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 a preliminary amendment filed 08/01/2024 and papers filed 09/01/2026.
Claims 1-12 have been amended. No claims have been newly added or newly canceled.
Claims 1-12 are currently pending.
Election/Restrictions
Applicant’s election of Group II (claims 7-10) and species A) factors expressed from claim 8 in the reply filed on 09/01/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has requested that the claims of Group I and Group III be reinstated for allowance upon allowance of Group II claims.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 1-6 and 11-12 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 09/01/2026.
Claims 7 and 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/01/2026.
The Restriction Requirement is made Final.
Claim 8 has been examined on the merits.
Claim Objections
Claim 8 is objected to because of the following informalities:
It appears that during the markups of claim 8 for amendment that the parenthesis were left behind while the contents were struck through and deleted--see after “T-box Transcription Factor 4 ()”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature judicial exception without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Independent claim 8 is drawn to a cell population comprising mesenchymal cells comprising: lung mesenchymal cells that express at least one transcription factor selected from a group consisting of FOXF1, TCF21, TBX4 and OSR1.
The claim is directed to a composition, which is a statutory category of invention (Step 1: YES).
The claimed cells are considered a nature-based product as lung mesenchymal cells that express FOXF1 and TCF21 are naturally occurring cell types.
Evidence that lung mesenchymal cells that express FOXF1 and TCF21 are found in nature are provided by Hein et al (bioRxiv, published April 6, 2021, page 2 last paragraph, page 3 second paragraph, page 6 third paragraph, page 21 Figure 1B ), Black et al (Cell Reports 2018, page 444 column 2) and Hein et al (Development Cell, 2022, page 4 results).
Thus, the claim is not considered markedly different than natural lung mesenchymal cells, the claim is considered to read on a product of nature judicial exception (Step 2A, Prong 1: YES).
The claim does not integrate the product into a practical application because the claim is to the product lung mesenchymal cells, per se, not a method of use. (Step 2A, Prong 2: NO).
On balance the relevant factors weigh against eligibility and claims do not qualify as eligible subject matter under 35 U.S.C. § 101.
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 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hein et al (bioRxiv, published April 6, 2021, -from IDS filed 03/06/2026).
Regarding claim 8, Hein disclose a cell population comprising mesenchymal cells comprising lung mesenchymal cells that express FOXF1 and TCF21 (page 2 last paragraph, page 3 second paragraph, page 6 third paragraph, page 21 Figure 1B).
Therefore, the teaching of Hein et al anticipates Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Braeuer et al., “Transcription factor FOXF1 identifies compartmentally distinct mesenchymal cells with a role in lung allograft fibrogenesis”, The Journal of Clinical Investigation, 2021, 131(21):e147343, pp. 1-8.
Braeuer disclose immunofluorescence staining of adult human lung tissue sections confirmed the peribronchiolar niche of the FOXF1-expressing MCs, where FOXF1 expression was noted in MCs interspersed between the smooth muscle and bronchial epithelium (Figure 2E) (page 3, column 2).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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