DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 95-97 and 99-108 are pending in the instant application and have not been amended since 22 August 2023.
Claims 102-108 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 103 (Maintained)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 95-97 and 99-101 stand as rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Masur et al. 1996; in view of Belluci et al., 2007; Surban et al., 2008; and evidenced by the Millipore Matrigel® and Corning® pamphlets (all cited previously).
On page 3 of Remarks filed 19 November 2025, Applicant argues that the Millipore and Corning references are not prior art and therefore cannot be used as a reference in the rejection.
This is not persuasive because the Office action explicitly sets forth that these references are used in accordance with MPEP §2131.01, namely, to: (C) Show that a characteristic not disclosed in the reference is inherent. Millipore is relied upon as showing the differing volumes of Matrigel are inherently required in order to coat culture plates having different surface areas. Corning is relied upon as evidence that the Matrigel composition taught by the prior art reference is inherently comprised of “Engelbreth-Holm-Swarm mouse sarcoma extract, laminin, collagen IV, heparin sulfate proteoglycans, entactin/nidogen, and growth factors”, as claimed. Indeed, Applicant amended the claim to recite the generic components of Matrigel® in response to a rejection under 35 U.S.C. 112(b) because the claims previously recited “BD Matrigel” and recitation of a Trademark/tradename as a claimed element renders indefinite the metes and bounds of the invention (see pgs. 3-4 of Office action mailed 03/06/2023; and Claim Amendments filed in the Response on 08/22/2023).
MPEP §2124 states that references showing a universal fact need not be available as prior art before the effective filing date, “Such facts include the characteristics and properties of a material”. The Millipore pamphlet provides the universal fact that at least 300 µL of Matrigel® is needed to coat the bottom surface of the 12-well plate, and at least 700 µL is needed to coat the bottom surface of a 6-well plate.
Applicant asserts, “use of a 700 µl volume of a basement membrane matrix is not ‘a universal fact’” because there is no evidence that these protocols existed before 2021.
This is not persuasive because, rather, it is the fact that tissue culture plates having different surface areas existed before the filing date of the application (as taught by Masur et al. 1996; in view of Belluci et al., 2007; and Surban et al., 2008) that is relevant to the rejection at hand.
The Examiner maintains the position that, more pertinent to this rejection, is the argument made in previous actions, but not traversed by Applicant, that a person having ordinary skill could optimize the volume of Matrigel applied to the surface of the plate through routine experimentation; and the fact that there is no evidence in the disclosure as filed that 700 µl volume of a basement membrane matrix is critical to the material invention of the instant claims.
Figure 13 of the disclosure teaches a range of Matrigel volumes deposited in a 12 well plate yields a range of basement layer thicknesses. Therefore, Applicant’s own disclosure demonstrates that as little as 400 µl coats a 12-well plate to a thickness of 1mm. Figure 14 teaches the effects a small volume of Matrigel (400 µl and 500 µl) have on fractal dimension (Fig. 14A) and lacunarity (Fig. 14B) relative to larger volumes of 600-800 µl, but neither of these figures provides evidence that 700 µl is critical to the composition of the claims. While the description of Figure 15 states, “the importance of using 700ul of Matrigel where the curves show a peak and the effect is maximum”, it should be noted that this is only in relation to a peak and maximal effect at 40-80h after plating. Demonstration of a maximal effect of a method is not evidence that 700 µl is critical to the material invention of the claims, particularly since the broadest claims require no specific culture dish surface area for the claimed 700 µl volume.
When a reference is silent about an asserted inherent characteristic, such as the amount of liquid needed to coat the bottom surface of a known culture plate (Masur prior art teaches 24-well plates and 100-mm dishes; and depending claims recite a 12-well plate), such gap in the teachings of the reference may be filled with recourse to extrinsic evidence, and this need not antedate the filing date of the application if it is only pointing out “the characteristics and properties of a material or a scientific truism” MPEP 2124. The Millipore evidence makes clear that the element missing from the Masur prior art –namely, the volume of Matrigel necessary to coat culture plates having specific surface areas – is necessarily present in the teaching of Matrigel coating of the different culture dishes (24-well plates and 100-mm dishes) disclosed in the Masur reference. A person having ordinary skill would recognize that different volumes of Matrigel would be required to coat the bottom surface of culture wells that have different surface areas. In light of the disclosure as filed, the amount of volume claimed is not a critical feature to the material composition of the invention, and further volume deposited on culture plates can be optimized by one having ordinary skill in the art via routine experimentation.
The Corning pamphlet is relied upon as evidence that Matrigel basement membrane comprises Engelbreth-Holm-Swarm mouse sarcoma extract, laminin, collagen IV, heparin sulfate proteoglycans, entactin/nidogen, and growth factors, which are the same elements recited in instant claim 95. Applicant has provided no specific traverse of this teaching.
For all these reasons, the composition invention is obvious in view of the compositions disclosed in the art before the effective filing date of the application, and the rejection is maintained.
Conclusion
No claim is allowed.
This is a Request for Continued Examination of applicant's earlier Application No. 17,066,961. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/Examiner, Art Unit 1675
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675