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 .
Examiner’s note
The current claim set filed 04/08/2025 recites claim 10 as being “amended” , wherein claim 10 recites “A thread embedding therapy needle apparatus including [[a]] the thread embedding therapy rope of claim 1”. However, the claim set filed on 09/16/2024 recites claim 10 as being amended to read “A thread embedding therapy needle apparatus including [[a]] the thread embedding therapy rope of claim 1”. Therefore, because the amendment to claim 10 was made previously in the claim set filed on 09/16/2024, the current claim 10, filed on 04/08/2025, should reflect the amended language without any mark up, and claim 10 should be marked as “Previously Presented” as the language of claim 10 was not newly amended in current claim set. For the purpose of expediting prosecution the Examiner has chosen to examine the claims as is and acknowledges that the limitations of current claim 10 are not different from the limitations of claim 10 filed on 09/16/2024.
Response to Amendment
This Office action is in response to the applicant’s communication filed 04/08/2025.
Status of the claims:
Claims 1, 2, and 4 – 19 are pending in the application.
Claim 1 is amended.
Claim 19 is new.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities:
Claims 1 and 19 recite “the linear core including a biodegradable polymer” in line 12, although the line is understood by the Examiner to mean “the linear core including the biodegradable polymer” as the “biodegradable polymer” of the linear core was previously defined, the Examiner suggests the line be amended to read “the linear core including the biodegradable polymer” for the purpose of maintaining consistent language throughout the claims;
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 1 – 18 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 10/09/2024 have been withdrawn in light of the Applicant’s amendments filed 04/08/2025. Specifically, the rejection of claim 1, regarding the phrase “the thread embedding therapy rope has a low bending stiffness compared with embedding therapy rope having a same metal material and a cross-sectional area as the metal wire”, has been withdrawn as the claim no longer recites the phrase and the rejection of claims 2 – 4, 6 – 13, and 15 – 18 for being dependent on an indefinite claim has been withdrawn as the claims are no longer dependent on an indefinite claim. However, based on Applicant’s amendments a new grounds of rejection under 112(b) for claims 4, 12, and 13 has been set forth below and the rejection of claims 5 and 14 for being dependent on an indefinite claim has been maintained.
Claims 4, 5, and 12 – 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4, 12, and 13, the phrases "a protrusion portion" and either “protrusions” or “a plurality of protrusions” renders the claim indefinite because it is unclear if Applicant is intending for the “protrusion portion” and the “protrusions” of claims 4, 12, and 13 to be the same “protrusion portion” and “plurality of protrusions” defined in claim 1 or if Applicant is intending for the “protrusion portion” and the “protrusions” of claims 4, 12, and 13 to be separate and different “protrusion portion” and “protrusions” from the “protrusion portion” and the “plurality of protrusions” defined in claim 1 such that there are two protrusion portions each with a plurality of protrusions. For the purpose of examination, the Examiner will read the claim to mean the former, such that the claims only require one “protrusion portion” and one set of protrusions. Examiner’s note: because the Examiner is reading claim 12 to mean the former, claim 12 has been further rejected under 112(d) for failing to further limit the subject matter as claim 12 recites limitations already required by claim 1. Additionally, if Applicant is intending for claims 4, 12, and 13 to recite the latter the Examiner suggests Applicant amend claim 1 to recite “a first protrusion portion” and “a first plurality of protrusions” and for claims 4, 12, and 13 to be amended to read “a second protrusion portion” and “a second plurality of protrusions”.
Claims 5 and 14 are rejected under 112(b) for being dependent upon 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.
Claim 12 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites “the metal wire having a protrusion portion including a plurality of protrusions irregularly or regularly arranged on at least one surface thereof”, however, Claim 1, from which Claim 12 depends, already requires the limitation above. Therefore, Claim 12 does not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 4 – 7, 9 – 16, and 18 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Won (WO 2011/034286 A2) (previously cited), and in view of 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). (Examiner’s note: a translated PDF version of Won has been attached, and the translated PDF is what is cited by the Examiner via page number and paragraph number).
Regarding claims 1, 4 – 5, and 19, Won discloses a thread embedding therapy rope (surgical suture thread for binding together tissue) (abstract / page 2) comprising:
[claims 1 and 19] a linear core (core wire 100) (page 4 paragraph [0001] and Figs. 1 – 2); and
[claims 1 and 19] an outer line 200 spirally wound on an outer circumferential surface of the linear core (core wire 100) (page 4 paragraph [0004] and Fig. 1);
[claims 1, 4, and 19] the metal wire has a protrusion portion (see annotated Fig. 1) including a plurality of protrusions having a triangular cross-section are arranged regularly and continuously on at least one surface thereof (Examiner’s note: as shown in Fig. 4C and discussed in page 4 paragraph [0007] the protrusions have a triangular cross-section and as shown in annotated Fig. 1 the protrusions are arranged regularly and continuously on the top surface of the outer line 200 (i.e., the wire));
[claim 5] wherein the thread embedding therapy rope (surgical suture) 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 surgical suture of Won is a cylindrical bar with projections on its outer edge as shown in annotated Fig. 1).
However, Won is silent regarding [claims 1 and 19] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the outer line is a metal wire and the metal wire includes 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) the biodegradable metal is controlled in a decomposition rate thereof by including intermetallic compounds having different potentials, and (iv) wherein the metal wire wound on the outer circumferential surface of the linear core including a biodegradable polymer 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.
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).
Won teaches the surgical suture is used to bind tissue together and is therefore embedded in the tissue, in order for the tissue to heal fully the suture would need to be removed, and having a biodegradable / absorbable polymer suture removes the need the need to extract the suture 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 core line of Won to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii) and (iii), 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 outer line 200 of Won) 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 outer line of Won to be formed of the magnesium, zinc, and manganese alloy (ZM21), based on the teachings of Schaffer, for the purpose of making the outer line of Won biodegradable, increasing the life of the suture (i.e., the linear core of Won), and promote 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 outer line of Won is made up of the ZM21 alloy of Schaffer. The Examiner is not substituting the outer line of Won 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 outer line of Won is a thin flexible thread made up of the ZM21 alloy (i.e., a metal), and therefore the modified outer line is a biodegradable metal wire.
As to (iv), as discussed above the combination comprises the biodegradable metal wire (outer line of Won 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
Annotated Figure 1 of Won
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Regarding claim 2, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 outer line 200 of Won 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 outer line 200 of Won in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the metal wire (outer line 200 of Won 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 core wire 100 of Won in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core (core wire 100 of Won modified in view of Odermatt) 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)).
Regarding claim 10, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt and Schaffer. Additionally, Won further teaches a thread embedding therapy needle (needle 400 - Won) apparatus including a thread embedding therapy rope of claim 1 (page 6 paragraph [0010] – Won).
Regarding claim 11, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 12, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt, Schaffer, and Hirsch. Won further teaches wherein the metal wire (outer line 200 of Won modified to be made up of ZM21) has the protrusion portion (see annotated Fig. 1 – Won) including the plurality of protrusions (see annotated Fig. 1 – Won) irregularly or regularly arranged on at least one surface thereof (Examiner’s note: as shown in the annotated Fig. 1, the protrusions are arranged regularly on the top surface of the outer line 200).
Annotated Figure 1 of Won
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Regarding claim 13, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt, Schaffer, and Hirsch. Won further teaches wherein the protrusion portion (see annotated Fig. 1 – Won) of the metal wire (outer line 200 of Won modified to be made up of ZM21) have a triangular section arranged continuously on one surface thereof (Examiner’s note: as shown in Fig. 4C and discussed in page 4 paragraph [0007] the protrusions have a triangular cross-section and as shown in annotated Fig. 1 the protrusions are arranged continuously on the top surface).
Regarding claim 14, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt, Schaffer, and Hirsch. Won further teaches wherein the thread embedding therapy rope (surgical suture of Won) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; with that said, the surgical suture of Won is a cylindrical bar with projections on its outer edge as shown in annotated Fig. 1 of Won).
Regarding claim 15, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 outer line 200 of Won in view of Odermatt to comprise the biodegradable metal (ZM21) of Schaffer. Additionally, Schaffer teaches wherein the metal wire (outer line 200 of Won 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 core wire 100 of Won in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core (core wire 100 of Won modified in view of Odermatt) 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)).
Claims 1, 2, 4 – 5, 8 – 14, and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Won (WO 2011/034286 A2) (previously cited), and in view of Odermatt et al (US 2012/0136388 A1) (previously cited) and Schafer et al (US 8,663,308 B2) (previously cited). (Examiner’s note: a translated PDF version of Won has been attached, and the translated PDF is what is cited by the Examiner via page number and paragraph number).
Regarding claims 1, 4 – 5, and 19, Won discloses a thread embedding therapy rope (surgical suture thread for binding together tissue) (abstract / page 2) comprising:
[claims 1 and 19] a linear core (core wire 100) (page 4 paragraph [0001] and Figs. 1 – 2); and
[claims 1 and 19] an outer line 200 spirally wound on an outer circumferential surface of the linear core (core wire 100) (page 4 paragraph [0004] and Fig. 1);
[claims 1, 4, and 19]the metal wire has a protrusion portion (see annotated Fig. 1) including a plurality of protrusions having a triangular cross-section are arranged regularly and continuously on at least one surface thereof (Examiner’s note: as shown in Fig. 4C and discussed in page 4 paragraph [0007] the protrusions have a triangular cross-section and as shown in annotated Fig. 1 the protrusions are arranged regularly and continuously on the top surface of the outer line 200 (i.e., the wire));
[claim 5] wherein the thread embedding therapy rope (surgical suture) 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 surgical suture of Won is a cylindrical bar with projections on its outer edge as shown in annotated Fig. 1).
However, Won is silent regarding [claims 1 and 19] (i) wherein the linear core includes a biodegradable polymer, (ii) wherein the outer line is a metal wire and the metal wire includes 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) the biodegradable metal is controlled in a decomposition rate thereof by including intermetallic compounds having different potentials, and (iv) wherein the metal wire wound on the outer circumferential surface of the linear core including a biodegradable polymer 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.
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).
Won teaches the surgical suture is used to bind tissue together and is therefore embedded in the tissue, in order for the tissue to heal fully the suture would need to be removed; and having a biodegradable / absorbable polymer suture removes the need the need to extract the suture 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 core line of Won to be made up of an absorbable polymer, as taught by Odermatt.
As to (ii) and (iii), Schafer teaches, in a similar field of endeavor, an implantable medical device with a linear core (support frame 20 which equates to the core wire 100 of Won) 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 outer wire of Won to be formed of the ZnTi, based on the teachings of Schafer, so that the outer line of Won 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 outer line of Won is made up of the zinc-titanium alloy. The Examiner is not substituting the outer line of Won 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 outer line of Won is a thin flexible thread made up of metal, and therefore the modified outer line is a biodegradable metal wire..
As to (iv), as discussed above the combination comprises the biodegradable metal wire (outer line of Won 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
Annotated Figure 1 of Won
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Regarding claim 2, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 outer line 200 of Won 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 core wire 100 of Won in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core (core wire 100 of Won modified in view of Odermatt) 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)).
Regarding claim 10, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt and Schafer. Additionally, Won discloses a thread embedding therapy needle (needle 400 - Won) (page 6 paragraph [0010] – Won) apparatus including a thread embedding therapy rope of claim 1.
Regarding claim 11, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 12, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt and Schafer. Additionally, Won discloses wherein the metal wire (outer line 200 of Won modified to be made up of the zinc alloy) has the protrusion portion (see annotated Fig. 1 – Won) including the plurality of protrusions (see annotated Fig. 1 – Won) irregularly or regularly arranged on at least one surface thereof (Examiner’s note: as shown in the annotated Fig. 1, the protrusions are arranged regularly on the top surface of the outer line 200).
Annotated Figure 1 of Won
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Greyscale
Regarding claim 13, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt and Schafer. Additionally, Won discloses wherein the protrusion portion (see annotated Fig. 1 – Won) of the metal wire (outer line 200 of Won modified to be made up of ZnTi) have a triangular section arranged continuously on one surface thereof (Examiner’s note: as shown in Fig. 4C and discussed in page 4 paragraph [0007] the protrusions have a triangular cross-section and as shown in annotated Fig. 1 the protrusions are arranged continuously on the top surface).
Regarding claim 14, as discussed above, it would have been obvious to modify the device of Won in view of Odermatt and Schafer. Additionally, Won discloses wherein the thread embedding therapy rope (surgical suture of Won) has a shape of a cog embedding thread (Examiner’s note: a cog is defined as a bar with projections on its edge; with that said, the surgical suture of Won is a cylindrical bar with projections on its outer edge as shown in annotated Fig. 1 of Won).
Regarding claim 17, as discussed above, it would have been obvious to modify the outer line 200 of Won 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 core wire 100 of Won in view of Schaffer to comprise the biodegradable polymer of Odermatt. Additionally, Odermatt teaches wherein the linear core (core wire 100 of Won modified in view of Odermatt) 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)).
Response to Arguments
Applicant's arguments filed on 04/08/2025, with respect to the rejection of claims 1, 2, and 4 – 19 under Won, Odermatt, Hirsch, and Shaffer or Schafer, have been fully considered but they are not persuasive. More specifically:
Regarding the arguments with respect to the newly added claim limitations and the Examiner has provided a detailed response in the rejection above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues “But Won fails to teach or disclose "a metal wire including a biodegradable metal or alloy is spirally wound on an outer circumferential surface of the linear core including a biodegradable polymer," as recited in amended claim 1”, “Schaffer fails to teach "a metal wire including a biodegradable metal or alloy is spirally wound on an outer circumferential surface of the linear core including a biodegradable polymer" as recited in amended claim 1”, and “Odermatt et al. and Hirsch also fail to disclose or teach the claimed structural and functional features as discussed in the foregoing. In view thereof, it is submitted that Won in view of Odermatt et al., and Schaffer et al fails to disclose or teach the claimed structural and functional features as discussed in the foregoing.”, firstly, as discussed in the rejections of claim 1 above, the Examiner acknowledges that Won does not disclose every limitation of claim 1 including wherein the outer wire is a biodegradable metal wire and wherein the linear core is biodegradable, therefore the Examiner is not relying on Won to teach those limitations and the argument is not persuasive. Furthermore, the Examiner is only relying on Schaffer, Odermatt, and Schafer to teach it would be obvious to form the components of the device of Won out of materials known to make up similar medical devices for the reasons stated in the rejection above (i.e., to promote better healing and reduce inflammation of the tissue) and not on other structures within the above references. The Examiner is not relying on any one reference to teach all of the components of the claim and, therefore, the arguments are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would be obvious to form the components of the device of Won out of materials known to make up similar medical devices for the reasons stated in the rejection above (i.e., to promote better healing and reduce inflammation of the tissue).
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew P. Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew P. Restaino/Examiner, Art Unit 3771