DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 31-40 are objected to because of the following informalities:
Claim 31, line 5, the “1)” should be changed to “i)” to stay consistent with the numbering style used in the rest of the claim.
Appropriate correction is required.
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) 31-32 and 34-38, and 40 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Rioux et al. (US 6961620; “Rioux”).
Claim 31, Rioux discloses a system (Figs. 1-6) capable of retracting tissue (Figs. 1-6; abstract) comprising: at least one magnetically active implant (Fig. 6; 42) configured to be inserted into a body and configured to be removably affixed to soft tissue or an organ in the body (Fig. 6); and at least one external magnetically active element (130) capable of: i) being positioned outside the body (Fig. 6; all magnets can be placed inside or outside a body), ii) controlled with a computer (Fig. 6; electromagnets can be controlled with a computer), or iii) at least one of attract the at least one magnetically active implant when the at least one magnetically active implant is affixed within the body, or position the at least one magnetically active implant when the at least one magnetically active implant is affixed within the body (Fig. 6; col. 9), wherein when the at least one magnetically active implant is affixed to the soft tissue or the organ, movement of the at least one external magnetically active element outside of the body imparts a change in at least one of location, shape, or position of the soft tissue or the organ in the body (Fig. 6; cols. 9-10).
Claim 32, Rioux discloses the system of claim 31, wherein the at least one magnetically active implant is comprised of at least two components (could be considered as two of the beads).
Claim 34, Rioux discloses the system of claim 31, further comprising a cannula (Figs. 1-6; col. 1, lines 60-64) configured to pass through an incision, the cannula defining a passage from outside the body to inside the body through which the at least one magnetically active implant is configured to be inserted (Figs. 1-6; col. 1, lines 60-64).
Claim 35, Rioux discloses he system of claim 31, further comprising an instrument (Fig. 6; 130, 132, claim does not stop the instrument from being the magnetic element as well) configured to be inserted into the body and comprised in part of a magnetically active material (Fig. 6).
Claim 36, Rioux discloses the system of claim 35, wherein the instrument is configured to magnetically attract the at least one magnetically active implant (col. 9, lines 38-58).
Claim 37, Rioux 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 (col. 9, lines 38-58).
Claim 38, Rioux discloses the system of claim 31, wherein the at least one external magnetically active element has a magnetic field with adjustable magnetic intensity (col. 9, lines 38-58).
Claim 40, Rioux discloses the system of claim 31, wherein the organ is a stomach or an intestine (Fig. 6; functional limitation and the system could be used in stomach or intestine).
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.
Claim 21-22 and 24-28, and 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Freedman (US 4978323), in view of Rioux et al. (US 6961620; “Rioux”).
Claim 21, Freedman discloses a system (Figs. 1-7) capable of retracting tissue comprising: a first magnetically active implant (Fig. 7; 10) configured to be inserted into a body and configured to be removably affixed to at least one of soft tissue and an organ (Fig. 7); a first external magnetically active element (15; could be placed on the outside of the face) capable of i) being positioned outside the body (any magnet can be placed within or outside the body as desired), ii) being controlled with a computer (a computer could be linked to a different magnet that helps control magnet 15), and iii) at least one of attract the first magnetically active implant when the first magnetically active implant is affixed within the body, or orient the first magnetically active implant when the first magnetically active implant is affixed within the body (Fig. 7; magnets can attract or repel depending on how they face one another); a second magnetically active implant (11) configured to be inserted into the body and removably affixed to the first soft tissue or the first organ to which the first magnetically active implant is attached, or a different second soft tissue or second organ (Fig. 7); and a second external magnetically active element (16) capable of i) being positioned outside the body, ii) controlled with a computer (a computer could be linked to a different magnet that helps control magnet 16), and iii) at least one of attract the second magnetically active implant when the second magnetically active implant is affixed within the body, or orient the second magnetically active implant (Fig. 7) when the second magnetically active implant is affixed within the body (Fig. 7), wherein when the first magnetically active implant is affixed to the first soft tissue or the first organ, movement of the first external magnetically active element outside of the body imparts a change in at least one of location, shape, or position of the corresponding one of the first soft tissue or the first organ to which the first magnetically active implant is affixed (Fig. 7; cols. 5-12 mentions many different uses and setups and how the magnets manipulate the tissue), and wherein when the second magnetically active implant is affixed to the first tissue, the first organ, the second tissue, or the second organ, movement of the second external magnetically active element outside of the body imparts a change in at least one of location, shape, or position of the corresponding one of the first tissue, the first organ, the second tissue, or the second organ to which the second magnetically active implant is affixed (Figs. 1-7).
However, in Fig. 7 the magnet is not positioned outside of the body.
Freedman discloses an alternate embodiment (Fig. 1) wherein a magnet (8) can be placed outside the body and able to manipulate a magnet inside the body (Fig. 1; cols. 5-6).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine and/or substitute any of the internal magnets and use them outside the body, as taught by the alternate embodiment of Freedman, since it would all result in the same function (cols. 5-12) and it is just a preference for the surgeon and patient if they would rather have everything hidden internally or use and external device as well (Figs. 1-7).
Furthermore, Fig. 7 is mainly relied upon because it is the embodiment that has 4 magnets. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use two magnets or slightly more as long as they will still work as intended and to have them as internally or externally located, since it is shown to use them both internal and externally (Figs. 1-7) and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
Lastly, for the limitation regarding the magnet being capable of being controlled by a computer, Freedman teaches magnets 15 and 16 to just be permanent magnets, which could be controlled by a computer as noted above, but they are not electromagnets that are directly linked to the computer.
Rioux teaches using electromagnets in medical applications (col. 5, lines 8-12).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to substitute the permanent magnets of Freedman, to be an electromagnet, as taught by Rioux, since electromagnets allow for more variability of their strength and pole orientation (col. 5).
Claim 22, Freedman in view of Rioux discloses the system of claim 21, Freedman discloses wherein at least one of the first magnetically active implant or the second magnetically active implant comprises at least two components (Figs. 3 and 4; 1 and 13; col. 7, lines 10-24).
Claim 24, Freedman in view of Rioux discloses the system of claim 21.
However, Freedman does not disclose the system comprising a cannula.
Rioux teaches a system (Figs. 1-6) comprising a cannula (col. 1, lines 60-64) through which the first and second magnetically active implants are configured to be inserted into the body (Figs. 1-6; col. 1, lines 60-64).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a cannula, as taught by Rioux, to the system of Freedman, in order to help place the magnetic implants (col. 1, lines 60-64).
Claim 25, Freedman in view of Rioux discloses the system of claim 21, Freedman discloses further comprising an instrument (col. 11, lines 13-30) configured to be inserted into the body and comprised in part of a magnetically active material (col. 11, lines 13-30).
Claim 26, Freedman in view of Rioux discloses the system of claim 25, Freedman discloses wherein the instrument is configured to magnetically attract at least one of the first magnetically active implant or the second magnetically active implant (col. 11, lines 13-30).
Claim 27, Freedman in view of Rioux discloses the system of claim 21, the combination discloses wherein each of the first and second magnetically active elements comprises at least one of a permanent magnet (Freedman – abstract) or an electromagnet (Rioux- col. 5).
Claim 28, Freedman in view of Rioux discloses the system of claim 21, the combination discloses wherein at least one of the first magnetically active implant or the second magnetically active implant has a magnetic field with adjustable magnetic intensity (Freedman -abstract; even permanent magnets can be recharged or demagnetized under certain conditions like changing the temperature) (Rioux, col. 5).
Claim 30, Freedman in view of Rioux discloses the system of claim 21, Freedman discloses wherein the organ is a stomach or an intestine (this is a functional limitation of where the magnets are capable of being located, and the magnets could be placed in those areas).
Claim 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Freedman (US 4978323), in view of Rioux et al. (US 6961620; “Rioux”), in further view of Nelson et al. (US 6955172; “Nelson”).
Claim 23, Freedman in view of Rioux discloses the system of claim 21.
However, Freedman does not disclose how the magnetic implants are attached to the tissue.
Nelson teaches magnetic implants wherein the magnetically active implants comprise at least one of a band, an adhesive, a suture, a staple, a clip, or a clamp, each of which being configured to affix to the corresponding one of the first soft tissue, the second soft tissue, the first organ, or the second organ (Figs. 4a and 7-9; col. 8, lines 32-38).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the attachment mechanism, taught by Nelson, to attach the magnetic implants of Freedman in view of Rioux, since this is a well-known way to attach a magnetic implant to a tissue (Figs. 4a and 7-9; col. 8, lines 32-38).
Claim 29 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Freedman (US 4978323), in view of Rioux et al. (US 6961620; “Rioux”), in further view of Pham (US 6554745).
Claim 29, Freedman in view of Rioux discloses the system of claim 21, the combination discloses further comprising a first arm (Freedman - Fig. 1; 9) connected to the first external magnetically active element and configured to move the first external magnetically active element (Freedman - Fig. 1), and a second arm (Freedman - Fig. 1; as noted above the parts could be duplicated so you have two of these external devices to control two different internal magnets) connected to the second external magnetically active element and configured to move the second external magnetically active element (Fig. 1), wherein the first arm and the second arm are electromechanically controlled with the computer (Rioux – col. 5).
Rioux relies on a generator to manipulate the electromagnet, which could in a sense be considered a computer.
Assuming the generator cannot be considered a computer, Pham teaches using a computer to control an electromagnet (col. 5, lines 49-64).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to control the electromagnet of Freedman in view of Rioux, using a computer, as taught by Pham, in order to give the user the full ability to adjust the parameters of the electromagnet (col. 5, lines 49-64).
Claim 33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rioux et al. (US 6961620; “Rioux”), in view of Nelson et al. (US 6955172; “Nelson”).
Claim 33, Rioux discloses the system of claim 31.
However, Rioux does not disclose the magnetic implants being attached to the tissue.
Nelson teaches magnetic implants wherein the magnetically active implants comprise in part of at least one of a band, an adhesive, a suture, a staple, a clip, or a clamp configured to affix to the soft tissue or the organ (Figs. 4a and 7-9; col. 8, lines 32-38).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the attachment mechanism, taught by Nelson, to attach the magnetic implants of Rioux, since this is a well-known way to attach a magnetic implant to a tissue (Figs. 4a and 7-9; col. 8, lines 32-38).
Claim 39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rioux et al. (US 6961620; “Rioux”), in view of Pham (US 6554745).
Claim 39, Rioux discloses the system of claim 31, further comprising an arm (Fig. 6; 130) connected to the at least one external magnetically active element and configured to move the at least one external magnetically active element, wherein the arm is electromechanically controlled with the computer (Fig. 6; cols. 9-10).
Rioux relies on a generator to manipulate the electromagnet, which could in a sense be considered a computer.
Assuming the generator cannot be considered a computer, Pham teaches using a computer to control an electromagnet (col. 5, lines 49-64).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to control the electromagnet of Rioux, using a computer, as taught by Pham, in order to give the user the full ability to adjust the parameters of the electromagnet (col. 5, lines 49-64).
Response to Arguments
In response to Applicant’s arguments that the magnets of Rioux are not capable of being controlled with a computer, the Examiner respectfully disagrees. As noted above, the magnets, whether permanent or electromagnet, can be controlled via a computer system that controls a separate electromagnet which can control the magnets shown by Rioux. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant’s argument that Rioux does not disclose the external magnetically active element configured to be positioned outside the body, the Examiner respectfully disagrees. Any magnet is capable of being placed inside or outside the body. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to Applicant’s argument that Freedman does not disclose magnets that are capable of being controlled by a computer, the Examiner respectfully disagrees. As noted above, the magnets, whether permanent or electromagnet, can be controlled via a computer system that controls a separate electromagnet which can control the magnets shown by Rioux. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775