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 11/24/2025 in which claim 3 was amended, claim 4 was cancelled, and claim 21 was added, claims 1-3 and 5-21 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 In light of the reply to restriction requirement filed 08/11/2025 in which claims 14-20 were withdrawn, claims 1-3, 5-13, and 21 are examined on the merits herein.
The previous non-final Office Action filed 08/28/2025 has been replaced/superseded by this Office Action. This action is dependent upon the newly provided rejection under 35 U.S.C. 112(b).
Priority
The instant application claims priority to U.S. Provisional App. no. 63/344,694 filed on 05/23/2022.
Claims 1-3 and 5-21 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 withdraws the requirement for the applicant to increase the length of the abstract in view of the applicant’s arguments field 11/24/2025; however, the applicant has failed to address that the abstract comprises phrases which may be implied.
Regarding the remaining objections to the specification, the examiner withdraws the objections in view of the amendments to the specification filed 11/24/2025.
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 11/24/2025.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding the independent claims, the applicant asserts on pg. 6 that the prior art to Singh provides no teachings whatsoever as to how to produce a functional surgical material detectable by MRI, CT, or X-ray.
In response to the applicant’s argument, the examiner respectfully disagrees. Singh (para. 0020-0023) provides an explanation of a strip (110) which may be inserted inside or positioned on the surface of a gauze (105/205). As explained in the rejection of the claims in the previous Office Action filed 08/28/2025, this strip is considered to be the coating on the surgical material. Singh further discloses that the strip (110) may be comprised of beads (305) which contain or are at least partially formed of a material configured to be detected by MRI, and further, that the strip (110) is at least partially formed of a polymer or a chemical compound that combines a metal or chemical that encompasses molecules that render it detectable by MRI, X-ray, and CT scan (para. 0020-0023); therefore, Singh can be considered to read on the structure of the claim. Further still, the claim is not directed to the production of a surgical material detectable by MRI, X-ray, and CT scan, but rather the structure of said surgical material, which as explained above, Singh discloses.
Further, regarding the independent claims, the applicant asserts on pg. 6-7 that the prior art to Cormode does not disclose or suggest the use of the nanoparticle of their invention as a coating for a surgical material, and one of ordinary skill in the art would not be motivated to use the disclosures of Cormode as a coating on a surgical material as presently claimed.
In response to the applicant’s argument, the examiner respectfully disagrees. In the previous Office Action filed 08/28/2025, Cormode was utilized to teach nanoparticles that that may act as dual modality contrast agents, which when provided within the coating of Singh would provide Singh with the ability to be detectable by the modes required. In response to the applicant’s assertion that Cormode’s nanoparticles if used as a coating would result in a quick loss of contrast or signal for the material of Singh, Singh does not disclose any time restraints on the detectability of their surgical material and Singh further discloses that the MRI detectable material may be provided within the beads of their coating such that the MRI detectable material may not be provided directly in contact with the body (para. 0020-0023).
Further still, regarding the independent claims, the applicant asserts on pg. 7 that neither reference to Singh or Cormode provides any guidance as to how to actually achieve the surgical material recited in claim 1.
In response to the applicant’s argument, the examiner respectfully notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As explained above, the combined teachings of the references may be considered to suggest the surgical material recited in claim 1.
The rejections of the independent claims are maintained. The amendments to claim 3 have necessitated a new grounds of rejection.
Specification
The abstract of the disclosure is objected to because the abstract comprises phrases which may be implied (“[p]rovided herein are”; “[i]n some embodiments”). 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 § 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 6 and 13 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.
Claims 6 and 13 recite the limitation “use of the surgical material of claim 1 in a patient” and nothing more. This limitation is indefinite in that attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness per MPEP 2173.05(q). For the sake of compact prosecution, the examiner is treating the claim as though using the surgical material in any way would read on the claim.
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 and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over US/2021/0259894 A1 to Singh in view of US/2016/0271275 A1 to Cormode.
Regarding claim 1, Singh discloses a surgical material comprising a detectable coating (Fig. 2, surgical material 105 comprising strip 110; para. 0018; para. 0021) detectable by magnetic resonance imaging (MRI) and/or computerized tomography (CT) (para. 0021), wherein the detectable coating comprises a chemical compound or molecules that combine a metal or chemical (para. 0021) and/or wherein the detectable coating comprises beads filled with contrast agents or chemicals (para. 0007).
Singh differs from the instantly claimed invention in that Singh fails to disclose wherein the detectable coating comprises bismuth nanoparticles and/or iron oxide nanoparticles.
Cormode discloses a contrast agent comprising bismuth and iron oxide nanoparticles (para. 0005; para. 0006; para. 0024-0027).
Cormode is considered to be analogous to the instantly claimed invention in that Cormode discloses contrast agents for both MRI and CT. 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 Singh to comprise the contrast agent of Cormode, because Singh discloses that the detectable coating of their invention may be at least partially formed by a chemical compound or molecules that combine a metal or chemical that renders it detectable by MRI, X-Ray, and CT scan (para. 0021) and Cormode teaches that their contrast agent is a combination of a metal and a chemical compound detectable by MRI, X-Ray, and CT scan (para. 0024).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Cormode (as in the rejection of claim 1) further teaches: wherein the detectable coating comprises Fe3O4 nanoparticles (para. 0026).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Singh further discloses: wherein the surgical material comprises a fibrous material (para. 0013-0014; para. 0018; Fig. 1, 105 gauze).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Singh further discloses: use of the surgical material of claim 1 in a patient (para. 0025).
Regarding claim 7, Singh discloses a surgical material comprising a detectable coating (Fig. 2, surgical material 105 comprising strip 110; para. 0018; para. 0021) detectable by magnetic resonance imaging (MRI) and computerized tomography (CT) (para. 0021), wherein the detectable coating comprises a chemical compound or molecules that combine a metal or chemical (para. 0021) and/or wherein the detectable coating comprises beads filled with contrast agents or chemicals (para. 0007).
Singh differs from the instantly claimed invention in that Singh fails to disclose wherein the detectable coating comprises bismuth nanoparticles and iron oxide nanoparticles.
Cormode discloses a contrast agent comprising bismuth and iron oxide nanoparticles (para. 0005; para. 0006; para. 0024-0027).
Cormode is considered to be analogous to the instantly claimed invention in that Cormode discloses contrast agents for both MRI and CT. 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 Singh to comprise the contrast agent of Cormode, because Singh discloses that the detectable coating of their invention may be at least partially formed by a chemical compound or molecules that combine a metal or chemical that renders it detectable by MRI, X-Ray, and CT scan (para. 0021) and Cormode teaches that their contrast agent is a combination of a metal and a chemical compound detectable by MRI, X-Ray, and CT scan (para. 0024).
Regarding claim 8, the cited prior art suggests the invention of claim 7. Cormode (as in the rejection of claim 7) further teaches: wherein the detectable coating comprises bismuth nanoparticles and Fe3O4 nanoparticles (para. 0026).
Regarding claim 9, the cited prior art suggests the invention of claim 7. Cormode (as in the rejection of claim 7) further teaches: wherein the nanoparticles comprises at least 20% bismuth (para. 0027); however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein the detectable coating comprises at least 20% bismuth.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to modify the detectable coating to comprise at least 20% bismuth since there are only a finite number of predictable solutions (i.e. 0-100% bismuth). Singh discloses the use of the contrast agent detectable by MRI, X-Ray, and CT scan to reduce the likelihood of incidences of gossypiboma (para. 0003; para. 0021); therefore, it would be important to utilize an amount of the contrast agent that would be accurately detectable. Thus, utilizing at least 20% bismuth would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 10, the cited prior art suggests the invention of claim 7. Cormode (as in the rejection of claim 7) further teaches: wherein the nanoparticles comprises 20% to 40% bismuth (para. 0027); however, the prior art differ from the instantly claimed invention in that they fail to disclose wherein the detectable coating comprises 20% to 40% bismuth.
It would have been obvious to try to one of ordinary skill in the art before the effective filing date of the instant application to modify the detectable coating to comprise 20% to 40% bismuth since there are only a finite number of predictable solutions (i.e. 0-100% bismuth). Singh discloses the use of the contrast agent detectable by MRI, X-Ray, and CT scan to reduce the likelihood of incidences of gossypiboma (para. 0003; para. 0021); therefore, it would be important to utilize an amount of the contrast agent that would be accurately detectable. Thus, utilizing 20% to 40% bismuth would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that the product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under §103." KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Regarding claim 11, the cited prior art suggests the invention of claim 7; however, the prior art differs from the instantly claimed invention in the prior art fails to 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 Singh and Cormode to comprise about 1-10 µg 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Singh and Cormode would not operate differently with the claimed relative amounts and since the detectable coating can be any size or shape so long as it is detectable the device would function appropriately having the claimed relative amounts. 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 (specification pg. 15 ln. 1-7).
Regarding claim 12, the cited prior art suggests the invention of claim 7. Singh further discloses: wherein the surgical material comprises a fibrous material (para. 0013-0014; para. 0018; Fig. 1, 105 gauze).
Regarding claim 13, the cited prior art suggests the invention of claim 7. Singh further discloses: use of the surgical material of claim 1 in a patient (para. 0025).
Claims 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Cormode as applied above, and further in view of WO/2006/119645 A1 to Plewes.
Regarding claim 3, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the detectable coating further comprises copper and/or nickel.
Plewes teaches a medical device comprising copper microspheres to provide MRI detectability and decreased susceptibility artifacts (pg. 11 ln. 18-24).
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 detectable coating of Singh and Cormode to further comprise copper microspheres as taught by Plewes, because Plewes teaches that copper microspheres produce decreased susceptibility artifacts (pg. 11 ln. 18-24), such that the location of the surgical material may be more accurately determined.
Regarding claim 21, the cited prior art suggests the invention of claim 7; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the detectable coating further comprises copper and/or nickel.
Plewes teaches a medical device comprising copper microspheres to provide MRI detectability and decreased susceptibility artifacts (pg. 11 ln. 18-24).
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 detectable coating of Singh and Cormode to further comprise copper microspheres as taught by Plewes, because Plewes teaches that copper microspheres produce decreased susceptibility artifacts (pg. 11 ln. 18-24), such that the location of the surgical material may be more accurately determined.
Conclusion
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.
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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 18 March 2026