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
Drawing Objections
Applicant’s arguments, see Remarks, Replacement Drawings, and amended Specification, filed 6/15/25, with respect to the omission of “the dimensions and structural elements of the interstitial marker in claims 1-4 and 18-19” from the drawings have been fully considered and are persuasive in light of Applicant’s newly introduced Figure 10. This objection to the drawings has been withdrawn.
Applicant’s arguments, see Remarks, Replacement Drawings, and Amended Specification, filed 6/15/25, with respect to “Figs. 1-4 lack labels and image clarity necessary to illustrate the features described in the corresponding PGPub US2026/0060776A1 paragraphs [0012]-[0015] and [0051]-[0060]” have been fully considered and are persuasive in light of Applicant’s replacements for Figs. 1-4 and the corresponding descriptions thereof in the amended specification. These objections to the drawings has been withdrawn.
112(b) Rejections
Applicant’s arguments, see Remarks and amended claim set, filed 6/15/26, with respect to the recitation of a trademark/trade name in claim 6, line 2 have been fully considered and are persuasive. The rejection of claim 6 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Remarks and amended claim set, filed 6/15/26, with respect to the lack of clarity in the scope of claim 11 have been fully considered and are persuasive. The rejection of claim 11 under 35 U.S.C. 112(b) has been withdrawn.
102 Rejections
Applicant’s arguments with respect to claims 1-3, 5-6, 8-13, 15, 18, and 20 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 for any teaching or matter specifically challenged in the argument.
As detailed in infra rejection, claims 1-3, 5-6, 8-13, 15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara in further view of Agostinelli ’21.
103 Rejections
Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive.
With regard to the rejections of claims 14, 17, and 19 over the combination of Okihara in view of Chee, Applicant first argues that “the Examiner has not articulated a rationale with rational underpinning for combining Okihira… with Chee.” Remarks at 12. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as stated in the Non-Final Rejection mailed 4/20/2026 (“NF”) at 11:
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chee’s known technique of providing a flexible coil marker to Okihara’s known marker to achieve the predictable result that this flexibility/conformability allows the coil to have a predictable memory shape and size in the tissue into which the coil is inserted. See, e.g., Chee, 4:6 – 4:27.
Applicant makes no argument and presents no evidence to rebut the teaching, suggestion, or motivation identified by the Office from the Chee reference. Thus, Applicant fails to satisfy its burden of proof.
Second, Applicant argues that:
[a] person of ordinary skill in the art designing an improved fiducial for multi-modal radiotherapy would not have been motivated to consult Chee absent impermissible hindsight reconstruction informed by Applicant’s own disclosure. Remarks at 12.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant makes no argument and presents no evidence that the Office relied solely or in part upon hindsight reasoning in reaching its conclusion of obviousness beyond a bare, unsubstantiated allegation. Again, Applicant makes no argument and presents no evidence to rebut the teaching, suggestion, or motivation identified by the Office from the Chee reference. Thus, Applicant fails to satisfy its burden of proof.
With regard to the rejection of claim 17 over the combination of Okihara in view of Chee in further view of Agostinelli ’21, Applicant first argues that “the combination of three disparate reference spanning 1994 (Chee), 2021 (Agostinelli ’21), and 2022 (Okihara), with no unified field of endeavor does not establish a prima facie case of obviousness absent impermissible hindsight.
First, that the publication of the Chee reference is older than that of the Agostinelli ’21 and Okihara references bears little or no relevance or weight in obviousness analysis. Applicant points to no authority that establishes that mere temporal separation between the publication of prior art references in a combination is of any relevance in considering the teachings thereof or the combination of the teachings. As stated in MPEP 2141.03:
The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). [AltContent: rect]
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 13
The PHOSITA is presumed to have known the relevant art, which encompasses Chee, Agostinelli ’21, and Okihara. Applicant provides no evidence that a PHOSITA would have found Chee any less relevant simply because of its older publication date or that Chee would be outside the field of what a PHOSITA would find relevant/analogous in searching for the claimed intervention, an interstitial marker, for example given that Chee’s title is “Large Diameter Vasoocclusion Coil,” i.e., interstitial, and the description of the first embodiment states that “the coil 10 will typically be made of a radiopaque,” i.e., a marker, Chee, P.2, lines 30-35.
Second, in response to applicant's argument that Okihara, Chee, and/or Agostinelli ‘21 is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Okihara, Chee, and Agostinelli ’21 are each in the field of inventor’s endeavor. The claimed invention is directed to “[a]n interstitial marker.” Each of the references are directed in the field of interstitial markers. For example, Okihara’s title “Medical Image Guidance Marker,” i.e., a marker, and Abstract “a medical image guidance marker to be placed in a body,” i.e., interstitial. For example, Chee’s title “Large Diameter Vasoocclusion Coil” and description of the first embodiment “the coil 10 will typically be made of a radiopaque,” i.e., a marker, Chee, P.2, lines 30-35. For example, Agostinelli ‘21’s title “Magnetic Markers for Surgical Guidance,” i.e., a marker, and Abstract “[a]n implantable marker… deployed to mark a tissue site,” i.e., interstitial. See also the CPC classifications common to the present application, Chee, Okihara, and Agostinelli ’21 such as CPC 90/39. Applicant makes no argument and presents no evidence that the Okihara, Chee, and Agostinelli ’21 references are non-analogous art beyond a bare, unsupported assertion. Thus, Applicant fails to satisfy its burden of proof.
Third, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant makes no argument and presents no evidence that the Office relied solely or in part upon hindsight reasoning in reaching its conclusion of obviousness beyond a bare, unsubstantiated allegation. As addressed above, Applicant makes no argument and presents no evidence to rebut the teaching, suggestion, or motivation identified by the Office from the Chee reference. Regarding the combination of Okihara in view of Chee with Agostinelli ’21, Applicant argues that:
[t]he Examiner’s stated motivation that ‘varying the pitch of the helical coil can provide a more uniform response’ (Office Action at p. 13) is inapposite to the claimed purpose of minimizing proton beam perturbation across multi-modal imaging. Remarks at 13.
Applicant presents no arguments or evidence to support Applicant’s allegation that “a more uniform response” is inapposite to “minimizing proton beam perturbation across multi-modal imaging.” For example, Applicant presents no arguments or evidence that customizing the variations in pitch along the longitudinal axis or length of the marker to adjust the magnetic response including providing a more uniform response as taught in Agostinelli ’21 paragraphs [0025] and [0097] precludes minimizing proton beam perturbation across multi-modal imaging. In fact, as recited in claim 1, lines 6-7 “customized pitch values to minimize proton beam perturbation, having a pitch value in range of about 0.25 mm to about 1.5mm” establishes that the customization of the pitch values in the recited range results in the minimized proton beam perturbation. Nothing in Agostinelli ‘21’s teaching of customizing the variations in pitch prevents minimizing proton beam perturbation. For example, Agostinelli ’21 teaches various examples of pitch values ranging from 0.32 to 5.3 mm (Tables 2 and 3). Moreover, as per MPEP 716.01(c) "[t]he arguments of counsel cannot take the place of evidence in the record." In re Schulze, 346 F. 2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)." Thus, Applicant fails to satisfy its burden of proof.
As detailed in infra rejections: claims 1-3, 5-6, 8-13, 15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara in further view of Agostinelli ’21; claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21 in further view of Agostinelli ’19; claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21, or, in the alternative, in further view of Neustadter; and claims 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21 in further view of Chee.
Drawings
The drawings were received on 6/15/26. These drawings are accepted.
Specification
The specification was received on 6/14/26. This specification is accepted.
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 (i.e., changing from AIA to pre-AIA ) 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-3, 5-6, 8-13, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okihara et al. (U.S. Pub. No. 2022/0354615), hereinafter “Okihara” in further view of Agostinelli et al. (U.S. Pub. No. 2021/0153970), hereinafter “Agostinelli ’21.”
Regarding claim 1, Okihara discloses an interstitial marker configured to be imaged when inserted into soft tissue of a subject’s body (marker configured to be imaged when placed in a body, Abstract; placement within prostate/tissue, [0024], [0032]), the interstitial marker comprising a non-radioactive wire formed in a helical coil (marker is a non-radioactive wire flexed to form as a helical coil, Abstract, [0009], [0011], [0021], [0023]-[0024], [0027]), wherein the helical coil comprises sections with a pitch (helical coil has a pitch, [0023]),
wherein the interstitial marker is optimized for multi-modality compatibility by maintaining necessary dimensions for visibility, trackability and material reduction in a beam path via customized pitch values to minimize proton beam perturbation, having a pitch value in a range of about 0.25 mm to about 1.5 mm (marker is configured with dimensions to achieve multi-modal imaging including use during external-beam radiotherapy, having a pitch value in a range of 0.3-1.5 mm, Abstract, [0033]; note that the limitation “is optimized for multi-modality compatibility by maintaining necessary dimensions for visibility, trackability and material reduction in a beam path via customized pitch values to minimize proton beam perturbation” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.), and
wherein the interstitial marker has a diameter of at least 0.50 mm (marker has a diameter of 0.55-1.20mm, Abstract).
However, Okihara does not appear to teach the helical coil comprises sections of different pitch.
However, in the same field of endeavor of interstitial markers, Agostinelli ’21 teaches a wire formed in a helical coil, wherein the helical coil comprises sections of different pitch (wire formed into a helical coil formed of portions of varying pitch, [0025], [0097]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Agostinelli ’21’s known technique of varying the pitch of the helical coil formed of a wire to Okihara’s known marker comprising a wire formed into a helical coil to achieve the predictable result that varying the pitch of the helical coil can provide a customizable magnetic response including a more uniform response. See, e.g., Agostinelli ’21, [0025], [0097].
Regarding claim 2, Okihara discloses the interstitial marker is a fiducial marker (marker is used to determine positional information, [0031], [0033]).
Regarding claim 3, Okihara discloses the interstitial marker has a diameter in a range of about 0.50 mm to about 0.75 mm (marker has a diameter of 0.55-1.20mm, Abstract).
Regarding claim 5, Okihara discloses the interstitial marker is configured to perform effectively across multiple treatment modalities (marker is configured with dimensions to achieve multi-modal imaging including use during external-beam radiotherapy, Abstract, [0033]; note that the limitation “perform effectively across multiple treatment modalities” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
Regarding claim 6, Okihara discloses the visibility and trackability of the interstitial marker is capable of evaluation under CT, MRI, IGRT, and robotic radiosurgery systems (marker is visible and trackable for evaluation under computed tomography, magnetic resonance imaging, image guided radiotherapy, and radiation therapy systems, Abstract, [0001], [0008], [0021], [0023], [0031], [0033]; see also image guidance examples, [0034]-[0097]; note that the limitation “capable of evaluation under CT, MRI, IGRT, and robotic radiosurgery systems” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
Regarding claim 8, Okihara discloses the interstitial marker has a longitudinal length (marker has a length, [0010]) and rings made of non-radioactive wire (marker has rings made of non-radioactive wire, Abstract, [0009], [0011], [0021], [0023]-[0024], [0027]), the rings being held in spaced relation along the longitudinal length of the marker (marker is in the shape of a coil with turn-to-turn spacing, pitch, therebetween, [0023]).
Regarding claim 9, Okihara discloses the longitudinal length of the interstitial marker is longer than an outer diameter of the rings (length of the marker is longer than the coil diameter, [0009]-[0010]).
Regarding claim 10, Okihara discloses the rings have an outer diameter of from 25 µm to 2500 µm (coil has a diameter of 0.55-1.20 mm, 550-1200 µm, Abstract, [0009], [0024]).
Regarding claim 11, Okihara discloses a ratio of length of the interstitial marker to outer diameter of the rings is at least ten (10) (coil has a length of 6-7 mm and a diameter of 0.55-1.20 mm, encompassing a ratio of 10 or more, Abstract, [0009]-[0010], [0024], [0026]).
Regarding claim 12, Okihara discloses wherein the non-radioactive wire has a cross section length of from 10 µm to 2500 µm (wire diameter of 0.15-0.45 mm, 150-450 µm, Abstract, [0009], [0024]).
Regarding claim 13, Okihara discloses the interstitial marker is configured for insertion into soft tissue inside the subject’s body and held by the soft tissue (marker is configured for insertion into tissue in the body and anchored within the tissue, [0024], [0032]).
Regarding claim 15, Okihara discloses the rings are separated by a distance along the longitudinal length of the interstitial marker, and a ratio of wire cross section length to a separation distance of the rings is about 1: 1.2± about 0.2 (marker is in the shape of a coil with turn-to-turn spacing along the longitudinal length of the marker, pitch, and a wire diameter of 0.15-0.45 mm and a pitch of 0.3 – 1.5 mm, a ratio of about 1: 1.2± about 0.2, Abstract, [0009], [0024]).
Regarding claim 18, Okihara discloses the non-radioactive wire has a circular cross section with a diameter of from 10 µm to 2500 µm, or a rectangular cross section with a length of from 10 µm to 500 µm (the non-radioactive wire has a circular cross section with a diameter of 0.15-0.45 mm, 150-450 µm, Abstract, [0009], [0024]).
Regarding claim 19, Okihara discloses portions of the interstitial marker are made of radiopaque material (marker creates artifacts for positioning in computed tomography, CT, images, Abstract, [0014], [0016], [0023], [0031], [0033], [0034]-[0043], Fig. 2).
Regarding claim 20, Okihara discloses the interstitial marker is made of biocompatible material suitable for permanent implantation selected from at least one member of a group consisting of rhodium, platinum, iridium, tantalum, titanium, silver, gold, nickel, and stainless steel, or mixtures thereof (the marker is made of biocompatible material such as platinum, gold, or mixtures thereof, [0030]; marker is configured for insertion into tissue in the body and anchored within the tissue, [0024], [0032]; note that the limitation “suitable for permanent implantation” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21 as applied to claim 1 above, and further in view of Agostinelli et al. (U.S. Pub. No. 2019/0223975), hereinafter “Agostinelli ’19).
Regarding claim 4, Okihara does not appear to disclose the interstitial marker has a mass in the range of 0.009 gram to 0.0266 gram.
However, in the same field of endeavor of interstitial markers, Agostinelli ’19 teaches the interstitial marker has a mass in the range of 0.009 gram to 0.0266 gram (marker has a mass of 5-10 mg, i.e., 0.005-0.01 grams, [0109]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Agostinelli ‘19’s known technique of utilizing a marker with a mass between 5 and 10 mg to Okihara in further view of Agostinelli ‘21’s known marker to achieve the predictable result that a “low mass…. means that the marker produces a small artifact on MRI typically of the order of a few mm around the marker.” See, e.g., Agostinelli ‘19, [0109].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21, or, in the alternative, as being unpatentable over Okihara in view of Agostinelli ’21 in further view of Neustadter et al. (U.S. Pub. No. 2009/0131734), hereinafter “Neustadter.”
Regarding claim 7, Okihara discloses the interstitial marker is capable of providing assessments conducted for both photon and proton modalities (marker is visible and trackable for evaluation under computed tomography, magnetic resonance imaging, image guided radiotherapy, and radiation therapy systems including external-beam radiotherapy, i.e., photon, Abstract, [0001], [0008], [0021], [0023], [0031], [0033]; see also image guidance examples, [0034]-[0097]; note that the limitation “capable of providing assessments conducted for both photon and proton modalities” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
Additionally, or, in the alternative, while Okihara does not explicitly disclose the external-beam radiotherapy comprises both photon and proton modalities, Neustadter teaches external-beam radiotherapy includes both photon and proton modalities (trackable markers can be employed for external beam radiation therapy, i.e., photon, and proton therapy, [0242]; see also coil marker for implantation into soft tissue of the body imageable using x-ray, CT, MRI, and/or ultrasound, [0148]-[0156], [0197]-[0217]; see also radioisotope is optional, [0046], [0203]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Neustadter’s known technique of using coil markers for localization in both photon and proton modalities to Okihara in further view of Agostinelli ‘21’s known coil marker for localization in external beam radiation therapy to achieve the predictable result that tracking an implanted coil marker using x-ray or CT prior to beginning radiation therapy improves therapy by allowing for calculation of the target position based on the marker position. See, e.g., Neustadter, [0061].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ‘21 as applied to claim 8 above, and further in view of Chee et al. (WO9411051A1), hereinafter “Chee.”
Regarding claim 14, Okihara discloses the longitudinal length of the interstitial marker, wire cross section length, outer diameter of the rings and ratio of longitudinal length of the interstitial marker to the outer diameter of the rings are effective for flexibility transverse to the longitudinal length of the marker and which flexibility is effective to permit the interstitial marker to be responsive to changes of shape of an organ, tumor or tumor bed and to follow movements of the organ, tumor, or tumor bed after insertion (marker has a wire diameter of 0.15-0.45 mm and the coil has a length of 6-7 mm and a diameter of 0.55-1.20 mm, encompassing a ratio of 10 or more, Abstract, [0009]-[0010], [0024], [0026]; marker is configured for insertion into tissue in the body and anchored within the tissue including lesions, [0024], [0031]-[0033]; note that the limitation “effective for flexibility transverse to the longitudinal length of the marker and which flexibility is effective to permit the interstitial marker to be responsive to changes of shape of an organ, tumor or tumor bed and to follow movements of the organ, tumor, or tumor bed after insertion” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
However, Okihara may not explictly disclose these features provide flexibility effective for flexibility transverse to the longitudinal length of the marker and which flexibility is effective to permit the interstitial marker to be responsive to changes of shape of an organ, tumor or tumor bed and to follow movements of the organ, tumor, or tumor bed after insertion.
However, in the same field of endeavor of interstitial markers, Chee teaches the longitudinal length of the interstitial marker, wire cross section length, outer diameter of the rings and ratio of longitudinal length of the interstitial marker to the outer diameter of the rings are effective for flexibility transverse to the longitudinal length of the marker and which flexibility is effective to permit the interstitial marker to be responsive to changes of shape of an organ, tumor or tumor bed and to follow movements of the organ, tumor, or tumor bed after insertion (a marker for insertion into the tissue, 5:20 – 6:5; having a coil length, wire diameter, coil diameter, and a ratio of coil length and coil diameter effective to form a flexible coil, 2:30 – 3:28; note that the limitation “effective for flexibility transverse to the longitudinal length of the marker and which flexibility is effective to permit the interstitial marker to be responsive to changes of shape of an organ, tumor or tumor bed and to follow movements of the organ, tumor, or tumor bed after insertion” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chee’s known technique of providing a flexible coil marker to Okihara in view of Agostinelli ‘21’s known marker to achieve the predictable result that this flexibility/conformability allows the coil to have a predictable memory shape and size in the tissue into which the coil is inserted. See, e.g., Chee, 4:6 – 4:27.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ’21 as applied to claim 15 above, and further in view of Chee.
Regarding claim 16, Okihara discloses the separation distance, the marker longitudinal length, the wire cross section length, the outer diameter of the rings, the ratio of longitudinal length to outer diameter of the rings is effective for providing lateral flexibility transverse to the longitudinal length of the marker (marker has a pitch of 0.25-1.5 mm, has a wire diameter of 0.15-0.45 mm and the coil has a length of 6-7 mm and a diameter of 0.55-1.20 mm, encompassing a ratio of 10 or more, Abstract, [0009]-[0010], [0024], [0026], [0033]; marker is configured for insertion into tissue in the body and anchored within the tissue, [0024], [0032]; note that the limitation “effective for flexibility transverse to the longitudinal length of the marker” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
However, Okihara may not explictly disclose these features provide flexibility effective for providing lateral flexibility transverse to the longitudinal length of the marker.
However, in the same field of endeavor of interstitial markers, Chee teaches the separation distance, the marker longitudinal length, the wire cross section length, the outer diameter of the rings, the ratio of longitudinal length to outer diameter of the rings is effective for providing lateral flexibility transverse to the longitudinal length of the marker (a marker for insertion into the tissue, 5:20 – 6:5; having a separation distance, coil length, wire diameter, coil diameter, and a ratio of coil length and coil diameter effective to form a flexible coil, 2:30 – 3:28, Fig. 2; note that the limitation “effective for flexibility transverse to the longitudinal length of the marker” is merely a purpose and/or intended use for the claimed “interstitial marker” and, therefore, does not have patentable weight as it does not result in a structural difference, MPEP 2114 I. and II.).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chee’s known technique of providing a flexible coil marker to Okihara in view of Agostinelli ‘21’s known marker to achieve the predictable result that this flexibility/conformability allows the coil to have a predictable memory shape and size in the tissue into which the coil is inserted. See, e.g., Chee, 4:6 – 4:27.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Okihara in view of Agostinelli ‘21 as applied to claim 8 above, and further in view of Chee.
Regarding claim 17, Okihara discloses the non-radioactive wire is flexible wire, wherein a portion of the flexible wire are formed in a helical coil, wherein the portion comprises sections with a pitch (marker is a non-radioactive wire flexed to form as a helical coil, Abstract, [0009], [0011], [0021], [0023]-[0024], [0027], helical coil has a pitch, [0023]).
However, Okihara in further view of Chee does not appear to teach the portion of the flexible wire formed in a helical coil comprises sections of different pitch.
However, in the same field of endeavor of interstitial markers, Agostinelli ’21 teaches a portion of a wire formed in a helical coil, wherein the portion comprises sections of different pitch (wire formed into a helical coil formed of portions of varying pitch, [0025], [0097]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Agostinelli ’21’s known technique of varying the pitch of the helical coil formed of a wire to Okihara’s known marker comprising a wire formed into a helical coil to achieve the predictable result that varying the pitch of the helical coil can provide a customizable magnetic response including a more uniform response. See, e.g., Agostinelli ’21, [0025], [0097].
However, Okihara in view of Agostinelli ‘21 does not appear to explictly disclose the non-radioactive wire is flexible wire.
However, in the same field of endeavor of interstitial markers, Chee teaches the non-radioactive wire is flexible wire (marker is a flexible non-radioactive wire flexed to form a helical coil, 2:30 – 3:28, Fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Chee’s known technique of providing a flexible coil marker to Okihara in view of Agostinelli ‘21’s known marker to achieve the predictable result that this flexibility/conformability allows the coil to have a predictable memory shape and size in the tissue into which the coil is inserted. See, e.g., Chee, 4:6 – 4:27.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Udale et al. (U.S. Pub. No. 2024/0310462), Udale et al. (U.S. Pub. No. 2025/0025260), Udale et al. (U.S. Pub. No. 2025/0255693), Kasher et al. (U.S. Pub. No. 2021/0145584), and Carlson et al. (U.S. Pub. No. 2007/0162108) disclose at least an interstitial marker configured to be imaged when inserted into soft tissue of a subject’s body, wherein the interstitial marker is optimized for multi-modality compatibility by maintaining necessary dimensions for visibility, trackability and material reduction in a beam path via customized pitch values to minimize proton beam perturbation, having a pitch value in a range of about 0.25 mm to about 1.5 mm, and wherein the interstitial marker has a diameter of at least 0.50 mm.
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.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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