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 of Group I (claims 29-54) and Species A, Figs. 5A-H in the reply filed on 12/19/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 55-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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: surgical apparatus (an apparatus for surgery); an operating element for operating the surgical apparatus 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.
Claims 39, 46, and 51 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 39 recites the limitation "the counter element" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it will be presumed that claim 39 should depend from claim 37, which provides proper antecedent basis for “the counter element”.
Claim 51 recites the limitation "the fixation device" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it will be presumed that claim 51 should depend from claim 50, which provides proper antecedent basis for “the counter element”.
Regarding claim 46, the phrase "especially" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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(s) 29-31, 34-47, 50, and 52-54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0100971 A1 to McGuckin, Jr. (hereinafter “McGuckin”).
Regarding claim 29, McGuckin discloses (see abstract; Figs. 1-21; and [0052]-[0066]) an apparatus for endoscopic anastomosis of the stomach and the bowel of a patient to allow food to bypass the duodenum (see last sentence of [0064]), comprising: a tube (14) insertable into the stomach (see [0052]), the tube having a proximal end (near #16, Fig. 1) and a distal end (near #15, Fig. 1); surgical apparatus (32, which is a cutting device equivalent under 112f to the cutting device disclosed in the spec.) which is deployable at the distal end of the tube and is at least partially insertable through the tube (see Figs. 8-9 and [0062]); and at least one operating element (30, [0062], which is an internal tube equivalent under 112f to the internal tube disclosed in the spec.) connected or connectable to the surgical apparatus for operating the surgical apparatus from the proximal end (see [0062]); wherein the surgical apparatus is configured for establishing anastomosis between a first area of the stomach ("S") and a second area of the bowel ("B") (see [0061]-[0064] and Fig. 20).
McGuckin further discloses (claim 30) wherein the surgical apparatus comprises a cutting device (32) for cutting tissue (see [0062] and Figs. 9-10); (claim 31) wherein the cutting device is rotatable in the direction along the circumference of the tube (see Fig. 9, 30/32 are fully capable of being rotated in a direction along a circumference of the tube); (claim 34) wherein the cutting device is mounted on a shaft (33), wherein the cutting device is fully capable of cutting a closed-loop shape aperture in tissue (see Figs. 9-10, the shape in the tissue that is cut would be a closed-loop having a circumference closely matching the outer circumference of the needle 32), the closed loop shape extending around an axis of the shaft (see Figs. 9-10); (claim 35) wherein the cutting device, when deployed for cutting, has a cutting element and/or cutting surface facing towards the distal end of the tube (see Fig. 9); (claim 36) wherein the cutting device, when deployed, is configured for cutting tissue in a cutting direction towards the distal end of the tube (see Fig. 9); (claim 37) wherein the cutting device is configured for cutting tissue from a first side, and the apparatus further comprises a counter element (34) deployable on an opposite second side of the tissue (see Fig. 10 and [0062]); (claim 38) wherein the cutting device is positioned distally of the counter element, at least in the deployed configuration of the cutting device (see Fig. 10, 32 is distal of 34); (claim 39) wherein the counter element is configured to protect surrounding tissue on the second side from the cutting device (see Fig. 11, element 34 protects bowel tissue from being inadvertently pierced or cut by the needle); (claim 40) wherein the counter element is convertible between (i) a stowed configuration for introduction to the first and/or second area, the stowed configuration having a first lateral profile about an axis of the tube (see Fig. 9); and (ii) a deployed configuration having a second lateral profile about an axis of the tube larger than the first lateral profile (see Fig. 10); (claim 41) wherein the cutting device comprises a piercing element (see [0062] and Fig. 9); (claim 42) wherein the cutting device is movable during cutting in an axial direction (see Figs. 9-10); (claim 43) wherein the apparatus comprises at least one insertable element (stent 52) insertable through a tissue wall at the first and/or second area, the insertable element having a stowed configuration for introduction through the tissue wall (see Fig. 18), and being expandable to a deployed configuration for overlapping, at least partially, tissue of the tissue wall (see Figs. 19-20); (claim 44) wherein the insertable element is movable relative to the tube up to 20 cm from a distal end of the tube (see Figs. 19-20); (claim 45) wherein the distal region of the insertable element in the stowed configuration comprises a second cutting device for piercing and/or cutting tissue (see Figs. 19-20 and [0064]); (claim 46) wherein at least two of: the insertable element in the deployed configuration (see Fig. 19); the counter element in the deployed configuration (see Fig. 11); or the cutting device, are adapted to form an interface to enclose tissue, especially the first area and/or second area; (claim 47) wherein the insertable element is foldable radially outward from the longitudinal axis of the tube from the stowed configuration into the deployed configuration (see Figs. 18-19); (claim 50) wherein, the apparatus comprises a fixation device, wherein the fixation device is designed to suture and/or staple the outer edges of the first area and the second area (see [0064]); (claim 52) wherein the device comprises a second tube (12), wherein a distal end of the second tube is guidable from the stomach through the duodenum and connectable with the distal end of the tube across the stomach wall of the first area and the bowel wall of the second area (see Fig. 7 and [0061]); (claim 53) wherein the apparatus comprises a guiding wire (shown in Fig. 15), wherein the tube is fully capable of being guided along the guiding wire to enclose the first area (see Fig. 15, can push tube 14 of endoscope 10 distally along the wire shown if desired); (claim 54) wherein the apparatus is configured to create the anastomosis by insertion of the apparatus into the body via a single orifice, the orifice being a natural body orifice (see [0052] and [0061]).
Claim(s) 29 and 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2010/0191264 A1 to Kassab et al. (hereinafter “Kassab”).
Regarding claim 29, Kassab discloses (see abstract; Figs. 1A-15; and [0043]-[0087]) an apparatus (as shown in the Figures) for endoscopic anastomosis of the stomach and the bowel of a patient to allow food to bypass the duodenum (see abstract and [0087]), comprising: a tube (112) insertable into the stomach (see [0075]), the tube having a proximal end (118) and a distal end (120); a surgical apparatus (198, which is a cutting device equivalent under 112f to the cutting device disclosed in the spec.) which is deployable at the distal end of the tube and is at least partially insertable through the tube (see Figs. 2A-B and [0062]); and at least one operating element (catheter 90) connected or connectable to the surgical apparatus for operating the surgical apparatus from the proximal end (see [0062]); wherein the surgical apparatus is configured for establishing anastomosis between a first area of the stomach and a second area of the bowel (see [0073]/[0087]).
Kassab further discloses (claim 49) wherein the apparatus comprises a pressure device (vacuum port 130 and vacuum source, see [0076]) for selectively applying a negative pressure to at least one area in the tube for retaining a distal end of the apparatus to tissue (see [0076]).
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.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of US2011/0295055 A1 to Albrecht et al. (hereinafter “Albrecht”).
Regarding claim 48, McGuckin discloses wherein the apparatus comprises an implantable stent but fails to specifically disclose wherein the stent comprises a non-return mechanism convertible between an open state and a closed state, wherein the closed state prevents passage of fluid and an open state enables crossing of fluid or a non-return valve enabling only one-directional passage of fluid. Albrecht discloses (see abstract; Figs. 24-27B; and [0099]-[0106]), in the same field of endeavor, an apparatus for bowel/stomach anastomosis (see abstract), wherein the apparatus comprises an implantable stent (230, see Figs. 26A-27B and [0102]-[0106]) comprising a non-return mechanism (valve 232) convertible between an open state and a closed state, wherein the closed state prevents passage of fluid and an open state enables crossing of fluid or a non-return valve enabling only one-directional passage of fluid (see [0100]) for the purpose of providing a solution for one-way redirection of nutrients directly into the ileum (see [0100]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified McGuckin's device with the one-way valve taught by Albrecht in order to provide a solution for one-way redirection of nutrients directly into the ileum.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGuckin in view of US2020/0337706 A1 to Truckai et al. (hereinafter “Truckai”).
Regarding claim 51, McGuckin discloses the invention substantially as claimed as discussed above, however, McGuckin fails to specifically disclose wherein the fixation device comprises fusing means, wherein the fusing means are designed to cause fusion of tissue of the first area of the stomach and the second area of the bowel, by applying a pressure and heating at least on the edges of the first area and the second area. Truckai discloses, in the same field of endeavor of anastomosis devices, the known use of a fusing means designed to cause fusion of two areas of tissue together, such as gastric tissue (see [0003]), by applying pressure and heating edges of the first and second areas (see [0002]-[0005] and [0022]) for the purpose of connecting tubular organ segments via a thermal weld to couple them together (see [0022]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified McGuckin's device with the fusing means of Truckai in order to connect tubular organ segments via a thermal weld to couple them together.
Allowable Subject Matter
Claims 32-33 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: McGuckin’s cutting device does not convert between a stowed configuration and a deployed configuration where the lateral profile about an axis of the tube changes so that it is larger. Rather, McGuckin’s device maintains the same lateral profile when changing between a stowed and deployed configuration. There is no apparent reason or motivation to modify McGuckin’s device to arrive at the claimed invention. Further, no other prior art of record in the field of anastomosis devices teaches or suggests a cutter having a lateral profile that enlarges when deployed versus a stowed configuration configured to cut a hole in tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see the attached PTO-892 Notice of References cited for additional relevant prior art disclosing devices for anastomosing the stomach and the bowel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771