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 .
Response to Amendment
This Office action is responsive to the amendment filed 10/13/2025. Claims 1, 9-12, 19 and 21 have been amended. Claims 7-8 have been cancelled. Claims 1-6 and 9-21 are currently pending in the application.
Response to Arguments
Applicant's arguments, see pg. 9, filed 10/13/2025, with respect to the drawings objection have been fully considered but they are not persuasive.
The updated drawings do not address all of the objections made to the drawings in the Non-Final Rejection mailed 07/14/2025. Specifically, the drawings were objected to because solid black shading areas are not permitted except when used to represent bar graphs or color (see Fig. 6-10 of the application). Additionally, each of the views in Fig. 19-22 must have its own figure number. Therefore, new corrected drawings are still required.
Applicant’s arguments, see pg. 9, with respect to the rejections of the claims under 35 U.S.C. 112(a) and 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, see pg. 10, filed with respect to the rejection of claim 1 under 35 U.S.C. 102 as being anticipated by Barclay (US 2015/0272587) have been fully considered but they are not persuasive.
Applicant argues that Barclay fails to teach a projection extending radially inward at a proximal end of a least one of the arms as recited by amended claim 1.
The Examiner disagrees. As shown in annotated Fig. 3 below, Barclay teaches a projection extending radially inward at an end of at least one of the arms (208a).
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Applicant further argues that Barclay fails to teach the projection configured to mate with a groove on the loading device.
The Examiner disagrees. Regarding the language “the projection configured to mate with a groove on the loading device,” it is noted that the loading device is not positively recited by the claim and is therefore not a required structure. Further, the language constitutes functional claim language and since the claim is an apparatus claim, and it is to be limited by structural limitations. The device of Barclay meets the structural limitations of the claim, and the projection on the pusher of Barclay would be capable of mating with a groove an appropriately dimensioned loading device.
Applicant’s arguments, see pg. 11-12, with respect to the rejection of claim 12 under 35 U.S.C. 102 as being anticipated by Barclay (US 2015/0272587) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Horppu et al. (US 8,491,607).
Applicant’s arguments, see pg. 11-12, with respect to the rejection of claim 19 under 35 U.S.C. 102 as being anticipated by Barclay (US 2015/0272587) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pg. 13, with respect to the rejections of claims 1-2 under 35 U.S.C. 102 as being anticipated by Wurster (US 6,066,145) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoon (US 4,860,746).
Applicant's arguments, see pg. 13-14, with respect to the rejection of claim 19 under 35 U.S.C. 102 as being anticipated by Horppu et al. (US 8,491,607) have been fully considered but they are not persuasive.
Applicant argues that Horppu fails to teach a longitudinally extending groove in the loading device as recited by amended claim 19.
The Examiner disagrees. Horppu teaches a loading device (14, see Fig. 8) with longitudinally extending grooves extending between each finger 22.
Drawings
The drawings filed 10/13/2025 are unacceptable. Each of the views in Fig. 19-22 each show multiple views of different components of the device but each view does not have its own figure number. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because “[t]he different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter”. See MPEP 608.02.
Additionally, Fig. 6-10 of the application use solid black shading. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because solid black shading areas are not permitted, except when used to represent bar graphs or color. No new matter should be entered. See MPEP 608.02.
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.
Specification
The amendment to the Specification filed 10/13/2025 is accepted.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 11 “the protrusion” should read “the projection”.
Appropriate correction is required.
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:
“ligation band engagement structure” in claims 10 and 20 which has been interpreted, based on the Specification, as a ramp (see [0016]), shelf (see [0070]) or any structural equivalent thereof.
“engagement structure” in claim 12 has been interpreted, based on the Specification, as a projection (see [0019]) or any structural equivalent thereof.
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 § 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.
Claims 1, 3-6, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barclay (US 2015/0272587).
Regarding claim 1, Barclay discloses a pusher (see Fig. 2C-3) for loading an elastic band (106) on a ligation device (100, see Fig. 1A), comprising: a base (208); at least two arms (208a) extending in a proximal direction from the base, the arms inclined radially inwardly in the proximal direction and defining a proximal opening (see Fig. 2D); and the arms movable between a first position (which defines a first diameter for the opening (first position and diameter shown in Fig. 2D) and a second, radially outwardly displaced position, which defines a second, larger diameter opening in response to distal advance of a loading device therein (while not shown in the figures, Barclay discloses that as the cone 210 is advanced into the loader, prongs 208a deflect outwardly to accommodate the increasing diameter of the cone, see [0056]), and a projection extending radially inward at a proximal end of at least one of the arms (see annotated Fig. 3 above.
Regarding the language “the projection configured to mate with a groove on the loading device,” it is noted that the loading device is not positively recited by the claim and is therefore not a required structure. Further, the language constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Barclay meets the structural limitations of the claim, and the projection on the pusher of Barclay would be capable of mating with a groove an appropriately dimensioned loading device.
Regarding claim 3, Barclay discloses a pusher as in Claim 1, comprising three arms (see Fig. 2D).
Regarding claim 4, Barclay discloses a pusher as in Claim 1, wherein the base comprises a radially outwardly extending flange (see annotated Fig. 2D below).
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Regarding claim 5, Barclay discloses a pusher as in Claim 4, wherein the arms are integrally formed with the base (see Fig. 2D).
Regarding claim 6, Barclay discloses a pusher as in Claim 3, further comprising an aperture in the base, in communication with the proximal opening through a central lumen defined by the arms (although not labeled in the figures, it is understood there is are four apertures in the band feeder 208 which are in communication with the proximal openings defined by the sets of prongs 208a through a central lumen since the channel 218 is shown extending through prongs 208a, see Fig. 2C-2D).
Regarding claim 9, Barclay discloses a pusher as in Claim 1, wherein the projection includes a tapered tooth on the proximal end of each arm (the projection appears to be a tapered tooth, see annotated Fig. 3 above).
Regarding claim 10, Barclay discloses a pusher as in Claim 3, further comprising a ligation band engagement structure on proximal ends of the arms, for rolling the ligation band along the loading device (feet 209 are considered ligation band engagement structures, which has been interpreted under 35 U.S.C. 112(f) as a distally facing ramp, see [0051] and Fig. 2D and 3).
Regarding claim 11, Barclay discloses a pusher as in Claim 10, wherein the ligation band engagement structure comprises a shelf at a distal end of the projection (see feet 209 which include a portion extending distally of the projection, see annotated Fig. 3 above).
Claims 12-14 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horppu et al. (US 8,491,607).
Regarding claim 12, Horppu discloses a loading device (14, see Fig. 5-8), configured for loading an elastic band (2, see Fig. 13) onto a ligation device (1, see Fig. 1), comprising: a body having a proximal end (towards 20) and a distal end (towards 16), the body increasing in diameter from the distal end to the proximal end (see Fig. 5); an engagement structure carried by the proximal end (mounting plug 20 is considered an engagement structure, which has been interpreted under 35 U.S.C. 112f as a projection, see Fig. 5), configured for releasable engagement with a distal end of a ligation device (see col. 5, lines 14-18); a recessed guide extending along a surface of the body (the spaces between fingers 22 are each grooves, see Fig. 8), for rotational engagement with an elastic band pusher (24, see Fig. 9) while permitting relative longitudinal movement between the loading device and the pusher (when the adaptor 14 and the expander device 24 engage as shown in Fig. 13-15, relative movement is permitted between the adaptor and expander device); and wherein the loading device is configured to control an exact radial expansion of the elastic band to a prescribed percentage (it is note that the claim does not require that the loading device control radial expansion of an elastic band in a specific way or to a specific percentage, therefore, adaptor 14 of Horppu is considered to be capable of controlling an exact radial expansion of an elastic band to a prescribed percentage since it facilitates expansion of a band 2 onto a ligation device); wherein the loading device is configured to be isolated from environmental conditions (the adaptor can be isolated from environmental conditions if desired).
Regarding claim 13, Horppu discloses a loading device as in Claim 12, wherein the engagement structure comprises a proximal projection (20, see Fig. 5) configured to be removably received within a distal aperture on the ligation device (mounting plug 20 is removably coupled with the ligation device 1, see col. 5, lines 14-18).
Regarding claim 14, Horppu discloses a loading device as in Claim 12, further comprising a ligation band (2) carried proximate the distal end (see Fig. 13).
Regarding claim 19, Horppu discloses a method of loading a ligation band (2, see Fig. 13-18) onto a ligation device (1, see Fig. 1), comprising steps of: removably attaching a proximal end (20) of a loading device (14) to a distal end of the ligation device (see col. 5, lines 14-18), the loading device carrying a ligation band (2, see Fig. 13); positioning a distal end of the loading device into a proximal end of a pusher (24) and engaging a guide of the pusher (forward facing ends of the expander device 24 can be considered a guide of the pusher, see Fig. 12) with a longitudinally extending groove (the longitudinally extending spaces between each finger 22 is a groove, see Fig. 8) in the loading device (see Fig. 13-15); and advancing the ligation device distally relative to the pusher with attached loading device, causing the pusher to advance the ligation band proximally along the loading device and onto the ligation device (see col. 5, line 47- col. 6, line 6).
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Wurster (US 6,066,145) in view of Yoon (US 4,860,746) .
Regarding claim 1, Wurster discloses a pusher (38, see Fig. 1-2) for loading an elastic band (2) on a ligation device (34, see Fig. 1), comprising: a base (the bottom portion of the pusher 38, see Fig. 1); at least two arms (there are a plurality of bendable arms 10, see col. 7, lines 26-29) extending in a proximal direction from the base, the arms inclined radially inwardly in the proximal direction and defining a proximal opening (the arms appear to extend radially inwardly since the pusher 38 has a tapered profile, see Fig. 1-2); and the arms movable between a first position which defines a first diameter for the opening and a second, radially outwardly displaced position, which defines a second, larger diameter opening in response to distal advance of a loading device therein (while not expressly stated, it is understood based on Wurster's disclosure of how the device functions that the arms move between a first position shown in Fig. 1 and a second radially outwardly displaced position when engaged with the shaft 34 to push a ligation ring 2 onto the shaft since the arms are disclosed as bendable and the shaft 34 has an increasing diameter along its longitudinal axis, see col. 7, lines 19-43).
Wurster fails to teach a projection extending radially inward at a proximal end of at least one of the arms, the projection configured to mate with a groove on the loading device.
Yoon, in the same field of art, teaches a related pusher (30, see Fig. 6-7) having arms 48 and projections 44 that project radially inward at a proximal end of the arms (see Fig. 4) for facilitating engaging engagement with an elastic band as the device is used to bush the band onto a loading device 28 (see col. 3, lines 33-35).
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 pusher of Wurster to include a projection, as taught by Yoon, since doing so would facilitate engagement with an elastic band and pushing the band onto a loading device.
Regarding the language “the projection configured to mate with a groove on the loading device,” it is noted that the loading device is not positively recited by the claim and is therefore not a required structure. Further, the language constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Wurster and Yoon meets the structural limitations of the claim, and the projection on the pusher Wurster and Yoon would be capable of mating with a groove an appropriately dimensioned loading device.
Regarding claim 2, Wurster further teaches an elastic band carried by the arms to bias the arms in the direction of the first position (the arms 10 are joined together by a circular spring 11 which is considered an elastic band, see col. 7, lines 26-29).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over in Horppu view of McGown (US 8,932,306).
Regarding claim 20, Horppu discloses a method of loading a ligation band as in Claim 19, and further teaches a ligation band engagement structure on the proximal end of the pusher (forward ends 30 of the expander device are considered ligation band engagement structures, which has been interpreted under 35 U.S.C. 112(f) as a ramp, since they have a slanted, ramp-like shape, see Fig. 9) which pushes the band along the loading device during the advancing step (see Fig. 13-14). Horppu fails to expressly teach the ligation band rolls during the advancement step.
McGown, in the same field, of art teaches a related method where the elastic band can be either slid or rolled along a loading device (see col. 2, lines 21-27).
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 method of Horppu so that the band rolls along the loading device during the advancement step, since causing a band to roll or slide were known alternative ways of moving a band along a loading device, as taught by McGown, and the modification would have yielded nothing more than predictable results, namely, causing the band to roll in the method of Horppu would have resulted in movement along the loading device as intended.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over in Horppu view of Barclay (US 2015/0272587).
Regarding claim 21, Horppu discloses a method of treating a patient, comprising steps of: providing a ligation device (see Fig. 1); attaching a loading device (14, see Fig. 5) to a distal end of the ligation device (see col. 5, lines 6-9); advancing a ligation band distally along the loading device by advancing the loading device distally with respect to a pusher (24) such that a guide of the pusher (forward ends 30 are considered guides of the expander device 24, see Fig. 12) engages a longitudinal groove in the loading device (forward ends 30 of the expander device 24 engages the spaces between finger 22 of the adaptor, which are considered grooves, see Fig. 13-15) and the pusher advances the ligation band along the loading device and onto the ligation device (see Fig. 13-15); removing the loading device from the ligation device; and deploying the ligation band into the patient (see col. 4, lines 48-61).
Horppu fails to teach deploying a second ligation band into a patient by providing a ligation device that has previously deployed a first ligation band into a patient.
Barclay, in the same field of art, teaches a related method of treating a patient where a ligation device that has previously deployed a first ligation band into a patient is used to deploy a second ligation band into the patient (the ligator 100 cab be re-sterilized for reuse and in this way, can be considered a ligation device that has previously deployed a first ligation band into a patient, see [0061]).
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 method of Horppu to include the step of providing a ligation device that has previously deployed a first ligation band into a patient, as taught by Barclay, since doing so would make the ligation device of Horppu reusable.
Allowable Subject Matter
Claims 15-18 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:
Regarding claim 15, the closest prior art documents of record, Barclay and Horppu teach the pusher as in claim 1 and the loading device as in claim 12 and at least one ligation band.
However, It would not have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the references to arrive at the technical solutions of claim 15 since the structure and function of the pusher of Barclay and the loading device of Horppu are different.
Regarding claims 16-18, the closest prior art documents of record fail to teach the ligation device loading kit as in claim 15.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related ligation devices, pushers and loading devices.
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 SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771