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 Amendment
This Office Action is in response to the Applicant’s amendment filed 3 June 2026 wherein Claims 1, 2, 4, 8, 10, and 12 – 17, Claims 6, 11, and 18 are or previously were cancelled, no claims are newly added or withdrawn. Therefore Claims 1 – 5, 7 – 10, and 12 – 17 are currently pending.
The Applicant’s amendments to the Claims dated 3 June 2026 has overcome each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection dated 9 March 2026 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Claim Objection and Claim Rejection under 35 U.S.C. § 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 7 – 9, filed 3 June 2026, with respect to the rejection(s) of independent claim(s) 1 and 10 and their respective 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 Therefore, the rejection has been withdrawn.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 Silich (US 2009/0287155 A1), Thomas (US 2015/0305738 A1), and Kay (US 5,662,683 A).
Claim Objections
Claims 2, 10, and 16 are objected to because of the following informalities:
Claim 2 is suggested to be amended to recite the following to resolve an antecedent basis issue:
The assembly as claimed in claim 1, wherein the at least one securing device comprises a manual actuating element at which the at least one securing device is grippable manually and [[a]] the rotational movement for securing the at least one securing device on the skin of the living being is exertable on the at least one securing device.
Claim 10 is suggested to be amended to recite the following to resolve some antecedent basis 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 [[the]] 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;
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]] a medical, cosmetic, decorative or other article to the respective first or second securing device; and
a coupling portion arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element,
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, wherein the at least one cutout of the first retaining element is a first through hole, wherein the at least one skin piercing element of the first securing device and the coupling portion of the first securing device are passable through the first through hole from a top surface of the first retaining element,
wherein the second retaining element has at least one cutout, wherein the at least one cutout of the second retaining element is a second through hole, wherein the at least one skin piercing element of the second securing device and the coupling portion of the second securing device are passable through the second through hole from a top surface of the second retaining element,
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]] the 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.
Claim 16 is suggested to be amended to recite the following to resolve an antecedent basis issue:
The assembly as claimed in claim 15, wherein the first retaining element has a fastening element which is complementary to the at least one connecting element of the first securing device and which is bringable into engagement with the at least one connecting element of the first securing device 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.
Appropriate correction is required.
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, 10, and 12 – 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silich (US 2009/0287155 A1), Thomas (US 2015/0305738 A1), and Kay (US 5,662,683 A).
With regards to claim 1, Silich discloses an assembly (see Fig. 1), comprising
at least one securing device (see [0039] “suture or non-suture anchoring device”) designed for securing a medical, cosmetic, decorative or other article (14) (see [0036]) to skin of a living being (see [0010] “installed into the skin of a patient” and [0036]),
a retaining element (24) (see [0038]) comprising at least one cutout (27) (see [0039]), wherein the cutout is a through hole (see [0039] “apertures 27”),
wherein the retaining element is securable on the skin of the living being by the at least one securing device (see [0010], [0036], and [0039]).
However, Silich is silent with regards to
the at least one securing device comprising:
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,
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 at least one securing device, and
a coupling portion arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element; and
wherein the at least one skin piercing element and the coupling portion are passable through the through hole from a top surface of the retaining element,
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 through hole is larger than the coupling portion in a direction orthogonal to the axis of rotation, 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 Thomas, which is within the analogous art of surgical fasteners (see abstract), teaches (see Fig. 3 – 5) the at least one securing device (100) (see [0033]) comprising:
at least one skin piercing element (112) (see [0035]) designed to penetrate the skin of the living being (see [0033] and [0039]), wherein the at least one skin piercing element comprises a piercing tip (124) (see [0041]), wherein the at least one skin piercing element is configured as a spiral spring (see Fig. 4 and [0035]), wherein the at least one skin piercing element has a length (see Fig. 4) and a diameter (see Fig. 4),
at least one securing portion (130) (see [0035]) coupled to the at least one skin piercing element (see Fig. 4), wherein the at least one securing portion is designed for securing the medical, cosmetic, decorative or other article to the at least one securing device (see [0033]), and
a coupling portion (see Examiner annotated Fig. 4 below hereinafter referred to as “Fig. A”) arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element (see Fig. A below); and
PNG
media_image1.png
265
667
media_image1.png
Greyscale
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 [0037] and [0038]),
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 (see Fig. A above where the annotated coupling portion is larger in the direction orthogonal to the axis of rotation than the diameter of the at least one skin piercing element 112).
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 device of the assembly of Silich in view of a teaching of Thomas such that the assembly further comprises at least one securing device designed for securing a medical, cosmetic decorative or other article to skin of a living being, the at least one securing device comprising: 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, 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 at least one securing device, and a coupling portion arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element; and 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, 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.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
The assembly of Silich modified in view of a teaching of Thomas will hereinafter be referred to as the assembly of Silich and Thomas.
The assembly of Silich and Thomas teaches the following:
wherein the at least one skin piercing element and the coupling portion are passable through the through hole from a top surface of the retaining element (The at least one skin piercing element and the coupling portion of the securing device of Thomas are passable through the through hole from a top surface of the retaining element of Silich because paragraph [0039] of Silich teaches that the apertures 27 are understood that they may be any shape or size effective to facilitate attachment of the catheter clamp 12 to a patient with the non-suture anchoring device. Therefore the apertures 27 are sized to allow the at least one skin piercing element and coupling portion to be passable through the through hole from the top surface of the retaining element.), and
wherein the through hole is larger than the coupling portion in a direction orthogonal to the axis of rotation (The through hole of Silich is larger than the coupling portion in a direction orthogonal to the axis of rotation because paragraph [0039] of Silich teaches that the apertures 27 are understood that they may be any shape or size effective to facilitate attachment of the catheter clamp 12 to a patient with the non-suture anchoring device. Therefore the apertures 27 are sized such that they are larger than the coupling portion in a direction orthogonal of the axis of rotation to facilitate the incorporation of the securing device taught by Thomas such that the catheter clamp is attached to the patient.).
However, neither Silich nor Thomas teaches
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 Silich and Thomas 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 Silich and Thomas modified in view of a teaching of Kay will hereinafter be referred to as the assembly of Silich, Thomas, and Kay.
With regards to claim 4, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 1, however Silich is silent with regards to wherein the at least one securing device further comprises a skin contact surface which comes into contact with the surface of the skin of the living being when the at least one securing device is secured on the skin of the living being.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), further teaches (see Fig. 3 – 5) the at least one securing device (100) (see [0033]) further comprises a skin contact surface (see Fig. A above) which comes into contact with the surface of the skin of the living being when the at least one securing device is secured on the skin of the living being (see [0033], [0037], and [0038]).
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 device of the assembly of Silich, Thomas, and Kay in view of a further teaching of Thomas such that the at least one securing device further comprises a skin contact surface which comes into contact with the surface of the skin of the living being when the at least one securing device is secured on the skin of the living being.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
With regards to claim 5, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 4, however Silich is silent with regards to wherein the at least one skin piercing element protrudes directly from the skin contact surface.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), further teaches (see Fig. 3 – 5) the at least one skin piercing element (112) (see [0035]) protrudes directly from the skin contact surface (see Fig. A above).
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 device of the assembly of Silich, Thomas, and Kay in view of a further teaching of Thomas such that the at least one skin piercing element protrudes directly from the skin contact surface.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
With regards to claim 7, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 1, however Silich is silent with regards to wherein the spiral spring 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.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), further teaches (see Fig. 3 – 5) the spiral spring (see Fig. 4 and [0035]) 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 (112) (see [0035] and Fig. 4).
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 device of the assembly of Silich, Thomas, and Kay in view of a further teaching of Thomas such that the spiral spring 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.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
With regards to claim 10, Silich discloses an assembly (see Fig. 1), comprising:
a securing bridge (10) (see [0037]) comprising a first retaining element (left 24 in Fig. 1), a second retaining element (right 24 in Fig. 1), and a bridge region (see the structure that connects the left 24 from the right 24 in Fig. 1) that connects the first and second retaining elements to one another;
a first securing device (see [0039] “suture or non-suture anchoring device” that is located in the left 24 in Fig. 1); and
a second securing device (see [0039] “suture or non-suture anchoring device” that is located in the right 24 in Fig. 1);
wherein the first retaining element has at least one cutout (27) (see [0039]), wherein the at least one cutout of the first retaining element is a first through hole (see [0039] “aperture 27” and Fig. 1),
wherein the second retaining element has at least one cutout (27) (see [0039] and Fig. 1), wherein the at least one cutout of the second retaining element is a second through hole (see [0039] “aperture 27”).
However Silich is silent with regards to:
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;
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 respective first or second securing device; and
a coupling portion arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element,
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 at least one skin piercing element of the first securing device and the coupling portion of the first securing device are passable through the first through hole from a top surface of the first retaining element,
wherein the at least one skin piercing element of the second securing device and the coupling portion of the second securing device are passable through the second through hole from a top surface of the second retaining element,
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.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), teaches (see Figs. 3 – 5) the following:
wherein each of the first and second securing devices (100) (see [0033]) respectively comprises:
at least one skin piercing element (112) (see [0035]) designed to penetrate the skin of the living being (see [0033] and [0039]), wherein the at least one skin piercing element comprises a piercing tip (124) (see [0041]), wherein the at least one skin piercing element is configured as a spiral spring (see Fig. 4 and [0035]), wherein the at least one skin piercing element has a length (see Fig. 4) and a diameter (see Fig. 4),
at least one securing portion (130) (see [0035]) coupled to the at least one skin piercing element (see Fig. 4), wherein the at least one securing portion is designed for securing the medical, cosmetic, decorative or other article to the respective first or second securing device (see [0033]); and
a coupling portion (see Fig. A reiterated below) arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element (see Fig. A reiterated below),
PNG
media_image1.png
265
667
media_image1.png
Greyscale
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 [0037] and [0038]),
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 [0037] and [0038]).
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 first and second securing devices of the assembly of Silich in view of a teaching of Thomas such that 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, 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 respective first or second securing device; and a coupling portion arranged in a longitudinal direction between the at least one securing portion and the at least one skin piercing element, 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, and wherein the axes of rotation of the first and second securing devices run orthogonally to the surface of the skin of the living being.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
The assembly of Silich modified in view of a teaching of Thomas will hereinafter be referred to as the assembly of Silich and Thomas.
The assembly of Silich and Thomas teaches the following:
wherein the at least one skin piercing element of the first securing device and the coupling portion of the first securing device are passable through the first through hole from a top surface of the first retaining element (The at least one skin piercing element of the first securing device and the coupling portion of the first securing device of Thomas are passable through the first through hole from a top surface of the first retaining element of Silich because paragraph [0039] of Silich teaches that the apertures 27 are understood that they may be any shape or size effective to facilitate attachment of the catheter clamp 12 to a patient with the non-suture anchoring device. Therefore the apertures 27 are sized to allow the at least one skin piercing element and coupling portion to be passable through the through hole from the top surface of the retaining element.),
wherein the at least one skin piercing element of the second securing device and the coupling portion of the second securing device are passable through the second through hole from a top surface of the second retaining element (The at least one skin piercing element of the second securing device and the coupling portion of the second securing device of Thomas are passable through the second through hole from a top surface of the second retaining element of Silich because paragraph [0039] of Silich teaches that the apertures 27 are understood that they may be any shape or size effective to facilitate attachment of the catheter clamp 12 to a patient with the non-suture anchoring device. Therefore the apertures 27 are sized to allow the at least one skin piercing element and coupling portion to be passable through the through hole from the top surface of the retaining element.), and
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 [0039] of Silich and [0033] – [0035] and [0037] – [0039] of Thomas which teaches the first and second securing devices of Thomas being inserted through the apertures 27 of Silich to secure the securing bridge of Silich to the skin of the living being 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).
However, neither Silich nor Thomas teaches 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 first and second securing devices of the assembly of Silich and Thomas 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 Silich and Thomas modified in view of a teaching of Kay will hereinafter be referred to as the assembly of Silich, Thomas, and Kay.
With regards to claim 12, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 10, and the assembly of Silich, Thomas, and Kay further teaches wherein the coupling portion of the first securing device is guidable into the at least one cutout of the first retaining element and is mounted rotatably in the at least one cutout of the first retaining element (see [0039] of Silich and [0033] – [0035] and [0037] – [0039] of Thomas which teaches the first and second securing devices of Thomas being inserted through the apertures 27 of Silich wherein the coupling portion of the first securing device is guidable into the at least one cutout of the first retaining element and is mounted rotatably in the at least one cutout of the first retaining element).
With regards to claim 13, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 10, however, Silich is silent with regards to wherein the coupling portion of the first securing device directly adjoins the at least one skin piercing element of the first securing device in the longitudinal direction.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), further teaches (see Figs. 3 – 5) the coupling portion (see Fig. A above) of the first securing device (100) (see [0033]) directly adjoins the at least one skin piercing element (112) (see [0035] and Fig. 4) of the first securing device in the longitudinal direction.
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 coupling portion of the first securing device of the assembly of Silich, Thomas and Kay in view of a further teaching of Thomas such that the coupling portion of the first securing device directly adjoins the at least one skin piercing element of the first securing device in the longitudinal direction.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
With regards to claim 14, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 10, however, Silich is silent with regards to wherein the at least one securing portion or a further securing portion of the first securing device protrudes over the coupling portion of the first securing device in a circumferential direction.
Nonetheless Thomas, which is within the analogous art of surgical fasteners (see abstract), further teaches (see Figs. 3 – 5) the at least one securing portion (130) (see [0035]) or a further securing portion of the first securing device (100) (see [0035]) protrudes over the coupling portion (see Fig. A above) of the first securing device in a circumferential direction (see Figs. 3 – 5).
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 of the first securing device of the assembly of Silich, Thomas, and Kay in view of a further teaching of Thomas such that the at least one securing portion or a further securing portion of the first securing device protrudes over the coupling portion of the first securing device in a circumferential direction.
One of ordinary skill in the art would have been motivated to make this modification because Silich teaches that the apertures 27 are provided to give medical personnel the option of a more conventional attachment mechanism for sutures or non-suture anchoring devices. See [0039] of Silich. A person having ordinary skill in the art would refer to the prior art of Thomas as an exemplary non-suture anchoring device which could be utilized within the apertures 27 of Silich. Thomas teaches that the surgical fastener 100 is beneficial because its structure has an atraumatic proximal end that protects the tissue and organs from damage. See [0006], [0007], and [0035] of Thomas.
Claim(s) 2 – 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silich, Thomas, and Kay as applied to Claim 1 above, and further in view of Okuda et al. (US 6,120,474 A) (hereinafter referred to as “Okuda”).
With regards to claim 2, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 1, however Silich is silent with regards to wherein the at least one securing device comprises a manual actuating element at which the at least one securing device is grippable manually and a rotational movement for securing the at least one securing device on the skin of the living being is exertable on the at least one securing device.
Nonetheless Okuda, which is within the analogous art of securing devices with manual actuating elements (see Fig. 1 and Col. 6, lines 46 – 67), the at least one securing device (8) comprises a manual actuating element (27) at which the at least one securing device is grippable manually (see Col. 6, lines 46 – 67).
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 Silich, Thomas, and Kay in view of a teaching of Okuda such that the at least one securing device comprises a manual actuating element at which the at least one securing device is grippable manually and a rotational movement for securing the at least one securing device on the skin of the living being is exertable on the at least one securing device. One of ordinary skill in the art would have been motivated to make this modification because Okuda teaches the grasping portion provides for an easier surface for a user to grip while rotating the at least one securing device. See Col. 6, lines 46 – 67 and Fig. 1 of Okuda. This structure would also allow a user to manipulate the securing device without needing an applicator.
The assembly of Silich, Thomas, and Kay modified in view of Okuda will hereinafter be referred to as the assembly of Silich, Thomas, Kay, and Okuda.
The assembly of Silich, Thomas, Kay, and Okuda teaches a rotational movement for securing the at least one securing device on the skin of the living being is exertable on the at least one securing device (see [0039] of Silich, [0034] of Thomas, and Col. 6, lines 46 – 67 of Okuda wherein the grasping portion of Okuda is modified onto the at least one securing portion of the at least one securing device of Thomas wherein this modified securing device is inserted within the retaining element of Silich).
With regards to claim 3, the assembly of Silich, Thomas, Kay, and Okuda teaches the claimed invention of claim 2, however Silich is silent with regards to wherein the at least one securing portion is arranged on the manual actuating element.
Nonetheless Okuda, which is within the analogous art of cannula anchoring systems (see Fig. 1 and Col. 6, lines 46 – 67), teaches (see Fig. 1) the at least one securing portion (9) is arranged on the manual actuating element (27) (see Col. 6, lines 46 – 67).
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 Silich, Thomas, Kay, and Okuda in view of a further teaching of Okuda 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 Okuda teaches the grasping portion provides for an easier surface for a user to grip while rotating the at least one securing device. See Col. 6, lines 46 – 67 and Fig. 1 of Okuda. This structure would also allow a user to manipulate the securing device without needing an applicator.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silich, Thomas, and Kay 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 Silich, Thomas, and Kay teaches the claimed invention of claim 1, and wherein the at least one securing device further comprises at least one stop by which a maximum angle of rotation of the at least one securing device about the axis of rotation is limited, wherein the at least one stop is configured to prevent the at least one securing device from being screwed too far into the skin.
Nonetheless 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 at least one 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 at least one securing device about the axis of rotation is limited, wherein the stop is configured to prevent the at least one 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 Silich, Thomas, and Kay in view of a teaching of Ingvarsson such that the at least one securing device further comprises at least one stop by which a maximum angle of rotation of the at least one 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 of the retaining element of Silich such that it includes the protrusions taught by Ingvarsson wherein the cap 130 of Silich 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 Silich, Thomas, and Kay as applied to claim 1 above, and further in view of Whiting et al. (US 2007/0083168 A1) (hereinafter referred to as “Whiting”).
With regards to claim 9, the assembly of Silich, Thomas and Kay teaches the claimed invention of claim 1, however, Silich is silent with regards to wherein a main piercing element of the spiral spring has a pitch of less than 3 mm/360º.
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 Silich, Thomas, and Kay 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) 15 – 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silich, Thomas, and Kay as applied to claim 10 above, and further in view of Yoon (US 5,540,648 A) (hereinafter referred to as Yoon ’648).
With regards to claim 15, the assembly of Silich, Thomas, and Kay teaches the claimed invention of claim 1, however Silich is silent with regards to wherein the coupling portion of the first securing device has, on an outer circumference, at least one connecting element via which the first securing device is fastenable to the first retaining element and which is mountable rotatably on the first retaining element.
Nonetheless Yoon ’648, which is within the analogous art of medical instrument stabilizer with anchoring systems and methods (see abstract and title), teaches (Figs. 7 – 10) wherein the coupling portion (132) of the first securing device 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”).
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 coupling portion of the first securing device of the assembly of Silich, Thomas and Kay in view of a teaching of Yoon ’648 such that the coupling portion of the first securing device has, on an outer circumference, at least one connecting element via which the first securing device is fastenable to the first retaining element and which is mountable rotatably on the first retaining element. One of ordinary skill in the art would have been motivated to make this modification because Yoon ’648 teaches the at least one connecting element on the coupling element provide cooperative engagement with the retaining element. See Col. 6, lines 35 – 60 of Yoon ’648.
The assembly of Silich, Thomas, and Kay modified in view of a teaching of Yoon ’648 will hereinafter be referred to as the assembly of Silich, Thomas, Kay, and Yoon ’648.
With regards to claim 16, the assembly of Silich, Thomas, Kay, and Yoon ’648 teaches the claimed invention of claim 15 however, Silich is silent with regards to wherein the first retaining element has a fastening element which is complementary to the at least one connecting element and which is bringable into engagement with the at least one connecting element of the first securing device 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.
Nonetheless Yoon ’648, which is within the analogous art of medical instrument stabilizer with anchoring systems and methods (see abstract and title), 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).
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 first retaining element of the assembly of Silich, Thomas, Kay, and Yoon ’648 in view of a further teaching of Yoon ’648 such that the first retaining element has a fastening element which is complementary to the at least one connecting element and which is bringable into engagement with the at least one connecting element of the first securing device 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. One of ordinary skill in the art would have been motivated to make this modification because Yoon ’648 teaches the at least one connecting element on the coupling element provide cooperative engagement with the fastening element of the retaining element. See Col. 6, lines 35 – 60 of Yoon ’648.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silich, Thomas, and Kay as applied to claim 1 above, and further in view of Eckerdal (US 2011/0034982 A1).
With regards to claim 17, the assembly of Silich, Thomas and Kay teaches the claimed invention of claim 1, however, Silich is silent with regards to wherein the at least one securing device further comprises at least one electrical insulating element which prevents an electrical current flow between the at least one 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 at least one 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 Silich, Thomas, and Kay in view of a teaching of Eckerdal such that the at least one 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 Silich, Thomas, and Kay modified in view of a teaching of Eckerdal will hereinafter be referred to as the assembly of Silich, Thomas, Kay and Eckerdal.
The assembly of Silich, Thomas, Kay, 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 of the at least one securing device of the assembly of Silich, Thomas, Kay and Eckerdal, prevents an electrical current flow between the at least one 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.
Conclusion
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 ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/18/2026
Prosecution Insights