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 .
Election/Restrictions
Applicant’s election of invention Group II in the reply filed on 11/13/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 17-22, 28, and 30-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 23 is objected to because of the following informalities:
Regarding claim 23, the limitation “The implantable marker” should be changed to –An [[The]] implantable marker--.
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 23-27 and 29 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.
Claim 23 recites the limitation “the winding planes” in line 8. There is insufficient antecedent basis for this limitation in the claim. There is only a singular “winding plane” recited in line 5. For the present purposes of examination, the limitation has been interpreted as referring to a winding plane of each of the first and second strand eyes. Further clarification is required. There is also insufficient antecedent basis for the subsequent recitation of the limitation “the winding planes” in claim 25 in line 1.
Claims 25 and 27 each recite the limitation “the arc plane” in line 2. There is insufficient antecedent basis for this limitation in either claim. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 27 recites the exact same range for angle b as those recited in claim 25 from which claim 27 depends. There are no further limitations to claim 25 recites in claim 27. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 23 is rejected under 35 U.S.C. 102(a) as being anticipated by Barnhart (WO 99/43268, The University of Iowa Research Foundation, applicant submitted prior art via the IDS).
Regarding claim 23, as best understood in light of the 35 U.S.C. 112(b) stated above, Barnhart discloses the implantable marker (lesion localization device 10, Abstract) for marking an intracorporeal tissue region of an animal or human (“Lesion localization device 110 is loaded within lumen 133 of introducer needle 130 prior to advancing distal end 132 of introducer needle 130 to a predetermined location, preferably on the opposite side of the lesion from the insertion site. Introducer needle 130 is preferably passed through the lesion. Lesion localization device 110 is advanced towards distal end 132 of introducer needle 130 until anchoring portion 113 is no longer restrained by introducer needle 130. Friction may be felt within lumen 133 of introducer needle 30 as lesion localization device 110 is advanced and no further friction is felt when anchoring portion 113 emerges from distal end 132 of introducer needle 130. After anchoring portion 113 emerges from distal end 132 of introducer needle 130, anchoring portion 113 regains its predisposed multiple loop configuration.” Page 8, lines 24-29), comprising:
at least one strand (15a in Fig. 1, reproduced below, and corresponding description) of biocompatible material (“Localization device 10 is constructed of two unitary lengths of wire 15a and 15b which are preferably made of a superelastic/shape memory material such as the nickel- titanium alloy known as Nitinol. In one preferred embodiment, wires 15a and 15b are made from polished Nitinol monofilament wire (0.011 in, 0.28 mm).” page 5, lines 13-17) configured into a three-dimensional shape (see Fig. 2, reproduced below, and corresponding description) comprising at least first and second fixed strand eyes (loops 116a , 116d in Fig. 2 and corresponding description), each strand eye includes at least one winding of the biocompatible material within a winding plane of one of the first and second strand eyes (“FIG. 3 shows a top view of anchoring portion 113 of lesion localization device 110 shown in FIG. 2. Loops 116a-116d are oppositely disposed about transverse axis 120 which is perpendicular to longitudinal axis 118. Loops 116b and 116d form a set of loops that generally lie in a plane intersecting longitudinal axis 118 and radially extend from longitudinal axis 118. Loops 116a and 116c form a second set of loops that also lie in a plane intersecting longitudinal axis 118 and radially extend from longitudinal axis 118. Loops 116a and 116c lie generally in a common plane which is perpendicular to the general plane containing loops 116b and 116d. Loops 116a-d each respectively close about themselves along adjacent transverse sections, as shown in FIGS. 2 and 3, wherein it is seen that each loop is positioned slightly out of line with the axis of tension when device 110 is pulled along longitudinal axis 118.” page 7, lines 1-12; also see Fig. 3, reproduced below, and corresponding description); and
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the at least first and second strand eyes are configured into a figure eight (“Anchoring portion 13 thus forms the shape of a figure eight.” page 6, line 22; also see Figs. 1-3 and corresponding descriptions), are connected together via a curved strand portion (see Fig. 2 and corresponding description) and the winding planes of the at least first and second strand eyes meet and form an angle a which is not equal to 00 (see Figs. 1-3 and corresponding descriptions; also see page 7, lines 7-17).
Claim Rejections - 35 USC § 103
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.
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Barnhart as applied to claim 23 above and further in view of Guo et al. (US 2021/0338249, filed April 7, 2021).
Regarding claim 24, Barnhart discloses the limitations of claim 23 as stated above but fails to disclose wherein the curved strand portion is semi-circular.
However, Guo teaches, in the same field of endeavor, wherein the curved strand portion is semi-circular (see Fig. 1, reproduced below, and corresponding description; also see Fig. 5 and corresponding description).
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Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Barnhart with wherein the curved strand portion is semi-circular as taught by Guo since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.IV. B.
Regarding claim 25, as best understood in light of the 35 U.S.C. 112(b) stated above, Barnhart modified by Guo discloses the limitations of claim 24 as stated above but is silent on wherein the winding planes of at least one of the two strand eyes forms an angle b of 50° ≤ b≤70° with the arc plane.
However, Guo teaches, in the same field of endeavor, wherein the winding planes of at least one of the two strand eyes forms an angle b of 50° ≤ b≤ 70° with the arc plane (“the embolization device may be a combination of two or more coils 10, and in any two of the coils 10, one may be swiveled about the axis of the embolization device at an angle of preferably 0°-90°, more preferably 30°, 45°, 60° or 90°.” [0064]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Barnhart with wherein the winding planes of at least one of the two strand eyes forms an angle b of 50° ≤ b ≤ 70° with the arc plane as taught by Guo in order to provide increased stability ([0064] of Guo). Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is noted that no criticality is given for the claimed range. See MPEP 2144.05.II.A.
Regarding claim 26, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Barnhart modified by Guo discloses the limitations of claim 25 as stated above. Guo was relied on to teach the range of angle b in claim 25. Guo further teaches, in the same field of endeavor, wherein b [Symbol font/0x3D] 60° (“the embolization device may be a combination of two or more coils 10, and in any two of the coils 10, one may be swiveled about the axis of the embolization device at an angle of preferably 0°-90°, more preferably 30°, 45°, 60° or 90°. ” [0064]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Barnhart with wherein b [Symbol font/0x3D] 60° as taught by Guo in order to provide increased stability ([0064] of Guo). Further it has been held that that discovering an optimum value of a result effective variable involves only routine skill in the ar. It is noted that no criticality is given for the value. See MPEP 2144.05.II.A.
Regarding claim 27, as best understood in light of the 35 U.S.C. 112(b) and (d) rejections stated above, Barnhart modified by Guo discloses the limitations of claim 25 as stated above. Guo was relied on to teach the range of angle b in claim 25. Guo further teaches, in the same field of endeavor, wherein the winding plane of at least one of the two strand eyes forms an angle b in which 50° ≤ b ≤70° with the arc plane (“the embolization device may be a combination of two or more coils 10, and in any two of the coils 10, one may be swiveled about the axis of the embolization device at an angle of preferably 0°-90°, more preferably 30°, 45°, 60° or 90°.” [0064]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Barnhart with wherein the winding plane of at least one of the two strand eyes forms an angle b in which 50° ≤ b ≤70° with the arc plane as taught by Guo in order to provide increased stability ([0064] of Guo). Further it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. It is noted that no criticality is given for the claimed range. See MPEP 2144.05.II.A.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Barnhart as applied to claim 23 above and further in view of Vayser et al. (US 2020/0261742, August 20, 2020).
Regarding claim 29, Barnhart discloses the limitations of claim 23 as stated above. Although Barnhart suggests wherein the biocompatible material of the at least one strand reflects ultrasonic waves (“Localization device 10 is constructed of two unitary lengths of wire 15a and 15b which are preferably made of a superelastic/shape memory material such as the nickel- titanium alloy known as Nitinol. In one preferred embodiment, wires 15a and 15b are made from polished Nitinol monofilament wire (0.011 in, 0.28 mm).” page 5, lines 13-17; examiner notes that metals reflect ultrasonic waves; examiner also notes that the biocompatible material is disclosed as being a metallic shape-memory material such as Nitinol in e.g., [0029] of the pre-grant publication of the instant application), Barnhart does not explicitly disclose wherein the biocompatible material of the at least one strand reflects ultrasonic waves.
However, Vayser teaches, in the same field of endeavor, wherein the biocompatible material of the at least one strand reflects ultrasonic waves (“Coatings can also be applied to enhance visualization under specific imaging modalities such as ultrasound and MRI. Thus, a marker may be visible only under x-ray for example and a coating could be applied to the marker to make the marker visible under MRI or ultrasound.” [0035]; also see [0034]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Barnhart with wherein the biocompatible material of the at least one strand reflects ultrasonic waves as taught by Vayser in order to enhance visualization under ultrasound ([0035] of Vayser).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINAH ASGHAR whose telephone number is (571)272-0527. The examiner can normally be reached M-W, F 9am-5pm EST.
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/A.A./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797