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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 May 2026 has been entered.
Claim Status
Applicant’s claim amendments filed 19 May 2026 are acknowledged.
Claims 1, 9-12, 14, 16, 17 & 19-21 are pending.
Claim 21 is new.
Claims 2-8, 13, 15 & 18 are cancelled.
Claims 1, 19 & 20 are amended.
Claims 9-12 & 14 is withdrawn.
Claims 1, 16, 17 & 19-21 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
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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.
Objections/Rejections
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, 16, 17 & 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto [(US 6,638,538; Published: 10/28/2003; previously cited); as evidenced by Zhao (US 2018/0126677; Published: 05/10/2018; previously cited)] in view of Priewe (US 2004/0091603; Published: 05/13/2004; previously cited).
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 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 1, 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 1, 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 1, 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 Examples 1 & 12 teaches sodium hyaluronate and the second polymer were present in the same amount (i.e. 0.5 mass % and 1% mass; col. 6, ll. 50-65; col. 14 & 15). With regard to claims 1, 19, 20 & 21, more broadly, Hashimoto teaches “the blend ratio of the aqueous solution or dispersion containing hyaluronic acid and a polymer… is not particularly limited, so long as a hyaluronic acid gel composition can be obtained by freezing and unfreezing this liquid. For example, the blend ratio as an adhesion preventive, is preferably from 50:1 to 1:20” (i.e. the concentration of PEG is the same or greater than the concentration of hyaluronic acid; i.e. col 5, ll. 1-10). With regard to claims 1, 19, 20 & 21, given that Hashimoto teaches the ratio of hyaluronic acid to second polymer/PEG encompasses a 1:1 ratio, and a 1:1 ratio is an obvious place to start optimization, and Hashimoto teaches sodium hyaluronate in an amount of 2.5% or less, the ordinary skilled artisan would immediately envisage PEG in an amount of 2.5% or less (col. 5, ll. 1-5). This assertion is supported by Hashimoto’s Example 12 teaching of 1% sodium hyaluronate and 1% sodium carboxymethyl cellulose/second polymer in a 1:1 ratio (col. 14-15). As such the ordinary skilled artisan would immediately envisage a range of PEG being present in an amount between 1.0 mass % by simple substitution of one second polymer for another. Hashimoto teaches the compositions of their invention are implantable and are spongy (i.e. porous; Example 1-col. 6; Example 11-col. 11).
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 Hashimoto’s 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 hyaluronic acid and PEG and the concentration of hyaluronic acid and PEG, 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, 6, 15-17, and 20 under 35 U.S.C. § 103 over Hashimoto [as evidenced by Zhao], Applicant argues the molecular weight/concentrations of hyaluronic acid and PEG and the energy irradiation must be satisfied to form a hydrogel (reply, pg. 5-6, 8 & 9). Applicant argues the specification shows unpredictability in ascertaining which conditions the hydrogel are formed and there is a lack of expectation of success (reply, pg. 7). Applicant argues that simple substitution of PEG would not lead to predicable results (reply, pg. 10). Applicant argues that while Hashimoto teaches forming a gel composition with gamma rays, electron rays, plasma and the like, Hashimoto does not provide one of ordinary skill in the art with any guidance how to do so with any reasonable expectation of success (reply, pg. 7).
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.
With regard to the Applicant’s arguments pertaining to the molecular weight and teach away as it pertains to the molecular weight of PEG, the teachings of Hashimoto and Priewe suggest the molecular weight PEG recited by amended claim 1 for use in implantable gels. Priewe clearly points to 20 kDa PEG in an implantable gel formed from irradiation.
With regard to Applicant’s arguments pertaining to forming the hydrogel using gamma rays, electron rays, plasma and the like, Applicant is arguing unrecited features as it pertains to method of making the composition. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, the invention under examination is the composition and not the method of making.
Lastly, Hashimoto teaches freeze-thawing, gamma rays, electron rays, plasma and the like are used to create the gel. "[A] specification need not disclose what is well known in the art.’" Id. (quoting Genentech, Inc.v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997)); see also AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1244 (Fed. Cir. 2003). “Not everything necessary to practice the invention need be disclosed.” Trs. of Bos. Univ. v. Everlight Elecs. Co., LTD., 896 F.3d 1357, 1364 (Fed. Cir. 2018). Hashimoto is also a US patent and “[p]rior art is presumed to be operable/enabling” (MPEP 2121. I). A person of ordinary skill through routine optimization would alter the freeze-thaw conditions and the radiation conditions to achieve a gel because Hashimoto teaches these techniques are suitable for gel formation. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 550 U.S. .....82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at __, 82 USPQ2d at 1396.
Applicant argues the criticality of ranges and points to Example 1 on page 17 through page 33 of the instant specification to demonstrate the conditions a hydrogel may be provided (reply, pg. 9). Applicant further argues that neither Hashimoto nor Zhao teach the criticality of the ranges (reply, pg. 9).
This is not persuasive. The experiments are not commensurate with the scope of the claims in that the experimental results were achieved using 100 kDa hyaluronic acid in a concentration between 0.1-1% and 3-35 kDa PEG in a concentration of 1% using an electron beam irradiation to achieve a gel (specification-pg. 17-25). The molecular weights of hyaluronic acid and concentrations of hyaluronic acid and PEG examined are more narrow than what is claimed. In other words, the claims are not commensurate with the scope of claim 1. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
The examiner notes that the experiments on page 26-32 suggest that electron beam energy matters for the formation of the gel. It is noted that the beam energy is unrecited.
Applicant is also reciting known polymers (i.e. PEG and hyaluronic acid) known for producing intra- and/or inter-molecular crosslinks in molecular weights and concentrations known as suitable for producing a gel. Basically, Applicant has confirmed that the art recognized reagents, molecular weights, concentrations and techniques known to produce gels without a cross-linking agent or organic solvent work. The Federal Circuit concluded that “[g]ood science and useful contributions do not necessarily result in patentability.” Id. at 1364, 83 USPQ2d at 1304.(MPEP 2145).
Lastly, Applicant has not compared their invention to the closest prior art which is Hashimoto. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 16, 17, & 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 3-10 are of copending Application No. 18/272,951 (hereinafter ‘951; claims-05/22/2026) in view of Hashimoto (US 6,638,538; Published: 10/28/2003). Both the instant claims and the ‘951 recite a hydrogel comprising PEG and hyaluronic acid in overlapping amounts. The molecular weights of the PEG and the hyaluronic acid are overlapping. The PEG and the hyaluronic acid are recited to be inter-molecularly cross-linked, intra-molecularly cross-linked, or inter-molecularly and intramolecularly cross-linked. The ‘951 recites the crosslinking occurs by irradiation and does not require/recite inclusion of crosslinking agents or organic solvents (i.e. the cross-linking agent does not contain a crosslinking agent or an organic solvent). The ‘951 does not teach a particle size, nanoparticle, microparticle or a method of micronizing, as such the hydrogel of the ‘951 is reasonable a bulk hydrogel. The ‘951 does not recite the salt of hyaluronic acid is sodium hyaluronate. The teachings of Hashimoto are described above. It would have been prima facie obvious before the effective filing date to have modified the hydrogel recited by the ‘951 composition by substituting the hyaluronic acid with sodium hyaluronate as suggested by Hashimoto because the ‘951 and Hashimoto are directed to hyaluronic acid hydrogels comprising PEG which are inter-molecularly cross-linked or intra-molecularly cross-linked by irradiation 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 pick a hyaluronate which is art recognized as suitable for forming hydrogels when combined with PEG and irradiated. With regard to the recited molecular weights of PEG and hyaluronic acid, and the recited amounts of PEG and hyaluronic acid, the combined teachings/recitations of ‘951 and Hashimoto suggest these parameters which overlap or fall within the recited range. 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).
The copending claims are therefore an obvious variant of the conflicting, copending claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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
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