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 communication filed 10/22/2025.
Status of the claims:
Claims 1, 2, 4 – 11, and 13 – 19 are pending in the application.
Claims 1, 4, 10, and 19 are amended.
Claim Objections
The objections to claims 1 and 19 in the previous action dated 04/23/2025 have been withdrawn in light of the Applicant’s amendments filed 10/22/2025. Specifically, the objection to claims 1 and 19 regarding the phrase “the linear core including a biodegradable polymer” in line 12, has been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s amendments.
Claims 9, 10, and 18 are objected to because of the following informalities:
Claims 9 and 18 recite “wherein the linear core includes at least one biodegradable polymer selected from” in line 2, although the lines do not rise to the level of being indefinite as the lines are understood by the Examiner, based on Applicant’s disclosure, to mean “wherein the biodegradable polymer of the linear core includes at least one biodegradable polymer selected from” as “the biodegradable polymer” (defined in claim 1 and 10, separately) includes “the at least one biodegradable polymer” selected from the claimed group, therefore the Examiner suggests the lines be amended to read “wherein the biodegradable polymer of the linear core includes at least one biodegradable polymer selected from” for the purpose of maintaining consistent language throughout the claims;
Claim 10 recites “tissues of human body” in lines 12, 16, and 18, however the lines are not grammatically correct as there is no article (a/an/the) before the noun, therefore, the Examiner suggests the lines be amended to read either “tissues of a human body” and “tissues of the human body”;
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.
The rejection of claims 4, 5, and 12 – 14 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 04/23/2025 have been withdrawn in light of the Applicant’s amendments filed 10/22/2025. Specifically, the rejection of claims 4, 12, and 13 regarding the phrases "a protrusion portion" and either “protrusions” or “a plurality of protrusions”, has been withdrawn as claim 1 no longer defines “a protrusion” or “protrusions” and the rejection of claims 5 and 14 has been withdrawn as the claims are no longer dependent on an indefinite claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The rejection of claim 12 under U.S.C 35 112(d) for failing to further limit the subject matter of the claim upon which it depends, recited in the previous action dated 04/23/2025 has been withdrawn in light of the Applicant’s amendments filed 10/22/2025. Specifically, the rejection of claim 12 for failing to limit the subject matter of claim 1, from which claim 12 depended form has been withdrawn as claim 12 is no longer dependent on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The 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.
The rejection of claims 1, 2, 4 – 7, 9 – 16, and 18 under U.S.C 35 103 with respect to Won in view of Odermatt, Hirsch, and Schaffer, recited in the previous action dated 04/23/2025 have been withdrawn in light of the Applicant’s amendments filed 10/22/2025. Specifically, the rejection of claim 1, with respect to the combination of Won, Odermatt, Hirsch, and Schaffer has been withdrawn because the combination does not anticipate or make obvious wherein the metal wire is spirally wound forming spaces between the intervals of the wire, wherein a drug is impregnated in the space as recited in the current claim set. However, a new rejection has been set forth below in view of Park, Odermatt, Hirsch, Schaffer, and Phan. Wherein Park and Phan are relied upon for teaching the newly added limitations.
Claims 1, 2, 4 – 7, 9 – 16, and 18 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Park (KR 20140049848 A) [1], and in view of Phan et al (US 2007/0067045 A1), Odermatt et al (US 2012/0136388 A1) (previously cited), Hirsch (US 3,557,795) (previously cited), and Schaffer et al (US 2017/0119936 A1) (previously cited).
Regarding claims 1, 4 – 5, and 19, Park discloses a thread embedding therapy rope (body-insertable member 100) (abstract, page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14) comprising:
[claims 1 and 19] a linear core (body-insertable member 100) (page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14); and
[claims 1 and 19] a wire (wire with protrusions 120 and toothed grooves 130) spirally wound at predetermined intervals on an outer circumferential surface of the linear core (body-insertable member 100) such that the predetermined intervals from a space (page 4 paragraph [0004] and Figs. 13, 14) (Examiner’s note: the intervals are determined prior to use);
[claims 4 and 19] the wire has a protrusion portion (protrusions 120) including a plurality of protrusions having a triangular cross-section (Figs. 13, 14) are arranged regularly and continuously on at least one surface thereof (Figs. 13, 14);
[claim 5] wherein the thread embedding therapy rope (body-insertable member 100) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; and the body-insertable member 100 is a cylindrical bar with projections on its outer edge as shown in Fig. 14).
However, Park is silent regarding [claims 1 and 19] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the wire is a metal wire including at least one biodegradable metal selected from magnesium or zinc only or a mixture thereof, and an alloy formed of magnesium or zinc as a main component, (iii) wherein the metal wire is configured to be absorbed and decomposed in tissues of a human body to release metal ions and hydrogen gas into the tissues to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased, and (iv) wherein the space(s) includes a drug impregnated therein and which is used as a drug carrier.
As to (i), Odermatt teaches, in the same field of endeavor, a thread embedding therapy rope (suture for anchoring in tissues) (abstract) comprising a linear core (polymeric core) including a biodegradable polymer (Examiner’s note: as stated in paragraph [0036] the polymeric core is made up of a polymer that is absorbable, and absorbable is another term for biodegradable).
Park teaches the body-insertable member 100 is inserted in vivo (abstract and page 5 paragraph [0007]), i.e., embedded in the tissue. Additionally, as stated in claim 8 the body-insertable member 100 is removable from the body; and having a biodegradable / absorbable polymer suture removes the need to extract the body-insertable member 100 manually, thereby reducing the amount of trauma to the tissue. Therefore, in order to reduce the amount of trauma to the tissue it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the body-insertable member 100 of Park to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii), Schaffer teaches a biodegradable wire comprising a linear core (filament 14) made up of a biodegradable material (paragraph [0065] and Figs. 1 – 4) and a biodegradable metal wire (shell 12) on an outer circumference of the linear core (paragraphs [0025] and [0067] and Figs. 1 – 3), wherein the biodegradable metal is a mixture of magnesium, zinc, and an alloy of magnesium and zinc (ZM21) (paragraph [0067]) which has a controlled decomposition rate by including intermetallic compounds having different potentials (Examiner’s note: as stated in paragraph [0027] the absorption (i.e., the decomposition rate) is controlled; and as stated in paragraph [0067] the shell is made up of ZM21 which is comprised of [97%wt] magnesium, 2%wt zinc, and 1%wt manganese which is an intermetallic compound).
Additionally, Hirsch teaches, in a similar field of endeavor, a thread embedding therapy rope (sutures for closing wounds) (column 1 lines 10 – 24) comprising a linear core (suture 126) (column 5 lines 18 – 20) and with a metal coating 128 (equated to wire with protrusions 120 and toothed grooves 130 of Park) wherein the metal coating is a biodegradable metal (magnesium) (column 1 line 42 – column 2 line 7) which works to increase the life of the suture, and promote healing of the tissue (column 1 line 42 – column 2 line 7).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wire with protrusions 120 and toothed grooves 130 of Park to be formed of the magnesium, zinc, and manganese alloy (ZM21), based on the teachings of Schaffer and Hirsch, for the purpose of making the body-insertable member 100 of Park fully biodegradable, increasing the life of the suture (i.e., the body-insertable member 100 of Park), and for promoting healing of the tissue (col. 1 line 42 – col. 2 line 7 – Hirsch).
It should be understood that the modification made by the Examiner above is such that the wire (wire with protrusions 120 and toothed grooves 130) of Park is made up of the ZM21 alloy of Schaffer. The Examiner is not substituting the wire of Park for the shell 12 of Schaffer. Moreover, it should be noted that a wire is defined as a metal drawn out into the form of a thin flexible thread; and the now modified wire of Park is a thin flexible thread made up of the ZM21 alloy (i.e., a metal), and therefore the modified wire with protrusions 120 and toothed grooves 130 is a biodegradable metal wire.
As to (iii), as discussed above the combination comprises the biodegradable metal wire (wire with protrusions 120 and toothed grooves 130 of Park modified to comprise ZM21), and when ZM21 is decomposed, ZM21 releases metal ions and H2 gas. The degradation of ZM21 first dissolves into Mg2+(s) and 2e-, the ions then react with the water in the environment (i.e., the tissue) to produce Mg(OH)2 and hydrogen gas. Thus, as the biodegradable metal wire degrades and is absorbed within the tissue of the body, the reaction will produce/release metal ions (i.e., Mg2+(s)) and hydrogen gas into the tissue; and because the reaction produces/releases the same products as claimed in the same claimed environment (i.e., the tissue), then it can be said that the products created by the degradation of the metal wire of the prior art would also function as claimed to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased.
As to (iv), Phan teaches an embedded therapy implant comprising a drug coating applied to the outer surface for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the implant of Park to incorporate a drug coating to the outer surface thereof, based on the teachings of Phan, for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026] – Phan). The Examiner notes that the prior art makes obvious applying the drug coating to all exposed surfaces of the implant of Park, so as to minimize the foreign body response thereto, which includes the spaces between the intervals of the wire around the core. Therefore, the prior art makes obvious the limitations above.
Regarding claim 2, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the biodegradable metal (Zm21 – Schaffer) is represented by Formula 1:
[Formula 1]
MgaZnbXc
wherein a, b, and c are weight percent of each component,
a + b + c = 100wt%
0≤ a ≤ 100, 0≤ b ≤ 100, and 0≤ c ≤ 30
a or b is greater than c,
X is a metal other than magnesium or zinc (manganese, Mn).
(Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg and satisfies the limitation requirements above where a = 97, b = 2, and c = 1).
Regarding claim 6, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein:
i) 90≤ a ≤ 100, 0≤ b ≤ 10, 0≤ c ≤ 10, or ii) 0≤ a ≤ 10, 90≤ b ≤ 100, and 0≤ c ≤ 10
where X includes Mn (Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg and satisfies the limitation requirements above where a = 97, b = 2, and c = 1).
Regarding claim 7, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the metal wire (wire with protrusions 120 and toothed grooves 130 of Park modified to be made up of ZM21) includes Mg having a purity of 95% or more (Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg).
Regarding claim 9, as discussed above, it would have been obvious to modify the body-insertable member 100 of Park in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core includes at least one biodegradable polymer selected from polydioxanone, polylactic acid, poly-L-lactic acid, polyglycolic acid, polycaprolactone, and a copolymer thereof (Examiner’s note: as stated in paragraph [0033] of Odermatt the polymer is made up of polylactic acid (polylactide)). Therefore, the combination of the prior art makes obvious the limitations above.
Regarding claims 10, 13, and 14, Park discloses a thread embedding therapy needle apparatus (needle 200) including a thread embedding therapy rope (body-insertable member 100) (abstract, page 4 paragraphs [0002 – 0005], page 5 paragraphs [0002 – 0007], and Figs. 13 and 14) comprising:
[claim 10] a linear core (body-insertable member 100) (page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14); and
[claim 10] a wire (wire with protrusions 120 and toothed grooves 130) spirally wound at predetermined intervals on an outer circumferential surface of the linear core (body-insertable member 100) such that the predetermined intervals from a space (page 4 paragraph [0004] and Figs. 13, 14) (Examiner’s note: the intervals are determined prior to use);
[claim 10] wherein the needle apparatus is configured to be inserted into the tissues of a human along with the thread embedding therapy rope (body-insertable member 100) (abstract, page 3 paragraph [0007], and claim 1) such that the needle is used as a drug carrier in the tissues of the human body (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the needle 200 of Park is capable of being used as a drug carrier in the tissues of the human body. Therefore, Park encompasses the limitation above);
[claim 13] the wire has a protrusion portion (protrusions 120) including a plurality of protrusions having a triangular cross-section (Figs. 13, 14) are arranged regularly and continuously on at least one surface thereof (Figs. 13, 14);
[claim 14] wherein the thread embedding therapy rope (body-insertable member 100) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; and the body-insertable member 100 is a cylindrical bar with projections on its outer edge as shown in Fig. 14).
However, Park is silent regarding [claim 10] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the wire is a metal wire including at least one biodegradable metal selected from magnesium or zinc only or a mixture thereof, and an alloy formed of magnesium or zinc as a main component, (iii) wherein the metal wire is configured to be absorbed and decomposed in tissues of a human body to release metal ions and hydrogen gas into the tissues to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased, and (iv) wherein the space(s) includes a drug impregnated therein and which is used as a drug carrier.
As to (i), Odermatt teaches, in the same field of endeavor, a thread embedding therapy rope (suture for anchoring in tissues) (abstract) comprising a linear core (polymeric core) including a biodegradable polymer (Examiner’s note: as stated in paragraph [0036] the polymeric core is made up of a polymer that is absorbable, and absorbable is another term for biodegradable).
Park teaches the body-insertable member 100 is inserted in vivo (abstract and page 5 paragraph [0007]), i.e., embedded in the tissue. Additionally, as stated in claim 8 the body-insertable member 100 is removable from the body; and having a biodegradable / absorbable polymer suture removes the need to extract the body-insertable member 100 manually, thereby reducing the amount of trauma to the tissue. Therefore, in order to reduce the amount of trauma to the tissue it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the body-insertable member 100 of Park to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii), Schaffer teaches a biodegradable wire comprising a linear core (filament 14) made up of a biodegradable material (paragraph [0065] and Figs. 1 – 4) and a biodegradable metal wire (shell 12) on an outer circumference of the linear core (paragraphs [0025] and [0067] and Figs. 1 – 3), wherein the biodegradable metal is a mixture of magnesium, zinc, and an alloy of magnesium and zinc (ZM21) (paragraph [0067]) which has a controlled decomposition rate by including intermetallic compounds having different potentials (Examiner’s note: as stated in paragraph [0027] the absorption (i.e., the decomposition rate) is controlled; and as stated in paragraph [0067] the shell is made up of ZM21 which is comprised of [97%wt] magnesium, 2%wt zinc, and 1%wt manganese which is an intermetallic compound).
Additionally, Hirsch teaches, in a similar field of endeavor, a thread embedding therapy rope (sutures for closing wounds) (column 1 lines 10 – 24) comprising a linear core (suture 126) (column 5 lines 18 – 20) and with a metal coating 128 (equated to wire with protrusions 120 and toothed grooves 130 of Park) wherein the metal coating is a biodegradable metal (magnesium) (column 1 line 42 – column 2 line 7) which works to increase the life of the suture, and promote healing of the tissue (column 1 line 42 – column 2 line 7).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wire with protrusions 120 and toothed grooves 130 of Park to be formed of the magnesium, zinc, and manganese alloy (ZM21), based on the teachings of Schaffer and Hirsch, for the purpose of making the body-insertable member 100 of Park fully biodegradable, increasing the life of the suture (i.e., the body-insertable member 100 of Park), and for promoting healing of the tissue (col. 1 line 42 – col. 2 line 7 – Hirsch).
It should be understood that the modification made by the Examiner above is such that the wire (wire with protrusions 120 and toothed grooves 130) of Park is made up of the ZM21 alloy of Schaffer. The Examiner is not substituting the wire of Park for the shell 12 of Schaffer. Moreover, it should be noted that a wire is defined as a metal drawn out into the form of a thin flexible thread; and the now modified wire of Park is a thin flexible thread made up of the ZM21 alloy (i.e., a metal), and therefore the modified wire with protrusions 120 and toothed grooves 130 is a biodegradable metal wire.
As to (iii), as discussed above the combination comprises the biodegradable metal wire (wire with protrusions 120 and toothed grooves 130 of Park modified to comprise ZM21), and when ZM21 is decomposed, ZM21 releases metal ions and H2 gas. The degradation of ZM21 first dissolves into Mg2+(s) and 2e-, the ions then react with the water in the environment (i.e., the tissue) to produce Mg(OH)2 and hydrogen gas. Thus, as the biodegradable metal wire degrades and is absorbed within the tissue of the body, the reaction will produce/release metal ions (i.e., Mg2+(s)) and hydrogen gas into the tissue; and because the reaction produces/releases the same products as claimed in the same claimed environment (i.e., the tissue), then it can be said that the products created by the degradation of the metal wire of the prior art would also function as claimed to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased.
As to (iv), Phan teaches an embedded therapy implant comprising a drug coating applied to the outer surface for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the implant of Park to incorporate a drug coating to the outer surface thereof, based on the teachings of Phan, for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026] – Phan). The Examiner notes that the prior art makes obvious applying the drug coating to all exposed surfaces of the implant of Park, so as to minimize the foreign body response thereto, which includes the spaces between the intervals of the wire around the core. Therefore, the prior art makes obvious the limitations above.
Regarding claim 11, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the biodegradable metal (ZM21 of Schaffer) is represented by Formula 1:
[Formula 1]
MgaZnbXc
wherein a, b, and c are weight percent of each component,
a + b + c = 100wt%
0≤ a ≤ 100, 0≤ b ≤ 100, and 0≤ c ≤ 30
a or b is greater than c,
X is a metal other than magnesium or zinc (manganese, Mn).
(Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg and satisfies the limitation requirements above where a = 97, b = 2, and c = 1).
Regarding claim 15, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein:
i) 90≤ a ≤ 100, 0≤ b ≤ 10, 0≤ c ≤ 10, or ii) 0≤ a ≤ 10, 90≤ b ≤ 100, and 0≤ c ≤ 10
wherein X is Mn (Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg and satisfies the limitation requirements above where a = 97, b = 2, and c = 1).
Regarding claim 16, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the metal wire (wire with protrusions 120 and toothed grooves 130 modified to be made up of ZM21) includes Mg having a purity of 95% or more (Examiner’s note: as stated in paragraph [0067] of Schaffer, the ZM21 alloy is comprised of 2%wt Zn, 1%wt Mn, and Mg; therefore, the modified device comprises 97%wt Mg).
Regarding claim 18, as discussed above, it would have been obvious to modify the body-insertable member 100 of Park in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core includes at least one biodegradable polymer selected from polydioxanone, polylactic acid, poly-L-lactic acid, polyglycolic acid, polycaprolactone, and a copolymer thereof (Examiner’s note: as stated in paragraph [0033] of Odermatt the polymer is made up of polylactic acid (polylactide)). Therefore, the combination of the prior art makes obvious the limitations above.
Claims 1, 2, 4 – 5, 8 – 14, and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Park (KR 20140049848 A) [1], and in view of Phan et al (US 2007/0067045 A1), Odermatt et al (US 2012/0136388 A1) (previously cited) and Schafer et al (US 8,663,308 B2) (previously cited).
Regarding claims 1, 4 – 5, and 19, Park discloses a thread embedding therapy rope (body-insertable member 100) (abstract, page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14) comprising:
[claims 1 and 19] a linear core (body-insertable member 100) (page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14); and
[claims 1 and 19] a wire (wire with protrusions 120 and toothed grooves 130) spirally wound at predetermined intervals on an outer circumferential surface of the linear core (body-insertable member 100) such that the predetermined intervals from a space (page 4 paragraph [0004] and Figs. 13, 14) (Examiner’s note: the intervals are determined prior to use);
[claims 4 and 19] the wire has a protrusion portion (protrusions 120) including a plurality of protrusions having a triangular cross-section (Figs. 13, 14) are arranged regularly and continuously on at least one surface thereof (Figs. 13, 14);
[claim 5] wherein the thread embedding therapy rope (body-insertable member 100) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; and the body-insertable member 100 is a cylindrical bar with projections on its outer edge as shown in Fig. 14).
However, Park is silent regarding [claims 1 and 19] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the wire is a metal wire including at least one biodegradable metal selected from magnesium or zinc only or a mixture thereof, and an alloy formed of magnesium or zinc as a main component, (iii) wherein the metal wire is configured to be absorbed and decomposed in tissues of a human body to release metal ions and hydrogen gas into the tissues to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased, and (iv) wherein the space(s) includes a drug impregnated therein and which is used as a drug carrier.
As to (i), Odermatt teaches, in the same field of endeavor, a thread embedding therapy rope (suture for anchoring in tissues) (abstract) comprising a linear core (polymeric core) including a biodegradable polymer (Examiner’s note: as stated in paragraph [0036] the polymeric core is made up of a polymer that is absorbable, and absorbable is another term for biodegradable).
Park teaches the body-insertable member 100 is inserted in vivo (abstract and page 5 paragraph [0007]), i.e., embedded in the tissue. Additionally, as stated in claim 8 the body-insertable member 100 is removable from the body; and having a biodegradable / absorbable polymer suture removes the need to extract the body-insertable member 100 manually, thereby reducing the amount of trauma to the tissue. Therefore, in order to reduce the amount of trauma to the tissue it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the body-insertable member 100 of Park to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii), Schafer teaches, in a similar field of endeavor, an implantable medical device with a linear core (support frame 20 which equates to the body-insertable member 100 of Park) with a biodegradable metal coating (ZnTi alloy) (column 14 lines 19 – 22). Schafer teaches the use of the metallic bioabsorbable material provides the advantages of promoting desirable biological processes within the body vessel, such as the remodeling of an extracellular matrix graft material attached thereto or reducing inflammation of a body vessel in contact with the graft material or support frame (column 6 lines 34 – 48); additionally, Schafer teaches the biodegradable metal (ZnTi alloy) has a controlled decomposition (col. 12 lines 37 – 40) by including an intermetallic compounds having different potentials (Examiner’s note: as stated in col. 12 lines 37 – 40 the rate of dissolution (i.e., the decomposition rate) of the bioabsorbable materials is dependent on the composition of the alloy, and since the composition of the alloy is controlled then the dissolution rate is also controlled; additionally, Zn and Ti are intermetallic compounds which have different dissolution rates).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wire with protrusions 120 and toothed grooves 130 of Park to be formed of the ZnTi, based on the teachings of Schafer, so that the wire with protrusions 120 and toothed grooves 130 of Park can biodegrade within the body which removes the need to manually remove the implant, and additionally, the biodegradable metal provides the advantages of promoting desirable biological processes within the body vessel, such as the remodeling of an extracellular matrix graft material attached thereto or reducing inflammation of a body vessel in contact with the graft material or support frame (column 6 lines 34 – 48 – Schafer).
It should be understood that the modification made by the Examiner above is such that the wire with protrusions 120 and toothed grooves 130 of Park is made up of the zinc-titanium alloy. The Examiner is not substituting the wire with protrusions 120 and toothed grooves 130 of Park for the zinc alloy coating of Schafer. Moreover, it should be noted that a wire is defined as metal drawn out into the form of a thin flexible thread; and the now modified the wire with protrusions 120 and toothed grooves 130 of Park is a thin flexible thread made up of metal, and therefore is a biodegradable metal wire.
As to (iii), as discussed above the combination comprises the biodegradable metal wire (the wire with protrusions 120 and toothed grooves 130 of Park modified to comprise ZnTi), and when ZnTi is decomposed, ZnTi releases metal ions and H2 gas. The degradation of ZnTi first dissolves into Zn2+(s) + Ti4+(s) + and e-, the ions then react with the water in the environment (i.e., the tissue) such that the water molecules split to form Zn(OH)2, Ti(OH)2, and hydrogen gas. Thus, as the biodegradable metal wire degrades and is absorbed within the tissue of the body, the reaction will produce/release metal ions (i.e., Zn2+(s) and Ti4+(s)) and hydrogen gas into the tissue; and because the reaction produces/releases the same products as claimed in the same claimed environment (i.e., the tissue), then it can be said that the products created by the degradation of the metal wire of the prior art would also function as claimed to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased.
As to (iv), Phan teaches an embedded therapy implant comprising a drug coating applied to the outer surface for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the implant of Park to incorporate a drug coating to the outer surface thereof, based on the teachings of Phan, for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026] – Phan). The Examiner notes that the prior art makes obvious applying the drug coating to all exposed surfaces of the implant of Park, so as to minimize the foreign body response thereto, which includes the spaces between the intervals of the wire around the core. Therefore, the prior art makes obvious the limitations above.
Regarding claim 2, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZnTi) of Schafer. Additionally, Schafer teaches wherein the biodegradable metal is represented by Formula 1:
[Formula 1]
MgaZnbXc
wherein a, b, and c are weight percent of each component,
a + b + c = 100wt%
0≤ a ≤ 100, 0≤ b ≤ 100, and 0≤ c ≤ 30
a or b is greater than c,
X is Ti (Examiner’s note: as stated in column 14 lines 19 – 22 of Schafer, the alloy is made up of 99%wt Zn and 1%wt Ti, thereby satisfying the limitation requirements above where a = 0, 0≤ b ≤ 100, and c =1).
Regarding claim 8, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZnTi) of Schafer. Additionally, Schafer teaches wherein the metal wire includes Zn having a purity of 95% or more (Examiner’s note: as stated in column 14 lines 19 – 22 of Schafer, the zinc alloy is 1%wt Ti and thus 99%wt Zn).
Regarding claim 9, as discussed above, it would have been obvious to modify the body-insertable member 100 of Park in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core includes at least one biodegradable polymer selected from polydioxanone, polylactic acid, poly-L-lactic acid, polyglycolic acid, polycaprolactone, and a copolymer thereof (Examiner’s note: as stated in paragraph [0033] of Odermatt the polymer is made up of polylactic acid (polylactide)). Therefore, the combination of the prior art makes obvious the limitations above.
Regarding claims 10, 13, and 14, Park discloses a thread embedding therapy needle apparatus (needle 200) including a thread embedding therapy rope (body-insertable member 100) (abstract, page 4 paragraphs [0002 – 0005], page 5 paragraphs [0002 – 0007], and Figs. 13 and 14) comprising:
[claim 10] a linear core (body-insertable member 100) (page 4 paragraphs [0003 – 0005], page 5 paragraph [0007], and Figs. 13 and 14); and
[claim 10] a wire (wire with protrusions 120 and toothed grooves 130) spirally wound at predetermined intervals on an outer circumferential surface of the linear core (body-insertable member 100) such that the predetermined intervals from a space (page 4 paragraph [0004] and Figs. 13, 14) (Examiner’s note: the intervals are determined prior to use);
[claim 10] wherein the needle apparatus is configured to be inserted into the tissues of a human along with the thread embedding therapy rope (body-insertable member 100) (abstract, page 3 paragraph [0007], and claim 1) such that the needle is used as a drug carrier in the tissues of the human body (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the needle 200 of Park is capable of being used as a drug carrier in the tissues of the human body. Therefore, Park encompasses the limitation above);
[claim 13] the wire has a protrusion portion (protrusions 120) including a plurality of protrusions having a triangular cross-section (Figs. 13, 14) are arranged regularly and continuously on at least one surface thereof (Figs. 13, 14);
[claim 14] wherein the thread embedding therapy rope (body-insertable member 100) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; and the body-insertable member 100 is a cylindrical bar with projections on its outer edge as shown in Fig. 14).
However, Park is silent regarding [claim 10] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the wire is a metal wire including at least one biodegradable metal selected from magnesium or zinc only or a mixture thereof, and an alloy formed of magnesium or zinc as a main component, (iii) wherein the metal wire is configured to be absorbed and decomposed in tissues of a human body to release metal ions and hydrogen gas into the tissues to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased, and (iv) wherein the space(s) includes a drug impregnated therein and which is used as a drug carrier.
As to (i), Odermatt teaches, in the same field of endeavor, a thread embedding therapy rope (suture for anchoring in tissues) (abstract) comprising a linear core (polymeric core) including a biodegradable polymer (Examiner’s note: as stated in paragraph [0036] the polymeric core is made up of a polymer that is absorbable, and absorbable is another term for biodegradable).
Park teaches the body-insertable member 100 is inserted in vivo (abstract and page 5 paragraph [0007]), i.e., embedded in the tissue. Additionally, as stated in claim 8 the body-insertable member 100 is removable from the body; and having a biodegradable / absorbable polymer suture removes the need to extract the body-insertable member 100 manually, thereby reducing the amount of trauma to the tissue. Therefore, in order to reduce the amount of trauma to the tissue it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the body-insertable member 100 of Park to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii), Schafer teaches, in a similar field of endeavor, an implantable medical device with a linear core (support frame 20 which equates to the body-insertable member of Park) with a biodegradable metal coating (ZnTi alloy) (column 14 lines 19 – 22). Schafer teaches the use of the metallic bioabsorbable material provides the advantages of promoting desirable biological processes within the body vessel, such as the remodeling of an extracellular matrix graft material attached thereto or reducing inflammation of a body vessel in contact with the graft material or support frame (column 6 lines 34 – 48); additionally, Schafer teaches the biodegradable metal (ZnTi alloy) has a controlled decomposition (col. 12 lines 37 – 40) by including an intermetallic compounds having different potentials (Examiner’s note: as stated in col. 12 lines 37 – 40 the rate of dissolution (i.e., the decomposition rate) of the bioabsorbable materials is dependent on the composition of the alloy, and since the composition of the alloy is controlled then the dissolution rate is also controlled; additionally, Zn and Ti are intermetallic compounds which have different dissolution rates).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the wire with protrusions 120 and toothed grooves 130 of Park to be formed of the ZnTi, based on the teachings of Schafer, so that the wire with protrusions 120 and toothed grooves 130 of Park can biodegrade within the body which removes the need to manually remove the implant, and additionally, the biodegradable metal provides the advantages of promoting desirable biological processes within the body vessel, such as the remodeling of an extracellular matrix graft material attached thereto or reducing inflammation of a body vessel in contact with the graft material or support frame (column 6 lines 34 – 48 – Schafer).
It should be understood that the modification made by the Examiner above is such that the wire with protrusions 120 and toothed grooves 130 of Park is made up of the zinc-titanium alloy. The Examiner is not substituting the wire with protrusions 120 and toothed grooves 130 of Park for the zinc alloy coating of Schafer. Moreover, it should be noted that a wire is defined as metal drawn out into the form of a thin flexible thread; and the now modified the wire with protrusions 120 and toothed grooves 130 of Park is a thin flexible thread made up of metal, and therefore is a biodegradable metal wire.
As to (iii), as discussed above the combination comprises the biodegradable metal wire (the wire with protrusions 120 and toothed grooves 130 of Park modified to comprise ZnTi), and when ZnTi is decomposed, ZnTi releases metal ions and H2 gas. The degradation of ZnTi first dissolves into Zn2+(s) + Ti4+(s) + and e-, the ions then react with the water in the environment (i.e., the tissue) such that the water molecules split to form Zn(OH)2, Ti(OH)2, and hydrogen gas. Thus, as the biodegradable metal wire degrades and is absorbed within the tissue of the body, the reaction will produce/release metal ions (i.e., Zn2+(s) and Ti4+(s)) and hydrogen gas into the tissue; and because the reaction produces/releases the same products as claimed in the same claimed environment (i.e., the tissue), then it can be said that the products created by the degradation of the metal wire of the prior art would also function as claimed to implement a swelling effect in the tissues when applied for thread embedding therapy such that a contact area between the biodegradable polymeric linear core and the tissues is reduced and thus a remaining life of the thread embedding therapy rope in the tissues is increased.
As to (iv), Phan teaches an embedded therapy implant comprising a drug coating applied to the outer surface for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the implant of Park to incorporate a drug coating to the outer surface thereof, based on the teachings of Phan, for the purpose of minimizing the foreign body response by the body to the implant (paragraph [0026] – Phan). The Examiner notes that the prior art makes obvious applying the drug coating to all exposed surfaces of the implant of Park, so as to minimize the foreign body response thereto, which includes the spaces between the intervals of the wire around the core. Therefore, the prior art makes obvious the limitations above.
Regarding claim 11, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZnTi) of Schafer. Additionally, Schafer teaches wherein the biodegradable metal is represented by Formula 1:
[Formula 1]
MgaZnbXc
wherein a, b, and c are weight percent of each component,
a + b + c = 100wt%
0≤ a ≤ 100, 0≤ b ≤ 100, and 0≤ c ≤ 30
a or b is greater than c,
X is Ti (Examiner’s note: as stated in column 14 lines 19 – 22 of Schafer, the alloy is made up of 99%wt Zn and 1%wt Ti, thereby satisfying the limitation requirements above where a = 0, 0≤ b ≤ 100, and c =1).
Regarding claim 17, as discussed above, it would have been obvious to modify the wire with protrusions 120 and toothed grooves 130 of Park in view of Odermatt to comprise the biodegradable metal (ZnTi) of Schafer. Additionally, Schafer teaches wherein the metal wire includes Zn having a purity of 95% or more (Examiner’s note: as stated in column 14 lines 19 – 22 of Schafer, the alloy is made up of 99%wt Zn and 1%wt Ti).
Regarding claim 18, as discussed above, it would have been obvious to modify the body-insertable member 100 of Park in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core includes at least one biodegradable polymer selected from polydioxanone, polylactic acid, poly-L-lactic acid, polyglycolic acid, polycaprolactone, and a copolymer thereof (Examiner’s note: as stated in paragraph [0033] of Odermatt the polymer is made up of polylactic acid (polylactide)). Therefore, the combination of the prior art makes obvious the limitations above.
Examiner’s note
[1] a translated PDF version of Park has been attached, and the translated PDF is what is cited by the Examiner via page number and paragraph number.
Response to Arguments
Applicant’s arguments, filed 10/22/2025, with respect to the rejection of claims 1, 2, and 4 – 19 under Won, Odermatt, Hirsch, and Shaffer or Schafer have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because the combination of Won, Odermatt, Hirsch, and Shaffer or Schafer does not teach wherein wire has spaces between the revolutions of the wire around the linear core.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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