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Claims 1, 2, 4-15 and 18-20 are pending in this application, Claims 7-15 and 18-20 are acknowledged as withdrawn, Claims 1, 2 and 4-6 were examined on their merits.
The objection to the Drawings because Figure 1A is prior art has been withdrawn due to the Applicant’s amendments to the Drawings filed 02/26/2026
The rejection of Claims 1 and 3-6 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, has been withdrawn due to the Applicant’s amendments to the claims filed 02/26/2026.
The rejection of Claim 1 under 35 U.S.C. § 103 as being unpatentable over Fan et al. (US 2006/0088935 A1), of record, in view of Xu (US 6,410,244 B1), has been withdrawn due to the Applicant’s amendments to the claims filed 02/26/2026.
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.
Claim(s) 1 and 4-6 are rejected under 35 U.S.C. § 103 as being unpatentable
over Fan et al. (US 2006/0088935 A1), in view of Xu (US 6,410,244 B1) and
Bates (2013), all of record.
Fan et al. teaches a nutrient medium comprising a carbohydrate nutrient (Pg. 20,
Claim 1) and an embodiment thereof further comprising agar, agarose and
methylcellulose (Pg. 20, Claim 39) wherein the concentrations of the agar, agarose and
methylcellulose in the nutrient medium ranges from between 0-6% w/v (thus the claimed ranges overlap and render obvious the concentration ranges of the prior art of about
0.5-1% agarose and about 0.5-0.7% methylcellulose) (Pg. 20, Claim 40). See the MPEP at 2131.03, II. and 2144.05, I., and reading on Claim 1.
The teachings of Fan et al. were discussed above.
Fan et al. did not reach a composition wherein the agarose is an ultra-low gelling
temperature agarose, and the agarose has a gelling temperature of 8-17 °C, as now required by Claim 1;
wherein the composition is a firm gel at 4 °C, as required by Claim 4;
wherein the composition is a soft gel at 2.5 °C, as required by Claim 5;
or wherein the composition is a viscous liquid at 37 °C, as required by Claim 6.
Xu teaches a composition for growing microorganism comprising nutrient media
and a gelling agent such as agar or agarose has been added (Column 3, Lines 44-55)
wherein a preferred gelling agent is SEAPREP™ agarose as well as commercially
available gelling agents from Sigma (Column 3, Lines 61-67) wherein SEAPREP™
agarose is an ultra-low gelling temperature agarose (Column 5, Lines 26-27).
Bates teaches 3D cell culturing with Sigma A5030 agarose type IX ultra-low
gelling temperature with a sol-gel transition state between 8-17 °C and wherein agarose
hydrogels are advantageous for 3D cell culture, are thermosensitive and non-toxic
towards cells, transparent and non-adhesive (Pg. 3, Lines 2-20).
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 cell culture composition of Fan et al.
comprising agarose, methylcellulose and nutrient media to substitute the ultra-low
gelling temperature agarose of Xu for the unspecified agar of Fan et al. because Fan et
al. is not particularly limited to the type of agar/agarose used in the composition and Xu
teaches a specific agarose type which is suitable for cell culture applications. Those of
ordinary skill in the art would have been motivated to make this modification based on
the availability of compounds and artisan preference. There would have been a reasonable expectation of success in making this modification because Fan et al. is drawn to a cell culture composition comprising a generic agar and Xu teaches a specific agarose suitable for cell culturing.
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 cell culture composition of Fan et al.
and Xu comprising ultra-low temperature gelling agarose, methylcellulose and nutrient
media to substitute the ultra-low gelling temperature agarose of Bates for the ultra-low
gelling temperature agarose of Xu because this would provide an ultra-low temperature
gelling agarose in the composition suitable for 3D cell culturing. Those of ordinary skill
in the art would have been motivated to make this modification in order prepare a
suitable 3D cell culturing composition.
There would have been a reasonable expectation of success in making this modification because Fan et al. is drawn to a cell culture composition comprising a generic agar, Xu teaches a specific ultra-low temperature gelling agarose suitable for cell culturing and Bates teaches a specific ultra-low temperature gelling agarose suitable for 3D cell culturing.
With regard to the claimed properties and characteristics of the agarose set forth
in Claims 1 and 4-6, the instant Specification states that the ultra-low temperature gelling agarose may be Sigma A5030 (Pg. 35, Paragraph [0161]. As the agarose of Bates is the same as the exemplary agarose of the disclosure, it would be expected to have the same properties and characteristics. See the MPEP at 2112.01, II.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/26/2026, with respect to the above withdrawn objection/rejections have been fully considered and are persuasive.
Applicant's remaining arguments have been fully considered but they are not persuasive for the following reasons.
The Applicant argues that the disclosure provides evidence of the criticality of the claimed ranges of the agarose and methylcellulose to stabilize 3D cell cultures during storage and transport (Remarks, Pg. 7, Lines 22-32 and Pg. 8, Lines 1-13).
This is not found to be persuasive for the following reasons, the Applicant’s evidence is directed to embodiments which are not commensurate in scope with the claimed invention, being drawn to storage of particular cells (HT-29 spheroids) in a particular percentage (0.5%) of low temperature gelling agarose and particular percentage range of methylcellulose (0.7-0.35%) under particular storage conditions while the claims are drawn to any cells in any ultra-low gelling temperature agarose in a concentration of about 0.5-1% and methylcellulose at a concentration range of about 0.5-0.7% and do not require any storage at all. Secondly, the Applicant’s evidence does not show any evidence of criticality over the entirety of the claimed ranges such that one of ordinary skill in the art would be able to determine a trend in the exemplified data. See the MPEP at 716.02(d).
The Applicant argues that Fan does not disclose a nutrient medium for three-dimensional cell culture/storage comprising an ultra-low gelling temperature agarose (Remarks, Pg. 8, Lines 14-26).
In response to Applicant's arguments against the Fan reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this instance, Fan discloses a nutrient medium suitable for cell culture comprising agar/agarose and methylcellulose in either anticipating or obviating concentrations, while Xu discloses a nutrient medium comprising ultra-low gelling temperature agarose and Bates discloses 3D cell culturing comprising ultra-low gelling temperature agarose as well as the advantages thereof. Thus, the deficiencies of Fan with regard to the claimed limitations are made obvious by the other cited references as set forth above and in the prior action.
The Applicant argues that Fan does not teach a nutrient medium for three-dimensional cell culture/storage comprising an ultra-low gelling temperature agarose and methylcellulose in the claimed critical concentration ranges. Applicant further argues that the compositions disclosed by Fan render it inoperable for its’ intended purpose (Remarks, Pg. 8, Lines 27-33 and Pg. 9, Lines 1-12).
This is not found to be persuasive for the following reasons, initially the Applicant has provided no evidence on the record that modifying the teachings of Fan in view of Xu and Bates would render Fan unsatisfactory for its’ intended purpose of a nutrient medium. Secondly, as discussed above, the Applicant has not established the criticality of the claimed concentration ranges of ultra-low gelling temperature agarose and methylcellulose, which were made obvious by the combination of the cited prior art as set forth both above and in the prior action.
The Applicant argues that Xu and Bates do not remedy the alleged deficiencies of Fan in teaching the claimed invention. Applicant asserts that neither reference is drawn to or concerned with cell storage and transport, noting that the agarose used by Bates was unsuitable for stability and the ordinary artisan would not therefore be motivated to use the teachings of Bates or its’ agarose (Remarks, Pg. 9, Lines 13-31).
This is not found to be persuasive for the reasoning provided above and in the prior action, wherein the deficiencies of Fan with regard to the claimed limitations are made obvious by the other cited references. That Bates and Xu are not concerned with the non-limiting intended use (cell storage and transport medium) of the claim preamble is immaterial to a finding of obviousness. The combined prior art, particularly Bates makes obvious the claimed 3D culturing structural aspect of the preamble. Further, the Examiner notes that Bates was not cited for its’ success in preparing a 3D culture but for its’ use of an ultra-low gelling temperature agarose in a cell 3D culture medium and the advantages of using agarose hydrogels as platforms for 3D cell culturing. That the embodiment used by Bates was unsuccessful is not a teaching away from the use of an ultra-low gelling temperature agarose in a cell 3D culture medium. See the MPEP at 2123, I and II. The Examiner maintains that the ordinary artisan would have been motivated to modify the teachings of Fan and Xu in view of Bates as set forth above and in the prior action to prepare a suitable 3D culture medium for cells.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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