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 .
DETAILED ACTION
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed Nov. 5, 2025 has been received and entered into the present application.
Status of claims
The amendment filed on Nov. 5, 2025 is acknowledged. Claims 2, 4-12, 15-23, 26-35, 37-50, 52-53, and 57 have been canceled and new claim 59 is added. Claims 1, 3, 13-14, 24-25, 36, 51, 54-56, and 58-59 are under examination in the instant office action.
Applicants' arguments, filed on Nov. 5, 2025, have been fully considered but they are not found to be persuasive or moot in view of new grounds of rejections. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical errors.
In claim 1, in the recitation of “any the dermal filler” in line 12, “of” should be inserted between “any” and “the dermal filler”.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention
New matter Rejection
Claim 58 is rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 58 recite “the thread is formulated in the shape of a hollow thread, at least partly filled with the dermal filler.” Since claim 58 depends from claim 1, the thread of claim 58 requires having exterior pores and/or grooves as well as the shape of a hollow thread. However, such embodiment is not supported by the original disclosure because the specification discloses each of a grooved thread, a porous thread, and a hollow thread only as an alternative embodiment, not combination thereof (see [0019] and Figure 3). Therefore, it is considered as new matter.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 (a) to § 608.04(c).
Due to lack of sufficient disclosure for the claimed specific embodiment, the specification does not allow persons of ordinary skill in the art to recognize that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of claimed embodiment. Thus, claim 58 does not meet the written description requirement.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, 3, 13-14, 24-25, 36, 51, 54-56, and 58-59 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 pre-AIA the applicant regards as the invention.
Independent claim 1 recites “at least one of the selected is rigid or simi-solid”. However, it is unclear which dermal fillers out of those listed in claim 1 is considered rigid or simi-solid. The specification generally discloses that fillers can be liquids, solids, or semi-solids (like gels) (published application at [0015], [0075], [0109]). While the specification discloses that hyaluronic acid may be solid, semi-solid or liquid [0073], many of the other dermal filler materials recited in claim 1 are not specifically identified to be rigid or semi-solid. Is it intended to mean that the listed dermal filler itself is rigid or semi-solid, or requires unrecited components which might affect/contribute to the rigidity or solidity of the filler, that is, the dermal filler is used in form of rigid or semi-solid? Accordingly, one of ordinary skill in the art would not ascertain the scope of dermal filler which is rigid or semi-solid. Classification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 13-14, 24, 36, 56, and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (J. Mater. Chem., 2010, 20, 8894–8903; hereafter, Lee).
Lee teaches a Orthocord surgical suture coated with hydroxyapatite mineral layer (CaP coating) wherein the Orthocord suture is a braided suture blended with polydioxanone and polyethylene (abstract, p8895, col 1, para 3 and col 2, para 1-2). Fig. 1 in Lee shows that the Orthocord suture is in the shape of a thread with exterior grooves and sutures were uniformly covered with CaP coatings (substantially evenly and homogenously distributed along at least section of the thread) (see Fig. 1 and p8896, col 2, para 3). The hydroxyapatite is claimed rigid dermal filler and “chemically different” from the thread material (polydioxanone and polyethylene) with the thread being “free of any of the dermal filler materials”.
Lee further discloses CaP coatings on Orthocord sutures were robust enough to remain intact after multiple passages through sheep tendon and meniscus tissues (p8900, col 2, para 1 and Fig 6). This implicitly disclose that the thread necessarily has an ultimate tensile strength sufficient to pull through a human skin or sub-cutis and the integrity of the thread is no substantially compromised as claimed when this terminology is given its broadest reasonable interpretation.
With respect to the recitation in claim 1 that “the dermal filler is configured to gradually dissociate from the flexible solid matrix” of the thread, since Lee teaches the exact same materials for the dermal filler, as well as the same thread materials, it is presumed that Lee’s filler would also necessarily be so configured. Also, Lee discloses release of calcium from the thread (Fig. 3-5). Furthermore, Lee indicates that hydroxyapatite coated on the thread, i.e., they are not covalently or permanently attached. As the coating on the thread is open, not enclosed, it is presumed that it would gradually dissociate from the thread and migrate into the surrounding tissue. See MPEP 2112.01(II):
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.).
As claims 13-14, the hydroxylapatite of the prior art is the same rigid dermal filler as recited in the instant claim. Thus, it inherently has the same characteristics of the rigid dermal filler as recited in claims 13-14 because products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable as stated above.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
As to claim 36, the claimed kit does not have additional features different from the claimed surgical suture. The definition for kit is: a set of articles or equipment needed for a specific purpose. In this case, the set of articles is the surgical suture, thus the teaching of the surgical thread by the prior art reads on a kit as recited in claim 36.
As to claim 56, the external grooves are at least partly filled with hydroxyapatite (see Fig 3)
As to claim 59, the Orthocord thread has a full core.
As such, the instant claims are anticipated by Lee.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 3, 13-14, 24-25, 36, 51, 54-56, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over by Lee et al. (J. Mater. Chem., 2010, 20, 8894–8903; hereafter, Lee) in view of WO2014/041531 (prior art of record).
The teachings of Lee as applied supra are herein applied for the same teachings in their entirety.
Lee does not specifically disclose the average diameter of the hydroxyapatite particles recited in claim 25 and 51. Also, Lee does not teach an agent which promotes the dissociation of the dermal filler recited in claims 54-55.
WO2014/041531 teaches biocompatible ceramic skin augmentation materials, such as hydroxyapatite, were known to be efficient skin augmentation bioactive materials (dermal filler) due to the following properties: hydroxyapatite is a naturally occurring mineral form of calcium phosphate, hydroxyapatite comprises the mineral constituent of bone, therefore rendering it biocompatible and non-immunogenic when introduced into the body of a subject; hydroxyapatite is biodegradable following the same metabolic pathways as bone debris resulting from common bone fractures, yet is semi-permanent, as it lasts up to 3 years when implanted into a subject; moreover, when injected as small microspheres, hydroxyapatite acts as a scaffold that promotes new tissue formation similar to its surrounding environment; and inside skins such as the dermis, deposited particles of hydroxyapatite support fibroblastic ingrowth and new collagen formation as evidenced by (p2, lines 17-28). WO2014/041531 further discloses the use of a skin augmentation composition comprising the biocompatible ceramic materials such as hydroxyapatite which is administered to a skin and/or subcutis of a subject with an applicator for filling the undesired lines, wrinkles, depressed scars and folds of a subject's skin and restoring youthful fullness to the skin (abstract and claim 1). WO2014/041531 also teaches that the biocompatible ceramic material such as hydroxyapatite is in the form of particles having a size of about 10-100 µm (p6, lines 23-30). In addition, it discloses that according to some embodiments, the biocompatible ceramic material comprises beads and/or particles having a size of up to 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 µm or 25-45 µm (p19, line 9-23). WO2014/041531 further discloses that said augmentation composition further comprises at least one type of skin augmentation material selected from the group consisting of: a biodegradable natural substance such as bovine collagen, porcine collagen, recombinant collagen, a biodegradable synthetic polymer, a non-biodegradable synthetic polymer, a non-biodegradable natural substance and combinations thereof (claim 8 and p7, lines 9-19). In addition, WO2014/041531 discloses that there are dozens of known dermal filling agents for which include autologous implantable materials, allogeneic products, xenogeneic products and synthetically derived products and available dermal fillers comprise biodegradable natural substances (such as collagen, gelatine, hyaluronic acid, dextran and dried acellular particulate dermal matrix), biodegradable synthetic polymers (such as poly-L-lactic acid, polyethylene oxide and carboxymethylcellulose), non-biodegradable synthetic polymers (such as polymethyl methacrylate, polyacrylamide, polyalkylimide and silicones) and combinations thereof (p2, lines 10-16).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the surgical thread of Lee for delivering a biocompatible ceramic material such as hydroxyapatite particles having the average particle diameter of 10 to 100 micron or 25 to 45 microns taught by WO2014/041531 in skin augmentation because of the following reasons. Lee already teaches the surgical thread is suitable for drug delivery and discloses the thread coated with hydroxyapatite. WO2014/041531 teaches that the hydroxyapatite particles as rigid material are biocompatible active material for promoting new tissue formation similar to its surrounding environment and supporting fibroblastic ingrowth and new collagen formation when deposited to skins such as the dermis in skin augmentation procedure. Thus, one of ordinary skill in the art would have been motivated to use the hydroxyapatite-coated suture in combination with other dermal fillers such as collagen and hyaluronic acid on the reasonable expectation that the thread coated with hydroxyapatite particles would provide a suture suitable for skin augmentation procedures with additional benefits (e.g., promoting new tissue formation and supporting fibroblastic ingrowth and new collagen formation in skin augmentation and making the thread sufficiently hard such that the thread is used to penetrate the skin).
As to claims 54-55, WO2014/041531 teaches that addition of a salt to the composition may result in water diffusion into the composition, thus assisting in uniform dispersion of the biocompatible ceramic material within the composition and/or within the treated area (p22, lines p22, lines 24-30). The salt is an osmotic agent that promotes the dissociation of the dermal filler from the thread as recited in claims 54-55. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further add an osmotic agent such as salts for promoting diffusion of the biocompatible ceramic material such as hydroxyapatite because the salts would facilitate water to diffuse into the synthetic collagen thread comprising a dermal filler so that the thread would be swelled and the dermal filler could be dissociated from the thread.
Claims 1, 3, 13-14, 24-25, 36, 51, 54-56, and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150327972 (hereafter, Horne, prior art of record) in view of WO2014/041531 (prior art of record).
Horne teaches soft tissue augmentation threads, methods of making such threads and uses thereof in aesthetic applications (e.g., filling wrinkles, facial contouring, soft tissue augmentation products), surgery (e.g., sutures), and drug delivery (abstract and [0094]).
Horne teaches that the thread can be coated with an aqueous composition of hyaluronic acid or collagen (dermal filler) and the thread is coated, either totally or in part, with the gel composition (semi-solid) to form a layered material ([0089]).
Horne teaches that the threads can be braided, coiled (grooved), layered or woven and in some embodiments, braids may be formed from the threads and more complex braids can have a structure of hollow (hollow thread) or solid cylindrical cords (full core) ([0090]-[0092], and Fig. 7A, Fig. 8, Fig. 9A, 9B).
Horne teaches that the present disclosure is directed to a method of treating a wrinkle in a patient in need thereof by 1) inserting the thread into the skin of the patient adjacent to or under the wrinkle ([0096] and Fig. 1-A and 10B). Horne further teaches that the thread is manipulated in such a fashion such that one end of the thread is sufficiently hard such that the thread is used to penetrate the skin and this may be accomplished by coating the thread with a hardening material (rigid filler) ([0099]).
Horne also teaches that the thread is attached to the proximal end of a needle and the thread is inserted by a needle which needle is then removed ([0096]) and the kit comprises a thread and a means for delivering or implanting the thread to a patient such as needle ([0135]).
Horne teaches that the threads are comprised of one or more biocompatible polymers wherein biocompatible polymers include one or more of chondroitin sulfate, cyclodextrin, alginate, chitosan, carboxy methyl chitosan, heparin, gellan gum, agarose, cellulose, poly (glycerol-sebacate) elastomer, poly(ethylene glycol)-sebacic acid, poly(sebacic acid-co-ricinoleic acid), guar gum, xanthan gum, and combinations and/or derivatives thereof ([0005] and [0033]). The poly(ethylene glycol)-sebacic acid comprise ethyl glycol recited in the instant claim and is free of any dermal filler.
In addition, Horne teaches that to form the thread, the gel composition is typically extruded onto a substrate wherein the substrate include nylon, polyethylene terephthalate (PET), polystyrene, silicon, polyurethane, and activated cellulose (non-biodegradable) ([0078]). The substrate is composed of the core of thread ([0077] and [0142]) and the substrate is devoid of any dermal filler.
Horne does not specifically disclose a rigid dermal filler such as hydroxyapatite (elected species) and is silent about “temporarily accommodating the dermal filler in the exterior pores and groves of the thread”.
However, biocompatible ceramic skin augmentation materials, such as hydroxyapatite, were known to be efficient skin augmentation bioactive materials (dermal filler) due to the following properties: hydroxyapatite is a naturally occurring mineral form of calcium phosphate, hydroxyapatite comprises the mineral constituent of bone, therefore rendering it biocompatible and non-immunogenic when introduced into the body of a subject; hydroxyapatite is biodegradable following the same metabolic pathways as bone debris resulting from common bone fractures, yet is semi-permanent, as it lasts up to 3 years when implanted into a subject; moreover, when injected as small microspheres, hydroxyapatite acts as a scaffold that promotes new tissue formation similar to its surrounding environment; and inside skins such as the dermis, deposited particles of hydroxyapatite support fibroblastic ingrowth and new collagen formation as evidenced by WO2014/041531 (p2, lines 17-28). WO2014/041531 discloses the use of a skin augmentation composition comprising the biocompatible ceramic materials such as hydroxyapatite which is administered to a skin and/or subcutis of a subject with an applicator for filling the undesired lines, wrinkles, depressed scars and folds of a subject's skin and restoring youthful fullness to the skin (abstract and claim 1). WO2014/041531 further teaches that the biocompatible ceramic material such as hydroxyapatite is in the form of particles having a size of about 10-100 µm (p6, lines 23-30). In addition, it discloses that according to some embodiments, the biocompatible ceramic material comprises beads and/or particles having a size of up to 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100 µm or 25-45 µm (p19, line 9-23). WO2014/041531 further discloses that said augmentation composition further comprises at least one type of skin augmentation material selected from the group consisting of: a biodegradable natural substance such as bovine collagen, porcine collagen, recombinant collagen, a biodegradable synthetic polymer, a non-biodegradable synthetic polymer, a non-biodegradable natural substance and combinations thereof (claim 8 and p7, lines 9-19). In addition, WO2014/041531 discloses that there are dozens of known dermal filling agents for which include autologous implantable materials, allogeneic products, xenogeneic products and synthetically derived products and available dermal fillers comprise biodegradable natural substances (such as collagen, gelatine, hyaluronic acid, dextran and dried acellular particulate dermal matrix), biodegradable synthetic polymers (such as poly-L-lactic acid, polyethylene oxide and carboxymethylcellulose), non-biodegradable synthetic polymers (such as polymethyl methacrylate, polyacrylamide, polyalkylimide and silicones) and combinations thereof (p2, lines 10-16).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the surgical thread of Horne for delivering a biocompatible ceramic material such as hydroxyapatite particles having the average particle diameter of 10 to 100 micron or 25 to 45 microns taught by WO2014/041531 in skin augmentation because of the following reasons. Horne already teaches the surgical thread is suitable for drug delivery and discloses that the thread can be coated with an aqueous composition of hyaluronic acid or collagen (dermal filler) or rigid/semi-solid material. The hydroxyapatite particles as rigid material were taught to be biocompatible active material for promoting new tissue formation similar to its surrounding environment and supporting fibroblastic ingrowth and new collagen formation when deposited to skins such as the dermis in skin augmentation procedure as evidenced by WO2014/041531. Thus, one of ordinary skill in the art would have been motivated to use the rigid hydroxyapatite particles as coating material in place of, or in combination with hyaluronic acid or collagen on the reasonable expectation that coating the thread with hydroxyapatite particles would provide a suture suitable for skin augmentation procedures with additional benefits (e.g., promoting new tissue formation and supporting fibroblastic ingrowth and new collagen formation in skin augmentation and making the thread sufficiently hard such that the thread is used to penetrate the skin).
Also, Horne already teaches that the thread can be in form of braided, coiled, layered or woven structure, and complex braids can have a structure of hollow or solid cylindrical cords. Grooves and pores are created by braided or coiled structure (see Fig. 7a and 7B). Also, Horne specifically discloses porous lyophilized threads ([0141]). Thus, when such braided, coiled or porous threads are coated with an aqueous composition of hyaluronic acid or collagen (dermal filler) or rigid material as taught by Horne, the skilled artisan would reasonably expect that the exterior grooves, pores, or the hollow section would necessarily accommodate such materials during coating.
As claims 13-14, the hydroxylapatite particles of the prior art is the same rigid dermal filler as recited in the instant claim. Thus, it necessarily gradually dissociates from the suture thread (solid matrix) when used with the suture thread as taught and motivated by the prior art and inherently has the same characteristics of the rigid dermal filler as recited in claims 13-14 because products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention”).
As to claims 54-55, WO2014/041531 teaches that addition of a salt to the composition may result in water diffusion into the composition, thus assisting in uniform dispersion of the biocompatible ceramic material within the composition and/or within the treated area (p22, lines p22, lines 24-30). The salt is an osmotic agent that promotes the dissociation of the dermal filler from the thread as recited in claims 54-55. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further add an osmotic agent such as salts for promoting diffusion of the biocompatible ceramic material such as hydroxyapatite because the salts would facilitate water to diffuse into the synthetic collagen thread comprising a dermal filler so that the thread would be swelled and the dermal filler could be dissociated from the thread.
Response to Applicant’s arguments:
Applicant argued that Horne’s disclosure teaches away from any thread having exterior pores or grooves since such a structure would prevent the very uniform coating Horne’s disclosure seeks to achieve. Also, Applicant argued that the embodiments of Horne are devoid of any teaching, suggesting, or implication of surface pores or grooves. Applicant further argued that if Horne disclosure had intended its braided or coiled threads to include defined pore for accommodating other materials, it would have provided pore size parameters for those embodiments and the absence of such disclosure confirms that Horne’s threads are not porous in any functional or structural sense.
In response, the instant claims also seeks even and homogenous coating along the thread (see instant claim 3). Nothing in Horne discourages any thread having exterior pores or grooves. Instead, Horne does teach that the thread can be in form of braided, coiled, layered or woven structure and exterior grooves and pores are created by braided or coiled structure (see Fig. 7A and 7B). Thus, when such braided, coiled or porous threads are coated with an aqueous composition of hyaluronic acid or collagen (dermal filler) or rigid material as taught by Horne, the skilled artisan would reasonably expect that the exterior grooves, pores, or the hollow section would necessarily accommodate such materials during coating. Thus, Horne’s disclosure does not teach away from the claimed thread. In In re Fulton, the Federal Circuit explained that “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed . . . .” 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Also, the instant specification discloses Example 1 using Polyglactin 910 (ETHICON), which is commercially available braided thread (multi-filament) as evidenced by US 2006/0047312 (see [0017] and Fig. 1A, prior art of record). Thus, the instant application evidences that a braided thread is a thread having exterior pores/grooves (see [0109]).
In addition, it is noted that the instant application also does not provide pore size parameters. If taken to Applicants' logical conclusion that “the absence of the disclosure of pore size confirms that Horne’s threads are not porous in any functional or structural sense”, Applicant's argument ultimately cast doubt on applicants' own invention and raises written description issue for claimed thread having exterior pores/grooves. Further, it is noted that there is no disclosure for preparing threads having exterior pores/grooves itself in the specification, instead it only discloses the use of commercial braided or coiled threads.
In response to Applicant’s argument regarding paragraph [0141], A reference is not limited to its working examples, but must be evaluated for what it teaches those of ordinary skill in the art. In re Boe, 355 F.2d 961, 148 USPQ 507 (C.C.P.A 1966). In re Chapman, 357 F.2d 418, 148 USPQ 711 (C.C.P.A. 1966). Horne explicitly teaches that to form the thread, the gel composition is typically extruded onto a substrate wherein the substrate include nylon, polyethylene terephthalate (PET), polystyrene, silicon, polyurethane, and activated cellulose (non-biodegradable) (see [0078]) and the substrate is composed of the core of thread (see [0077] and [0142]). Also, Horne explicitly teaches that the thread is manipulated in such a fashion such that one end of the thread is sufficiently hard such that the thread is used to penetrate the skin and this may be accomplished by coating the thread with a hardening material (rigid filler) (see [0099]). Thus, Horne does teach that the thread is composed of a gel composition comprising dermal filler on a solid matrix (substrate), which is associated with the dermal filler as claimed.
In addition, Applicant argued that the coating in Horne’s disclosure may be stripped away from the underlying thread surface and as result, the coating would be deposited at or near the skin entry site and would not remain integrated with the suture in the deeper issue planes. In response, it is noted that there is no evidence supporting such assertion. Arguments of counsel cannot take the place of evidence in the record. See: In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Also, the prior art references in combination teach, motivate, and motivates the same surgical suture as claimed, thus such functional features would flow naturally from following the suggestion of the prior art in the absence of evidence to the contrary. Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611