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 .
Claims 14, 17, 19-30 and 32-37 are pending in this application, Claims 29, 30, 33, 34 and 35 are acknowledged as withdrawn, Claims 14, 17, 19-28, 32, 35 and 37 were examined on their merits.
The rejection of Claims 14, 19, 20, 23, 24, 26, 27, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
The rejection of Claims 14, 17, 19, 20, 23, 24, 26, 27, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and Fisher (2025), both of record, and further in view of Narcisi et al. (2012), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
The rejection of Claims 14, 19, 20, 21, 23, 24, 26, 27, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and Fisher (2025), both of record, and further in view of Pomohac (WO 2008/086147 A1), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
The rejection of Claims 14, 19, 20, 22, 23, 24, 26, 27, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and Fisher (2025), both of record, and further in view of Kaps et al. (2002), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
The rejection of Claims 14, 19, 20, 23, 24, 25, 26, 27, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and Fisher (2025), both of record, and further in view of Shi et al. (2013), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
The rejection of Claims 14, 19, 20, 23, 24, 26, 27, 28, 32 and 35 under 35 U.S.C. § 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and Fisher (2025), both of record, and further in view of Stockwell et al. (1967), of record, has been withdrawn due to the Applicant’s amendments to the claims filed 07/06/2026.
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.
Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012) as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
Son et al. teaches a method (of forming artificial cartilage) wherein chondrocytes isolated from rabbits (subjects) (Pg. 4, Paragraph [0056]) are cultured/passaged in adherent 2D culture in an FGF containing (dedifferentiation) medium to obtain MSC-like dedifferentiated cells (Pg. 13, Claims 1-2 and Pg. 12, Paragraph [0209]), and reading on Claim 14, step i) and Claim 27 and Claim 32, step i) ;
then culturing the MSC-like dedifferentiated cells in a chondrogenic (redifferentiation) medium that does not contain FGF in a chitosan-based 3D scaffold in chondrogenic medium for 2 weeks (14 days) (Pg. 13, Claim 3 and Pg. 3, Paragraph [0044] and Pg. 13, Claim 5 and Pg. 7, Paragraph [0104] and Pg. 12, Paragraphs [0211]&[0215] and Fig. 29), and reading on Claim 14, steps ii) and iii) and Claim 26.
It would be inherent in the method of Son et al. that the chondrocytes cultured in dedifferentiation media are cultured under adherent conditions because they are treated with trypsin-EDTA upon reaching confluence (Pg. 6, Paragraph [0083]). Kaur et al. evidences that trypsin-EDTA is used for the enzymatic detachment of adherent cells (Pg. 119, Column 2, Lines 9-13).
The teachings of Son et al. were discussed above.
Son et al. did not teach a method wherein the MSC-like dedifferentiated cells are cultured for 2-10 days in an adherent monolayer/2D culture system in an FGF-2 free redifferentiation medium and wherein the dedifferentiation medium comprises FGF-2 and the redifferentiation/maturation culture medium is free of FGF-2, as now required by Claim 14, step ii);
wherein the redifferentiation/maturation culture medium comprises TGF-ß, as required by Claim 19;
wherein the redifferentiation/maturation culture medium comprises TGF-B3, as required by Claim 20;
wherein the dedifferentiation medium comprises serum, as required by Claim 23; wherein the induction/maturation medium comprises insulin, transferrin and selenium, as required by Claim 24;
wherein hyaline cartilage tissue is produced in spheroid form in vitro and administered in a therapeutically effective amount to the subject, as now required by Claim 32, steps ii) and iii);
wherein the produced hyaline cartilage tissue is a spheroid and presents glycosaminoglycan (GAG) content of between 10 and 100ug/spheroid, as required by Claim 35;
or wherein the produced hyaline cartilage tissue has a diameter of 1-2 mm and comprises between 50,000-250,000 cells, as now required by Claim 37.
Buchtova et al. teaches that FGF activates WNT/B-catenin signaling in chondrocytes and specifically exemplifies FGF2 (Pg. 841, Paragraph 2.1 and Lines 33- 36).
Caron et al. teaches the redifferentiation of chondrocytes in 2D (monolayer) culture for 7 days (and does not indicate the medium contains FGF-2), and wherein 2D redifferentiation systems are less laborious, require a lower cell count and have better reproducibility than redifferentiation in 3D culture systems (Abstract 288).
It would have been obvious to those of ordinary skill in the art to modify the method of Son et al. of first culturing chondrocytes in adherent 2D culture in an FGF containing (dedifferentiation) medium and then culturing the MSC-like dedifferentiated cells in a chondrogenic (redifferentiation) medium that does not contain FGF in a chitosan-based 3D scaffold in chondrogenic medium to include a further step of redifferentiating the chondrocytes in a 2D monolayer, as taught by Caron et al. before 3D culturing because of the advantages of adding such a step. Those of ordinary skill in the art would have been motivated to make this modification because Caron et al. teaches that 2D redifferentiation systems are less laborious, require a lower cell count and have better reproducibility than redifferentiation in 3D culture. There would have been a reasonable expectation of success in making this modification because both references are drawn to the redifferentiation of chondrocytes.
It would have been further obvious to those of ordinary skill in the art before the
effective filing date of the claimed invention to modify the method of Son et al. wherein chondrocytes are cultured/passaged in an FGF containing dedifferentiation medium to obtain MSC-like dedifferentiated cells (Pg. 13, Claims 1-2) to use FGF2 as taught by
Buchtova et al. because the method of Son et al. is not limited to any particular FGF
and Buchtova et al. teaches that FGF2 is a suitable FGF for use on chondrocytes.
Those of ordinary skill in the art would have been motivated to make this modification in
order to treat chondrocytes with a suitable FGF. There would have been a reasonable
expectation of success in making this modification because Son et al. treats
chondrocytes with FGF generally and Buchtova et al. teaches the treatment of
chondrocytes with FGF2 specifically.
With regard to the limitation of Claim 14, step i) of "a dedifferentiation culture medium that activates Wnt signaling pathway to obtain chondrocytes with a morphology of fibroblastic-like cells", Son et al. teaches that during in vitro expansion chondrocytes become morphologically fibroblastic shaped (Pg. 5, Paragraph [0070]). Son et al. further teaches the chondrocyte dedifferentiation medium contains FGF. Buchtova et al. evidences that FGF2 activates the canonical Wnt pathway in chondrocytes (Pg. 839, Abstract). Thus, it would be inherent in the method of Son et al. that the FGF treated, in vitro cultured chondrocytes would have a morphology of fibroblastic-like cells.
With regard to the limitation of Claim 14, step ii) of "an FGF-2 free redifferentiation medium that inactivates Wnt signaling pathway", Caron et al. teaches re-differentiating dedifferentiated chondrocyte cells in a 2D scaffold in a medium that does not contain FGF. Thus, it would be inherent in the method of Caron et al. that the 2D cultured redifferentiated cells would maintain the inactivation of the Wnt signaling pathway as claimed. See above, where Buchtova et al. evidences that FGF/FGF2 activates the canonical Wnt pathway in chondrocytes (Pg. 839, Abstract), thus the absence of FGF would be expected to maintain inactivation of the Wnt signaling pathway.
With regard to the limitation of Claim 14, step iii) of "induction/maturation medium that maintain the inactivation of Wnt signaling pathway", Son et al. teaches loading the re-differentiated cells on a chitosan-based 3D scaffold in a medium that does not contain FGF. Thus, it would be inherent in the method of Son et al. that the 3D cultured differentiated cells would maintain the inactivation of the Wnt signaling pathway as claimed. See above, where Buchtova et al. evidences that FGF/FGF2 activates the canonical Wnt pathway in chondrocytes (Pg. 839, Abstract), thus the absence of FGF would be expected to maintain inactivation of the Wnt signaling pathway.
With regard to Claims 19 and 20, Son et al. teaches the redifferentiation/maturation culture medium comprises TGF-β3 (Pg. 7, Paragraph [0104]).
With regard to Claim 23, Son et al. teaches dedifferentiation medium is Cambrex MSCGM-FGF (Pg. 6, Paragraph [0081]). Fisher evidences that Lonza (formerly Cambrex) MSCGM contains FBS (Pg. 1, Specifications).
With regard to Claim 24, Son et al. teaches the induction/maturation medium comprises insulin, transferrin and selenium (ITS+3) (Pg. 7, Paragraph [0104]).
With regard to Claims 27 and 32, Son et al. teaches the isolation of chondrocytes
from rabbit subjects (Pg. 5, Paragraph [0075]).
With regard to Claim 32, Son et al. teaches producing cartilage tissue in vitro
(Pg. 6, Paragraph [0088]) and administering a therapeutically effective amount to a
subject (Pg. 7, Paragraph [0120] and Pg. 8, Paragraph [0145]).
With regard to Claim 35, Son et al. teaches the cartilage tissue produced is
hyaline (Pg. 11, Paragraph [0188]), is in the form of a spheroid (Fig. 16) and presents a
GAG content of about 0.4-0.9 µg/300µl (Fig. 18B).
With regard to Claim 37, while the references listed above do not specifically
teach the limitation wherein the produced hyaline cartilage tissue has a diameter of 1-2mm and comprises between 50,000 to 250,000 cells, one of ordinary skill in
the art would recognize that the diameter of the produced hyaline cartilage and the number of cells therein is a result-effective variable. Son et al. teaches that the 3D scaffold in which the redifferentiated chondrocytes are cultured are 4 mm x 2mm and are initially seeded with 2 x 106 chondrocytes (Pg. 8, Paragraph [0131]). This is a starting point for the determination of a useful scaffold diameter and cell number range which encompasses the claimed ranges. This is motivation for someone of ordinary skill in the art to practice or test the scaffold diameter and cell number values widely to find those that are functional or optimal to sufficiently provide a suitable cartilage scaffold which then would be inclusive or cover the instantly claimed values. Absent any teaching of criticality by the Applicant concerning the diameter of the produced cartilage tissue and the cell number therein, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are an optimizable variable which can be met as a matter of routine optimization (see MPEP § 2144.05 (II)(B). Those of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make this modification in order to obtain culture of chondrocytes with the desired number of cells. There would have been a reasonable expectation of success in making this modification because Son et al. is drawn at least to the in vitro culture of differentiated chondrocytes in a scaffold which produce hyaline cartilage tissue (Pg. 11, Paragraph [0188]) in the form of a spheroid (Fig. 16) and contain a certain amount of chondrocytes.
Claims 14, 17, 19, 20, 23, 24, 26, 27, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012),as applied to Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 above, and further in view of
Narcisi et al. (2012), of record, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The teachings of Son et al., Caron et al. and Buchtova et al. were discussed above.
None of the above references taught a method wherein the dedifferentiation medium further comprises at least one growth factor selected from the group consisting of: PDGF-BB, EGF and TGF-B, as required by Claim 17.
Narcisi et al. taught a method wherein chondrocytes are treated with a
dedifferentiation medium comprising FGF-2, EGF and PDGF-BB (Pg. 1153, Column 1,
Lines 52-60).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Son et al., Caron et al. and Buchtova et al. wherein chondrocytes are cultured/passaged in an FGF-2 containing dedifferentiation medium to obtain MSC-like dedifferentiated cells to further include EGF and PDGF-BB in the dedifferentiation medium as taught by Narcisi et al. because the prior art recognizes these growth factors along with FGF-2 as suitable components for chondrocyte dedifferentiation media. Those of ordinary skill in the art would have been motivated to make this modification in order to treat chondrocytes with a suitable dedifferentiation medium. There would have been a reasonable expectation of success in making this modification because Son et al. treats chondrocytes with FGF to induce dedifferentiation, Buchtova et al. teaches treating chondrocytes with FGF-2 to induce dedifferentiation, and Narcisi et al. teaches treating chondrocytes with FGF-2, EFG and PDGF-BB to induce dedifferentiation.
Claims 14, 19, 20, 21, 23, 24, 26, 27, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012),as applied to Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 above, and further in view of Pomohac (WO 2008/086147 A1), of record, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The teachings of Son et al., Caron et al. and Buchtova et al. were discussed above.
None of the above references taught a method wherein the redifferentiation medium further comprises TGF-B and FGF-7, as required by Claim 21.
Pomohac teaches a "chondroinductive agent" or "chondroinductive factor" refers to any natural or synthetic, organic or inorganic chemical or biochemical compound or combination or mixture of compounds, or any mechanical or other physical device, container, influence or force that can be applied to any cells, progenitor cells or stem cells so as to effect their in vitro differentiation, for example into chondrocytes or cartilage or the production of cartilaginous tissue, wherein the chondroinductive agent may be TGF-β3 and Keratinocyte Growth Factor (KGF or FGF-7) (Pgs. 10-11, Paragraph [0044]).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Son et al., Caron et al. and Buchtova et al. wherein MSC-like dedifferentiated cells are cultured in a chondrogenic (redifferentiation) medium to include TGF-β and FGF-7 as taught by Pomohac because the reference teaches that TGF-β and FGF-7 are known chondroinductive/differentiation agents.
Those of ordinary skill in the art would have been motivated to make this modification because Son et al. teaches a redifferentiation medium to induce chondrocyte differentiation and Pomohac teaches that TGF-β and FGF-7 are known agents to induce chondrocyte differentiation.
Claims 14, 19, 20, 22, 23, 24, 26, 27, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012),as applied to Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 above, and further in view of Kaps et al. (2002), of record, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The teachings of Son et al., Caron et al. and Buchtova et al. were discussed above.
None of the above references taught wherein the redifferentiation medium
comprises platelet lysate, as required by Claim 22.
Kaps et al. teaches that treatment of chondrocytes treated with platelet lysate
(PL) showed stimulated growth and that PL is suitable for chondrocyte expansion (Pg.
485m Abstract).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Son et al., Caron et al. and Buchtova et al. wherein MSC-like dedifferentiated cells are cultured in a chondrogenic
(redifferentiation) medium to include platelet lysate in the medium as taught by Kaps et
al. because the reference teaches that PL is known to stimulate chondrocyte growth in
vitro. Those of ordinary skill in the art would have been motivated to make this
modification with a reasonable expectation of success because Son et al. teaches a redifferentiation medium to induce chondrocyte differentiation and Kaps et al. teaches that PL will stimulate the growth of those chondrocytes in culture.
Claims 14, 19, 20, 23, 24, 25, 26, 27, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012),as applied to Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 above, and further in view of Shi et al. (2013), of record, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The teachings of Son et al., Caron et al. and Buchtova et al. were discussed above.
None of the above references taught wherein the 3D cultured chondrocytes are
cultured in hypoxia atmosphere comprising less than 10% O₂ (v/v), as required by Claim
25.
Shi et al. teaches that 3D chondrocyte spheroids cultured under hypoxic
conditions (5% O₂) exhibit positive effects on the sustaining of chondrocytes phenotype
and expressions of collagen Il and aggrecan at protein and gene levels, indicating the
essential roles of biomimetic microenvironment in vitro in maintaining the tissue specific
functions in cartilage. Both hypoxic condition and 3D construction were prerequisite for in vitro cartilage engineering and tissue repair. It is also clinically necessary to select the superior chondrocytes by providing the physiologically relevant microenvironment before chondrocyte implantations (Pg. 5, Column 1, Lines 10-22).
It would have been obvious to those of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Son et al., Caron et al. and Buchtova et al. wherein redifferentiated chondrocyte cells are cultured on a chitosan based 3D scaffold to further culture the cells under hypoxia as taught by Shi et al. because the reference teaches 3D culture and hypoxia are necessary for sustaining chondrocytes phenotype in vitro and mimicking in vivo conditions. Those of ordinary skill in the art would have been motivated to make this modification because Son et al. teaches the 3D culture of redifferentiated chondrocytes and Shi et al. teaches that hypoxic and 3D culture conditions are necessary for chondrocytes to maintain their phenotype in vitro, which is necessary for in vivo applications.
There would have been a reasonable expectation of success in making this modification because at least both Son et al. and Shi et al. are both drawn to the same field of endeavor, the culture of chondrocytes.
Claims 14, 19, 20, 23, 24, 26, 27, 28, 32, 35 and 37 are newly rejected under 35 U.S.C.§ 103 as being unpatentable over Son et al. (US 2017/0274018 A1), in view of
Buchtova et al. (2015), both cited in the IDS, and evidenced by Kaur et al. (2015) and
Fisher (2025), both of record, and further in view of Caron et al. (2012),as applied to Claims 14, 19, 20, 23, 24, 26, 27, 32, 35 and 37 above, and further in view of Stockwell et al. (1967), of record, as necessitated by Applicant’s amendments to the claims filed 07/06/2026.
The teachings of Son et al., Caron et al. and Buchtova et al. were discussed above.
None of the above references taught wherein the chondrocytes are isolated from
human cartilage tissue, as required by Claim 28.
Stockwell teaches that human beings have chondrocyte containing costal
cartilage (Pg. 753, Abstract),
It would have been obvious to those of ordinary skill in the art before the
effective filing date of the claimed invention to modify the method of Son et al., Caron et al. and Buchtova et al. wherein chondrocytes are obtained from rabbit costal cartilage to use human costal cartilage as taught by Stockwell because both sources are recognized chondrocyte containing cartilage. Those of ordinary skill in the art would have been motivated to make this modification because both rabbit and human costal cartilage are recognized sources of chondrocytes. There would have been a reasonable expectation of success in making this modification because both rabbit and human cartilage contains the cells of interest.
Response to Arguments
Applicant’s arguments, see Remarks, filed07/06/2026, with respect to the rejection(s) of claim(s) 14, 17, 19-28, 32, 35 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Caron et al. (2012), as set forth above.
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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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