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 light of the amendments to the claims filed 07/17/2026 in which claims 1-3, 6-11, 13, and 21 were amended, claims 5 and 12 were cancelled, and claims 22-23 were added, claims 1-3, 6-11, and 13-23 are pending in the instant application. In light of the reply to restriction requirement filed 08/11/2025 in which claims 14-20 were withdrawn, claims 1-3, 6-11, 13, and 21-23 are examined on the merits herein.
Priority
The instant application claims priority to U.S. Provisional App. no. 63/344,694 filed on 05/23/2022.
Claims 1-3, 6-11, and 13-23 receive priority to the prior-filed application, filed on 05/23/2022.
Response to Arguments
Objections to the Specification
Regarding the objections to the abstract, the examiner maintains the objection in view of the newly amended abstract as explained below.
Rejections of the Claims under 35 U.S.C. 112(b)
The objections to the claims are withdrawn in view of the amendments to the claims filed 07/17/2026.
Rejections of the Claims under 35 U.S.C. 103
Applicant’s arguments filed 07/17/2026 with respect to the independent claims 1 and 7 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 (Singh, Cormode, and Plewes) for any teaching or matter specifically challenged in the argument.
The new grounds of rejection based on Robinson and/or Medeiros are explained below.
The amendments to the claims have necessitated new grounds of rejection.
Specification
The abstract of the disclosure is objected to because the abstract comprises phrases which may be implied (“[t]he disclosure describes”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Appropriate correction is required.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over GB/1068747 to Robinson.
Regarding claim 1, Robinson discloses a fibrous surgical material comprising a detectable coating (pg. 1:23-47; pg. 2:6-15) detectable by magnetic resonance imaging (MRI) (pg. 2:16-29) and optionally detectable by computerized tomography (CT) (pg. 2:35-58), wherein the detectable coating comprises iron oxide particles (pg. 1:32-37), and wherein the iron oxide particles adhere to fibers of the fibrous surgical material (pg. 1:23-47; pg. 1:75-2:5).
Robinson differs from the instantly claimed invention in that Robinson fails to disclose wherein the detectable coating comprises nanoparticles.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the particles of Robinson to be nanoparticles as Robinson discloses that the iron oxide particles are suitably in a finely divided form and dispersed and embedded in the elastomer, which may be extruded into the desired shape for securing to the dressing (pg. 1:23-68).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the particles of Robinson to be nanoparticles since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” See MPEP 2144.04. As explained above, the device of Robinson would not operate differently with the claimed particle size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the particles are nanoparticles in some embodiments (Applicant’s specification: pg. 9:30-10:31).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Robinson further teaches: wherein the detectable coating comprises Fe3O4 particles (pg. 1:32-34, ferrosoferric oxide).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Robinson further discloses: a method comprising placing the fibrous surgical material of claim 1 into a subject (pg. 1:23-26).
Regarding claim 22, the cited prior art suggests the invention of claim 1.
The limitations drawn to the ability of the coating to be detected by MRI and/or CT after dialyzing the fibrous surgical material comprising the detectable coating are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, Robinson suggests all of the structure as claimed by the Applicant. Robinson is further considered to be able to perform the function as claimed in that the detectable particles are embedded in a polymer and adhered to the surgical material (pg. 1:27-2:5) suggesting that the detectable particles would not simply wash away and the dressing is steam sterilized before use (pg. 2:6-15) suggesting that washing the dressing does not reduce the detectability of the dressing. See MPEP 2112.01(I).
Claims 3, 7-11, 13, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over GB/1068747 to Robinson in view of US/2018/0280206 to Medeiros.
Regarding claim 3, the cited prior art suggests the invention of claim 1.
Robinson differs from the instantly claimed invention in that Robinson fails to disclose wherein the detectable coating further comprises copper and/or nickel.
Medeiros teaches a fibrous x-ray detectable fabric comprising copper (para. 0008; para. 0010-0011) which may be produced in the same manner as the coating of Robinson (para. 0013).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the coating of Robinson to further comprise bismuth and/or copper as taught by Medeiros, because Robinson discloses that the coating of their invention may optionally be detectable by CT scan by adding one or more components which are x-ray opaque to allow the possibility of a post-operative double check (pg. 2:35-58) and Medeiros teaches that copper is an x-ray detectable element (para. 0011).
Regarding claims 7-10 and 21, Robinson discloses
(Claim 7) a fibrous surgical material comprising a detectable coating (pg. 1:23-47; pg. 2:6-15) detectable by magnetic resonance imaging (MRI) (pg. 2:16-29) and optionally detectable by computerized tomography (CT) (pg. 2:35-58), wherein the detectable coating comprises iron oxide particles (pg. 1:32-37), and wherein the iron oxide particles adhere to fibers of the fibrous surgical material (pg. 1:23-47; pg. 1:75-2:5); and
(Claim 8) wherein the detectable coating comprises Fe3O4 particles (pg. 1:32-34).
Robinson differs from the instantly claimed invention in that Robinson fails to disclose
(Claims 7 and 8) wherein the detectable coating comprises bismuth particles;
(Claim 9) wherein the detectable coating comprises at least 20% bismuth;
(Claim 10) wherein the detectable coating comprises 20% to 40% bismuth; and
(Claim 21) wherein the detectable coating further comprises copper and/or nickel.
Medeiros teaches a fibrous x-ray detectable fabric comprising bismuth and/or copper particles in an amount comprising 20% bismuth and/or copper or 20% to 40% bismuth and/or copper (para. 0008; para. 0010-0011) which may be produced in the same manner as the coating of Robinson (para. 0013).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the coating of Robinson to further comprise bismuth and/or copper as taught by Medeiros, because Robinson discloses that the coating of their invention may optionally be detectable by CT scan by adding one or more components which are x-ray opaque to allow the possibility of a post-operative double check (pg. 2:35-58) and Medeiros teaches that bismuth and copper are x-ray detectable elements (para. 0011).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of bismuth in Robinson, as modified by Medeiros, from any amount as disclosed in Medeiros to at least 20% or 20% to 40% as applicant appears to have placed no criticality on the claimed range (Applicant’s specification: pg. 15:8-17) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” See MPEP 2144.05.
Further, the cited prior art differs from the instantly claimed invention in that the prior art fail to disclose
(Claims 7 and 8) wherein the detectable coating comprises nanoparticles.
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the particles of Robinson, as modified by Medeiros, to be nanoparticles as Robinson discloses that the iron oxide particles are suitably in a finely divided form and dispersed and embedded in the elastomer, which may be extruded into the desired shape for securing to the dressing (pg. 1:23-68) and Medeiros teaches that the CT detectable particles are embedded in a polymer (para. 0013).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the particles of Robinson, as modified by Medeiros, to be nanoparticles since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” See MPEP 2144.04. As explained above, the device of Robinson, as modified by Medeiros would not operate differently with the claimed particle size. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the particles are nanoparticles in some embodiments (Applicant’s specification: pg. 9:30-10:31).
Regarding claim 11, the cited prior art suggests the invention of claim 7.
Robinson discloses that the detectable coating comprises 20-90% of iron compound (pg. 1:69-74).
The prior art differs from the instantly claimed invention in the prior art fails to explicitly disclose wherein the detectable coating comprises about 1 µg iron to about 10 µg iron per milligram of the surgical material.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detectable coating of Robinson, as modified by Medeiros, to comprise about 1-10 µg iron per milligram of the surgical material since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” See MPEP 2144.04. In the instant case, the device of Robinson, as modified by Mederios, would not operate differently with the claimed relative amounts as long as the coating is still detectable by an electromagnetic metal detector (pg. 1:23-26; pg. 1:69-4). Further, it appears that applicant places no criticality on the range claimed, indicating simply that the amount of iron is within 2-15 µg in some embodiments (Applicant’s specification: pg. 15 ln. 1-7).
Regarding claim 13, the cited prior art suggests the invention of claim 7. Robinson further discloses: a method comprising placing the fibrous surgical material of claim 7 into a subject (pg. 1:23-26).
Regarding claim 23, the cited prior art suggests the invention of claim 7.
The limitations drawn to the ability of the coating to be detected by MRI and/or CT after dialyzing the fibrous surgical material comprising the detectable coating are considered to be functional language. If a prior art structure is capable of performing the function as recited in the claim, the prior art structure is considered to reasonably meet the limitations of the claim. In the instant case, the combination of Robinson and Medeiros suggests all of the structure as claimed by the Applicant. Robinson is further considered to be able to perform the function as claimed in that the detectable particles are embedded in a polymer and adhered to the surgical material (pg. 1:27-2:5) suggesting that the detectable particles would not simply wash away and the dressing is steam sterilized before use (pg. 2:6-15) suggesting that washing the dressing does not reduce the detectability of the dressing. Medeiros further teaches that the CT detectable particles are embedded in a polymer (para. 0013). See MPEP 2112.01(I).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
28 September 2026
