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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/1/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tissue shaper being displaceable by a user to close the tissue shaper around a fold of tissue (in claims 94 and 102) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 83-89, 91-100 and 102 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kraemer et al. (US 2005/0085829).
Kraemer discloses (see Figs. 14-31) an endoscopic gastroesophageal flap valve restoration system comprising the following claim limitations:
(claim 83) A system for forming a fold of tissue, the system comprising: a tissue manipulating device comprising: a shaft (202, Figs. 14 and 16) extending along a length (as shown in Figs. 14 and 16); and a tissue displacing element (212, Figs. 14 and 16) operatively coupled to the shaft (202) (as shown in Figs. 14-31), the tissue displacing element (212) being configured to (i.e., capable of) engage tissue (as shown in Figs. 17-22 and 27-31); and one or more fasteners (80, see Figs. 3-11) deployable from the tissue manipulating device to fasten a fold of tissue (as shown in Figs. 3-11; [0070]; [0087]; fasteners 80 depicted in Figs. 3-11 expressly are part of the device of Figs. 14-31, more specifically one or more fasteners are deployed in the step of Fig. 21);
(claims 84 and 96) further comprising a fastener applier (99, Fig. 5) operatively coupled to the shaft (202) (as shown in exemplary Fig. 13, wherein fasteners 80 are shown being deployed into tissue), the fastener applier (99) configured to (i.e., capable of) displace the one or more fasteners (80) into a fold of tissue (as shown in Figs. 5, 10 and 13; [0062]);
(claims 85 and 97) wherein the fastener applier (99) is integrated into the tissue manipulating device (as expressly shown in Figs. 5, 10 and 13);
(claims 86 and 98) wherein the fastener applier (99) is longitudinally displaceable with respect to the shaft (202) (as shown in Figs. 5, 10 and 13; [0062]; downward longitudinal displacement with respect to shaft 202 deploys fixation devices 80);
(claims 87 and 99) wherein the system is configured such that the one or more fasteners (80) can be deployed at multiple orientations around a fold of tissue (see Figs. 3 and 5; [0052]-[0053]; [0062]; [0065]-[0066]; deployment of multiple fixation devices 80 at multiple locations is expressly disclosed);
(claims 88 and 100) wherein the system is configured such that multiple fasteners (80) can be simultaneously deployed from the tissue manipulating device (as shown in Figs. 3, 5, 10 and 13; [0052]-[0053]; [0062]; [0065]-[0066]; deployment of multiple fixation devices 80 each disposed in their individual lumens 82, and deployed by their individual push rods 99 allows for simultaneous deployment of fixation devices 80);
(claim 89) wherein the one or more fasteners comprise one or more staples (80) (as expressly shown in Fig. 9);
(claim 91) further comprising a tissue shaper (230, Figs. 29-31) coupled to the shaft (202), the tissue shaper (230) configured to receive a fold of tissue (as shown in Figs. 29-31);
(claim 92) wherein the tissue displacing element (212) is configured to (i.e., capable of) displace tissue into the tissue shaper (230) (as shown in Figs. 29-31);
(claim 93) wherein the tissue shaper (230) is displaceable relative to the shaft ([0083]; tissue shaper 230 expressly may collapse and expand relative to the shaft);
(claims 94 and 102) wherein the tissue shaper (230) is displaceable by a user to close the tissue shaper (230) around a fold of tissue ([0083]; tissue shaper 230 expressly may be shifted between collapsed and expanded configurations allowing for collapse around tissue disposed therein); and
(claim 95) A system for forming a fold of tissue, the system comprising: a tissue manipulating device comprising: a shaft (202, Figs. 14 and 16) extending along a length (as shown in Figs. 14 and 16); a tissue shaper (230, Figs. 29-31) coupled to the shaft (202) (as shown in Figs. 29-31); and a tissue displacing element (212, Figs. 14 and 16) operatively coupled to the shaft (202) (as shown in Figs. 14-31), the tissue displacing element (212) being configured to (i.e., capable of) engage tissue and draw the tissue toward the tissue shaper (230) (as shown in Figs. 17-22 and 27-31); and one or more fasteners (80, see Figs. 3-11) deployable from the tissue manipulating device to fasten a fold of tissue (as shown in Figs. 3-11; [0070]; [0087]; fasteners 80 depicted in Figs. 3-11 expressly are part of the device of Figs. 14-31, more specifically one or more fasteners are deployed in the step of Fig. 21);
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) 90 and 101 are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figs. 14-31 of Kraemer as applied to claims 83 and 95 above, and further in view of the embodiment of Figs. 12-13 of Kraemer (US 2005/0085829).
The embodiment of Figs. 14-31 of Kraemer, as applied above, discloses an endoscopic gastroesophageal flap valve restoration system comprising all the limitations of the claim except for comprising a plurality of vacuum orifices on the shaft.
However, the embodiment of Figs. 12-13 of Kraemer teaches slidably coupling an invaginator device (130) to a gastroesophageal flap valve restoration device (60) ([0072]-[0078]) wherein the invaginator device (130) comprises a plurality of vacuum orifices (144) on the shaft (as shown in Figs. 12-13) in order to beneficially aid in the creation of the fold of tissue by partially pre-forming the fundus tissue and by improving the position and presentment of the fundus tissue to the gastroesophageal flap valve restoration device ([0078]; see also [0075] for an alternative embodiment taught comprising the plurality of vacuum orifices disposed directly on the longitudinal member of the gastroesophageal flap valve restoration device). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of the embodiment of Figs. 14-31 of Kraemer to have a plurality of vacuum orifices on the shaft in order to beneficially aid in the creation of the fold of tissue by partially pre-forming the fundus tissue and by improving the position and presentment of the fundus tissue to the gastroesophageal flap valve restoration device, as taught by the embodiment of Figs. 12-13 of Kraemer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 83, 90-93, 95 and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,955,957. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 9,955,957
83
1-29
90
1-29
91
1-29
92
1-29
93
1-29
95
1-29
101
1-29
Claims 83, 90-92, 95 and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,010,319. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 10,010,319
83
1-28
90
8-9,14
91
1-28
92
1-28
95
1-28
101
8-9,14
Claims 83-87, 90-93, 95-99 and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,595,860. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 10,595,860
83
1-9
84
6-9
85
6-9
86
7-8
87
8
90
1-9
91
1-9
92
1-9
93
2-4
95
1-9
96
6-9
97
6-9
98
7-8
99
8
101
1-9
Claims 83-87, 90-93, 95-99 and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,607,215. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,607,215
83
1-8
84
6-7
85
6-7
86
6-7
87
7
90
1-8
91
1-8
92
1-8
93
2-8
95
1-8
96
6-7
97
1-8
98
6-7
99
7
101
1-8
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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