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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on June 29, 2026 has been entered. Claims 1, 3-5, 7-22, and 30-31 are pending in the application with claims 7-17 and 19-22 being withdrawn from further consideration.
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.
Claims 1, 3-4, 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) engageable with a positioning marker guiding instrument (secondary device such as “a cannula , a sheath , the channel of an endoscope , a surgical robot , and the like;” para. [0068]) and 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 at the target location (the distal magnetic segment (118) of placement instrument (110) is insertable (i.e., capable of being inserted) through the wall of the digestive tract at the target location 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),
the positioning marker being configured to remain at the target location following disengagement from the positioning marker guiding instrument and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis (the placement instrument (110) is capable of remaining at the target location following disengagement from the positioning marker guiding instrument and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis because it is sized and shaped to be introduced into the tissue of a patient’s body (paras. [0068]-[0069], [0108]-[0109]) with the aid of a secondary device (e.g., “a cannula , a sheath , the channel of an endoscope, a surgical robot , and the like;” para. [0068]) and no structure of the instrument would prevent the placement instrument from remaining at the target location after disengagement and retrieval of the secondary device while the first magnetic implant travels through the digestive tract due to peristalsis).
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 June 29, 2026 have been fully considered but they are not persuasive.
On pages 7-10 of the Response, Applicant argues that Harrison does not disclose “a positioning marker engageable with a positioning marker guiding instrument” or “the positioning marker being configured to remain at the target location following disengagement from the positioning marker guiding instrument and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis” as recited in claim 1. This argument is not persuasive.
The limitations of the positioning marker being “engageable with a positioning marker guiding instrument” and “configured to remain at the target location following disengagement from the positioning marker guiding instrument and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis,” as recited in claim 1, are interpreted as functional limitations because each recites what the positioning marker does rather than what the positioning marker is.
“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, the elongate placement instrument (110) of Harrison is capable of performing these claimed functions.
The placement instrument is engageable (i.e., capable of engagement) with a positioning marker guiding instrument because it is configured to be introduced into a patient “with the aid of a secondary device , such as a cannula , a sheath , the channel of an endoscope , a surgical robot , and the like” (Harrison para. [0068]).
Additionally, the placement instrument is capable of remaining at the target location following disengagement from the positioning marker guiding instrument (e.g., a secondary device; para. [0068]) and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis because it is sized and shaped to be introduced into the tissue of a patient’s body (paras. [0068]-[0069], [0108]-[0109]) with the aid of a secondary device (e.g., “a cannula , a sheath , the channel of an endoscope, a surgical robot , and the like;” para. [0068]) and no structure of the instrument would prevent the placement instrument from remaining at the target location after disengagement and retrieval of the secondary device while the first magnetic implant travels through the digestive tract due to peristalsis.
Exemplary secondary devices for introducing instruments are disclosed in Brown (U.S. Patent Application Publication No. 20070287885); Ley et al. (U.S. Patent Application Publication No. 20130217974); Dubrul et al. (U.S. Patent Application Publication No. 20010039430); Gobel (U.S. Patent Application Publication No. 20080097491); and Mantri et al. (U.S. Patent No. 11096753). Although not an exhaustive disclosure of exemplary secondary device known in the art, these references disclose various secondary devices that are disengageable from a laparoscopic or endoscopic instrument and retrievable from a patient.
Furthermore, no structure of the placement instrument would prevent it from performing the claimed functions.
Therefore, placement instrument (110) of Harrison is capable of engaging “with a positioning marker guiding instrument” and structured to be capable of remaining “at the target location following disengagement from the positioning marker guiding instrument and retrieval of the positioning marker guiding instrument from the patient, while the first magnetic implant travels through the digestive tract due to peristalsis,” and meets these functional limitations recited in claim 1.
Applicant’s argument that the placement tool of Harrison depends on physician handling (Response pp. 7-9) is not persuasive because the cited portions of Harrison do not render the placement tool incapable of performing the claimed functional limitations.
Applicant’s argument that Harrison does not disclose the claimed invention as allegedly failing to disclose a “separate guiding instrument that would engage the placement instrument 110, position the placement instrument 110 at the target location, disengage from the placement instrument 110, and that would then be retrieved while the placement instrument 110 would remain at the location where the anastomosis is intended to be formed,” (Response pg. 8) is not persuasive because a “guiding instrument” is not positively 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).
Here, claim 1 merely recites positioning marker that is “engageable with a positioning marker guiding instrument.” Thus, the “positioning marker guiding instrument” is positively recited as part of the claimed system.
Applicant’s argument that the placement instrument of Harrison does not “remain[] at the target location after disengagement from and retrieval of a separate positioning marker guiding instrument while a swallowed first magnetic implant travels through the digestive tract due to peristalsis” (Response pg. 9) is not persuasive.
As explained above, the functional claim limitations cover all devices that are capable of performing the recited functions. Thus, placement instrument (110) of Harrison is not required to perform the claimed functions to meet the claimed invention. Rather, the placement instrument need only be capable of performing the functions to meet the claimed functional limitations. As explained above, the placement instrument of Harrison is structured to be capable of performing the claimed functions and, therefore, meets the functional claim limitations.
On pages 9-10 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bonner et al. (U.S. Patent Application Publication No. 20040082850) disclosing a magnetically guided probe element (Figs. 3-15).
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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