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 .
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 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.
Response to Amendment
The Response filed February 18, 2026 has been entered. Claims 1-5, 7-22, and 30-31 are pending in the application with claims 7-17 and 19-22 being withdrawn from further consideration. Response to applicant's arguments can be found at the end of this Office action.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 18, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harrison et al. (U.S. Patent Application Publication No. 20200138438; hereinafter “Harrison”).
Regarding claim 1, Harrison discloses a system for forming an anastomosis between two adjacent walls of a digestive tract of a patient (Figs. 5A-6C; paras. [0113]-[0135]), the system comprising:
first (310) and second (320) magnetic implants configured to magnetically couple to each other through the two adjacent walls of the digestive tract at a desired site of the anastomosis to compress a portion of the two adjacent walls therebetween and form a necrotic area that becomes surrounded by a scarred edge following a healing time period (para. [0124]), the first magnetic implant being swallowable (first magnetic member (310) is swallowable (i.e., capable of being swallowed) because it is sized and shaped to be introduced orally (paras. [0067] and [0082]) and no structure of the magnetic member would prevent it from being swallowed);
a positioning marker (110) positionable at a target location corresponding to a first location on one side the desired site of the anastomosis for the first magnetic implant (Figs 5A and/or 6A; para. [0120]), the positioning marker comprising a distal magnetic segment (118) and a proximal non-magnetic segment (114), the distal magnetic segment being insertable into a lumen of a digestive tract through the wall of the digestive tract where the target location for the first magnetic implant is located (placement instrument (110) is insertable (i.e., capable of being inserted) through the wall of the digestive tract where the target location for the first magnetic implant is located because it is sized and shaped to be introduced into the tissue of a patient’s body (paras. [0068]-[0069], [0108]-[0109]) and no structure of the instrument would prevent insertion through the wall, such as through an incision, under sufficient force directed at the tissue at the location, via a secondary instrument, etc.) to intercept the first magnetic implant at the target location from within the digestive tract once swallowed by the patient and avoid the first magnetic implant from traveling past the target location due to peristalsis (the placement instrument (110) is capable of intercepting first magnetic implant (310) at a target location from within the digestive tract once swallowed by a patient and avoiding the first magnetic implant from traveling past the target location due to peristalsis because it is configured to interact with and move the first magnetic member (310) through tissue (Figs. 5A-6C; para. [0112]) and no structure of the instrument would prevent insertion of the instrument into the digestive tract prior to interacting with the magnetic member, such as through an incision, under sufficient force directed at the tissue at the location, via a secondary instrument, etc., and intercepting the implant within the digestive tract to avoid the implant from traveling past the target location due to peristalsis).
Regarding claim 2, Harrison discloses wherein the positioning marker is engageable with a positioning marker guiding instrument (para. [0068]).
Regarding claim 3, Harrison discloses wherein the positioning marker guiding instrument comprises a laparoscopic instrument or an endoscopic instrument (para. [0068]).
Regarding claim 4, Harrison discloses wherein the positioning marker comprises a floppy wire (para. [0108]).
Regarding claim 18, Harrison discloses wherein the positioning marker comprises a positioning marker magnet (118) having an opposite magnetic pole relative to a magnetic pole of the first magnetic implant such that the first magnetic implant is attracted to the magnet of the positioning marker (paras. [0115], [0131]).
Regrading claim 30, Harrison discloses wherein a portion of the positioning marker comprises a floppy wire (para. [0108]) insertable through one of the two adjacent walls of the digestive tract (as no structure prevents such insertion, the placement instrument (110) is capable of insertion through one of two adjacent walls of a digestive tract; paras. [0068]-[0069]).
Regarding claim 31, Harrison discloses wherein the portion of the positioning marker is a distal end of the positioning marker (Fig. 4B; paras. [0108]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Harrison in view of Surti et al. (U.S. Patent Application Publication No. 20080208224; hereinafter “Surti”).
Regarding claim 5, Harrison discloses the invention substantially as claimed except for the floppy wire including a spring coil.
Surti, a reference in the magnetic anastomosis device field of endeavor, teaches that a positioning element (64) with a floppy wire including spring coil (see Fig. 1 of U.S. Patent No. 6805676 which is incorporated by reference into Surti; para. [0027]) is suitable for positioning a magnetic anastomosis element (para. [0027]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the positioning element of Harrison such that the floppy wire comprises a spring coil, in view of Surti, in order to provide the positioning element with desirable characteristics, such as flexibility and/or pushability, to facilitate placement of the positioning element within a patient.
Response to Arguments
Applicant's arguments filed February 18, 2026 have been fully considered but they are not persuasive.
On pages 6-10, Applicant argues that Harrison does not disclose a positioning marker having a distal magnetic segment
being insertable into a lumen of the digestive tract through the wall of the digestive tract where the target location for the first magnetic implant is located to intercept the first magnetic implant at the target location from within the digestive tract once swallowed by the patient and avoid the first magnetic implant from traveling past the target location due to peristalsis
as recited in amended claim 1. Applicant’s arguments are not persuasive.
These limitations are interpreted as functional limitations because they describe what elements of the claimed invention do rather than what those elements structurally are.
“A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.” (MPEP § 2114(II))(citing Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). “Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function.” (MPEP § 2114(IV)).
Here, placement instrument (110) of Harrison teaches all the structural limitations of the claim, i.e., the positioning marker comprising a distal magnetic segment (118) and a proximal non-magnetic segment (114; Fig. 5A).
Further, the distal magnetic segment disclosed by Harrison is capable of performing the claimed function of “being insertable into a lumen of the digestive tract through the wall of the digestive tract where the target location for the first magnetic implant is located to intercept the first magnetic implant at the target location from within the digestive tract once swallowed by the patient and avoid the first magnetic implant from traveling past the target location due to peristalsis.”
Harrison discloses that placement instrument (110) has dimensions suitable for introduction into the tissue of a patient’s body (paras. [0068]-[0069] and [0108]-[0109]). The placement instrument is shaped and sized so it “can contact the magnetic member (e.g. , to install , to manipulate , to position , or even to retrieve the magnetic member if appropriate ).” (Para. [0115]).
Additionally, Harrison does not disclose placement instrument (110) having structure that would prevent insertion through a wall of a digestive tract, such as through an incision, under sufficient force directed at the tissue at the location, via a secondary instrument, etc.
Therefore, the placement instrument of Harrison meets the structural and limitations of the claimed positioning marker and is capable of performing the recited function of being insertable into a lumen of the digestive tract through the wall of the digestive tract where the target location for the first magnetic implant is located to intercept the first magnetic implant at the target location from within the digestive tract once swallowed by the patient and avoid the first magnetic implant from traveling past the target location due to peristalsis.
On page 8 of the Response, Applicant argues that the Office action has not provided “an articulated factual/technical basis” to conclude that Harrison anticipates the functional limitations of the positioning marker recited in claim 1. (Response pg. 8). This argument is not persuasive.
Examiner has pointed to Figs. 5A and/or 6A of Harrison and paragraphs [0068]-[0069] of Harrison as evidence that placement instrument (110) meets the structural and functional limitation of claim 1. Additionally, as explained in further detail below, Harrison discloses a shape and dimensions of the placement instrument that would enable it to be positioned within a lumen of a digestive tract through the wall of the digestive tract.
Therefore, Examiner’s conclusion that Harrison discloses the structural and functional limitations of the positioning marker recited in claim 1 is sufficiently supported by an articulated factual and technical basis.
On pages 8-10 of the Response, Applicant attempts to distinguish the claimed invention from Harrison alleging that the placement instrument of Harrison lacks “any piercing capability.” (Response pg. 9). This line of argument is not persuasive because the features upon which applicant relies (i.e., piercing capability) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On pages 9-10 of the Response, Applicant argues that because placement instrument (110) of Harrison is configured to interact with a magnetic implant from outside of a digestive tract, “the placement instrument 110 of Harrison is necessarily configured to not be inserted into a lumen of the digestive tract through the wall of the digestive tract.” (Response pp. 9-10). This argument is not persuasive because the shape and dimensions of the placement instrument would enable it to be inserted into a lumen of a digestive tract through a wall of the digestive tract.
Harrison discloses the placement instrument having a length between 50cm and 120cm (para. [0108]) and a cross-sectional width between 0.01 mm to about 10mm (para. [0109]). The placement instrument can be “rounded or unrounded” (para. [0106]) and have a rounded or polygonal cross-sectional shape (para. [0109]). The placement instrument is also configured to contact the magnetic member to retrieve the magnetic member (para. [0115]).
Indeed, Harrison lacks explicit disclosure that the structure of placement instrument would prevent it from being capable of insertion into a lumen of a digestive tract through the wall of the digestive tract. Disclosure by Harrison of an exemplary use of the placement instrument without penetrating a wall of the biological tissue (para. [0058]) does not undermine the fact that the placement instrument has a shape and dimensions enable it to be inserted and fit within a lumen of a digestive tract.
Therefore, a person having ordinary skill in the art would readily recognize that the dimensions and shape of the placement instrument are sized to be able to fit within the lumen of a digestive tract through a wall of the digestive tract.
On page 10 of the Response, Applicant’s argues that Harrison does not achieve “various technical effects” of the claimed invention, such as the positioning marker being left within a patient without further manipulation by a healthcare provider or the patient swallowing the magnetic implant at home. This argument is not persuasive.
Applicant's arguments concerning the merits of the invention of the instant application and drawbacks of the prior art are not commensurate with the scope of the claims. As such, these arguments concerning merits of the instant application are not given patentable weight until they are commensurate with the scope of the claims.
Applicant’s argument that Surtie does not remedy alleged deficiencies in Harrison (Response pg. 10) is not persuasive because Harrison is not deficient, as explained above in this Office Action.
For all the reasons above, Examiner maintains that the claimed invention is not allowable over the applied prior art.
Conclusion
Applicant's amendment necessitated any 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 Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H/Jonathan HollmExaminer, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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