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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 12/12/2025 has 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 12/12/2025 in which claims 4-5, 7-10, and 15-74 were canceled; and claim 1 was amended. All the amendments have been thoroughly reviewed and entered.
Claims 1-3, 6, and 11-14 are under examination.
Modified Rejection
Necessitated by Applicant’s Claim Amendments
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 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues that neither Silvetti nor Larsen teach or suggest a hydrogel that comprises chitosan and collagen. Applicant alleges “the present application demonstrates that a hydrogel comprising a chitosan (CS) and collagen that is loaded with a D-deoxyribose sugar is strongly angiogenic (Example 1, Figure 7).” Applicant alleges “[s]uch a hydrogel also 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. (Example 1, Figures 8, 9).” Applicant alleges “[b]ecause Silvetti and Larsen do not disclose a hydrogel of the amended claims, and because the Examples of Silvetti and Larsen disclose different hydrogels, that results of the claimed method of promoting wound healing would not have been predictable to a person of ordinary skill in the art.” (Remarks, pages 4-5).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, 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.
Applicant’s alleged the claimed hydrogel has strong angiogenic properties shown in Example 1 and Figure 7 of the specification, 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, as shown in Example 1 and Figures 8 and 9. However, while the results shown in specification are considered, said results are insufficient to obviate the pending 103 rejection because 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.
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 pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613