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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/16/2026 has been entered.
Response to Amendment
The Amendment filed 02/16/2026 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 10/24/2025 (note the new Examiner for this Application, where continuity of rationale will continue as much as possible, but style may slightly differ due to process specific practices). Furthermore, with regard to the approach to the Application within this Office Action, “there is nothing unusual, certainly, about an examiner changing his viewpoint as to the patentability of claims as the prosecution of a case progresses, and so long as the rules of Patent Office practice are duly complied with an applicant has no legal ground for complaint because of such change in view. The life of a patent solicitor has always been a hard one. In re Ruschig, 154 USPQ 118, 120-21 (CCPA 1967).” In this case, the difference in search and interpretation of the Prior Art has led to a modified approach to the instant claim set.
Applicant’s claims have been amended in the following manner: independent claims 1 and 19 demonstrate modification of the “wherein” clause (that finds support in Applicant’s Specification at [0032]).
The following objections/rejections are withdrawn: the claim objections to claims 7-9 (based on amendment), and the 112(b) of claim 14 (due to cancellation of the claim).
The Examiner further acknowledges the following:
Claims 1-2, 4-13, and 15-19 are pending.
Claims 1-2, 4-13, and 15-19 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 13, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gatenholm (WO2020035734A1; published 2/20/2020 compared to 07/31/2020 provisional filing date; WO publication Assignee is Cellheal AS).
Applicant’s claims are directed to an injectable aqueous dispersion comprising cellulose nanofibrils, wherein the cellulose nanofibrils are biocompatible and derived from or originate from a tunicate or tunicates, wherein the aqueous dispersion undergoes shear thinning during injection, and wherein the aqueous dispersion comprising the cellulose nanofibrils is configured to form a crosslinked hydrogel in situ based on interaction of the cellulose nanofibrils, or the cellulose nanofibrils combined in the injectable aqueous dispersion with one or more additional biopolymer, with physiological divalent cations, physiological calcium ions, or combinations thereof.
Gatenholm teaches 3D graft compositions that comprise nanofibrillar cellulose (Gatenholm – claims 1-34.
Regarding claim 1 and 19: Gatenholm discloses an injectable aqueous [0006] dispersions (abstract) comprising disintegrated lipoaspirate and biocompatible cellulose nanofibrils (CNF) with shear thinning properties (abstract) that is crosslinked (Gatenholm – claims 1-3), and a method of injection said dispersion (abstract). The 3D construct formed (e.g., the composition formed from tunicate nanofibrillar cellulose, from Gatenholm – claim 4) is further crosslinked either in situ at the implantation site or before implantation (abstract), and further mechanism is described by the crosslinking in the presence of calcium ions (reads on calcium ions of instant claims 1 and 19) (Gatenholm – claims 10, 13, and 14).
Regarding claim 2: Gatenholm teaches carboxymethylation or oxidation of the nanofibrillar cellulose (Gatenholm – claim 13).
Regarding claim 4: The nanofibrillar cellulose is derived from tunicates, bacteria, and/or plants, whereby no additional calcium and/or cation is required (Gatenholm – claim 4).
Regarding claims 5-6: Gatenholm teaches incorporation of alginate (Gatenholm – claim 10).
Regarding claim 13: Gatenholm teaches incorporation of human or animal lipoaspirate-derived adipose tissue (reads on cells) (Gatenholm – claim 1).
Regarding claim 17: Gatenholm teaches a fibril length 0.1-5 microns for the nanofibrillar cellulose (Gatenholm – claim 5).
Regarding claim 18: Gatenholm teaches a dispersion having a solid content greater than 1.5% and less than 4% by weight (Gatenholm – claim 6).
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 1-2, 4-13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gatenholm (WO2020035734A1), as applied to claims 1-2, 4-6, 13, and 17-19, in further view of Bacakova (Versatile Application of Nanocellulose, 2019).
As discussed above, Gatenholm teaches injectable compositions comprising cellulose nanofibrils for therapeutic use. However, Gatenholm does not teach controlled release of one or more pharmaceutical and/or drugs (instant claims 7-9), or controlled release of one or more growth factors and/or signaling molecules (instant claim 10-12).
Bacakova teaches that nanocellulose nanofibril compositions have a wide range of biomedical applications like controlled drug delivery, including by diffusion (pg 9, paragraphs 1-3), for therapeutic effect in various tissue locations (abstract) or application of growth factors (pg 15-16) to further improve therapeutical effect. In order to repair skin defects, nanocellulose can incorporate growth factors (pg 15-16; nanocellulose as a carrier for cell delivery into skin defects). Nanocellulose can also adapt to 3D structures (abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Gatenholm to incorporate a pharmaceutical, drug, or growth factor for controlled release, as taught by Bacakova, because nanocellulose nanofibril compositions have a wide range of biomedical applications like controlled drug delivery, including by diffusion (pg 9, paragraphs 1-3), for therapeutic effect in various tissue locations (abstract) or application of growth factors (pg 15-16) to further improve therapeutical effect, whereby Gatenholm teaches that cellulose nanofibril based compositions can allow for nutrient diffusion (i.e., “controlled release”) and neovascularization (i.e., a therapy of sorts) (abstract), whereby fat grafts also have roles in other forms of treatments [0003] that would benefit from drug and/or growth factor exposure (i.e., to correct soft tissue contour deformities in reconstructive and aesthetic surgery (abstract)).
Claims 1-2, 4-6, 13, and 15-19, are rejected under 35 U.S.C. 103 as being unpatentable over Gatenholm (WO2020035734A1), as applied to claims 1-2, 4-6, 13, and 17-19, in further view of Frenguelli (WO 2019/122351 A1).
As discussed above, Gatenholm teaches injectable compositions comprising cellulose nanofibrils for therapeutic use. However, Gatenholm does not teach the hydrogel is bioconjugated with one or more adhesion protein, one or more other molecule affecting cell adhesion, or combinations thereof (instant claim 15-16).
Frenguelli teaches CELLINK RGD is a suitable bioink for 3D bioprinting of human tissues and scaffolds, that offers the same 3D environment as CELLINK bioink (i.e., a nanofibrillated cellulose dispersion (pg 17, line 24; pg 18 lines 6-7), whereby the biofunctionalization of RGD motifs (RGD = a covalently conjugated L-Arginine-Glycine-L- Aspartic Acid peptide sequence) improves cell attachment (pg 21, lines 20-22). Therefore, the RGD motif grafted to the nanofibrillated cellulose dispersion reads on “the aqueous dispersion is bioconjugated with…one or more other molecule(s) affecting cell adhesion” (reads on instant claims 15-16).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Gatenholm to incorporate a bioconjugated RGD motif as taught by Frenguelli, because these conjugated motifs improve cell attachment for nanofibrillated cellulose dispersions (pg 21, lines 20-22). Furthermore, Gatenholm has interest in the 3D grafts surviving implantation [0024] and the predetermined implantation site (abstract). Note that, in claim 16, whereby the composition is injected into targeted area is an intended use of the composition, and does not provide patentable weight for a composition claim.
Response to Arguments
Applicants arguments, see pg 6-9, filed 02/16/2026, with respect to the 102 and 103 rejection of claims 1-2, 4-19 under rejection have been fully considered but they are not persuasive. The 102 and 103 rejections have been modified with respect to amendments made to the claim set (i.e., the narrowing by including “one or more additional biopolymer, with physiological divalent cations, physiological calcium ions, or combinations thereof” in claim 1).
On page 6, Applicant describes modifications to the claim scope to address the claim objections and 112 rejection, where were found acceptable.
On page 6-7, Applicant argues that (1) Gatenholm at [0029-0030] requires “addition of 0.1 M CaCl2 solution” (in contrast to Applicant’s disclosure that is directed to an embodiment that relies on endogenous calcium only), which is problematic because the addition of 0.1 M calcium ions can damage cells (i.e., note that this statement regarding calcium ion damage has not been supported by objective evidence from Applicant, because Gatenholm demonstrates example 3, which adds calcium ions, as suitable for injection [0029-0030]), and (2) Applicant claims Gatenholm does not teach crosslinking of endogenous calcium ions because the concentration of physiological calcium ions would be insufficient for gelation within Gatenholm’s teachings.
In response to point (1): Gatenholm makes no requirement of “addition of 0.1 M CaCl2 solution” as demonstrated by example 3 [0029-0030], because Gatenholm’s claims do not require specific calcium amounts (i.e., concentration) used in the composition (especially, Gatenholm – claim 4, for a composition that comprises a nanofibrillar cellulose that is derived from tunicates…). Applicant points to an embodiment of the Art, that does not represent the Gatenholm’s teachings as a whole. Note that specific embodiments do not define the teachings: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Thus, in contrast to Applicant’s focus on example 3 [0029-0030], the Examiner points to Gatenholm – claim 4, where there is no calcium required, and Gatenholm – claims 10 and 13-14, which do not restrict the amount of calcium (i.e., concentration) used in the composition.
While Applicant claims Gatenholm’s compositions would not gel in the presence of endogenous CaCl2 concentrations (i.e., as evidenced by Farkas (IBCC, 2026), this concentration is estimated by the Examiner to be around 1-3.5 mM within human physiology (pg 3, Table)), Applicant provides no objective evidence in support of this position.
As a counterpoint, as evidenced by Fiorati (Materials, 2020), TEMPO-oxidized cellulose nanofibers (abstract; pg 3, Figure 1) undergo ion-driven crosslinking (pg 3, Figure 1) via demonstration of dynamic viscosity increases at even 2 mM (pg 7, Figure 3), which is within the range of ionized calcium levels found in humans (as evidenced by Farkas). Thus, in contrast to Applicant’s arguments, the objective evidence (i.e., TEMPO-oxidized cellulose nanofibers relate to the cellulose nanofibrils of instant claim 2, which are TEMPO oxidized) supports crosslinking of Gatenholm’s compositions in the presence of endogenous concentrations of CaCl2 (e.g., about 2 mM), as an expected outcome. Note that any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Consequently, we must determine whether the results obtained in the closest prior art and those set forth by Applicants are sufficiently different in kind, and not merely in degree, so as to be unexpected by a person of ordinary skill in the art at the time of invention. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (Unexpected results that are probative of nonobviousness are those that are "different in kind and not merely in degree from the results of the prior art") (citation omitted). Thus, the evidence is counter to Applicant’s position, until further objective evidence and/or argument is provided.
Furthermore, there is no limitation in instant claim 1, that excludes additional calcium ions. Limitations are being argued that are not claimed: Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims). Thus, the arguments are based on unclaimed limitations.
Furthermore, even in an embodiment of Gatenholm’s composition with added calcium ions, one would still expect “physiological calcium ions” of instant claim 1 to participate in crosslinking of any non-crosslinked nanofibrils, as Fiorati demonstrates that a further increase in cross-linking occurs (i.e., marked by viscosity increase), based on increasing calcium ion levels (pg 7, Figure 3).
Finally, Gatenholm teaches that the “…3D construct formed is further crosslinked either in situ at the implantation site…” (abstract), thus teaching cross-linking in situ with endogenous cations and/or calcium. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). Thus, the statement of the abstract above, implicitly teaches cross-linking in situ with endogenous cations and/or calcium, with the nanofibrillar cellulose that is derived from tunicates, bacteria, and/or plants (Gatenholm – claim 4). Farkas and Fiorati evidentiary information demonstrate that Gatenholm’s in situ crosslinking at the implantation site would necessarily occur.
In response to point (2): Just because Gatenholm is silent on a specific configuration of the disclosure (i.e., explicitly stating induction of crosslinking specifically relying only on endogenous CaCl2) does not represent a teaching away. In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The art does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner. Furthermore, with regard to the claims under 102 rejection, teaching away is irrelevant for a 102 rejection.
Furthermore, Gatenholm teaches that the “…3D construct formed is further crosslinked either in situ at the implantation site…” (abstract), thus teaching cross-linking in situ with endogenous cations and/or calcium, as evidenced by the Prior Art.
On page 8, Applicant differentiates the instant claim scope from Bacakova and Frenguelli by reciting specific differences of each reference. Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). Note that Bacakova and Frenguelli demonstrate analogy to the instant claim scope by being directed to cellulose nanofibril compositions for injection for therapeutic benefit.
Furthermore, an obviousness analysis is based on the combined teachings: One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Thus, Gatenholm complements Bacakova and Frenguelli to teach the limitations of the entire instant claim scope, based on the rationale of the 102 and 103 rejections above.
On pg 9, Applicant concludes, but the claims remain under rejection.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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, Ali Soroush can be reached on 571-272-9925. 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.
/R.P./Examiner, Art Unit 1614 6/29/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
Prosecution Insights