DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 5, 2025 has been entered.
Claim Objections
Claim 32 is objected to because of the following informalities:
Claim 32, line 2, “comprising” should be –comprises--.
Appropriate correction is required.
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 21 and 23-40 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.
The claims are not entirely clear on which embodiment is being claimed. First off, the mechanical clip does not seem to be shown in any of the figures, so it is not entirely clear on the structural characteristics of the clip and its functions. Further the claims have been significantly changed and seem to be geared towards a specific embodiment, perhaps what is shown in Fig. 16, which may be different than the originally claimed embodiment. However, claims 25-26 and 35-36 include an instrument which seems to be geared towards an embodiment shown in Fig. 20. It is recommended to clarify which embodiment is intending to be claimed and claims geared towards alternate embodiments will likely be withdrawn if they are not generic to that particular species.
Claim 32, “the mechanical clip” lacks antecedent basis in the claims. It should be “the mechanical clip portion.”
Claims that should potentially be withdrawn:
Claims. 25-26 and 35-36 geared towards Fig. 20.
Claim 29 geared towards Fig. 13.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21, 23-28, 30-38, and 40 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ueda et al. (US 2004/0050395; “Ueda”).
Claim 21, Ueda discloses a system (Fig. 1) for retracting tissue (Fig. 1; abstract) comprising: an implant (Fig. 1; 1) comprising a magnetically active portion (1a) and a mechanical clip (3) coupled to the magnetically active portion (Fig. 1), wherein the implant is configured to be inserted into a body (Fig. 1) and the mechanical clip is configured to be removably affixed to soft tissue or an organ in the body (Fig. 1); an external magnetically active element (52) configured to: i) be positioned outside the body (Fig. 1), ii) be controlled with a computer (paragraphs [0056]-[0061]), and iii) attract the magnetically active portion of the implant when the mechanical clip is affixed within the body (Fig. 1; paragraphs [0056]-[0061]), wherein when the mechanical clip is affixed to the soft tissue or the organ, movement of the external magnetically active element outside of the body imparts direct movement of the magnetically active portion of the implant, thereby imparting movement of the mechanical clip to change at least one of location, shape, or position of the corresponding one of the soft tissue or the organ to which the mechanical clip is affixed (Fig. 1; paragraphs [0056]-[0061]).
Claim 23, Ueda discloses the system of claim 21, wherein the external magnetically active element comprises a flat shaped magnetically active portion (Fig. 4; 52a and 52c).
Claim 24, Ueda discloses the system of claim 21, further comprising a cannula (Figs. 6-10; 25) through which the implant is configured to be inserted into the body (Figs. 6-10; paragraph [0064]).
Claim 25, Ueda discloses the system of claim 21, further comprising an instrument (Fig. 1; 23) comprising a magnetically active material (Fig. 1; endoscopes and the forceps are typically a metal material), the instrument configured to be inserted into the body and deliver the implant (Figs. 6-10).
Claim 26, Ueda discloses the system of claim 25, wherein the instrument is configured to magnetically attract the magnetically active portion of the implant (Fig. 1; the instrument can be magnetized or carry a magnet to attract the magnet 1a).
Claim 27, Ueda discloses the system of claim 21, wherein the external magnetically active element comprises at least one of a permanent magnet or an electromagnet (paragraph [0056]).
Claim 28, Ueda discloses the system of claim 21, wherein the magnetically active portion of the implant has a magnetic field with adjustable magnetic intensity (paragraph [0052]).
Claim 30, Ueda discloses the system of claim 21, wherein the organ is a stomach or an intestine (Fig. 1; paragraphs [0001]-[0006]; while it doesn’t specifically state stomach or intestine this type of system can be used in those parts of the body).
Claim 31, Ueda discloses a system (Fig. 1) for retracting tissue (Fig. 1; abstract) comprising: at least one magnetically active implant (Fig. 1; 1) comprising a mechanical clip portion (3) configured to be inserted into a body (Fig. 1) and removably affixed to soft tissue or an organ in the body (Fig. 1); and at least one external magnetically active element (52) configured to: i) be positioned outside the body (Fig. 1), ii) be controlled with a computer (paragraphs [0056]-[0061]), and iii) attract the at least one magnetically active implant when the at least one magnetically active implant is affixed within the body (Fig. 1; paragraphs [0056]-[0061]), wherein when the at least one magnetically active implant is affixed to the soft tissue or the organ using the mechanical clip portion, movement of the at least one external magnetically active element outside of the body moves the at least one magnetically active implant to impart a change in at least one of location, shape or position of the soft tissue or the organ in the body (Fig. 1; paragraphs [0056]-[0061]).
Claim 32, Ueda discloses the system of claim 31, wherein the at least one magnetically active implant further comprises a magnetically active portion (Fig. 1; 1a) coupled to the mechanical clip portion (Fig. 1).
Claim 33, Ueda discloses wherein the at least one external magnetically active element comprises a flat shaped magnetically active portion (Fig. 4; 52a and 52c).
Claim 34, Ueda discloses the system of claim 31, further comprising a cannula (Figs. 6-10; 25) configured to pass through an incision, the cannula defining a passage (Fig. 1; paragraph [0064]) from outside the body to inside the body through which the at least one magnetically active implant is configured to be inserted (Figs. 6-10; paragraph [0064]).
Claim 35, Ueda discloses the system of claim 31, further comprising an instrument (Fig. 1; 23) comprising a magnetically active material (Fig. 1; endoscopes and the forceps are typically a metal material), the instrument configured to be inserted into the body and deliver the at least one magnetically active implant (Figs. 6-10).
Claim 36, Ueda discloses the system of claim 35, wherein the instrument is configured to magnetically attract the at least one magnetically active implant (Fig. 1; the instrument can be magnetized or carry a magnet to attract the magnet 1a).
Claim 37, Ueda discloses the system of claim 31, wherein the at least one external magnetically active element is at least one of a permanent magnet or an electromagnet (paragraph [0056]).
Claim 38, Ueda discloses the system of claim 31, wherein the at least one external magnetically active element has a magnetic field with adjustable magnetic intensity (paragraphs [0056] and [0087]).
Claim 40, Ueda discloses the system of claim 31, wherein the organ is a stomach or an intestine (Fig. 1; paragraphs [0001]-[0006]; while it doesn’t specifically state stomach or intestine this type of system can be used in those parts of the body).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 29 and 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ueda et al. (US 2004/0050395; “Ueda”), in view of Creighton et al. (US 6459924; “Creighton”).
Claim 29, Ueda discloses the system of claim 21, further comprising an arm (Fig. 4; 50) connected to the external magnetically active element (Fig. 4) and configured to move the external magnetically active element (Fig. 4).
However, Ueda does not disclose the arm being electromechanically controlled with the computer.
Creighton teaches a system (Fig. 4) that connects an arm to a magnetic element that is electromagnetically controlled with a computer (Fig. 4; col. 6, lines 12-32).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a computer system, as taught by Creighton, to move parts in the system of Ueda, in order to have more precise control over how the device moves (col. 6, lines 12-32).
Claim 39, Ueda discloses the system of claim 31, further comprising an arm (Fig. 4; 50) connected to the at least one external magnetically active element (Fig. 4) and configured to move the at least one external magnetically active element
However, Ueda does not disclose the arm being electromechanically controlled with the computer.
Creighton teaches a system (Fig. 4) that connects an arm to a magnetic element that is electromagnetically controlled with a computer (Fig. 4; col. 6, lines 12-32).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a computer system, as taught by Creighton, to move parts in the system of Ueda, in order to have more precise control over how the device moves (col. 6, lines 12-32).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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/Zade Coley/Primary Examiner, Art Unit 3775
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