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 .
Status of Claims
Claims 19-20, 24-26, and 30-31 are pending, claims 1-18, 21-23, 27-29, and 32-42 have been cancelled, and claims 19-20, 24-26, and 30-31 are currently under consideration for patentability under 37 CFR 1.104.
Response to Arguments
Applicant’s arguments with respect to claim(s) 19-20, 24-26, 30-31 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.
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: “an annular attachment mechanism” in claim 24.
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19-20, 24-26, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik (US 2006/0258904), in view of Nobis (US 2005/0261674) and Adams (US 2007/0078430).
Regarding claim 19, Stefanchik discloses a method of delivering a gastrostomy tube (figure 25-29), comprising: attaching a gastrostomy tube (600, figure 1b) to an endoscope (200, figure 1b); passing the endoscope and attached gastrostomy tube through an oral cavity and into a stomach (see figure 25); inserting a large bore needle (needle 22, figure 25) through an abdominal wall, a gastric wall, and into a lumen of the stomach (see figure 25); grabbing a distal loop of the gastrostomy tube (tether/suture 830, figure 38 | tether/suture can be a loop); pulling the distal loop distally such that the gastrostomy tube is pulled distally out of the stomach (figure 29); and attaching the gastrostomy tube to the abdominal wall and the gastric wall (see figure 30). Stefanchik is silent regarding after attaching the gastrostomy tube to the endoscope, passing the endoscope and attached gastrostomy tube together through an oral cavity and into a stomach; grabbing a distal loop of the gastrostomy tube with the large bore needle
Nobis teaches an endoscope (100, figures 4a and 15) with a rail (30, figure 4a). A first device (118, figure 15) may be a feeding tube that is introduced onto the rail and advanced distally along the rail ([0084]). The rail can be positioned within the body lumen by being associated with an endoscope which is introduced into the body lumen ([0084]). The rail is supported on the endoscope prior to insertion of the endoscope into the patient ([0044]).
Adams teaches a kit (111, figure 7) for positioning a guide element in a patient ([0013]). A dual-function tool (113, figure 7) has a needle tip (115, figure 7) at the distal end to insert through an incision and extend into the patient’s stomach (abstract; same manner as a style 19 [0043]). A j-hook (117, figure 7 | same manner as tool 15 [0043]) is used to catch a looped leading end (see P, figure 4e) and withdraw into the cannula (17, figure 7).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the method to use a rail (30, figure 4a) supported on the endoscope prior to insertion of the endoscope into the patient ([0044]) as taught by Nobis. Doing so would allow the rail to be positioned near a field of view or distal end of the endoscope prior to insertion into a patient ([0044]). Further, it would have been obvious to modify the method to use a large bore needle with a built in j-hook (117, figure 7). Doing so would provide a dual-function tool (113, figure 7; [0043]). The modified method would comprise after attaching the gastrostomy tube to the endoscope (feeding tube 600 can be positioned on the carrier 500 outside of the patient’s body [0121]; Stefanchik | rail 30 can be supported on the endoscope prior to insertion of the endoscope into the patient [0044]; Nobis), passing the endoscope and attached gastrostomy tube together through an oral cavity and into a stomach (the modified method would have both the feeding tube and carrier/rail positioned on the endoscope prior to insertion into the patient); grabbing a distal loop of the gastrostomy tube with the large bore needle (see j-hook 117, figure 7; Adams).
Regarding claim 20, Stefanchik further discloses pulling the distal loop distally disengages the gastrostomy tube from the endoscope (as feeding tube is pushed off the sheath assembly…grasped with…[0128]; Stefanchik).
Regarding claim 24, Stefanchik further discloses attaching the gastrostomy tube to the endoscope comprises placing an annular attachment mechanism (this element is interpreted under 35 USC 112f as continuous lobes | endcap 400, figure 2a, see carrier 500, figure 2, track 300, figure 3; Stefanchik) around a distal tip of the endoscope (endcap 400 disposed at the distal end [0071]) and extending the gastrostomy tube parallel to the endoscope (see figures 2-3).
Regarding claim 25, Stefanchik further discloses disengaging the gastrostomy tube from the endoscope by pulling laterally on the distal loop (as feeding tube is pushed off the sheath assembly…grasped with…[0128]; Stefanchik). Laterally pulling on 830 can also disengage from the gastronomy tube (see figure 28).
Regarding claim 26, Stefanchik further discloses the endoscope is left in the stomach during the step of pulling the distal loop distally (see figures 28-29).
Regarding claim 30, Stefanchik and Adams further disclose the large bore needle comprises an inner stylet (113, figure 7; Adams) and an outer sheath (17, figure 7; Adams | 24, figure 25; Stefanchik), and wherein grabbing the distal loop of the gastrostomy tube with the large bore needle comprises grabbing the distal loop with a groove in the inner stylet (see 117, figure 7; Adams).
Regarding claim 31, Stefanchik further discloses pushing the outer sheath over the distal loop when the distal loop is positioned in the groove (24 can be pushed over the distal loop caught by 32, see figure 28 of Stefanchik) prior to the step of pulling the distal loop distally (24 is withdrawn along with pulling the distal loop, see figure 29).
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
March 11, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795