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 .
Claim Status
Applicant’s amendments and remarks, filed 12/05/2025, are acknowledged.
Claims 1-2, 4-5, 7-12, 14, and 16-22 are canceled.
Claims 13 and 23 are amended.
Claims 3, 6, 13, 15, and 23-24 are pending.
It is noted that Applicant has identified claims 3, 6, and 15 as “(Withdrawn)”, however these claims were previously examined. As such, these claims will remain pending examination.
As such, claims 3, 6, 13, 15, and 23-24 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The drawings objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the specification on 12/05/2025.
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 12/05/2025.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 12/05/2025.
Withdrawn Rejections
Applicant’s arguments, see page 12, filed 12/05/2025, with respect to claims 16-18 and 23 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 16-18 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 12 and 13, filed 12/05/2025, with respect to claims 1-6, 11-12, and 16-18 rejected under 35 USC 112(a) as allegedly lacking written description have been fully considered and are persuasive. The issue regarding the specification failing to disclose Applicant’s possession of treating keloids with any therapeutic composition that: inhibits the Th2 cytokine signaling pathway; inhibits IL-4, IL-13, IL-4/IL-13 cytokine, or type 2 chemokine signaling; and/or inhibits type 2 cytokine or chemokine signaling has been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 1-2, 4-5, 11-12, and 16-18 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see pages 8-10, filed 12/05/2025, with respect to claims 1-6, 11-13, 16-18, and 23 rejected under 35 USC 102 as allegedly anticipated by Chen et al; and, claims 1 and 16 rejected under 35 USC 102 as allegedly anticipated by Di Paolo et al as evidenced by Ashino et al have been fully considered and are persuasive. Examiner acknowledges that claims 1-2, 4-5, 11-12, and 16-18 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that claim 13 was amended to recite “a therapeutic composition consisting essentially of dupilumab” which is not disclosed by Chen et al. As such, the rejection of claims 3, 6, 13, and 23 under 35 USC 102 is withdrawn.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 6, and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
First, claims 3, 6, and 15 depend from canceled claims. As such, claims 3, 6, and 15 are improper dependent claims.
Second, claims 3, 6, and 15 recite other species of therapeutic agents. This broadens the scope of the base claim (i.e., claim 13) because the base claim recites “a therapeutic composition consisting essentially of dupilumab”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 6, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3, 6, and 15 depend from canceled claims. Thus, the scope of claims 3, 6, and 15 are unclear. For the sake of prosecution, Examiner is assuming claims 3, 6, and 15 are depending from base claim 13.
Claims 3 and 6 recite the limitation "the antibody" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Lastly, claims 3, 6, and 15 recite other species of therapeutic agents. This broadens the scope of the base claim (i.e., claim 13) because the base claim recites “a therapeutic composition consisting essentially of dupilumab”.
Maintained Objections and Rejections
Claim Objections
Applicant is advised that should claim 3 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Applicant did not address the objection of claim 6. As stated above, while Applicant has identified claims 3, 6, and 15 as “(Withdrawn)”, these claims were previously examined. Thus, these claims will remain pending examination. As such, the claim objection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 6, 13, and 23 are rejected under 35 U.S.C. 103 as being obvious over Guttman-Yassky et al (J Allergy Clin Immunol 2019;143:155-72; published online: 09/05/2018; previously submitted in the Office Action mailed 09/05/2025) in view of Hajdarbegovic et al (Indian J Dermatol 2015;60:635; previously submitted in the Office Action mailed 09/05/2025).
The applied reference has a common joint 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)(1).
With respect to instant claims 3, 6, and 13, Guttman-Yassky et al disclose of administering dupilumab, an IL-4Rα mAb inhibiting signaling of IL-4 and IL-13, resulting in improved systemic and cutaneous abnormalities in patients with atopic dermatitis (AD) (see Abstract). Guttman-Yassky et al disclose that dupilumab significantly reduced expression of genes involved in type 2 inflammation (IL13, IL31, CCL17, CCL18, and CCL26) and concurrently increased expression of epidermal differentiation, barrier, and lipid metabolism genes (see Abstract). Dupilumab also significantly suppressed total and allergen-specific IgEs (see Abstract).
With respect to instant claim 23, Guttman-Yassky et al disclose that the patients were randomized 1:1 to weekly subcutaneous injections of 200 mg of dupilumab or placebo after a 400 mg loading dose or placebo on day 1, for a total of 16 weeks (see pg. 157, left col.).
Guttman-Yassky et al fails to teach of treating keloids. However, Hajdarbegovic et al disclose that keloids and atopic disorders share common inducing and maintaining inflammatory pathways that are characterized by T-helper cell 2 (Th2) cytokines (see Abstract). The key players for the inflammatory pathways are IL-13 and IL-4, which induce collagen production by the fibroblasts (see pg. 1, right col.). Thus, cytokine milieus in keloids and atopic disorders appear to be similar, and therefore, patients with atopic disorders may have an increased risk of developing keloids (see pg. 1, right col.).
Therefore, one of skill in the art would have combined the teachings of Guttman-Yassky et al and Hajdarbegovic et al to develop the present invention. One would be motivated to do so because the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. In this particular case, one would have been motivated to treat keloids with the method of treating AD as described by Guttman-Yassky et al because both AD and keloids share Th2 cytokines, IL-4 and IL-13, as inflammatory pathways; thus, one would have a reasonable expectation that administering dupilumab to keloid patients would treat the condition as the drug was effective in treating AD.
This rejection under 35 U.S.C. 103 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)(1)(A); or (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(1)(B). See generally MPEP § 2153.01(a).
Applicant’s Arguments
Applicant respectfully disagrees with the 103 rejection (see pages 10-12 of the Remarks filed 12/05/2025).
Applicant asserts that Hajdarbegovic does not demonstrate that there is an association between atopic disorders and keloids, and, therefore, it cannot demonstrate that the disorders share the same inflammatory pathways (specifically IL-4 and IL-13). Without this alleged teaching, a person of skill would not have sought to use dupilumab, which allegedly antagonizes the IL-13 and IL-4 pathways (per the present rejections reading of Guttman-Yassky) to treat keloids, which have no demonstrated association with these pathways (despite the assertions of the present rejection regarding Hajdarbegovic)… First, all statements in Hajdarbegovic regarding its findings are inherently flawed because the reference does not include a proper control group. Hajdarbegovic at p. 5, col. 2 states that there is a mismatch in ethnicity between the subjects and the control group. Specifically, the control group is heavily weighted toward people with European ancestry… Second, the alleged teaching that there is an association between asthma and keloids, and, therefore between the immune pathways of both disorders relies on an alleged association with keloids and the atopic disorders studied (and thus the inflammatory pathways associated with those atopic disorders). This is not supported by the data… In sum, Hajdarbegovic does not provide the requisite rigor for a person of skill in the art to find an association between atopic disorders (and their related immune pathways) and keloids. Without this association, a person of skill would not seek to treat a patient afflicted with keloids using a treatment (dupilumab) that allegedly targets these pathways according to Guttman-Yassky. This is particularly true when considering that experimentation on humans for treating diseases is never routine and requires extensive effort to design, test, and obtain approval for any such studies. Simply put, a person of skill in the art would not launch such an effort based on the scant and defective data provided in Hajdarbegovic. More would be required. Thus, a person of skill would not seek to combine the alleged teachings of the cited references and conclude that the combination makes the present invention obvious to try, let alone to achieve. Applicant respectfully requests withdrawal of the present rejection.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As stated in the rejection, Guttman-Yassky et al disclose of administering dupilumab, an IL-4Rα mAb inhibiting signaling of IL-4 and IL-13, resulting in improved systemic and cutaneous abnormalities in patients with atopic dermatitis (AD) (see Abstract). Guttman-Yassky et al disclose that dupilumab significantly reduced expression of genes involved in type 2 inflammation (IL13, IL31, CCL17, CCL18, and CCL26) and concurrently increased expression of epidermal differentiation, barrier, and lipid metabolism genes (see Abstract). Dupilumab also significantly suppressed total and allergen-specific IgEs (see Abstract). Further, Hajdarbegovic et al disclose that keloids and atopic disorders share common inducing and maintaining inflammatory pathways that are characterized by T-helper cell 2 (Th2) cytokines (see Abstract). The key players for the inflammatory pathways are IL-13 and IL-4, which induce collagen production by the fibroblasts (see pg. 1, right col.). Applicant’s assertion that Hajdarbegovic does not demonstrate that there is an association between atopic disorders and keloids, is factually untrue as it is known in the art that keloids express IL-4 and IL-13 and that there is an increased risk of developing keloids if a subject has atopic dermatitis as evidenced by Jumper et al (PLoS ONE 12(3): e0172955, 2017) and Lu et al (BMJ Open 2018;8:e022865). Thus, while the control group of Hajdarbegovic may not consist of a non-European majority, there is still a correlation between an upregulation of these inflammatory cytokines in keloid patients compared to those without keloids.
Therefore, one of skill in the art would have combined the teachings of Guttman-Yassky et al and Hajdarbegovic et al to develop the present invention. One would be motivated to do so because the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. In this particular case, one would have been motivated to treat keloids with the method of treating AD as described by Guttman-Yassky et al because both AD and keloids share Th2 cytokines, IL-4 and IL-13, as inflammatory pathways; thus, one would have a reasonable expectation that administering dupilumab to keloid patients would treat the condition as the drug was effective in treating AD.
As such, the 103 rejection is maintained.
Conclusion
Claims 3, 6, 13, 15, and 23 are rejected.
Claim 24 is objected to as being dependent upon a rejected base claim.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674