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
The preliminary amendment dated 27 October 2023, in which claims 1-18 have been cancelled, and new claims 19-29 have been added, is acknowledged.
The preliminary amendment of 6 March 2026, in which claim 19 has been amended, is acknowledged.
Claims 19-29 are pending in the instant application.
Claims 19-29 are examined herein.
Priority
The instant application is a National stage entry on International Patent Application PCT/KR2021/014993, filed on 5 January 2022, which claims priority from Korean Patent Applications No. 10-2021-0142296, filed on 25 October 2021, and 10-2021-0054247, filed 27 April, 2021.
A certified copy of the priority document Korean Patent Application No. 10-2021-0054247, filed 27 April, 2021, in Korean, has been submitted on 8 April 2024.
No certified copy of the priority document Korean Patent Application No. 10-2021-0142296, filed on 25 October 2021, has been submitted. No English translation of any of the priority documents has been submitted.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 March 2025 is acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of meloxicam as the specific oxicam-based compound administered in the method, and the election of patients suffering from sarcopenia, as the patient population suffering from a specific muscular disease, to be treated, for initial examination, in the reply filed on 6 March 2026, is acknowledged. Claims 19-29 read on the elected species.
Since Applicant has set forth no arguments against the requirement for restriction/election, the requirement for restriction/election is maintained and is herewith made FINAL.
Claims 19-29 have been examined to the extent they read on the elected species and the following objections and rejections are made below.
Objection to the Claims
Claim 19 is objected to because the recitation “an oxicam-based compound and a pharmaceutically acceptable salt thereof” is unclear, because it seems to indicate that both an oxicam compound and its salt are administered in the method. Further the text ”comprising a step of administering” can read --comprising administering-- (no other steps are recited by the claim(s)).
It is suggested that claim 19 could read -- A method of alleviating or treating a muscular disease in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a composition comprising an oxicam-based compound or a pharmaceutically acceptable salt thereof.—
Similarly, claim 25 could read -- A method of alleviating a muscular disease, strengthening muscle strength, improving muscle function, improving motor performance, for promoting differentiation of muscular stem cells, regenerating muscle, or increasing muscle mass in a subject in need thereof, comprising administering to the subject a composition comprising an oxicam-based compound or a pharmaceutically acceptable salt thereof.—
Claims 20 and 27 are objected to because each of them recites “tenoxicam”, “piroxicam” twice. Further, “lornoxicam” and “chlortenoxicam” (misspelled chlornotexicam) in claim 20 and in claim 27 are two alternative names for the same chemical compound. Removal of duplicates is required.
Claims 20 and 27 recite “anpyroxicam” instead of –ampiroxicam--. Appropriate correction of the compound name is required.
Objection to the Specification
The Specification is objected to because it recites “sitologically acceptable salt” (at least 3 instances). It is believed that the meaning is that of cytologically acceptable salt, which refers to a counterion or chemical formulation used in cell collection or diagnostic staining that preserves cell morphology, prevents lysis, and ensures accurate microscopic evaluation/for handling cell samples.
The Specification is objected to because it recites some oxicam compounds in duplicate in the same sentence. The Specification teaches (page 7) that the oxicam-based compound of the present invention is a compound widely used as a non-steroidal anti-inflammatory agent, and more specifically, may include lornoxicam, piroxicam, tenoxicam, anpyroxicam, droxicam, meloxicam, chlornotexicam, tenoxicam, and piroxicam. The terms “tenoxicam”, “piroxicam” are recited twice in the same sentence. Further, “lornoxicam” and “chlortenoxicam” (misspelled chlornotexicam) are two alternative names for the same chemical compound. Further,
–ampiroxicam-- is misspelled as “anpyroxicam”.
Applicant is invited to identify all instances in the Specification where these compounds are listed twice in the same sentence or the names of the compounds are misspelled.
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.
Claim 26 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 26 recites the broad recitation “food”, and the claim also recites “functional food”, “health functional food”, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claims 24, 29 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.
Claims 24, 29 recite the term “normal muscle”. It is unclear what normal muscle is, as opposed, perhaps, to abnormal muscle? The Specification does not define the term “normal muscle”. The Specification teaches (page 24) that the motor performance improving effect by meloxicam was found not only in aged muscles but also in normal muscles. This sentence seems to lead the reader to interpret the term “normal muscle” as being muscle that is not aged.
The Specification also teaches (point 3.3, pages 25-26) changes in muscle strength and motor performance in normal mice (4 months old) upon long-term meloxicam administration. It was found that when meloxicam is administered, muscle function is improved and thus muscle strength and motor performance are increased even in normal young mice. In this context, assuming that “normal muscle” is present in “normal mice”, it seems that the term “normal muscle” refers to muscle in a subject that does not suffer from a muscle disease. Yet, claim 24 depends on claim 19, which is drawn to a method of treating a muscular disease in a subject in need thereof; as such, it is unclear what is meant by “normal” muscle in claim 24.
The claim and the Specification fail to clearly or precisely define the term “normal muscle”. Absent this information, the claim fails to set forth the metes and bounds of the subject matter for which Applicant is presently seeking protection.
Further, claims 24, 29 recite the term “long-term administration”. The Specification does not define this term. The Specification discloses (point 3-3, page 25) changes in muscle strength and motor performance in normal mice (4 months old) upon long-term administration of meloxicam, where administration is for 2 months. It is unclear whether the same length of treatment, 2 months, is considered long-term administration for a subject that is not a 4 months old mouse. The duration of treatment in days, weeks, months depends on the condition to be treated, whether acute or chronic, on the route of administration, etc. There are conditions that require life-long treatment. As such, the term “long-term treatment” is a relative term, and the claims and the Specification fail to clearly or precisely define the term. Absent this information, the claims fail to set forth the metes and bounds of the subject matter for which Applicant is presently seeking protection.
Appropriate clarification of the claim language is required.
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.
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 19-22, 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beyer et al. (BMC Musculoskeletal Disorders 2011, 12:292, p. 1-12, cited in IDS).
Beyer teaches a method of treating muscle performance and mobility in geriatric patients hospitalized with acute infection-induced inflammation by administering to the patients piroxicam, which is an oxicam compound of instant claims 20, 27, and a non-selective COX inhibitor (page 11, left column, last paragraph, lines 3-4).
Beyer teaches (page 7, right column, last paragraph) that muscle function is impaired in geriatric hospitalized patients with inflammation.
The patients treated have a median age 84.5 years (page 3 of 12, last paragraph), which is consistent with patients suffering from sarcopenia (Applicant’s elected species of a muscular disease), as in instant claim 21, which is gradual loss of skeletal muscle mass and function caused by aging, as in instant claim 22; the patients also suffer from muscle wasting, as in instant claim 22, caused by inflammation (Abstract, Background, first sentence).
Beyer teaches (Abstract) that administration of piroxicam 10 mg/day, as a pharmaceutical composition, as in instant claim 26, significantly improved Elderly Mobility Scale (EMS) scores, grip strength (GS), fatigue resistance (FR) and grip work (GW), a measure taking into account grip strength (GS) and fatigue resistance (FR), in patients; placebo had no effect.
Beyer teaches (page 4, last paragraph) changes in mobility and muscle performance overtime upon treatment of patients with piroxicam: Elderly Mobility Scale EMS scores improved significantly after two weeks with piroxicam.
Beyer teaches (page 5, left column) that fatigue resistance FR increased in the piroxicam group. A significant overall time effect was observed at week 3.
Beyer teaches (page 5, left column) that grip work (GW), a measure taking into account grip strength (GS) and fatigue resistance (FR), also improved with piroxicam; significant improvements at weeks 2 and 3 compared to baseline (Figure 2).
Beyer teaches (page 5, right column, first paragraph) that FR and GW showed no change in the placebo group.
Thus, Beyer teaches a method of alleviating of treating a muscular disease which is impaired muscle function as sarcopenia (due to aging) and muscle wasting due to inflammation, as in instant claim 19, 20, 21, 22, and a method of strengthening muscle/recovery of muscle performance (as evaluated by FR and GW, page 7, right column, last paragraph), improving motor function, improving motor performance (assessed by EMS, page 7, right column, last paragraph), as in instant claim 25, 27, with piroxicam.
As such, a method of instant claims 19-22, 25-27 is anticipated by Beyer.
Claims 19-23, 25-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Granado et al. (Am J Physiol Endocrinol Metab 2007, 292: E1656-E1665, cited in IDS).
Granado teaches a method of treating chronic arthritis-induced cachexia and muscle wasting, which are muscular diseases of claims 20, 21, 22, 25, by administering to a patient in need thereof meloxicam (Applicant’s elected species of an oxicam compound), which is an oxicam compound of instant claims 20, 27, and a COX-2 selective inhibitor (Abstract).
Granado teaches (Abstract) that administration of meloxicam increased gastrocnemius weight (Fig. 9), which is consistent with an increase in muscle mass, as in instant claims 23, 25, 28.
Meloxicam is administered as a pharmaceutical composition, as in instant claim 26.
Granado teaches (Figure 10) the effect of meloxicam administration on IGF-I mRNA and IGFPB-5 mRNA in gastrocnemius muscle, and the effect of meloxicam administration (Figure 11) on muscle atrophy (as in instant claim 21) in gastrocnemius in arthritic rats, and the effect of meloxicam administration on MAFbx and on MuRF1 gene expression in gastrocnemius (Figure 11).
As such, a method of instant claims 19-23, 25-28 is anticipated by Granado.
Claims 19-22, 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hussey et al. (Int J Cancer 2000, 87, 95-100, cited in IDS).
Hussey teaches a method of treating cancer-induced cachexia, which is a muscular disease of claims 20, 21, 22, 25, by administering to a patient in need thereof meloxicam (Applicant’s elected species of an oxicam compound), which is an oxicam compound of instant claims 20, 27, and a COX-2 selective inhibitor (Abstract).
Hussey teaches (Abstract) that administration of meloxicam exerted a direct effect on the cachectic process (page 98, left column, last paragraph, right column, first paragraph). Studies on protein degradation were carried out using C2C12 mouse myoblasts in response to a proteolysis-inducing factor (PIF). Using C2C12 mouse myoblasts in vitro, meloxicam was found to effectively suppress the elevation of protein catabolism induced by PIF, which suggests that COX-2 inhibitor meloxicam is an effective anticachetic agent in addition to suppressing tumor growth (page 99, right column, first paragraph).
Meloxicam is administered as a pharmaceutical composition, as in instant claim 26.
As such, a method of instant claims 19-22, 25-27 is anticipated by Hussey.
Claims 19, 20, 22, 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heere (The American Journal of Medicine 1988, 84 (Suppl 5A), p. 50-55, cited in IDS).
Heere teaches a method of treating musculoskeletal disorders and sports injuries characterized by reduction of muscle strength (page 52, right column, second paragraph), which is a muscular disease as in instant claims 19, 22, 25, by administering to a patient in need thereof piroxicam, which is an oxicam compound of instant claims 20, 27.
Heere teaches (page 52, right column, first paragraph under Results) that administration of piroxicam improved muscle strength significantly, as in instant claim 25.
Piroxicam is administered as a pharmaceutical composition, as in instant claim 26.
As such, a method of instant claims 19, 20, 22, 25-27 is anticipated by Herre.
Claims 19, 20, 22, 25-27 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bullemore et al. (US 2017/0319519, cited in IDS).
Bullemore teaches meloxicam, which is an oxicam compound of instant claims 20, 27, administered in sport-derived muscle pain management after muscle injury/muscle damage, which is a muscular disease as in instant claims 19, 22, 25.
Bullemore teaches a method of treating /alleviating [0208] muscle micro-tears, which is a form of muscle damage, as in instant claim 22, to muscle fibers, with meloxicam.
Bullemore teaches (Example 9, [0325]) a combination comprising 7.5 mg meloxicam (+500 mg Vitamin C+120 mg magnesium) being administered to 35 elite rugby players with serious muscle strain and perception of potential muscle injury immediately after regular training or at post-game kinesics management.
Bullemore teaches (claims 1, 3) that other COX inhibitors such as tenoxicam, piroxicam, ampiroxicam, lornoxicam, can be used interchangeably with meloxicam in the method.
Meloxicam is administered as a pharmaceutical composition, as in instant claim 26.
As such, a method of instant claims 19, 20, 22, 25-27 is anticipated by Bullemore.
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 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 19-23, 25-28 are rejected under 35 U.S.C. 103 as obvious over Huang et al. (Scientific reports 2020, 10, 2558, cited in IDS, and Supplementary information), in view of Yokoyama et al. (Int J Mol Sci 2020, 21, 6376, p. 1-17, cited in PTO-892).
Huang teaches that piroxicam (a non-selective COX inhibitor, page 7, under Methods, also Figure 1), which is an oxicam compound of instant claims 20, 27, is effective to enhance Mbnl1 transcription in C2C12 myoblasts and myotubes (Figure 1).
Huang also teaches that meloxicam (a COX-2 selective inhibitor, page 7, under Methods), which is an oxicam compound of instant claims 20, 27, is effective to enhance Mbnl1 transcription in C2C12 myoblasts and myotubes (Figure 1).
Huang also teaches that tenoxicam (a COX-1 selective inhibitor, page 7, under Methods), which is an oxicam compound of instant claims 20, 27, is effective to enhance Mbnl1 transcription in C2C12 myoblasts and myotubes (Figure 1).
Huang teaches (page 1) that downregulation of MBLN1 availability leads to progressive muscle wasting.
Huang teaches (page 2, second paragraph) that another NSAID previously studied ameliorates muscle weakness and muscle pathology by enhancement of MBLN1 expression.
Huang teaches piroxicam, meloxicam, tenoxicam as pharmaceutical compositions, as in instant claim 26.
Huang does not teach a method of treating sarcopenia with an oxicam compound.
Yokoyama teaches that MBNL1 plays a role in aging-associated muscle atrophy (sarcopenia).
Yokoyama teaches (Figure 7, page 9, first paragraph under Discussion) that lower expression levels of MBNL1 (mRNA and protein) and smaller muscle fiber size in plantaris muscles of old mice were observed compared to young mice.
It would have been obvious to combine the teachings of Huang and Yokoyama to arrive at the instant invention.
The person of ordinary skill in the art would have been motivated to administer piroxicam or meloxicam or tenoxicam to a patient suffering from sarcopenia, because Huang teaches that piroxicam, meloxicam, tenoxicam are effective to enhance Mbnl1 transcription in C2C12 myoblasts and myotubes, and Yokoyama teaches that MBNL1 plays a role in aging-associated muscle atrophy (called sarcopenia) and Yokoyama teaches that lower expression levels of MBNL1 (mRNA and protein) and smaller muscle fiber size in plantaris muscles of old mice were observed compared to young mice. Thus, the person of ordinary skill in the art would have administered an oxicam compound which is piroxicam, meloxicam, tenoxicam to a subject suffering from aging-associated muscle atrophy (sarcopenia), with the expectation that said compound enhances levels of MBNL1 in muscle and ameliorates muscle weakness and muscle pathology by enhancement of MBLN1 expression in the subject.
As such, claims 19-23, 25-28 are rejected as prima facie obvious.
Claims 19-23, 25-28 are rejected under 35 U.S.C. 103 as obvious over Beyer et al. (BMC Musculoskeletal Disorders 2011, 12:292, p. 1-12, cited in IDS), in view of Granado et al. (Am J Physiol Endocrinol Metab 2007, 292: E1656-E1665, cited in IDS).
Beyer teaches a method of treating muscle performance and mobility in geriatric patients hospitalized with acute infection-induced inflammation by administering to the patients piroxicam, which is an oxicam compound of instant claims 20, 27, and a non-selective COX inhibitor (page 11, left column, last paragraph, lines 3-4).
Beyer teaches (page 7, right column, last paragraph) that muscle function is impaired in geriatric hospitalized patients with inflammation.
The patients treated have a median age 84.5 years (page 3 of 12, last paragraph), which is consistent with patients suffering from sarcopenia (Applicant’s elected species of a muscular disease), as in instant claim 21, which is gradual loss of skeletal muscle mass and function caused by aging, as in instant claim 22; the patients also suffer from muscle wasting, as in instant claim 22, caused by inflammation (Abstract, Background, first sentence).
Beyer teaches (Abstract) that administration of piroxicam 10 mg/day, as a pharmaceutical composition, as in instant claim 26, significantly improved Elderly Mobility Scale (EMS) scores, grip strength (GS), fatigue resistance (FR) and grip work (GW), a measure taking into account grip strength (GS) and fatigue resistance (FR), in patients; placebo had no effect.
Beyer teaches (page 4, last paragraph) changes in mobility and muscle performance overtime upon treatment of patients with piroxicam: Elderly Mobility Scale EMS scores improved significantly after two weeks with piroxicam.
Beyer teaches (page 5, left column) that fatigue resistance FR increased in the piroxicam group. A significant overall time effect was observed at week 3.
Beyer teaches (page 5, left column) that grip work (GW), a measure taking into account grip strength (GS) and fatigue resistance (FR), also improved with piroxicam; significant improvements at weeks 2 and 3 compared to baseline (Figure 2).
Beyer teaches (page 5, right column, first paragraph) that FR and GW showed no change in the placebo group.
Thus, Beyer teaches a method of alleviating of treating a muscular disease which is impaired muscle function as sarcopenia (due to aging) and muscle wasting due to inflammation, as in instant claim 19, 20, 21, 22, and a method of strengthening muscle/recovery of muscle performance (as evaluated by FR and GW, page 7, right column, last paragraph), improving motor function, improving motor performance (assessed by EMS, page 7, right column, last paragraph), as in instant claim 25, 27, with piroxicam, a non-selective NSAID.
Beyer also teaches (page 2, left column, first paragraph) a better recovery of muscle endurance following treatment with celecoxib, a COX-2 selective drug, in hospitalized geriatric patients with acute infection.
Beyer does not teach a method of treating muscle disease in geriatric patients with acute infection by administration of meloxicam, Applicant’s elected species.
Granado teaches that meloxicam, which is an oxicam compound of instant claims 20, 27, is a COX-2 selective inhibitor (Abstract).
It would have been obvious to combine the teachings of Beyer and Granado to arrive at the instant invention.
The person of ordinary skill in the art would have been motivated to administer meloxicam to a patient suffering from sarcopenia, because
Beyer teaches that piroxicam, a non-selective COX inhibitor, is effective to treat muscle disease in hospitalized geriatric patients with acute infection, and
Beyer also teaches recovery of muscle endurance following treatment with celecoxib, a COX-2 selective drug, in hospitalized geriatric patients with acute infection, and
Granado teaches that meloxicam is a COX-2 selective inhibitor.
Thus, the person of ordinary skill in the art would have replaced piroxicam with COX-2 selective inhibitor meloxicam, in a method of treating muscle disease in geriatric patients with acute infection, with the expectation that meloxicam (like COX2 selective inhibitor celecoxib) will be effective to recover muscle strength and endurance in said patients.
The person of ordinary skill in the art would have measured the effectiveness of meloxicam in strengthening muscle/recovery of muscle performance (as evaluated by FR and GW), improving motor function, improving motor performance (assessed by EMS), as in instant claim 25, 27, with meloxicam, following the protocol taught by Beyer, and would have measured the degree of muscle regeneration or muscle mass in ageing muscle before and after treatment, as in instant claims 23, 28, with the expectation that meloxicam is effective to recover muscle strength in the patients.
As such, claims 19-23, 25-28 are rejected as prima facie obvious.
Conclusion
Claims 19-29 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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