DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/30/2025 has been entered.
Claim Status
Claims 1-4, 6-8, 14-17, and 19 are pending.
Claims 1, 8, and 14 are currently amended.
Claims 5, 9-13, 18, and 20-21 are canceled.
Claims 1-4, 6-8, 14-17, and 19 have been examined.
Claims 1-4, 6-8, 14-17, and 19 are rejected.
New Claim Rejections - 35 USC § 112(d)
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.
Claims 2-4 and 16 are 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 2 recites the limitation “wherein the metal element is at least one metal element selected from the group consisting of transition metal elements and base metal elements.” Claim 2 depends from claim 1 which recites “the metal element is at least one selected from the group consisting of palladium, platinum, and gold,” which are transition metals. Thus, the group consisting of transition metal elements and base metal elements does not further limit claim 1.
Claim 3 recites the limitation “wherein the metal element is at least one metal element selected from the group consisting of transition metals of Group 10, transition metals of Group 11, and metals of Group 12 of the periodic table.” Claim 3 depends from claim 1 which recites “the metal element is at least one selected from the group consisting of palladium, platinum, and gold,” which are transition metals of groups 10 and 11 of the periodic table. Thus, the group consisting of transition metals of Group 10, transition metals of Group 11, and metals of Group 12 of the periodic table does not further limit claim 1.
Claim 4 recites the limitation “wherein the metal element is at least one selected from the group consisting of copper, zinc, palladium, platinum, and gold.” Claim 4 depends from claim 1 which recites “the metal element is at least one selected from the group consisting of palladium, platinum, and gold.” Thus, the group consisting of palladium, platinum, and gold also consists additionally of copper and zinc and, therefore, does not further limit claim 1.
Claim 16 recites the limitation “wherein the metal element is at least one metal element selected from the group consisting of transition metal elements and base metal elements.” Claim 16 depends from claim 14 which recites “the metal element is at least one selected from the group consisting of palladium, platinum, and gold,” which are transition metals. Thus, the group consisting of transition metal elements and base metal elements does not further limit claim 14.
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.
New 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
This is a new claim rejection in view of the amendments to the claims.
Claims 1-4, 6-8, 14-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Matsui et al. (JP 3,337,362 B2, Oct. 21, 2002) (cited by examiner on Form 892 dated 05/06/2025) (hereinafter Matsui) in view of Scalesciani (US 2016/0106674 A1, April 21, 2016) (hereinafter Scalesciani) and in view of Sun et al., (Multistimuli-Responsive, Moldable Supramolecular Hydrogels Cross-Linked by Ultrafast Complexation of Metal Ions and Biopolymers, June 24, 2015) (hereinafter Sun).
Matsui discloses a material for supplementing living tissues such as skin and bone which is a water-insoluble collagen (i.e., extracellular matrix component) gel or a collagen sheet ([0001]). Collagen can be reduced in immunogenicity by converting it into atelocollagen by enzymatic treatment and requires various cross-linking treatments like chitin and chitosan ([0006]). To form the collagen gel, 0.1 mM metal ions is added to an atelocollagen solution. The mixture is then treated with a crosslinking accelerator ([0008]). A collagen sheet is obtained by drying the collagen gel ([0009]). The metal ion is a copper (i.e., transition metal element of Group 11) ion or an iron ion, however, the metal ions used are not particularly limited ([0015] – end of page 2). Atelocollagen is obtained from a tissue rich in by removing the highly antigenic telopeptide region at the molecular end with proctase or pepsin. And is dissolved in an acidic solution (i.e., a solvent) having a pH of 2 to 4 to form a viscous solution (page 3, fourth paragraph). Crosslinking is introduced between the atelocollagen molecules by causing a metal ion such as copper ion and a crosslinking accelerator such as ascorbic acid to act on the atelocollagen solution (page 3, fifth paragraph from bottom). Example 1 describes preparing a collagen solution using atelocollagen powder and a hydrochloric acid solution (i.e., a solvent) mixed with a cupric chloride solution and ascorbic acid added. When the collagen solution was immersed in 4°C for 4 hours, the collagen solution became a suspension containing a translucent hydrogel. After adding an EDTA solution to the suspension, centrifuging the suspension, and collecting the sediment, a hydro-like collagen gel was obtained ([0031] through end of page 3). The obtained collagen gel was poured into a thick sheet and freeze-dried to form a sponge-like sheet, which, when immersed in physiological saline heated to 37 ° C., the sponge-like sheet became transparent (page 4, first paragraph). In Test Example 1, the sponge-like sheet of Example 1 was implanted onto a living body. Once implanted it showed invasion of fibroblasts (i.e. cells) and demonstrated excellent biocompatibility (i.e. a three-dimensional tissue body comprising cells) (page 4, Test Example 1). The collagen gel and collagen sheet have cell penetration, sustained drug release and can be used as a wound dressing material or drug delivery system carrier ([0058]).
Matsui differs from the instant claims insofar as not disclosing wherein the metal ion is obtained by dissolving an ion source of the ion of the metal element in a solvent, and the metal element is at least one selected from the group consisting of palladium, platinum, and gold; and a fragmented extracellular matrix component having an average diameter of 10 nm or more and 30 µm or less.
However, Sun discloses a multistimuli-responsive hydrogels cross-linked by metal ions and biopolymers. By mixing the biopolymer chitosan (CS) with a variety of metal ions at the appropriate pH values, a series of transparent and stable hydrogels within a few seconds through supramolecular complexation were obtained (Abstract). Ultrafast hydro-gelation was achieved via cross-linking by supramolecular complexation between a native biopolymer, chitosan (CS), and transition metal ions, specifically Pd2+. The gelation speed was very fast, occurring mostly within two seconds. The hydrogel was found to have a high water content, to be stable at room temperature, and could be easily reproduced (page 7944, right column).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Matsui discloses wherein the composition is crosslinked by metal ions. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated palladium ions into the composition of Matsui since they are known and effective metal ions used to crosslink hydrogels as taught by Sun.
The combined teachings of Matsui and Sun do not disclose a fragmented extracellular matrix component having an average diameter of 10 nm or more and 30 µm or less.
However, Scalesciani discloses a collagen powder in which at least 99.5% of the particles have a maximum size of 80 microns 25% to 45% by volume of the particles have a size of more than 30 microns and 35% to 50% by volume of the particles have a size in the range of 20 to 70 microns (Abstract) used for the treatment of wounds ([0001]). A product comprising, in addition to the particles having a size of less than 25 microns, a certain amount of larger particles, up to 80 μm (microns), exhibits superior wound healing properties with respect to known collagen powders ([0020]). Thus, the invention provides a product that comprises a significant portion of particles having a size of greater than 30 microns, which improves its wound healing properties ([0021]). In an exemplary embodiment, the collagen powder may be produced according to a process which utilizes commercially available atomizers. According to said process an aqueous viscous solution of collagen with a concentration of 0.1 2.0%, having a pH of from 3 to 6 is introduced into an atomizer and struck by a stream of inert gas, generally air, having a temperature of up to 130° C (i.e., fragmented extracellular matrix component) ([0032]). The powered product thus obtained has generally a particle size of less than 150 microns ([0033]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Matsui discloses wherein the wound dressing material comprises collagen. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated atomized collagen powder (i.e., fragmented extracellular matrix component) having a particle size of less than 150 microns into the composition of Matsui since it is a known and effective collagen and particle size for the treatment of wounds as taught by Scalesciani.
Regarding the limitation of claims 1, 8, and 14 reciting “obtained by dissolving an ion source of the ion of the metal element in a solvent,” as discussed above, Matsui discloses an ion obtained from copper chloride solution (i.e., metal element) used in a collagen gel composition. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113.
Regarding the limitation of claim 15 reciting “wherein a total light transmittance at 37°C is 80% or more”, since Matsui teaches substantially the same three-dimensional tissue body composition as claimed (e.g., a sponge-like sheet comprising an extracellular matrix component (e.g., collagen); cells; and copper ions, and is transparent at 37°C), the sponge-like sheet of Matsui would necessarily possess a total light transmittance at 37°C of 80% or more.
Response to Applicant’s Arguments
The rejection of claim(s) 1-4, 6-8, 14-17 and 19 under 35 U.S.C. 103 as being unpatentable over Matsui et al. (JP 3,337,362 B2, Oct. 21, 2002) (cited by examiner on Form 892 dated 05/06/2025) (hereinafter Matsui) in view of Wallace et al., (Collagen Gel Systems For Sustained Delivery And Tissue Engineering, Aug. 26, 2003) (hereinafter Wallace) is withdrawn in view of amendments to the claims.
The rejection of claim(s) 18 and 20-21 under 35 U.S.C. 103 as being unpatentable over Matsui et al. (JP 3,337,362 B2, Oct. 21, 2002) Matsui et al. (JP 3,337,362 B2, Oct. 21, 2002) (cited by examiner on Form 892 dated 05/06/2025) (hereinafter Matsui) in view of Wallace et al., (Collagen Gel Systems For Sustained Delivery And Tissue Engineering, Aug. 26, 2003) (hereinafter Wallace) an further in view of Mohandas et al., (Exploration Of Alginate Hydrogel/Nano Zinc Oxide Composite Bandages For Infected Wounds, Oct. 01, 2015) (hereinafter Mohandas) is moot since the claims are canceled.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614