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 .
Claim Status
Applicant’s claim amendments filed 08 August 2025 are acknowledged.
Claims 1, 5, 6, 9-12 & 14-20 are pending.
Claims 2-4, 7, 8 & 13 are cancelled.
Claims 15-20 are new.
Claims 1, 5 & 6 are amended.
Claims 9-12 & 14 is withdrawn.
Claims 1, 5, 6, & 15-20 are under consideration.
Examination is to the extent of the following species:
Type of Irradiation-Electron beams; -and-
2) Type of Biomedical Device-sheet type wound dressing
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 September 2025 has been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Withdrawn Objections/Rejections
The objection of the abstract is withdrawn due to amendments which delete legal phraseology.
The objection to claim 4 and the rejection of claim 4 under 35 USC 112(b), 35 USC 112(d) and 35 USC 103(a) is withdrawn due to cancellation of the claim.
The objection to claim 5 is withdrawn due amendments which use the abbreviation, PEG.
The rejection of claims 1-7 under 35 U.S.C. 103 as over Yoo (WO 2017/126939) and claim 8 under 35 U.S.C. 103 over Yoo and further in view of Al-Assaf (Published: 2016) is withdrawn due to Applicant’s amendments to recite a bulk hydrogel. Yoo is a nanogel or a nanohydrogel.
Objections/Rejections
Claim Objections
Claims 5, 6, 19 & 20 are objected to because of the following informalities: Claims 5, 6, 19 & 20 recite “(w/v)”. Parenthetical expressions are asides and are not a part of the main subject. Units of measurement are important and should be “w/v”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, 6, & 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 recites “the hydrogel does not contain a cross-linking agent, a curing agent, or an organic solvent”. Applicant does not state where support for the amendment is found. MPEP 2163.II. states “Applicant should ... specifically point out the support for any amendments made to the disclosure.”. Support for the hydrogel not having an organic solvent or cross-linking agent is present at page 15 of the specification “Advantageous Effects”. However, Applicant only discusses a curing agent in the “Background Art” section; this is only in relation to what others have done and not what Applicant has done. As a result, the claim changes the scope of the disclosure thereby introducing new matter.
Claims 5, 6, & 15-20 are rejected under 35 USC 112(a)-New Matter because they ultimately depend from rejected claim 1.
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.
Claims 1, 6, 15-17 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto [(US 6,638,538; Published: 10/28/2003); as evidenced by Zhao (US 2018/0126677; Published: 05/10/2018)] .
With regard to claims 1, 16 & 17, Hashimoto in Example 1 teaches admixing sodium hyaluronate and sodium carboxymethyl cellulose in distilled water, the mixture was frozen, thawed and a spongy hyaluronic acid gel was obtained (col. 6, ll. 50-65). Hashimoto teaches polyethylene glycol and carboxymethyl cellulose are suitable polymers capable of forming the gel and supplementing the inherent properties for the physical properties required for a medical material which cannot be satisfied by the hyaluronic acid gel alone (col. 4, ll. 18-60). It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified by Hashimoto’s Example 1 gel by substituting Hashimoto’s sodium carboxymethylcellulose with polyethylene glycol because these are taught as suitable polymers capable for forming the gel for medical applications. As evidenced by Zhao, freeze thawing of long chain network polymers which may be polyethylene glycol result in cross linking (Zhao’s claims 5 & 9; [0012]; intra-molecularly cross-linked). Further, Hashimoto teaches irradiating the inventive hyaluronic acid gel composition (Hashimoto’s-claim 8; col. 5, ll. 35-60). As evidenced by pg. 1, of the as filed specification, biocompatible hydrogels are prepared by inducing inter-molecular and/or intra-molecular cross-linking of hyaluronic acid and polyethylene glycol “merely by irradiating radiation”. With regard to claim 1, Hashimoto’s gel does not contain a cross-linking agent, curing agent, or organic solvent as required by claim 1. With regard to claim 1, Hashimoto teaches the hyaluronic acid gel composition can be formed into a sheet-like structure by putting the composition in a flat bottom container (i.e. bulk gel; col. 3, ll. 60-70). With regard to claim 6, Hashimoto teaches the molecular weight of the hyaluronic acid is about 1 x105 to about 1 x 107 Da and further teaches the hyaluronic acid is 2x106 Da or higher (i.e. 100 KDa-10,000KDa; 2,000 KDa or higher; col. 4, ll. 5-15; col. 5, ll. 1-10). With regard to claim 15, as such, the ordinary skilled artisan would immediately envisage the molecular weight of the hyaluronic acid being present in a range of about 100 KDa to 2,000 KDa (col. 4, ll. 5-15; col. 5, ll. 1-10). With regard to claim 6, Hashimoto teaches “[e]specially when hyaluronic acid having a molecular weight of 2x106 Da or higher, is used, the concentration of the hyaluronic acid is preferably 2.5 mass % or lower” (col. 5, ll. 1-5). With regard to claim 20, Hashimoto in Example 1 teaches sodium hyaluronate and the second polymer were present in the same amount (i.e. 0.5 mass %; col. 6, ll. 50-65).
While there is not a single example comprising each of the claimed components, the hyaluronic acid, and second polymer which may be polyethylene glycol for the gel are included among short lists of reagents. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
With regard to molecular weight of the hyaluronic acid, concentration of hyaluronic acid, and concentration of PEG, Hashimoto’s teaches these parameters with values which overlap or fall within the claimed ranges. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 5, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto [as evidenced by Zhao] as applied to claims 1, 6, 15-17 & 20 above, and further in view of Priewe (US 2004/0091603; Published: 05/13/2004).
Hashimoto teaches the compositions of their invention are implantable and are spongy (i.e. porous; Example 1-col. 6; Example 11-col. 11). Hashimoto in Example 1 teaches the second polymer, which may be PEG in an amount of 0.5 mass % (col. 6, ll. 50-65). Hashimoto in Example 6 teaches inclusion of 1.0 mass % of the second polymer (col. 12-Example 10 ). As such the ordinary skilled artisan would immediately envisage a range of second polymer being present in an amount between 0.5 and 1.0 mass % (Examples 1 & 10- Example 1-col. 6 & 12).
Hashimoto does not teach the molecular weight of PEG.
In the related field of porous medical implants comprising polyethylene glycol that is crosslinked by irradiation to produce a hydrogel, Priewe teaches a molecular weight of greater than 20,000, preferably greater than 100,000 and particularly preferably greater than 1,000,000 (i.e. 20 kDa, preferably greater than 100 kDa, and particular preferably 1,000 kDa; title; abstract; [0017]). Priewe teaches the molecular weight of the PEG has an effect on the crosslinking with irradiation by teaching “ as a rule, the smaller the energy dose of gamma ray required to cross-link the hydrogel element, the greater the molecular weight of the starting substances. As a result, a higher molecular weight results in a smaller radiation load for the material of the basic structure” [0017].
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rational (B) may be employed in which it would have been prima facie obvious before the effective filing date to have modified Hashimoto’s porous/spongy PEG containing medical implant by substituting the generically taught PEG with Priewe’s PEG having a molecular weight of greater than 20 kDa because Hashimoto and Priewe are both drawn to porous/spongy implantable gels comprising PEG and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use PEG with a molecular weight suitable for porous/spongy gels.
With regard to molecular weight of the PEG and the concentration of PEG, the combined teachings of Hashimoto and Priewe suggest these parameters with values which overlap or fall within the claimed ranges. 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
In the traverse of the rejection of claims 1-7 under 35 USC 103 over Yoo, Applicant argues Yoo is not available as prior art because Yoo is drawn to hydrogel nanoparticles and the claims are now directed to a bulk hydrogel (reply, pg. 7 & 8). Applicant further argues that Yoo made bulk hydrogels with carboxymethyl dextran and PEG and compares their reaction conditions to that of Yoo (reply, pg. 8 & 9).
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner notes that Yoo teaches away from formation of bulk hydrogels.
Applicant argues Al-Assaf is not applicable prior art because it is used to reject claim 8 and claim 8 has been cancelled (reply, pg. 9).
This was found persuasive. Al-Assaf has not been used in the new grounds of rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619