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 .
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.
Priority
Receipt is acknowledged of certified copies of papers (SINGAPORE 10202105680V 05/28/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements dated 11/8/2023 and 2/6/2024 have been considered and made of record.
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 2, 6, 11, 20 and 24 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.
With respect to claims 2, 11 and 24, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2, 11 and 24 recites the broad recitation “elongation break” of “at least 100%” or “weight” of “40% to 80%”, and the claim also recites “elongation break” of “200% to 400%” or “weight” of “55% to 65%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With respect to claims 6 and 20, these claims appear to present alternative option for “magnetic particles” which are presented with the language “comprise” which renders the claim indefinite because the claim appears to be an improper Markush grouping (MPEP 2117 and 2173.05(h)).
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, 5, 6, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayer et al. (PLOS.ONE)(IDS of 11/8/2023).
With respect to claim 1, the reference of Mayer et al. discloses:
Magnetic material for a cell-culture platform, comprising:
an elastomeric material (PDMS)(page 2, col. 1 and 2) and a dispersion of a plurality of magnetic particles (iron particles)(page 2, col. 2) embedded in the elastomeric material.
With respect to claim 5, the reference of Mayer et al. discloses that the dispersion of the plurality of magnetic particles comprises a substantially homogenous distribution of the magnetic particles within the elastomeric material (“The distribution of iron particles in the elastomer was isotropic”)(page 2, col. 2).
With respect to claim 6, the magnetic particles are iron filings or Iron (iron particles)(page 2, col. 2).
With respect to claim 18, the reference of Mayer et al. discloses:
A method of producing a magnetic material for a cell-culture platform,
comprising: mixing a predetermined weight of magnetic particles (iron particles) into a quantity of a liquid elastomer (uncured PDMS) to disperse the magnetic particles in the quantity of the liquid elastomer; and curing the quantity of the liquid elastomer to form the magnetic material (page 2, col. 1 and col. 2).
With respect to claim 20, the magnetic particles are iron filings or Iron (iron particles)(page 2, col. 2).
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.
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 2, 11 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer et al. (PLOS.ONE)(IDS of 11/8/2023).
The reference of Mayer et al. has been discussed above with respect to claims 1 and 18.
With respect to claim 2, in the absence of a showing of unexpected results, determination of optimal values of elongation at break are considerations expected of the skilled person during routine optimization.
With respect to claims 11 and 24, in the absence of a showing of unexpected results, determination of an optimum amount of magnetic particles for inclusion into the magnetic material are considerations expected of the skilled person during routine optimization.
Claims 13, 14, 15, 17, 27-29, 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Rosell Ferrer et al. (US 2016/0032234)(Attached PTO-892) in view of Mayer et al. (PLOS.ONE)(IDS of 11/8/2023).
With respect to claim 13, the reference of Rosell Ferrer et al. discloses:
Cell-culture platform (device)(100)(Fig. 1), comprising:
a biocompatible deformable receptacle for cell culture media (cell culture pool)(110); and
a deformation actuator (bracket)(120) attached to the biocompatible deformable receptacle, the deformation actuator (120) comprising a magnetic material (ferromagnetic material)(126), and being operable to deform the biocompatible deformable receptacle in response to a magnetic field (¶[0007]-[0017], [0040] and [0041]).
Claim 13 differs by reciting that the deformation actuator comprises a magnetic material according to claim 1.
As discussed previously with respect to claim 1, the reference of Mayer et al. discloses:
Magnetic material for a cell-culture platform, comprising:
an elastomeric material (PDMS)(page 2, col. 1 and 2) and a dispersion of a plurality of magnetic particles (iron particles)(page 2, col. 2) embedded in the elastomeric material.
The reference of Rosell Ferrer et al. discloses that the bracket (120) can be made using PDMS (¶[0010]).
The reference of Mayer et al. discloses that movements of the material can be induced by varying the magnetic field strength (page 2, col. 1).
In view of these disclosures and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ the magnetic material of the reference of Mayer et al. as a bracket in the device of the reference of Rosell Ferrer et al. for the known and expected result of providing an alternative means recognized in the art to achieve the same result, provide a magnetic material that is magnetically responsive so as to expose cultured cells to stretch deformation.
With respect to claim 14, the structure resulting from the combination of the references as discussed above with respect claim 13 would result wherein the biocompatible deformable receptacle comprises a further elastomeric material (PDMS), and wherein the deformation actuator and the biocompatible deformable receptacle are integrally formed as a composite material (¶[0008]-[0017] of Rosell Ferrer et al. ).
With respect to claim 15, the reference of Rosell Ferrer et al. discloses the use of a silicone rubber (PDMS)(¶[0008]-[0017]).
With respect to claim 17, while the reference of Rosell Ferrer et al. discloses that the deformable receptacle comprises a base (substrate)(114), the reference is silent with respect to its transparency. However, if not intrinsic, it would have been obvious to one of ordinary skill in the art to provide a base that is transparent for the known and expected result of allowing the cells to be optically observed during their culture.
With respect to claims 27 and 28, fabrication of the device suggested by the combination of the references discussed above with respect to claim 13 would encompass the method steps required of claims 27 and 28.
With respect to claim 29, the reference of Rosell Ferrer et al. discloses the use of a silicone rubber (PDMS)(¶[0008]-[0017]).
With respect to claim 31, use of the device suggested by the combination of the references discussed above with respect to claim 13 to culture cells would encompass the method steps required of claim 31. With respect to the step of applying a cell-binding coating, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a cell binding material for the known and expected result of ensuring that the cultured cells attached to the receptable base to ensure that they are properly exposed to the stretching conditions created when using the device.
With respect to claim 33, the reference of Rosell Ferrer et al. discloses the use of a magnet (320 and 345) as part of the cell culture system.
Allowable Subject Matter
Claims 16, 30 and 32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claims 16, 30 and 32, the prior art of record fails to teach or fairly suggest a cell culture platform, a method of making the platform or a method of using a platform, in the claimed environment or scope of claim, that includes i) wherein the deformation actuator encloses the biocompatible deformable receptacle and is operable to deform the biocompatible deformable receptacle along a plurality of axes (Claim 16); ii) wherein applying the further quantity of the further liquid elastomer to the magnetic material includes: removing a portion of the magnetic material to form a through-hole in the magnetic material; and introducing the further quantity of the further liquid elastomer into the through-hole (Claim 30); or iii) adjusting an axis of deformation of the one or more cells by adjusting an angle of the applied magnetic field relative to the cell-culture platform (Claim 32).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art references of Isenberg et al. (US 2022/0340848)(Attached PTO-892); Stottlemire et al. (US 2022/0204911)(Attached PTO-892) and Bentz et al. (DE 102011010757)(Attached PTO-892) are cited as prior art that pertains to magnetic material used in a cell culture platform.
The prior art references of Muthiah et al. (US 2012/0219981)(Attached PTO-892) and Chang et al. (US 2013/0337554)(Attached PTO-892) are cited as prior art reference which pertain to biocompatible deformable receptacles for cell culture.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights