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 .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
1. Claims 1-3, 13-14, 17, 54, 62,102, 106-107, 116, 122, 126-127, and 132-136 are pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 08/18/2026 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Drawings
3. The drawings filed on 05/23/2024 are accepted by the examiner.
Claim Rejections--Nonstatutory Obviousness-Type Double Patenting
4. Basis for nonstatutory 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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
5. Claims 106-107, 116, 122, and 126-127 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US Patent No. 9,663,571 B2.
An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. See, e.g., In re Berg, 140F.3d1428, 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).
Claims 1-16 of US Patent No. 9,663,571 B2 are drawn to a method of treating pruritis, said method comprising administering a therapeutically effective amount of an anti-OSMR antibody to a patient in need thereof, the administering includes subcutaneous delivery. On the other hand, claims 106-107, 116, 122, and 126-127 of the instant application is drawn to a method of treating a disease, disorder or condition associated with OSMR comprising administering into a subject in need of treatment a stable formulation, wherein the formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. Claims 106-107, 116, 122, and 126-127 of the instant application and claims 1-16 of US Patent No. 9,663,571 B2 vary in scope and are obvious over each other.
6. Claims 106-107, 116, 122, and 126-127 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US Patent No. 10,421,813 B2.
An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. See, e.g., In re Berg, 140F.3d1428, 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).
Claims 1-12 of US Patent No. 10,421,813 B2 are drawn to a method of treating pruritis, said method comprising systemically injecting a therapeutically effective amount of an anti-OSMR monoclonal antibody to a human patient in need thereof. On the other hand, claims 106-107, 116, 122, and 126-127 of the instant application is drawn to a method of treating a disease, disorder or condition associated with OSMR comprising administering into a subject in need of treatment a stable formulation, wherein the formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. Claims 106-107, 116, 122, and 126-127 of the instant application and claims 1-12 of US Patent No. 10,421,813 B2 vary in scope and are obvious over each other.
7. Claims 1-3, 13-14, 17, and 102 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US Patent No. 10,391,170 B2.
An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. See, e.g., In re Berg, 140F.3d1428, 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).
Claims 1-16 of US Patent No. 10,391,170 B2 are drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody at a concentration of 100-250 mg/mL and having a pH ranging from approximately 6.0-7.6, wherein the anti-OSMR antibody comprises the a light chain having an amino acid sequence set forth in SEQ ID NO: 2; and a heavy chain having an amino acid sequence set forth in SEQ ID NO: 1.
On the other hand, claims 1-3, 13-14, 17, and 102 of the instant application is drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. Claims 1-3, 13-14, 17, and 102 of the instant application and claims 1-16 of US Patent No. 10,391,170 B2 vary in scope and are obvious over each other.
8. Claims 1-3, 13-14, 17, 54, 62,102, and 132-136 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent No. 10,493,149 B2.
An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. See, e.g., In re Berg, 140F.3d1428, 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).
Claims 1-19 of US Patent No. 10,493,149 B2 are drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein the formulation comprises 10-150 mM arginine, 10-20 mM histidine, or 5-75 mM phosphate, wherein the anti-OSMR antibody has a pI ranging from 6.5-8.0 and is present in the formulation at a concentration ranging from 100-250 mg/ml, and wherein at least 90% of the anti-OSMR antibody exists as monomer in the formulation upon storage at 40 °C for two weeks.
On the other hand, claims 1-3, 13-14, 17, 54, 62,102, and 132-136 of the instant application is drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. Claims 1-3, 13-14, 17, 54, 62,102, and 132-136 of the instant application and claims 1-19 of US Patent No. 10,493,149 B2 vary in scope and are obvious over each other.
9. Claims 1-3, 13-14, 17, 54, 62,102, and 132-136 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent No. 11,141,479 B2.
An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. See, e.g., In re Berg, 140F.3d1428, 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).
Claims 1-19 of US Patent No. 11,141,479 B2 are drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.1-7.1, wherein the formulation comprises 10-150 mM arginine, 10-20 mM histidine, or 5-75 mM phosphate, wherein the anti-OSMR antibody has a pI ranging from 6.5-8.0 and is present in the formulation at a concentration ranging from 100-250 mg/ml, and wherein at least 90% of the anti-OSMR antibody exists as monomer in the formulation upon storage at 40 0C for two weeks; and wherein the anti-OSMR antibody comprises (i) a heavy chain having the amino acid sequence set forth in SEQ ID NO: 1; and a light chain having the amino acid sequence set forth in SEQ ID NO: 2; or (ii) a heavy chain variable domain having the amino acid sequence set forth in SEQ ID NO: 3; and a light chain variable domain having the amino acid sequence set forth in SEQ ID NO: 4, wherein the formulation is aqueous.
On the other hand, claims 1-3, 13-14, 17, 54, 62,102, and 132-136 of the instant application is drawn to a stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. Claims 1-3, 13-14, 17, 54, 62,102, and 132-136 of the instant application and claims 1-19 of US Patent No. 11,141,479 B2 vary in scope and are obvious over each other.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
10. The following is a quotation of the first paragraph of 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.
11. Claims 106-107, 116, 122, and 126-127 are rejected under 35 U.S.C. 112(a), 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 use the invention.
The factors that are considered when determining whether a disclosure satisfies enablement requirement include: (i) the quantity of experimentation necessary; (ii) the amount of direction or guidance presented; (iii) the existence of working examples; (iv) the nature of the invention; (v) the state of the prior art; (vi) the relative skill of those in the art; (vii) the predictability or unpredictability of the art; and (viii) the breadth of the claims. Ex Parte Forman, 230 USPQ 546 (Bd Pat. App. & Int. 1986); In re Wands, 858 F. 2d 731, 8 USPQ 2d 1400 (Fed. Cir. 1988).
Claims 106-107, 116, 122, and 126-127 are drawn to a method of treating a disease, disorder or condition associated with OSMR comprising administering into a subject in need of treatment a stable formulation of an anti-OSMR antibody. The specification provides a laundry list of diseases, disorders, or conditions to be treated (page 10, paragraph [0024]). Thus, the claims are broad because they encompass a method of treating a wide range of diseases, which possess distinct pathological features.
The specification does not provide sufficient guidance/direction or working examples on how to treat a disease or condition associated with OSMR comprising administering into a subject in need of treatment a stable formulation of an anti-OSMR antibody. There is no evidence on the record showing that administering to a subject a formulation of an anti-OSMR antibody can treat a disease or condition associated with OSMR, such as those disclosed in the specification (page 10, paragraph [0024]).
Due to the large quantity for experimentation necessary to make and use the instantly claimed method, the limited directions guidance presented in the specification regarding the same, the limited working example directed to the same, the complex nature of the invention, the unpredictability in the art, and the breadth of the claims, undue experimentation would be required for the skilled artisan to make and use the claimed invention.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
12. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
13. Claims 1, 14, and 106 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i). Claims 1 and 14 are indefinite because it recites “less than approximately”. It is suggested that the word “approximately” be deleted.
(ii). Claim 106 recites “a disease, disorder or condition associated with OSMR”. It is unclear what the particular disease or condition is and it fails to provide reasonable certainty as to the scope of the invention.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
14. 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.
15. Claims 1-3, 13-14, 17, 102, 106-107, 116, 122, and 126-127 are rejected under 35 U.S.C. 102 (a)(1) or 102 (a)(2) as being anticipated by WO 2014194274 A2 (December 4, 2014).
WO 2014194274 A2 teaches an anti-OSMR antibody comprising a light chain variable domain having an amino acid sequence set forth in SEQ ID NO: 4 and a heavy chain variable domain having an amino acid sequence set forth in SEQ ID NO: 3 (see sequence alignment below), said antibody comprises a light chain having an amino acid sequence set forth in SEQ ID NO: 2 and a heavy chain having an amino acid sequence that is 94.8% identical to the amino acid sequence set forth in SEQ ID NO:1.
WO 2014194274 A2 teaches a pharmaceutical formulation comprising the anti-OSMR antibody (page 65, paragraph [00252]), tonicity enhancing agents, such as sodium chloride (page 66, paragraph 00254), polysorbate 80 (page 71, paragraph [00272]), lysine and arginine (page 70, paragraph [00268]). The formulation has a physiological pH (approximately 7.4) or a pH range of 5-8 (page 68, paragraph [00256]). The formulation may be liquid and lyophilized formulation (page 70, paragraph [00268]). WO 2014194274 A2 further teaches that the formulation may contain materials for modifying or preserving the pH, osmolarity, viscosity, isotonicity, or stability of the composition (page 66, paragraph [00254]). The materials include amino acids such as arginine (page 66, paragraph [00254]).
Since WO 2014194274 A2 teaches apparently the same formulation of anti-OSMR antibody, the property of recited in claim 1, “wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation” and other properties recited in claims 1-3, 126-127, and 132-136 are inherent to the formulation taught by the cited art.
Thus, the teachings of WO 2014194274 A2 meet the limitations of claims 1-3, 13-14, 17, 102, 106-107, 116, 122, and 126-127.
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Claim Rejections under 35 USC § 103(a)
16. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
17. Claims 54, 62, 102, and 132-136 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2014194274 A2 (December 4, 2014) as applied to claims 1-3, 13-14, 17, 102, 106-107, 116, 122, and 126-127 above, and further in view of US Patent No. 8,883,979 B2 (Nov. 11, 2014).
WO 2014194274 A2 teaches a pharmaceutical formulation comprising the anti-OSMR antibody as applied to claims 1-3, 13-14, 17, 102, 106-107, 116, 122, and 126-127 above.
WO 2014194274 A2 does not teach (i) the concentration of anti-OSMR antibody as recited in claims 54, 62, and 102; (ii) histidine in the formulation as recited in claim 54; and (iii) the particular range of concentrations of the formulation components as recited in claim 54.
US Patent No. 8,883,979 B2 teaches a high concentration, low viscosity, isosmotic anti-PRLR antibody formulation comprising 150 mg/ml anti-PRLR antibody, 0-70 mM histidine, 50 ppm to about 300 ppm of polysorbate 80, 0-50 mM arginine at pH 5.0-6.5 (column 4, last paragraph). The teachings of US Patent No. 8,883,979 B2 (equivalent to WO06138181 A2) is acknowledged in WO 2014194274 A2 (page 70, paragraph [00262]).
It would have been obvious for one skilled in the art to make a formulation comprising a high concentration of the anti-OSMR antibody taught by WO 2014194274 A2, such as 150 mg/ml, and the components of the formulation taught by US Patent No. 8,883,979 B2 with a reasonable expectation of success. One would have been motivated to do so because the components and concentrations thereof are well-known in the art and could have been routinely determined by experimentation. Moreover, since the cited art in combination teaches apparently the same formulation of anti-OSMR antibody, the property of recited in claims 54 and 132-136 are inherent to the formulation taught by the cited art.
Conclusion
18. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
September 23, 2026
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