Refusal of application for a European Union trade mark

(Article 7 EUTMR and Rule 11(3) EUTMIR)

Alicante, 31/03/2017

Novo Nordisk A/S

Att: Corporate Trademarks

Novo Allé

DK-2880 Bagsværd

DINAMARCA

Application No:	016127607
Your reference:	12726/EM/AXJH
Trade mark:	Redefiniendo la Obesidad
Mark type:	Word mark
Applicant:	Novo Nordisk A/S Novo Allé DK-2880 Bagsværd DINAMARCA

The Office raised an objection on 13/12/2017 pursuant to Article 7(1)(b) EUTMR and Article 7(2) EUTMR because it found that the trade mark applied for is devoid of any distinctive character, for the reasons set out in the attached letter.

Together with a request for continuation of proceedings, the applicant submitted its observations on 03/03/2017, which may be summarised as follows:

1. The mark is not devoid of distinctive character. The mark is nearly identical to the applicant’s two previously registered marks ‘RETHINK OBESITY’ and ‘REPLATEANDO LA OBESIDAD’.

The request for continuation of proceedings has been accepted.

Pursuant to Article 75 EUTMR, it is up to the Office to take a decision based on reasons or evidence on which the applicant has had an opportunity to present its comments.

After giving due consideration to the applicant’s arguments, the Office has decided to maintain the objection.

Under Article 7(1)(b) EUTMR, ‘trade marks which are devoid of any distinctive character’ are not to be registered.

It is settled case-law that each of the grounds for refusal to register listed in Article 7(1) EUTMR is independent and requires separate examination. Moreover, it is appropriate to interpret those grounds for refusal in the light of the general interest underlying each of them. The general interest to be taken into consideration must reflect different considerations according to the ground for refusal in question (16/09/2004, C‑329/02 P, SAT/2, EU:C:2004:532, § 25).

The marks referred to in Article 7(1)(b) EUTMR are, in particular, those that do not enable the relevant public ‘to repeat the experience of a purchase, if it proves to be positive, or to avoid it, if it proves to be negative, on the occasion of a subsequent acquisition of the goods or services concerned’ (27/02/2002, T‑79/00, Lite, EU:T:2002:42, § 26).

The applicant supports its claim, that the mark has distinctive character, in the fact that the Office previously has accepted two of the applicant’s nearly identical marks, namely ‘RETHINK OBESITY’ and ‘REPLANTEANDO LA OBESIDAD’ (‘Rethink obesity’ in Spanish).

According to settled case‑law, ‘decisions concerning registration of a sign as a European Union trade mark … are adopted in the exercise of circumscribed powers and are not a matter of discretion’. Accordingly, the registrability of a sign as a European Union trade mark must be assessed solely on the basis of the EUTMR, as interpreted by the Union judicature, and not on the basis of previous Office practice (15/09/2005, C‑37/03 P, BioID, EU:C:2005:547, § 47; and 09/10/2002, T‑36/01, Glass pattern, EU:T:2002:245, § 35).

‘It is clear from the case-law of the Court of Justice that observance of the principle of equal treatment must be reconciled with observance of the principle of legality according to which no person may rely, in support of his claim, on unlawful acts committed in favour of another’ (27/02/2002, T‑106/00, Streamserve, EU:T:2002:43, § 67).

The Office withholds that the mark is devoid of distinctive character. The relevant consumers would not perceive the mark ‘Redefiniendo la Obesidad’’ as an indication of commercial origin, but as reference to a scientific concept, namely redefining obesity.

In the medical literature ‘redefining obesity’ refers to shifting the emphasis from the body mass index (BMI) to excess weight. The method of defining obesity based on BMI has been criticised as having various deficiencies, for example, because it does not take age, gender, bone- and muscle mass into account¹. The development of diabetes, in particular, diabetes 2², and related diseases and disorders are correlated with obesity³. Considering obesity in a new way will help health practitioners improve prevention and treat diseases related to or caused by obesity⁴.

The relevant consumer would perceive the term ‘Redefiniendo la Obesidad’ as a new way of considering obesity, for example, a new way of measuring or determining when people are considered to be obese. In relation to the applicant´s services, the mark informs the relevant consumers that the medical information provided on pharmaceutical preparations for prevention and treatment of diabetes and diabetes related to diseases and disorders are based on another definition of obesity, than the traditional and most commonly used method, namely the determination of obesity based on body mass index (BMI). In other words, that the medical information provided by the applicant on pharmaceutical products is more specific to the individual needs of patients, because the pharmaceutical product for prevention or treatment of, for example, diabetes in relation to obesity, can be suggested based on a more accurate estimation of excess body fat.

In addition, the fact that the term ‘redefine obesity’ is a commonly used expression in the medical literature also supports, at least, that the specialised public would be familiar with the term. As ‘Redefiniendo la obesidad’ is a direct translation of the English term, the specialised Spanish consumers would also without further thought understand the meaning.

In conclusion, the Office maintains that the mark ‘Redefiniendo la obesidad’ is devoid of distinctive character.

For the abovementioned reasons, and pursuant to Article 7(1)(b) and (c) EUTMR and Article 7(2) EUTMR, the application for European Union trade mark No 16 127 607 is hereby rejected for all the services claimed.

According to Article 59 EUTMR, you have a right to appeal against this decision. According to Article 60 EUTMR, notice of appeal must be filed in writing at the Office within two months of the date of notification of this decision. It must be filed in the language of the proceedings in which the decision subject to appeal was taken. Furthermore, a written statement of the grounds of appeal must be filed within four months of the same date. The notice of appeal will be deemed to be filed only when the appeal fee of EUR 720 has been paid.

Anja Pernille LIGUNA

Annex I

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4672357/

Nutr Diabetes . 2015 Nov; 5(11): e186.

Published online 2015 Nov 30. doi:  10.1038/nutd.2015.36

PMCID: PMC4672357

The need to redefine age- and gender-specific overweight and obese body mass index cutoff points

Abstract

For convenience, health practitioners and clinicians are inclined to classify people/patients as overweight or obese based on body mass index (BMI) cutoff points of 25 and 30 kg m⁻² respectively, irrespective of age and gender. The purpose of the current study was to identity whether, for the same levels of adiposity, BMI is the same across different age groups and gender. A two-way ANCOVA revealed significant differences in BMI between different age groups and gender (plus an interaction), using body fat (%) as the covariate, data taken from a random sample of the English population (n=2993). Younger people had greater BMI than older people for the same levels of adiposity (differences ranged by 4 BMI units for males, and 3 BMI units for females). In conclusion, if BMI thresholds for overweight (BMI=25 kg m⁻²) and obese (BMI=30 kg m⁻²) are to reflect the same levels of adiposity across all gender and age groups within a population, then age- and gender-specific BMI adjustments outlined here are necessary to more accurately/fairly reflect the same critical levels of adiposity.

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Introduction

Body mass index (BMI) is undoubtedly the most frequently used proxy of adiposity/obesity in large epidemiological studies in both healthy and diseased populations. Despite its wide use, which pertains to convenience since it only requires the measurement of height and mass, BMI has been frequently criticised as having various deficiencies as a measure of obesity¹ both for healthy and diseased populations.^{2 , 3}

One of the major issues with BMI is that it does not reflect the changes in body composition that occur with age, in particular the presence of sarcopaenia, which is characterised by reduced muscle mass and increased adiposity. As such the utilisation of BMI in evidence-based approaches relevant to dietary interventions and/or clinical decision making needs to be reconsidered and where appropriate, readjusted. Therefore, the aim of the present study was to investigate the cutoff points of BMI in relation to adiposity in a large cohort of participants in order to validate if the established cutoff points accurately reflect adiposity.

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Patients and methods

The current data, used to explore the association between BMI (kg m⁻²) and body fat percentage (BF%), has been previously published⁴ although originally obtained from the Allied Dunbar National Fitness Survey (ADNFS) (1992). The ADNFS recruited 4316 randomly selected healthy participants, aged 16 years and over, from thirty English parliamentary constituencies. A sub-sample took part in a physical appraisal yielding BMI and estimates of BF% data for 2993 healthy people (male n=1420; female n=1573). Estimates of BF%, taken for the ADNFS, were determined using the methods based on skin fold thicknesses at four sites; the biceps, triceps, sub-scapular and supra-iliac.⁵

Statistical methods

In order to detect any systematic differences in gender and age groups (16–29, 30–39, 40–49, 50–59, 60–69, 70–79, 80+, age in years) holding BF% constant, a two-way (gender-by-age group) analysis of covariance (ANCOVA) was employed using BF% as the covariate. Finally, we have used Bonferroni multiple comparisons to investigate BMI differences amongst the different age groups. The level of significance was set at P<0.05 and all the analyses were conducted with the Statistical Package for the Social Sciences (SPSS) version 20.

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Results

The relationship between BMI and BF% was found to be approximately linear. The ANCOVA revealed significant main effects of age group (P<0.001) and gender (P<0.001), and a significant age group-by-gender interaction (P<0.001) together with a significant covariate of BF% with the BMI slope parameter B=0.570 (s.e.=0.010) per unit BF%, means (±s.e.) given in Figure 1 . The group-by-gender interaction was due to a greater difference in BMI between the younger and older males compared with the difference in BMI observed in females.

Figure 1

Mean (±s.e) BMI by age group and by gender holding BF% constant, all BMIs evaluated at BF%=29.49%.

The median age of the sample was 45 years. As such, taking the ‘anchored' baseline group as the 40- to 49-year-old group, and assuming the overweight and obese threshold for these groups are BMI=25 and 30 kg m⁻², respectively, we estimated the BMI of all other age groups and by gender, based on the differences observed in Figure 1 . Anchoring the overweight threshold BMI value=25 kg m⁻² for the 40–49 years age group, all other age group and gender differences are estimated in Table 1 (BMI means (rounded to a whole BMI unit number) estimated for the same BF%=25.3 and 34.8 for all male and female participants, respectively). Similarly anchoring the obese threshold BMI value=30 kg m⁻² for the 40–49 years age group, all other age group and gender differences are estimated in Table 1 (BMI means (rounded) estimated for the same BF%=34.1 and 43.5 for all male and female participants, respectively).

Table 1

Redefined overweight and obese BMI thresholds (rounded) for different gender and age groups

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Discussion

For the same level of adiposity (using BF%), systematic differences in BMI were found in different gender and age groups from a randomly selected national sample (male n=1420; female n=1573) taken from 30 English parliamentary constituencies (Figure 1 ). On the basis of these differences, the BMI means (rounded), calculated and reported in Table 1 suggest that younger males and, to a lesser extent female participants have significantly higher levels of BMI compared with their older counterparts, for the same levels of adiposity (BF%). This is unsurprising given that younger males are likely to be more active than younger females and that physical activity will naturally decline in both genders in older people. This trend is well documented with ageing,⁶ in particular the presence of sarcopaenia that is characterised by reduced muscle mass and increased adiposity, the latter being the result of lower energy expenditure.

Although this trend is well known amongst health practitioners, most still persist in prescribing common BMI thresholds for being overweight (BMI=25 kg m⁻²) and obese (BMI=30 kg m⁻²) irrespective of the individuals age and gender. Our findings suggest an alternative strategy should be considered. Given that younger males will have a higher percentage of muscle mass than a 40- to 49-year-old male, their BMI obesity threshold could be raised to a less restrictive 33 kg m⁻² (as per our relevant calculations in Table 1 ) to equate to the same level of adiposity as their older 40- to 49-year-old counterparts. A similar recommendation can be made for younger females, that is, their BMI obesity threshold could be raised to 32 kg m⁻² (see Table 1 for newly developed cutoff points) to equate to the same level of adiposity as a 40- to 49-year-old female. In contrast, the BMI obesity threshold for both male and female 50- to 59-year-old participants could be reduced to a more restrictive/conservative level. For these older age groups, we would recommend that such participants are regarded as obese once their BMI exceeds 29 rather than 30 kg m⁻² (to equate with the same level of adiposity associated with 40- to 49-year-old subjects). Similar adjustments would be required for the overweight thresholds for the various gender and age groups outlined in Table 1 .

In conclusion, if BMI thresholds for overweight and obese participants are to reflect similar levels of adiposity across all gender and age groups within a population, then age- and gender-specific BMI adjustments outlined in Table 1 are necessary to more accurately and fairly reflect the same levels of adiposity.

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Notes

The author declare no conflict of interest.

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References

1. 1Rothman KJ. BMI-related errors in the measurement of obesity. Int J Obes (Lond) 2008; 32(Suppl 3): S56–S59. [PubMed ]

2. 2Nevill AM, Stavropoulos-Kalinoglou A, Metsios GS, Koutedakis Y, Holder RL, Kitas GD et al. Inverted BMI rather than BMI is a better proxy for percentage of body fat. Ann Hum Biol 2011; 38: 681–684. [PubMed ]

3. 3Stavropoulos-Kalinoglou A, Metsios GS, Yiannis Koutedakis Y, Nevill AM, Douglas KM, Jamurtas A et al. Redefining overweight and obesity in rheumatoid arthritis patients. Ann Rheum Dis 2007; 66: 1316–1321. [PMC free article ] [PubMed ]

4. 4Nevill AM, Holder RL. Body mass index: a measure of fatness or leanness? Br J Nutr 1995; 73: 507–516. [PubMed ]

5. 5Durnin JV, Womersley J. Body fat assessed from total body density and its estimation from skinfold thickness: measurements on 481 men and women aged from 16 to 72 years. Br J Nutr 1974; 32: 77–97. [PubMed ]

6. 6Fragala MS, Kenny AM, Kuchel GA. Muscle quality in aging: a multi-dimensional approach to muscle functioning with applications for treatment. Sports Med 2015; 45: 641–658. [PubMed ]

Annex II

http://www.medscape.com/viewarticle/873874#vp_2

Adiposity-Based Chronic Disease: A New Name for Obesity?

Becky McCall

December 29, 2016

In a new position statement, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) introduced a novel term for obesity — adiposity-based chronic disease (ABCD) — which frames it as a far-reaching, complications-centric chronic disease.

The statement, published online December 14 in Endocrine Practice, redefines the medical diagnostic term for obesity and shifts the emphasis to the pathophysiological effects of excess weight rather than the weight and/or body mass index (BMI) itself.

The "adiposity-based" component of ABCD points to abnormalities in the mass, distribution, and/or function of adipose tissue, whereas the "chronic disease" part underscores associated complications such as hypertension, diabetes, and sleep apnea that produce morbidity and mortality.

The authors, led by Jeffrey I Mechanick, MD, president of the ACE and clinical professor of medicine at Icahn School of Medicine at Mount Sinai, New York City, argue that ABCD represents a structured approach to reducing disease risk and illness burden through improved nutrition, increased levels of physical activity, and behavioral interventions.

"It allows a more robust ability for diagnostics based not only on weight and height and waist circumference, but also body imaging and molecular biology," Dr Mechanick told Medscape Medical News.

The term ABCD grew out of the 2014 AACE/ACE Consensus Conference on Obesity, where participants from biomedicine, government agencies, the health industry, and professional organizations acknowledged a disconnection between use of the term obesity in relation to the health of individuals.

Also, the stigma associated with the term was recognized as a barrier to successful disease management.

Challenging the Status Quo

In an interview with Medscape Medical News, Dr Mechanick emphasized that the new statement challenges the status quo and explained that although prevalence of overweight/obesity is reaching a plateau in the general US population, prevalence is continuing to rise in certain subgroups, including those with severe obesity, children, and minority groups.

"We're not bending the curve as well as we'd like to, so we need to change the health messaging of this disease," he said. He notes that, despite advances in disease understanding, medications, surgery, and awareness of lifestyle medicine, "we are missing the right messaging and communications around obesity, including the stigma attached to it."

Dr Mechanick said that the term ABCD is not set to replace the term obesity. He said that valuable traction had been gained with the term obesity, so it would be wrong to displace it. "Rather, we are introducing it as a new diagnostic term so the medical community can familiarize with the term and reconceptualize this chronic disease within the ABCD paradigm."

Ultimately, the aim is to improve care for people with obesity. "We believe that when this disease is viewed through the lens of ABCD, it will become clearer and we'll be able to help more people," he said. The position statement is also aimed at shifting the physician–patient dialogue toward the need to prevent downstream complications and problems as a result of adipose tissue problems.

Importantly, lifestyle medicine lies at the core of the new paradigm. "Physical activity, eating patterns, sleep, behavior, all the nonpharmacologic and nonsurgical means of disease management, are central," Dr Mechanick pointed out.

He also stressed that taking the ABCD approach to disease management addresses prevention on various levels. "We know this paradigm is part of primary, secondary, and tertiary prevention, but also primordial prevention, which is population-based when risk has not been identified. It also works at the quaternary prevention level that prevents overmedicalization of disease, where treatments and surgeries can represent unnecessary risk if not absolutely necessary. In this situation, lifestyle measures can prevent this overtreatment and associated iatrogenic complications."

ABCD and ICD-10 Coding

The authors write that the AACE/ACE also endorses a "continued, concerted, and vigorous effort regarding health policy and the legislative agenda pertaining to reimbursement for structured lifestyle medicine and indeed all evidence-based therapeutic modalities for patients with ABCD."

Regarding International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) coding, Dr Mechanick said, "we would envisage different ICD codes for adiposity-related complications."

The authors add that the AACE/ACE will "spearhead clear definition and positioning of ABCD in the human disease ontology database and then creation of relevant complication-based ICD-10 coding to facilitate [healthcare professionals] reimbursements, routine implementation, and realizable quality metrics."

Further, Dr Mechanick pointed out that it would be necessary to develop the technology to better establish normative data, including further research on specific tools to quantify abnormalities in adiposity mass, distribution, and function.

However, a major challenge to using the ABCD term, according to the authors, is identification of appropriate, available, and affordable markers/metrics reflecting the effect of adiposity on health. They highlight that BMI still plays an important role but that, "to combat this prevalent, chronic, and injurious disease, [healthcare professionals] will need to incorporate a conceptual approach to management that goes beyond a singular focus on BMI. The adoption of the new ABCD diagnostic term is a clear step forward."

Dr Mechanick has received honoraria for program development by Abbott Nutrition International and honoraria for lectures from the NCD Pre-Disease Forum. Disclosures for the coauthors are listed in the article.

For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

Endocr Pract. Published online December 14, 2016. Article

Annex III

http://www.livestrong.com/article/331890-bmi-index-according-to-bone-structure/

BMI Index According to Bone Structure

by LINDA RAY Last Updated: Nov 08, 2015

BMI, or body mass index, is a measurement used to determine your level of fat in the context of your weight and height. The numbers often are used to determine whether you are obese or overweight. The measure of your body fat is based on your weight and height and does not include bone structure, which can skew the results.

Disparities

BMI calculations often list big-boned or muscular individuals as obese, notes the Harvard School of Public Health. Bone and muscle are denser than fat, making people with denser bones and more muscles weigh more. An athlete with high bone density and developed muscles may have a high body mass index but still not be overweight or obese.

Considerations

A BMI calculation that takes into account your bone and muscle development is most accurate when you're in your 20s. According to the Harvard School of Public Health, adults over 30 rarely add significant bone and muscle weight. Weight gain after age 30 most often is due to fat and is reflected most accurately by the BMI charts that rely on your current weight and height.

Measurements for Children

Because the standard body mass index tests do not take into account the bone development of growing children, a better way to measure fat on a child is through neck measurements, according to a study published in "Pediatrics." Relying on the BMI, pediatricians then must take into account the bone structure of the child to make an accurate assessment of childhood obesity. Neck size measurements also are easy to take and compare with the average neck size of children who are the same age. Neck measurements rely on bone structure and fat to best determine and predict a healthy growth weight for your child.

Perspective

The body mass index should be considered when looking at your overall health and taken into proper perspective. BMI calculators are widely available online, but if you'd prefer to do the calculation yourself, divide your weight by the number of inches that make up your height. Take that final number and multiply it by 703. The resulting number is your body mass index. Ranges for obesity allow you to consider your bone structure and muscle development. A BMI between 18.5 and 24.9 reflects a normal weight.

Guidelines

Using the numbers as a guide, you should take into consideration your age as well as your bone structure, because your bones becomes less dense and muscles tend to atrophy as you age. Keep in mind that BMI may underestimate your body fat levels if you are over 50 and may overestimate your body fat composition if you are athletic and muscular.

Annex IV

https://www.researchgate.net/publication/11258865_Redefining_Type_2_diabetes_'Diabesity'_or_'Obesity_Dependent_Diabetes_Mellitus '