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 .
Priority
This application claims priority to provisional application 63/192303, filed on 24 May 2021, and PCT/IB2022/054817, filed on 23 May 2022, via 371. The effective filing date is 24 May 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 13 February 2024 was considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-21 are the original claims. In the amendment of 10 June 2024, claims 3-5, 8-10, 13-21 were amended. Claims 1-21 are pending and the subject of this office action.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Figures 3-5 appear to have been originally generated in color, but are unintelligible in black white. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US20190269754 (herein Goldhahn).
In regard to claim 1, Goldhahn et al teach methods and compositions for the treatment of cartilage damage and arthritis (Abstract). A protease-resistant protein, derived from angiopoietin-related 3 (ANGPTL3), is taught to comprise an amino acid sequence corresponding to SEQ ID NO: 17. This sequence shares 100 percent sequence identity with the “Compound 1” of the current application, SEQ ID NO:1, as shown in the amino acid sequence alignment below.
REF SEQ ID NO:17 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
Instant SEQ ID NO:1 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
************************************************************
REF SEQ ID NO:17 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
Instant SEQ ID NO:1 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
************************************************************
REF SEQ ID NO:17 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
Instant SEQ ID NO:1 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
************************************************************
REF SEQ ID NO:17 ASSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
Instant SEQ ID NO:1 AQSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
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Goldhahn teaches methods comprising the administration of the ANGPTL3-derived polypeptide, via intra-articular injection into the knee of human subjects, using dosages ranging from 0.2 mg – 40 mg/knee (Figure 1) (Relevant to instant claim 3). The use of a 40 mg dose was specifically suggested, following initial trials using a 20 mg dose, as estimated systemic exposure at the 40 mg dose still provided ample safety margins, based on animal toxicity studies ([0125]). It is disclosed that certain embodiments involve administering the method to a human subject, suffering from osteoarthritis ([0007]). It is also taught that the method may comprise multiple injections administered monthly for a period of time, sufficient for effective treatment of the arthritis or cartilage damage ([0011] and [0067]).
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by clinical trial NCT01160822 (herein ‘822), completed in June 2011 and last updated 30 October 2012. This trial was cited in the IDS, filed on 13 February 2024, of the current application.
In regard to claims 6-10, ‘822 teaches a method for treating human subjects, suffering mild to moderate osteoarthritis of the knee, comprising an intra-articular injection of canakinumab, an anti-IL-1β antibody, to the subject’s knee at a dose ranging from 150mg – 600mg (Study Overview).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US20190269754 (herein Goldhahn).
In regard to claims 2 and 4, Goldhahn et al teach methods and compositions for the treatment of cartilage damage and arthritis, as detailed in the 35 U.S.C. 102 rejections of claims 1 and 3. These teachings disclose a method for treating osteoarthritis, comprising the intra-articular injection of a polypeptide matching the description of “Compound 1”, referenced in claim 1 of the current application. In the referenced disclosure, the structural limitations of the administered therapeutic described in instant claim 1 and 3 are met, but the limitations established in instant claims 2 (regarding the dosing cycle) and 4 (regarding the number of dosing cycles) are not explicitly stated. Despite not being explicitly stated, the limitations established in instant claims 2 and 4 would have been obvious to one skilled in the art, based on the teachings of Goldhahn.
Goldhahn describes a single dose regimen, intended to evaluate safety and tolerability (Figure 1), but also suggests optimization of the dosing amount and dosage regimen (i.e. cycle) to better suit the disease or condition to be treated ([0065-0067]). Goldhahn teaches the administered dosage (40 mg) ([0125]), the interval of time between administrations (1 month) ([0011] and [0067]), and provides the suggestion that the dosing regimen (i.e. cycle) could be further optimized to provide the desired response ([0066]). MPEP 2144.05 (II) speaks to Routine Optimization stating that "’[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)” and ‘It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.’ In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)”. The limitations established in instant claims 2 and 4, regarding dosing cycles, would have been obvious following routine optimization using the initial guidance provided by Goldhahn.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US20190269754 (herein Goldhahn) in view of Rodrigues MB, Camanho GL. (2015) MRI EVALUATION OF KNEE CARTILAGE. Rev Bras Ortop. 2015 Nov 17;45(4):340-6 (herein Rodrigues).
Goldhahn teaches a method for treating osteoarthritis comprising intra-articular administration of a chondrogenic peptides, “Compound 1”, as discussed above for the 35 U.S.C. 102 rejection of claims 1 and 3. Goldhahn does not teach a method, in which maintenance or regeneration of articular cartilage is determined by MRI analysis. Rodrigues teaches this deficiency.
Rodrigues et al provide a review highlighting the evolution of MRI analysis for the evaluation of knee cartilage. The authors state that MRI enables direct evaluation of hyaline cartilage, and is considered to be the best noninvasive method for assessing articular cartilage, due to the high soft-tissue contrast achieved by the method (Introduction: Magnetic resonance).
It would have been obvious to one skilled in the art to combine the teachings of Rodrigues with those of Goldhahn, as a means for evaluating treatment efficacy. As taught by, Rodrigues, MRI analysis provides the highest likelihood of success for non-invasive evaluation of joint cartilage.
Claims 11-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over clinical trial NCT01160822 (herein ‘822) in view of Lane N, Felson D. (2020) A Promising Treatment for Osteoarthritis? Ann Intern Med. 2020 Oct 6;173(7):580-581 (herein Lane) and US20190269754 (herein Goldhahn).
In regard to claim 11, ‘822 teaches a method for treating human subjects, suffering mild to moderate osteoarthritis of the knee, comprising an intra-articular injection of canakinumab, an anti-IL-1β antibody, to the subject’s knee at a dose ranging from 150mg – 600mg, (Study Overview) (Relevant to instant claim 15).
‘822 does not teach a method for treating knee osteoarthritis comprising the intra-articular administration of a therapeutically effective amount of an IL-1β antibody and one or more doses of “Compound 1”, an ANGPTL3-derived polypeptide. Lane and Goldhahn teach this deficiency.
Lane teaches that osteoarthritis is characterized by bone remodeling, synovial inflammation, and articular cartilage loss (Paragraph 1). It is taught that abnormal joint loading and inflammation leads to the release of inflammatory cytokine release, including IL-6, tumor necrosis factor, and IL-1β, which leads to upregulation of proteins, which drive cartilage and bone catabolism (Paragraph 1). The authors state that in a secondary analysis of osteoarthritis data from the canakinumab anti-inflammatory thrombosis outcomes study (CANTOS), a clinical trial testing IL-Iβ inhibition as a treatment for secondary prevention of cardiovascular disease, it was observed that patients treated with canakinumab were less likely to receive knee joint replacement, than those treated with a placebo (Paragraph 6). It was also taught that pain level is a critical indicator for joint replacement (Paragraph 8). Once an unacceptable level of pain is reached, joint replacement is then performed. Since patients treated with canakinumab had fewer joint replacements, it is logical to conclude that canakinumab lowers pain level in patients with osteoarthritis (Relevant to instant claim 10 and 21).
Goldhahn et al teach methods and compositions for the treatment of cartilage damage and arthritis (Abstract). These methods comprise administering a protease-resistant protein, derived from angiopoietin-related 3 (ANGPTL3) and corresponding to “Compound 1” of the current application, using dosages ranging from 0.2 mg – 40 mg/knee (Figure 1) (Relevant to instant claim 17). Goldhahn et al, incorporates WO2014138687 in its entirety, which teaches that the C-terminal domain of ANGPTL3 induces the differentiation of mesenchymal stem cells into chondrocytes (WO2014138687 [0004]). The modified ANGPTL3 fragment was assessed for in vivo efficacy, using a mouse chronic osteoarthritis model, and was found to increase type 2 collagen levels in treated joints and induce regeneration of the cartilage matrix (WO2014138687 [0127-0128]). In this model system, ANGPTL3 was administered via intra-articular injection to the knee of osteoarthritic mice, over a 3-week cycle comprising weekly administration of the protein (WO2014138687 [0127]).
It would have been obvious to combine the teachings of Goldhahn (chondrogenic peptides administered to osteoarthritic joints) and ‘822 (inhibitory IL-1β administered to osteoarthritic joints) based on the motivation provided by Lane. Lane teaches that the localized release of inflammatory cytokines, triggered by inflammation and abnormal joint loading, leads to increased cartilage and bone catabolism in the context of osteoarthritis (Paragraph 1). By combining anti-IL-1β antibodies and chondrogenic peptides into a method for treating osteoarthritis, one is effectively preventing further damage (anti-IL-1β antibodies) while repairing pre-existing damage (via chondrogenic peptide). Both elements are merely performing the same function that they did individually, and as taught by Lane (citing the CANTOS trial) and Goldhahn (citing the animal results in WO2014138687) presents a high likelihood of success.
In regard to claim 12-14 and 19, Lane teaches that cytokines, such as IL-1β, alter the chromatin landscape, resulting in the catabolism of cartilage and bone (Paragraph 1). When considering this teaching in context with the method, taught by ‘822, Goldhahn, and Lane, the administration of anti-IL-1β antibodies prior to the administration of a chondrogenic ANGPTL3 fragment would have been obvious to one skilled in the art. One would have been motivated to inhibit cartilage catabolism, prior to inducing regeneration of cartilage tissue (via ANGPTL3 fragment administration), as the effect of the ANGPTL3 fragment would be directly countered by the catabolism triggered by the presence of inflammatory IL-1β (relevant to instant claims 12 and 19). In regard to the timing between anti-IL-1β antibody administration and ANGPTL3 fragment administration, within the dosing cycle, the limitations defined within instant claims 13 and 14 would have been obvious to try based on the terminal half-life measurements of canakinumab, after intra-articular administration, disclosed within ‘822 (Section 22). ‘822 teaches that the measured half-life of canakinumab, following intra-articular administration to the knee, was approximately two weeks, 474 hours with a standard deviation of 93.6 hours (19.75 days with a standard deviation of 3.9 days). The two-week staggering of anti-IL-1β and ANGPTL3 fragment administration, described in instant claim 13, aligns well with this teaching, and would have been an obvious timing to try, as it represents a point in the IL-1β treatment, in which the treatment has presumably had sufficient time to affect the chromatin landscape (inhibiting cartilage catabolism), while a significant portion of the therapeutic is still retained. Additionally, the four-week staggering, described in instant claim 14, also would have been obvious to try as it represents a point in the treatment, at which the chromatin landscape has been significantly altered (inhibiting cartilage catabolism) and there is no longer a significant amount of retained therapeutic. This scenario would limit possible complications associated with combining the two therapeutics of the method, as at the time of filing there was no safety data available, regarding the two therapeutics in combination.
In regard to claim 16 and 18, Goldhahn et al teach methods and compositions for the treatment of cartilage damage and arthritis, as detailed in the 35 U.S.C. 102 rejections of claims 1 and 3. These teachings disclose a method for treating osteoarthritis, comprising the intra-articular injection of a polypeptide matching the description of “Compound 1”, referenced in claim 1 of the current application. In the referenced disclosure, the structural limitations of the administered therapeutic described in instant claim 1 and 3 are met, but the limitations established in instant claims 16 (regarding the dosing cycle) and 18 (regarding the number of dosing cycles) are not explicitly stated. Despite not being explicitly stated, the limitations established in instant claims 16 and 18 would have been obvious to one skilled in the art, based on the teachings of Goldhahn.
Goldhahn describes a single dose regimen, intended to evaluate safety and tolerability (Figure 1), but also suggests optimization of the dosing amount and dosage regimen (i.e. cycle) to better suit the disease or condition to be treated ([0065-0067]). Goldhahn teaches the administered dosage (40 mg) ([0125]), the interval of time between administrations (1 month) ([0011] and [0067]), and provides the suggestion that the dosing regimen (i.e. cycle) could be further optimized to provide the desired response ([0066]). MPEP 2144.05 (II) speaks to Routine Optimization stating that "’[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)” and ‘It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.’ In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)”. The limitations established in instant claims 16 and 18, regarding dosing cycles, would have been obvious following routine optimization using the initial guidance provided by Goldhahn.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over clinical trial NCT01160822 (herein ‘822), Lane N, Felson D. (2020) A Promising Treatment for Osteoarthritis? Ann Intern Med. 2020 Oct 6;173(7):580-581 (herein Lane), and US20190269754 (herein Goldhahn) in view of Rodrigues MB, Camanho GL. (2015) MRI EVALUATION OF KNEE CARTILAGE. Rev Bras Ortop. 2015 Nov 17;45(4):340-6 (herein Rodrigues).
‘822, Goldhahn, and Lane teach a method for treating osteoarthritis comprising intra-articular administration of an anti-IL-1β antibodies and chondrogenic peptides, “Compound 1”, as discussed above for the 35 U.S.C. 103 rejection of claim 11. ’22, Goldhahm, and Lane do not teach a method, in which maintenance or regeneration of articular cartilage is determined by MRI analysis. Rodrigues teaches this deficiency.
Rodrigues et al provide a review highlighting the evolution of MRI analysis for the evaluation of knee cartilage. The authors state that MRI analysis enables direct evaluation of hyaline cartilage, and is considered to be the best noninvasive method for assessing articular cartilage, due to the high soft-tissue contrast achieved by the method (Introduction: Magnetic resonance).
It would have been obvious to one skilled in the art to combine the teachings of Rodrigues with those of ‘822, Goldhahn, and Lane, as a means for evaluating treatment efficacy. As taught by, Rodrigues, MRI analysis provides the highest likelihood of success for non-invasive evaluation of joint cartilage.
Double Patenting
STATUTORY
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1-4 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 3, 21, and 4 of copending Application No. 18/562075. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
NON-STATUTORY
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 1-21 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 68 and 71 of U.S. Patent No. 11351223 (herein ‘223) in view of NCT01160822 (herein ‘822), Lane N, Felson D. (2020) A Promising Treatment for Osteoarthritis? Ann Intern Med. 2020 Oct 6;173(7):580-581 (herein Lane), US20190269754 (herein Goldhahn), and Rodrigues MB, Camanho GL. (2015) MRI EVALUATION OF KNEE CARTILAGE. Rev Bras Ortop. 2015 Nov 17;45(4):340-6 (herein Rodrigues).
‘223 claim 68 relates to a method of treating arthritis or cartilage damage, further targeted to osteoarthritis in claim 71, in a human subject comprising the administration of dose of about 40 mg of a chondrogenic polypeptide comprising SEQ ID NO:17, which as evidence by the following amino acid sequence alignment is identical to “Compound 1” of the current application (Relevant to instant claims 1 and 3).
Ref SEQ ID NO: 17 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
Instant SEQ ID NO:1 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
************************************************************
Ref SEQ ID NO: 17 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
Instant SEQ ID NO:1 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
************************************************************
Ref SEQ ID NO: 17 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
Instant SEQ ID NO:1 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
************************************************************
Ref SEQ ID NO: 17 AQSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
Instant SEQ ID NO:1 AQSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
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‘223 does not teach the dosing cycle limitations defined in instant claims 2 and 4, the use of MRI analysis for efficacy evaluation, nor does it teach the combining of the chondrogenic polypeptide with an anti-IL-1β antibody. Godhahn, ‘822, Rodrigues, and Lane teach these deficiencies.
In regard to claims 2 and 4, as discussed for the 35 U.S.C. 103 rejection, Goldhahn provides the initial teachings and suggested optimization required for one skilled in the art to arrive at dosing cycle parameters defined in instant claims 2 and 4.
In regard to claims 6-19 and 21, as discussed for the 35 U.S.C 103 rejections of claims 11-21, Lane provides motivation for the combination of treatment methods aimed at treating osteoarthritis comprising the administration of an anti-IL-1β antibody (taught by ‘822) and the administration of a chondrogenic peptide (relevant to instant claims 11-19 and 21). When combining these teachings, one would also teach the use of anti-IL-1β antibodies, defined in instant claims 6-10.
In regard to claims 5 and 20, as discussed above for the 35 U.S.C. 103 rejections of claims 5 and 20, Rodrigues provides clear instruction and motivation for the use of MRI analysis to evaluate therapeutic efficacy of the described treatment.
Claims 5-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 21, 24, 25 of copending Application No. 18/562075 (herein ‘075) in view of NCT01160822 (herein ‘822), Lane N, Felson D. (2020) A Promising Treatment for Osteoarthritis? Ann Intern Med. 2020 Oct 6;173(7):580-581 (herein Lane), and US20190269754 (herein Goldhahn).
As indicated by the statutory double patenting rejection of claims 1-4, ‘075 defines claim limitations identical to those defined in instant claims 1-4, further illustrated by the amino acid sequence alignment of the chondrogenic peptides referenced in ‘075 and the current application:
Ref SEQ ID:1 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
Instant SEQ ID NO:1 IPAECTTIYNRGEHTSGMYAIRPSNSQVFHVYCDVISGSPWTLIQHRIDGSQNFNETWEN 60
************************************************************
Ref SEQ ID:1 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
Instant SEQ ID NO:1 YKYGFGRLDGEFWLGLEKIYSIVKQSNYVLRIELEDWKDNKHYIEYSFYLGNHETNYTLH 120
************************************************************
Ref SEQ ID:1 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
Instant SEQ ID NO:1 LVAITGNVPNAIPENKDLVFSTWDHKAKGHFNCPEGYSGGWWWHDECGENNLNGKYNKPR 180
************************************************************
Ref SEQ ID:1 AQSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
Instant SEQ ID NO:1 AQSKPERRRGLSWKSQNGRLYSIKSTKMLIHPTDSESFE 219
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Additionally, claim 24 of ‘075 teaches the use of MRI analysis to evaluate the efficacy of cartilage repair (relevant to instant claims 5 and 20).
‘075 does not teach the combining of the chondrogenic polypeptide with an anti-IL-1β antibody. ‘822 and Lane teach these deficiencies.
In regard to claims 6-19 and 21, as discussed for the 35 U.S.C 103 rejections of claims 11-21, Lane provides motivation for the combination of treatment methods aimed at treating osteoarthritis comprising the administration of an anti-IL-1β antibody (taught by ‘822) and the administration of a chondrogenic peptide (relevant to instant claims 11-19 and 21). When combining these teachings, one would also teach the use of anti-IL-1β antibodies, defined in instant claims 6-10.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 7:30AM-5:00PM.
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/MATTHEW CURRAN METCALF/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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