration, e.g., manufactured from rigid plastic or stainless steel. Cuff member 22′ preferably has a non-variable inner diameter that is slightly larger than an external diameter of cholangioscope 50 and is disposed for longitudinal movement with respect to cholangioscope 50…”) to the exterior surface (Figs. 2, 4 surface of cholangioscope 50) of the endoscope (Fig. 2 cholangioscope 50), the at least one push tube (Fig. 4 cuff member 22’) comprising a proximal end (Fig. 4 proximal end 25’) and a distal end (Fig. 4 distal end 26’); and
a balloon (Fig. 4 balloon 30) secured to the distal end (Fig. 4 distal end 26’) of the at least one push tube (Fig. 4 cuff member 22’);
wherein the at least one push tube (Fig. 4 cuff member 22’) comprises a handle (Fig. 2 proximal end of push rod 78 via actuation device 46) for moving ([0037, 0051]) the at least one push tube (Fig. 4 cuff member 22’) relative to the endoscope (Fig. 2 cholangioscope 50), wherein the balloon (Fig. 4 balloon 30) is capable of assuming a deflated condition and an inflated condition ([0028] “ Distal end 42 of inflation means 40 is in fluid communication with balloon 30 and includes an inflation lumen for the passage of an inflation fluid that may be used to selectively inflate and deflate the balloon.”, [0037], [0051]),;
positioning (Figs. 5B-E) the apparatus (Fig. 2) in the body lumen and/or body cavity (Figs. 5B-E bile duct B) while the balloon (Fig. 4 balloon 30) is disposed in the deflated condition (Fig. 5B) and disposed on the exterior surface (Figs. 2, 4 surface of cholangioscope 50) of the endoscope (Figs. 2, 4 cholangioscope 50), wherein the balloon (Fig. 4 balloon 30) comprises an axial opening (Fig. 1 axial opening of lumen 28 near reference numeral 28 of Fig. 1) for receiving (Fig. 2 illustrates balloon 30 circumferentially surrounds cholangioscope 50, [0034] “Lumen 28 is sized to be disposed on an exterior surface of a first endoscope….”, [0051]), the endoscope (Figs. 2, 4 cholangioscope 50) when the balloon (Fig. 4 balloon 30) is in the deflated condition (Fig. 5B);
advancing ([0037-0051])the at least one push tube distally to position the balloon (Fig. 4 balloon 30) distal to the distal end (Fig. 2 distal end 54) of the endoscope (Figs. 2, 4 cholangioscope 50);
inflating ([0051]) the balloon (Fig. 4 balloon 30) to the inflated condition (Figs. 5C-E), and
performing the procedure ([0051]).
Skerven is silent as to explicitly disclose wherein when the balloon is in the inflated condition, the axial opening is closed down.
However Reydel, in the same field of endeavor, teaches a balloon (Reydel – Fig. 12A dome 1210, [0050] “FIGS. 12 a and 12 b show yet another embodiment of a transparent dome 1210 in the form of a balloon…”) capable of being inflated/deflating (Reydel –[0050-0054]) and when the balloon (Reydel – Fig. 12A dome 1210) is inflated to the inflated condition ([0052] hyper-inflated), the axial opening (Reydel – Fig. 12a, [0052] “The transparent dome 1210 is shown in FIG. 12 a as being hyper-inflated to a first level of inflation such that the transparent dome 1210 extends to be more distal than, and generally surrounds, the distal tip of the catheter 1224, and the therapeutic device 1226. By surrounding the distal tip of the catheter 1224 and the therapeutic device 1226, the scope 120 and hyper-inflated transparent dome 1210 may be more easily and safely further inserted into a bodily cavity. Thus, after hyper-inflating the transparent dome as shown in FIG. 12 a, the user may further insert the scope 120 and hyper-inflated transparent dome 1210 into the bodily cavity.”) is closed down (Reydel – [0052]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Skerven to include (ii) when the balloon is in the inflated condition, the axial opening is closed down as taught by Reydel to have the benefit of “safely further insert[ing] … the scope…into the body cavity” (Reydel – [0052]).
Regarding Claim 63, Skerven in view of Reydel teaches the apparatus of claim 61 further comprising an inflation mechanism for inflating and deflating the balloon (Examiner’s Note: As the claim interpretation section states above, the inflation mechanism is being interpreted as a hand inflator. Here Skerven teaches a hand inflator in the actuation device 46 using a button by hand to enable the inflation. Skerven – [0033] “The proximal end of inflation means 40 is coupled to actuation device 46, as depicted in FIG. 2. In one embodiment, actuation device 46 may comprise a button (not shown) configured to enable the physician to selectively inflate and deflate balloon 30. The proximal end of actuation device 46 may be coupled to an inflation source (not shown) capable of providing fluid such as air, saline, and the like to inflation means 40 via actuation device 46.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795