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
In response to the amendment filed on 10/29/2025, No Claims have been cancelled, and Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues, on Page 5 of 10 and Page 6 of 10, that both Wood and Zoll, individually, fail to disclose “wherein the indicia representing designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue”, however the Examiner respectfully disagrees. Applicant asserts that is because Wood and Zoll merely teach a surgical mesh or medical devices that incorporate dyes. The Examiner agrees with Applicant statement, however disagrees that the prior art references fails to disclose the claim language.
The recitation in the claims that the device is “wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Wood discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that the anchoring device is not positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Lastly, Wood teaches that “dye can also be used to mark other medical apparatuses that are implanted near the surface of a patient's body to facilitate confirming their placement and other parameters.” (Paragraph 0027). It’s the Examiner’s position that these dyes that are marked on the implant can be used to designate fixation points for an anchor.
Zoll teaches “The energy absorbing material (e.g., nanoparticles, dye, etc.) in the bonding material absorbs the energy and generates heat, which activates solder material in the bonding material, resulting in a bond (e.g., a crosslinked bond) between the mesh and the vaginal wall tissue.” in Paragraph 0078, and thus Zoll does teach where the dye is used to represent designated fixation points.
The Examiner notes that in Claim 7, the claims positively recite the anchoring device and Stopek is relied upon to teach indicia (210) on an implant (200) which clearly represent fixation points for the anchoring devices (300; see Figure 8).
As to Applicant’s arguments directed to the dependent claims as being patentable due to their dependency to Claim 1 and 15 , the rejection of Claims 1 and 15 is being maintained in light of the teachings of Wood and Zoll. Applicant has not separately argued the patentability of the dependent claims. Thus, the dependent claims are also being rejected.
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.
Claim(s) 1, 2, and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood (US PGPub 2011/0017217).
Regarding Claim 1, Wood teaches a surgical system, comprising:
a surgical implant including indicia that is non-visible to a human eye (Paragraph 0017, 0032, and 0034-0035), wherein the indicia is capable of representing designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue (see intended use argument, provided below); and
a detecting device configured to detect the indicia on the surgical implant (Paragraph 0017, 0032, and 0034-0035).
The recitation in the claims that the device is “wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Wood discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that the anchoring device is not positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Regarding Claim 2, Wood teaches the surgical system according to claim 1, wherein the indicia is made from indocyanine green (Paragraph 0035 and 0039).
Regarding Claim 14, Wood teaches the surgical system according to claim 1, wherein the indicia is configured to be reflected by ultraviolet light (Paragraph 0042).
Regarding Claim 15, Wood teaches a surgical implant (700; Figure 7) (800; Figure 8), comprising:
a first indicia made from a cyanine dye that is invisible to a human eye (Paragraph 0050 discloses a plurality of indicia in the form of rings), wherein the first indicia is capable of representing designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue (see intended use argument, provided below); and
a second indicia (Paragraph 0050 discloses a plurality of indicia in the form of rings).
The recitation in the claims that the device is “wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Wood discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that the anchoring device is not positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Regarding Claim 16, Wood teaches the surgical implant according to claim 15, wherein the second indicia is made from the cyanine dye that is invisible to a human eye (Paragraph 0050).
Regarding Claim 17, Wood teaches the surgical implant according to claim 15, wherein the cyanine dye is indocyanine green (Paragraph 0039).
Claim(s) 1-4 and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zoll (US PGPub 2016/0270895).
Regarding Claim 1, Zoll teaches a surgical system, comprising:
a surgical implant (700; Figure 7) including indicia that is non-visible to a human eye (the bonding material on arms 710b as disclosed in Paragraph 0090, and in Paragraph 0008 states that the mesh has a bonding material that comprises a tissue solder and an absorber material, Paragraph 0043 states that the boding material can be indocyanine green), wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue (Paragraph 0078; see intended use argument, provided below); and
a detecting device configured to detect the indicia on the surgical implant (Paragraph 0047 states activating the indocyanine green with a 800-nm laser, but also see Paragraph 0078).
The recitation in the claims that the device is “wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Zoll discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that the anchoring device is not positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Regarding Claim 2, Zoll teaches the surgical system according to claim 1, wherein the indicia is made from indocyanine green (Paragraph 0043, 0046, and 0047).
Regarding Claim 3, Zoll teaches the surgical system according to claim 1, wherein the surgical implant includes secondary indicia that is visible to a human eye (Paragraph 0043 which states combinations of 2 or more and the examiner notes that methylene blue dye and reactive black 5 dye are both visible to the human eye)
Regarding Claim 4, Zoll teaches the surgical system according to claim 1, wherein the surgical implant is a surgical mesh (See Figure 7), and wherein the surgical system further includes an anchoring device in the form of a suture configured to secure the surgical mesh to the underlying tissue (Paragraph 0090 states that one arm 710a of the mesh is sutured onto tissue adjacent).
Regarding Claim 15, Zoll teaches a surgical implant (700; Figure 7) (800; Figure 8), comprising:
a first indicia made from a cyanine dye that is invisible to a human eye (Paragraph 0043), wherein the first indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue (Paragraph 0078; see intended use argument, provided below); and
a second indicia (Paragraph 0043 states combination of two or more) (furthermore, see Figure 8 and Paragraph 0065-0066 which states the visualization agent can be incorporated into the reactive component (210; Figure 8, in which there are multiple) or can be incorporated onto the reinforcing member (300; Figure 8; in which there are three shown).
The recitation in the claims that the device is “wherein the indicia represents designated fixation points for securing of the surgical implant to underlying tissue by an anchoring device extending through the surgical implant and into the underlying tissue” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Zoll discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that the anchoring device is not positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Regarding Claim 16, Zoll teaches the surgical implant according to claim 15, wherein the second indicia is made from the cyanine dye that is invisible to a human eye (Paragraph 0043).
Regarding Claim 17, Zoll teaches the surgical implant according to claim 15, wherein the cyanine dye is indocyanine green (Paragraph 0043).
Regarding Claim 18, Zoll teaches the surgical implant according to claim 15, wherein the second indicia is visible to a human eye (Paragraph 0043 states methylene blue dye and reactive black 5 dye, which are both visible to the human eye).
Regarding Claim 19, Zoll teaches the surgical implant according to claim 15, wherein the first indicia includes one of a linear pattern or a circular pattern (Figure 8).
Regarding Claim 20, Zoll teaches the surgical implant according to claim 15, wherein the cyanine dye of the first indicia is detectable by a detecting device (Paragraph 0047 states activating the indocyanine green with a 800-nm laser, but also see Paragraph 0078), and wherein the first indicia provides guidance to a surgical robot to secure the surgical implant at the designated fixation points.
The recitation in the claims that the device is “wherein the first indicia provides guidance to a surgical robot to secure the surgical implant at the designated fixation points” is merely an intended use. Applicants attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Zoll discloses a surgical system that comprises an implant with indicia as presently claimed, it is clear that the indicia of Wood would be capable of performing the intended use, i.e. (being interpreted as fixation points for anchoring by a surgical robot), presently claimed as required in the above cited portion of the MPEP.
Furthermore, the Examiner notes that neither the anchoring device nor the surgical robot are positively recited in the claims, and thus the indicia need only be capable of being used as fixation point designation for the anchoring device to be implants through and into the underlying tissue.
Claim Rejections - 35 USC § 103
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 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(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Zoll (US PGPub 2016/0270895) as applied to claim 4 above, and further in view of Stopek (US PGPub 2010/0331880).
Regarding Claim 5, Zoll teaches the surgical system according to claim 4, but fails to disclose wherein the suture includes indicia that is non-visible to a human eye.
Stopek teaches a surgical mesh with reinforcement materials to create a self sealing implant (abstract), wherein the surgical mesh comprises visualization agents to improve invisibility (Paragraph 0065), wherein the surgical mesh can be attached to the body using sutures (Paragraph 0059, 00063) or have sutures embedded within (Paragraph 0062), wherein the suture can comprise indocyanine green (Paragraph 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Zoll to include a suture that has indicia that is non-visible to the eye, as taught by Stopek, for the advantage of improving visibility during procedures, including visualizing fluid flow through and around the device (Paragraph 0065; Stopek)
Regarding Claim 6, the combination of references disclosed above teaches the surgical system according to claim 5, where Stopek teaches the indicia on the suture is made from indocyanine green (Paragraph 0065).
Regarding Claim 7, Zoll teaches the surgical system according to claim 1, wherein the surgical implant is a surgical mesh (Figure 7; Zoll), and but fails to disclose wherein the surgical system further includes an anchoring device in the form of a surgical tack configured to secure the surgical mesh to the underlying tissue.
Stopek teaches a surgical mesh with reinforcement materials to create a self sealing implant (abstract), wherein the surgical mesh comprises visualization agents to improve invisibility (Paragraph 0065), wherein the surgical mesh can be attached to the body using tacks for securing the surgical mesh to underlying tissues (Paragraph 0005, 0063)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Zoll to include a surgical tack configured to secure the surgical mesh to tissue, as taught by Stopek, for the advantage of securing the mesh in place (Paragraph 0049). Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case the tacks would be sufficient to replace the suture as the tacks are for the same purpose and yields the predictable result of securing the mesh to tissue.
Regarding Claim 8, the combination of references disclosed above teaches the surgical system according to claim 7, wherein Stopek further teaches the surgical tack includes indicia that is non-visible to a human eye (Paragraph 0063 states that any part of the implant (the mesh or the reinforcing materials) can include a fluoroscopic contrast agent (see Paragraphs 0064-0065 which discloses indocyanine green).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the material of the tack to be include a fluoroscopic contrast agent, as taught by Stopek, for the advantage of having better visibility in the presence of blood on a pink or white tissue (Paragraph 0065; Stopek)
Regarding Claim 9, the combination of references disclosed above teaches the surgical system according to claim 8, where Stopek teaches the indicia on the surgical tack is made from indocyanine green.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the material of the tack to be indocyanine green, as taught by Stopek, for the advantage of having better visibility in the presence of blood on a pink or white tissue (Paragraph 0065; Stopek).
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zoll (US PGPub 2016/0270895) as applied to claim 1 above, and further in view of Bonutti (US PGPub 2003/0181800).
Regarding Claim 10, Zoll teaches the surgical system according to claim 1, wherein the surgical implant is a surgical mesh (Figure 7; Paragraph 0090), and but fails to disclose wherein the surgical system further includes a surgical robot in communication with the detecting device and configured to secure the surgical mesh to tissue using suture, and wherein the indicia provides guidance to the surgical robot.
Bonutti teaches a robotic mechanism (Figure 1; abstract) configured to attached a surgical mesh to tissue (Paragraph 00237), the surgical robot is in communication with a detecting device (40; Paragraph 0007 and 0296; Figure 37; in which the robotic system is utilized with a fluoroscope 520) and configured to secure the surgical mesh to tissue using a suture (Paragraph 0056-0057), and wherein the indicia provides guidance to the surgical robot (Paragraph 0277, 0304, 0326).
It would have been obvious to one of ordinary skill in the art to modify the system of Zoll such that the mesh is delivered via a surgical robot for the advantage of automation and the minimizing risk of manual mistakes during delivery of the mesh into the patient.
Regarding Claim 12, Zoll teaches the surgical system according to claim 1, wherein the surgical implant is a surgical mesh (Figure 7; Paragraph 0090), and but fails wherein the surgical system further includes a surgical robot disposed in communication with the detecting device and configured to secure the surgical mesh to tissue using a surgical tack, and wherein the indicia provides guidance to the surgical robot to secure the surgical implant at the designated fixation points.
Bonutti teaches a robotic mechanism (Figure 1; abstract) configured to attached a surgical mesh to tissue (Paragraph 00237), the surgical robot is in communication with a detecting device (40; Paragraph 0007 and 0296; Figure 37; in which the robotic system is utilized with a fluoroscope 520) and configured to secure the surgical mesh to tissue using a surgical tack (Paragraph 0003, 0009, 0102, and 0322), and wherein the indicia provides guidance to the surgical robot to secure the surgical implant at the designated fixation points (Paragraph 0304, 0326).
It would have been obvious to one of ordinary skill in the art to modify the system of Zoll such that the mesh is delivered via a surgical robot for the advantage of automation and the minimizing risk of manual mistakes during delivery of the mesh into the patient.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zoll (US PGPub 2016/0270895) and Bonutti (US PGPub 2003/0181800) as applied to claim 10 and 12 above, and further in view of Stopek (US PGPub 2010/0331880).
Regarding Claim 11 and 13, the combination of references disclosed above teaches the surgical system according to claim 10/14, but fails to disclose wherein the suture (Claim 11) or the surgical tack (Claim 13) includes indicia that is non-visible to a human eye.
Stopek teaches a surgical mesh with reinforcement materials to create a self sealing implant (abstract), wherein the surgical mesh comprises visualization agents to improve invisibility (Paragraph 0065), wherein the surgical mesh can be attached to the body using sutures (Paragraph 0059, 00063) or have sutures embedded within (Paragraph 0062), wherein the suture can comprise indocyanine green (Paragraph 0065), and wherein the surgical mesh can be attached to the body using tacks for securing the surgical mesh to tissues (Paragraph 0005, 0063), wherein the suture or surgical tack is non-visible to the human eye (Paragraph 0064-0065)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the material of the suture or the tack to be include a fluoroscopic contrast agent that is non-visible to the human eye, as taught by Stopek, for the advantage of once the contract agent is excited with the right wavelength, the contrast agent has better visibility in the presence of blood on a pink or white tissue (Paragraph 0065; Stopek)
Conclusion
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMED G GABR/Primary Examiner, Art Unit 3771