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 Arguments
Applicant’s arguments, see pg. 5, filed 29 May 2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 08 Apr 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 5, filed 29 May 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 08 Apr 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 5-9, filed 29 May 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Status of Claims
Claims 1, 5-11, 15-16, and 19-20 are currently under examination. Claims 2-4, 12-14, and 17-18 have been cancelled since the Non-Final Office Action of 08 Apr 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8, 11, 15-16, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites the new limitation “wherein the single elongate flexible monofilament is configured to be attached only to itself or to the tissue after implantation”. With respect to the claimed single elongate flexible monofilament being configured to be attached only to itself, a review of the original specification of the instant application, however, only discloses the claimed monofilament configured to knot (see at least [0035], [0086], [00103], [00118], [00121]-[00124]). Thus, the limitation recites a broader scope of “attached only to itself”, which may encompass, for example, attaching using an adhesive or a magnetism that are well known in the art, when the original specification discloses a single species of knotting as a form of attaching to itself. Therefore, the broader scope of the new limitation is not supported by the narrower scope of the original specification.
Claim 11 recites the new limitation “wherein the single elongate flexible monofilament is configured to be attached only to itself or to the tissue after implantation”. With respect to the claimed single elongate flexible monofilament being configured to be attached only to itself, a review of the original specification of the instant application, however, only discloses the claimed monofilament configured to knot (see at least [0035], [0086], [00103], [00118], [00121]-[00124]). Thus, the limitation recites a broader scope of “attached only to itself”, which may encompass, for example, attaching using an adhesive or a magnetism that are well known in the art, when the original specification discloses a single species of knotting as a form of attaching to itself. Therefore, the broader scope of the new limitation is not supported by the narrower scope of the original specification. Claims 15-16 and 19-20 inherit the deficiency by the nature of their dependency on claim 11.
Claim Rejections - 35 USC § 103
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, 5, 7-11, 15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vayser et al. (US PG Pub No. 2020/0261742, published 20 Aug 2020) – hereinafter referred to Vayser – in view of Pagoria et al. (US PG Pub No. 2018/0333562) – hereinafter referred to as Pagoria – as evidenced by Coomaraswamy et al. (Coomaraswamy et al. Evaluation of Different Radiopacifiers for an MTA-like Dental Cement. Key Engineering Materials. (2007). 361-363: 885-888. doi: 10.4028/www.scientific.net/KEM.361-363.885. A copy attached to this Office action.) – hereinafter referred to as Coomaraswamy.
Regarding claim 1, Vayser discloses a radiopaque fiducial marker (RFM; at least Fig. 3-4) comprising:
a filament structure (Fig. 3-4: marker 302/404) consisting of a single elongate flexible monofilament having a radiopaque dopant disposed therein ([0035]: elongated flexible, continuous radiopaque tissue marker formed into one, single filament; [0041]: filament radiopaque with barium sulfate),
wherein the single elongate flexible monofilament is configured to extend along a perimeter of a surgical cavity such that the RFM does not fill a volume of the surgical cavity (Fig. 3-4: marker extending along the perimeter of the surgical cavity 304, 402), and
wherein the RFM is radiopaque ([0035]: elongated flexible, continuous radiopaque tissue marker formed into one, single filament).
Regarding the limitation “wherein the RFM … minimizes or avoids artifacts under radiographic imaging”, a review of the specification of the instant application discloses in [0066]-[0067] that the claimed radiopaque material of bismuth minimizes or avoids artifacts under radiographic imaging. Therefore, Vayser’s radiopaque tissue marker comprising bismuth inherently minimizes or avoids artifacts under radiographic imaging.
Vayser does not disclose:
wherein the radiopaque dopant comprises bismuth oxychloride (BiOCl), bismuth oxide (Bi2O3), or bismuth subcarbonate (Bi2O2(CO3-)).
In the same field of radiopaque filament, Pagoria, however, teaches:
a radiopaque dopant comprising bismuth oxychloride (BiOCI), bismuth oxide (Bi2O3), or bismuth subcarbonate (Bi2O2(CO3)) ([0067]: radiopaque filament including bismuth salts such as bismuth subcarbonate, bismuth oxychloride, and bismuth trioxide).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vayser’s marker to include Pagoria’s bismuth dopant. One of ordinary skill in the art would have substituted the elements (in this case, substitute Vayser’s barium sulfate dopant with Pagoria’s bismuth dopant), and the substitution would have yielded a reasonable expectation of success since both Vayser and Pagoria are directed to a radiopaque filament. The motivation for the substitution would have been since bismuth dopant is well known in the art to be more radiopaque than barium sulfate (as evidenced by Coomaraswamy: see Fig. 1), thus improved visualization of the radiopaque filament under X-ray imaging.
Regarding claim 5, Vayser in view of Pagoria discloses all limitations of claim 1, as discussed above, and Vayser does not disclose:
wherein the single elongate flexible monofilament comprises polypropylene, polyester, polyvinylidene fluoride, catgut, polyglactin, silk, or polyamide.
In the same field of radiopaque filament, Pagoria, however, teaches:
a radiopaque elongate filament comprising polypropylene, polyester, polyvinylidene fluoride, catgut, polyglactin, silk, or polyamide ([0065]: filament made of polymeric material, including polypropylene, polyester, and polyamide).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vayser’s marker to include Pagoria’s polymeric filament. One of ordinary skill in the art would have substituted the elements (in this case, substitute Vayser’s polymeric filament with Pagoria’s polypropylene, polyester, or polyamide filament), and the substitution would have yielded a reasonable expectation of success since both Vayser and Pagoria are directed to a radiopaque filament. The motivation for the substitution would have been to provide a flexible filament ([0009] of Pagoria).
Regarding claim 7, Vayser in view of Pagoria discloses all limitations of claim 1, as discussed above, and Vayser further discloses:
wherein the RFM has a diameter of 100 microns to 1000 microns ([0041]: filament diameter between 0.1 and 0.3 mm, or 100 and 300 microns).
Regarding claim 8, Vayser in view of Pagoria discloses all limitations of claim 1, as discussed above, and Vayser further discloses:
wherein the RFM is configured to remain permanently in tissue of a patient's body ([0041]: filament may remain permanently in the body), and
wherein the single elongate flexible monofilament is configured to be attached only to itself or to the tissue after implantation ([0035]: filament can be self-knotted to itself and secured/anchored to tissue).
Regarding claim 9, Vayser in view of Pagoria discloses all limitations of claim 1, as discussed above, and Vayser further discloses:
a dye or colorant configured to facilitate visualization of the RFM when disposed in a tissue of a patient's body ([0036]: other optical indicator added to radiopaque marker (e.g., adding a blue color to the filament)).
Regarding claim 10, Vayser in view of Pagoria discloses all limitations of claim 1, as discussed above, and Vayser further discloses:
a needle coupled to the single elongate flexible monofilament ([0035]: marker formed into a filament with an attached needle),
the needle configured to facilitate attachment of the RFM to a tissue in a patient’s body ([0035]: attached needle to thread through or otherwise attach the filament marker to tissue).
Regarding claim 11, Vayser in view of Pagoria discloses a radiopaque fiducial marker (RFM; at least Fig. 1-2) comprising:
a filament structure (Fig. 3-4: marker 302/404) consisting of a single elongate flexible monofilament having a radiopaque dopant disposed therein ([0035]: elongated flexible, continuous radiopaque tissue marker formed into one, single filament; [0041]: filament radiopaque with barium sulfate),
wherein the single elongate flexible monofilament is configured to extend along a perimeter of a surgical cavity such that the RFM does not fill a volume of the surgical cavity (Fig. 3-4: marker extending along the perimeter of the surgical cavity 304, 402),
wherein the RFM has a diameter of 100 microns to 1000 microns ([0041]: filament diameter between 0.1 and 0.3 mm, or 100 and 300 microns),
wherein the RFM is radiopaque ([0035]: elongated flexible, continuous radiopaque tissue marker formed into one, single filament),
wherein the RFM is configured to remain permanently in tissue of a patient's body ([0041]: filament may remain permanently in the body), and
wherein the single elongate flexible monofilament is configured to be attached only to itself or to the tissue after implantation ([0035]: filament can be self-knotted to itself and secured/anchored to tissue).
Regarding the limitation “wherein the RFM … minimizes or avoids artifacts under radiographic imaging”, a review of the specification of the instant application discloses in [0066]-[0067] that the claimed radiopaque material of bismuth minimizes or avoids artifacts under radiographic imaging. Therefore, Vayser’s radiopaque tissue marker comprising bismuth inherently minimizes or avoids artifacts under radiographic imaging.
Vayser does not disclose:
wherein the radiopaque dopant comprises bismuth oxychloride (BiOCl), bismuth oxide (Bi2O3), or bismuth subcarbonate (Bi2O2(CO3-)).
In the same field of radiopaque filament, Pagoria, however, teaches:
a radiopaque dopant comprising bismuth oxychloride (BiOCI), bismuth oxide (Bi2O3), or bismuth subcarbonate (Bi2O2(CO3)) ([0067]: radiopaque filament including bismuth salts such as bismuth subcarbonate, bismuth oxychloride, and bismuth trioxide).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vayser’s marker to include Pagoria’s bismuth dopant. One of ordinary skill in the art would have substituted the elements (in this case, substitute Vayser’s barium sulfate dopant with Pagoria’s bismuth dopant), and the substitution would have yielded a reasonable expectation of success since both Vayser and Pagoria. The motivation for the substitution would have been since bismuth dopant is well known in the art to be more radiopaque than barium sulfate (as evidenced by Coomaraswamy: see Fig. 1), thus improved visualization of the radiopaque filament under X-ray imaging.
Regarding claim 15, Vayser in view of Pagoria discloses all limitations of claim 11, as discussed above, and Vayser does not disclose:
wherein the single elongate flexible monofilament comprises polypropylene, polyester, polyvinylidene fluoride, catgut, polyglactin, silk, or polyamide.
In the same field of radiopaque filament, Pagoria, however, teaches:
a radiopaque elongate filament comprising polypropylene, polyester, polyvinylidene fluoride, catgut, polyglactin, silk, or polyamide ([0065]: filament made of polymeric material, including polypropylene, polyester, and polyamide).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vayser’s marker to include Pagoria’s polymeric filament. One of ordinary skill in the art would have substituted the elements (in this case, substitute Vayser’s polymeric filament with Pagoria’s polypropylene, polyester, or polyamide filament), and the substitution would have yielded a reasonable expectation of success since both Vayser and Pagoria are directed to a radiopaque filament. The motivation for the substitution would have been to provide a flexible filament ([0009] of Pagoria).
Regarding claim 19, Vayser in view of Pagoria discloses all limitations of claim 11, as discussed above, and Vayser further discloses:
a dye or colorant configured to facilitate visualization of the RFM when disposed in a tissue of a patient's body ([0036]: other optical indicator added to radiopaque marker (e.g., adding a blue color to the filament)).
Regarding claim 20, Vayser in view of Pagoria discloses all limitations of claim 11, as discussed above, and Vayser further discloses:
a needle coupled to the single elongate flexible monofilament ([0035]: marker formed into a filament with an attached needle),
the needle configured to facilitate attachment of the RFM to a tissue in a patient’s body ([0035]: attached needle to thread through or otherwise attach the filament marker to tissue).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Vayser in view of Pagoria, as applied to claims 1 and 11 respectively above, and further in view of De Langen et al. (US PG Pub No. 2008/0234532) – hereinafter referred to as De Langen.
Regarding claims 6 and 16, Vayser in view of Pagoria discloses all limitations of claims 1 and 11, respectively, as discussed above, and Vayser does not disclose:
wherein the RFM has a density of < 1.5 g/cm3.
In the same field of radiopaque filament, De Langen, however, teaches:
a radiopaque marker having a density of < 1.5 g/cm3 ([0018]: fiducial marker having a density of at least 1.1 g/cm3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vayser’s marker to include De Langen’s radiopaque marker density. One of ordinary skill in the art would have combined the elements as claimed (i.e., providing a radiopaque marker having a density of at least 1.1 g/cm3, as disclosed by De Langen), and the combination would have yielded a reasonable expectation of success since both Vayser and De Langen are directed to a radiopaque marker. The motivation for the modification would be so that the marker is distinguishable from the surrounding tissue when the marker is implanted in the tissue by the difference in density.
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 Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 7/28/26
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