DETAILED ACTION
This action is in reply to papers filed 7/30/2026. Claims 1-27 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240318143A1, Published 9/26/2024.
Withdrawn Claim Objections
The objection to claims 9 and 20 is withdrawn in view of amendments to said claims.
Withdrawn Claim Rejections
The 102 (a)(1)/(a)(2) rejection of claim(s) 1, 3-5, 7 and 10-14 as being anticipated by Gobaa et al. (PgPub US20200385659A1, Published 12/10/2020) is withdrawn in view of amendments to independent claim 1.
The 102 (a)(1)/(a)(2) rejection of claim(s) 18-19, 21 and 23-24 as being anticipated by Griffith et al. (PgPub US20210087534A1, Published 3/25/2021 ) is withdrawn in view of amendments to independent claim 18.
The 35 U.S.C. 103 (a) rejection of claim(s) 2, 6, 8-9 and 17 as being unpatentable over Gobaa et al. (PgPub US20200385659A1, Published 12/10/2020) as applied to claims 1, 3-5, 7 and 10-14 and further in view of Ulbricht et al. (PgPub US6515039B1, Published 2/4/2003), Lutolff et al. (PgPub US20180258403A1, Published 9/13/2018) and Kaur et al. ( WO2022236061A1, Published 11/10/2022; Ref. A1 in IDS filed 8/22/24) is withdrawn in view of amendments to independent claim 1.
The 35 U.S.C. 103 (a) rejection of claim(s) 15-16 as being unpatentable over Gobaa et al. (PgPub US20200385659A1, Published 12/10/2020) as applied to claims 1, 3-5, 7 and 10-14 and further in view of Baptista et al. (Tissue Eng Part C Methods. 2016 Feb 12;22(3):199–207) is withdrawn in view of amendments to independent claim 1.
The 35 U.S.C. 103 (a) rejection of claim(s) 20, 22 and 25-26 as being unpatentable over Griffith et al. (PgPub US20210087534A1, Published 3/25/2021) as applied to claims 18-19, 21 and 23-24 and further in view of Kaur et al. (WO2022236061A1, Published 11/10/2022; Ref. A1 in IDS filed 8/22/24) is withdrawn in view of amendments to independent claim 18.
The 35 U.S.C. 103 (a) rejection of claim 27 as being unpatentable over Griffith et al. (PgPub US20210087534A1, Published 3/25/2021), Kaur et al. (WO2022236061A1, Published 11/10/2022; Ref. A1 in IDS filed 8/22/24) and Skardal (PgPub US20210324311A1, Published 10/21/2021) is withdrawn in view of amendments to independent claim 1.
Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Prior Art Rejection 1
Claim(s) 1-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gobaa et al. (PgPub US20200385659A1, Published 12/10/2020; previously cited), Kaur et al. (PgPub US20220389374A1, Published 12/8/2022), Ulbricht et al. (PgPub US6515039B1, Published 2/4/2003; previously cited) and Lutolff et al. (PgPub US20180258403A1, Published 9/13/2018; previously cited).
Gobaa teaches polydimethylsiloxane base was mixed with a curing agent in a ratio of 1:10. Then the obtained solution was vigorously stirred for 3 min and degassed by keeping it under vacuum for another 30 min. The obtained mixture was poured into a petri dish containing the microfabricated mold without introducing new bubbles. Finally, the cast PDMS was baked for 2 hours at 80° C. in order to obtain a fully cross-linked replica of the soft lithography printed (as in claim 10) microfabricated master(~ 3D article of claim 1) (Pg. 12,para. 179). Gobaa teaches that once the PDMS has cured, a scalpel and a small spatula were used to remove the PDMS from its mold. Gobaa teaches the PDMS body was then exposed to an oxygen plasma for 1 min. Continuing, Gobaa teaches prior to the preparation of a hydrogel, the PDMS body was first incubated in a 10 mM dithiothreitol (DTT) solution (as in claim 3 and claim 12) for a minimum of 10 minutes in order to reduce the disulphide bonds at the surface of the PDMS body (~reactive groups as in claim 1) (Pg. 12,para. 180-182).
Gobaa teaches hydrogels were then prepared by mixing stock solutions of two different functionalized polyethylene glycol (PEG) macromonomers of 10 kDa. Specifically, four-arm thiol- (functionalized peptides~ as further in claim 1 and as in claim 4) and eight-arm vinylsulfone-functionalized PEG macromeres were mixed using a stoichiometric ratio insuring an excess of 1.2 mM of vinylsulfone. Typically, 50 μl of 7.5% (w/v) PEG hydrogels were obtained by mixing 10.1 μl of PEG-VS (12% w/v), 21.2 μl of PEG-SH (12% w/v) and 18.7 μl of triethanolamine (TEA) buffer (0.3 M, pH 7.5 ~ buffered solution as in claim 5) (Pg.12, para. 182).
Gobaa adds that a thiol- activated PDMS body was then gently pressed onto the surface of the hydrogel so that the hydrogel covers completely the two channels of the PDMS body as in claim 1b). The assembly was then left for one hour at room temperature in order for the excess vinylsulfone groups of the hydrogel and the thiols of the PDMS surface to covalently react. Once bonded, the two pieces were carefully separated, with the hydrogel transferred to the surface of the PDMS body(Pg. 12, para. 183).
Gobaa teaches that in order to confirm that the obtained hydrogel deformation affected the cells seeded on both faces of the hydrogel layer, the hydrogel layer was functionalized with a fibronectin fragment (as in claim 7 and claim 11) (Pg. 11, para. 170). Gobaa teaches before seeding the cells as in claim 13,in-part, the device was assembled in a custom made holder. Before placing the device the reservoir was filled with EGM2 medium while ensuring no air bubbles were trapped. The device was then placed with the hydrogel facing the reservoir (as in claim 14,in-part) (Pg.13, para. 187). Once a monolayer was obtained, the upper microfluidic channel of the device was connected to a glass syringe containing Caco2 medium. Continuous perfusion was started by connecting the syringe to a pump system. Both flow rates and periods were adjusted to vary the strain on the hydrogel layer. Each experiment was typically carried out over a period of 7 days (as in claim 14) (Pg. 13, para. 188). Gobaa teaches this demonstrates that PEG hydrogels could be functionalized with fibronectin and other ECM proteins (Pg. 11,para. 167).
However, Gobaa fails to teach the functionalized peptides comprise SEQ ID NO: 2 (as in claim 1(a)) and SEQ ID NO: 3 (as in claim 9).
Before the effective filing date of the claimed invention, Kaur et al. teach a printed hydrogel comprising bioink to support cell attachment, proliferation, and spreading. Kaur teaches compounds in the bioink may be modified to incorporate chemical functionality, such as by chemical synthesis means (Abstract). Kaur teaches the printable composition may also include a poly(ethylene glycol) di-(meth)acrylate monomer. The printable composition may include one or more mono- or di-(meth)acrylated ECM or ECM- like material (Pg. 2, para. 12).
Ine embodiment, Kaur teaches the hydrogel is functionalized with at least one synthetic peptide (Pg. 3, para. 30).
The alignment between SEQ ID NO: 2 (Qy, query) (as in claim 1a) and the synthetic peptide taught by Kaur et al. (Db, database) is provided below.
RESULT 1
US-17-738-694-27
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 27, US/17738694
Publication No. US20220389374A1
GENERAL INFORMATION
APPLICANT: LUNG BIOTECHNOLOGY PBC
TITLE OF INVENTION: USE OF FUNCTIONALIZED AND NON-FUNCTIONALIZED ECMS, ECM FRAGMENTS,
TITLE OF INVENTION: PEPTIDES AND BIOACTIVE COMPONENTS TO CREATE CELL ADHESIVE 3D
TITLE OF INVENTION: PRINTED OBJECTS
FILE REFERENCE: 080618-2084
CURRENT APPLICATION NUMBER: US/17/738,694
CURRENT FILING DATE: 2022-05-06
PRIOR APPLICATION NUMBER: 63/185,293
PRIOR FILING DATE: 2021-05-06
NUMBER OF SEQ ID NOS: 30
SEQ ID NO 27
LENGTH: 17
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
peptide
Query Match 100.0%; Score 100; Length 17;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PHSRNGGGKGGRGDSPY 17
|||||||||||||||||
Db 1 PHSRNGGGKGGRGDSPY 17
The alignment between SEQ ID NO: 3 (Qy, query) (as in claim 9) and the synthetic peptide taught by Kaur et al. (Db, database) is provided below.
RESULT 1
US-17-738-694-25
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 25, US/17738694
Publication No. US20220389374A1
GENERAL INFORMATION
APPLICANT: LUNG BIOTECHNOLOGY PBC
TITLE OF INVENTION: USE OF FUNCTIONALIZED AND NON-FUNCTIONALIZED ECMS, ECM FRAGMENTS,
TITLE OF INVENTION: PEPTIDES AND BIOACTIVE COMPONENTS TO CREATE CELL ADHESIVE 3D
TITLE OF INVENTION: PRINTED OBJECTS
FILE REFERENCE: 080618-2084
CURRENT APPLICATION NUMBER: US/17/738,694
CURRENT FILING DATE: 2022-05-06
PRIOR APPLICATION NUMBER: 63/185,293
PRIOR FILING DATE: 2021-05-06
NUMBER OF SEQ ID NOS: 30
SEQ ID NO 25
LENGTH: 7
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
peptide
Query Match 100.0%; Score 43; Length 7;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GGGERCG 7
|||||||
Db 1 GGGERCG 7
And although none of these references teach washing unreacted functionalized peptides- in order to product purity- such would have been prima facie obvious to skilled artisan. Note also that, in order to maintain hydrogel purity, it would have been prima facie obvious to remove unreacted functionalized peptides from the hydrogel (as in claim 2).
However, neither Gobaa nor Kaur nor teach the concentration of functionalized peptides is from about 0.02 μmol per cm2 on the surface of the 3D article to about 8.00 μmol per cm2 on the surface of the 3D article (as in claim 6).
Before the effective filing date of the claimed invention, Ulbricht et al. teach a continuous polymeric solid phase supporting material is prepared, the material comprising a matrix of a supporting polymeric material and graft copolymer chains covalently bound to the supporting matrix, the graft copolymer chains having reactive groups being able to react with organic compounds, thereby forming spatially defined reaction sites (Abstract). Ulbricht teaches the requirements for the functional surface with respect to synthesis are that the reactive groups be present in large quantity (at least up to 1 μmole/cm2) (as in claim 6) and with good, constant accessibility (over all synthesis steps for the target molecules) (Col. 4, lines 25-37).
And although none of Gobaa, Kaur et al. and Ulbricht et al. teach functionalized peptides comprises binding domains for integrin and syndecan (as in claim 8), this deficiency is cured by Lutolff et al. who teaches a three-dimensional hydrogel of an organoid lung(as in claim 17 ) (Pg. 8,para. 102). Lutolff teaches said hydrogel may be rendered biofunctional by incorporation of one or more biofunctional molecules that constitute the intestinal extracellular matrix, including but not limited to integrin-binding RGD containing peptides (Pg. 2,para. 21) and Syndecan-I (proteoglycan) (Pg. 10, para. 125) or peptides containing the adhesion sequences within these molecules(as in claim 8).
When taken with the teachings of Gobaa, wherein Gobaa teaches a functionalized hydrogel, one of ordinary skill in the art would have found it prima facie obvious to require the functional groups of the hydrogel to comprise a large quantity of the surface area, as set forth in Ulbricht, so that it reacts with the reactive groups of the PDMS body. The skilled artisan would have had a reasonable expectation of success given Lutolff’s teachings. It would have been prima facie obvious to also include the teachings of Kaur who teach a printed hydrogel comprising bioink to support cell attachment, proliferation and spreading.
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 2
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gobaa et al. (PgPub US20200385659A1, Published 12/10/2020; previously cited), Kaur et al. (PgPub US20220389374A1, Published 12/8/2022), Ulbricht et al. (PgPub US6515039B1, Published 2/4/2003; previously cited) and Lutolff et al. (PgPub US20180258403A1, Published 9/13/2018; previously cited) as applied to claims 1-14 and 17 and further in view of Baptista et al. (Tissue Eng Part C Methods. 2016 Feb 12;22(3):199–207; previously cited).
Baptista teaches modeling of human liver development, especially cellular organization and the mechanisms underlying it, is fundamental for studying liver organogenesis and congenital diseases, yet there are no reliable models that mimic these processes ex vivo (Abstract). Using an organ engineering approach and relevant cell lines, Baptista and colleagues teach a total of 60 million cells were seeded per scaffold at different flow rates. Cell seeding was carried through multiple intervals of cell injections into the culture media, with 4 h in between injections. Baptista teaches system perfusion at 6 mL/min delivers the cells into the scaffold through portal vein circulation (as in claim 15 and claim 16) (Pg. 200, Col. 2, para. 1).
When taken with the teachings of Gobaa, wherein Gobaa teaches a functionalized hydrogel, one of ordinary skill in the art would have found it prima facie obvious to perfuse the hydrogel with cells at 6 mL/min delivers the cells, because Baptiste teaches such is suitability for modeling liver.
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 3
Claim(s) 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (PgPub US20210087534A1, Published 3/25/2021; previously cited) and Kaur et al. (PgPub US20220389374A1, Published 12/8/2022).
Regarding claim 18, Griffith et al. teach a synthetic hydrogel cell culture matrix comprising biodegradable polymers and binders comprising one or more adhesion ligands and one or more peptide binders. Griffith teaches the one or more peptide binders are one or more extracellular matrix (ECM) protein-binding peptides covalently bonded to the polymers (Pg. 10, para. 116) via cysteine bridge via a thiol-acrylate Michael addition reaction (as in claim 24) (Pg. 15-16, para. 195). Griffith teaches the least one of the binders is an ECM protein-binding peptide comprises a peptide having affinity to fibronectin, collagen, laminin, other basement membrane proteins, or combinations thereof (as further in claim 18 and as in claim 19) (Pg. 7,para. 88). Griffith teaches induced pluripotent stem cells are disposed on the surface of the scaffold (as in claim 21 and claim 23) (Pg. 13, para. 163).
However, Griffith fails to teach the plurality of peptides comprises SEQ ID NO: 2 (as further in claim 18) and SEQ ID NO: 3 (as in claim 20).
Before the effective filing date of the claimed invention, Kaur et al. teach a printed hydrogel (as in claim 25, in-part) (Abstract) comprising bioink to support cell attachment, proliferation, and spreading. Biologically active peptides were synthesized by performing Michael-type reactions to link the peptide to one or more (meth)acrylate monomer or polymer (as further in claim 25) (Pg. 10,para. 78). Kaur teaches compounds in the bioink may be modified to incorporate chemical functionality, such as by chemical synthesis means (Abstract). Ine embodiment, Kaur teaches the hydrogel comprises lung smooth muscle cells (as in claim 22) (Pg. 10, para. 85) and is modeled after a lung (as in claim 26).
Note that although Kaur does not ipsis verbis teach adult primary lung fibroblasts, such would have been prima facie obvious to model adult lungs. Kaur teaches the printable composition may also include a poly(ethylene glycol) di-(meth)acrylate monomer. The printable composition may include one or more mono- or di-(meth)acrylated ECM or ECM- like material (Pg.1, para. 7-8). The printable composition may include one or more mono- or di-(meth)acrylated ECM or ECM- like material (Pg. 2, para. 12). Ine embodiment, Kaur teaches the hydrogel is functionalized with at least one synthetic peptide (Pg. 3, para. 30).
The alignment between SEQ ID NO: 2 (Qy, query) (as in claim 18) and the synthetic peptide taught by Kaur et al. (Db, database) is provided below.
RESULT 1
US-17-738-694-27
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 27, US/17738694
Publication No. US20220389374A1
GENERAL INFORMATION
APPLICANT: LUNG BIOTECHNOLOGY PBC
TITLE OF INVENTION: USE OF FUNCTIONALIZED AND NON-FUNCTIONALIZED ECMS, ECM FRAGMENTS,
TITLE OF INVENTION: PEPTIDES AND BIOACTIVE COMPONENTS TO CREATE CELL ADHESIVE 3D
TITLE OF INVENTION: PRINTED OBJECTS
FILE REFERENCE: 080618-2084
CURRENT APPLICATION NUMBER: US/17/738,694
CURRENT FILING DATE: 2022-05-06
PRIOR APPLICATION NUMBER: 63/185,293
PRIOR FILING DATE: 2021-05-06
NUMBER OF SEQ ID NOS: 30
SEQ ID NO 27
LENGTH: 17
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
peptide
Query Match 100.0%; Score 100; Length 17;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PHSRNGGGKGGRGDSPY 17
|||||||||||||||||
Db 1 PHSRNGGGKGGRGDSPY 17
The alignment between SEQ ID NO: 3 (Qy, query) (as in claim 20) and the synthetic peptide taught by Kaur et al. (Db, database) is provided below.
RESULT 1
US-17-738-694-25
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 25, US/17738694
Publication No. US20220389374A1
GENERAL INFORMATION
APPLICANT: LUNG BIOTECHNOLOGY PBC
TITLE OF INVENTION: USE OF FUNCTIONALIZED AND NON-FUNCTIONALIZED ECMS, ECM FRAGMENTS,
TITLE OF INVENTION: PEPTIDES AND BIOACTIVE COMPONENTS TO CREATE CELL ADHESIVE 3D
TITLE OF INVENTION: PRINTED OBJECTS
FILE REFERENCE: 080618-2084
CURRENT APPLICATION NUMBER: US/17/738,694
CURRENT FILING DATE: 2022-05-06
PRIOR APPLICATION NUMBER: 63/185,293
PRIOR FILING DATE: 2021-05-06
NUMBER OF SEQ ID NOS: 30
SEQ ID NO 25
LENGTH: 7
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
peptide
Query Match 100.0%; Score 43; Length 7;
Best Local Similarity 100.0%;
Matches 7; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GGGERCG 7
|||||||
Db 1 GGGERCG 7
And although neither Griffth et al. nor Kauer et al. teach washing unreacted functionalized peptides- in order to derive a product having a purity- such would have been prima facie obvious to skilled artisan.
When taken with the teachings of Griffith et al., wherein Griffith teaches a synthetic hydrogel cell culture matrix comprising one or more ECM protein-binding peptides having affinity to fibronectin, it would have been prima facie obvious to use the fibronectin of Kaur who teach a printed functionalized hydrogel comprising bioink to support cell attachment, proliferation and spreading.
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 4
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (PgPub US20210087534A1, Published 3/25/2021; previously cited), Kaur et al. (PgPub US20220389374A1, Published 12/8/2022) and Skardal (PgPub US20210324311A1, Published 10/21/2021; previously cited).
Regarding claim 27, Griffith et al. teach a synthetic hydrogel cell culture matrix comprising biodegradable polymers and binders comprising one or more adhesion ligands and one or more peptide binders. Griffith teaches the one or more peptide binders are one or more extracellular matrix (ECM) protein-binding peptides covalently bonded to the polymers(Pg. 10, para. 116) via cysteine bridge via a thiol-acrylate Michael addition reaction at a pH of 7.8 (Pg. 15, para. 195). Griffith teaches the least one of the binders is an ECM protein-binding peptide comprises a peptide having affinity to fibronectin, collagen, laminin, other basement membrane proteins, or combinations thereof (Pg. 7, para. 88).
However, Griffith et al. fails to teach the cell culture matrix is a lung scaffold (as further in claim 27).
Before the effective filing date of the claimed invention, Kaur et al. taught a printed (as in claim 27, in-part) (Abstract) hydrogel lung scaffold (as further in claim 27) (Pg. 6,para. 55) comprising bioink to support cell attachment, proliferation, and spreading (Abstract). Biologically active peptides were synthesized by performing Michael-type reactions to link the peptide to one or more (meth)acrylate monomer or polymer (as further in claim 27) (Pg. 23, Para. 73). The printable composition may include one or more mono- or di-(meth)acrylated ECM or ECM- like material (Pg. 2, para. 12). Ine embodiment, Kaur teaches the hydrogel is functionalized with at least one synthetic peptide (Pg. 3, para. 30).
The alignment between SEQ ID NO: 2 (Qy, query) (as in claim 27)and the synthetic peptide taught by Kaur et al. (Db, database) is provided below.
RESULT 1
US-17-738-694-27
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
Sequence 27, US/17738694
Publication No. US20220389374A1
GENERAL INFORMATION
APPLICANT: LUNG BIOTECHNOLOGY PBC
TITLE OF INVENTION: USE OF FUNCTIONALIZED AND NON-FUNCTIONALIZED ECMS, ECM FRAGMENTS,
TITLE OF INVENTION: PEPTIDES AND BIOACTIVE COMPONENTS TO CREATE CELL ADHESIVE 3D
TITLE OF INVENTION: PRINTED OBJECTS
FILE REFERENCE: 080618-2084
CURRENT APPLICATION NUMBER: US/17/738,694
CURRENT FILING DATE: 2022-05-06
PRIOR APPLICATION NUMBER: 63/185,293
PRIOR FILING DATE: 2021-05-06
NUMBER OF SEQ ID NOS: 30
SEQ ID NO 27
LENGTH: 17
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Description of Artificial Sequence: Synthetic
peptide
Query Match 100.0%; Score 100; Length 17;
Best Local Similarity 100.0%;
Matches 17; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PHSRNGGGKGGRGDSPY 17
|||||||||||||||||
Db 1 PHSRNGGGKGGRGDSPY 17
And although Kaur teaches a lung scaffold, Kaur fails to teach after conditioning, seeding biological cells on the outer surface of the lung scaffold using at least one of a static suspension of the biological cells or a flowing suspension of the biological cells (as further in claim 27).
Before the effective filing date of the claimed invention, Baptista teach modeling of human liver development, especially cellular organization and the mechanisms underlying it, is fundamental for studying liver organogenesis and congenital diseases, yet there are no reliable models that mimic these processes ex vivo (Abstract). Using an organ engineering approach and relevant cell lines, Baptista and colleagues teach a total of 60 million cells were seeded per scaffold at different flow rates. Cell seeding was carried through multiple intervals of cell injections into the culture media, with 4 h in between injections. Baptista teaches system perfusion at 6 mL/min delivers the cells into the scaffold through portal vein circulation (as further in claim 27) (Pg. 200, Col. 2, para. 1).
It is noted that although none of the references teach removing unreacted thiol-functionalized peptides or after washing, conditioning the lung scaffold with cell media; such would have been prima facie obvious. The former for the purposes of maintaining the purity of the scaffold and the latter in order to acclimate the scaffold with cell culture media, prior to seeding.
When taken with the teachings of Griffith et al., wherein Griffith teaches a synthetic hydrogel cell culture matrix comprising one or more ECM protein-binding peptides having affinity to fibronectin, it would have been prima facie obvious to incorporate the teachings of Kaur et al., wherein Kaur teach a printed functionalized hydrogel comprising bioink to support cell attachment, proliferation and spreading. Moreover, the skilled artisan would have looked to the teachings of Baptista et al. in order to determine fluid flow.
Thus, the combination would have been prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TITILAYO MOLOYE whose telephone number is (571)270-1094. The examiner can normally be reached Working Hours: 5:30 a.m-3:00 p.m. M-F. Off first Friday of biweek..
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
Prosecution Insights