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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date of 23 Nov 2016 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10 Jun 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
[0012] and [0013] are duplicates; and
In [0012] of the specification, the sentence “preferably configured minimize a specular appearance under ultrasound when hydrated” should read “preferably configure to minimize a specular appearance under ultrasound when hydrated”.
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.
Claim 1 is 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.
Claim 1 recites “the radiopaque marker” in lines 5 and 11. The antecedent basis for “the radiopaque marker” is unclear. In particular, it is unclear whether “the radiopaque marker” is referring to “a radiopaque element” recited in line 3 of claim 1; or otherwise. For purposes of the examination, the recitations “the radiopaque marker” are being given a broadest reasonable interpretation as “the radiopaque element”.
Claim 1 recites “the body” in lines 5, 6, and 10. The antecedent basis for “the body” is unclear. In particular, the preamble of the claim recites “a patient’s body” and the body of the claim recites “a non-palpable body”. It is unclear to which “the body” is referring. For purposes of the examination, the recitations “the body” are being a broadest reasonable interpretation as “the non-palpable body”.
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herbert et al. (US Patent Pub No. 2016/0206323, provided by the Applicant in the IDS of 10 Jun 2025) - hereinafter referred to as Herbert.
Regarding claim 1, Herbert discloses a marker (see at least Fig. 2) comprising:
a radiopaque element (micrograft 10) having a distinguishing pattern for unique identification under x-ray imaging ([0154]: To provide radiopacity so the device is visible under fluoroscopy (x-ray), the micrograft 10 include radiopaque marker bands 22; Fig. 1, 4A, 17); and
a body ([0161]: hydrogels added to inner diameter of tubular body 12 of micrograft 10) coupled to the radiopaque marker ([0154]: To provide radiopacity so the device is visible under fluoroscopy (x-ray), the micrograft 10 include radiopaque marker bands 22).
First, it is noted that the preamble “for implantation in a targeted site within a patient’s body from which tissue has been removed” is given limited patentable weight, because a preamble is not generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See MPEP 2111.02.
Second, a review of the specification of the instant application, specifically [0012]-[0013], discloses that the claimed non-palpable body, or a body intended to be non-palpable, is “made out of a hydrogel”. Therefore, the limitations “the body comprised of a substantially dehydrated material in a pre-deployment configuration, wherein the body is configured to expand between 5 and 100 percent of its pre-deployment volume in approximately 30 to 60 minutes when exposed to fluid, and to remain substantially physically stable when implanted within the targeted site for at least approximately 52 weeks; wherein the body is configured to reflect ultrasound in a way that the body is recognizable as being artificial and is distinguishable from the radiopaque marker” recited in claim 1 is an inherent features of a hydrogel. Therefore, Herbert’s disclosure of a hydrogel anticipates the claimed inherent characteristics of the body “made out of a hydrogel”. See MPEP 2112.III and 2114. Further, Herbert teaches an initial dehydrated state of the hydrogel because it is “swellable” to additionally fill the body cavity ([0161]) during use.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11877898 – hereinafter referred to as ‘898. Although the claims at issue are not identical, they are not patentably distinct from each other, because claim 1 of the instant application is anticipated by the patented claim 1 of ‘898.
Regarding claim 1 of the instant application, patented claim 1 of ‘898 recites a remotely detectable marker for implantation in a targeted site within a patient's body from which tissue has been removed, the marker comprising: a radiopaque element … having a distinguishing pattern for unique identification under x-ray imaging … and a non-palpable body contained within the interior region of the radiopaque element, the non-palpable body being configured to transition between a pre-deployment configuration and a post-deployment configuration when exposed to a fluid, wherein: in the pre-deployment configuration, the non-palpable body comprises a substantially dehydrated material (or “the body comprised of a substantially dehydrated material in a pre-deployment configuration” in claim 1 of the instant application), and in the post-deployment configuration, the substantially dehydrated material of the non-palpable body is swells to a final, fully expanded size, such that a post-deployment volume of the non-palpable body is between 5 and 100 percent greater than a pre-deployment volume of the non-palpable body in approximately 30 to 60 minutes … and to remain substantially physically stable when implanted within the cavity for at least approximately 52 weeks, the non-palpable body being configured to reflect ultrasound in a way that the non-palpable body is recognizable as being artificial and is distinguishable from the radiopaque element … Therefore, the patented claim 1 of ‘898 is in essence a “species” of the generic invention of claim 1 of the instant application. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
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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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
10/15/25