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
Applicant’s arguments, see pg. 7, filed 26 Aug 2025, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of 27 May 2025 has been withdrawn in view of the cancelled claim 5.
Applicant's arguments, see pg. 7-9, filed 26 Aug 2025, with respect to the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive.
Regarding the independent claims 1, 8, and 15, Applicant argues, see pg. 9, that “The arms 26 disclosed in SKERVEN may open and close depending on the position of arms 26 relative to the collar 32 or the tube 12, and therefore, the arms 26 reversibly deform because they spring open when the collar is removed (emphasis added; see Figs. 3-5 above). The arms nor the teeth 28 of SKERVEN deform irreversibly to attach the device to the area associated with the surgical cavity, as recited in claim 1, as amended (emphasis added)”. However, the Examiner respectfully disagrees. As presented in the 35 U.S.C. 112(b) rejections below, the amended limitations “a protrusion that is configured to irreversibly deform to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area” in claims 1 and 8 as well as “the first protrusion and the second protrusion being configured to irreversibly deform to attach the device to the area and to penetrate a portion of the area” in claim 15 are unclear – specifically the metes and bounds of the protrusion(s) being configured to “irreversibly deform” are unclear. It is unclear whether “irreversibly deforming” is permanent (absolute) or temporary (relative): permanent as in, for example, breaking a piece of metal, or temporary as in, for example, keeping a staple “stapled” until it is “unstapled”. Neither the claim nor a review of the original specification of the instant application discloses the mechanism for “irreversibly deforming” to impart the claimed structure: the original specification merely discloses in two sentences “The at least one protrusion may irreversibly deform to attach the marker to the body tissue of the patient” ([0014]) and “The protrusion may be barbed and/or may project from second element 110 and may penetrate into a body tissue of a patient. In this way, the protrusion may reversibly or irreversibly deform to attach marker 106 to a portion of a surgical margin 104” ([0033]) without any further details. Therefore, the phrase “irreversibly deforming” is being given a broadest reasonable interpretation as temporarily deforming irreversibly to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area. In view of such broadest reasonable interpretation, as Applicant even admits, Skerven’s arms 26 close relative to the collar 32 “when the collar 32 is moved distally over the arms 26 it closes and holds them in a closed position” (see [0034] of Skerven), and as further disclosed in [0030] of Skerven, “arms 26 are formed of a resilient material and are shaped such that the arms 26 have a tendency to be in an open position towards the distal end of the clip 22”. Thus Skerven’s arms in the closed position while the collar is disposed over the arms are temporarily being deformed irreversibly from the open position to attach and penetrate the tissue of interest until the collar is moved proximally from the arms 26 (see at least Fig. 2-3 of Skerven).
Regarding the dependent claims, Applicant argues, see pg. 9, that the dependent claims “patentable for at least the reasons set forth above with respect to claims 1, 8, and 15”. However, the Examiner respectfully disagrees at least for the reasons explained above for the independent claims 1, 8, and 15.
Applicant's arguments, see pg. 10, filed 26 Aug 2025, with respect to the new claim 27 have been fully considered but they are not persuasive at least for the reasons explained above for the independent claim 1, to which claim 27 depends as well as in view of the 35 U.S.C. 103 rejection to claim 27 presented below.
Status of Claims
Claims 1-4, 7-12, 14-18, 20, and 24-27 are currently under examination. Claim 27 has been newly added since the Non-Final Office Action of 27 May 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitations “a protrusion that is configured to irreversibly deform to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area” in claims 1 and 8 as well as “the first protrusion and the second protrusion being configured to irreversibly deform to attach the device to the area and to penetrate a portion of the area” in claim 15 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7-12, 14-18, 20, and 24-27 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 1 recites the limitation “a first element comprising a protrusion that is configured to irreversibly deform to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area”. The metes and bounds of the protrusion being configured to “irreversibly deform” are unclear. In particular, it is unclear whether “irreversibly deforming” is permanent (absolute) or temporary (relative): permanent as in, for example, breaking a piece of metal, or temporary as in, for example, keeping a staple “stapled” until it is “unstapled”. Neither the claim nor a review of the original specification of the instant application discloses the mechanism for “irreversibly deforming” to impart the claimed structure. Claims 2-4, 7, 24, and 27 inherit the deficiency by the nature of their dependency on claim 1. For purposes of the examination, the phrase “irreversibly deforming” is being given a broadest reasonable interpretation as temporarily deforming irreversibly to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area.
Claim 8 recites the limitation “wherein the first device comprises a protrusion that is configured to irreversibly deform to attach the first device to the first area and to penetrate a portion of the first area”. The metes and bounds of the protrusion being configured to “irreversibly deform” are unclear. In particular, it is unclear whether “irreversibly deforming” is permanent (absolute) or temporary (relative): permanent as in, for example, breaking a piece of metal, or temporary as in, for example, keeping a staple “stapled” until it is “unstapled”. Neither the claim nor a review of the original specification of the instant application discloses the mechanism for “irreversibly deforming” to impart the claimed structure. Claims 9-12, 14, and 15 inherit the deficiency by the nature of their dependency on claim 8. For purposes of the examination, the phrase “irreversibly deforming” is being given a broadest reasonable interpretation as temporarily deforming irreversibly to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area.
Claim 15 recites the limitation “the first protrusion and the second protrusion being configured to irreversibly deform to attach the device to the area and to penetrate a portion of the area”. The metes and bounds of the first and second protrusions being configured to “irreversibly deform” are unclear. In particular, it is unclear whether “irreversibly deforming” is permanent (absolute) or temporary (relative): permanent as in, for example, breaking a piece of metal, or temporary as in, for example, keeping a staple “stapled” until it is “unstapled”. Neither the claim nor a review of the original specification of the instant application discloses the mechanism for “irreversibly deforming” to impart the claimed structure. Claims 16-18, 20, and 26 inherit the deficiency by the nature of their dependency on claim 15. For purposes of the examination, the phrase “irreversibly deforming” is being given a broadest reasonable interpretation as temporarily deforming irreversibly to attach the device to an area associated with a surgical cavity and to penetrate a portion of the area.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 7-11, 14-17, 20, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Skerven (US PG Pub No. 2012/0083804, provided by the Applicant in the IDS of 04 May 2023) in view of Stubbs et al. (US PG Pub No. 2011/0004094, provided by the Applicant in the IDS of 04 May 2023) - hereinafter referred to as Stubbs.
Regarding claim 1, Skerven discloses a device (at least Fig. 2-5) comprising:
a first element comprising protrusion (Fig. 2-5: arms 26 protruding from marker clip 102) that is configured to irreversibly deform to attach the device to an area associated with a surgical cavity (Fig. 2-3: arms 26 of marker clip 102 in closed position (first configuration) v. open position (second configuration); [0030]: arms 26 of a resilient material and have a tendency to be in an open position towards the distal end of clip 22/102; [0034]: arms 26, including teeth 28, held in a closed position, or irreversibly deformed temporarily from the open position, by expandable collar 32 within introducing tube 12; [0030]: teeth 28 overlap with each other when the marker clip 22 is in closed position; [0048]-[0049]: arms 26 of marker clip 102 extended from introducing tube 12 to position about target tissue 40 and arms 26 closed onto the tissue by marker clip 102 being pulled or drawn proximally into introducing tube 12) and to penetrate a portion of the area (Fig. 3-5: teeth 28 of arms 26 of marker clip 102 penetrating target tissue 40); and
a second element (Fig. 2-5, 9-10: collar 32) comprising an indicator (Fig. 9-10 and [0039]-[0040]: collar 32 is color coded or marked with unique color alpha-numeric symbol).
It is noted that Skerven discloses its arms being irreversibly deformed temporarily by collar 32 from the open position in attaching to and penetrating an area associated with a surgical cavity. See the Response to Arguments above.
Skerven does not disclose:
wherein the indicator is detectable via a radiological scan,
wherein a remaining portion of the second element, other than the indicator, is less detectable via the radiological scan relative to the indicator, and
wherein a first material of the indicator is different from a second material of the remaining portion.
However, Stubbs teaches in the same medical field of endeavor:
an indicator (Fig. 15E-K: one of letters 224) detectable via a radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)),
wherein a remaining portion of a second element (Fig. 15E-K: one of circular caps 226/228), other than the indicator, is less detectable via the radiological scan relative to the indicator ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); [0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)), and
wherein a first material of the indicator ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless) is different from a second material of the remaining portion ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); Fig. 15E-K).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s device to include Stubbs’s indicator detectable in a radiological scan and having a different material and detectability relative to the second element. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting radiologically detectable indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to improve the visibility of the indicator in the surgical cavity under a radiological scan ([0060] of Stubbs).
Regarding claim 2, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Skerven further discloses:
wherein the second element (Fig. 8-10: collar 32) comprises a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38), and
wherein the indicator is configured to be on one or more surfaces of the plurality of surfaces (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32).
Regarding claim 3, Schwartz in view of Stubbs discloses all limitations of claim 1, as discussed above, and Schwartz further discloses:
wherein the second element (Fig. 8-10: collar 32) comprises a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38), and
wherein one or more surfaces of the plurality of surfaces include the indicator (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32).
Regarding claim 5, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Skerven further discloses:
wherein the first element comprises an attachment device (Fig. 2-5: arms 26 protruding from marker clip 102) configured to attach to the area associated with the surgical cavity ([0048]-[0049]: arms 26 of marker clip 102 extended from introducing tube 12 to position about target tissue 40 and arms 26 closed onto the tissue by marker clip 102 being pulled or drawn proximally into introducing tube 12).
Regarding claim 7, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Skerven further discloses:
wherein the indicator comprises at least one of: an alphanumeric character, a shape, or a symbol (Fig. 9-10 and [0039]-[0040]: collar 32 is color coded or marked with unique color alpha-numeric symbol).
Regarding claim 24, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Skerven discloses:
wherein the first element comprising one or more protrusions (Fig. 2-5: arms 26 protruding from marker clip 102) that include the protrusion (Fig. 2-5: arms 26 protruding from marker clip 102).
Regarding claim 27, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Skerven does not disclose:
wherein the indicator is configured to identify a location of the area associated with the surgical cavity.
However, Stubbs teaches in the same medical field of endeavor:
wherein the indicator (Fig. 15E-K and [0102]: one of letters 224 among A (anterior) P (posterior), S (superior), I (inferior), M (medial), L (lateral or left), and R (right)) is configured to identify a location of the area associated with the surgical cavity ([0102]-[0103]: each letter 224 indicates a direction or orientation relative to the cavity, and each circular cap comprising a letter 224 is encapsulated by the cavity wall).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s device to include Stubbs’s indicator configured to identify a location of a target area. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting a location indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to allow “the surgeon [is] able to visually confirm placement (of the marker) in the appropriate orientation because the various elements are labeled with markers relating to anatomic orientation”, as taught by Stubbs ([0102]).
Regarding claim 8, Skerven discloses a system (at least Fig. 2-5), the system comprising:
a plurality of devices (Fig. 2-5, 9-10: clip markers 102/104/106/108),
wherein a first device (Fig. 2-5, 9-10: marker clip 102), of the plurality of devices, comprises a first indicator (Fig. 9-10 and [0039]-[0040]: collars 32 are individually color coded or marked with a unique color alpha-numeric symbol),
wherein a second device (Fig. 2-5, 9-10: marker clip 104), of the plurality of devices, comprises a second indicator (Fig. 9-10 and [0039]-[0040]: collars 32 are individually color coded or marked with a unique color alpha-numeric symbol),
wherein the first device comprises a protrusion (Fig. 2-5: arms 26 protruding from marker clip 102) that is configured to irreversibly deform to attach the device to the first area (Fig. 2-3: arms 26 of marker clip 102 in closed position (first configuration) v. open position (second configuration); [0030]: arms 26 of a resilient material and have a tendency to be in an open position towards the distal end of clip 22/102; [0034]: arms 26, including teeth 28, held in a closed position, or irreversibly deformed temporarily from the open position, by expandable collar 32 within introducing tube 12; [0030]: teeth 28 overlap with each other when the marker clip 22 is in closed position; [0048]-[0049]: arms 26 of marker clip 102 extended from introducing tube 12 to position about target tissue 40 and arms 26 closed onto the tissue by marker clip 102 being pulled or drawn proximally into introducing tube 12; [0050]-[0051]: once marker clip 22/102 is secured to the target tissue, next marker clip 22/104 is then deployed, allowing for individual marking of target tissue at various locations) and to penetrate a portion of the first area (Fig. 3-5: teeth 28 of arms 26 of marker clip 102 penetrating target tissue 40),
wherein the second device is configured to attach to a second area associated with the surgical cavity ([0050]-[0051]: once marker clip 22/102 is secured to the target tissue, next marker clip 22/104 is then deployed, allowing for individual marking of target tissue at various locations.
It is noted that Skerven discloses its arms being irreversibly deformed temporarily by collar 32 from the open position in attaching to and penetrating an area associated with a surgical cavity. See the Response to Arguments above.
Skerven does not disclose:
wherein the first indicator is detectable via a radiological scan,
wherein a remaining portion of the first device is less detectable via the radiological scan relative to the first indicator, and
wherein a first material of the first indicator is different from a second material of the remaining portion.
However, Stubbs teaches in the same medical field of endeavor:
an indicator (Fig. 15E-K: one of letters 224) detectable via a radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)),
wherein a remaining portion of a first device (Fig. 15E-K: one of circular caps 226/228) is less detectable via the radiological scan relative to the first indicator ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); [0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)), and
wherein a first material of the indicator ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)) is different from a second material of the remaining portion ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); Fig. 15E-K).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s first device to include Stubbs’s indicator detectable in a radiological scan and having a different material and detectability relative to the second element. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting radiologically detectable indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to improve the visibility of the indicator in the surgical cavity under a radiological scan ([0060] of Stubbs).
Regarding claim 9, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Skerven further discloses:
wherein one or more surfaces of the first device comprises a first pattern (Fig. 9-10 and [0039]-[0040]: collars 32 are individually color coded or marked with a unique color alpha-numeric symbol), and
wherein one or more surfaces of the second device comprises a second pattern (Fig. 9-10 and [0039]-[0040]: collars 32 are individually color coded or marked with a unique color alpha-numeric symbol).
Regarding claim 10, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Skerven further discloses:
wherein the first device (Fig. 8-10: collar 32 of marker clip 102) comprises a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38), and
wherein the first indicator is configured to be on one or more surfaces of the plurality of surfaces (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32 ).
Regarding claim 11, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Skerven further discloses:
wherein the first device (Fig. 8-10: collar 32 of marker clip 102) comprises a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38), and
wherein one or more surfaces of the plurality of surfaces include the first indicator (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32).
Regarding claim 14, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Skerven does not disclose:
wherein the first indicator is configured to identify a location of the first area.
However, Stubbs teaches in the same medical field of endeavor:
wherein the first indicator is configured to identify a location of the first area (Fig. 15E-K and [0102]: shapes of letters 224 are A (anterior) P (posterior), S (superior), I (inferior), M (medial), L (lateral or left), and R (right)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s first device to include Stubbs’s indicator configured to identify a location of a target area. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting a location indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to allow “the surgeon [is] able to visually confirm placement (of the marker) in the appropriate orientation because the various elements are labeled with markers relating to anatomic orientation”, as taught by Stubbs ([0102]).
Regarding claim 25, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Skerven discloses:
wherein the first device comprising one or more protrusions (Fig. 2-5: arms 26 protruding from marker clip 102) that include the protrusion (Fig. 2-5: arms 26 protruding from marker clip 102).
Regarding claim 15, Skerven discloses a device (at least Fig. 2-5), comprising:
an indicator (Fig. 9-10 and [0039]-[0040]: collar 32 is color coded or marked with unique color alpha-numeric symbol),
wherein the device is configured to attach to an area associated with a surgical cavity (Fig. 2-5 and [0048]-[0049]: arms 26 of marker clip 102 extended from introducing tube 12 to position about target tissue 40 and arms 26 closed onto the tissue by marker clip 102 being pulled or drawn proximally into introducing tube 12) via:
a first protrusion and a second protrusion (Fig. 2-5: arms 26 protruding from marker clip 102), the first protrusion and the second protrusion (Fig. 2-5: arms 26 protruding from marker clip 102) being configured to irreversibly deform to attach the device to the area (Fig. 2-3: arms 26 of marker clip 102 in closed position (first configuration) v. open position (second configuration); [0030]: arms 26 of a resilient material and have a tendency to be in an open position towards the distal end of clip 22/102; [0034]: arms 26, including teeth 28, held in a closed position, or irreversibly deformed temporarily from the open position, by expandable collar 32 within introducing tube 12; [0030]: teeth 28 overlap with each other when the marker clip 22 is in closed position; [0048]-[0049]: arms 26 of marker clip 102 extended from introducing tube 12 to position about target tissue 40 and arms 26 closed onto the tissue by marker clip 102 being pulled or drawn proximally into introducing tube 12) and to penetrate a portion of the area (Fig. 3-5: teeth 28 of arms 26 of marker clip 102 penetrating target tissue 40).
It is noted that Skerven discloses its arms being irreversibly deformed temporarily by collar 32 from the open position in attaching to and penetrating an area associated with a surgical cavity. See the Response to Arguments above.
Skerven does not disclose:
the indicator detectable via a radiological scan,
wherein a remaining portion of the device, other than the indicator, is less detectable via the radiological scan relative to the indicator, and
wherein a first material of the indicator is different from a second material of the remaining portion.
However, Stubbs teaches in the same medical field of endeavor:
an indicator (Fig. 15E-K: one of letters 224) detectable via a radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)),
wherein a remaining portion of a first device (Fig. 15E-K: one of circular caps 226/228) is less detectable via the radiological scan relative to the first indicator ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); [0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)), and
wherein a first material of the indicator ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)) is different from a second material of the remaining portion ([0018]: caps are bioabsorbable; [0062]: bioabsorbable materials include polyglycolic acid (PGA, e.g., Dexon, Davis & Geck); polyglactin material (Vicryl, Ethicon); poliglecaprone (Monocryl, Ethicon); and synthetic absorbable lactomer 9-1 (Polysorb, United States Surgical Corporation); Fig. 15E-K).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s device to include Stubbs’s indicator detectable in a radiological scan and having a different material and detectability relative to the second element. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting radiologically detectable indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to improve the visibility of the indicator in the surgical cavity under a radiological scan ([0060] of Stubbs).
Regarding claim 16, Skerven in view of Stubbs discloses all limitations of claim 15, as discussed above, and Skerven further discloses:
a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38), wherein the indicator is configured to be on one or more surfaces of the plurality of surface (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32).
Regarding claim 17, Skerven in view of Stubbs discloses all limitations of claim 15, as discussed above, and Skerven discloses:
a plurality of surfaces (Fig. 8 and [0034]-[0036]: collar 32 comprising expanding portion 34, moving arms 36, central lumen 38, and an outer surface surrounding the central lumen 38),
wherein one or more surfaces of the plurality of surfaces include the indicator (Fig. 9-10 and [0039]-[0040]: color coating or unique color alpha-numeric symbol on outer surface of collar 32).
Regarding claim 20, Skerven in view of Stubbs discloses all limitations of claim 15, as discussed above, and Skerven does not disclose:
wherein the indicator is configured to identify a location of the area associated with the surgical cavity.
However, Stubbs teaches in the same medical field of endeavor:
wherein the indicator (Fig. 15E-K and [0102]: one of letters 224 among A (anterior) P (posterior), S (superior), I (inferior), M (medial), L (lateral or left), and R (right)) is configured to identify a location of the area associated with the surgical cavity ([0102]-[0103]: each letter 224 indicates a direction or orientation relative to the cavity, and each circular cap comprising a letter 224 is encapsulated by the cavity wall).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Skerven’s device to include Stubbs’s indicator configured to identify a location of a target area. One of ordinary skill in the art would have combined the elements as claimed by known method (i.e., imprinting a location indicator on a marker, as disclosed by Stubbs), and the combination would have yielded a reasonable expectation of success, since both Skerven and Stubbs are directed to a marker configured to attach to an area associated with a surgical cavity. The motivation for the combination would have been to allow “the surgeon [is] able to visually confirm placement (of the marker) in the appropriate orientation because the various elements are labeled with markers relating to anatomic orientation”, as taught by Stubbs ([0102]).
Regarding claim 26, Skerven in view of Stubbs discloses all limitations of claim 15, as discussed above, and Skerven further discloses:
wherein the area associated with the surgical cavity is a surgical margin of the surgical cavity ([0051]: marking target tissue at various locations within the body cavity for removal for diagnostic or therapeutic medical procedures).
Claims 4, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Skerven in view of Stubbs, as applied to claims 1, 8, and 15 above, respectively, as evidenced by Choi et al. (Choi et al. Bioabsorbable bone fixation plates for X-ray imaging diagnosis by a radiopaque layer of barium sulfate and poly(lactic-co-glycolic acid). J Biomed Mater Res B Appl Biomater. 2015 Apr;103(3):596-607. doi: 10.1002/jbm.b.33235. Epub 2014 Jun 26. PMID: 24964903. A copy previously provided in the Non-Final Office Action of 08 Dec 2023) - hereinafter referred to as Choi.
Regarding claim 4, Skerven in view of Stubbs discloses all limitations of claim 1, as discussed above, and Stubbs further discloses, as discussed above for claim 1:
wherein only the first material is detectable in a targeted radiation associated with the radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)).
It is noted that bioabsorbable material including polyglycolic acid is well known in the art to be radiolucent, as evidenced by Choi. Therefore, Stubbs’s circular cap of bioabsorbable material polyglycolic acid is radiolucent, or negative contrast, relative to radiopaque letters that have a positive contrast, or detectable in a targeted radiation.
Regarding claim 12, Skerven in view of Stubbs discloses all limitations of claim 8, as discussed above, and Stubbs further discloses, as discussed above for claim 8:
wherein only the first material is detectable in a targeted radiation associated with the radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)).
It is noted that bioabsorbable material including polyglycolic acid is well known in the art to be radiolucent, as evidenced by Choi. Therefore, Stubbs’s circular cap of bioabsorbable material polyglycolic acid is radiolucent, or negative contrast, relative to radiopaque letters that have a positive contrast, or detectable in a targeted radiation.
Regarding claim 18, Skerven in view of Stubbs discloses all limitations of claim 15, as discussed above, and Stubbs further discloses, as discussed above for claim 15:
wherein only the first material is detectable in targeted radiation associated with the radiological scan ([0102]: each letter 224 formed of radiopaque wire (e.g., titanium, stainless)).
It is noted that bioabsorbable material including polyglycolic acid is well known in the art to be radiolucent, as evidenced by Choi (Abstract). Therefore, Stubbs’s circular cap of bioabsorbable material polyglycolic acid is radiolucent, or negative contrast, relative to radiopaque letters that have a positive contrast, or detectable in a targeted radiation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McGuire (Tanya McGuire. (2018, Jan 12). Charmed Paper Clips for your Journal of Planner [Video]. YouTube. https://www.youtube.com/watch?v=G-ksDz2klTU.) discloses a device comprising a first element configured to irreversibly deform temporarily (paper clip as the first element) and a second element comprising an indicator that is more detectable via a radiological scan than a remaining portion of the second element (various charms of metal beads vs. glass beads could have inherently varying radiopacities due to due to material difference; see attached Appendix). Applicant is reminded that the claims of the instant application are directed to a product. See MPEP 2114.II.
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 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
01/23/26