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
Summary
This is the Non-Final Office action based on the 18/606302 filed 05/28/2024.
Claims 1-3, 7, 9, 12-15, 19, 21-22, 24, 44-46, 50, 52-53, 55, 57 & 59 are pending.
Claims 4-6, 8, 10-11, 16-18, 20, 23, 25-43, 47-49, 51, 54, 56, 58, & 60 are cancelled.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 7, 9, 12-15, 19, 21-22, 24, 44-46, 50, 52-53, 55, 57 & 59 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation and abstract idea without significantly more.
Step 1: Independent Claims 1, 13 & 44 are directed towards methods.
Step 2A, Prong One: Independent Claims 1, 13, & 44 recite natural correlations and abstract ideas which are “comparing,” the measured level of biomarker to the level in a control sample. Comparing is a mental process which is an abstract idea. Based on the comparison, it is determined if the patient has OA or has risk of progressing to total joint replacement or if the patient has a response to a treatment (the disease goes away or gets better). Though the word diagnosis or diagnosing is not used in Claim 44, the diagnosis is still implicitly there, as it is in Claim 1 & 13. The independent claims follow a similar analysis to that of Example 29 of the USPTO subject matter eligibility examples.
Comparison to a control or threshold or score and calculation, even including the generally claimed “weighted aggregate of expression,” of that score, “risk score,” is a mental process or at best, a mathematical comparison using an equation. Formulas or equations are mathematical concepts, which are an enumerated abstract idea (MPEP § 2106.04(a)).
Step 2A, Prong Two: The abstract idea in independent Claims 1, 13 & 44 are not integrated into a practical application because upon or after the comparison to the threshold, no particular and specific practical application occurs.
As claimed for Claims 1 & 13 either a NGF antagonist or a “therapeutic agent that treats OA, “is administered only “when” the subject has a score greater than the threshold. Specifically, the therapeutic agent that treats OA is not a specific treatment and reads similar to “administering a suitable medication,” to a patient, which has been shown to not be particular and instead is merely instructions to “apply,” the judicial exception. See MPEP 2106.04 (d)(2)(a). If the score is less than the threshold, nothing occurs as all, so there is no application, much less a practical one.
For Claim 44- it carries a very similar analysis to Claims 1 & 13. In Claim 44, a treatment is only administered if the score is “less than or equal,” to a threshold, and otherwise no treatment is performed. Further, the therapeutic agent that treats OA is not a specific treatment nor is administering an NSAID or general opioid. and reads similar to “administering a suitable medication,” to a patient, which has been shown to not be particular and instead is merely instructions to “apply,” the judicial exception.
Also- the claimed “determining,” steps as instantly claimed as just data gathering to perform the judicial exceptions. Data gathering is considered to be extra-solution activity, and does not practically apply the judicial exception. See MPEP 2106.05 (g).
Step 2B: There is nothing in independent Claims 1, 13, & 44 which add something which is non routine and conventional or significantly more to the claimed abstract idea judicial exception.
“Determining,” especially as generally claimed instantly claimed is well understood routine and conventional (WURC) in the art. Also, treatment with a therapeutic agent that treats OA is not a specific treatment nor is administering an NSAID or general opioid is also well understood, routine and conventional in the art.
This is evidenced by URDEA in US 20080171319 which teaches of the claimed determining and VETTER in US 20150290337 which teaches of the claimed treatments.
Specifically, URDEA teaches of determining a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
URDEA further teaches of combining the panel of risk markers to create a single numerical risk indices or risk score (0121, 0108) and that this calculation and analysis involves proteomics--- so reads on the claimed proteomic risk score (0120).
VETTER teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor and also including opioids, NSAIDS, and small molecules (paragraph 0780).
Further, though no claimed detection apparatus is claimed, See MPEP 2106.05(d)- “laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner.”
The dependent claims are analyzed the same way as above.
Claim 2-3 & 7, 14-15 & 19, 45-46 & 50 recites what the sample is which is measured and what biomarkers are used and in which the data gathering is done. These are part of the natural correlation itself and do not practically apply at step 2A/2, nor to add significantly more at step 2B.
Claims 9-10, & 12, 21-22 & 24, 52-53, 55, 57 & 59, recite further treatments, but this does not change the fact that sometimes no treatment is performed and that sometimes the treatment is just a “therapeutic agent,” which is not particular and specific. These elements carry the same analysis as in the independent claim so does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 7, 9, 12-15, 19, 21-22, 24, 44-46, 50, 52-53, 55, 57 & 59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to Claims 1 & 13, “increased,” and “decreased,” are relative terms and therefore unclear. It is unclear in the claims what the risk is relative to. Is it to population that doesn’t have OA? For Claim 44, the same applies to “less,” treatment response and less is relative to something and it is unclear what it is relative to.
Further, for Claim 44- “treatment response,” and what is in parenthesis “(pain and functional improvement)” and unclear in the claim and it seems to be a claiming of a broad limitation followed by a narrow limitation, and it is unclear which is limiting in the claim.
Claims 2-3, 7, 9, 12, 14-15, 19, 21-22, 24, 45-46, 50, 52-53, 55, 57 & 59 are rejected by virtue of their dependency on the independent Claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, 9, 12-15, 19, 21-22, 24, 44-46, 50, 52-53, 55, 57 & 59 are rejected under U.S.C. 103 as being obvious by URDEA in US 20080171319 in view of VETTER in US 20150290337.
With respect to Claim 1, URDEA teaches methods of identifying subjects with osteoporosis or osteopenia, subjects at risk for developing osteoporosis, osteopenia, and bone fractures, methods of evaluating the effectiveness of osteoporosis treatments in subjects with osteoporosis or osteopenia, and methods of selecting therapies for treating osteoporosis or osteopenia, using biomarkers (abstract).
URDEA also teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds and more specifically that the expression levels of these compounds are measured (paragraph 0014, 0085, 0129, 0179-0180) and of comparison to a control threshold (paragraph 0129).
URDEA further teaches of combining the panel of risk markers to create a single numerical risk indices or risk score (0121, 0108) and that this calculation and analysis involves proteomics--- so reads on the claimed proteomic risk score (0120). URDEA further teaches of using equations to determine the risk prediction and algorithms for them (paragraph 0110-0121, 0178). URDEA teaches that boosting can be used which involves “weighting,” as claimed among many other statistical methods which involved weighting (paragraphs 0114-0121).
URDEA further teaches of identifying increased risk for the bone diseases (0003-0004, 0011) based on increased levels of the osteo risk markers (paragraph 0028, 0128).
URDEA further teaches of treating the patient based on the detection of an increased level of the osteo risk markers (paragraph 0128, 0014), and further of monitoring the patient and the treatment and the effective amount of the treatment and making subsequent measurements over the course of treatment (0017-0018, 0020, 0078, 0096, 0123).
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 2, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 3, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 7, URDEA teaches of determining the biomarkers and risk score from blood or serum or bone marrow, sputum, cerebrospinal fluid, saliva, or urine (paragraph 0021, 0082, 0088).
With respect to Claim 9, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 10, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies and more specifically of the antibodies being tanezumab (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 12, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment that is small molecule of the claimed small molecules.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being a small molecule dihydrochloride such as ibuprofen or naproxen (paragraph 0812).
It would have been obvious to one of ordinary skill in the art to use the small molecule treatment as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 13, URDEA teaches methods of identifying subjects with osteoporosis or osteopenia, subjects at risk for developing osteoporosis, osteopenia, and bone fractures, methods of evaluating the effectiveness of osteoporosis treatments in subjects with osteoporosis or osteopenia, and methods of selecting therapies for treating osteoporosis or osteopenia, using biomarkers (abstract).
URDEA also teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
URDEA further teaches of combining the panel of risk markers to create a single numerical risk indices or risk score (0121, 0108) and that this calculation and analysis involves proteomics--- so reads on the claimed proteomic risk score (0120).
URDEA further teaches of identifying increased risk for the bone diseases (0003-0004, 0011) based on increased levels of the osteo risk markers (paragraph 0028, 0128).
URDEA further teaches of treating the patient based on the detection of an increased level of the osteo risk markers (paragraph 0128, 0014), and further of monitoring the patient and the treatment and the effective amount of the treatment and making subsequent measurements over the course of treatment (0017-0018, 0020, 0078, 0096, 0123).
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA or association with total joint replacement.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of the treatments being associated with joint replacement in addition to OA (paragraph 0004).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 14, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 15, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 19, URDEA teaches of determining the biomarkers and risk score from blood or serum or bone marrow, sputum, cerebrospinal fluid, saliva, or urine (paragraph 0021, 0082, 0088).
With respect to Claim 21, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 22, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies and more specifically of the antibodies being tanezumab (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 24, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment that is small molecule of the claimed small molecules.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being a small molecule dihydrochloride such as ibuprofen or naproxen (paragraph 0812).
It would have been obvious to one of ordinary skill in the art to use the small molecule treatment as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 44, With respect to Claim 1, URDEA teaches methods of identifying subjects with osteoporosis or osteopenia, subjects at risk for developing osteoporosis, osteopenia, and bone fractures, methods of evaluating the effectiveness of osteoporosis treatments in subjects with osteoporosis or osteopenia, and methods of selecting therapies for treating osteoporosis or osteopenia, using biomarkers (abstract).
URDEA also teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
URDEA further teaches of combining the panel of risk markers to create a single numerical risk indices or risk score (0121, 0108) and that this calculation and analysis involves proteomics--- so reads on the claimed proteomic risk score (0120).
URDEA further teaches of identifying increased risk for the bone diseases (0003-0004, 0011) based on increased levels of the osteo risk markers (paragraph 0028, 0128).
URDEA further teaches of treating the patient based on the detection of an increased level of the osteo risk markers (paragraph 0128, 0014), and further of monitoring the patient and the treatment and the effective amount of the treatment and making subsequent measurements over the course of treatment (0017-0018, 0020, 0078, 0096, 0123).
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 45, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 46, URDEA teaches that a panel of osteo risk markers is detected and can be specific to osteoarthritis (Table 1 & 0165) and that these markers are COL9A1, COL9A2 and COL9A3 as claimed (paragraph 0140) and also PTH as claimed (Table 1) among other compounds.
With respect to Claim 50, URDEA teaches of determining the biomarkers and risk score from blood or serum or bone marrow, sputum, cerebrospinal fluid, saliva, or urine (paragraph 0021, 0082, 0088).
With respect to Claim 52, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 53, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment.
URDEA does not teach of treatment with the claimed nerve growth factor antagonist or specifically a therapeutic agent that treats OA.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being anti-NGF antibodies and more specifically of the antibodies being tanezumab (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the nerve growth factor inhibitor or antagonist as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 55, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment that is small molecule of the claimed small molecules.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being a small molecule dihydrochloride such as ibuprofen or naproxen (paragraph 0812).
It would have been obvious to one of ordinary skill in the art to use the small molecule treatment as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 57, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment that is an NSAID of the claimed NSAIDs.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being NSAIDS such as ibuprofen or naproxen (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the NSAID treatment as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
With respect to Claim 59, URDEA teaches of the claim as shown above, but does not teach of using an NGF antagonist for treatment that is an opioid of the claimed opioids.
VETTER is used to remedy this and teaches of drugs for treatment (abstract) and specifically drugs which can treat diseases of the joint including osteoarthritis (paragraph 0001, 0807, 0808) and that the treatment can be a nerve growth factor antagonist or inhibitor (paragraph 0780). VETTER also teaches of joint replacement being one of the possible treatments (paragraph 0004).
VETTER further teaches of the treatment being opioids such as oxycodone (paragraph 0780).
It would have been obvious to one of ordinary skill in the art to use the opioid treatment as is done in VETTER in the method of URDEA to treat osteoarthritis due to the advantage it offers as being a biologically active moiety for polymeric prodrugs which are injected into joints when there is joint disease and the advantage these compounds offer in that that they provide a long lasting deposit which is beneficial for the prevention, diagnosis and or treatment of a disease of the joint (VETTER, 0780, 0014-0015).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
STYRKARSDOTTIR in The CRTAC1 in Protein in Plasma Associated with Osteoarthritis and Predicts Progression to Joint Replacement: A Large Scale Proteomics Scan in Iceland (as cited on IDS dated 06/27/2024).
STYRKARSDOTTIR teaches of a method of measuring biomarkers for OA and of their use in predicting progression to joint replacement including detection of CRTAC1 and also odds ratios/scores from this (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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