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 .
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 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.
DETAILED ACTION
The preliminary amendments filed on 9/22/2022 is acknowledged. Claims 7-8, 13-14, 17-19, 47, were canceled.
Claims 2, 4-6, 9-12, 15-16, 20-23, 25, 29, 33, 37, 41, 44-46, 48-51, and 53-61 are pending in the instant application.
Priority
This application is a 371 of PCT/EP2021/057463, filed on 8/16/2025, and a continuation of application 17084957. This application also claims priority to the foreign applications JP2020-182046 filed on 10/30/2020, AU2020260519 filed on 10/30/2020, and CA3097453 filed on 10/30/2020. This application also claims priority to the provisional applications 63068593 filed on 8/21/2020, 63061497 filed on 8/5/2020, 63037783 filed on 6/11/2020, 62993443 filed on 3/23/2020.
2020-0323
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan, Australia, and Canada on 10/30/2020. It is noted, however, that applicant has not filed a certified copy of these application as required by 37 CFR 1.55. No such priority documents exist in the parent application, 17/084957.
Election/Restriction
Applicant’s election without traverse of Group I (claims 2, 4-23, 44-51, and 53-61) in the reply filed on 12/31/2025 is acknowledged.
Claims 25, 29, 33, 37, and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025.
Claims 2, 4-6, 9-12, 15-16, 20-23, 44-46, 48-51, and 53-61 are examined herein.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/18/2022, 2/27/2023, 5/7/2024, and 6/27/2025 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Objections to the Claims
Claim 6 contains too many conjunctions. Please delete all conjunctions except for the one between the last two list items: “health status and/or quality of life”.
Claim 12 lacks a “step ” before it states “(b)”.
Claim 15 is dependent on a canceled claim 13.
Claim 16 includes the typo “is continued for from 2 weeks”. Please replace with “is continued for 2 weeks”.
Correction is required. See MPEP § 608.01(m).
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 4, 20-23, and 61 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.
Claim 4, 61
Claim 4 and 61 refers to a percentage improvement using the metrics of the “EASI-50” or “EASI-75” system for assessing atopic dermatitis, wherein it is unclear what the “50” and “75” is referring to when the measurement is applied to a single individual. The EASI system assigns points according to each system to give an overall score as a point total (see Fig 1 Hanifin, doi: 10.1097/DER.0000000000000895). Reference to EASI-50 or EASI-75 is in reference to the dosage required to achieve a certain response in 50% or 75% of the population (see Wollenberg pg 138, Fig 2). It appears “EASI-50” is analogous to an LD50, where the value reported is the quantity of substance where 50% of the animal population have died. Thus one of skill in the art would not know how this value could be determined for an individual.
Claim 20-23
The term “around” in claims 20-23 is a relative term which renders the claim indefinite. The term “around” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant specification does not give any quantitative measure of determining “around.” For example, “around 8 to 16 weeks” could include a breadth of 6-20 weeks for one artisan, while another would assume that only variations of the tenths place that round to these values would be acceptable, such as 7.5-16.4 weeks.
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.
Claim 6 is 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.
Claim 6
Claim 6 is drawn to the method of parent claim 2 “for treating a skin infection, pruritus, eczema-related sleep interference, anxiety and/or depression, or for improving health status and/or quality of life.” None of the referred to conditions are a subtype of “atopic dermatitis”, thus claim 6 represents an expansion of scope over parent claim 2.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4-6, 9-12, 15-16, 20-23, 44-46, 48-51, and 53-61 are rejected under 35 U.S.C. 103 as being unpatentable over Paul (US20190153471) in view of Doughty (WO2017139290), Fotin (US20200023076), Wollenberg (doi: 10.1016/j.jaci.2018.05.029), and Walpole (doi: 10.1186/1471-2458-12-439)
Claim 2, 9, 55-56
Regarding claim 2, 9, and 55-56, Paul teaches an AAV particle that contains a viral genome encoding an antibody (abstract) comprising 100% sequence identity to the heavy chain of instant SEQ ID NO: 11 (Paul 5037), with the HCDRs of instant SEQ ID NOs: 4-6 underlined below.
instant_11 QVQLVQSGAEVKKPGASVKVSCKASGYTFTNYGLSWVRQAPGQGLEWMGWISANNGDTNY 60
Paul_5037 QVQLVQSGAEVKKPGASVKVSCKASGYTFTNYGLSWVRQAPGQGLEWMGWISANNGDTNY 60
************************************************************
instant_11 GQEFQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDSSSSWARWFFDLWGRGTLVTV 120
Paul_5037 GQEFQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDSSSSWARWFFDLWGRGTLVTV 120
************************************************************
instant_11 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Paul_5037 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
************************************************************
instant_11 SSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPSCPAPEFLGGP 240
Paul_5037 SSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPSCPAPEFLGGP 240
************************************************************
instant_11 SVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNS 300
Paul_5037 SVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNS 300
************************************************************
instant_11 TYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEM 360
Paul_5037 TYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEM 360
************************************************************
instant_11 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
Paul_5037 TKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQ 420
************************************************************
instant_11 EGNVFSCSVMHEALHNHYTQKSLSLSLGK 449
Paul_5037 EGNVFSCSVMHEALHNHYTQKSLSLSLGK 449
*****************************
Paul also teaches the AAV encodes a light chain comprising 100% sequence identity to the light chain of instant SEQ ID NO: 12 (Paul 7723), with the LCDRs of instant SEQ ID NOs: 1-3 underlined below.
instant_12 SYVLTQPPSVSVAPGKTARITCGGNIIGSKLVHWYQQKPGQAPVLVIYDDGDRPSGIPER 60
Paul_7723 SYVLTQPPSVSVAPGKTARITCGGNIIGSKLVHWYQQKPGQAPVLVIYDDGDRPSGIPER 60
************************************************************
instant_12 FSGSNSGNTATLTISRVEAGDEADYYCQVWDTGSDPVVFGGGTKLTVLGQPKAAPSVTLF 120
Paul_7723 FSGSNSGNTATLTISRVEAGDEADYYCQVWDTGSDPVVFGGGTKLTVLGQPKAAPSVTLF 120
************************************************************
instant_12 PPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYL 180
Paul_7723 PPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAGVETTTPSKQSNNKYAASSYL 180
************************************************************
instant_12 SLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 214
Paul_7723 SLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS 214
**********************************
Paul teaches a method of administering the AAV particles of their invention as a means of producing a functional antibody in a subject in need thereof (claim 23), wherein the AAV is administered for the purposed of treating atopic dermatitis (para 0490). Paul teaches administering the AAV particles every two weeks (pg 228, para 0455), thus satisfying the limitations of claim 2, step (a). Regarding claim 2, step (b), Paul teaches the AAV particles can be administered every four weeks (pg 228, para 0455). Paul teaches the chosen dosage and dosage schedule is a result-effective variable:
“The exact amount required will vary from subject to subject, depending on the species, age, and general condition of the subject, the severity of the disease, the particular composition, its mode of administration, its mode of activity, and the like… It will be understood, however, that the total daily usage of the compositions of the present invention may be decided by the attending physician within the scope of sound medical judgment. The specific therapeutically effective, prophylactically effective, or appropriate diagnostic dose level for any particular individual will depend upon a variety of factors including the disorder being treated and the severity of the disorder; the activity of the specific payload employed; the specific composition employed; the age, body weight, general health, sex and diet of the patient; the time of administration, route of administration, and rate of excretion of the specific AAV particle employed; the duration of the treatment; drugs used in combination or coincidental with the specific AAV particle employed, and like factors well known in the medical arts.” (pg 228, para 0452).
Absent the evidence of criticality of administering the medicament from every two weeks to every four weeks, one of skill in the art would have been able to arrive at the instantly claimed dosage schedule using routine optimization. See MPEP § 2144.05 (II)(A).
Doughty teaches a pharmaceutical formulation for injection comprising tralokinumab, wherein the pharmaceutical formulation is dispensed in a drug delivery device that is configured for subcutaneous delivery of the pharmaceutical formulation (see e.g. claims 1 and 3). As an evidentiary reference, Fotin (US20200023076) teaches the antibody tralokinumab (pg 40, Table 3), as having the same heavy chain (Fotin’s SEQ ID NO: 881) and light chain (Fotin’s SEQ ID NO: 882) as instantly claimed (e.g. instant SEQ ID NO: 11 and 12, respectively). Doughty teaches tralokinumab is a treatment for atopic dermatitis (pg 1, para 0005). Doughty teaches a method for administering the composition with a drug delivery device to a human subject in need thereof (see e.g. paragraph [0011]). The device can be configured to deliver the tralokinumab once every four weeks (see e.g. claim 6, paragraph [0008]). Alternatively, Doughty teaches the drug can be delivered once every two weeks (pg 7, para 0012). The tralokinumab may be administered in two or more doses, indicating that at least 3 doses are possible (see e.g. paragraph [0008]). While Doughty does not teach a two-step dosage schedule wherein the dosage is first administered every two weeks, followed by a longer window of administering tralokinumab every four weeks; absent the evidence of criticality of administering the medicament from every two weeks to every four weeks, one of skill in the art would have been able to arrive at the instantly claimed dosage schedule using routine optimization. See MPEP § 2144.05 (II)(A).
It would have been obvious to combine the teachings of Paul and Doughty because (1) Paul teaches an AAV that deliver tralokinumab is useful for treating atopic dermatitis when delivered either 1x every 2 weeks or 1x every 4 weeks; and (2) Doughty confirms that the antibody tralokinumab cis effective for treating atopic dermatitis when delivered either 1x every 2 weeks or 1x every 4 weeks. One of skill in the art would have had a reasonable expectation of success because the dosage schedule could be arrived at via routine experimentation.
Claim 4-5
Paul does not teach reducing the Eczema Area Severity Index (EASI) score or that the atopic dermatitis is moderate-to-severe.
Wollenberg teaches study participants with atopic dermatitis were selected as those having an EASI score ≥ 12, or an IG score ≥ 3 (pg 136, col 1, para 2). Wollenberg teaches the selected participants were given tralokinumab subcutaneously every 2 weeks for a total of 12 weeks before undergoing a 10-week long follow up period (pg 136, col 1, para 2). Wollenberg classified those as exhibiting these scores as having moderate-to-severe atopic dermatitis (pg 136, col 1, para 2). Wollenberg teaches 51 participants exhibited a reduction of 50% or more on the EASI scale when given 300 mg of tralokinumab (Fig 2A, see caption). Thus satisfying the limitation of exhibiting a ≥ 50% improvement on the EASI scale. See 112(b) rejection regarding this claim above.
It would have been obvious to combine the teachings of Paul, Doughty, and Wollenberg because (1) Paul teaches an AAV particle comprising tralokinumab is useful for treating dermatitis; (2) Doughty teaches administering tralokinumab directly for treating dermatitis; and (3) Wollenberg supplies the means of assessing how effective a treatment is for atopic dermatitis using the EASI scale and using a tralokinumab dosage regimen as an exemplary treatment. One of skill in the art would have had a reasonable expectation of success because all of the references are referring to the same treatment and the same disease, using a very similar dosage regimen that achieves the same desired results of a 50% reduction on the EASI scale.
Claim 6
Regarding claim 6, Paul teaches their invention can also be used to treat depression (pg 237, para 0486), but Paul does not teach tralokinumab being useful for also treating pruritus.
Wollenberg teaches the tralokinumab treatment group also exhibited improvements in pruritus (pg 137, col 2, para 2). Thus satisfying the limitations of tralokinumab being effective for also treating pruritus.
Claim 9-10, 12
Regarding claims 9-10, and 12, that are drawn to the length of step (b) being continued for at least 8 weeks, at least 4 weeks, and at least 12 weeks, respectively.
Paul does not teach a particular dosage schedule.
Doughty teaches a follow-up period of 10-weeks after the initial 12 week dosage period of 45, 150, 300 mg of tralokinumab (pg 136, col 1, para 2). Thus satisfying the limitation of a second period lasting at least 4-8 weeks. However, this fails to encompass the instantly claimed period of “at least 12 weeks”. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In the instant case, applicant has not provided any evidence of criticality, thus arriving at an optimal follow-up period of at least 12 weeks is considered a matter of routine experimentation. See MPEP § 2144.05(II)(A).
claim 15
Regarding claim 15 that is drawn to the length of step (a) being continued for at least 2 weeks.
Paul does not teach a particular dosage schedule length.
Doughty teaches a 12-week dosage regimen of 45, 150, and 300 mg of tralokinumab (pg 136, col 1, para 2). Thus rendering obvious the durations of step (a) envisaged.
Claims 16, 20-23
Regarding claims 16 and 20-23, which are drawn to the following dosage regimen combinations of step (a) and (b). For added clarity, indefinite relative terminology such as “around” has been deleted from the table below.
Claim
Step (a) dosage (mg)
Step (a) duration (weeks)
Step (b) dosage (mg)
Step (b) duration (weeks)
16
10-600
2-36
10-600
≥ 8
20
250-350
8-16
250-350
≥ 12
21
300-600*
8-16
300
≥ 12
22
300
12-16
300
≥ 16
23
300-600*
12-16
300
≥ 16
*only the first dose given is 600 mg, all subsequent doses are 300 mg.
Paul teaches administering the AAV particles every two weeks (pg 228, para 0455), thus satisfying the limitations of claim 2, step (a). Regarding claim 2, step (b), Paul teaches the AAV particles can be administered every four weeks (pg 228, para 0455). Paul teaches the AAV particles may be administered sufficient to deliver an antibody dosage of about 0.1 to 10 mg/kg (pg 228, para 0452).
Paul does not teach a particular dosage schedule length or the dosages as total administered per individual.
Walpole teaches average human weighs 62.0 (Table 3, line 7). Because the dosage of Paul encompasses the value 4.83 mg/kg, when multiplied by the average human body weight of 62.0 kg, these teachings combined arrive at a dosage of 300 mg/individual in claims 10 and 21-23. Similarly, because the dosage of Paul encompasses the value 9.67 mg/kg, when multiplied by the average human body weight of 62.0 kg, these teachings combined arrive at a dosage of 600 mg/individual described in claim 16, 21, and 23. Similarly, because the dosage of Paul encompasses the value 4.03 mg/kg, when multiplied by the average human body weight of 62.0 kg, these teachings combined arrive at a dosage of 250 mg/individual described in claim 20. In light of the teachings of Walpole (discussed below) the dosage range of Paul encompasses 6.2 - 620 mg/individual, which renders obvious all instantly claimed dosages for claims 16, 20-23.
Regarding the dosage schedule of step (a), Wollenberg teaches an initial dosage period of 12 weeks followed by a 10-week follow up period, wherein 45, 150, and 300 mg of tralokinumab are administered (pg 136, col 1, para 2), thus rendering obvious the duration and dosage of step (a) for claims 16, 20, and 22. The dosage quantity for this step is rendered obvious in combination with the teachings of Paul and Walpole. Although the combination of references do not explicitly cite administering an elevated dosage of 600 mg for the first dose in step (a), finding the optimal dosage regimen is considered a matter of routine experimentation absent the evidence of criticality. Applicant has not supplied any evidence of criticality, thus this variation in the dosage schedule is rendered obvious.
Regarding the dosage schedule of step (b), Wollenberg teaches a 10-week follow up period, rendering the dosage period length of claim 16 obvious. For the longer dosage periods of instant claims 20-23, finding the optimal dosage regimen is considered a matter of routine experimentation absent the evidence of criticality. Applicant has not supplied any evidence of criticality, thus this variation in the dosage schedule is rendered obvious. Furthermore, Paul teaches administering a treatment every four weeks in a dosage encompassing 10-600 mg, thus renders obvious the instantly claimed dosages of claims 20-23. Absent the evidence of criticality of administering the medicament from every two weeks to every four weeks, one of skill in the art would have been able to arrive at the instantly claimed dosage schedules using routine optimization. See MPEP § 2144.05 (II)(A).
Claim 11, 44-45
Regarding claims 11 and 44-45, Paul teaches the invention may be administered subcutaneously (pg 2, para 0030). Paul teaches the dose may be delivered as a single dose or split into two administration events (pg 228, para 00455). Taken together, this satisfies the limitation of administering the two dosages subcutaneously.
Wollenberg also teaches administering tralokinumab subcutaneously (pg 136, col 1, para 2).
claim 46
Regarding claim 46, Paul teaches the AAV particles may be delivered in a composition comprising sodium acetate buffer, sodium chloride, polysorbate 80 (pg 225, para 0426; pg 222, para 00395).
Paul is silent on the specific concentration of these excipients and the desired pH.
Doughty teaches the dosage form can comprise a formulation of 50 mM sodium acetate buffer, 85 mM sodium chloride, 0.01%(w/v) polysorbate 80, at a pH of 5.5 (see e.g. paragraph [0066], [0114], [0135]).
Claim 48-50
Paul is silent on this particular antibody being human, monoclonal, or IgG4 based.
Wollenberg teaches tralokinumab is a fully human mAb (monoclonal antibody) (pg 135, abstract). Wollenberg teaches tralokinumab is an IgG4 mAb (pg 135, col 2, para 3).
Claim 51
Regarding claim 51, Paul teaches the AAV can encode a scFv or Fab (pg 255, para 0635).
Doughty also teaches the antibody can be an antibody fragment such as a Fab, Fab’ or other fragments (see e.g. paragraph [0045]).
Claim 53-54
Regarding claim 53-54, Paul teaches 100% sequence identity to the VH of instant SEQ ID NO: 8 (Paul’s SEQ ID NO: 5037), shown below.
instant_8 QVQLVQSGAEVKKPGASVKVSCKASGYTFTNYGLSWVRQAPGQGLEWMGWISANNGDTNY 60
Paul_5037 QVQLVQSGAEVKKPGASVKVSCKASGYTFTNYGLSWVRQAPGQGLEWMGWISANNGDTNY 60
************************************************************
instant_8 GQEFQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDSSSSWARWFFDLWGRGTLVTV 120
Paul_5037 GQEFQGRVTMTTDTSTSTAYMELRSLRSDDTAVYYCARDSSSSWARWFFDLWGRGTLVTV 120
************************************************************
instant_8 SS---------------------------------------------------------- 122
Paul_5037 SSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
**
Paul also teaches 100% sequence identity to the VL of instant SEQ ID NO: 10 (Paul’s SEQ ID NO: 7723), shown below.
instant_10 SYVLTQPPSVSVAPGKTARITCGGNIIGSKLVHWYQQKPGQAPVLVIYDDGDRPSGIPER 60
Paul_7723 SYVLTQPPSVSVAPGKTARITCGGNIIGSKLVHWYQQKPGQAPVLVIYDDGDRPSGIPER 60
************************************************************
instant_10 FSGSNSGNTATLTISRVEAGDEADYYCQVWDTGSDPVVFGGGTKLTVL------------ 108
Paul_7723 FSGSNSGNTATLTISRVEAGDEADYYCQVWDTGSDPVVFGGGTKLTVLGQPKAAPSVTLF 120
************************************************
Claim 57
Regarding claim 57, Paul teaches the AAV particles are optionally co-administered as part of a combination therapy (pg 3, para 0031). Thus satisfying the limitation “administered as a monotherapy” because Paul teaches that combinations are optional, as opposed to being required.
Doughty also teaches tralokinumab can be administered as a monotherapy (see e.g. paragraph [0068]).
claim 58
Regarding claim 58, Paul teaches the AAV particles are optionally co-administered as part of a combination therapy (pg 3, para 0031).
Paul is silent on what the identity of potential co-therapies might be.
Doughty teaches tralokinumab can be administered with another treatment such as an antibiotic, which is an anti-bacterial therapeutic (see e.g. paragraph [0068]).
!claim 59-60
Regarding claims 59-60, Paul is silent on the subject having any particular contraindications, or if they have a past experience with conjunctivitis while undergoing therapy with an IL-13 binding protein.
Doughty teaches the subject has previously received one or more doses of a therapeutic agent such as cyclosporin A (pg 17, para 0058).
Wollenberg teaches tralokinumab exhibits high efficacy when combined with concomitant glucocorticoid therapy (pg 140, col 1, para 4).
The combination of references fail to teach (i) the new property of tralokinumab being effective in patients that are unresponsive to cyclosporine A/possess contraindications against cyclosporine A; and (ii) the medical history of the subject experiencing conjunctivitis while undergoing treatment with an IL-13 binding protein and a topical corticosteroid. However, because the instantly claimed invention is materially identical to that instantly claimed, it inherently possesses the property of (i). See MPEP § 2112(I): Something which is old does not become patentable upon the discovery of a new property. Regarding (ii), the references are drawn to any subject with any medical history regarding conjunctivitis, thus encompasses subjects with the medical history described in (ii). Because the medical history of the subject does not materially affect the method, it is indistinguishable to that described by the references. This inherent feature of the method being effective for subjects with this particular medical history need not be recognized at the time because it is drawn to the inherent feature of tralokinumab. MPEP 2112.01(II) states: A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
claim 61
Paul is silent on achieving a particular IGA or EASI-75 score after treatment.
Wollenberg teaches 51 participants exhibited a reduction of 75% or more on the EASI scale when given 300 mg of tralokinumab (Fig 2A, see caption). Thus satisfying the limitation of exhibiting a ≥ 75% improvement on the EASI scale. See 112(b) rejection regarding this claim above.
Double Patenting Rejection Not Made
A Double Patenting Rejection over the parent application 17/084957 was not made because applicant filed an approved terminal disclaimer on 8/6/2024.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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, Jeffrey Stucker can be reached on 571-272-0911. 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.
/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights