DETAILED OFFICE ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The request filed on 10 September 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 15/505,056 is acceptable, and an RCE has been established. An action on the RCE follows.
Applicant’s amendment filed on 10 September 2025 is acknowledged and entered. Following the amendment, claims 1, 13 and 28 are amended, and the new claims 35-52 are added.
Newly submitted claims 46-52 (indefinite) seem directed to a method of improving mental health (only?) of a subject having RA, since the improvement is only measured by SF-36 MCS (claim 46, for example), which patient population or subpopulation and purpose seem differing from that of claim 1.
Since applicant has received an action on the merits for the previously presented invention (claim 1, for example), accordingly, the new claims 46-52 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 CFR 1.142(b) and MPEP § 821.03.
Currently, claims 1, 3, 13, 14, 25, 26, 28 and 35-52 are pending, and claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are under consideration. Claims 46-52 are withdrawn from further consideration as being drawn to a non-elected invention/species.
Withdrawal of Objections and Rejections:
The prior art rejection of claims 1, 3, 13, 14, 25, 26 and 28 under 35 U.S.C. 103(a) as being unpatentable over Jasson et al. (US 2013/0149310, 6/13/2013), or Jasson et al. (US 9,943,594, 4/17/2018), and further in view of Fragiadaki et al. (J Rheumatol 2012; 39:60-2), and Wolfe et al. (J Rheumatol 2006;33;1942-1951) is withdrawn in view of applicant’s amendment, and new ground of rejection, which is set forth below.
The provisional obviousness-type double patenting rejection of claims 1, 3, 13, 14, 25, 26 and 28 as being unpatentable over claims 1, 5, 6, 10-14, 16-18 and 21-31 of copending Application No. 15/910,733, and in view of Fragiadaki et al. (J Rheumatol 2012; 39:60-2), and Wolfe et al. (J Rheumatol 2006;33;1942-1951) is moot as the ‘733 application has been abandoned.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 9/10/2025 is acknowledged and has been considered. A signed copy is attached hereto.
Claims
Applicant is advised that should claim 1 be found allowable, claims 3 and 42 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claims 3 and 42 recite the same limitations that are present in claim 1, from which claims 3 and 42 are dependent.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Rejections under 35 U.S.C. §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, 13, 14, 25, 26, 28 and 35-45 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 pre-AIA the applicant regards as the invention, for the reasons of record set forth in the previous Office Actions mailed on 6/27/2024, 11/19/2024 and 6/10/2025, and the following.
The amended claim 1 is indefinite for the limitation “wherein the subject after at least 24 weeks of administering the antibody achieves an improvement from BL in the SF-36 MCS score of at least 5” (last 3 lines) for the reasons of record, as such a limitation represents the result/efficacy of the antibody treatment, and requires that the patient being treated must meet the limitation of the result, which does not make sense as no treatment can achieve or demand 100% specific efficacy; and there is no way to pre-select such a patient, knowing that the patient would achieve the required efficacy after the treatment, let alone, achieve all specific scores in a patient (claim 35, for example). Claims 28 and 35-41 are similarly indefinite.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Applicants argument filed on 10 September 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At pages 8-9 of the response, the applicant argues that the claim (claim 28) does not require pre-selecting only those patients who will respond to treatment, nor does it guarantee that all patients will achieve the result, rather, it defines the scope of the claimed method by reference to the outcome achieved in subjects who exhibits the improvement as recited in the present claims; that the claim provides objective criteria, and one of ordinary skill would understand how to evaluate a change from baseline and whether such change is maintained over time; that while the Office continues to assert that the claim is indefinite under 35 U.S.C. § 112(b), it simultaneously relies on that same limitation as being inherently disclosed in the prior art under 35 U.S.C. § 103, which positions are logically incompatible; and the Office overlooks a fundamental principle: a claim cannot be both indefinite and subject to a prior art rejection; and that as stated in MPEP § 2173.06(II), if a claim limitation is too vague to be understood, it cannot reasonably be determined to be disclosed-either expressly or inherently-in the prior art.
This argument is not persuasive for the reasons of record. Applicants arguments are contradictory because while applicant argues that the claim does not require pre-selecting only those patients who will respond to treatment, nor does it guarantee that all patients will achieve the result, the claim, as written, does require that the patient being treated must achieve said improvement score. It is the claim, not applicants argument, determining what is or is not required. Accordingly, pre-selecting a patient who would achieve the required improvement score after the antibody treatment, i.e., meeting the limitation of the claim, would be required; and it is unclear how such can be carried out. Further, it is unclear as to why a claim cannot be both indefinite and subject to a prior art rejection, which even becomes a fundamental principle? Nowhere in MPEP is it indicated that a claim cannot be both indefinite and subject to an art rejection. In fact, MPEP clearly indicates that where the degree of uncertainty is not great, and where the claim is subject to more than one interpretation and at least one interpretation would render the claim unpatentable over the prior art, an appropriate course of action would be for the examiner to enter two rejections (MPEP §2173.06(II). In the instant case, the claims seem (indefinite) drawn to a method of treating a RA patient having sleep disturbance and associated mental health issues with an anti-hIL-6R antibody (sarilumab), wherein the active ingredient, method steps, and the patient population, which determine the invention, are taught or suggested by the cited prior art references. As such, the degree of uncertainty is not great (the treatment result or efficacy, which cannot be controlled or demanded by anyone), therefore, it is clear that the claims should be rejected for both indefinite and unpatentable over the prior art. In addition, in the interest of compact prosecution, as noted in the prior art rejection in the previous Office Actions, “Note, once again, claim 28 remains indefinite for the reasons of record and above, the recited limitation of the specific efficacy has been interpreted as an “inherent” property of the method as such is out of anyone’s control” (page 5 of last Office Action, for example). Is there another way to interpret the result/efficacy of the claimed method of treatment other than being “inherent property”? Further, contrary to applicant argument, MPEP § 2173.05(g) does not indicate that result-oriented claim language is not indefinite. According to MPEP § 2173.05(g), “[E]xaminers should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, the issue is not whether the result limitation itself (English) is clear or not, rather, the issue is that the result limitations do not make sense because said in vivo therapeutic result cannot be predicted or demanded/required, let alone, the very specific results recited, whereas the claims require that the patient being treated must achieve said results. As such, one skilled in the art would not know, prior to the treatment, how to select a patient for the treatment in order to achieve said result after the treatment, as the claims require. Therefore, the patient population of the claims is not clearly defined, and there is no clearcut indication of the scope of the subject matter covered by the claims.
Prior Art Rejections
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 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.
Claim interpretation: as claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are indefinite for the reasons above, the recited result/efficacy limitations in claims 1, 28 and 35-41 are interpreted as being “inherent” properties of the method of treatment in the following prior art rejection, as such is out of anyone’s control once the antibody is administered.
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 of this title, 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.
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, 13, 14, 25, 26, 28 and 35-45 are rejected under 35 U.S.C. 103 as being unpatentable over Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), or Jasson et al. (US 9,943,594, 4/17/2018), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), and Wolfe et al. (J Rheumatol 2006;33;1942-1951), and further in view of Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the reasons of record set forth in the previous Office Actions, and for the reasons below.
The teachings of Jasson, Fragiadaki and Wolfe were reviewed in the previous Office Action, and are paraphrased below.
Jasson discloses a method of treating rheumatoid arthritis using an effective amount of sarilumab (an anti-hIL-6R antibody) and methotrexate, wherein the subject was previously ineffectively treated for RA by administering an anti-TNF- therapeutic (such as etanercept, infliximab, adalimumab, golimumab or certolizumab) or methotrexate; and methotrexate can be administered at between 6 and 25 mg per week (page 1, [0013]-[0015]). Additionally, Jasson teaches that sarilumab comprises the VH of SEQ ID NO:2 and the VL of SEQ ID NO:3 (page 9, [0158] and [0159]), which are 100% identical to the present SEQ ID NO:1 and 2, respectively. Further, Jasson teaches that the hIL-6R antibody can be administered subcutaneously, and the amount of the hIL-6R antibody contained is generally about 100 to 200 mg per subcutaneous dosage form (page 11, 1st column, lines 10-11, and [0179]). Furthermore, Jasson teaches that the sarilumab can be administered at 150 mg per two weeks, at 200 mg per two weeks (page 2, [0029]). Furthermore, Jasson teaches that as a result of the treatment, the subject achieves a 20%, 50% or 70% improvement in the American College of Rheumatology core set disease index after 24 weeks of treatment (page 1, [0010]); and that health economic assessments will be also added such as SF-36 to the calculation of the Sharp score (page 15, [0257]). Furthermore, Jasson teaches that sarilumab demonstrated significant benefit/ improvement in signs and symptoms of RA, including decreased patient VAS and pain VAS (page 15, [0237] - [0245], esp. [0243]); and that the results provide evidence that IL-6R blockade with sarilumab represents a promising new anti-inflammatory investigational therapy for reducing RA disease symptoms (US 2013/0149310, page 1, [0003], and page 15, [0246], for example). Furthermore, Jasson teaches that, as a part of evaluation of the RA patients, health economic assessments will be also added such as SF-36 (page 15, [0257]), which includes physical component summary (SF-36 PCS) and mental component summary (SF-36 MCS) scores. Jasson does not specifically mention to treat only the RA patient having sleep disturbance with sarilumab.
Fragiadaki teaches that sleep quality represents a central component of health-related quality of life in patients with RA and correlates with disease activity, pain, and psychological distress; and proinflammatory cytokines have been examined as potential mediators of sleep disturbances in RA; and that tocilizumab is a humanized antibody against the IL-6R used for the treatment of RA, and its role in improving sleep disturbances in RA patients was examined (page 60, first two paragraphs), which results suggest that tocilizumab treatment is associated with rapid and significant improvement in sleep quality and daytime sleepiness (page 61, 2nd column, 1st paragraph under “DISCUSSION”; and page 62, 1st column, last paragraph, for example).
Wolfe teaches evaluation of sleep disturbance (SD) in patients with RA using the Medical Outcome Study (MOS) sleep questionnaire (including 2 MOS sleep problem indexes (SPI-I, SPI-II) and the MOS SD), and a visual analog scale (VAS) sleep disturbance scale (SDS) (abstract, for example), wherein the psychometric properties (sleep related variables) of the MOS and VAS sleep scales of the patients are shown in Table 3 (page 1944). Further, Wolfe teaches that the VAS scale was more strongly associated with RA clinical variables than the MOS scales; however, the distributional characteristics of the scales differed, with the VAS scales capturing more extreme values; and that SD is linked to pain, mood, and disease activity, and it would be expected that treatments that improve RA clinical status will reduce sleep disturbance (abstract; and page 1949, 1st column, 2nd paragraph). Furthermore, Wolfe teaches that if one believes that measurement of sleep has a role in the clinic, then the VAS sleep scale is the only appropriate choice for the clinic because of the difficulty in administering and scoring the MOS questionnaires, particularly when other questionnaire assessments are also being made (page 1949, 1st column, 3rd paragraph).
None of the above references specifically teaches using SF-36 MCS for measuring or assessing mental health of health-related quality of life in a RA patient.
Till Uhlig teaches that RA inflicts a substantial disease burden, and the disease affects all health-related quality of life (HRQOL) dimensions, which can be assessed/measured by SF-36; and that physical functioning is predominantly affected, but RA has social and mental consequences (abstract, for example); that RA patients had worse overall scores for PCS and
MCS health across all age groups (page 1244, 1st column, 2nd paragraph); and that the 36 items in the questionnaire of SF-36 are grouped into 8 multi-item subscales measuring physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, mental health, and role limitation due to emotional problems; and the SF-36 scores correlate to a variety of disease specific measures capturing the same dimensions of health in patients with RA; physical (PCS) and mental component summary scores (MCS) were aggregated from the SF-36 (page 1242, 1st column, 6th paragraph; and Tables 2 and 3).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat RA, including the RA patients in need of improving quality of sleep and mental health, and previously ineffectively treated with a DMARD such as methotrexate, with an anti-IL-6R antibody such as sarilumab or sarilumab and methotrexate for at least 24 weeks; wherein sarilumab is administered at 150 mg per two weeks, at 200 mg per two weeks; and wherein the patients sleep disturbance (SD) is evaluated using VAS sleep scales, and mental health is evaluated using SF-36 MCS scales to establish a baseline before the treatment (as comparison control) in order to monitoring the efficacy (one of the variables) of the treatment, following the teachings of Jasson, Fragiadaki, Wolfe and Till Uhlig. The person of ordinary skill in the art would have been motivated to do so for better disease treatment (RA) (reduce inflammation and improve sleep); and reasonably would have expected success because Jasson has demonstrated that sarilumab reduces disease activity and improve signs and symptoms of RA such as, among others, pain, which would, in turn, improve the mental health of the patient; Fragiadaki has demonstrated that tocilizumab (another anti-IL-6R antibody) treatment is associated with rapid and significant improvement in sleep quality and daytime sleepiness; Wolfe teaches and demonstrates that the VAS sleep scale is the appropriate choice for the clinic when evaluating SD as the VAS scale was more strongly associated with RA clinical variables and captures more extreme values; and Till Uhlig teaches the use of SF-36 for assessing/measuring HRQOL dimensions in RA patients, and demonstrates that SF-36 scores correlate to a variety of disease specific measures capturing the same dimensions of health in patients with RA.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting Rejections:
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 claims at issue 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,943,594 in view of Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the reasons of record set forth in the previous Office Actions mailed on 11/6/2020, 6/8/2023, and 12/13/2023; and for the reasons above (see the discussion in the prior art rejection), which are also discussed below.
Claims 1-13 of '594 patent are directed to a method of treating rheumatoid arthritis (RA) with methotrexate and an anti-IL-6R antibody comprising the VH of SEQ ID NO:2 and the VL of SEQ ID NO:3, which are 100% identical to the present SEQ ID NO:1 and 2, respectively; wherein the patient was ineffectively treated by methotrexate and a TNF-a antagonist such as etanercept; about 150-200 mg of the antibody is administered subcutaneously once every two weeks (claims 1-3 and 10, for example) (vs. the present claims 1, 3, 7, 8, 10-12 and 14, for example); 6 to 25 mg of methotrexate/week is administered (claim 13, for example) (vs. the present claim 13, for example). Although the scope of the inventions in the patent and the instant application is different, they share the same inventive concept: treating the same disease (RA) with the same antibody with the same or similar regimen. In addition, as discussed above (in the prior art rejection), Fragiadaki teaches the use of an anti-IL-6R antibody tocilizumab in improving sleep disturbances in RA patients, which results suggest that tocilizumab treatment is associated with rapid and significant improvement in sleep quality and daytime sleepiness (page 61, 2nd column, 1st paragraph under “DISCUSSION”; and page 62, 1st column, last paragraph, for example); and Wolfe teaches the use of VAS sleep disturbance scale for evaluation of sleep disturbance (SD) in patients with RA; and Till Uhlig teaches the use of SF-36 (PCS and MCS) for assessing/ measuring HRQOL dimensions in RA patients. Therefore, it would have been obvious to treat RA, including the RA patients who was previously ineffectively treated with a DMARD such as a TNF-a antagonist etanercept, and the RA patients in need of improving quality of sleep and mental health with an anti-IL-6R antibody such as sarilumab or sarilumab and methotrexate using the regimens in the claims of the patent. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 11, 12 and 14 of copending Application No. 15/034,531, and in view of Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the reasons of record set forth in the previous Office Action mailed on 6/8/2023, and for the reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 9-11 and 22-33 of Application No. 14/350,973 (now issued as US 10,927,435), and in view of Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,080,248 (provided by applicants), in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the reasons of record set forth in the previous Office Action mailed on 6/8/2023, and for the reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 10 of U.S. Patent No. 8,192,741 (provided by applicants), in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US8,080,248), and for the reasons of record set forth in in the previous Office Action mailed on 6/8/2023, and for the reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,568,721 (provided by applicants), in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US8,080,248), and the reasons above (see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2 and 9 of U.S. Patent No. 9,308,256 (provided by applicants), in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US8,080,248), and the reasons above (see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 7,582,298, and in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the reasons of record set forth in the previous Office Action mailed on 6/8/2023, and for the reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,173,880 (provided by applicants) in view of Jasson et al. (US 2013/ 0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US7,582,298, and prior art rejection), and for the reasons of record set forth in in the previous Office Action mailed on 6/8/2023, and for the reasons above (also see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,072,086 in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US7,582,298), and the reasons above (see prior art rejection).
Claims 1, 3, 13, 14, 25, 26, 28 and 35-45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 32-58 of the previously copending Application No. 16/100,020 (now issued as US 11,098,127), in view of Jasson et al. (US 2013/0149310, 6/13/2013; provided by applicants), Fragiadaki et al. (J Rheumatol 2012; 39:60-2), Wolfe et al. (J Rheumatol 2006;33;1942-1951), and Till Uhlig et al. (J Rheumatol. 2007 Jun; 34(6):1241-7), for the similar reasons above (for US7,582,298), and the reasons above (see prior art rejection).
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DONG JIANG/
Primary Examiner, Art Unit 1674
1/6/26