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 .
Applicant’s response on 02/18/2026 has been received and entered.
Claims 1 and 3-25 are pending. Claims 1, 3-13, and 23-25 have been examined on the merits. Claims 14-22 are withdrawn from consideration as being directed to a non-elected invention.
Claim Interpretation
The instant application is drawn to a cell culture feeding device comprising a non-degradable hydrogel polymer support. The instant application defines “non-degradable” as biologically acceptable materials that do not break down or deteriorate chemically on pg. 12, lns 3-4. However, most materials can be broken down using conditions such as treatment with acid or high heat. For example, in some embodiments of the instant application, the hydrogel support is a PEG hydrogel (See pg. 15, lns 19-22). PEG can be degraded by heat (i.e. 70° C), through oxidation by hydrogen peroxide, and by hydrolysis and therefore does not meet the definition of a material that does not break down or deteriorate chemically. Page 12 goes on to soften this definition by stating “more specifically the term refers to biologically acceptable plastics and other material that do not deteriorate or break down in cell culture medium”. Given the specification teaches the hydrogel can be a PEG hydrogel and PEG can be broken down chemically, the term “non-biodegradable”, in the instant application, is interpreted as encompassing biologically acceptable materials that do not deteriorate or break down in cell culture medium.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities: claim 5 depends from cancelled claim 2 and is thus improper dependent. Claim 6 depends from claim 5 and inherits the deficiencies of claim 5. Appropriate correction is required.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1, 3-8, 11, 13, and 24 under 35 U.S.C. 103 over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1).
Applicants’ traversed the rejection of record on the grounds that it would not have been obvious to substitute the PEG hydrogel of Carmichael with the HAMC hydrogel of Donaghue and Shoichet in the method of Carmichael because the HAMC of Donaghue and Shoichet is degradable.
In response, it appears applicants misinterpreted the rejection. The rejection is based on substituting the HAMC of Donaghue and Shoichet with the non-degradable PEG hydrogel of Carmichael in the method of Donaghue and Shoichet.
The rejection is maintained.
Claims 1, 3-9, 11, 13, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Ma et al (WO2015191547A1).
Applicants assert the rejection is non-obvious for the same reasons as claim 1.
In response, the rejection over claim 1 is maintained.
Applicants have not provided further arguments regarding the rejection. The rejection is therefore, maintained.
Claims 1, 3-8, 11, 13, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Liao et al (Biomacromolecules, 2020).
Applicants assert the rejection is non-obvious for the same reasons as claim 1.
In response, the rejection over claim 1 is maintained.
Applicants have not provided further arguments regarding the rejection. The rejection is therefore, maintained.
Claims 1, 3-8, 11-13, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Borden et al (WO2011028690A1).
Applicants assert the rejection is non-obvious for the same reasons as claim 1.
In response, the rejection over claim 1 is maintained.
Applicants have not provided further arguments regarding the rejection. The rejection is therefore, maintained.
New/Maintained Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 depends from cancelled claim 2. There is insufficient antecedent basis for “[t]he device of claim 2” in the claim. Claim 6 depends from claim 5 and thus inherits the deficiencies of claim 5. For the purpose of compact prosecution, claim 5 is being interpreted as depending from claim 1. Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1, 3-8, 11, 13, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1).
Donaghue and Shoichet teaches a hydrogel-nanoparticle composite system for controlled release of bioactive PDGFA-AA. The system uses PDGF-AA loaded PLGA nanoparticles dispersed in a HAMC (hyaluronic acid and methylcellulose) hydrogel (See graphical abstract and section 2.1). Donaghue and Shoichet test the release of PDGF-AA from PLGA and PLGA/PEG nanoparticles in the HAMC hydrogel over a span of 21 days (See sec 2.3-2.4 and Fig, 1). Additionally, the bioactivity of released PDGF-AA from the hydrogel-nanoparticle composite system was tested in culture in cell culture. (See sec. 2.5). For cell culture experiments, neural stem/progenitor cells were seeded onto fibronectin-coated coverslips in a cell culture dish (See sec. 2.5). The PDGF-AA loaded nanoparticles were mixed with the HAMC hydrogel and added to a transwell insert. The insert was then inserted into the cell culture dish maintaining the hydrogel system separate from the cells where they were cultured for seven days (See sec. 2.5 and graphical abstract).
Regarding claims 1, 3-8, and 24: Donaghue and Shoichet teaches a hydrogel-nanoparticle composite system comprising PDGFA-AA (reads on growth factor) loaded PLGA (reads on biodegradable) nanoparticles (reads on a plurality of microbeads) dispersed in a HAMC hydrogel (reads on the polymer comprises hyaluronic acid). The hydrogel-nanoparticle system can be used for controlled feeding of a cell culture, over seven days (reads on releasing GFs at a controlled rate over a period of time), using a transwell system in which the hydrogel is placed in the transwell insert and the cells are attached to the culture well which reads on the polymer support is removable from the cell culture without removing cells from the culture.
Donaghue and Shoichet does not teach a non-degradable hydrogel polymer support or a polymer comprising PEG, wherein the support has been dried.
Carmichael et al teaches an implantable (reads on a biologically acceptable material) depot delivery system comprising microparticles patterned within a hydrogel, for sustained release of growth factors over time (See ¶005). In an illustrative embodiment, the system comprises PLGA microparticles comprising growth factors entrapped within a PEG hydrogel base (reads on comprises polyethylene glycol and a non-degradable hydrogel)(See ¶0061).
Given that both Donaghue and Shoichet and Carmichael. et al teach a hydrogel system for controlled release of growth factors wherein the growth factors are released from PLGA microbeads disbursed throughout the hydrogel, it would have been prima facie obvious to substitute the HAMC hydrogel taught by Donaghue and Shoichet with the PEG hydrogel taught by Carmichael. One would have expected the PEG hydrogel to work equivocally with the HAMC hydrogel of Donaghue and Shoichet in the method of Donaghue and Shoichet because both hydrogels are used for sustained release of growth factors from PLGA microbeads. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
Regarding claims 11 and 13: Following the discussion of claim 1 above, Donaghue and Shoichet teach a hydrogel-nanoparticle system for controlled release of PDGF-AA.
Donaghue and Shoichet does not teach the support further comprising a color embedded in the polymer support or color being incorporated in a microbead.
Although Donaghue and Shoichet does not teach the support or microbeads comprising color, MPEP 2144.04(I) In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) teaches matters related to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed intention from the prior art. Therefore, adding color to the polymer support or microbeads of the instant application doesn’t make them patentably distinct from the hydrogel-nanoparticle system taught by Donaghue and Shoichet.
Regarding claim 25: Following the discussion of claim 1 above, Donaghue and Shoichet teach a hydrogel-nanoparticle system for controlled release of PDGF-AA. It would have been prima facie obvious to substitute the hydrogel of Donaghue and Shoichet with the PEG hydrogel of Carmichael et al in the method of Donaghue and Shoichet (See rejection of claim 1).
Carmichael et al teaches, in various embodiments, the hydrogel is provided as lyophilized (reads on dehydrated) hydrogel components (See ¶0070). Thus, the hydrogel of Carmichael et al is dehydrated.
Claims 1, 3-9, 11, 13, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Ma et al (WO2015191547A1).
The teachings of Donaghue and Shoichet and Carmichael are set for the above. Donaghue and Shoichet and Carmichael et al render obvious claims 1, 3-8, 11, 13, and 24-25.
Regarding claims 9, and 23: Following the discussion of claim 1 above, Donaghue and Shoichet teaches a hydrogel system for use in cell culture in which a hydrogel-nanoparticle system is placed in a transwell insert. The transwell insert keeps the hydrogel separated from the cells and allows the hydrogel to be removed from the cell culture without disrupting the cells.
Donaghue and Shoichet does not teach a support attached to a tether wherein the tether is a string, thread, wire, or filament.
Ma et al teaches an implantable therapeutic delivery system comprising an elongate fiber surrounded by a substrate which is further surrounded by a hydrogel (See abstract and claims 1-2). The system is used to deliver a therapeutic agent which can comprise a growth factor (See ¶0058). Additionally, the system of Ma et al can comprise a tether that aids in retrieval of the system and anchors the system to prevent it from moving.
Given that both Donaghue and Shoichet and Ma et al teach growth factor releasing systems with a means for removing the hydrogel, it would have been prima facie obvious to a person of ordinary skill in the art to substitute the tether of Ma et al for the transwell insert of Donaghue and Shoichet in the method of Donaghue and Shoichet. One would have expected the tether of Ma et al to work equivocally with the transwell of Donaghue and Shoichet because the tether and transwell both provide means of facilitating removal of the hydrogel. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
Additionally, while Ma et al does not disclose the specific material of the tether, given that the hydrogel of Ma comprises an elongated fiber, it would have been prima facie obvious to further use the elongated fiber as the tether.
Claims 1, 3-8, 11, 13, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Liao et al (Biomacromolecules, 2020).
The teachings of Donaghue and Shoichet and Carmichael are set for the above. Donaghue and Shoichet and Carmichael et al render obvious claims 1, 3-8, 11, 13, and 24-25.
Regarding claim 10: Following the discussion of claim 1 above, Donaghue and Shoichet teaches a cell feeding device comprising a hydrogel comprising microbeads which release growth factors at a controlled rate.
Donaghue and Shoichet do not teach the device further comprises magnetic particles.
Liao et al review the use of magnetic hydrogels for drug delivery. Liao et al teaches dispersing magnetic nanoparticles throughout a hydrogel can be used to control drug-release rates by switching directions of magnetic fields (See Secs. Introduction and 3.1 controlled Release).
Given that Donaghue and Shoichet teach a hydrogel for controlled release of a growth factor (reads on a drug) and Liao et al teaches incorporating magnetic nanoparticles into a hydrogel can be used to control the rate of drug release from a hydrogel, it would have been prima facie obvious to modify the hydrogel of Donaghue and Shoichet by incorporating magnetic nanoparticles in order to further control the rate of release of growth factors into the cell culture. One would have been motivated to modify the hydrogel of Donaghue and Shoichet because Ma et al teaches nanoparticles can be used to change the direction of magnetic fields in order to control drug release rate. There is a reasonable expectation of success because Ma et al teaches magnetic fields regulate the rate of release from hydrogels.
Claims 1, 3-8, 11-13, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Donaghue and Shoichet (Acta Biomaterialia, 2015) in view of Carmichael et al (US20170340706A1) and further in view of Borden et al (WO2011028690A1).
The teachings of Donaghue and Shoichet and Carmichael are set for the above. Donaghue and Shoichet and Carmichael et al render obvious claims 1, 3-8, 11, 13, and 24-25.
Regarding claim 12: Following the discussion of claim 1 above, Donaghue and Shoichet teaches a hydrogel system for use in cell culture in which a hydrogel-nanoparticle system is placed in a transwell insert and inserted into a dish of cultured cells allowing the hydrogel to be kept separate from the cells.
Donaghue and Shoichet does not teach a support system containing gas bubbles to enable the support to float at or near the surface of cell culture media.
Borden et al discloses a hydrogel scaffold having microbubbles which can be filled with gas allowing the hydrogel to float (See claims 1-2).
Given that Donaghue and Shoichet and Borden et al. both teach methods of keeping a hydrogel elevated in a cell culture, it would have been prima facie obvious to substitute the transwell insert taught by Donaghue and Shoichet for gas filled bubbles which allow the hydrogel to float as taught by Borden et al. One would have expected the bubbles taught by Borden et al to work equivocally with the transwell insert of Donaghue and Shoichet because both the bubbles and the transwell insert provide a means for keeping the hydrogel separate from cells attached to a culture dish. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
Conclusion
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 MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633