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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/18/2026 has been entered.
The rejection under section 103 is withdrawn in favor of the following new grounds of rejection under this section:
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.
Claims 5-14 remain rejected under 35 U.S.C. 103 as being unpatentable over:
U.S. Publication Nos. 20160066610, 20160038457, and 20150057350, assigned to Abbott Laboratories (collectively “Abbott Applications”);
WO 2010068696 (WO 696); or
U.S. Publication No. 20100179112 to Rathmacher et al. (Rathmacher);
in view of:
Knoop et al., J Rehabil Med 2014; 46: 703–707; Knoop et al., Physiotherapy 101 (2015) 171-177 (Knoop references); or
Messier et al., Arthritis & Rheumatism (Arthritis Care & Research) Vol. 47, No. 2, April 15, 2002, pp 141–148 (Messier); or
CN 105727247, downloaded 28 November 2023 from: https://patents.google.com/patent/CN105727247A/en?oq=105727247+ (CN 247); and
Applicant’s Admission in the Background of the Specification.
All references previously cited.
The Abbott Applications teach that a certain level of muscle function is necessary for mobility and carrying out activities of daily living. A decline in muscle function can have a number of adverse effects on an individual including, but not limited to, general weakness, fatigue, a lessening of joint mobility, a reduction in physical activities…, see paragraph 0003 of the ‘457 application.
Also, the Abbott Applications teach that extended bed rest or physical inactivity may lead to a number of complications such as low-grade inflammation (Hojbjerre, L., et al., Diabetes Care 34(10): 2265-2272, 2011), cardiovascular complications (Sonne, M. P., et al., Exp Physiol 96(10): 1000-1009, 2011), rapid muscle atrophy, and degenerative joint disease (Dittmer, D. K., et al., Can Fam Physician 39: 1428-1432, 1435-1437, 1993). Such complications may be related to the development of fibrosis in tissue due to dysregulated matrix metalloproteinase (MMP) activity. The development of fibrosis may in turn lead to the development of other conditions or complications such as arthritis, atherosclerosis, nephritis, tissue ulcers, aneurysms, and muscle atrophy, see paragraph 0003 of the ‘350 application.
In order to reduce fibrosis, increase muscle regeneration and decrease muscle function decline, the Abbott Applications teach the administration of compositions comprising HMB (“[a]lso provided is a method of reducing the effect of prolonged physical inactivity on the development of fibrosis in a subject who is experiencing or is expected to experience prolonged physical inactivity in the near future by administering a therapeutically effective amount of a leucine metabolite (e.g., β-hydroxy-β-methylbutyric acid (HMB)) to the subject….[c]ompositions and methods for enhancing the regenerative capacity of an individual are provided. The compositions include, and the methods provide, a combination of an effective amount of epigallocatechin-3-gallate (EGCg) and an effective amount of β-hydroxy-β-methylbutyrate (HMB) to decrease the level of intramuscular FGF2, to enhance the regenerative capacity of muscle, or both.”).
The Abbott Applications clearly demonstrate the relationship between muscle and joint health, namely, a decline in muscle function can have a number of adverse effects on joint mobility and joint health. Within this context, the Abbott Applications teach that compositions comprising HMB can increase muscle regeneration, decrease fibrosis and decrease muscle decline, and invariably, benefits joint health.
In this relationship, see also Rathmacher (“A method for increasing muscle mass of an animal in need thereof comprising the steps of administering to said animal HMB and Vitamin D in amounts sufficient to increase muscle mass, wherein upon said administration of HMB and Vitamin D to the animal, said muscle mass is increased”, see claim 20.)
WO 696 also teaches administration of HMB and vitamin D to increase muscle mass strength and functionality, see abstract, for example.
The primary references may not teach improving joint stability or treating joint inflammation, joint damage, and/or joint injury. However, the secondary references teach that muscle mass and muscle contractions are essential to maintain functional joints. The loss of muscle mass can lead to joint instability and affect the joint function, which may then lead to inflammation and eventually arthritis. See Applicant’s remarks dated 8/17/2019 in a reply filed in parent application 15/405,880, citing the Knoop references and Messier:
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See Remarks dated 8/27/2019, 15/405,880, pp. 6-7.
In this manner, increasing muscle mass with HMB necessarily improves joint instability and joint function, as admitted by Applicant.
Nonetheless, CN 247 teaches a parental drink for relieving joint chronic strain comprising B- hydroxy-B methylbutyric acid calcium, see example 8 of Machine Translation, previously provided.
Moreover, The Background of the invention admits that joint injury recovery can be treated indirectly by strengthening and preserving the surrounding muscles:
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See published application US 20210077439
In this way, those of ordinary skill could have applied the HMB compositions taught by the primary references in a predictable fashion for the purposes of improving joint health. Specifically, the references teach that the particular known technique of improving muscle health with HMB was within the ordinary capabilities of those of ordinary skill. Since the references and Applicant’s Admission also demonstrate that muscle and joint health are recognized as invariably interconnected, those of ordinary skill would have recognized that applying the known technique would have yielded a reasonable expectation of improving joint health. Accordingly, applying HMB compositions for improving joint health would have been prima facie obvious.
Applicant argues that, while it has long been known that HMB increases strength and muscle mass, improvements in these areas do not necessarily correspond to effects on joint health. The literature contains many examples of this, including the Magni reference and the Bartholdy reference which show increases in muscle strength without improvements in joint health. Further, the Beschoft paper also shows an increase in muscle mass and muscle strength but no improvement in physical function. Thus, Applicant's results showing an improvement in joint health when using a supplement that affects muscle strength and muscle mass was surprising an unexpected and surprising result. One of skill in the art would not expect use of HMB to affect joint health in view of the data demonstrating that increases in muscle strength and mass do not correspond to improvements in joint health. This is an unexpected and surprising result that must be weighted in the obviousness analysis.However, the references teach a decline in muscle function can have a number of adverse effects on an individual including a lessening of joint mobility and that increasing muscle mass can be achieved by administering HMB. In this manner, the references provide a reason to administer HMB to those with joint instability and injury. Any other observed effects, such as those mentioned by applicant, or recited in the claims, would have been an invariable aspect of this administration.
However, Applicant's results showing an improvement in joint health when using a supplement that affects muscle strength and muscle mass is not surprising and unexpected. Namely, the Background of the invention admits that joint injury recovery can be treated indirectly by strengthening and preserving the surrounding muscles, which acts as a natural brace to offload stress from damaged cartilage or ligaments.
Therefore, Beta-hydroxy-beta-methylbutyrate (HMB) supports joint injury recovery indirectly by building and preserving the muscles rather than healing the joint cartilage or ligaments directly. Therefore, the prior art provides ample reason to provide HMB to patients with joint inflammation, damage or injury.
Any observed result of this administration, such as increase muscle mass in the limb contralateral to the effected joint to a degree greater than any change in muscle mass in the limb ipsilateral to the affected joint, thereby improving neuromuscular balance and joint stability, is an invariable aspect of HMB administration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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