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 the Claims
Claims 1-10 and 13-14 are pending in this application.
Claims 1-10 and 13-14 are presently under consideration.
Claim Objections
Claims 1 and 7-9 are objected to because of the following informalities: With respect to claims 1, 7 and 9, the acronym “LINK_TSG6” should be spelled out the first time it is mentioned in every independent claim. The claims should be rewritten to replace “LINK_TSG” with “Link module of TSG-6 (LINK_TSG6)”. Claim 8 should be rewritten to recite “The composition according to claim 7, wherein the composition comprises 10 mg to 15 mg of LINK_TSG6 per dose”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of treating osteoarthritis pain comprising administering LINK_TSG6 to a patient in need thereof.
When referring to the LINK_TSG6, the specification teaches that “[L]INK_TSG6 polypeptide comprises, consists, or consists essentially of (i) the amino acid sequence of SEQ ID NO: 7 or SEQ ID NO: 9, or (ii) an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 7 or 9” (para [0046]).
The specification does not provide any other structural attributes associated with the LINK_TSG6.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of the sequence correlates with the required activity (i.e. to treat osteoarthritis pain).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the LINK_TSG6 can be any polypeptide having at least 80% identity to SEQ ID NO: 7 or SEQ ID NO: 9.
It is noted that SEQ ID NO: 7 and SEQ ID NO: 9 consist of 92 and 98 amino acids, respectively.
Therefore, even considering only naturally occurring amino acids, one would have 7.5x1035 (92x91x90x89x88x87x86x85x84x83x82x81x80x79x78x77x76x75x20) possible polypeptides having at least 80% identity to SEQ ID NO: 7, and 2.1x1038 (98x97x96x95x94x93x92x91x90x89x88x87x86x85x84x83x82x81x80x20) possible polypeptides having at least 80% identity to SEQ ID NO: 9.
However, the specification fails to provide a representative number of examples for the claimed LINK_TSG6.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Day et al. (US 2015/0057229) as evidenced by Curtis (Osteoarthritis Symptoms and Signs, 11/12/2020) and Milner et al. (A Novel Chondroprotective Property of TSG-6 Has Therapeutic Potential for OA; Osteoarthritis and Cartilage, 24: Abstract, 2 pages (2016)).
With respect to claims 1 and 6, Day et al. teach a method for inhibiting cartilage degradation in a subject, the method comprising administering to a subject in need of treatment a therapeutically effective amount of a Link_TSG6 polypeptide, or a therapeutically effective amount of a polynucleotide encoding a Link_TSG6 polypeptide, thereby inhibiting cartilage degradation (claim 1), wherein the subject has osteoarthritis (claim 3), and wherein the Link_TSG6 polypeptide comprises, consists or consists essentially of (i) the amino acid sequence of SEQ ID NO: 9, 27, 7 or 26, or (ii) an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 9, 27, 7 or 26 (claim 5). It is noted that SEQ ID NOs: 26 and 27 corresponds to instantly claimed SEQ ID NOs: 7 and 9, respectively.
In the instant case, the Link_TSG6 polypeptide of Day et al. is the same Link_TSG6 polypeptide instantly claimed.
Furthermore, the MPEP 2112.01 states that “'Products of identical chemical composition cannot have mutually exclusive properties.’ 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.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP 2112.01).
It is noted that claim 1 requires only the step of administering the Link_TSG6 polypeptide to a subject with osteoarthritis.
Therefore, the teachings of Day et al. anticipate the instant claims because, once the Link_TSG6 polypeptide is administered to a subject with osteoarthritis, it would inherently treat osteoarthritic pain.
Furthermore, as evidenced by Milner et al. administration of Link_TSG6 polypeptide to subjects with osteoarthritis reduced pain (see “Results”).
Similarly, with respect to claim 4, once the Link_TSG6 polypeptide is administered to a subject with osteoarthritis, it would inherently treat referred pain.
Alternatively, with respect to claim 4, Day et al. teach that “[O]steoarthritis is a clinical syndrome of joint pain and reduced function of the joint (for example, stiffness and/or reduced range of motion). Symptoms include joint pain, stiffness and problems moving the joint. It may be characterised pathologically by localised loss of cartilage, remodeling of bone and/or inflammation. Joints most commonly affected by arthritis are knee joints, hip joints and joints in the hands and feet, but other joints can also be affected (para [0202]). As evidenced by Curtis, “[W]hile osteoarthritis pain is usually felt in the affected joint, it is possible for the pain to be referred to other areas of the body. For example, hip osteoarthritis may lead to knee pain” (page 2, 3rd para).
Therefore, once the Link_TSG6 polypeptide is administered to a subject with hip osteoarthritis, it would inherently treat referred pain.
With respect to claims 2 and 7, Day et al. teach that the Link_TSG6 polypeptide is administered subcutaneously (para [0230]).
With respect to claims 3 and 5, Day et al. teach that the Link_TSG6 polypeptide is administered weekly (para [0247]).
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 1-8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Day et al. (US 2015/0057229).
The teachings of Day et al. with respect to claims 1-7 have been discussed above.
Day et al. do not teach the claimed amount of LINK_TSG6 (i.e. 10 mg to 150 mg).
However, Day et al. also teach that “[a] physician will be able to determine the required route of administration and dosage for any particular patient. A typical daily dose is from about 0.1 to 50 mg per kg, preferably from about 0.1 mg/kg to 10 mg/kg of body weight, according to the activity of the specific inhibitor, the age, weight and conditions of the subject to be treated, the type and severity of the disease and the frequency and route of administration. Preferably, daily dosage levels are from 5 mg to 2 g” (para [0239]).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage and time interval between dosages by normal optimization procedures known in the pharmaceutical art.
Claims 1-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Day et al. (US 2015/0057229) as applied to claims 1-8 and 13 above, and further in view of Milner et al. (A Novel Chondroprotective Property of TSG-6 Has Therapeutic Potential for OA; Osteoarthritis and Cartilage, 24: Abstract, 2 pages (2016)).
The teachings of Day et al. with respect to claims 1-8 and 13 have been discussed above.
Day et al. do not teach: 1) intra-articular administration; and 2) the amount of LINK_TSG6 (i.e. 1 mg to 180 mg).
However, Day et al. further teach that “[a] physician will be able to determine the required route of administration and dosage for any particular patient” (para [0239]).
Milner et al. teach intra-articular administration of Link_TSG6 polypeptide to subjects with osteoarthritis (see “Methods”).
Therefore, one of ordinary skill in the art would have been motivated to administer the LINL_TSG6 polypeptide directly into the joint (i.e. intra-articular administration).
The skilled artisan would have had a reasonable expectation of success because Milner et al. teach intra-articular administration of Link_TSG6 polypeptide to subjects with osteoarthritis.
With respect to the claimed amount of LINK_TSG6, Day et al. teach that “[A] typical daily dose is from about 0.1 to 50 mg per kg, preferably from about 0.1 mg/kg to 10 mg/kg of body weight, according to the activity of the specific inhibitor, the age, weight and conditions of the subject to be treated, the type and severity of the disease and the frequency and route of administration. Preferably, daily dosage levels are from 5 mg to 2 g” (para [0239]).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage, route of administration and time interval between dosages by normal optimization procedures known in the pharmaceutical art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9878003 (hereafter Day et al.), as evidenced by Curtis (Osteoarthritis Symptoms and Signs, 11/12/2020) and Milner et al. (A Novel Chondroprotective Property of TSG-6 Has Therapeutic Potential for OA; Osteoarthritis and Cartilage, 24: Abstract, 2 pages (2016)). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same composition and method instantly claimed.
With respect to claims 1 and 6, Day et al. teach a method for inhibiting cartilage degradation in a subject, the method comprising administering to a subject in need of treatment a therapeutically effective amount of a Link_TSG6 polypeptide, thereby inhibiting cartilage degradation, wherein the Link_TSG6 polypeptide is a fragment of the human TSG6 polypeptide that consists of (i) the amino acid sequence of SEQ ID NO : 9, 27 , 7 or 26 , or (ii) an amino acid sequence having at least 95 % identity to the amino acid sequence of SEQ ID NO : 9 , 27, 7 or 26 and being capable of inhibiting IL-1a , IL-b or TNFa induced expression of ADAMTS-4 ADAMTS-5 or MMP13 (claim 1), wherein the subject has osteoarthritis (claim 3), and wherein the Link_TSG6 polypeptide comprises, consists or consists essentially of (i) the amino acid sequence of SEQ ID NO: 9, 27, 7 or 26, or (ii) an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 9, 27, 7 or 26 (claim 5). It is noted that SEQ ID NOs: 26 and 27 corresponds to instantly claimed SEQ ID NOs: 7 and 9, respectively.
In the instant case, the Link_TSG6 polypeptide of Day et al. is the same Link_TSG6 polypeptide instantly claimed.
Furthermore, the MPEP 2112.01 states that “'Products of identical chemical composition cannot have mutually exclusive properties.’ 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.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP 2112.01).
It is noted that claim 1 requires only the step of administering the Link_TSG6 polypeptide to a subject with osteoarthritis.
Therefore, the teachings of Day et al. anticipate the instant claims because, once the Link_TSG6 polypeptide is administered to a subject with osteoarthritis, it would inherently treat osteoarthritic pain.
Furthermore, as evidenced by Milner et al. administration of Link_TSG6 polypeptide to subjects with osteoarthritis reduced pain (see “Results”).
Similarly, with respect to claim 4, once the Link_TSG6 polypeptide is administered to a subject with osteoarthritis, it would inherently treat referred pain.
Alternatively, with respect to claim 4, Day et al. teach that “[O]steoarthritis is a clinical syndrome of joint pain and reduced function of the joint (for example, stiffness and/or reduced range of motion). Symptoms include joint pain, stiffness and problems moving the joint. It may be characterised pathologically by localised loss of cartilage, remodeling of bone and/or inflammation. Joints most commonly affected by arthritis are knee joints, hip joints and joints in the hands and feet, but other joints can also be affected (column 22, lines 46-53). As evidenced by Curtis, “[W]hile osteoarthritis pain is usually felt in the affected joint, it is possible for the pain to be referred to other areas of the body. For example, hip osteoarthritis may lead to knee pain” (page 2, 3rd para).
Therefore, once the Link_TSG6 polypeptide is administered to a subject with hip osteoarthritis, it would inherently treat referred pain.
With respect to claims 2 and 7, Day et al. teach that the Link_TSG6 polypeptide is administered subcutaneously (column 27, lines 11-19). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
With respect to claims 3 and 5, Day et al. teach that the Link_TSG6 polypeptide is administered weekly (column 29, lines 40-48).
Claims 1-8 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9878003 (hereafter Day et al.).
The teachings of Day et al. with respect to claims 1-7 have been discussed above.
Day et al. do not teach the claimed amount of LINK_TSG6 (i.e. 10 mg to 150 mg).
However, Day et al. also teach that “[a] physician will be able to determine the required route of administration and dosage for any particular patient. A typical daily dose is from about 0.1 to 50 mg per kg, preferably from about 0.1 mg/kg to 10 mg/kg of body weight, according to the activity of the specific inhibitor, the age, weight and conditions of the subject to be treated, the type and severity of the disease and the frequency and route of administration. Preferably, daily dosage levels are from 5 mg to 2 g” (column 28, lines 20-28).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage and time interval between dosages by normal optimization procedures known in the pharmaceutical art.
Claims 1-10 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9878003 (hereafter Day et al.) in view of Milner et al. (A Novel Chondroprotective Property of TSG-6 Has Therapeutic Potential for OA; Osteoarthritis and Cartilage, 24: Abstract, 2 pages (2016)).
The teachings of Day et al. with respect to claims 1-8 and 13 have been discussed above.
Day et al. do not teach: 1) intra-articular administration; and 2) the amount of LINK_TSG6 (i.e. 1 mg to 180 mg).
However, Day et al. further teach that “[a] physician will be able to determine the required route of administration and dosage for any particular patient” (column 28, lines 20-22).
Milner et al. teach intra-articular administration of Link_TSG6 polypeptide to subjects with osteoarthritis (see “Methods”).
Therefore, one of ordinary skill in the art would have been motivated to administer the LINL_TSG6 polypeptide directly into the joint (i.e. intra-articular administration).
The skilled artisan would have had a reasonable expectation of success because Milner et al. teach intra-articular administration of Link_TSG6 polypeptide to subjects with osteoarthritis.
With respect to the claimed amount of LINK_TSG6, Day et al. teach that “[A] typical daily dose is from about 0.1 to 50 mg per kg, preferably from about 0.1 mg/kg to 10 mg/kg of body weight, according to the activity of the specific inhibitor, the age, weight and conditions of the subject to be treated, the type and severity of the disease and the frequency and route of administration. Preferably, daily dosage levels are from 5 mg to 2 g” (column 28, lines 22-28).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable dosage, route of administration and time interval between dosages by normal optimization procedures known in the pharmaceutical art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658