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 .
This action is responsive to papers filed 07/06/2026.
Claim 14 was amended. No claims have been newly added or newly canceled.
Claims, 1, 4-8, 11-19 are currently pending.
Claims 1, 4-7, 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/12/2026.
Claims 8 and 11-14 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 8 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang et al (BMC, Cell Biology, 2010-from IDS filed 10/18/2023).
Regarding claim 8, 11-14, Jang disclose culturing human adipose-derived mesenchymal stem cells (hADSCs) in a first culture medium containing 100 ng/mL bFGF for 7 days and then culturing these cells in a second culture medium containing 10 µM forskolin for 7 days, and then removing these cells so as to obtain a second cell culture for additional testing (page 10, paragraph bridging columns 1-2, page 10 column 2–page11 column 1).
Therefore, the teaching of Jang et al anticipates Applicant’s invention as claimed.
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not fully persuasive. Applicant’s amendment to claim 14 has overcome the rejection under 25 USC 112b and thus this rejection has been withdrawn. Applicant’s arguments have been addressed in so far as they relate to the remaining rejection above.
Applicant argues that the claimed “second culture” must be properly construed. Applicant asserts that read in light of the Specification the phrase “second culture” is not the differentiated cell culture itself, but rather the substantially cell-free culture that remains after the differentiated cells have been removed-for example the collected supernatant. Applicant asserts that the Specification is explicit on this point and point to paragraphs 70, 69, 88-89 as examples. Applicant asserts that “second culture” recited in claim 8 is the cell-free culture that constitutes the pharmaceutical composition produced by the claimed method.
This is not found persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the collected supernatant”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant has not defined the phrase “second culture” to mean “the collected supernatant” in their disclosure. In the art of cell biology the term “culture” is generally recognized as meaning the cultivation of cells within a medium as evidenced by the disclosure of Lee et al (US 2020/0181551, page 20 paragraph 199). This is how the claims have been interpreted for examination as requiring a second culture of cells to be obtained as the last step in the process.
Applicant’s disclosure contains various references to a “second culture”, in one embodiment this second culture contains cells (specifically differentiated neurons”) and suggests that as an alternative that the supernatant of the second culture may be used (see pages 15-16 para 70). However, this is not a claim limitation as limitations from the Specification are not read into the claims.
Applicant argues that Jang does not disclose the limitation “so as to obtain a second culture”. Applicant asserts that Jang is directed to preparing and characterizing differentiated neural cells for biological study and not to produce a pharmaceutical composition. Applicant argues that following induction with 100 ng/ml bFGF for seven days and 10 µM forskolin over the next seven days, Jang subjects the differentiated cells themselves to immunocytochemical, electrophysical, and RT-PCR analyses and thus prepares differentiated cells for characterization which is different from claim 8.
This is not found persuasive. In response to applicant's argument that Jang prepares their second culture of cells for a different intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. Jang removes the cells from the second culture for a different purpose, but at that moment that they are removed that are in a form suitable for pharmaceutical use. The transitional phrase “comprising” is open-ended and allows for additional steps to be present in the method such as taking the cells for additional testing.
Applicant argues that claim 8 does not merely require that cells be removed, but that it also requires that cells be removed “so as to obtain a second culture”. Applicant asserts that this means so as to obtain and use the resulting cell-free culture as the product of the method. Applicant argues that Jang does not disclose collecting a cell-free culture, such as a supernatant after removal of the cells, nor does Jang identify or use any such cultures as a product.
This is not found persuasive. This is not found persuasive. In response to applicant's argument that Jang prepares their second culture of cells for a different intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations.
Applicant asserts that incidental removal or discarding of cells in the course of characterizing those cells is not a disclosure of obtaining the claimed second culture. Applicant asserts that a reference cannot anticipate merely because a claimed result might inherently or coincidently follow from what the reference does. Applicant asserts that anticipation requires that the reference actually disclose the limitation arranged as claimed.
This is not found persuasive. This is not found persuasive. In response to applicant's argument that Jang prepares their second culture of cells for a different intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations.
Applicant argues that even if Jang necessarily results in a remaining liquid after differentiated cells are separated or discarded during experimental processing, the mere existence of such residual material does not disclose the claimed step of removing cells so as to obtain a second culture that constitutes the product of the claimed production method. Applicant asserts that because the Jang reference neither recognizes nor identifies any such cell-free culture as the product of its process, nor does it disclose collecting or using that culture as a pharmaceutical composition that the alleged residual liquid cannot satisfy the expressly recited limitation of claim 8.
This is not found persuasive. This is not found persuasive. In response to applicant's argument that Jang prepares their second culture of cells for a different intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations.
Applicant argues that the finding by the Office Action that Jang teaches removing cels so as to obtain a second cell culture for additional testing is unsupported by any citation to Jang. Applicant asserts that Jang nowhere describes collecting a culture after removal of cells nor identifies any such culture as a product of the disclosed process. Applicant asserts that additional testing in Jang is performed on the cells, not on any cell-free culture.
This is not found persuasive. Applicant has not defined the phrase “second culture” to mean “the collected supernatant” in their disclosure. In the art of cell biology, the term “culture” is generally recognized as meaning the cultivation of cells within a medium as evidenced by the disclosure of Lee et al (US 2020/0181551, page 20 paragraph 199). This is how the claims have been interpreted for examination as requiring a second culture of cells to be obtained as the last step in the process.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the collected supernatant”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of anticipation.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lim et al., “Mesenchymal Stem Cell Conditioned Medium”, WO 2008/020815. Discloses therapeutic effect of conditioned medium obtained from mesenchymal stem cells in culture.
Lee et al., “Pumpless Platform for High-Throughput Dynamic Multicellular Culture and Chemosensitivity Evaluation”, US 2020/0181551, discloses definition of the terms “culture”, “cell culture”, and “culture medium” (page 20 para 199).
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 LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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