FINAL 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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted 06/11/2026 and 09/01/2026 have been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action
Status of the Claims
This action is in response to papers filed 06/11/2026 in which claims 4-5, 7-10, and 15-74 were previously canceled.
Claims 1-3, 6, and 11-14 are under examination.
Maintained Rejection
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, 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.
Claim(s) 1-3, 6, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silvetti, Sr. et al (US 5,177,065) in view of Larsen et al (US 2011/0021964 A1) and Gravagna et al (US 2009/0068250 A1).
Regarding claim 1, Silvetti teaches a method of promoting wound healing comprising topically applying to a wound area a composition containing a therapeutically effective amount of D-2-deoxyribose. Silvetti teaches the D-2-deoxyribose is useful to be incorporated in carrier such as hydrogels (column 3, lines 25-end; column 5, lines 60-end; columns 6-7; column 9, lines 38-40; claims 8-9).
It would have been obvious to one of ordinary skill in the art to select hydrogel as the carrier for D-2-deoxyribose in Silvetti, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Larsen provided the guidance to do by teaching that suitable matrix material for promoting wound healing is a hydrogel (Larsen: Abstract; [0165], [0209]-[0218], [0264], [0381-[0393], [0415]-[0434] and [0592])). Thus, an ordinary artisan provided the guidance from Silvetti and Larsen would have looked to known carriers in the art useful for wound healing including hydrogel for use as the carrier for D-2-deoxyribose to arrive a desired hydrogel containing D-2-deoxyribose that can be effectively use for promoting wound healing at a wound area, and achieve Applicant’s claimed invention with reasonable expectation of success.
While Silvetti does not expressly teach chitosan and collagen as component of the hydrogel, it would have been obvious to one of ordinary skill in the art to use chitosan and collagen as the biomaterials that forms the hydrogel of Silvetti in view of the guidance from Gravagna.
Gravagna teaches a hydrogel containing a crosslinked mixture of collagen and chitosan, wherein the hydrogel is bioresorbable and biocompatible and wherein the hydrogel containing collagen and chitosan provide optimal support for cell differentiation and growth and for tissue regeneration, as collagen and chitosan have angiogenic and antibacterial properties (Abstract; [0004]-[0006], [0018]-[0019], [0028]-[0032], [0040]; Example 6).
It would have been obvious to one of ordinary skill in the art to use a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel of Silvetti, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Silvetti is drawn to using the hydrogel for antibacterial treatment and tissue regeneration during wound healing processes (Silvetti: column 3, lines 46-61), and Gravagna provided the guidance for using a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel, as hydrogel containing collagen and chitosan are well-known in the art for their optimal support for cell differentiation and growth and tissue regeneration, as collagen and chitosan have angiogenic and antibacterial properties (Gravagna: Abstract; [0004]-[0006], [0018]-[0019], [0028]-[0032], [0040]; Example 6), which is consistent with the general knowledge of the prior art, in which Larsen established that collagen and chitosan are known biologically absorbable materials with hemostatic or wound healing effects (Larsen: [0194]-[0195]). Thus, an ordinary artisan seeking to provide a hydrogel that promoting wound healing would have looked to using a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel of Silvetti, as collagen and chitosan are known biomaterials used for forming hydrogel and are also known biologically absorbable materials with hemostatic or wound healing effects, per Gravagna and Larsen, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 2, as discussed above, Silvetti teaches D-2-deoxyribose.
Regarding claim 3, Silvetti teaches the composition contains starch hydrolysate and alginate (columns 5-7; claims 1, 2 and 6), which are natural polymers, thereby composition which carries the D-2-deoxyribose of Silvetti is biodegradable. Larsen teaches hydrogel containing natural polymers such as alginate is biodegradable (Larsen: [0383]).
Regarding claim 6, Larsen provides the guidance for using a crosslinked hydrogel as the carrier, as a crosslinked hydrogel is a known matrix material in the art useful for wound healing ([0381-[0385]).
Regarding claim 11, Silvetti teaches the composition further contains antibiotics (column 9, lines 38-50). Larsen teaches the hydrogel can contains antibiotics useful for wound healing ([0199], [0205], and [0234]).
Regarding claims 12-14, Silvetti teaches the wound is any skin or connective tissue trauma, such as thermal burns, pressure ulcers, ischemic ulcers, chemical and radiation burns, abscesses, fistulae, bone defects, malunion of fractures, vasculitis, tropical parasitic ulcers, leprosy ulcers, and acne or psoriasis lesions (column 3, lines 1-25), thereby meeting “chronic wound” of claim 12, “a full thickness wound” of claim 13, and “a burn injury” of claim 14.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Applicant argues by presenting a Declaration of Ian M. Brook under 37 C.F.R. §1.132 showing unpredictability of the art using Exhibits B-R provided therewith and alleging that “according to the Declaration, the use of small sugars in the claimed hydrogels for wound healing would not have been predictable before the filing of the present application at least because of the lack of predictability of the effects of small sugars on angiogenesis.” Applicant alleges that “Before the priority date of the present application, one skilled in the art would have known that D-deoxyribose sugars have a role in an angiogenesis, but it was not known or suggested that D- deoxyribose sugars would be efficacious at promoting angiogenesis in the context of wound healing. While angiogenesis is a key process in wound healing, the cellular environment around a wound is very different to the cellular environment in healthy, non-wounded tissue. Angiogenesis in healthy, non-wounded tissue is therefore not predictive of angiogenesis in wounded tissue.” Thus, Applicant alleges that based the above and the surprising results shown in the specification from Example 1, pages 23-26 and Figures 6A, and 8-10, “it would have not been predictable to a person skilled in the art that administering a D-deoxyribose sugar such as 2dDR to a wound would promote wound healing and angiogenesis. A person skilled in the art would have predicted that administering a D-deoxyribose sugar to a wound, where cells were already stressed and an inflammatory state, would increase inflammation and decrease healing around the wound, not increase wound healing as shown in the present application.” (Remarks, pages 4-7; Declaration, paragraphs 5-16).
In response, Applicant’s arguments and evidence of unpredictability of the art shown in the Declaration of Ian M. Brook under 37 C.F.R. §1.132 filed on 06/11/2026 are considered, but found insufficient to obviate the standing 103 rejection over the combined teachings of Silvetti, Larsen and Gravagna. The evidence of unpredictability of the art shown in the Brook Declaration, as well as, the evidence of unexpected results shown in the specification were thoroughly reviewed, but are not persuasive, because the claimed invention is drawn to a method of promoting wound healing by topically administering a D-deoxyribose sugar to a wound surface, wherein the sugar is provided a hydrogel carrier containing chitosan and collagen. As discussed in the standing 103 rejection, , Silvetti teaches a method of promoting wound healing comprising topically applying to a wound area a composition containing a therapeutically effective amount of D-2-deoxyribose (103 rejection, page 3 of this office action). Thus, Applicant’s evidence of unpredictability of the art shown in the Declaration of Ian M. Brook under 37 C.F.R. §1.132 are insufficient to obviate the standing 103 rejection because the evidence of unpredictability of the art provided in the Declaration is drawn to showing the inconsistency of small sugars ribose and glucose other than D-deoxyribose (e.g.,, 2-deoxy-L-ribose, deoxy-D-glucose, etc.) in promoting angiogenesis are not pertinent to issue of the claimed invention, as Silvetti teaches structurally the same sugar used in the claimed method, which is D-deoxyribose, and Silvetti also teaches the use of the structurally the same sugar as the claimed invention in promoting wound healing when topically applied to a wound area.
As previously discussed, it is reiterated that the results (Example 1 and Figures 7-9) shown in the specification of strong angiogenic properties using the claimed hydrogel and how the claimed hydrogel promotes wound healing by attaching to surrounding tissues with good mechanical strength at a wound site, closing the wound completely by day 17 after being placed there, are reasonably expected based on the teachings of the cited prior arts. As previously discussed, it is reiterated that it would have been obvious to one of ordinary skill in the art to use a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel of Silvetti, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Silvetti is drawn to using the hydrogel for antibacterial treatment and tissue regeneration during wound healing processes (Silvetti: column 3, lines 46-61), and Gravagna provided the guidance for using a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel, as hydrogel containing collagen and chitosan are well-known in the art for their optimal support for cell differentiation and growth and tissue regeneration, as collagen and chitosan have angiogenic and antibacterial properties (Gravagna: Abstract; [0004]-[0006], [0018]-[0019], [0028]-[0032], [0040]; Example 6), which is consistent with the general knowledge of the prior art, in which Larsen established that collagen and chitosan are known biologically absorbable materials with hemostatic or wound healing effects (Larsen: [0194]-[0195]). Thus, an ordinary artisan seeking to provide a hydrogel that promoting wound healing would have looked to using a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel of Silvetti, as collagen and chitosan are known biomaterials used for forming hydrogel and are also known biologically absorbable materials with hemostatic or wound healing effects, per Gravagna and Larsen. It is reiterated that chitosan and collagen are known in the prior arts for having angiogenic properties per Gravagna and Larsen supra, as well as, chitosan per Larsen is known for its adhesive properties (Larsen: [0218]). Thus, the use of a crosslinked mixture of collagen and chitosan as the biomaterials used for forming the hydrogel containing D-deoxyribose of Silvetti would be reasonable expected and predicted by the cited prior arts to provide a resultant hydrogel with improved wound healing properties due to known angiogenic properties of chitosan and collagen, as well as, the known bioadhesive properties of chitosan.
Accordingly, it is noted that the Examiner had provided a strong case of prima facie obviousness in the standing 103 rejection based on the combined teachings of Silvetti, Larsen, and Gravagna and thus, [e]ven though Applicant have presented evidence of unexpected results for secondary consideration; however, the submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987). Provided that a strong prima facie case of obviousness have been established based upon the teachings from Silvetti, Larsen, and Gravagna, it is noted that [a]lthough the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record also established such a strong case of obviousness that the allegedly unexpectedly superior results were ultimately insufficient to overcome obviousness conclusion. See, e.g., Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372, 82 USPQ2d 1321, 1339 (Fed. Cir. 2007). In addition, the courts have stated “given the strength of the prima facie obviousness showing, the evidence on secondary considerations was inadequate to overcome a final conclusion" of obviousness. See MPEP §2145 and §716.01(d). As a result, for at least the reasons discussed above and of record, Applicant’s objective indicia of nonobviousness is insufficient to obviate the strong obviousness rejection based on the combined teachings of Silvetti, Larsen, and Gravagna.
As a result, for at least the reasons discussed above, claims 1-3, 6, and 11-14 remain rejected as being obvious and unpatentable over the combined teachings of Silvetti, Larsen, and Gravagna in the standing 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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