Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
2. The preliminary amendment filed 24 March 2023 has been entered in full. Claims 3-8 and 15 have been amended. Therefore, claims 1-15 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 24 March 2023 has been considered by the examiner.
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
6. Claim(s) 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jia et al. (Molecular Medicine Reports. 9:779-785; published 2013).
7. Jia et al. disclose tight junction proteins, as well as claudin proteins, including the Claudin-5 protein (See pp. 781-782). Applicants are advised that the limitation “for use in treating or preventing epilepsy in a subject, wherein the use comprises administering the tight junction protein to the subject” in claim 1 has not been given patentable weight (See In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004); MPEP 2111.02II). Furthermore, the recitations of “wherein the epilepsy is temporal lobe epilepsy, optionally mesial temporal lobe epilepsy”; “wherein the epilepsy is drug-resistant epilepsy”; “wherein the use is for treating or preventing epileptic seizures, optionally focal epileptic seizures”; “wherein the use comprises increasing the quantitative or qualitative level of the tight junction protein in an endothelial cell of the brain”; “wherein the use comprises administering an agent capable of increasing the quantitative or qualitative level of the tight junction protein in an endothelial cell of the brain to the subject”, or wherein “wherein the agent is a nucleic acid encoding the tight junction protein, or a functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the nucleic acid encoding the tight junction protein”, “wherein the agent is a vector comprising a first nucleic acid encoding the tight junction protein, or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the first nucleic acid, operatively linked to a second nucleic acid comprising an endothelial-cell-specific promoter, or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the second nucleic acid”, or “wherein the first nucleic acid or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the first nucleic acid encodes a claudin-5 protein, and the second nucleic acid comprises a claudin-5 promoter or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the second nucleic acid”, or “wherein the first nucleic acid or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the first nucleic acid encodes a claudin-5 protein, and the second nucleic acid comprises an intercellular adhesion molecule 2 (ICAM2) promoter or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to the second nucleic acid”, or “wherein the first nucleic acid has a nucleic acid sequence according to any one or more of SEQ ID NO: 1, SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4; and the second nucleic acid has a nucleic acid sequence according to any one or more of SEQ ID NO:5, and SEQ ID NO:6”, or “wherein the vector comprises a first nucleic acid having a nucleic acid sequence according to SEQ ID NO:2, or functional fragment or nucleic acid having a nucleic acid sequence with at least 70% sequence identity to SEQ ID NO:2, operatively linked to a second nucleic acid having a nucleic acid sequence according to SEQ ID NO:6, or functional fragment or SEQ ID NO:2 nucleic acid having a nucleic acid sequence with at least 70% sequence identity to SEQ ID NO:6”; and “wherein the agent is an isolated adeno-associated virus (AAV) comprising a vector” have not been given patentable weight, as they are merely an intended use of the tight junction protein. 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 limitations of the claim (See MPEP 2111.02II). Therefore, the reference of Jia et al. meets all the limitations of claims 1-15.
Claim Rejections - 35 USC § 101
8. 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.
9. Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more. The claim(s) recite(s) a tight junction protein (claim 1), a claudin protein (claim 2) and a claudin-5 protein (claim 3). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the proteins are a nature-based product, and as indicated supra, the intended uses have not been given patentable weight, as they do not result in a structural difference of the proteins.
10. Applicant’s attention is directed to the USPTO January 7, 2019 Revised Patent Subject Matter Eligibility Guidance (i.e. Guidance) available at URL:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf.
11. The guidance addresses the impact of Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S._, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013) (Myriad) on the Supreme Court’s long-standing “rule against patents on naturally occurring things”, as expressed in its earlier precedent including Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) {Mayo). See Myriad, 133 S. Ct. at 2116. Myriad relied on Chakrabarty as “central” to the eligibility inquiry, and re-affirmed the Office’s reliance on Chakrabartys criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). Id. at 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
12. In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961,1965-1966 (SC 2012) it was stated:
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. (Emphasis added)
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.”
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112-120; Benson, supra, at 71-72. And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, supra, at_(slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity’” (quoting Diehr, supra, at 191-192)). (Emphasis added)
We find that the process claims at issue here do not satisfy these conditions, in particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. (Emphasis added)
13. Regarding Step 1 of the Guidance, the claims are directed to the statutory category of a product.
14. Regarding Step 2A, prong one, the claims are directed to and recite the judicial exception of a nature-based product. The instant claims are directed to compositions of matter consisting of a protein. The claimed proteins are naturally occurring proteins, therefore, they are considered a nature-based product, which is a judicial exception.
15. Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application. There are no additional elements recited in the claims
16. Regarding Step 2B, the next question is whether the remaining elements/steps -i.e., the non-patent-ineligible elements/steps - either in isolation or combination, amount to significantly more than the judicial exception. Here, the claims as a whole are not considered to recite any additional steps or elements so as to render the claims patent-eligible.
The additional elements recited in claims 1-15 are nothing other than intended uses, which are not given patentable weight. Under the holding of Myriad, the claimed proteins are not eligible because they are not different enough from what exists in nature to avoid improperly tying up the future use and study of the individual components of the formulations. Accordingly, the claims are directed to a judicial exception. Because the claims do not include any additional features that could add significantly more to the exception, the claims do not qualify as eligible subject matter.
17. For the reasons set forth above, when the claim is considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby are not directed to patent eligible subject matter.
Summary
18. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON M LOCKARD/
Examiner, Art Unit 1647
September 27, 2025