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 .
Detailed Action
This is response to the amendment filed 07/17/2026.
Allowable Subject Matter
Claims 29, 30, 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 29 recites wherein the flared portion comprises a gripping surface having a plurality of teeth that secure the flared portion at about the distal end of the tube. Claim 40 recites wherein a cap is coupled to a proximal end of the flared portion and a fastener is coupled to a distal end of the flared portion, wherein the cap and fastener are configured to further secure the flared portion at about the distal end of the tube.
The Office agrees the art of record fail to teach or suggest these features.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 21, 22, 31-34 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication Number 2016/0015544 (Holseten et al.)
Regarding claim 21, 22, 31 Holsten et al. discloses as shown in Figures 2, 4, a calibration tube for a sleeve gastrectomy, comprising: (a) a tube (tube 110, see paragraph [0024]) having a proximal end and a distal end with a length extending therebetween, wherein the tube is capable of being inserted into an interior of a stomach, the stomach having a lesser curvature and a greater curvature and wherein the tube is cylindrical in shape (Figure 2 shows the tube is half a cylinder and thus cylindrical); (b) at least one light source comprising a plurality of light elements (light sources 148, see paragraph [0024]) disposed along the length of the tube (see Figure 2), wherein one or more of the plurality of light elements is disposed on a portion of the tube capable of indicating accurate placement of the tube relative to the stomach at a predetermined anatomical landmark; and (c) at least one channel (groove 136, see paragraph [0030]) formed in the tube, wherein the predetermined anatomical landmark is an incisura angularis, and wherein after being inserted into the interior of the stomach, of the tube having the one or more plurality of light elements is positioned at about the incisura angularis along the lesser curvature of the stomach, wherein the calibration tube is capable of use with a sleeve gastrectomy stapler having a first end and a second end configured to be positioned on an exterior of the stomach relative to and anatomically lateral to the tube to define a resection line, wherein operating the stapler provides a complete gastrectomy staple line along the resection line to resect a portion of the stomach to form a sleeve.
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holsten et al. to rearrange the location of the light sources 148 such that they were on tube 110 and disposed along its length because it would only require a rearrangement of parts without changing how the device operates (lights would still illuminate operating area) and this has been recognized as obvious to one of ordinary skill in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holsten et al. such that the tube is cylindrical in shape as matter of engineering design choice. Applicant has not disclosed that the shape of the tube being cylindrical provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0038].
One of ordinary skill in the art, furthermore, would have expected Holsten’s tube, and applicant’s invention, to perform equally well with either shape because both spacing dimensions would perform the same function of calibrating for sleeve gastrectomy equally well considering the relative dimensions disclosed.
Regarding claims 32-34, Holsten et al. discloses as shown in Figures 2, 4, a gastric calibration tube for performing sleeve gastrectomies, comprising: (a) a tube (tube 110, see paragraph [0024]) having a predetermined length, wherein the tube is configured to be inserted into an interior of a stomach, the stomach having a lesser curvature and a greater curvature and wherein the tube is cylindrical in shape (Figure 2 shows the tube is half a cylinder and thus cylindrical); (b) a first light source having a plurality of light elements (six of eight light sources 148, see paragraph [0024]) disposed along the length of the tube; (c) a second light source (one of the remaining light sources 148, see paragraph [0024]) having at least one light element positioned at a portion of the tube for indicating accurate placement of the tube relative to the stomach at a predetermined anatomical landmark, wherein after being inserted, the portion of the tube having the second light source is positioned along the lesser curvature of the stomach; and (d) at least one channel (groove 136, see paragraph [0030]) formed in the tube for suction or inflation, wherein the predetermined anatomical landmark is an incisura angularis, wherein the tube further comprises a proximal end and a distal end with the predetermined length extending therebetween.
Holsten et al. fails to disclose the first and second light sources are on the tube.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holsten et al. to rearrange the location of the light sources 148 such that they were on tube 110 and disposed along its length because it would only require a rearrangement of parts without changing how the device operates (lights would still illuminate operating area) and this has been recognized as obvious to one of ordinary skill in the art. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Alternatively, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holsten et al. such that the tube is cylindrical in shape as matter of engineering design choice. Applicant has not disclosed that the shape of the tube being cylindrical provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0038].
One of ordinary skill in the art, furthermore, would have expected Holsten’s tube, and applicant’s invention, to perform equally well with either shape because both spacing dimensions would perform the same function of calibrating for sleeve gastrectomy equally well considering the relative dimensions disclosed.
Claim(s) 23, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0015544 (Holseten et al.) in view of U.S. Patent Publication Number 2001/0031975 (Whitman et al.)
Regarding claims 23, 35 Holseten et al. fails to disclose wherein the plurality of light elements comprise at least one optic fiber, at least one LED, or combinations thereof, wherein the first light source and the second light source each comprise at least one optic fiber, at least one LED, or combinations thereof.
Whitman, from a related field of endeavor teaches a similar light element as show in Figure 1, wherein the light element is in the form an LED. See paragraph [0076].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holseten by substituting the light element disclosed by Holseten for the LED taught by Whitman or substituting the first light source and the second light source disclosed by Holseten for the LED taught by Whitman et al. each comprise at least one optic fiber, at least one LED, or combinations thereof because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 24-28, 36-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0015544 (Holseten et al.) in view of U.S. Patent Publication Number 2013/0165774 (Nocca)
Regarding claims 24-28, 36-39 Holseten et al. fails to disclose wherein the portion is a flared portion at about the distal end of the tube, wherein the tube has a first diameter and the flared portion has a second diameter larger than the first diameter, wherein the flared portion comprises a singular balloon that is inflated and deflated from at about the proximal end of the tube.
Nocca, from the same field of endeavor teaches a similar tube as shown in Figure 4, wherein the portion is a flared portion (portion where balloon 25 extends, see paragraph [0055]) at about the distal end of the tube, wherein the tube has a first diameter and the flared portion has a second diameter larger than the first diameter, wherein the flared portion comprises a singular balloon that is inflated and deflated from at about the proximal end of the tube, wherein the flared portion comprises a first flared portion (left portion of balloon) and a second flared portion (right portion of balloon), wherein the first flared portion is pivotally coupled to the second flared portion, wherein the first flared portion is pivotally coupled to the second flared portion through a hinge (middle portion of balloon), for the purpose of creating a reference point on one side of the tube. See paragraph [0020].
It would have been obvious to one of ordinary skill in the art to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holseten et al. to include the balloon taught by Nocca such that the portion is a flared portion at about the distal end of the tube, wherein the tube has a first diameter and the flared portion has a second diameter larger than the first diameter, wherein the flared portion comprises a singular balloon that is inflated and deflated from at about the proximal end of the tube.
Response to Arguments
Applicant's arguments filed 07/17/2026, see pages 7-10 have been fully considered but they are not persuasive.
The applicant argues Holsten et al. fails to disclose the tube has a cylindrical shape because Holsten discloses the tube has a non-circular cross-section. In response, the Office respectfully disagrees for several reasons. First, Holsten et al. only discloses part of the tube has non-circular cross-section. See abstract. Thus, Holsten et al. necessarily teaches the tube has other parts with a circular cross-section and would be in the shape of cylinder. Second, the plain and ordinary meaning of the term “cylindrical” according to webster’s dictionary is relating to or having the form or properties of a cylinder (which is not inconsistent with the specification). Something which is cylindrical is not necessarily a cylinder and thus non-circular cross-section is not excluded from being considered a cylinder. On the contrary, Figure 2 of Holsten et al. clearly shows tube 110 has half the shape of a cylinder and is thus relates or has the properties of cylinder and is thus cylindrical.
Regardless, the Office has issued the new ground of rejection that it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tube disclosed by Holsten et al. such that the tube is cylindrical in shape as matter of engineering design choice. Applicant has not disclosed that the shape of the tube being cylindrical provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0038].
One of ordinary skill in the art, furthermore, would have expected Holsten’s tube, and applicant’s invention, to perform equally well with either shape because both spacing dimensions would perform the same function of calibrating for sleeve gastrectomy equally well considering the relative dimensions disclosed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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