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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/05/2025 has been entered.
Applicant’s amendment, filed 11/05/2025, has been entered.
Claims 1-43 have been canceled.
Claims 62-65 has been added.
Claims 44-61 are pending and currently under examination as they read on a method for treating atopic dermatitis comprising administering an inhibitor of LIGHT.
This Office Action will be in response to Applicant’s arguments/remarks, filed 11/05/2025.
The Rejections of Record can be found in the previous Office Action, mailed 05/07/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 44-60, 62-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is insufficient written description for the recited genus of “an inhibitor of LIGHT comprising an Fc fusion protein that comprises a polypeptide having an amino acid sequence with at least 90% sequence identity with SEQ ID NO: 1, 2, or 3”
The specification discloses the following:
“LIGHT inhibitors include, for example, molecules that bind to LIGHT and inhibit LIGHT binding or interaction with HVEM. LIGHT inhibitors also include molecules that bind to LIGHT and inhibit LIGHT binding or interaction with LTβR. LIGHT inhibitors further include molecules that bind to HVEM and inhibit LIGHT binding or interaction with HVEM. LIGHT inhibitors additionally include molecules that bind to LTβR. LIGHT inhibitors moreover include prodrugs of the foregoing.” (Paragraph [0011]).
With regard to the elected species of LTβR-Ig fusion, the specification discloses the following:
“Peptides synthesized and expressed as fusion proteins have one or more additional domains linked thereto, and are also referred to as chimeric polypeptides. The additional domain(s) may confer an additional function upon the sequence. For example, HVEM-IgG or LT.beta.R-IgG fusion proteins can have LIGHT inhibitory activity.
The term "fusion," when used in reference to two or more molecules (e.g., polypeptides) means that the molecules are covalently attached. A particular example for attachment of two protein sequences is an amide bond or equivalent. The term "chimeric," and grammatical variations thereof, when used in reference to a protein, means that the protein is comprised of one or more heterologous amino acid residues from one or more different proteins.” (Paragraphs [0049]-[0050])
The fact that two polypeptides that are homologous in structure or share certain degrees of identity in sequence does not in and of itself required that the two sequences share any functional activity such as promoting quiescent state. In the absence of sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, the claimed invention is not described in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of all the variants encompassed by the newly added claim.
A person of skill is well aware, at the time of the invention was made, that different molecules, even with sequence similarity, do not necessarily have the same function. For example, Attwood (Science 290: 471-473, 2000) teaches that “[i]t is presumptuous to make functional assignments merely on the basis of some degree of similarity between sequences. Similarly, Skolnick et al. (Trends in Biotech. 18: 34-39, 2000) teach that the skilled artisan is well aware that assigning functional activities for any particular protein or protein family based upon sequence homology is inaccurate, in part because of the multifunctional nature of proteins (e.g., "Abstract" and "Sequence-based approaches to function prediction", page 34). Even in situations where there is some confidence of a similar overall structure between two proteins, only experimental research can confirm the artisan's best guess as to the function of the structurally related protein (see in particular "Abstract" and Box 2).
The problem here is that there is insufficient written description to lead a person of skill in the art to know, regarding the polypeptide with the percent identity, which sequences are essential, which sequences are non-essential for the variants to have function of inhibiting LIGHT binding to its receptors.
Therefore, the disclosed species are not sufficiently representative of the genus encompassing all the variants encompassed by the above mentioned limitation because the disclosure fails to describe the common attributes or characteristics that identify all members of the genus, known and unknown at the time the invention was made.
There are no known correlation between any structural component and the ability to selectively bind or inhibit LIGHT protein for the genus of LIGHT inhibitor/ LTβR-Ig fusion encompassed by the claim. Thus, the disclosure does not allow one of skill in the art to visualize or recognize the structure of any compound required to practice the claimed invention. Accordingly, one of skill in the art would conclude that Applicant would not have been in possession of the claimed genus of variants comprising 90% sequence homology because the genus possessing the desired function and activity are not adequately described in the instant disclosure as-filed.
To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
Response to Applicant’s argument
Applicant’s argument has been considered but has not been found convincing for reasons of record.
Applicant argues that the newly added limitation in claim 44 was recited in claim 56 which was not subject to the Written Description rejection. In response, it is noted that the previous version of claim 56 did not recite “at least 90% sequence identity with SEQ ID NO: 1, 2, or 3” as shown below (claim set filed 03/17/2025):
PNG
media_image1.png
89
813
media_image1.png
Greyscale
Applicant’s amendment and argument have not been found convincing to overcome the rejection of record. Therefore, the rejection is maintained as it applies to amended/newly added claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 44-65 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Croft et al. (US 2009/0136427 A1; cite in IDS; see entire document).
The applied reference has a common Applicant/Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Croft et al. taught a method of treating atopic dermatitis in a human comprising administering a LTβR-Ig fusion protein as an inhibitor of LIGHT (see, e.g., paragraphs 0014, 0017, 0036, 0167, claim 10). Given the prior art taught the same disease and administering step, the prior art method would accomplish the mechanism of action recited in the present claims (e.g., claim 45, 49-51). Moreover, it is noted that atopic dermatitis would either be acute or chronic. Furthermore, the prior art taught that atopic dermatitis is either cause by or not caused by an allergen (paragraph 0068) and administration of a second drug that is a hormone or a steroid (paragraph 0020). The prior art disclosed the same SEQ ID NOs: 1-3 (see paragraphs 0033-0035). Therefore, the prior art disclosed the same Fc fusion proteins that inhibits LIGHT binding to its receptors.
With regards to the new limitation in claim 44, i.e., “reducing skin fibrosis”, it is noted that given the prior art taught the same disease, i.e., atopic dermatitis, and the same therapeutic agent, it would reduce skin fibrosis as it is an inherent property of the LTβR-Ig fusion protein.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
With regards to newly added claims 62-65, it is noted that the prior art taught administering to skin (paragraph [0115]). Furthermore, with regards to the subject having been identified as having increase expression of TSLP in the skin is a characterization of the patient having atopic dermatitis. The limitation does not recite any additional active method step as the identification is simply a mental step that maybe performed entirely in the human mind and is obviously not tied to any machine and does not transform any article into a different state or thing. Given the prior art taught the same disease and administering step, the prior art method would accomplish the mechanism of action recited in the present claims.
Response to Applicant’s argument
Applicant argues that they have discovered that LIGHT activity characterized by binding to one or more of its receptors strongly induces expression of TSLP and that Croft does not teach such. In response, it is noted that the newly discovered activity by LIGHT is an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
Applicant’s amendment and argument have not been found convincing to overcome the rejection of record. Therefore, the rejection is maintained as it applies to amended/newly added claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 44-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,301,994 in view of Croft et al. (US 2009/0136427 A1).
The patent claims disclosed a method of treating airway remodeling or fibrosis comprising an inhibitor of LIGHT comprising a chimeric polypeptide comprising an LTβR polypeptide. Given that the patent claims disclosed a LIGHT inhibitor comprising a chimeric LTβR polypeptide, it would have been obvious to one of ordinary skill in the art to make an LTβR-Ig fusion polypeptide because it was a well-known LIGHT inhibitor before effective filing of the claimed invention as taught by Croft et al. (US 2009/0136427 A1) (see above 102). Moreover, one of ordinary skill in the art would have been motivated to use the LTβR-Ig as a LIGHT inhibitor to treat various diseases taught by Croft, for example, atopic dermatitis (see above 102). Therefore, the patent claims in view of Croft render obvious the present claims.
Given that Croft et al. taught the same Fc fusion protein as discussed above (see 102), the claims of patent ‘994 would render obvious of the present claims in view of the teachings of Croft et al.
Response to Applicant’s argument
Applicant argues that the statement “it would have been obvious to one of ordinary skill in the art to make an LTβR-Ig fusion polypeptide because it was a well-known LIGHT inhibitor” is a conclusory statement. In response, as noted above, the statement ends with “as taught by Croft et al. (US 2009/0136427 A1) (see above 102)”. It has been explained above in 102 that Croft et al. has taught that LTβR-Ig fusion polypeptide was a LIGHT inhibitor. As explained above in 102, given that Croft taught using the same LIGHT inhibitor to treat the same skin disorder (i.e., atopic dermatitis), it would necessarily reduce skin fibrosis caused by atopic dermatitis as it is an inherent property of the LTβR-Ig fusion polypeptide.
Applicant’s amendment and argument have not been found convincing to overcome the rejection of record. Therefore, the rejection is maintained as it applies to amended/newly added claims.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. 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 SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHARON X WEN/Primary Examiner, Art Unit 1641