DETAILED ACTION
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 .
Status of Claims
2. Claims 1-17 are pending.
Information Disclosure Statement
3. No information disclosure statement was present at the time of this office action.
Specification
4. The disclosure is objected to because of the following informalities:
In paragraph 29, “titres” appears to be a misspelled word;
In paragraph 77, “trangenic” appears to be a misspelled word;
In paragraph 121, “similary” appears to be a misspelled word;
In paragraph 131, “gleatin” appears to be a misspelled word;
Appropriate correction is required.
5. The use of the following terms BD Autojector®, Humaject®, NovoPen®, B-D®Pen, AutoPen®, and OptiPen®, GenotropinPen®, Genotronorm Pen®, Humatro Pen®, Reco-Pen®, Roferon Pen®, Biojector®, Iject®, J-tip Needle-Free Injector®, Intraject®, Medi-Ject®, Smartject®, Eucerin®, Vaseline®, Lubriderm®, Enbrel™, Humira™, which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. ™
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
6. Claim 5 and 6 are objected to because of the following informalities:
The phrase “every 8 weeks after administration of the dose about 12 weeks after the initial dose” in claim 5 is grammatically incorrect.
The word “identied” appears to be a misspelled word in claim 6.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Enablement
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.
7. Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 17 stated the patient is a responder to the antibody by being identified as meeting a clinical endpoint, wherein the clinical endpoint is a change from baseline in Modified Rodnan Skin Score (mRSS). Modified Rodnan Skin Score is used to assess the severity of skin thickening in systemic sclerosis. A person of ordinary skill in the art would not be able to conclude that mRSS is a clinical tool used to assess clinical endpoints in psoriasis. According to Khanna et. al., Dr. Gerald Rodnan developed the Modified Rodnan Skin Score to estimate skin thickness by clinical palpation for systemic sclerosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with this claim.
Case law holds that applicant' s specification must be “commensurately enabling [regarding the scope of the claims]” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise undue experimentation would be involved in determining how to practice and use applicant' s invention. The test for undue experimentation as to whether or not [Claimed Feature] within the scope of the claims can be used [meet the claim requirements] as claimed and whether the claims meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 1986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed.Cir. 1988). Upon applying this test to claim 17, it is believed that undue experimentation would be required because: (A) Nature of the invention, (B) State of the prior art, (C) The level of one of ordinary skill, (D) The level of predictability in the art, (E) Amount of direction provided, (F) The existence of working examples,(G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the Invention and Breadth of Claims
With respect to claim breadth, the standard under 35 U.S.C. §112(a) entails determining what the claims recite and what claims mean as a whole. The nature of the invention is directed to fully human immunoglobulin G1 lambda (IgGllambda) monoclonal antibody (mAb) that binds to the p19 subunit of human interleukin (IL)-23 with high specificity and affinity. The binding of guselkumab to the IL-23p19 subunit blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, thus inhibiting IL-23-specific intracellular signaling and downstream activation and cytokine production. The antibody specific to IL-23 comprises a light chain variable region and a heavy chain variable region. The claims recite six complementarity determining regions, three for the light chain and three for the heavy chain with corresponding amino acid sequences of SEQ ID No. 1-6. Clinical endpoints are measured with IGA, PASI 90, PASI 100, ss-IGA, PSSD, NAPSI and Modified Rodnan Skin Score (mRSS)
Guidance of the Specification
In claim 17, the specification does not teach how to make and/or use Modified Rodnan Skin Score (mRSS). Further, the specification does not enable any person skilled in the art to which it pertains (i.e. the patient is a responder to the antibody by being identified as meeting a clinical endpoint about 24 weeks after the initial dose, wherein the clinical endpoint is change from baseline in Modified Rodnan Skin Score (mRSS)) to make and/or use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification or prior art with regard to using mRSS as a clinical endpoint for psoriasis. Applicant fails to provide guidance and information required to ascertain the claimed invention without
undue experimentation. Further, Applicant’s limited disclosure is noted but it is not sufficient to justify claiming mRSS as a measurement for clinical endpoint.
State of the Art
Khanna, et. al. (Khanna D, Furst DE, Clements PJ, et al. Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis. J Scleroderma Relat Disord. 2017;2(1):11-18. doi:10.5301/jsrd.5000231) teaches the modified Rodnan skin score (mRSS) is a measure of skin thickness and is used as a primary or secondary outcome measure in clinical trials of systemic sclerosis (SSc, scleroderma). SSc is subclassified into diffuse cutaneous SSc (dcSSc) or limited cutaneous SSc (lcSSc) based on the extent of skin involvement. lcSSc is defined as skin thickening distal to the elbows and knees, with or without involvement of the face. dcSSc is characterized by the presence of skin thickening, proximal as well as distal, to the elbows and knees with or without involvement of the face. Dr. Gerald Rodnan at the University of Pittsburgh theorized about, and then studied, the trajectory of skin thickening in the course of SSc. He noted that the skin, particularly the dermis, thickened initially and after some years usually thinned. He became convinced that an observer could, with practice, accurately estimate how thick skin is by palpating it. To substantiate his point, he developed a method for estimating thickness by clinical palpation using a 0–4 scale. Some years later, Dr. Rodnan’s colleagues modified his method by estimating skin thickness using a 0–3 scale in 17 body areas. Nine of the original areas (neck [1], shoulders [2], breasts [2], upper back [1], lower back [1], toes [2]) were dropped because clinical investigators found it too difficult to come to consensus due to high inter-observer variation. One of the first applications of this mRSS was in a randomized clinical trial (RCT) of high-dose versus low-dose D-penicillamine in early dcSSc. During the same period when the mRSS was developed, several groups were exploring different ways of assessing global skin involvement in patients with SSc. For example, Kahaleh et. al. proposed a modification of the Rodnan technique for measuring skin thickness (scores ranged from 0–66)(4). Investigators at UCLA developed a skin scoring technique which involved assessment of skin tethering or hidebinding in 10 body areas (scores ranged from 0–30). Another method assessed the percentage of total body surface area affected by scleroderma(6). However, consensus was eventually reached where the mRSS became the gold standard for measuring skin thickness in SSc.
As of the filing date, there is no prior art reciting that the modified Rodnan skin score is used as a clinical endpoint for psoriasis. Thus, without supporting data or structural and/or functional characterizations, one of skilled in the art cannot reasonably predict that mRSS can be used for measuring clinical endpoint for psoriasis.
Experimentation Required
In order to practice the claimed invention, an immense amount of experimentation would be required. For example, it would be necessary for one of ordinary skill in the art to conduct labor intensive experimentation:
A. Practical aspects
Positioning of the patient: This is an important part of assessing mRSS. Each area examined should be in the relaxed position so the underlying muscles are relaxed to avoid falsely overestimating the area skin scores. Proper scoring cannot be done with patients in regular clothes. An examination gown or loose clothing is needed with appropriate use of sheet/drape. When evaluating the upper extremities, face, and anterior chest, we recommend the patient be seated in a relaxed position with arms by the side of the body. When evaluating the abdomen and lower extremities, we recommend the patient lie supine on an examination table or bed with the hips at 45 degrees’ flexion and feet are dorsiflexed.
Assessing skin thickness:
There are 2 techniques to accomplish this by palpation of the skin.
Use an index finger and thumb where the skin is rolled or pinched gently to gauge thickness.
Use two thumbs to form a fold of skin between advancing lateral thumb borders. This method may be easier when skin overlies bone such as in the fingers and on the dorsum of the hands.
It is important to understand the relative distribution of subcutaneous fat and underlying musculoskeletal structures in different anatomical areas as they may alter the examiner’s appreciation of skin thickness.
Skin should be scored based on how it feels and not how it looks. For example, shiny skin or abnormally pigmented skin does not imply increased thickness.
B. Global average vs. maximum score vs. most representative area of an anatomic area
There are differences in scoring mRSS in clinical practice but we recommend standardizing mRSS measurement in clinical trials. The 3 commonly used techniques include:
Maximum score: The examiner assigns a score to individual anatomic areas according to the most severe local involvement. For example, if the distal forearm has a patch considered 2 whereas the remainder of the forearm is 1, then would be given a score of 2 is recorded.
Representative area: The examiner scores individual areas with a score that is most representative of the area. In the example above, 1 would be the most representative score.
Global average: The examiner scores individual areas and takes average of the area. In the example above, 1 would be the most representative score. However, if the distal forearm had areas scored 2 and 3 whereas the majority of the forearm is 1, the average would be 2 (differs from representative area where the score would be 1). Some investigators prefer not to divide the scored region formally into subareas but prefer to provide an average score that reflects overall skin thickness and accounts for the observed variation in a more flexible fashion. Both methods are sound and acceptable.
Scoring of each individual cutaneous area:
mRSS =0 is “normal skin” where the examiner appreciates fine wrinkles but no skin thickness is present.
mRSS =1 is defined as definite but “mild” skin thickness where the examiner can easily make skin folds between 2 fingers; fine wrinkles are acceptable.
mRSS =2 is defined as “moderate” skin thickness with difficulty in making skin folds and no wrinkles.
mRSS =3 is defined as “severe” skin thickness with inability to make skin folds between 2 examining fingers.
The same examiner should evaluate the skin thickness throughout the trial:
Each outcome measure inherently has measurement variability. It is recommended that the same assessor examine the patient for the duration of the trial. The inter-observer variability of the mRSS is 4.6 units (coefficient of variation=25%) and the intra-observer variability is 2.5 units (coefficient of variation= 12%)(11), with these variabilities better than that of measuring swollen and tender joint counts in rheumatoid arthritis, both part of the standard assessment in that disease. Others have found similar results for the variability of the mRSS.
Taking into consideration the factors outlined above, including the nature of the invention, the breadth of the claims, the state of the art, the guidance provided by the applicant and the specific examples, it is concluded that an unreasonable amount experimentation would be required to make and use the invention as claimed.
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.
9. The term “about” in claims 2, 3, 5, 8, 9, 10, and 17, is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, 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 word about introduces a range of possibilities and even wider in some interpretations which causes ambiguity. The rationale for avoiding such phrasing comes down to accuracy, reproducibility and the proper representation of uncertainty.
Claim Rejections - 35 USC § 102
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.
10. Claims 1-4, 6, 7, 12, and 14-17 are rejected under 35 U.S.C 102(a)(1) and 102 (a)(2) as being anticipated over Angsana, et. al. (U.S. Patent No. 11,548,941 B2; Issues 01/10/2023).
The instant claims are drawn to a method of treating mild to moderate psoriasis in a patient, comprising administering to the patient an antibody specific to IL23, wherein the antibody comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4; a CDRL2 amino acid sequence of SEQ ID NO:5; and a CDRL3 amino acid sequence of SEQ ID NO:6, said heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1; a CDRH2 amino acid sequence of SEQ ID NO:2; and a CDRH3 amino acid sequence of SEQ ID NO:3, wherein the patient is a responder to the antibody.
Angsana, et. al. teach a method of treating psoriasis in a patient previously treated with at least one dose of secukinumab, comprising discontinuing secukinumab treatment to the patient; and administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody to IL-23 comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:50; a CDRL2 amino acid sequence of SEQ ID NO:56; and a CDRL3 amino acid sequence of SEQ ID NO:73, said heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:5; a CDRH2 amino acid sequence of SEQ ID NO:20; and a CDRH3 amino acid sequence of SEQ ID NO:44. Angsana, et. al. teaches a heavy chain variable region and light chain variable region with amino acid sequences of SEQ ID NO: 50, 56, 73, 5, 20 and 44 (claim 1), which are 100% identical to the heavy chain variable region and light chain variable region with amino acid sequence of SEQ ID NO: 4, 5, 6, 1, 2 and 3 in instant claim 1.
Angsana et. al. goes on to teach administering IL-23 at a dose of 100 mg (claim 7), subcutaneously (claim 31), in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks (claim 5), as recited by instant claims 2-4. Additionally, Angsana, et. al. teaches treating a patient with the antibody to IL-23 to demonstrate efficacy in a psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0, and IGA 1 (claims 14 and 17), as recited in instant claims 6 and 7. Angsana et. al. further teaches a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 107 (claim 16 ), as recited in instant claim 12 as the prior art sequences are duplicates to instant SEQ ID NO: 8 and instant SEQ ID NO: 7. Angsana et. al. also teaches the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state (claim 8), as recited in instant claim 14. Angsana et. al. teaches administering to the patient one or more additional drugs used to treat psoriasis (claim 10), as recited in instant claim 15, wherein the additional drug is selected from the group consisting of immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers (claim 11), as recited instant claim 16).
Angsana et al. teaches an antibody comprising a light chain variable region amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO:106 (claim 31), as recited in instant claim 17 as the prior art sequences are duplicates to instant SEQ ID NO: 8 and instant SEQ ID NO: 7
11. Claim 1-4, 6-8, 12-13 and 17 are rejected under 35 U.S.C 102(a)(1) as being anticipated over Gordon, et al. (Gordon, et al. (2015). A phase 2 trial of guselkumab versus adalimumab for plaque psoriasis. New England Journal of Medicine, 373(2), 136–144. https://doi.org/10.1056/nejmoa1501646).
Gordon, et al. teach a method of guselkumab (CNTO 1959), an anti–interleukin-23 monoclonal antibody to treat patient with moderate-to-severe plaque psoriasis. Regarding instant claims 1, 12, 13 and 17 that recite “ a method of treating mild to moderate psoriasis in a patient, comprising administering to the patient an antibody specific to IL23, with a light chain variable region amino acid sequence of SEQ ID NO: 4-6 and with a heavy chain variable region amino acid sequence of SEQ ID NO: 1-3” (instant claim 1), “wherein the antibody comprises a light chain variable region amino acid sequence of SEQ ID NO: 8 and a heavy chain variable region amino acid sequence of SEQ ID NO: 7” (instant claim 12), “wherein the antibody comprises a light chain amino acid sequence of SEQ ID NO: 10 and a heavy chain amino acid sequence of SEQ ID NO: 9” (instant claim 13), wherein the antibody comprises a light chain variable region amino acid sequence of SEQ ID NO: 8 and a heavy chain variable region amino acid sequence of SEQ ID NO: 7 (instant claim 17), such structures would be inherent properties of practicing the method taught by Gordon, et al. because Gordon, et al. teaches administering the same antibody (Guselkumab, CNTO1959) at a specific dose to the same patient population, and therefore, the prior method would necessarily possess the same results claimed by Applicant. It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive
properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Gordon, et al. teach a method of administering guselkumab subcutaneously at 0, 4 and 12 weeks, as recited by instant claims 2 and 4. Gordon, et al. teach a method of administering the guselkumab at a dose of 100 mg (methods section), as recited by instant claim 3. Gordon, et al. teach he primary end point was the proportion of patients with a PGA score of 0 or 1 at week 16 and secondary end points were the proportion of patients with at least a 75% improvement from baseline in the PASI score at week 16 (efficacy and safety analyses section), as recited by instant claims 6-8.
12. Claim 1-4, 6-10, 12-13 and 17 are rejected under 35 U.S.C 102(a)(1) as being anticipated over Janssen Research & Development, LLC (Clinicaltrials.gov, July 22, 2021, clinicaltrials.gov/study/NCT02207244.)
Janssen Research & Development, LLC teach a method to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash). Instant claims 1, 12, 13 and 17 are inherent properties of practicing the method taught by Janssen Research & Development, LLC because Janssen Research & Development, LLC teaches administering the same antibody (Guselkumab, CNTO1959) at a specific dose to the same patient population, and therefore, the prior method would necessarily possess the same results claimed by Applicant. It is well settled that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (emphasis added); see In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368. Additionally, "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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.
Janssen Research & Development, LLC teach 100 mg of guselkumab is administration by subcutaneous injection at weeks 0,4, 12 and 20 (study plan section), as recited by instant claims 2,3 and 4. Janssen Research & Development, LLC teach clinical endpoints such as PASI and IGA are measured at weeks 16 and 24 (study plan section), as recited by instant claims 6-10.
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.
13. Claims 1-12 and 14-17 are rejected under 35 U.S.C 103 as being unpatentable over Angsana, et. al. (U.S. Patent No. 11,548,941 B2; Issued 01/10/2023).
The instant claims are drawn to a method of treating mild to moderate psoriasis in a patient, comprising administering to the patient an antibody specific to IL23, wherein the antibody comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:4; a CDRL2 amino acid sequence of SEQ ID NO:5; and a CDRL3 amino acid sequence of SEQ ID NO:6, said heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:1; a CDRH2 amino acid sequence of SEQ ID NO:2; and a CDRH3 amino acid sequence of SEQ ID NO:3, wherein the patient is a responder to the antibody.
Angsana, et. al. teach a method of treating psoriasis in a patient previously treated with at least one dose of secukinumab, comprising discontinuing secukinumab treatment to the patient; and administering an antibody to IL-23 to the patient in a clinically proven safe and clinically proven effective amount, wherein the antibody to IL-23 comprises a light chain variable region and a heavy chain variable region, said light chain variable region comprising: a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:50; a CDRL2 amino acid sequence of SEQ ID NO:56; and a CDRL3 amino acid sequence of SEQ ID NO:73, said heavy chain variable region comprising: a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:5; a CDRH2 amino acid sequence of SEQ ID NO:20; and a CDRH3 amino acid sequence of SEQ ID NO:44. Angsana, et. al. teaches a heavy chain variable region and light chain variable region with amino acid sequences of SEQ ID NO: 50, 56, 73, 5, 20 and 44 (claim 1), which are 100% identical to the heavy chain variable region and light chain variable region with amino acid sequence of SEQ ID NO: 4, 5, 6, 1, 2 and 3 in instant claim 1.
Angsana et. al. goes on to teach administering IL-23 at a dose of 100 mg (claim 7), subcutaneously (claim 31), in an initial dose, 4 weeks after the initial dose and every 8 weeks after the dose at 4 weeks (claim 5), as recited by instant claims 2-4. Additionally, Angsana, et. al. teaches treating a patient with the antibody to IL-23 to demonstrate efficacy in a psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0, and IGA 1 (claims 14 and 17), as recited in instant claims 6 and 7. Angsana et. al. further teaches a light chain variable region of the amino acid sequence of SEQ ID NO: 116 and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 107 (claim 16 ), as recited in instant claim 12 as the prior art sequences are duplicates to instant SEQ ID NO: 8 and instant SEQ ID NO: 7. Angsana et. al. also teaches the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state (claim 8), as recited in instant claim 14. Angsana et. al. teaches administering to the patient one or more additional drugs used to treat psoriasis (claim 10), as recited in instant claim 15, wherein the additional drug is selected from the group consisting of immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers (claim 11), as recited instant claim 16).
Angsana, et. al. teaches that doses can be administered in an initial dose at 4 weeks and 8 weeks after the initial dose at 4 weeks (claim 5), and clinical endpoints can be measured at 44 weeks and/or 48 weeks (claim 18). Angsana, et al. also teaches a variety doses of at least one antibody of the present invention from 0.1 to 100mg/kg, 1-52 weeks or 1-20 years (paragraph 183 and 185) as recited in instant claims 5, and 8-11.
Based on the applications disclosure in paragraph 136, optimization is reasonable of doses and dosage administration. Angsana, et al. teach in paragraph 136 that treatment can vary depending on specific activity of the active agent contained in the composition, particular disease state, particular patent undergoing treatment and it can be necessary to provide repeat administration. Angsana, et al. further teach that dosages administered can vary depending upon pharmacodynamic characteristics of the particular agent, and its mode and route of administration; age, health, and weight of the recipient; nature and extent of symptoms, kind of concurrent treatment, frequency of treatment, and the effect desired.
The time of dosage and measuring clinical endpoints can clearly be a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the dosage and dosing regimen, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). 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," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 11, Angsana et. al. teaches that subjects receiving previous therapies in each previous psoriasis medication category were comparable between the treatment groups. Overall, 37.1% of subjects were naïve to non-biologic systemic and biologic therapies (Appendix 3). Appendix 3 specifically mentions one of those previous therapies being a non-biologic systemic therapy called Apremilast. Apremilast is a pervious psoriasis medication that is comparable between the treatment groups, as recited in claim 11.
Double Patenting
14. 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.
15. Claims 1-4, 6, 7, 12, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 8, 10, 11, 14, 16, 17 and 31 of Angsana, et. al. (U.S. Patent No. 11,548,941 B2; Issued 01/10/2023). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, U.S. Patent 11548941 claim 1 taught a method of treating psoriasis in a patient, comprising administering to the patient an antibody specific to IL-23. wherein the antibody to IL-23 comprises a light chain variable region and a heavy chain variable region comprising CDRL-1 of SEQ ID NO:50 (identical to instant SEQ ID NO: 4), CDRL-2 of SEQ ID NO: 56 (identical to instant SEQ ID NO: 5), CDRL-3 of SEQ ID NO: 73 (identical to instant SEQ ID NO: 6), CDRH-1 of SEQ ID NO: 5 (identical to SEQ ID NO: 1), CDRH-2 of SEQ ID NO: 20 (identical to instant SEQ ID NO: 2), and CDRH-3 of SEQ ID NO: 44 (identical to SEQ ID NO: 3).
Regarding instant claims 2,3 and 4, further details of U.S. Patent 11548941 claim 5 anticipates instant claim 2 (overlapping dosing times at 4 weeks and 12 weeks), U.S. Patent 11548941 claim 7 anticipates instant claim 3 (administered dosage of 100 mg), and U.S. Patent 11548941 claim 31 anticipates instant claim 4 (administered by subcutaneous injection).
Regarding instant claim 6, U.S. Patent 11548941 claim 17 teaches treating a patient with the antibody to IL-23 to demonstrate efficacy in a psoriasis clinical endpoint selected from the group consisting of PASI90, PASI100, IGA 0, and IGA 1.
Regarding instant claim 7, U.S. Patent 11548941 claim 14 teaches measuring psoriasis clinical endpoint PASI90, PASI100, IGA 0 and/or IGA 1 (overlapping clinical endpoints).
Regarding instant claim 12, U.S patent 11548941 claim 16 teaches a light chain variable region of the amino acid sequence of SEQ ID NO: 116 (duplicate to instant SEQ NO: 8) and a heavy chain variable region of the amino acid sequence of SEQ ID NO: 107 (duplicate to instant SEQ NO: 7).
Regarding instant claim 14, U.S Patent 11548941 claim 8 teaches, wherein the antibody to IL-23 is in a composition comprising 100 mg/mL of antibody; 7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state (duplicate to instant claim 14).
Regarding instant claim 15, U.S Patient 11548941 claim 10 teaches administering to the patient one or more additional drugs used to treat psoriasis.
Regarding instant claim 16, U.S Patent 11548941 claim 11 anticipates instant claim 16 (wherein the additional drug is selected from the group consisting of: immunosuppressive agents, non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate (MTX), anti-B-cell surface marker antibodies, anti-CD20 antibodies, rituximab, TNF-inhibitors, corticosteroids, and co-stimulatory modifiers).
Regarding instant claim 17, U.S. Patient 11548941 claim 31 teaches an antibody comprising a light chain variable region amino acid sequence of SEQ ID NO: 116 (duplication to instant SEQ ID NO: 8) and a heavy chain variable region of the amino acid sequence of SEQ ID NO:106 (duplication to instant SEQ ID: NO 7). Since the patent teaches administering the same antibody to the same patient population, the clinical endpoint (mRSS) change would have to be present in the prior art.
Conclusion
16. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674