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
The amendment after non-final office action filed August 12, 2025 is acknowledged. Claims 5, 7, 9, 12 and 21-27 were cancelled, claim 1 was amended and claims 1-4, 6, 8, 10-11, 13-20 are pending.
Election/Restrictions
The restriction was deemed proper and made final in the previous office action. Claims 11, 13-20 remain withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-4, 6, 8, 10 are examined on the merits of this office action.
Withdrawn Objections/Rejections
The objection to claim 1 is withdrawn in view of amendment of the claims filed August 12, 2025.
The rejection of claims 1-10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed August 12, 2025. However, a new rejection for claims 6, 8 and 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is presented below.
The rejection of claims 5 and 7 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of amendment of the claims (cancellation) filed August 12, 2025.
The rejection of claim(s) 1, 3-8, 10 under 35 U.S.C. 103 as being unpatentable over Kalmeta (US20180154172 A1, cited previously) as in view Leung (US20140276493 A1, cited previously) is withdrawn in view of amendment of the claims filed August 12, 2025.
The rejection of claim(s) 1-4, 6, 8, 10 under 35 U.S.C. 103 as being unpatentable over Kalmeta (US20180154172 A1, cited previously) view Leung (US20140276493 A1, cited previously) and Maser (US6022557 A, cited previously) is withdrawn in view of amendment of the claims filed August 12, 2025.
The rejection of Claims 1-10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11389663 in view of Kalmeta (US20180154172 A1), Leung (US20140276493 A1, cited previously), Chattopadhyay (Biopolymers. 2014 Aug; 101(8): 821–833), and Maser (US6022557 A) is withdrawn in view of amendment of the claims filed August 12, 2025.
The rejection of Claims 1-10 on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of US Patent No. 11654293 (AN16349222) in view of Kalmeta (US20180154172 A1, cited previously), Leung (US20140276493 A1, cited previously), Chattopadhyay (Biopolymers. 2014 Aug; 101(8): 821–833) and Maser (US6022557 A, cited previously) is withdrawn in view of amendment of the claims filed August 12, 2025.
The rejection of Claims 1-10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of (US Patent NO. 11684797, former co-pending AN17735034) in view of Kalmeta (US20180154172 A1), Leung (US20140276493 A1, cited previously), Chattopadhyay (Biopolymers. 2014 Aug; 101(8): 821–833) and Maser (US6022557 A) is withdrawn in view of amendment of the claims filed August 12, 2025.
New Rejections
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.
Claims 6, 8, 10 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.
Claims 6 and 8 are rejected due to being dependent on canceled claims 5 (for claim 6) and claim 7 (for claim 8). One cannot determine the metes and bounds of the claim given that claims 5 and 7 were canceled. For examination purposes, claims 6 and 8 are being interpreted as being dependent on claim 1. Given that claim 1 claims “copper chloride” and “iron chloride” and not copper salt or iron salt, claims 6 and 8 lack antecedent basis. For compact prosecution, it is suggested that claim 6 be amended to be dependent on claim 1 and claim “wherein the copper chloride comprises…” and claim 8 be amended to be dependent on claim 1 and claim “wherein the iron chloride comprises…”
Claim 10 claims “wherein the composition comprises a water content in a range of 0 to 99%, 0% to 95%....” Claim 10 is dependent on claim 1 and claim 1 was amended to claim “…are combined to form an aqueous hydrogel substrate…” which requires water to be present. It is therefore unclear whether embodiments lacking water are intended to be included within the scope of the claim, rendering the metes and bounds of the claim uncertain.
Claim Rejections - 35 USC § 112
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 10 is 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 10 claims “wherein the composition comprises a water content in a range of 0 to 99%, 0% to 95%....” Claim 10 is dependent on claim 1 and claim 1 was amended to claim “…are combined to form an aqueous hydrogel substrate…” which requires water to be present. Thus claim 10 encompasses embodiments having 0% water, which would not constitute an aqueous hydrogel. Accordingly, claim 10 fails to further limit the scope of claim 1 but rather includes subject matter inconsistent with the limitation of claim 1 requiring the composition be an aqueous hydrogel.
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.
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.
Claim(s) 1, 3-4, 6, 8, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kalmeta (US20180154172 A1, cited previously) in view of Ying (Materials Science and Engineering, 1010, march 2019, 487-498) and Leung (US20140276493 A1, cited previously).
*Please note that claims 6 and 8 are dependent on canceled claims. For applying art purposes, claims 6 and 8 will be interpreted as being dependent on claim 1.
Kalmeta teaches a wound care composition comprising Collagen, CuCl3, FeCL3 and hyaluronic acid and silver (“Ag”) and AgCl2 (see claims 17-18, paragraph 0017, paragraph 0102, table 5). Regarding concentrations of each component (found in instant claim 1), Kalmeta teaches collagen at 50-150 g, hyaluronic acid at 3-6 grams (approximately 1-3%) within the claimed range of any amount up to 96%, Copper, iron and silver each at 0.1-1g(approximately 0.05-1 wt%), within the range of 0.00001-15 wt% (see Table 5). In Table 5, if one assumes the upper range for each component, the amount of silver at .1-1 grams could be .46 percent, the amount of HA in the range of 3-6 gm could be 1.39-2.7 percent or, the amount of copper at .1-1 gm could be .46 percent, the amount of iron at .1-1 gm could be .46 percent. Regarding claims 1, 6, 8, Kalmeta teaches copper, iron and silver salt (in particular chloride, see paragraph 01117).
Regarding claim 10, Kalmeta discloses including water and can be adjusted based on desired viscosity (see paragraph 0103). Kalmeta discloses wherein the copper and the iron are present between 0.00001-15%, (see Table 5, collagen 50-150 grams, HA 5.1g/27.9, Fe 1% and Cu 1%, Table 4). Kalmeta teaches 0.1-1 gram of silver and HA 5.1/.1 silver is 51:1 ratio. Regarding claim 1, Kalmeta teaches wherein the silver, copper and iron could all be in salt form (see paragraph 0117). Kalmeta teaches including water and that the formulation can be in form of gel for delivery (see paragraph 0104).
Kalmeta is silent to wherein the collagen is hydrolyzed collagen, specifically up to 15% of collagen, and a pH range of about 3-8 and a specific example in form of a hydrogel.
Ying teaches an injectable collagen hyaluronic acid hydrogel prepared by crosslinking at pH 7.4 in PBS (see section 2.4). The hydrogel is biocompatible, supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure (see section 2.20). Ying teaches good biocompatibility and biodegradation (see section 4). Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims.
Leung discloses a wound care composition comprising Collagen (hydrolyzed collagen), copper (see claims 1-7, paragraph 0026). Regarding claims 3-4, Leung teaches using hydrolyzed or partially hydrolyzed collagen via a strong acid (see paragraph 0024). Leung teaches treating a tissue site with the collagen/gelatin and wounds (see claims 1, 3, 15, 19). Leung teaches the hydrolyzed collagen is gelatin (see paragraph 0026) and that the pharmaceutical composition can comprising 6, 8, 10 and 15% gelatin (see paragraph 0028). Leung teaches that gelatin (hydrolyzed collagen) inhibits MMP activity which is beneficial in healing chronic wounds (see paragraph 0012).
It would have been obvious before the effective filing date of the claimed invention to prepare Kalmeta’s collagen/HA/metal composition in a hydrated gel form as taught by Ying, who used identical biomaterials to form a COL-HA hydrogel at pH 7.4 for wound healing. One of ordinary skill in the art would have been motivated to do so given the hydrogel of Ying supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure and has good biocompatibility and biodegradation (see section 4) all of which would be beneficial in the method of Kalmeta (treating wounds). There is a reasonable expectation of success given Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims and Kalmeta teaches the formulation can be aqueous and in form of a gel.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to use hydrolyzed collagen (gelatin) of Leung at the taught concentrations in the wound treating compositions of Kalmeta and Ying. One of ordinary skill in the art would have been motivated to do so given hydrolyzed collagen is known in the art for that purpose and the hydrolyzed collagen of Leung is suitable for the purpose of treating a wound/wound dressing and inhibiting excessive MMP activity. There is a reasonable expectation of success given that they are known and used for the purpose of being a collagen substrate in wound dressings and for inhibiting excess MMP activity. Furthermore, it would have been obvious to try hydrolyzed collagen of Leung with the method Kalmeta and Ying.
Furthermore, it would have been obvious before the effective filing date of the claimed invention to modify Kalmeta’s wound healing composition by incorporating Ying’s neutral pH hydrogel structure and Leung’s hydrolyzed collagen, as such modifications represent a predictable optimization of known wound heling materials. One of ordinary skill in the art would have been motivated to apply Ying’s hydrogel conditions (pH 7.4) to improve moisture retention and biocompatibility and use Leung’s hydrolyzed collagen (6-15 wt%) to enhance degradation rate and tissue remodeling. These represent recognized therapeutic goals under KSR Int’l Co. V. Teleflex inc. 550 U.S. 398 (2007) amounting to routine combination of known elements for their expected benefits in wound care (see MPEP2143, Examples of Rationales).
There is a reasonable expectation of success because Kalmeta, Ying and Leung all disclose collagen HA based wound healing compositions; the ingredient ranges and ratios overlap; and Ying demonstrates effective wound closure using COL-HA hydrogel at 7.4. A person of ordinary skill would therefore expect that combing these known features would yield a composition with predictable wound healing performance.
Regarding the concentrations of each component (collagen, HA, copper, Iron and silver salts) MPEP states “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists”. In the instant case, the concentrations of Kalmeta and Leung overlap with the concentration of the instant claims and thus a prima facie case of obviousness exists. Furthermore, MPEP 2144.05 states “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Nevertheless, each component is considered a result effective variable and it would have been obvious to optimize the amount of each result effect variables (including concentrations ratios thereof and pH) to achieve optimal therapeutic activity (treatment of the wound) and viscosity. In particular, Kalmeta teaches adjusting water (which can alter the final amount of collagen present in the hydrogel) to obtain the desired viscosity (see paragraph 0100) and metal content depending on the severity of the wound (see paragraph 0102).
Optimization of concentrations and pH to achieve desired viscosity or therapeutic effect would have been routine experimentation for a person of ordinary skill in the art.
Regarding the limitation of the collagen, HA, copper, iron and silver are in form of an aqueous gel substrate to be placed in, on or near tissue damage, Kalmeta in view of Ying and Leung teach formulations in form of a hydrogel for delivery to the wound site (see paragraph 0104, 0126 of Kalmeta an also section 3.9 of Ying and paragraphs 0024-0028 of Leung). Regarding the limitation of “for use in repairing the tissue damage subsequent to an acute or chronic injury” and wherein the tissue comprises tissue from skin…, Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the composition is taught to be used for treating wounds of the skin.
Response to Applicant’s Arguments
Applicant argues “the cited references fail to describe each and every claimed feature, alone or in combination. For example, the rejection of independent claim 1 should be withdrawn at least because, without acknowledging the propriety of the rejection and solely to expedite prosecution, claim 1 has been narrowed to recite a certain physical form (hydrogel) of the composition, a specific pH for the composition, and a specific area for application. Such features are not described by the cited references.
Neither Kalmeta, nor any of the other cited references, describe this specific composition of elements in their recited quantities, with all of the other limitations of claim 1.
For example, by confining the claimed composition to a hydrogel form, the amended claim is distinguished from Kalmeta, Leung, and Maser. Kalmeta discloses wound treatment "substrates" that could encompass a variety of physical forms, but it does not expressly teach formulating this specific combination of ingredients as a hydrogel. In Kalmeta, collagen-based mixtures are mentioned along with other solids, and with general guidance on adjusting water content for viscosity. For example, Kalmeta notes one can adjust the water content of a substrate by about 20% to change viscosity, but nowhere does Kalmeta explicitly describe a hydrogel comprising collagen, hyaluronic acid, copper, iron, and silver together. Amended claim 1's requirement of an "aqueous hydrogel" means the composition is a unified, hydrated matrix. This is a structural distinction. Kalmeta describes a large number of composition options (solid matrices, powders, mixtures with inorganic crystals, etc.), but did not describe selecting only the ingredients of the present claim and formulating them into an aqueous hydrogel preparation. By limiting the form to a hydrogel, the composition achieves prolonged contact with the wound and a controlled microenvironment for healing (e.g. moist, conforming to the wound bed). The choice of an aqueous hydrogel, as claimed, provides a distinct mode of delivering the composition (e.g., staying in the wound as a dressing rather than a transient liquid or a dry implant), which is not an obvious design choice suggested by the cited references. Even if one acknowledges that Kalmeta's disclosure encompasses many possible forms, picking this particular form (hydrogel) for this particular combination of ingredients is not obvious. Under KSR, an examiner must show a reason that a person of ordinary skill would have had good reason to pursue the claimed configuration. Here, there is no clear reason given in the cited references to specifically formulate collagen, hyaluronic acid, copper, iron, and silver together into an aqueous hydrogel. The selection of an aqueous hydrogel from the many possibilities is a result of the inventors' insight into what would optimally facilitate wound healing (e.g. maintaining a moist environment and localized delivery of ions). It was not merely a routine or predictable step to take Kalmeta's teachings and arrive at the claimed hydrogel composition. The aqueous hydrogel form in combination with the specified components, in their specified quantities, is a particular solution that is neither taught nor reasonably suggested by the cited references”.
Applicant further argues “amended claim 1 requires the metal components to be present as chlorides and sets an acidic pH range (about 3-8). Kalmeta did list metal chlorides among many possible compounds, but it did so merely as one option among countless others and never taught that the chloride form was preferred. By contrast, claim 1 recites chloride salts of copper, iron, and silver as the forms used in the claimed composition - and at particular concentration ranges - to achieve the desired healing effect. Moreover, one of ordinary skill reading Kalmeta would not know to set the pH in this window for this combination of ingredients - this is a detail gleaned from the applicants' own experimentation and not from the prior art.
In addition, Kalmeta's disclosure enumerates numerous optional components (collagen, hyaluronic acid, various metal nanoparticles or salts, etc.) that may be included in a wound substrate. Nowhere does Kalmeta single out the specific combination of collagen + hyaluronic acid + copper + iron + silver, in their recited quantities, as a preferred or exemplified formulation. The cited Kalmeta reference broadly allows "any combination" of listed metals and compounds, meaning a person of ordinary skill would be faced with a vast array of possible subsets. The amended claim targets one specific subset that was never expressly taught. Absent hindsight, was no reason to pick these components, in their recited quantities, from the myriad of possibilities.
Under KSR, an obviousness rationale might exist if there were a finite number of identified, predictable solutions to a known problem. Here, there was no finite set of predictable combinations - Kalmeta presents a large universe of components (metals, salts, organics) to try. Choosing this specific combination of elements and quantities of each element was not a predictable solution highlighted by the prior art. To the contrary, it required lengthy experimentation. It was not obvious to try this subset of components and quantities, given the countless other combinations. Accordingly, for this additional reason, the amended claim is patentably distinct.
Finally, the specific composition claimed in amended claim 1, combined with its functional applicability to regenerate tissue from ectodermal, mesodermal, and endodermal origins (vasculature; skin; muscle; nerves; and/or bone), is not disclosed or suggested by Kalmeta, Leung, or Maser. Amended claim 1 claims a particular composition structured and shown to achieve healing across multiple tissue types.
For all of these reasons, applicant respectfully submits that claim 1 and its dependent claims are not anticipated or rendered obvious by the cited references, alone or in combination. Accordingly, applicant respectfully requests that the § 103 rejections of all of the pending claims be withdrawn.
Applicants arguments have been fully considered but not found persuasive. Applicants argues that Kalmeta discloses “substrate” but does not specifically teach an aqueous hydrogel comprising collagen, HA and metal salts. However, Kalmeta explicitly discloses compositions containing collagen, HA and metal ions in water and teaches that the water content may be adjusted by about 20% to control viscosity (see paragraphs 0102-0104). Kalmeta teaches including water and that the formulation can be in form of gel for delivery (see paragraph 0104) thus meeting the limitations of a hydrogel (gel with water). Nevertheless, the selection of an “aqueous hydrogel” merely reflects a known form of delivery routinely employed in the wound care field. Accordingly, it would have been obvious before the effective filing date of the claimed invention to prepare Kalmeta’s collagen/HA/metal composition in a hydrated gel form as taught by Ying, who used identical biomaterials to form a COL-HA hydrogel at pH 7.4 for wound healing. One of ordinary skill in the art would have been motivated to do so given the hydrogel of Ying supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure and has good biocompatibility and biodegradation (see section 4) all of which would be beneficial in the method of Kalmeta (treating wounds). There is a reasonable expectation of success given Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims and Kalmeta teaches the formulation can be aqueous and in form of a gel.
Applicant further argues that Kalmeta does not teach the specific pH range in amended claim 1. However, Ying teaches an injectable collagen hyaluronic acid hydrogel prepared by crosslinking at pH 7.4 in PBS (see section 2.4). The hydrogel is biocompatible, supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure (see section 2.20). Ying teaches good biocompatibility and biodegradation (see section 4). Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims. Maser (see rejection below) teaches wound composition at pH 2.8 (about 3), overlapping the lower end. Thus, the prior art collectively spans the claimed range. It would have been obvious to adjust the formulation pH to maintain physiological compatibility and stability, both result-effective variables. Optimization of pH for biocompatibility and also viscosity constitutes routine experimentation within the skill in the art (MPEP 2144.05 II).
Applicants argue that Kalmeta lists many metal salts and that chloride was not preferred. However, Kalmeta expressly includes CuCl2, FeCL3, and AgCL2 (See paragraph 0017, 0117) and describes using them for the same purposes (treatment of wounds). For each metal species, Kalmeta teaches three salts (i.e. CuCl3, CuCl2 and CuCl). Accordingly, one of ordinary skill in the art would have envisaged the use of the chloride salts as a predictable selection from limited set of functionally equivalent options (see paragraph 0117).
Applicant argues there was no finite set of predictable solutions. This argument is unpersuasive. Importantly, only Kalmeta teaches the metal ion component, and Kalmeta discloses a small, finite and well defined set of metal ions and salts (see Table 5, paragraphs 0017, 0117). Thus, rather than presenting an open ended amount of options, Kalmeta actually restricts the wound healing metals component to specific metals and acceptable salts. Ying and Leung only supply collagen/HA component and do not expand the metal options. Thus, Kalmeta’s teaching of the specific metal ions defines the only predictable possibilities, not an unlimited universe. Furthermore, Table 5 of Kalmeta specifically teaches the combination of metal ions with collagen and hyaluronic acid.
Applicant argues that the claimed composition is distinct because it can treat tissue damage from ectodermal, mesodermal or endodermal origin (skin, vasculature, nerves, bones or muscles). This functional statement does not limit the composition structurally. The cited art already teaches collagen/HA/metal hydrogels for general wound healing and tissue regeneration, inherently encompassing multiple tissue layers. Therefore, this recitation represents an intended use and does not distinguish over the prior art.
Furthermore, Applicant’s assertion that the cited art present a myriad of possibilities and that there was no reason to pick these components, in their recited quantities, absent hindsight is not persuasive. The rejection does not rely on hindsight but on express teachings and predictable variations identified in the art. Kalmeta teaches uses of collagen, hyaluronic acid, and metal ions (Cu, Ag and Fe) in wound healing substrates, and further teaches that the concentration of both ions and water are adjusted depending on severity. Ying teaches forming aqueous collagen HA hydrogels for wound healing. Maser teaches (see below) collagen in fibrous form and formulated at differing pH values within the claimed range. A person of ordinary skill in the art would have been motivated to combine these teachings because each reference addresses the same purpose-wound healing collagen based compositions-and provides predictable guidance regarding pH, metal ion and concentration adjustments. This is a routine optimization of known wound healing components not an arbitrary selection from a vast amount of possibilities (see MPEP 2144). After full consideration of Applicant’s arguments, the rejection is maintained.
Claim(s) 1-4, 6, 8, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kalmeta (US20180154172 A1, cited previously) in view of Ying (Materials Science and Engineering, 1010, march 2019, 487-498) and Leung (US20140276493 A1, cited previously) as applied to Claim(s) 1, 3-4, 6, 8, 10 and in further view of Maser (US6022557 A, cited previously).
The teachings of Kalmeta in view of Ying and Leung are described in the above rejection.
Kalmeta is silent to including collagen fibers.
Maser discloses a wound care composition comprising Collagen and hyaluronic acid (see claim 9 for example). Maser teaches wherein the collagen comprises collagen fibers (see claim 11 for example). Maser teaches a water content of 12-18% (see claim 12). Maser teaches the composition comprising a pH of 2.8 (see Example 2, which meets the limitations of “about 3-8” given the lack of specific definition of “about” and the routine interpretation of about as being +/- 10%). Maser teaches that collagen fibers produced are extremely well suited for dressing material (wound dressings).
It would have been obvious before the effective filing date of the claimed invention to use collagen fibrils of Maser in the wound treating compositions of Kalmeta, Ying and Leung. One of ordinary skill in the art would have been motivated to do so given collagen fibrils are known in the art for the purpose of wound healing and collagen fibers as produced by Maser are extremely well suited for dressing material. There is a reasonable expectation of success since collagen fibers were routinely used in wound dressings and compatible with aqueous matrices. Furthermore, it would have been obvious to try the collagen fibers of Maser in the methods of Kalmeta, Ying and Leung given that there a finite identified predictable options (soluble collagen, hydrolyzed collagen, collagen fibers) for forming a wound dressing substrate.
It has been held that under KSR that “obvious to try” may be an appropriate test under 103. The Supreme Court stated in KSR, When there is motivation “to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727,_,82 USPQ2d 1385, 1397 (2007). The skilled artisan would have had reason to try collagen fibrils as the form of collage with the reasonable expectation that at least one would be successful. Thus, use of collagen fibrils as the collagen source is “the product not of innovation but of ordinary skill and common sense,” leading to the conclusion that invention is not patentable as it would have been obvious.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference. After full consideration of Applicant’s arguments, the rejection is maintained.
Maintained/Revised Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 6, 8, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11389663 in view of Kalmeta (US20180154172 A1, cited previously), Ying (Materials Science and Engineering, 1010, march 2019, 487-498), Leung (US20140276493 A1, cited previously).and Maser (US6022557 A, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A composition with wound healing and tissue regenerative properties, the composition comprising a. collagen b. hyaluronic acid c. copper, d. Iron and silver“ (see claim 1). Claim 1 further claims “ wherein the collagen is present in the composition in a range of up to 15% (wt/wt), the hyaluronic acid is present in the composition up to 96% (wt/wt), the copper is present in the composition in a range 0.00001-15% (wt/wt) and the iron is present in the composition in a range of up to 0.00001 to 15% (wt/wt); silver 0.00001-15 (wt/wt), a pH of 3.8, aqueous hydrogel.The instant application further claims: collagen fibers (claim 2), hydrolyzed collagen (claim 3), acid treated collagen (claim 4), copper salt (claim 6); iron salt (claim 8), water 0-99% (claim 10).
US Patent NO. ‘663 claims a method of treating tissue damage in a wound comprising using a composition comprising collagen, 200 mg-6 g of hyaluronic acid, water, .1-1 g copper, .1-1 gram of iron and 0.1-1g of silver(see claim 1 (b)).
US Patent NO. ‘663 is silent to claiming FeCl and CuCl, the pH of about 3-8, aqueous hydrogel and the type of collagen used and the amount.
However, Kalmeta discloses a wound care composition comprising 50-150 grams Collagen, CuCl3, FeCl3 and hyaluronic acid (see claims 17-18, paragraph 0017, paragraph 0102, table 5) and aqueous and gel formulations (See paragraphs 0103-0104).
Ying teaches an injectable collagen hyaluronic acid hydrogel prepared by crosslinking at pH 7.4 in PBS (see section 2.4). The hydrogel is biocompatible, supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure (see section 2.20). Ying teaches good biocompatibility and biodegradation (see section 4). Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims.
Leung discloses a wound care composition comprising Collagen (hydrolyzed collagen), copper (see claims 1-7, paragraph 0026). Leung teaches using hydrolyzed or partially hydrolyzed collagen via a strong acid (see paragraph 0024). Leung teaches treating a tissue site with the collagen/gelatin and wounds (see claims 1, 3, 15, 19). Leung teaches the hydrolyzed collagen is gelatin (see paragraph 0026) and that the pharmaceutical composition can comprising 6, 8, 10 and 15% gelatin (see paragraph 0028). Leung teaches that gelatin (hydrolyzed collagen) inhibits MMP activity which is beneficial in healing chronic wounds (see paragraph 0012).
Maser teaches collagen based wound healing compositions (collagen fibers) comprising a pH of 2.8 (see Example 2).
It would have been obvious before the effective filing date of the claimed invention to prepare US Patent No. ‘663 collagen/HA/metal composition in a hydrated gel form as taught by Ying, who used identical biomaterials to form a COL-HA hydrogel at pH 7.4 for wound healing. One of ordinary skill in the art would have been motivated to do so given the hydrogel of Ying supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure and has good biocompatibility and biodegradation (see section 4) all of which would be beneficial in the method of US Patent No. ‘663 (treating tissue damage). There is a reasonable expectation of success given Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims and Kalmeta teaches the formulation can be aqueous and in form of a gel.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to use hydrolyzed collagen (gelatin) of Leung at the taught concentrations in the wound treating compositions of US Patent No. ‘663. One of ordinary skill in the art would have been motivated to do so given hydrolyzed collagen is known in the art for that purpose and the hydrolyzed collagen of Leung is suitable for the purpose of treating a wound/wound dressing and inhibiting excessive MMP activity. There is a reasonable expectation of success given that they are known and used for the purpose of being a collagen substrate in wound dressings and for inhibiting excess MMP activity. Furthermore, it would have been obvious to try hydrolyzed collagen of Leung with the method US Patent No. ‘663.
There is a reasonable expectation of success because Kalmeta, Ying and Leung all disclose collagen HA based wound healing compositions; the ingredient ranges and ratios overlap; and Ying demonstrates effective wound closure using COL-HA hydrogel at 7.4. A person of ordinary skill would therefore expect that combing these known features would yield a composition with predictable wound healing performance.
Regarding the concentrations of each component (collagen, HA, copper, Iron and silver salts) each component is considered a result effective variable and it would have been obvious to optimize the amount of each result effect variables (including concentrations ratios thereof and pH) to achieve optimal therapeutic activity (treatment of tissue) and viscosity. In particular, Kalmeta teaches adjusting water (which can alter the final amount of collagen present in the hydrogel) to obtain the desired viscosity (see paragraph 0100) and metal content depending on the severity of the wound (see paragraph 0102).
Optimization of concentrations and pH to achieve desired viscosity or therapeutic effect would have been routine experimentation for a person of ordinary skill in the art.
It would have been obvious to try the different collagen types given that all of the collagen types listed, hydrolyzed, collagen fibers and acid treated are all utilized in the wound healing art for the same purposes. Lastly, it would have been obvious to optimize the pH range of the wound healing composition given that pH is a result effective variable and it would have been obvious to do so to achieve the most therapeutically effective composition for the purpose of treating wounds.
It would have been obvious before the filing date of the claimed invention to use copper, silver and iron salts as the source of ions. One of ordinary skill in the art would have been motivated to do so given Kalmeta teaches the exact formulations with CuCl3, AgCl2 and FeCl3 as the source of ions and it is routine in the art to use these salts as sources of the metal ions.
Regarding the limitation of the collagen, HA, copper, iron and silver are in form of an aqueous or gel substrate to be placed in, on or near tissue damage, Kalmeta teaches the formulations in form of a gel for delivery to the wound site (see paragraph 0104, 0126). Regarding the limitation of “for use in repairing the tissue damage subsequent to an acute or chronic injury” and wherein the tissue comprises tissue from skin…, Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the composition is to be used for treating wounds of the skin.
Response to Applicant’s Arguments
Applicant argues Claim 1 has been further narrowed, and is thus believed to be patentably distinct from the claims of U.S. Patent Nos. 11389663, 11654293, and 11684797. Applicants state “see arguments over US20180154172 A1, Kalmeta).
Applicant’s arguments have been fully considered but not found persuasive. Response to Applicant’s arguments Regarding Kalmeta (US20180154172 A1) are provided above and incorporated herein by reference. Thus, the rejection is maintained.
Claims 1-4, 6, 8, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of US Patent No. 11654293 (AN16349222) in view of Kalmeta (US20180154172 A1, cited previously), Ying (Materials Science and Engineering, 1010, march 2019, 487-498), Leung (US20140276493 A1, cited previously).and Maser (US6022557 A, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A composition with wound healing and tissue regenerative properties, the composition comprising a. collagen b. hyaluronic acid c. copper, d. Iron and silver“ (see claim 1). Claim 1 further claims “ wherein the collagen is present in the composition in a range of up to 15% (wt/wt), the hyaluronic acid is present in the composition up to 96% (wt/wt), the copper is present in the composition in a range 0.00001-15% (wt/wt) and the iron is present in the composition in a range of up to 0.00001 to 15% (wt/wt); silver 0.00001-15 (wt/wt), a pH of 3.8, aqueous hydrogel.The instant application further claims: collagen fibers (claim 2), hydrolyzed collagen (claim 3), acid treated collagen (claim 4), copper salt (claim 6); iron salt (claim 8), water 0-99% (claim 10).
US Patent No. 11654293 claims a system for treating tissue damage in a wound comprising using a composition comprising collagen, 200 mg-6 g of hyaluronic acid, water, .1-1 g copper (CuCl3), .1-1 gram of iron(FeCl3), 0.1-1 gram silver (see claims 2, 16-17).
US Patent No. 11654293 is silent to pH of about 3-8, aqueous hydrogel and the type of collagen used and the amount.
However, Kalmeta discloses a wound care composition comprising 50-150 grams Collagen, CuCl3, FeCl3 and hyaluronic acid (see claims 17-18, paragraph 0017, paragraph 0102, table 5) and aqueous and gel formulations (See paragraphs 0103-0104).
Ying teaches an injectable collagen hyaluronic acid hydrogel prepared by crosslinking at pH 7.4 in PBS (see section 2.4). The hydrogel is biocompatible, supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure (see section 2.20). Ying teaches good biocompatibility and biodegradation (see section 4). Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims.
Leung discloses a wound care composition comprising Collagen (hydrolyzed collagen), copper (see claims 1-7, paragraph 0026). Leung teaches using hydrolyzed or partially hydrolyzed collagen via a strong acid (see paragraph 0024). Leung teaches treating a tissue site with the collagen/gelatin and wounds (see claims 1, 3, 15, 19). Leung teaches the hydrolyzed collagen is gelatin (see paragraph 0026) and that the pharmaceutical composition can comprising 6, 8, 10 and 15% gelatin (see paragraph 0028). Leung teaches that gelatin (hydrolyzed collagen) inhibits MMP activity which is beneficial in healing chronic wounds (see paragraph 0012).
Maser teaches collagen based wound healing compositions (collagen fibers) comprising a pH of 2.8 (see Example 2).
It would have been obvious before the effective filing date of the claimed invention to prepare US Patent No. 11654293 collagen/HA/metal composition in a hydrated gel form as taught by Ying, who used identical biomaterials to form a COL-HA hydrogel at pH 7.4 for wound healing. One of ordinary skill in the art would have been motivated to do so given the hydrogel of Ying supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure and has good biocompatibility and biodegradation (see section 4) all of which would be beneficial in the method of US Patent No. 11654293 (treating tissue damage). There is a reasonable expectation of success given Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims and Kalmeta teaches the formulation can be aqueous and in form of a gel.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to use hydrolyzed collagen (gelatin) of Leung at the taught concentrations in the wound treating compositions of US Patent No. 11654293. One of ordinary skill in the art would have been motivated to do so given hydrolyzed collagen is known in the art for that purpose and the hydrolyzed collagen of Leung is suitable for the purpose of treating a wound/wound dressing and inhibiting excessive MMP activity. There is a reasonable expectation of success given that they are known and used for the purpose of being a collagen substrate in wound dressings and for inhibiting excess MMP activity. Furthermore, it would have been obvious to try hydrolyzed collagen of Leung with the method US Patent No. 11654293.
There is a reasonable expectation of success because Kalmeta, Ying and Leung all disclose collagen HA based wound healing compositions; the ingredient ranges and ratios overlap; and Ying demonstrates effective wound closure using COL-HA hydrogel at 7.4. A person of ordinary skill would therefore expect that combing these known features would yield a composition with predictable wound healing performance.
Regarding the concentrations of each component (collagen, HA, copper, Iron and silver salts) each component is considered a result effective variable and it would have been obvious to optimize the amount of each result effect variables (including concentrations ratios thereof and pH) to achieve optimal therapeutic activity (treatment of tissue) and viscosity. In particular, Kalmeta teaches adjusting water (which can alter the final amount of collagen present in the hydrogel) to obtain the desired viscosity (see paragraph 0100) and metal content depending on the severity of the wound (see paragraph 0102).
Optimization of concentrations and pH to achieve desired viscosity or therapeutic effect would have been routine experimentation for a person of ordinary skill in the art.
It would have been obvious to try the different collagen types given that all of the collagen types listed, hydrolyzed, collagen fibers and acid treated are all utilized in the wound healing art for the same purposes. Lastly, it would have been obvious to optimize the pH range of the wound healing composition given that pH is a result effective variable and it would have been obvious to do so to achieve the most therapeutically effective composition for the purpose of treating wounds.
Regarding the limitation of the collagen, HA, copper, iron and silver are in form of an aqueous or gel substrate to be placed in, on or near tissue damage, Kalmeta teaches the formulations in form of a gel for delivery to the wound site (see paragraph 0104, 0126). Regarding the limitation of “for use in repairing the tissue damage subsequent to an acute or chronic injury” and wherein the tissue comprises tissue from skin…, Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the composition is to be used for treating wounds of the skin.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference.
Claims 1-4, 6, 8, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of (US Patent NO. 11684797, former co-pending AN17735034) in view of Kalmeta (US20180154172 A1, cited previously), Ying (Materials Science and Engineering, 1010, march 2019, 487-498), Leung (US20140276493 A1, cited previously).and Maser (US6022557 A, cited previously).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A composition with wound healing and tissue regenerative properties, the composition comprising a. collagen b. hyaluronic acid c. copper, d. Iron and silver“ (see claim 1). Claim 1 further claims “ wherein the collagen is present in the composition in a range of up to 15% (wt/wt), the hyaluronic acid is present in the composition up to 96% (wt/wt), the copper is present in the composition in a range 0.00001-15% (wt/wt) and the iron is present in the composition in a range of up to 0.00001 to 15% (wt/wt); silver 0.00001-15 (wt/wt), a pH of 3.8, aqueous hydrogel.The instant application further claims: collagen fibers (claim 2), hydrolyzed collagen (claim 3), acid treated collagen (claim 4), copper salt (claim 6); iron salt (claim 8), water 0-99% (claim 10).
US Patent NO. ‘797 claims gel for treating tissue damage in a wound comprising using a composition comprising collagen, 200 mg-6 g of hyaluronic acid, water, .1-1 g copper, .1-1 gram of iron 0.1-1 gram of silver (see claims 20, 26, 30, 35).
US Patent NO. ‘797 is silent to is silent to claiming FeCl and CuCl, the pH of about 3-8, aqueous hydrogel and the type of collagen used and the amount.
However, Kalmeta discloses a wound care composition comprising 50-150 grams Collagen, CuCl3, FeCl3 and hyaluronic acid (see claims 17-18, paragraph 0017, paragraph 0102, table 5) and aqueous and gel formulations (See paragraphs 0103-0104).
Ying teaches an injectable collagen hyaluronic acid hydrogel prepared by crosslinking at pH 7.4 in PBS (see section 2.4). The hydrogel is biocompatible, supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure (see section 2.20). Ying teaches good biocompatibility and biodegradation (see section 4). Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims.
Leung discloses a wound care composition comprising Collagen (hydrolyzed collagen), copper (see claims 1-7, paragraph 0026). Leung teaches using hydrolyzed or partially hydrolyzed collagen via a strong acid (see paragraph 0024). Leung teaches treating a tissue site with the collagen/gelatin and wounds (see claims 1, 3, 15, 19). Leung teaches the hydrolyzed collagen is gelatin (see paragraph 0026) and that the pharmaceutical composition can comprising 6, 8, 10 and 15% gelatin (see paragraph 0028). Leung teaches that gelatin (hydrolyzed collagen) inhibits MMP activity which is beneficial in healing chronic wounds (see paragraph 0012).
Maser teaches collagen based wound healing compositions (collagen fibers) comprising a pH of 2.8 (see Example 2).
It would have been obvious before the effective filing date of the claimed invention to prepare US Patent NO. ‘797 collagen/HA/metal composition in a hydrated gel form as taught by Ying, who used identical biomaterials to form a COL-HA hydrogel at pH 7.4 for wound healing. One of ordinary skill in the art would have been motivated to do so given the hydrogel of Ying supports fibroblast and endothelial cell proliferation and accelerates full thickness wound closure and has good biocompatibility and biodegradation (see section 4) all of which would be beneficial in the method of US Patent NO. ‘797 (treating tissue damage). There is a reasonable expectation of success given Ying provides teaching of an aqueous hydrogel matrix formed by collagen and hyaluronic acid at physiological pH of 7.4 having the same intended use of the instant claims and Kalmeta teaches the formulation can be aqueous and in form of a gel.
Furthermore, It would have been obvious before the effective filing date of the claimed invention to use hydrolyzed collagen (gelatin) of Leung at the taught concentrations in the wound treating compositions of US Patent NO. ‘797. One of ordinary skill in the art would have been motivated to do so given hydrolyzed collagen is known in the art for that purpose and the hydrolyzed collagen of Leung is suitable for the purpose of treating a wound/wound dressing and inhibiting excessive MMP activity. There is a reasonable expectation of success given that they are known and used for the purpose of being a collagen substrate in wound dressings and for inhibiting excess MMP activity. Furthermore, it would have been obvious to try hydrolyzed collagen of Leung with the method US Patent NO. ‘797.
There is a reasonable expectation of success because Kalmeta, Ying and Leung all disclose collagen HA based wound healing compositions; the ingredient ranges and ratios overlap; and Ying demonstrates effective wound closure using COL-HA hydrogel at 7.4. A person of ordinary skill would therefore expect that combing these known features would yield a composition with predictable wound healing performance.
Regarding the concentrations of each component (collagen, HA, copper, Iron and silver salts) each component is considered a result effective variable and it would have been obvious to optimize the amount of each result effect variables (including concentrations ratios thereof and pH) to achieve optimal therapeutic activity (treatment of tissue) and viscosity. In particular, Kalmeta teaches adjusting water (which can alter the final amount of collagen present in the hydrogel) to obtain the desired viscosity (see paragraph 0100) and metal content depending on the severity of the wound (see paragraph 0102).
Optimization of concentrations and pH to achieve desired viscosity or therapeutic effect would have been routine experimentation for a person of ordinary skill in the art.
It would have been obvious to try the different collagen types given that all of the collagen types listed, hydrolyzed, collagen fibers and acid treated are all utilized in the wound healing art for the same purposes. Lastly, it would have been obvious to optimize the pH range of the wound healing composition given that pH is a result effective variable and it would have been obvious to do so to achieve the most therapeutically effective composition for the purpose of treating wounds.
It would have been obvious before the filing date of the claimed invention to use copper, silver and iron salts as the source of ions. One of ordinary skill in the art would have been motivated to do so given Kalmeta teaches the exact formulations with CuCl3, AgCl2 and FeCl3 as the source of ions and it is routine in the art to use these salts as sources of the metal ions.
Regarding the limitation of the collagen, HA, copper, iron and silver are in form of an aqueous or gel substrate to be placed in, on or near tissue damage, Kalmeta teaches the formulations in form of a gel for delivery to the wound site (see paragraph 0104, 0126). Regarding the limitation of “for use in repairing the tissue damage subsequent to an acute or chronic injury” and wherein the tissue comprises tissue from skin…, Please note that it is regarded that "intended use" of a composition or product will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the composition is to be used for treating wounds of the skin.
Response to Applicant’s Arguments
Applicants reiterate the aforementioned arguments with respect to the instant rejection. The Office’s rebuttal of these arguments remains the same and is incorporated herein by reference. After full consideration of Applicant’s arguments, the rejection is maintained.
Conclusion
No claims are allowed.
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.
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