DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Status
Applicant’s arguments and amendments dated 12/18/25 have been received and entered in the application.
Claims 15-32 are currently pending and examined on the merits
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
Claim Interpretation
With respect to claims 27-29, 32, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of a composition or apparatus is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. For example, “is an implant” and “is implanted” do not clearly define a structural limitation of the apparatus or composition. Consequently, these limitations are not considered in analyzing the patentability of the apparatus or composition.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 15-17, 21-29, 31-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bragd et al., (Feb 2004) TEMPO-mediated oxidation of polysaccharides: survey of methods and applications. Topics in Catalysis, 27(1-4): pp. 49-66 ( cited on IDS dated 8/3/22, hereinafter Bragd) as evidenced by Forget et al., (6 Aug 2013) Polysaccharide hydrogels with tunable stiffness and provasculogenic properties via α-helix to β-sheet switch in secondary structure. Proceedings of the National Academy of Sciences, 110(32): pp. 12887-12892 (cited on IDS dated 8/3/22, hereinafter Forget) and Ogawa et al., (2004) Three D structures of chitosan. International Journal of biological Macromolecules. 34(1-2): pp. 1-8 (cited on IDS dated 8/3/22 hereinafter Ogawa) and in view of Lam et al., US Publication No. 2004/0235027 (cited on IDS dated 8/3/22, hereinafter Lam).
Regarding claims 15-17, 21, 24-26, Bragd discloses reviews the use of (2,2,6,6-tetramethylpiperidin-1-yl)oxyl (TEMPO) as a catalyst in the oxidation of alcohols to functional groups in various polysaccharides (Abstract). Bragd explains that the use of TEMPO allows for the selective oxidation of primary alcohol groups into aldehydes and/or carboxylic acid groups (Introduction). Bragd discloses that the natural polysaccharides pullulan, chitosan, hyaluronan (hyaluronic acid), among others, have been oxidized using TEMPO with yields of >95%, 91% and 100% oxidation respectively (Section 4.2, Table 3; preparations with less than 100% oxidized polysaccharide are interpreted as a blend of oxidized (modified) and non-oxidized (non-modified) polysaccharide).
Bragd is silent as to the shear modulus of the resultant composition. Bragd is also silent as to the formation of at least a partial β-sheet structure. However, Bragd discloses utilizing natural polysaccharide hydrogels with α-helical backbones (See for example Ogawa, which discloses that chitosan, chitin and cellulose (polysaccharides explicitly described in Bragd) demonstrate a helical backbone) which have at least 91% oxidized functional groups (Section 4.2, Table 3). Further, as evidenced by Forget, both formation of at least a partial β-sheet structure and a shear modulus of between 10 Pa and 107 Pa is an inherent result of the TEMPO-mediated oxidation of alcohols to functional groups in polysaccharides with α-helical backbones (See Carboxylation promotes a β-sheet secondary structure). Forget also discloses that the degree of carboxylation results in changes to the shear modulus of the hydrogels, with magnitudes between 3.6 x 104 to 6 Pa (α-Helix to β-sheet reorganization of the polymer backbone enables tailoring of modulus of gels, Fig. 4). See MPEP §§ 2131.01 and 2112 regarding the use of references to demonstrate an inherent characteristic.
Bragd does not disclose that the polysaccharide may be agarose .
Lam discloses methods of modifying biopolymers for tissue engineering applications (Abstract). Lam explains that biopolymers, such as agarose, may be modified for use as cell scaffolds ([0006], [0009]). Lam discloses oxidizing agarose by using a TEMPO catalyzed reaction, followed by ketone modification and binding of a bioactive ligand, such as peptides or nucleic acids ([0145]-[0147], [0159]-[0163]).
As both Bragd and Lam disclose modifying polysaccharides with an α-helical structure using a TEMPO catalyzed reaction, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to combine the references for the tissue engineering applications suggested by Lam.
Regarding claims 22-23, Lam discloses that oxidation is followed by ketone modification and binding of a bioactive ligand, such as peptides or nucleic acids ([0145]-[0147], [0159]-[0163]).
Regarding claims 27-29, 32, Lam discloses that the matrix is useful for supporting cell growth and proliferation, and for the production of tissues such as skin, nerves, or other organs ([0148]-[0151]).
Regarding claim 30, the combination does not disclose that the composition is injectable. However, as per MPEP § 2112.01, where the claimed and prior art products are identical or substantially identical in structure or composition, claimed properties or functions are presumed to be inherent. Therefore, the combination of Bragd and Lam is presumed to be injectable.
Regarding claim 31, neither Bragd nor Lam explicitly discloses that the composition includes cells. However, Lam explains that the composition provides “a unique growth environment for unique cells, such as stem cells” and “other cells” ([0148]). Lam also explains that any cell that can be maintained in tissue culture may be useful in the invention ([0137]). Therefore, there is a suggestion in Lam that stem cells and somatic cells may be included in the composition.
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 15-21, 27-29, 31-32 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 11 of U.S. Patent No. 11,407,978. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are both directed to a composition comprising a modified agarose with at least partial β-sheet structure, wherein at least 11% of the disaccharide units of the agarose, and wherein the modified agarose has a shear modulus G′ in the range of from 10 Pa to 107 Pa.
Claims 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-34 of U.S. Patent No. 10,968285. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are both directed to a composition comprising a modified polysaccharide with at least partial β-sheet structure, wherein at least 11% of the disaccharide units of the agarose, and wherein the modified polysaccharide has a shear modulus G′ in the range of from 10 Pa to 107 Pa. The broader scope
Response to Arguments
Applicant's arguments dated 12/18/25 have been fully considered but are not persuasive as explained in detail below.
Claims 15-17, 21-29, 31-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bragd as evidenced by Forget and Ogawa and in view of Lam.
Applicant argues that one of ordinary skill in the art would not combine Bragd with Forget as Forget does not disclose a redox reaction facilitated by TEMPO (Response p6-7). Applicant argues that the teachings of Ogawa are limited to chitosan, and the teachings cannot be extrapolated to agarose (Response p7).
On a preliminary note, it appears that applicants have misunderstood the rejection. The references used as a basis for the obviousness rejection are Bragd in view of Lam. Forget and Ogawa are merely used as evidence references to demonstrate inherent characteristics of polysaccharide hydrogels; they are not used as teaching references to obviate the claims. Specifically, Ogawa is utilized to demonstrate that chitosan, chitin, and cellulose display a helical backbone, i.e., an inherent characteristic of the polysaccharides. Forget is used to demonstrate that partial β-sheet structure and a shear modulus of between 10 Pa and 107 Pa is an inherent result of the TEMPO-mediated oxidation of alcohols to functional groups in polysaccharides with α-helical backbones.
Applicant argues that one of ordinary skill in the art would have no rational reason to look at Bragd as it does not mention agarose (Response p5-6). Applicant argues that it is not clear how the teachings of Lam cure the deficiencies noted in the other references as the claims do not recite ketone modifications or binding of bioactive ligands (Response p7).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of Bragd and Lam teaches that polysaccharides comprising an α-helical structure, such as agarose, may be modified using a TEMPO catalyzed reaction to selectively oxidize primary alcohol groups into carboxylic acid groups produce a polysaccharide with at least a partial β-sheet structure. The combination further teaches
With respect to applicant’s arguments as to binding of bioactive ligands, claims 22 and 23 are directed to covalently coupling peptides or nucleic acids to the carboxylic acid groups, i.e., binding bioactive ligands to the composition. Therefore, applicant’s arguments are considered spurious.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KARA D JOHNSON/Primary Examiner, Art Unit 1632