Detailed Notice
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 .
Response to Amendment
The amendment filed on 1/25/2026 has been entered into the prosecution of the instant application. Claims 2 and 11 are pending consideration.
Applicant’s amendment necessitate the new ground(s) of rejection presented in this application.
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.
Claim(s) 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over by Xu (CN102698313B) in view of Izumi (CN1240103C) further in view of Ansari (US 20190117840-A1) in further view of Emilio I. Alarcon, Klas Udekwu, Mårten Skog, Natalia L. Pacioni, Kevin G. Stamplecoskie, María González-Béjar, Naresh Polisetti, Abeni Wickham, Agneta Richter-Dahlfors, May Griffith, Juan C. Scaiano, “The biocompatibility and antibacterial properties of collagen-stabilized, photochemically prepared silver nanoparticles.” Biomaterials, 2012, Volume 33, Issue 19, Pages 4947-4956.
Regarding Claim 2, Xu teaches a method for forming an antimicrobial hydrogel for “biomedical materials” [Pg. 1, Lines 26-28] by irradiation of an aqueous solution containing a natural polymer and silver ions [Pg. 1, Lines 16-24]. Xu teaches that the natural polymer may be collagen [Pg. 3, Lines 31-38]. Xu teaches that the silver ion may be silver nitrate [Pg. 4, Lines 3-7]. Xu teaches that the natural polymer and the silver ions are mixed into an aqueous solution and then sealed and packaged for radiation crosslinking [Pg. 4, Lines 17-20]. Xu teaches that the radiation crosslinking may be produced by ultraviolet rays, where the range of light is 200-400 nm and the irradiation may occur between 30 minutes and 24 hours [Pg. 4, Lines 21-27]. Xu teaches that the weight percent of the natural polymer in the hydrogel is 3- 20% [Pg. 3, Lines 31-38] and that the silver-ion concentration in the hydrogel is 0.005% to 0.2% [Pg. 4, Lines 3-5] such that the molar ratio is from 1:15-600 of collagen to silver-ion.
However, Xu does not teach that the light source include incandescent lamps, fluorescent lamps, flashlights, and searchlights.
Izumi teaches a fluorescent lamp comprising a glass bulb and a light emitter (abstract).
Izumi teaches that the fluorescent lamp irradiates UV-A light in the range of 315-400 nm [Para. 74].
Prior to the filing of the present invention it would have been obvious to one having ordinary skill in the art that the known fluorescent lamp system of Izumi could be incorporated into the known method of collagen cross-linking of Xu, in order to arrive at a protein cross linking method that uses fluorescent lamps with an emission in the range of 315-400 nm (see MPEP 2143 I D).
Further, with regard to the ratio of Ag+ to protein in the solution being 1:10, which is further specified as being a ratio of concentration of protein as 5 mg/mL and AgNO3 at 0.5 mg/mL, the courts have broadly held that where the proportions are so close there exists a case of prima facie obviousness to one of ordinary skill, as it would be expected there would be the same properties to the solution (see MPEP 2144.05 I). This prima facie case of obviousness further extends to the recited barring a demonstration that the proportion of 1:15, as disclosed by Xu, would render the method inoperable, it is understood that Xu teaches to the present limitation of the require ratio of materials. Further, with regards to the reaction duration being 12hr, the courts have held broadly that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see 2144.05 II A). That is, prior to the filing date of the present invention, one of ordinary skill would have arrived at a reaction time of 12hrs and solution concentrations of 5 and 0.5 mg/mL of collagen and silver nitrate, respectively, in the collagen crosslinking method of Xu in view of Izumi as a matter of routine optimization.
However, Xu in view of Izumi does not teach that the reaction the cross-linked protein is obtained after centrifugation.
Ansari teaches a method for cross-linking human particles of biological tissue for tissue scaffold engineering [0001].
Ansari teaches that collagen can be used to form dermal replacement tissue, and that collagen can be made more mechanically robust via cross-linking [0002]. Ansari teaches that collagen can be milled, washed and sterilized, then crosslinked to form paste pellets [0121]. Ansari teaches that paste pellets can be removed from the crosslinking solution using centrifugation and further treated to form a dermal paste [0121]. Dermal pastes made in this way were shown to be excellent dermal replacement tissue [0122].
Prior to the filing of the present invention it would have been obvious to one of ordinary skill that the method for forming a tissue engineering scaffold, as per Xu, was ready for improvement by the incorporation of a post-reaction centrifugation process for the removal of reagents, as per Ansari, in order that one would arrive at a method for obtaining tissue engineering scaffold with improved applicability as a dermal replacement tissue.
However, Xu in view Izumi in view of Ansari does not teach that the temperature range of the reaction is 0 – 37 °C.
Alarcon teaches a method to form a silver nanoparticle laden collagen biocomposite with antibacterial properties [abstract].
Alarcon teaches that the synthesis of the silver nanoparticle collagen biocomposite is formed by irradiation, using UVA light (having a range of 200-400 nm [Section 3.2, Paragraph 1]), of an aqueous solution of silver nitrate with type 1 collagen at room temperature [Section 2.2.].
Prior to the effective filing date of the present invention it would have been obvious to one of ordinary skill that the room temperature thermal conditions for the aqueous solution, as per Alarcon, could be applied to the method of forming cross-linked collagen and silver nanoparticles, as per Xu in view Izumi in view of Ansari, with a reasonable expectation of success.
Regarding Claim 11, Xu teaches that one such use of the disclosed method use could be for tissue engineering scaffold [Pg. 4, Lines 34-38].
Response to Arguments
Applicant's arguments filed 1/25/2026 have been fully considered but they are not persuasive.
Applicant argues that the instant application concerns visible light from 380-750 nm, whereas Xu teaches 200-400 nm. Similarly, applicant argues that Xu teaches a specific wavelength at which the cross-linking is performed (see Remarks filed 8/2/2025 page 1 bottom paragraph). This is a piece-meal analysis of the disclosure of Xu, as set forth in the previous office action, Xu does disclose that the irradiation can be performed in the range of UVA light (200-400 nm) (Pg. 4, lines 21-27) which overlaps with the range required in the application. Applicant is correct in their identification that Xu does not teach light irradiation further into the visible light spectrum. However, the instant Claim 2, owing to its breadth, merely requires a solution containing the protein and silver ions to be irradiated with light from 400-750 nm to form the cross-linked protein. Xu teaches irradiation within this range (see Pg. 5, lines 14-18 and Example 1).
Applicant argues that the ratio of the protein and silver ions, the reaction time and the temperature are not disclosed by Xu. As laid out in the rejection above and in previous rejections, using the disclosure Xu one of ordinary skill would have found it obvious to arrive at these concentration values, reaction time, and temperature and as a matter of routine optimization routine optimization.
Further, applicant argues that Ansari does not teach to the centrifugation limitation of Claim 2, as Ansari singularly teaches the collagen. This is a piecemeal analysis of the 103 rejection laid forth in the previous and current rejection, as it is the application of the centrifugation to the method of making cross-linked polymers, as per Xu, that is occurring in the instant rejection of Claim 2. Ansari discloses the use of centrifugation for the separation of reactants from the cross-linked product, which is being imported to the method of Xu. Arguments further are not commensurate with the limitations required by the claim language.
Conclusion
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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NATHANAEL JASON. DOWNES
Examiner
Art Unit 1794
/NATHANAEL JASON DOWNES/Examiner, Art Unit 1794
/BRIAN W COHEN/Primary Examiner, Art Unit 1759