DETAILED ACTION
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 .
Status of the Claims
Claims 1-37 are currently pending and are subject to this Office Action. This is the first Office Action on the merits of the claims.
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
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 1-37 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
The claims recite “judicial exceptions” as a limiting element or step without reciting additional elements/steps that integrate the judicial exceptions into the claimed inventions such that the judicial exceptions are practically applied, and are sufficient to ensure that the claims amount to significantly more than the judicial exceptions themselves. In the instant case, the “judicial exceptions” include the abstract idea,
“determining whether the subject is a candidate for continued treatment with the anti-NGF antibody or antigen-binding fragment thereof, comprising comparing the level of alkaline phosphatase in the subject at a timepoint after the start of treatment with the anti-NGF antibody to a baseline level of alkaline phosphatase in the subject prior to or at the start of treatment” which is not eligible for patent protection without significantly more recited in the claims.
A claim that focuses on use of judicial exceptions must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and “as an ordered combination” are considered to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. The second step—known as the “inventive concept”—requires that claims include elements which would render the method both new and useful.
The PTO’s revised guidance on the application of § 101. (USPTO's January 7, 2019, Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance indicates that we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human activity such as a fundamental economic practice, or mental
processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
"well-understood, routine, conventional" in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of generality, to the judicial exception.
The present claims are directed to judicial exceptions? The claims recite judicial exceptions as limiting elements, the abstract ideas being “determining whether the subject is a candidate for continued treatment with the anti-NGF antibody or antigen-binding fragment thereof, comprising comparing the level of alkaline phosphatase in the subject at a timepoint after the start of treatment with the anti-NGF antibody to a baseline level of alkaline phosphatase in the subject prior to or at the start of treatment”. These limitations could be done by merely reviewing the data mentally and mentally comparing and determining.
The question then becomes are there other limitations in the claim that show a patent-eligible application of the abstract idea, e.g., more than a mere instruction to apply the abstract idea? If there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim should be rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
In the present claims there are no active method steps that transform the process into a practical application of the comparing and determining steps. The limitation “(d) administering to the subject who is identified as a candidate for continued treatment one or more additional doses of the anti-NGF antibody or antigen-binding fragment thereof” has been interpreted as not being an active method step that transforms the process into a practical application because there would not be an administration step if the patient was identified as not being a candidate for continued treatment.
Amending the claim to read “(d) administering one or more additional doses of the anti-NGF antibody or antigen-binding fragment thereof to the subject who was identified as a candidate for continued treatment” would obviate this rejection.
In sum, when the relevant factors are analyzed, they weigh against the present claims amounting to significantly more than the judicial exceptions themselves. Accordingly, the claims do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-4 and 6-37 are rejected under 35 U.S.C. 112(b) as failing to set forth the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1, from which claims 2-4 and 6-37 depend, is indefinite in the recitation of “threshold value” without indicating what the threshold value is or is relative to. Similarly, claim 2 recites “baseline value” without indicating what this value is. Therefore, it is unclear which subjects actually belong to the claimed group and thus, the scope of claims cannot be established.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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, 6-16, 25-29, 31-34, 36-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geba1.
Regarding claims 1, 6-16, 25-29, 31-34, 36-37, Geba discloses the use of fasinumab in the treatment of pain associated with osteoarthritis of the knee and /or hip (see Geba, e.g., at the abstract, example 1; reads on instant claim 1.a.), determined by X-ray (see Geba, e.g., at para. [0038]-[0040], [0121]; FIG. 2-4; reads on instant claim 11, 26). Patients were randomized to receive 1, 3, 6, or 9 mg fasinumab or placebo administered subcutaneously every 4 weeks for a total of 4 doses over a 16- week treatment period (see Geba, e.g., p. 18, para. [0206]; reads on instant claim 1.b.). FIG. 37 shows a summary of alkaline phosphatase over time. FIG. 38 shows change from baseline in alkaline phosphatase (U/L) by visit: mean ( +/-SE).
Geba further discloses the following: routine monitoring of laboratory tests in the subjects revealed no significant change, with the exception of alkaline phosphatase (ALP), which increased in a time- and dose-related fashion over the course of the trial, but remained within normal range (see Geba, e.g., para. [0232]; reads on instant claim 1.c., 12), as well as the continued administration of the antibody in those subjects every 4 weeks, 8 weeks, or 8 to 16 weeks after the first administration (see Geba, e.g., claims, in particular claims 8, 14, 16-17, 20; examples; FIG. 38; see also para. [0122] and [0200] ; reads on instant claims 1.d., 6-7, 13-16, 21, 25); the level of pain was monitored during the study using WOMAC index (see Geba, e.g., para. [0220]-[0221]), where treatment was continued in subjects showing reduced pain, specifically if the subject exhibits a ≥30% improvement in WOMAC pain subscale score relative to the baseline level (see Geba, e.g., at Fig. 51; reads on instant claims 8-10); patients were excluded if they had a history of other joint diseases (see Geba, e.g., at example 1; reads on instant claims 27); patients were required to have a history of inadequate pain relief with or intolerance to standard analgesic therapy, specifically, acetaminophen and ≥1 oral NSAID, and a history of inadequate pain relief with, intolerance to, or unwillingness to use opioids. (see Geba, e.g., at example 1; reads on instant claims 28-29); wherein the anti-NGF antibody or the antigen binding fragment thereof comprises three heavy chain complementarity determining region (HCDR) sequences (HCDR1, HCDR2, HCDR3) comprising SEQ ID NOs: 4,6 and 8, respectively, and three light chain complementarity determining (LCDR) sequences (LCDR1, LCDR2, LCDR3) comprising SEQ ID NOs: 12, 14 and 16, respectively (see Geba, e.g., at claim 7; compare instantly claimed sequences to SEQ ID NOs: 4, 6, 8, 12, 14, and 16 of Geba; reads on instant claim 31); wherein the anti-NGF antibody or the antigen binding fragment thereof comprises a heavy chain variable region (HCVR)/light chain variable region (LCVR) amino acid sequence pair of SEQ ID NOs: 2/10 (see Geba, e.g., at claim 7; compare instantly claimed sequences to SEQ ID NOs: 2 and 10 of Geba; reads on instant claim 32); wherein the anti-NGF antibody or antigen-binding fragment thereof comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 17 and/or a light chain comprising the amino acid sequence of SEQ ID NO: 18 (see Geba, e.g., at para [0152]; compare instantly claimed sequences to SEQ ID NOs: 17 and 18 of Geba; reads on instant claim 33); wherein the anti-NGF antibody is fasinumab (see Geba, e.g., at claim 9; reads on instant claim 34); wherein the anti-NGF antibody or antigen-binding fragment thereof is administered at a dose from 0.5 mg to 10 mg wherein the anti-NGF antibody is fasinumab, and more specifically 1 mg (see Geba, e.g., at claims 11, 14, 21; see also para. [0192]-[0193]; reads on instant claims 36-37).
Accordingly, the disclosures of Geba anticipate instant claims 1, 6-16, 25-29, 31-34, 36-37.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 nonobviousness.
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 1-37 are rejected under 35 U.S.C. 103 as being unpatentable over Geba (supra) in view of Park2 and Sedaghati-Khayat3
Regarding claims 1, 6-16, 25-29, 31-34, 36-37, the teachings of Geba are discussed above and are incorporated herein.
Regarding claims 2-5 and 17-20, Geba demonstrates an up to 20-point change from baseline in alkaline phosphatase levels in subjects receiving 1-9 mg fasinumab (see Geba, e.g., FIG. 38).
Regarding claim 35, Geba discloses anti-NGF antibodies, tanezumab or fulranumab (see Geba, e.g., para. [0196]).
The prior art of Geba differs from the instantly claimed invention as follows: Geba does not expressly disclose the limitations set forth in instant claims 21-24 and 30.
Regarding claims 22-24, Park teaches : a positive association between bone-specific alkaline phosphatase level and osteoarthritis as well as between serum alkaline phosphatase level and osteoarthritis; and measurement of alkaline phosphatase via enzymatic assay (see Park, e.g., introduction, results, and discussion).
Regarding claims 30, Sedaghati-Khayat teaches clinical risk prediction for hip and knee osteoarthritis by a polygenic risk score (see entire text of Sedaghati-Khayat, e.g., at title and abstract).
Obviousness Analysis: In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of known anti-NGF antibodies (e.g., fasinumab for tanezumab or fulranumab) to obtain the predictable results; as well as some teaching, suggestion, or motivation in the prior art (e.g., the teachings of Park, discussed above) that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (e.g., the claimed types of and measurement method for alkaline phosphatase). See (MPEP 2143(I)(B), (G)).
Furthermore, the claimed threshold values of up to a 15-, 10-, and 5-point increase from baseline values of alkaline phosphatase fall within the up to 20-point increase from baseline, as taught by Geba. Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have established the claimed threshold values, as doing so would amount to no more than routine optimization. See MPEP § 2144.05(II).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably arrive at the claimed methods. See (MPEP 2143(I)(D)).
Accordingly, claims 1-37 are rejected.
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.
Copending Application No. 18/710,939:
Claims 1-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 14-25, 27, 32-34 of copending Application No. 18/710,939 (reference application; corresponding to 20250011408; effective filing date 11/19/2021) in view of Geba (supra), Park (supra), and Sedaghati-Khayat (supra).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The disclosures/teachings of Geba, Park, and Sedaghati-Khayat, are discussed above and are incorporated herein.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon obviousness analysis.
Regarding claims 1-37, the reference application claims methods for reducing pain in a subject with osteoarthritis comprising selecting a patient having osteoarthritis of the knee or hip and administering an anti-NGF antibody comprising the instantly claimed sequences, wherein the antibody is specifically fasinumab, as well as the claimed the dosage regimens/frequencies (compare reference claims 1, 5-7, 14-25, 27, 32-34 with instant claims 1-37).
Obviousness analysis: Although the reference patent doesn’t expressly claim determining whether the subject is a candidate for continued treatment with the anti-NGF antibody comprising monitoring the level of alkaline phosphatase, as set forth above in the rejections under 35 U.S.C. 103, the prior art of Geba, Park, and Sedaghati-Khayat teach and suggest the importance of monitoring alkaline phosphatase within the context of osteoarthritis, and remedy the deficiencies of the reference application by anticipating and/or rendering obvious the limitations of instant claims 1-37. Accordingly, the present claims are directed to obvious variants of the claimed invention.
Furthermore, a skilled artisan would have been motivated to modify the reference applications to incorporate the teachings of Geba, Park, and Sedaghati-Khayat, as it amounts to no more than: the simple substitution of one known element for another to obtain predictable results, namely, the substitution of known anti-NGF antibodies (e.g., fasinumab for tanezumab or fulranumab) to obtain the predictable results; as well as some teaching, suggestion, or motivation in the prior art (e.g., the teachings of Geba and Park, discussed above) that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (e.g., monitoring alkaline phosphatase for the continued treatment with an anti-NGF antibody). See (MPEP 2143(I)(B), (G)); MPEP § 804(II)(B) )(3)(C)-(D).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably arrive at the claimed methods. See (MPEP 2143(I)(D)).
Accordingly, the instant claims are not patentably distinct relative to the claims of the reference application.
Conclusion
Claims 1-37 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Friday 9:00AM - 5PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 US20200048337A1; cited on the IDS
2 Park et al. “Positive Association of Serum Alkaline Phosphatase Level with Severe Knee Osteoarthritis: A Nationwide Population-Based Study”. Diagnostics. 2020; 10(12):1016.
3 Sedaghati-Khayat et al. “Improving the accuracy of clinical risk prediction for hip and knee osteoarthritis by a polygenic risk score”. Genetics of Osteoarthritis consortium et al. Osteoarthritis and Cartilage, Volume 29, S163 - S164.