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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9 December 2025 has been entered.
Power of Attorney
No Power of Attorney is on file for this application. The Examiner suggests submitting a Power of Attorney so that the Examiner can discuss the merits of the application with the undersigned applicant representative within the Remarks dated 9 December 2025 if so needed.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 9 December 2025 wherein Claims 1 – 5, 7 – 11, and 14 – 17 are amended, Claims 6 and 18 are or previously were cancelled, no claims are newly added. Therefore, Claims 1 – 5 and 7 – 17 are currently pending.
The Applicant’s amendment to the claims dated 9 December 2025 has overcome each Claim Objection set forth in the Final Rejection dated 16 June 2025 (hereinafter referred to as the “Final Rejection”). Therefore, each Claim Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendment to the claims dated 9 December 2025 has overcome each Claim Rejection under 35 U.S.C. §§ 112(a) and (b) set forth in the Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. §§ 112(a) and (b) set forth in the Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 6 – 8, filed 9 December 2025, with respect to the rejection(s) of independent claim 1 and its dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoon (US 5,540,648 A), Kay (US 5,662,683 A1), and Lieberman (US 6,953,462 B2).
Applicant's arguments pertaining to the 35 U.S.C. § 103 rejection of Claim 10 and its dependent claims over Yoon (US 5,540,648 A) and Kay (US 5,662,683 A), filed 9 December 2025, have been fully considered but they are not persuasive.
The applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the bridge region being curved or angled such that the article to be secured is arranged below the bridge region; wherein the article to be secured is between the skin surface and the bridge region) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the Applicant’s argument that Yoon nor Kay teach the limitation of “a securing bridge with first and second retaining elements and the bridge region” is unpersuasive because based on the current claim language Yoon meets this limitation. The 35 U.S.C. § 103 rejection of Claims 10 – 16 is maintained.
Claim Objections
Claim(s) 1, 2, 4, 8, and 17 are objected to because of the following informalities:
Claim 1 recites “the securing device.” The Examiner suggests amending this to recite “the at least one securing device” to provide proper antecedent basis for this claim limitation.
Claim 2 recites “the securing device” a plurality of times. The Examiner suggests amending each of the recitations to recite “the at least one securing device” to provide proper antecedent basis for this claim limitation.
Claim 4 recites “the securing device” twice. The Examiner suggests amending each to recite “the at least one securing device” to provide proper antecedent basis for this claim limitation.
Claim 8 recites “the securing device” three times and “the stop.” The Examiner suggests amending these to recite “the at least one securing device” and “the at least one stop” to provide the proper antecedent basis for these claim limitations.
Claim 17 recites “the securing device” twice. The Examiner suggests amending each of these recitations to recite “the at least one securing device” to provide proper antecedent basis for this claim limitation.
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(s) 10 – 17 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 10 recites (bolded for emphasis):
An assembly, comprising:
a securing bridge comprising a first retaining element, a second retaining element, and a bridge region that connects the first and second retaining elements to one another;
a first securing device; and
a second securing device;
wherein the first retaining element has at least one cutout through which the first securing device is passable at least together with the at least one skin piercing element,
wherein the second retaining element has at least one cutout through which the second securing device is passable at least together with the at least one skin piercing element,
wherein each of the first and second securing devices respectively comprises:
at least one skin piercing element designed to penetrate the skin of the living being, wherein the at least one skin piercing element comprises a piercing tip, wherein the at least one skin piercing element is configured as a spiral spring, wherein the at least one skin piercing element has a length and a diameter, wherein the diameter is greater than the length; and
at least one securing portion coupled to the at least one skin piercing element, wherein the at least one securing portion is designed for securing the medical, cosmetic, decorative or other article to the securing device,
wherein the at least one securing portion is designed for securing the at least one skin piercing element in the skin of the living being by a rotational movement of the at least one securing portion, wherein an axis of rotation of the at least one securing portion runs orthogonally to a surface of the skin of the living being,
wherein the securing bridge is securable on the skin of the living being by the first and second securing devices by the respective at least one skin piercing element of each securing device being guided through the respective at least one cutout and secured in the skin of the living being by a rotational movement of each of the first and second securing devices,
wherein the axes of rotation of the first and second securing devices run orthogonally to the surface of the skin of the living being.
The order in which the structural elements of Claim 10 are recited creates indefiniteness because the claim fails to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. For example, Claim 10 recites “the at least one skin piercing element” however there is a lack of antecedent basis for this limitation until later within the claim.
Claim 10 recites “at least one skin piercing element designed to penetrate the skin of the living being.” The claim limitation reciting “the living being” lacks antecedent basis.
Claim 10 recites “wherein the first retaining element has at least one cutout through which the first securing device is passable at least together with the at least one skin piercing element.” It is unclear if “the at least one skin piercing element” is referring to the at least one skin piercing element of the first or second securing device.
Claim 10 recites “wherein the second retaining element has at least one cutout through which the second securing device is passable at least together with the at least one skin piercing element.” It is unclear if “the at least one skin piercing element” is referring to the at least one skin piercing element of the first or second securing device.
Claim 10 recites “the medical, cosmetic, decorative or other article” which lacks antecedent basis within the claim.
Claim 10 recites “the securing device.” It is unclear if this securing device is referring to the first or second securing device recited within the claim.
Claim 10 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 based on the aforementioned rationale.
The Examiner suggests amending Claim 10 to recite the following to resolve the aforementioned issues:
An assembly, comprising:
a securing bridge comprising a first retaining element, a second retaining element, and a bridge region that connects the first and second retaining elements to one another;
a first securing device; and
a second securing device;
wherein each of the first and second securing devices respectively comprises:
at least one skin piercing element designed to penetrate the skin of a living being, wherein the at least one skin piercing element comprises a piercing tip, wherein the at least one skin piercing element is configured as a spiral spring, wherein the at least one skin piercing element has a length and a diameter, wherein the diameter is greater than the length; and
at least one securing portion coupled to the at least one skin piercing element, wherein the at least one securing portion is designed for securing a medical, cosmetic, decorative or other article to the first and second securing devices respectively,
wherein the at least one securing portion is designed for securing the at least one skin piercing element in the skin of the living being by a rotational movement of the at least one securing portion, wherein an axis of rotation of the at least one securing portion runs orthogonally to a surface of the skin of the living being,
wherein the first retaining element has at least one cutout through which the first securing device is passable at least together with the at least one skin piercing element of the first securing device,
wherein the second retaining element has at least one cutout through which the second securing device is passable at least together with the at least one skin piercing element of the second securing device,
wherein the securing bridge is securable on the skin of the living being by the first and second securing devices by the respective at least one skin piercing element of each securing device being guided through the respective at least one cutout and secured in the skin of the living being by a rotational movement of each of the first and second securing devices,
wherein the axes of rotation of the first and second securing devices run orthogonally to the surface of the skin of the living being.
Claims 11 – 16 are dependent upon Claim 10 and therefore are rejected under 35 U.S.C. § 112(b) for the same rationale.
Claim 12 recites “the at least one cutout” twice. It is unclear if these claim limitations are referring to the at least one cutout of either the first or second retaining elements. The Examiner suggests amending each of these limitations to recite “the at least one cutout of the first retaining element” to clarify the antecedent basis of the claim language.
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.
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.
Claim(s) 1, 4, 5, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 5,540,648 A), Kay (US 5,662,683 A1), and Lieberman (US 6,953,462 B2).
Yoon is cited in the Notice of References cited form dated 3 January 2025.
Kay is cited in the Notice of References cited form dated 16 June 2025.
With regards to claim 1, Yoon discloses (Figs. 7 – 10) an assembly (see Fig. 8), comprising:
at least one securing device (124) (see Col. 6, lines 35 – 60) designed for securing a medical, cosmetic, decorative or other article (portal sleeve S and the recited instruments) to skin (W) of a living being (see Col. 6, line 61 – Col. 7, line 9 “With the needles 126 penetrating the anatomical wall W, the stabilizer 110 will be secured in place for stabilization of instruments introduced through ports 118 while allowing manipulation of the anatomical wall via the stabilizer 110 and/or inserted instruments.”), the at least one securing device comprising:
at least one skin piercing element (126) designed to penetrate the skin of the living being, wherein the at least one skin piercing element comprises a piercing tip (128) (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue”), wherein the at least one skin piercing element is configured as a spiral spring (see Col. 6, line 35 – Col. 7, line 9 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128”), wherein the at least one skin piercing element has a length and a diameter (see at 126 in Figs. 8 – 10),
at least one securing portion (134) coupled to the at least one skin piercing element, wherein the at least one securing portion is designed for securing the medical, cosmetic, decorative or other article to the securing device (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue and at a proximal end 130 connected with an arm 132 carrying a knob 134 disposed externally of body 112 for convenient grasping by a surgeon.”), and
a coupling portion (132) arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element (see Fig. 8); and
a retaining element (112) (see Col. 6, lines 35 – 60 “The stabilizer 110 includes a body 112”) comprising at least one cutout (the cutout formed by the structures of 136, 137, 139) through which the at least one securing device is passable at least together with the at least one skin piercing element (see Col. 6, lines 35 – 60 “Arms 132 extend through channels 136 formed through the thickness of body 112, the channels 136 having an upper portion 137 for guiding movement of arms 132 and a lower portion 139 for housing needles 126 in the retracted position.”), wherein the cutout is a through hole (the structure of 136, 137, 139 is a through hole because it extends through the thickness of body 112 as described in Col. 6, lines 35 – 60),
wherein the at least one securing portion is designed for securing the at least one skin piercing element in the skin of the living being by a rotational movement of the at least one securing portion, wherein an axis of rotation of the at least one securing portion runs orthogonally to a surface of the skin of the living being (see Col. 6, line 35 – Col. 7, line 9 “Use of medical instrument stabilizer 110 is similar to that previously described except that needles 126 are moved between the retracted and extended positions via rotation of knobs 134 to penetrate an anatomical wall W with a rotational penetrating motion. Once the stabilizer 110 has been positioned on the external surface of an anatomical wall W, knobs 134 are manually grasped and rotated causing the spiral needles 126 to be rotated into the tissue of the anatomical wall.”),
wherein the retaining element is securable on the skin of the living being by the at least one securing device (see Figs. 7 – 10 and Col. 6, line 35 – Col. 7, line 9),
wherein the through hole is larger than the coupling portion in a direction orthogonal to the axis of rotation (see Figs. 7 – 10 where the through hole 136, 137, 139 is larger than the coupling portion 132 in a direction orthogonal to the axis of rotation because these figures show the coupling portion being inserted through the through hole).
However, Yoon is silent with regards to:
wherein the diameter is greater than the length, and
wherein the coupling portion is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element.
Nonetheless Kay, which is within the analogous art of open helical organic tissue anchors (see abstract and title), teaches (Figs. 1 – 3) wherein the at least one skin piercing element (10) is configured as a spiral spring (see Col. 3, lines 34 – 41 “anchoring device 10 comprises an open helix 12 having a pointed insertion tip 14 at one end”), wherein the at least one skin piercing element has a length and a diameter, wherein the diameter is greater than the length (see Col. 3, line 54 – Col. 4, line 10 “the length of the anchor for the most general fastening or anchoring applications is from about 3 to about 18 millimeters…The overall outer diameter of the open helix portion 12 of the anchoring device 10 ranges from about 1.5 to about 11 millimeters” wherein there are multiple configurations where the diameter is greater than the length such as a length of 3 millimeters and a diameter of 4 millimeter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the length and diameter of the at least one skin piercing element of the securing device of the assembly of Yoon in view of a teaching of Kay such that the diameter is greater than the length. One of ordinary skill in the art would have been motivated to make this modification because Kay teaches the length and diameter of the at least one skin piercing element may vary in accordance with the application (see Col. 2, lines 10 – 20 of Kay). Therefore, a person having ordinary skill in the art would adjust the length and diameter of the at least one skin piercing element to accommodate the desired application of the assembly such that proper securement is achieved.
The assembly of Yoon modified in view of Kay will hereinafter be referred to as the assembly of Yoon and Kay.
However, neither Yoon nor Kay teach wherein the coupling portion is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element.
Nonetheless Lieberman, which is within the analogous art of securing devices (see abstract and title)¸ teaches (see Figs. 4 – 5) the coupling portion (24) is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element (50, 52) (see Col. 4, lines 32 – 53 “for structural stability reasons, the overall diameter of the helical spikes 50 and 52 should remain less than or equal to the diameter of the platform 24”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the size of the coupling portion in the direction orthogonal to the axis of rotation and the diameter of the at least one skin piercing element of the securing device of the assembly of Yoon and Kay in view of a teaching of Lieberman such that the coupling portion is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element. One of ordinary skill in the art would have been motivated to make this modification because Lieberman teaches that having a coupling portion that is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element assists with maintaining structural stability of the securing device (see Col. 4, lines 32 – 53 of Lieberman). Here, the complementary structures (i.e., the at least one cutout of the retainer element) of the assembly of Yoon would be modified to accommodate the changed size of the coupling portion of Yoon.
The assembly of Yoon and Kay modified in view of a teaching of Lieberman will hereinafter be referred to as the assembly of Yoon, Kay, and Lieberman.
Alternatively or additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention of modify the size of the coupling portion in the direction orthogonal to the axis of rotation and the diameter of the at least one skin piercing element of the securing device of the assembly of Yoon and Kay in view of a teaching Lieberman such that that the coupling portion is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element, since such a modification would have involved a mere change in the size of a component. The Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984); MPEP 2144.04(IV)(B). Here, the claimed assembly would not perform differently than the assembly of Yoon and Kay modified in view of Lieberman because both assemblies secure the medical, cosmetic, decorative or other article to the skin of a living being using at least one securing device. Therefore, the claimed assembly is not patentably distinct from the prior art assembly. Here, the complementary structures (i.e., the at least one cutout of the retainer element) of the assembly of Yoon would be modified to accommodate the changed size of the coupling portion of Yoon.
With regards to claim 4, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, and Yoon further teaches (Figs. 7 – 10) wherein the securing device (124) further comprises a skin contact surface (130) which comes into contact with the surface of the skin (W) of the living being when the securing device is secured on the skin of the living being (see the Examiner annotated Fig. 9 below; hereinafter referred to as Fig. A).
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With regards to claim 5, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 4, and Yoon further teaches (Figs. 7 – 10) wherein the at least one skin piercing element (126) protrudes directly from the skin contact surface (130) (see Fig. A above).
With regards to claim 7, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, and Yoon further teaches (Figs. 7 – 10) wherein the spiral spring (see at 126 in Fig. 8) comprises spiral spring turns which are spaced apart from one another in a direction of a longitudinal axis of the at least one skin piercing element (see Figs. 8 – 9 and Col. 6, line 35 – Col. 7, line 9).
With regards to claim 8, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, and Yoon further teaches (Figs. 7 – 10) wherein the securing device (124) further comprises at least one stop (130) by which a maximum angle of rotation of the securing device about the axis of rotation is limited (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue and at a proximal end 130 connected with an arm 132…” wherein where the maximum angle of rotation of the securing device about the axis of rotation is limited because contact between the proximal end 130 and the skin of the patient would limit further insertion via rotation about the axis of rotation) (this stop 130 is similar to the Applicant’s own “stop” described on page 7, lines 20 – 30 of the Specification dated October 27, 2022. Therefore, the stop 130 of Yoon would provide the same functionality as the Applicant’s own disclosure.), wherein the stop is configured to prevent the securing device from being screwed too far into the skin (see Col. 6, lines 35 – 60).
The Examiner has also provided a further 35 U.S.C. § 103 rejection for Claim 8 below.
Claim(s) 2 – 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Kay, and Lieberman as applied to Claim 1 above, and further in view of Yoon (US 5,653,718 A; hereinafter referred to as “Yoon ‘718”).
Yoon ‘718 is cited in the Notice of References cited form dated January 3, 2025.
With regards to claim 2, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, however, Yoon is silent with regards to wherein the securing device comprises a manual actuating element at which the securing device is grippable manually and a rotational movement for securing the securing device on the skin of the living being is exertable on the securing device.
Nonetheless Yoon ‘718, which is within the analogous art of cannula anchoring systems (see abstract), teaches (Figs. 1 – 5) the securing device (31) comprises a manual actuating element (39) at which the securing device is grippable manually and a rotational movement for securing the securing device on the skin of the living being is exertable on the securing device (see Col. 6, lines 3 – 14 “A radially extending handle 39 is secured to each rotatable shaft 35 externally of housing 21” and Col. 7, lines 6 – 45 “Rotation of each handle is continued until perpendicular to front wall 23 or until the needles 31 protrude from the front wall 23 of housing 21 as shown in FIG. 9 to capture tissue between the arcuate body 45 of each needle 31 and the front wall 23 of the housing 21 thereby anchoring the portal sleeve 11 in place.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the assembly of Yoon, Kay, and Lieberman in view of a teaching of Yoon ‘718 such that the securing device further comprises a manual actuating element at which the securing device is grippable manually and a rotational movement for securing the securing device on the skin of the living being is exertable on the securing device. One of ordinary skill in the art would have been motivated to make this modification because Yoon ‘718 teaches that the using a manual actuating element or a handle to facilitate anchoring provides stability and ease of use (see Col. 6, lines 45 – 64 and Col. 7, line 64 – Col. 8, line 6 of Yoon ‘718).
The assembly of Yoon, Kay, and Lieberman modified in view of Yoon ‘718 will hereinafter be referred to as the assembly of Yoon, Kay, Lieberman, and Yoon ‘718.
With regards to claim 3, the assembly of Yoon, Kay, Lieberman, and Yoon ‘718 teaches the claimed invention of claim 2, however, Yoon is silent with regards to wherein the at least one securing portion is arranged on the manual actuating element.
Nonetheless Yoon ‘718, which is within the analogous art of cannula anchoring systems (see abstract), teaches the at least one securing portion (35) is arranged on the manual actuating element (39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one securing portion and manual actuating element of the securing device of the assembly of Yoon, Kay, Lieberman and Yoon ‘718 such that the at least one securing portion is arranged on the manual actuating element. One of ordinary skill in the art would have been motivated to make this modification because Yoon ‘718 teaches that using a manual actuating element or a handle to facilitate anchoring provides stability and ease of use (see Col. 6, lines 45 – 64 and Col. 7, line 64 – Col. 8, line 6 of Yoon ‘718).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Kay, and Lieberman as applied to claim 1 above, and further in view of Ingvarsson (US 6,364,587 B1).
With regards to claim 8, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, and it is the Examiner’s position that Yoon teaches the subsequent limitation of claim 8 (see the rejection above under the 35 U.S.C. § 103 rejection in view of Yoon, Kay, and Lieberman), however, if it is determined that Yoon is silent with regards to the securing device further comprising at least one stop by which a maximum angle of rotation of the securing device about the axis of rotation is limited, wherein the stop is configured to prevent the securing device from being screwed too far into the skin then a PHOSITA would turn to a teaching of Ingvarsson.
Ingvarsson, which is within the analogous art of devices for preventing anti-rotation of a fastening element (see abstract and title), teaches (see Figs. 4 – 6) the securing device (screw) (see Col. 4, line 60 – Col. 5, line 4) further comprising at least one stop (each side of the screw head) (see Col. 4, line 60 – Col. 5, line 4) by which a maximum angle of rotation of the securing device about the axis of rotation is limited, wherein the stop is configured to prevent the securing device from being screwed too far into the skin (see Col. 5, lines 1 – 5 “each side of the screw head 14 will be in contact with one protrusion 11. In this way, a locking against rotation of the screw head 14 is obtained.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the assembly of Yoon, Kay, and Lieberman in view of a teaching of Ingvarsson such that the securing device further comprising at least one stop by which a maximum angle of rotation of the securing device about the axis of rotation is limited, wherein the stop is configured to prevent the securing device from being screwed too far into the skin. Here, the modification would be to the body 112 of the stabilizer 110 of Yoon such that it includes the protrusions taught by Ingvarsson such that the knob 134 of Yoon would engage with the protrusions as taught by Col. 4, line 60 – Col. 5, line 4 of Ingvarsson to prevent further rotation. One of ordinary skill in the art would have been motivated to make this modification because Ingvarsson teaches that this structure locks a screw against rotation thereby further securing the screw in place and preventing any inadvertent rotation (see Col. 4, line 60 – Col. 5, line 4).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Kay, and Lieberman as applied to claim 1 above, and further in view of Whiting et al. (US 2007/0083168 A1; hereinafter referred toas “Whiting”).
Whiting is cited in the Notice of References cited form dated January 3, 2025.
With regards to claim 9, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, however, Yoon is silent with regards to wherein a main piercing element of the spiral spring has a pitch of less than 3 mm/360°.
Nonetheless Whiting, which is within the analogous art of helical tissue penetration members (see [0136] and Fig. 2A), teaches a main piercing element (42; see [0136] “helical tissue penetration member 42”) of the spiral spring has a pitch of less than 3 mm/360º (see [0136] “The pitch of the coil structure may be from about 0.3 mm to about 1.5 mm of separation between axially adjacent coil elements of the helical tissue penetration member 42.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the pitch of the spiral spring of the at least one skin piercing element of the assembly of Yoon, Kay, and Lieberman in view of a teaching of Whiting such that a main piercing element of the spiral spring has a pitch of less than 3 mm/360º. One of ordinary skill in the art would have been motivated to make this modification, as Whiting teaches this pitch configuration facilitates tissue penetration upon rotation and advancement (see [0134] of Whiting).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Kay, and Lieberman as applied to claim 1 above, and further in view of Eckerdal (US 2011/0034982 A1).
Eckerdal is cited in the Notice of References Cited form dated 16 June 2025.
With regards to claim 17, the assembly of Yoon, Kay, and Lieberman teaches the claimed invention of claim 1, however, Yoon is silent with regards to wherein the securing device further comprises at least one electrical insulating element which prevents an electrical current flow between the securing device and the medical, cosmetic, decorative or other article secured on the at least one securing portion and the skin of the living being.
Nonetheless Eckerdal, which is within the analogous art of medical implantable leads (see abstract and title), teaches (Figs. 2 – 3) the securing device (3; see [0032] “helix 3”) further comprises at least one electrical insulating element (“electrically insulating coating”; see [0008] “where the fixation means, e.g. a helix, is electrically insulated and instead the lead is provided with a separate contact electrode,” [0010] “electrically insulating coating”, and [0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the at least one skin piercing element of the securing device of the assembly of Yoon, Kay, and Lieberman in view of a teaching of Eckerdal such that the securing device further comprises at least one electrical insulating element. One of ordinary skill in the art would have been motivated to make this modification because Eckerdal teaches that it is beneficial for the fixation means to be insulated in order to prevent the fixation means from conducting electrical signals (see [0008], [0010], and [0011] of Eckerdal).
The assembly of Yoon, Kay, and Lieberman modified in view of a teaching of Eckerdal will hereinafter be referred to as the assembly of Yoon, Kay, Lieberman and Eckerdal.
The assembly of Yoon, Kay, Lieberman and Eckerdal further teaches that the at least one electrical insulating element, the electrical insulating coating taught by Eckerdal modified onto the at least one skin piercing element 126 of Yoon, prevents an electrical current flow between the securing device and the medical, cosmetic, decorative or other article secured on the at least one securing portion and the skin of the living being.
Claim(s) 10 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon and Kay.
Yoon is cited in the Notice of References cited form dated 3 January 2025.
Kay is cited in the Notice of References cited form dated 16 June 2025.
With regards to claim 10, Yoon discloses (Figs. 7 – 10) an assembly (110) (see Col. 6, lines 35 – 60 “anchoring system 124 for stabilizer 110”), comprising:
a securing bridge (112) (see Col. 6, lines 35 – 60 “The stabilizer 110 includes a body 112”) comprising a first retaining element (see at left channel 136 in Fig. 8), a second retaining element (see at right channel 136 in Fig. 8), and a bridge region (see the region between the lower right and left 134 in Fig. 7 which is the same region that is between the two channels 136 in Fig. 8) that connects the first and second retaining elements to one another;
a first securing device (left 124) (see Col. 6, line 35 – 60 “anchoring system 124 for stabilizer 110”); and
a second securing device (right 124) (see Col. 6, line 35 – 60 “anchoring system 124 for stabilizer 110”);
wherein the first retaining element has at least one cutout (left 136, 137, 139) (see Figs. 8 – 9 and Col. 6, line 35 – Col. 7, line 9) through which the first securing device is passable at least together with the at least one skin piercing element (126) (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue” and see Fig. 8),
wherein the second retaining element has at least one cutout (right 136, 137, 139) (see Figs. 8 – 9 and Col. 6, line 35 – Col. 7, line 9) through which the second securing device is passable at least together with the at least one skin piercing element (126) (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue” and see Fig. 8),
wherein each of the first and second securing devices respectively comprises:
at least one skin piercing element designed to penetrate the skin of the living being, wherein the at least one skin piercing element comprises a piercing tip (128) (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue”), wherein the at least one skin piercing element is configured as a spiral spring (see Col. 6, line 35 – Col. 7, line 9 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128”), wherein the at least one skin piercing element has a length and a diameter (see at 126 in Figs. 7 – 10), and
at least one securing portion (134) coupled to the at least one skin piercing element, wherein the at least one securing portion is designed for securing the medical, cosmetic, decorative or other article to the securing device (see Col. 6, lines 35 – 60 “Each needle 126 has a spiral or corkscrew configuration terminating at a distal end 128 for penetrating anatomical tissue and at a proximal end 130 connected with an arm 132 carrying a knob 134 disposed externally of body 112 for convenient grasping by a surgeon.”),
wherein the at least one securing portion is designed for securing the at least one skin piercing element in the skin of the living being by a rotational movement of the at least one securing portion, wherein an axis of rotation of the at least one securing portion runs orthogonally to a surface of the skin of the living being (see Col. 6, line 35 – Col. 7, line 9 “Use of medical instrument stabilizer 110 is similar to that previously described except that needles 126 are moved between the retracted and extended positions via rotation of knobs 134 to penetrate an anatomical wall W with a rotational penetrating motion. Once the stabilizer 110 has been positioned on the external surface of an anatomical wall W, knobs 134 are manually grasped and rotated causing the spiral needles 126 to be rotated into the tissue of the anatomical wall.”),
wherein the securing bridge is securable on the skin of the living being by the first and second securing devices by the respective at least one skin piercing element of each securing device being guided through the respective at least one cutout and secured in the skin of the living being by a rotational movement of each of the first and second securing devices (see Col. 6, line 35 – Col. 7, line 9 and Figs. 7 – 10),
wherein the axes of rotation of the first and second securing devices run orthogonally to the surface of the skin of the living being (see Col. 6, line 35 – Col. 7, line 9 and Figs. 7 – 10).
However Yoon is silent with regards to:
wherein the diameter is greater than the length.
Nonetheless Kay, which is within the analogous art of open helical organic tissue anchors (see abstract and title), teaches (Figs. 1 – 3) wherein the at least one skin piercing element (10) is configured as a spiral spring (see Col. 3, lines 34 – 41 “anchoring device 10 comprises an open helix 12 having a pointed insertion tip 14 at one end”), wherein the at least one skin piercing element has a length and a diameter, wherein the diameter is greater than the length (see Col. 3, line 54 – Col. 4, line 10 “the length of the anchor for the most general fastening or anchoring applications is from about 3 to about 18 millimeters…The overall outer diameter of the open helix portion 12 of the anchoring device 10 ranges from about 1.5 to about 11 millimeters” wherein there are multiple configurations where the diameter is greater than the length such as a length of 3 millimeters and a diameter of 4 millimeter).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the length and diameter of the at least one skin piercing element of the securing device of the assembly of Yoon in view of a teaching of Kay such that the diameter is greater than the length. One of ordinary skill in the art would have been motivated to make this modification because Kay teaches the length and diameter of the at least one skin piercing element may vary in accordance with the application (see Col. 2, lines 10 – 20 of Kay). Therefore, a person having ordinary skill in the art would adjust the length and diameter of the at least one skin piercing element to accommodate the desired application of the assembly such that proper securement is achieved.
The assembly of Yoon modified in view of Kay will hereinafter be referred to as the assembly of Yoon and Kay.
With regards to claim 11, the assembly of Yoon and Kay teaches the claimed invention of claim 10, and Yoon further teaches (Figs. 7 – 10) wherein the first securing device (left 124 in Fig. 8) further comprises a coupling portion (132) arranged in a longitudinal direction between the at least one securing portion (134) and the at least one skin piercing element (126).
With regards to claim 12, the assembly of Yoon and Kay teaches the claimed invention of claim 11, and Yoon further teaches (Figs. 7 – 10) wherein the coupling portion (132) is guidable into the at least one cutout (136, 137, 139) and is mounted rotatably in the at least one cutout (see Figs. 8 – 9 and Col. 6, line 35 – Col. 7, line 9).
With regards to claim 13, the assembly of Yoon and Kay teaches the claimed invention of claim 11, and Yoon further teaches (Figs. 7 – 10) wherein the coupling portion (132) directly adjoins the at least one skin piercing element (126) in the longitudinal direction (see Figs. 8 – 9).
With regards to claim 14, the assembly of Yoon and Kay teaches the claimed invention of claim 11, and Yoon further teaches (Figs. 7 – 10) wherein the at least one securing portion (134) or further securing portion of the first securing device (left 124 in Fig. 8) protrudes over the coupling portion (132) in a circumferential direction (see Figs. 8 – 9 which shows the at least one securing portion 134 protruding over the coupling portion 132 in the circumferential direction).
With regards to claim 15, the assembly of Yoon and Kay teaches the claimed invention of claim 11, and Yoon further teaches (Figs. 7 – 10) wherein the coupling portion (132) has on an outer circumference, at least one connecting element (115) via which the first securing device (left 124 in Fig. 8) is fastenable to the first retaining element (see at left channel 136 in Fig. 8) and which is mountable rotatably on the first retaining element (see Col. 6, lines 35 – 60 “Arms 132 extend through channels 136 formed through the thickness of body 112…Arms 132 carry an external thread 115 for engagement with an internal thread along the channel upper portion 137”).
With regards to claim 16, the assembly of Yoon and Kay teaches the claimed invention of claim 15, and Yoon further teaches (Figs. 7 – 10) wherein the first retaining element (see at left channel 136 in Fig. 8) has a fastening element (internal thread; Col. 6, lines 35 – 60 “Arms 132 extend through channels 136 formed through the thickness of body 112…Arms 132 carry an external thread 115 for engagement with an internal thread along the channel upper portion 137”) which is complementary to the at least one connecting element (115) and which is bringable into engagement with the at least one connecting element of the first securing device (see left 124 in Fig. 8) in order to fasten the first securing device to the first retaining element and to mount the first securing device rotatably on the first retaining element (see Figs. 8 – 9 and Col. 6, lines 35 – 60).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
03/06/2026